Pharmacy and The US Health Care System 4th PDF

Pharmacy and the US Health Care System
Fourth Edition
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Pharmaceutical Press is the publishing division of the Royal Pharmaceutical Society
Pharmacy and the

US Health
Care System
FOURTH EDITION
Editors
Michael Ira Smith
PhD
President
MIS Pharmaceutical Consultants, Scottsdale, AZ, USA
Albert I. Wertheimer
PhD, MBA
Professor of Pharmacy
Department of Pharmacy Practice
Temple University School of Pharmacy, Philadelphia, PA, USA
Jack E. Fincham
PhD, RPh
Professor
Division of Pharmacy Practice and Administration
The University of Missouri Kansas City School of Pharmacy, Kansas City, MO, USA
Published by Pharmaceutical Press

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c Royal Pharmaceutical Society of Great Britain 2013

is a trade mark of Pharmaceutical Press
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ISBN 978 0 85711 022 0
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The publisher makes no representation, express or implied,
with regard to the accuracy of the information contained in this book
and cannot accept any legal responsibility or liability for any errors or
omissions that may be made.
A catalogue record for this book is available from the British Library.
Dedication
MIS: To Rita, Neil, Bethany, Mason and Aiden
AIW: To Joaquima, Lia, Debbie and Andrew
JEF: To Melinda, Derek and Joni, and Kelcie for making it all possible
Contents
Foreword
Contributors
1
Health and health care in the United States

David M. Scott, MPH, PhD
xiii
xvii
1
Health and disease

Historical evolution of health services
The private health care sector
The public health care system
Health care: right or privilege?
Conclusion
References and further reading
1
5
9
12
17
19
19
Financing US health care

Leanne Lai, PhD
21
Health care financing

Funding sources of health care financing
Challenges for US health care financing
Conclusions
21
21
31
33
33
Managed care pharmacy

Judith A. Cahill, CBES
35
What is managed care?

Managed care pharmacy tools
Roles pharmacists play in managed care settings
Bibliography
35
38
48
52
52
The health professions

Albert I. Wertheimer, Jr., PhD, MBA
53
Prescribing authority
Health manpower
Physicians
54
57
59
viii
Contents
Pharmacy personnel and practice site

Pharmacy issues and trends
Appendix 4.1
Appendix 4.2
Appendix 4.3
Appendix 4.4
Bibliography
60
64
66
68
72
73
73
74
Pharmacists and US health care

Yifei Liu, BSPharm, PhD
75
The workforce of pharmacists in the United States

Conclusions
76
90
91
Pharmacy organizations
Joseph Thomas III, PhD
95
Role of pharmacy organizations

Historical development of pharmacy organizations
Specific pharmacy organizations
Current issues for pharmacy organizations
Individual decisions regarding organizations
Web sites for organizations discussed in this chapter
National practitioner organizations
Fraternal, leadership and honorary societies
National trade organizations
Education, regulatory, and foundation organizations
95
99
99
110
111
112
112
112
113
113
113
Emerging roles
Richard J. Bertin, PhD, RPh
115
Advanced practice credentialing

Collaborative drug therapy management
Other emerging practice models
Conclusion
Bibliography
116
122
124
125
126
Political realities of pharmacy

Robert I. Field, MPH, JD, PhD
127
Growth of pharmaceutical use and spending: prelude to intensifying

political conflict
128
Contents
ix
Regulation, patents and politics

Insurance for prescriptions
Pharmaceutical industry research and marketing
Medicare coverage
The role of pharmacists
The next political realities: genetics and personalized medicine
Looking ahead
130
135
138
141
143
144
146
147
Hospital and health care institutions

Sherilyn J. VanOsdol, PharmD, BCPS, and
Charles E. Daniels, BSPharm, PhD
153
History of hospitals in the United States

Scope of the US health care system
Focus on patient safety
Future challenges facing hospitals
Conclusion
Bibliography
153
156
173
175
176
176
178
10 Pharmacist role in long-term care

Richard G. Stefanacci, DO, MPH, and
Thomas R. Clark, RPh, MHS, CGP
179
The growing population of older adults

Demand for health care services
Medicare Parts A, B, C, and D in long-term care
Health care reform
Special considerations in the provision of health care to older adults
Long-term care
Nursing facilities
The role of the geriatric pharmacist in other long-term care settings
Conclusion
Online resources
11 The research manufacturing pharmaceutical industry

Jean Paul Gagnon, BS, PhD
Economic impact
US pharmaceutical industry state of affairs
Future outlook for the US pharmaceutical industry
179
181
182
183
184
189
190
199
207
208
214
215
215
217
221
225
Contents
12 Drug distribution
Sheryl L. Szeinbach, PhD, MS, BSPharm, and
Earlene Lipowski, PhD, BSPharm
Distribution and marketing strategy
Pharmaceutical trends
Pharmaceutical manufacturers
Health care distributors in the United States
Contributions of the distributor industry
Packaging
Distribution in large community pharmacies
Other distribution channels
Availability and distribution of generic drugs
Other trends in distribution
Achieving operational efficiency through automation
Specialty pharmaceuticals
Conclusion
13 The consumers of health care

Somnath Pal, BS(Pharm), MS, MBA, PhD,
Damary Castanheira Torres, BS, PharmD, BCOP, and
Maria Marzella Mantione, BS, PharmD, CGP
The definition of the health care consumer
Why the shift toward consumerism?
Where do consumers most often get their health information?
Changing demographics of health care consumers
Behavioral models in the patientpractitioner relationship
Health, illness, and sick-role behavior
Diversity in the US consumer
Conclusion
14 The drug use process

Jack E. Fincham, PhD, RPh
Drug use in the health care system
Self-care
Patient compliance
Drug use by the elderly
The epidemic of prescribed drug abuse
Health care reform and the drug use process
227
228
228
229
230
232
233
235
236
238
239
239
240
242
242
245
246
247
250
251
255
265
272
278
278
283
285
285
287
291
293
293
Contents
Summary
15 Patient safety and pharmacovigilance

Stephen F. Eckel, PharmD, MHA, BCPS,
Alexander T. Jenkins, PharmD, MS, and Kayla Hansen, PharmD, MS
Overview of pharmacovigilance and medication error reporting
Regulatory approval process and post-marketing surveillance
Risk evaluation and mitigation strategies
Conclusions
xi
294
294
297
298
298
303
312
313
16 Provisions of care to subpopulations: a cultural perspective

Eucharia E. Nnadi, RPh, JD, PhD, and
Tracy E. Okolo, RPh, BSN, PharmD, BCPS
317
Minorities: diversity in the health care field

Culture, race, ethnicity, and health care
Cultural sensitivity
Epidemiology, ethnic variations and access to care
Ethnic and racial difference in treatment outcome variations
Cultural influences and use of health care and pharmaceutical services
Culture and treatment compliance
Conclusion
325
341
341
344
345
346
351
353
354
17 Professionalism and ethics

Dean L. Arneson, PhD
Pharmacy code of ethics
List, explain and give examples of ethical theories
List, define and give examples of ethical principles
Distinguish the difference between virtues, values, morals and rights
List and explain a decision process for determining solutions to ethical
dilemmas
Discuss ethical dilemmas in process of providing patient care
What is professionalism?
List and discuss the characteristics of professionalism
Discuss the concept of professionalism
What is caring?
Conclusion
Bibliography
359
362
368
370
373
374
375
377
380
381
382
382
382
383
xii
Contents
18 Health information technology: emerging challenges for

pharmacy
Mark Brueckl, RPh, MBA, Norrie Thomas, PhD, MS, RPh, and
Abigail Stoddard, PharmD, MBA
385
Key health IT concepts

HIT drivers
Key hit events and legislation
Future challenges: interoperability, HIT standards, and HIT
organizations
Implications for pharmacists
Research
The future of HIT
Questions for study
386
388
390
396
19 Unresolved issues in pharmacy: imagining the future

William A. Zellmer, BS (Pharmacy), MPH
413
Transformation: letting go of old dreams

Diffusion: steps toward the future
Imagination: measuring progress
Summary
Conclusion
20 The future
Eleanor L. Olvey, PharmD, PhD, and J. Lyle Bootman, PhD, ScD
Providing, demonstrating, and paying for value
Population dynamics
Technology
Education
Conclusion
Index
401
403
405
405
409
413
415
418
423
423
423
425
426
432
433
435
436
437
441
Foreword
This is the fourth edition of this book, first published in 1991. Much has
changed in pharmacy and in health care in the United States even since
the third edition was published in 2004. In 2009 major health care reform
began with the passage of the Patient Protection and Affordable Care Act.
This act, while not perfect, begins to recognize prevention and the services of
pharmacists as important ways to manage health care costs. At this writing,
the paint on the canvas of regulations is not dry.
Notably, the debate over health care reform spurred a new era of collaboration among the national and state pharmacy associationsthe Ns
(National Associations of. . . ) and As (American Associations of. . . ) of
pharmacy. This collaboration continues in the form of the Joint Council of
Pharmacy Practitioners (JCPP) and numerous formal and informal collaborative initiatives, all designed to enhance consumer access to high-quality
pharmacist services. The old complaint that I wish the pharmacy organizations could work together is simply not relevant today, and every pharmacist
should be proud of that.
The pharmacist shortage of a few years ago has been replaced with an
embarrassment of riches in the form of existing school expansion and
new school openings during a time when fewer pharmacists are retiring and
many mid-career part-timers are going back to full-time work. Soon our
nations approximately 120+ pharmacy schools will be graduating 14,000
new practitioners annually, and these highly trained and motivated pharmacists will provide patient carethe kind of care being pursued through the
collaborative efforts described above. This is relevant because our health care
system is challenged to keep up with the demand for primary care services,
at least as they are currently available in the mainstream. If we do this right,
the bolus of well-trained pharmacists will establish new roles in primary care
and other areas to meet our nations need for chronic disease management.
Pharmacy is gearing up to meet the demand! Independent and chain
community pharmacy organizations are investing heavily in systems to accommodate and document patient care services. Many have seen the writing
on the wall that buy low/sell high is not going to work much longer as
a business model, and the forward thinking organizations are investing in
pharmacist and technician training. Today, through APhAs immunization
Certificate Training Program, over 175,000 pharmacists (including me) have
been trained to immunize. No one would argue that the public health
xiv
Foreword
demand for improved access to immunizations has been largely met; nor is it
a stretch to say that consumers view of pharmacists as caregivers has been
greatly enhanced by the millions of vaccines administered by pharmacists
during last seasons H1N1 flu pandemic.
Meanwhile, over 450,000 pharmacy technicians have been certified by
the Pharmacy Technician Certification Board (PTCB), established in the
mid-1990s. These technicians support pharmacists in their patient care and
drug distribution responsibilities. PTCB is now exploring new areas of certification for technicians, such as specialty or advanced practice.
The US Surgeon General recently published a report, Improving patient
and health system outcomes through advanced pharmacy practice1 that describes the positive impact of pharmacists in the Public Health Service and the
benefits of their principles for collaborative practice that could be adopted
in the private sector. The pharmacy profession is not at a crossroads today,
as weve read for generations. Rather, we are at a major inflection point,
with clear direction in a rising curve of innovation and new role adoption.
New medications, services, systems, and technology are carrying health care
solutions inexorably closer to the consumer. While there is a human tendency
to seek a comfortable steady state, the winners will not resist these changes
but instead will embrace, harness, and optimize their uses. Change has one
constant characteristic: acceleration. Robotics, new audio, video, and social
media communication technologies will empower consumers in ways that
have not yet been imagined. But the dreamers, entrepreneurs, and change
agents are hard at work on the next disruptive solution to old problems of
access, quality, and cost of health care.
The most valuable form of communication is face-to-face. The next
most valuable is by phone or videoconference. . . . The least valuable forms
of communication are e-mail and texting.2
While face-to-face may have clear advantages as a communication
method, there are hundreds, if not thousands, of pharmacists communicating with patients telephonically, electronically, or via video conference,
and this trend will accelerate. Many pharmacies and pharmacists work
in collaboration with physicians, nurses, and physician assistants to better
manage medication use. These pharmacists have created numerous ways to
accomplish this, from working as employees of physician group practices or
health systems, to establishing themselves as solo practitioners, to working on
a contract basis at a community pharmacy. Some pharmacies offer primary
care services, with various practitioners working in the same location as the
dispensing pharmacy, and are changing practice models to deliver highly
enhanced medication therapy management services.
Some health systems have achieved integrated electronic health records
(EHR), and the more advanced ones have integrated pharmacist documentation, in addition to medication dispensing records, into these records,
thus achieving functional use of the EHR by the pharmacist. Organized
pharmacys collaboration to promote functional use is a great example of the
high level of collaboration noted above. These new technologies and practice
Foreword
xv
models should be viewed not as endpoints but rather as part of a continuum

of change that will go on indefinitely.
The JCPP 2015 Vision for Pharmacy Practice calls for autonomy, authority, accountability and outcomes. Authors who describe disruptive innovation describe the need for measurability and predictability. In 2009 we
began exploring the pros and cons of community pharmacy standards and an
accreditation process. In 2011 the APhA House of Delegates passed a policy
that called for our leadership in the development of standards. To that end,
and in collaboration with the National Association of Boards of Pharmacy,
we have formed the Center for Pharmacy Practice Accreditation, with the
expressed goal of creating consensus-based, profession-developed standards
that payers will value as an important step in achieving our mission and the
needs of payers for measurability and predictability. Perhaps the 5th edition
of this book will describe the professions successful implementation of those
standards and the resultant enhanced patient care.
In the 2004 edition of this book, my predecessor, John Gans, wrote
in the foreword, Today, the successful pharmacist must know more than
therapeutics, understanding the environment in which pharmacy is practiced,
and the forces at work both within and outside the profession that are critical
to being successful. This book is the single place where one can gain the data
and the perspective on the forces that are currently affecting the profession.
In addition, it can also give the pharmacist a perspective on the forces facing
other professions. These words are still true today.
My predecessor also wrote about pharmacys tendency to work in isolation. This, however, is far less true today, as we are breaking down those
barriers with compelling public health contributions and a collaborative
spirit that can stand up to the harshest critics.
Our star is rising! I hope youll use this book to stimulate your own
journey to new heights. Dont be afraid to take a flying leap. Pharmacists
are blessed with training that gives us a wide range of career options. The
profession needs you to innovate if we are to achieve our full potential in a
system that values our patient care contributions. Our patients are waiting.
References
1. Giberson S, Yoder S, Lee MP. Improving patient and health system outcomes through
advanced pharmacy practice. a report to the U.S. Surgeon General. Office of the Chief
Pharmacist. Rockville, MD: U.S. Public Service, December 2011.
2. Pentland AS. The new science of building great teams. Harvard Bus Rev 2012; April 2012:
65.
Thomas E. Menighan,
Executive Vice President and
Chief Executive Officer
American Pharmacists Association
Washington, DC
Contributors
David M. Scott, MPH, PhD, RPh
Professor, Department of Pharmacy Practice, College of Pharmacy, Nursing,
and Allied Sciences, North Dakota State University.
Leanne Lai, BS(Pharm), PhD
Professor, Department of Sociobehavioral and Administrative Pharmacy,
College of Pharmacy, Nova Southeastern University.
Chief Executive Officer, Academy of Managed Care Pharmacy, Alexandria.
Albert I. Wertheimer, PhD, MBA
Professor, School of Pharmacy, Temple University.
Yifei Liu
Assistant Professor, Division of Pharmacy Practice and Administration, The
University of Missouri Kansas City School of Pharmacy.
Professor, College of Pharmacy, Purdue University, West Lafayette, IN.
Richard J. Bertin, PhD
Certification and Accreditation Consulting, Brookeville.
Robert I. Field, JD, MPH, PhD
Professor of Law, Earle Mack School of Law at Drexel University and
Professor of Health Management and Policy, Drexel University School of
Public Health.
Sherilyn J. VanOsdol, PharmD, BCPS
Assistant Professor of Clinical Pharmacy, Department of Clinical Pharmacy,
Medication Outcomes Center, University of California, San Francisco.
Charles E. Daniels, RPh, PhD
Professor of Clinical Pharmacy, Associate Dean, and Pharmacist In Chief,
University of California San Diego.
Director of Clinical Affairs American Society of Consultant Pharmacists/
ASCP Foundation, Alexandria.
xviii
Contributors
Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD

Associate Professor Health Policy, University of the Sciences/Chief Medical
Officier, The Access Group/Chief Clinical Officier, TabSafe Health System.
Jean Paul Gagnon, PhD
Pharmaceutical Policy Consultant, Pittstown, New Jersey.
Sheryl L. Szeinbach, MS, PhD, RPh
Professor, Division of Pharmacy Practice and Administration, Ohio State
University, College of Pharmacy.
Somnath Pal, BS(Pharm), MS, MBA, PhD
Professor of Pharmacy Administration, Department of Pharmacy Administration & Allied Health Sciences, College of Pharmacy & Health Sciences,
St. Johns University, NY.
Jack E. Fincham
University of Missouri Kansas City.
Stephen F. Eckel, PharmD, MHA, BCPS
Assistant Director, Department of Pharmacy, UNC Hospitals, NC and Clinical Assistant Professor, UNC Eshelman School of Pharmacy.
Alexander T. Jenkins, PharmD, MS
Manager, Department of Pharmacy, WakeMed Health & Hospitals, Raleigh,
NC.
Kayla Hansen, PharmD, MS
Clinical Manager, Department of Pharmacy, University of North Carolina
Hospitals, NC.
Eucharia E. Nnadi, RPh, JD, PhD
Vice President for Academic Affairs & Program Planning, Roseman University of Health Sciences.
Dean L. Arneson, PharmD, PhD
Academic Dean, Concordia University Wisconsin, School of Pharmacy.
Norrie Thomas, RPh, MS, PhD
President, Manchester Square Group, Minnesota.
William A. Zellmer, BS Pharm, MPH
President, Pharmacy Foresight Consulting, Bethesda, Maryland.
J. Lyle Bootman, PhD, ScD
Dean, College of Pharmacy, Professor of Pharmacy, Medicine, and Public
Health and Founding Executive Director, Center for Health Outcomes and
Pharmacoeconomic, (HOPE) Research.
1
Health and health care in the
United States
David M. Scott, MPH, PhD
Health and disease
Although the purpose of health care is to promote health, the US health care
system is concerned primarily with the diagnosis and treatment of disease
rather than the promotion of health. The primary focus of a health professionals (e.g., pharmacist, physician) education traditionally has focused on
the pathophysiology of disease and drug treatment, rather than promoting
health. However, this situation is changing. As costs continue to rise, the
health care system has been undergoing increased scrutiny by consumers,
employers, health professional groups, and policy makers.
What is health?
Websters Unabridged Dictionary defines health as physical and mental
well-being, and freedom from defect, pain or disease. The World Health
Organization (WHO) in 1958 defined health as a state of complete physical,
mental and social well-being, and not merely the absence of disease or
infirmity.1 This definition has been criticized as describing an unrealistic,
ideal state. Other definitions of health have emphasized life functioning, such
as that of Banta and Jonas, who defined health as a state of well-being,
of feeling good about oneself, of optimum functioning, or the absence of
disease, and of the control and reduction of both internal and external
risk factors for both disease and negative health conditions.2 Risk factors
include environment, living conditions, and personal habits that increase the
possibility of developing a disease or negative health condition in the future.2
In 1979, the US Public Health Service published Healthy People: The
Surgeon Generals Report on Health Promotion and Disease Prevention.3
The Department of Health and Human Services (DHHS) has published the
framework of this work, Healthy People 2020, which represents the fourth
time they have developed a 10-year healthy lifestyle objective for the United
States.4 This is a valuable asset for pharmacists, physicians, and educators
who seek to improve health care delivery in the United States. The vision
of Healthy People 2020 is a society in which all people live long, healthy
lives, and this resource recognizes that health outcomes are derived from
five determinants: (1) biology and genetics; (2) individual behavior; (3) social
environment; (4) physical environment; and (5) health services. Healthy
People 2020 includes 43 topic areas (Table 1.1), with objectives listed for
each area. The major health focus areas for the nation include physical
activity, nutrition, obesity, tobacco use, substance use, and access to health
services. For instance, two physical fitness objectives to be attained by the
2020 are (1) to increase the proportion of children and adolescents aged
2 years through 12th grade who view television, videos, or play video games
for no more than 2 hours a day and (2) to increase the proportion of adults
who engage in aerobic physical activity of at least moderate intensity for at
least 150 minutes per week. Although some progress has been made to attain
healthy lifestyles, much more remains to be accomplished.
Health problems: impact of public health and lifestyle

The leading causes of death changed significantly between 1900 and 2007
(Table 1.2). In 1900, the leading causes of death, in descending order,
were influenza and pneumonia, tuberculosis, diarrhea, heart disease, senility,
ill-defined or unknown, stroke, renal disease, accidents, cancer, and diphtheria.5 In 2007, the ten leading causes of death, in descending order, were
heart disease, cancer, stroke, chronic lower respiratory diseases, unintentional
or accidental injuries, Alzheimer disease, diabetes, influenza and pneumonia,
renal disease, and septicemia. These ten leading causes of death accounted
for nearly 75 percent of all deaths in the United States.6 Infectious diseases
accounted for five of the ten leading killers in 1900; that number dropped to
three by 2007. Whereas in 1900, communicable diseases led to the majority
of deaths, today they have mostly been replaced by chronic diseases. For
todays top killers, lack of physical activity, poor nutrition, obesity, alcohol
abuse, and tobacco use all represent major risk factors.
US health levels have seen major improvements in since 1900. Between
1900 and 2007, the overall (crude) death rate declined by 50 percent and the
infant mortality rate (IMR) declined by 90 percent. The major contributor
to this decline is the remarkable drop in mortality in younger age groups. In
2007, the IMR was a record low of 6.8 deaths of infants under 1 year of age
per 1000 live births. The IMR for white infants declined to 5.6, while the rate
for black infants declined only to 13.2, which has widened the gap in infant
mortality between the two races.7 About two-thirds of all infant deaths occur
during the neonatal period (first 27 days of life), and the neonatal mortality
Table 1.1 Healthy People 2020 objective areas

Access to health services
HIV
Adolescent health
Immunization and infectious diseases
Arthritis, osteoporosis, and chronic back conditions
Injury and violence prevention
Blood disorders and blood safety
Lesbian, gay, bisexual, and transgender health
Cancer
Maternal, infant, and child health
Chronic kidney disease
Medical product safety
Dementias, including Alzheimer disease
Mental health and mental disorders
Diabetes
Nutrition and weight status
Disability and health
Occupational safety and health
Early and middle childhood
Older adults
Educational and community-based programs
Oral health
Environmental health
Physical activity
Family planning
Preparedness
Food safety
Public health infrastructure
Genomics
Respiratory diseases
Global health
Sexually transmitted diseases
Health communication and health information

technology
Sleep health
Health careassociated infections
Social determinants of health
Health-related quality of life and well-being
Substance abuse
Hearing and other sensory or communication disorders
Tobacco use
Heart disease and stroke
Vision
(Data from U.S. Department of Health and Human Services. Healthy People 2020. http://healthypeople.gov/
2020/topicsobjectives2020/pdfs/HP2020objectives.pdf [accessed December 6, 2012]).
for black infants was 2.4 times greater than that for white infants.7 This
suggests that both pre- and postnatal care, especially for black infants, needs
improvement.
Life expectancy rose from 47.3 years in 1900 to 77.9 years in 2007,
a record high. In 2007, life expectancy was 80.4 years for women and
75.4 years for men. The gender gap reached its peak in the late 1970s,
and has been narrowing since then. This trend may be fueled by factors
such as improvements in smoking, high blood pressure, and obesity. Life
expectancy at birth for the white population is 78.4 years, 4.8 years longer
than that for the black population.8 Lifestyle factors account for some of this
Table 1.2 Leading causes of death in the United States in 1900 and 2007
1900a
2007b
Cause of death
Percent of
all deaths
Cause of death
Percent of
all deaths
Influenza and pneumonia
11.8
Heart disease
25.4
Tuberculosis
11.3
Cancer
23.2
Diarrhea, colitis, enteritis
8.3
Stroke
5.6
Heart disease
8.0
Chronic lower respiratory diseases
5.3
Senility, ill-defined or unknown
6.8
Unintentional injuries (accidents)
5.1
Stroke
6.2
Alzheimer disease
3.1
Renal disease (kidney)
4.7
Diabetes
2.9
Unintentional injuries (accidents)
4.2
Influenza and pneumonia
2.2
Cancer
3.7
Renal disease (kidney)
1.9
Diphtheria
2.3
Septicemia
1.4
All other causes
32.6
All other causes
24.1
a Data from Centers for Disease Control and Prevention. National Office of Vital Statistics. Leading causes of
death, 19001998:67. www.cdc.gov/nchs/data/dvs/lead1900_98.pdf [accessed July 6, 2011].

b Data from Centers for Disease Control and Prevention. National Office of Vital Statistics. www.cdc.gov/
NCHS/data/nvsr/nvsr58/nvsr5819.pdf [accessed July 5, 2011].
difference in life expectancy. However, health care access, quality of care, and
environmental factors also contribute.
The United States reliance on sophisticated technology for the diagnosis
and treatment of disease has overtaken the ability to pay for it. In 1960, about
5 percent of the gross domestic product (GDP) paid for health care services;
in 2009 this figures was estimated at 17.6 percent (note: this represents a
14.9 percent average annual increase from 1993 to 2007).9 Many of the
leading causes of death are preventable, and given the escalating costs of
health care, an economic imperative is to renew interest in health promotion
and disease prevention.
In efforts to improve US health status, Victor Fuchs concluded that the
greatest current potential for improving the health of the American people is
to be found in what they do or dont do for themselves.10 Breslow showed
that life expectancy and better health are significantly related to a number
of simple basic health habits, including (1) three meals a day at regular
times instead of snacking; (2) breakfast every day; (3) moderate exercise
two or three times a week; (4) 7 to 8 hours sleep a night; (5) no smoking;
(6) maintain moderate weight; and (7) no alcohol, or use in moderation.11
Breslows health habits provide the background for Healthy People 2020s
objectives concerning healthy lifestyles. Although these health habits appear

to be common sense, they are not common practice. Some policy-makers
believe the primary barrier to good health is lack of financial access to quality
health care. While the need for quality health care for all Americans is an
important issue, the primary cause of poor health and premature death in the
United States today is the unhealthy lifestyle practices of many Americans.
Health is largely a result of the complex interaction among genetic factors,
environmental factors, lifestyle, and health care.12 The individuals genetic
make-up certainly plays an important role and has been linked to diseases
such as alcoholism and obesity. Environment also plays a key role in determining health and disease. A fertile area for continued research is to investigate the interrelationships between genetic factors and the environment in
producing disease. Risk factors such as diet, pollution, occupational hazards,
and smoking also are related to the genesis of chronic disease.
Most of the improvement in reducing the death rate from infectious disease such as tuberculosis is due not to effective drug therapy, but to improvements in nutrition, water supply, sewage disposal and other hygienic measures. Tuberculosis mortality rates had fallen from approximately 250 per
100,000 in 1890, to 35.6 in 1938.13 However, specific anti-tuberculosis drug
treatment was not in general use until 1938. Mortality from tuberculosis
and other communicable diseases was greatly reduced without effective drug
therapy measures, apparently in response to improvements in nutrition and
hygienic measures.14
In addition to environmental and genetic factors, important social and
psychological factors also have a significant impact on disease and health.
Americas health care system is focused primarily on treating disease rather
than promoting health. The United States spends billions of dollars to prolong the life of elderly citizens near the end of their lives, while spending very
little to promote healthy lives for elderly citizens, as well as the general population. The United States spends enormous amounts of dollars on high-tech
machines to save low-birthweight babies, yet spends very little to reduce the
incidence of low-birthweight babies.2 From a societal standpoint, Americas
economic resources are not providing the most health benefit for the least
cost.
Historical evolution of health services

1850 to 1900
From colonial times, most sick people were treated at home by the family
using medicinal herbs, relying on friends and family for advice, and later by
use of medical guides for lay people. Most physicians were trained under
an apprenticeship system and were also referred to as apothecaries. The
first medical school was established in 1756 at the College of Philadelphia
(later renamed the University of Pennsylvania).15 The role of the apothecary

later evolved into being solely the compounder and dispenser of medications,
and people frequently sought medical advice from the apothecary, as they
do from todays pharmacist. The first college of pharmacy was established
at the Philadelphia College of Pharmacy in 1821. Students were pharmacy
apprentices who worked full-time and attended classes at night.
Acute infectious diseases were the most critical health problems for most
Americans during the period 1850 to 1900.16 Many of these diseases, such as
cholera and tuberculosis, were associated with inadequate sewage disposal,
contaminated water, and impure food. As Boston, New York, Philadelphia,
and other cities developed sewage systems, water purification systems, and
improved standards for milk and food, the prevalence of diseases such as
cholera and tuberculosis declined.
1900 to 1945
The period from 1900 to the conclusion of World War II was an era of rugged
individualism and a pay-as-you-go system for health services. Communicable
disease epidemics were largely brought under control due to improved nutrition and improved environmental conditions. In 1906, the Food, Drug
and Cosmetic Act was passed, which established guidelines to prevent the
adulteration and misleading labeling of drugs and foods in the United
States. Most of the Acts impact was on food rather than drugs. In 1910,
the Flexner Report,17 published by the Carnegie Foundation, provided a
scathing review of US medical school education. This report brought about
necessary changes in the formal training of physicians and established The
Johns Hopkins School of Medicine, and its new 4-year curriculum, as the
preferred model for medical education. As a consequence of the Flexner
Report, many schools closed and others revised their curricula. State licensing
boards were empowered to raise practice standards and were encouraged to
establish rigorous qualifications for licensure. Physician training continued
to focus largely on general practice, which met most health care needs of
the time.
Notable therapeutic breakthroughs included the discovery of insulin in
1922 by Banting and Best, and, beginning in 1928, several discoveries by
Fleming that led to the development of penicillin. The discovery of penicillin
began the era of antibiotics, and this miracle drug revolutionized the
treatment of infectious diseases. Now, instead of disease leading to long-term
disability and possible death, in many cases a patient could be given an
injection of penicillin and sent home. With the eventual ability to treat many
infectious diseases by penicillin and other antibiotics, people lived to be older,
and chronic illnesses became the predominant problem of elderly American
citizens.
Community pharmacies were relatively small independent pharmacies;

most medicinal products were compounded and dispensed on the premises.
As pharmaceutical companies manufactured an increasing number of pharmaceutical products, the number of products compounded by community
pharmacists declined. Hospitals began to assume a more important role as
technology developed (e.g., anesthesia and aseptic surgical techniques) and
better-trained health professionals provided inpatient care.
1945 to 2010
As acute infectious diseases declined further with the arrival of the antibiotic
era, chronic illnesses began to dominate as the major problems in health.
While healthy lifestyle practices can help prevent the onset of chronic illnesses, these habits must be implemented long before the signs and symptoms
of chronic disease are manifested. Once chronic disease is diagnosed, it
usually is not cured by medical or drug treatment, and it stays with the
patient forever. Progression to later stages of chronic diseases is affected
by nutrition, smoking, alcohol use, sedentary lifestyle, obesity, and other
debilitating lifestyle habits.
The period from the end of World War II to about 1983 saw major
growth for hospitals. The Hill-Burton Act stimulated hospital renovation
and construction of new facilities in both urban and rural areas. The development of Blue Cross/Blue Shield plans and expansion of commercial
health insurance groups also fueled this expansion. In 1965, with the passage
of Medicare and Medicaid, health benefits were extended to the elderly
and the poor, which also increased the use of inpatient hospital facilities.
In 1965, 25 percent of the health care dollar was consumed by hospitals,
increasing to 30.2 percent by 2008.18 Hospital costs remain the largest
category of health spending, and also remain the primary target to control
costs. Hospitals desire to have the latest technology has been a major
force in driving up health care costs. While computed tomography and
magnetic resonance imaging scanners have advanced the diagnosis of some
diseases, these advances also have contributed to the high cost of health
care.
During this time period, Americas viewpoint on health switched from
rugged individualism to health care as a right, and many also came to believe
that government should assume greater responsibility for solving health
care problems for all American citizens. Examples of greater government
involvement included the passage in 1965 of Medicare and Medicaid, which
used public funds to provide health care. As health care expenditures continued to soar, policy-makers and employers began to exert pressure for cost
control. Recent attempts have been made to restrain inpatient health care by
emphasizing ambulatory health care.
Some of the strategies employed by the federal government to control

the rising cost of health care include hospital planning (that is, approving the
building of and services offered by new hospitals), changing the amounts and
methods of reimbursement for services, and encouraging the development of
managed care systems.19 One of the efforts that met with some success was
President Nixons Health Maintenance Organization (HMO) Act of 1973,
which sought a new health delivery system that could be implemented at a
reasonable cost. HMOs have been in existence for most of the 20th century,
although only a few of them have flourished. The HMO Act established
financial incentives for the development of HMOs (a pre-paid health delivery
system), and encouraged their use by employers with 25 or more employees.
HMOs and other forms of managed care have grown substantially since the
passage of the HMO Act. Managed care systems, such as preferred provider
organizations (PPOs), are expected to continue to grow at a rapid rate.
Another cost containment measure that met with some success was the
development of the 1983 Medicare prospective payment system, which paid
hospitals based on a preset diagnostic related group (DRG) amount that is
independent of the length of stay and services provided to the individual
patient.19,20 Given the governments success with prospective payment, other
third-party payers, such as Blue Cross/Blue Shield and commercial health
insurance carriers, also have converted to a prospective payment system.
2011 and beyond

In 2010, the Patient Protection and Affordable Care Act (ACA) was passed
and signed into law by President Obama. Legislative proposals such as this
try to balance cost, quality, and access without risking system strengths to
remedy weaknesses in our health care delivery system. This landmark health
care reform legislation was highly controversial, and its passage spurred a
negative political reaction against the Democrat party-controlled House and
Senate and was a major contributory factor for the sweeping 2010 elections
of conservatives. Health care reform proposals have always been controversial in the United States. It comes down to a basic philosophical difference
between legislative versus market-driven reforms and what the voting public
is willing to pay for those who do not have health insurance.
The health care delivery system in the United States has been marked by
three distinct evolutions; it is now in its fourth period. From the era of rugged
individualism to greater centralization of control by the federal government,
Americas health care system has certainly undergone dynamic changes. Our
health care system has been described as the best and the worst in the world:
the best when we speak of freedom to choose the physician, hospital and
pharmacist, and having access to the latest surgical and treatment techniques,
which are paid for by our private insurance plans, and the worst when we
speak of the lack of access to quality health care by millions of Americans

who have no health insurance or are underinsured, individuals who are on
expensive prescription drugs but cannot afford them, and the disparity in life
expectancy between Caucasians and other racial groups in the United States.
Our US system is characterized by the overlapping, unplanned, and wasteful
use of personal and public financial resources. Although our countrys health
care system has been described as both the best and worst in the world, the
reality resides somewhere in between.
While it is difficult to categorize the American health care system, the next
two sections of this chapter review two models of health care delivery: (1) the
private health care system, and (2) the public health care system. These are,
of course, somewhat arbitrary classifications.
The private health care sector

Employed, insured, middle-income America
When most Americans think of the US health care system, they usually
are thinking of employed, middle-income families with health insurance
provided through their employment.16 Ambulatory care services are provided
by physicians in private practice or managed care settings. Each individual
chooses a physician or managed care program to meet his or her own or
familys health care needs. This informal set of services is paid for directly
by the consumer or through a private health insurance plan. The coordination of this system depends on the customer or a primary care physician,
e.g., family practice physician. When a specialist referral is needed, that is
orchestrated by that gatekeeper physician. When medications are prescribed,
the individual decides which community pharmacy will be used to fill those
prescriptions. Depending on insurance coverage, these ambulatory services
may or may not be covered. Increasingly, prescription drug coverage is being
included in insurance plans. Typically, the individual pays out-of-pocket for
most of these services until a certain deductible is met, and then the health
insurance plan takes over the majority of further payments. When inpatient
hospital services are needed, the physician sends the patient to a community
hospital where that physician has medical staff privileges. Typically, the
majority of hospital care is covered under most health insurance plans.
Therefore, the burden of payment shifts from the individual to the insurance
plan.
Approximately 50 percent of the total health care expenditures are spent
by the private sector.9 Examples of private sector health insurance plans
include Blue Cross/Blue Shield plans, commercial health insurance companies, HMO and PPO plans, and employer self-insurance programs. The
private sector component percentage has been decreasing each year, while the
10
public sector component has increased. Examples of public sector expenditures include federal (e.g., Medicare, Medicaid, Childrens Health Insurance
Program [CHIP], Veterans Administration), state, and local (e.g., Medicaid,
CHIP). Public sector spending currently accounts for about 50 percent of
total health care costs,9 and this figure will continue to increase unless
funding cutbacks for health care are implemented by the federal and state
governments.
Long-term care
When long-term care is needed, a variety of services are available, some
of which are covered by health insurance plans. Most health insurance
plans (excluding long-term health insurance) provide little or no coverage
for nursing home costs, and the individual or his or her family must cover
costs (or obtain Medicaid coverage). Nursing home plans are increasingly
being promoted by private insurance companies. Much of long-term care
has shifted away from hospital and nursing home settings to home health care
groups and hospice settings. An array of living arrangements have developed,
including retirement communities that offer various degrees of independent
living to increase levels of health care services.
Mental health services

Some mental health services usually are covered by the familys health insurance plan. With a long-term diagnosis, however, a shift from the private
sector to the public sector may be required for additional services. Substance
abuse treatment may be part of an individuals private health insurance plan.
The family practice physician is trained to handle minor emotional problems,
but if the problem becomes more complex or severe, the patient usually is
referred to a psychiatrist or mental health facility for further evaluation and
treatment.
Managed care
Managed care is a planned, coordinated approach to providing health care,
the goal of which is to provide quality care at the lowest cost, with an
emphasis on preventive care. Managed care is provided by a network of
providers formed to offer cost-effective services. An HMO is a prepaid health
plan in which enrollees pay a fixed fee (often with copayment) for designated
health services. With HMOs, the provider usually is paid in advance for
services on a per-member, per-month basis. Thus, a provider is paid the same
amount of money every month for a member regardless of whether that
member receives services or not, and regardless of the actual cost of those
services, under the terms of the service contract.
In a PPO, the managed care organization contracts with health providers
to provide health services under a discounted-fee schedule. This health care
11
plan is prepaid, and the member or family usually is enrolled for a 1-year
period and is entitled to certain agreed-upon services. Health care services
usually include hospital services, physician visits, prescription drugs, mental
health services, and home health care services. Typically, a primary care
physician (gatekeeper) is chosen or assigned to coordinate an individual or
familys health care services. When a specialist referral or hospital service is
required, the gatekeeper physician must approve the need for these services. If
an individual or family goes outside the plan for these services, these services
usually are not fully reimbursed, or may not be reimbursable at all. Financial
incentives are built in to encourage members to stay within the system.
Prescription benefit programs

Prescription benefit programs have proliferated in recent years in both managed care and indemnity plans. Furthermore, pharmacy benefit managers
(PBM) carve out the pharmacy benefit from primary health insurance plans
and use on-line adjudication of pharmacy claims to administer the drug benefit plan. The two largest PBMs are Express Scripts Holding Company (which
acquired Medco Health Solutions), and CVS/Caremark. Increasingly, PBMs
not only administer prescription claims, but also design pharmaceutical
benefits such as formularies, plan designs, mail order pharmacies, electronic
prescribing, manufacturer discounts, and clinical management. Concerns
about PBMs have been expressed by pharmacists in regard to problems
with pricing structures, reimbursement, and lack of transparency in contract
negotiations. PBMs adjudicate prescription claims for over 70 percent of the
US population.
Pharmaceutical care
Hepler and Strand21 define pharmaceutical care as the responsible provision
of drug therapy for achieving specific outcomes that improves a patients
quality of life. These outcomes are: (1) cure of a disease; (2) elimination and
reduction of a patients symptomatology; (3) arrest or slowing of the disease
process; and (4) prevention of a disease or symptomatology. Traditionally,
pharmacists have been concerned primarily with the process of care, what
they do when the patients receives care (i.e., whether the correct drug and
the right dose at the right time are provided). With the more recent focus on
outcomes, the pharmacist also has become responsible for the outcome of
care, i.e., what happens to the patient when the drug is given. Examples of
outcome criteria include increased patient knowledge of disease, improved
medication compliance, improved medication therapy, decreased adverse
reactions, decreased misuse and abuse, and improved patient satisfaction.
Pharmaceutical care involves pharmacist involvement in patient care and
includes both medication therapy management (MTM) and disease state
management.
12
Summary
The distinctive feature of the private health care system is that the consumer
has the ability to choose the physician and pharmacist. If satisfied, they maintain that relationship. The major limitations of the traditional fee-for-service
system are the emphasis on over-utilization of resources by the provider,
and the lack of incentive to encourage healthy lifestyles and reduction of
high-tech care. With managed care, these incentives are reversed.
The public health care system

Federal government-provided care
Military medical care
The military medical care system is a general term that refers to the separate
systems of the US Army, Navy, Air Force, US Marines, and Coast Guard.
This system is responsible for providing health care for active-duty military
personnel, in the USA and throughout the world, where care is needed for
service-connected problems. It is a well-organized system where there is no
direct cost to the individual. There is considerable emphasis on promoting
wellness and prevention of injuries, so this system of care is unusual in that it
promotes health and does not just provide for sickness care. Medical corpsmen (medics) are non-physician personnel with special training who perform
many of the routine ambulatory care services, and refer more complicated
cases to physicians. Acute care services are provided at base dispensaries, sick
bays aboard ship, or base hospitals on various military installations. Regional
military hospitals provide more complicated services.
If a member of the armed forces receives a medical discharge, medical
care is generally provided at Veterans Administration (VA) facilities. The
VA system also cares for disabled and retired veterans of previous US
military service. As the nations largest integrated health care system, the
VA operates more than 1400 sites of care, including hospitals, community
clinics, community living centers, readjustment counseling centers, and various other facilities. Most of the patients are male veterans with multiple
system problems. As women take on an increased role in various military
branches, womens health is becoming a growing area for the VA system.
Services include comprehensive primary care as well as specialty care such
as reproductive services, rehabilitation, mental health, and treatment for
military sexual trauma. The VA system is funded by the federal government.
Recently, efforts have been made to privatize the VA system, but it is unlikely
that these efforts will be successful.
The Civilian Health and Medical Program of the Uniformed Services
(CHAMPUS) has been revised as a managed care system and renamed
TRICARE, which is the health care program that serves uniformed service
13
members, retirees, and their families worldwide. This extensive health insurance plan provides services that are financed and supervised by the military.
If local resources are available, families can use military services. If not,
this health insurance plan provides coverage from private practitioners or
managed care organizations within a reasonable distance of the military
installation.
Indian Health Service

Treaties signed between Native American tribes and the US government stipulated that American Indians would be provided certain medical and hospital
services, and this agreement continues to be in effect today. The Indian Health
Service (IHS) is managed by the US Department of Health and Human
Services Public Health Service (PHS). Currently, most IHS pharmacists are
PHS Commissioned Corps members. Health care and pharmacy services are
provided to 1.5 million Native Americans and Alaska Natives living on or
near reservations, which are in 34 states. IHS programs are carried out
through 49 hospitals and 180 ambulatory health centers. Although Native
Americans are distributed geographically throughout the United States, these
facilities are concentrated in the western and southwest areas of the country.
Most IHS pharmacists who were Commissioned Corps and PHS officers
were first assigned in 1953 to hospitals to establish dispensing policies and
practices.22,23 During the 1960s, several IHS innovations set the stage for an
active clinical pharmacist role:
The first innovation was the replacement of the traditional prescription

blank with the patients medical record as the primary document used
to fill all prescriptions. With access to the patients chart, pharmacists can
provide concurrent review of prescribed drug therapy for appropriateness
before dispensing.
The second innovation was that IHS pharmacists were the first to use
private counseling rooms and provide patient counseling to every patient
receiving a prescription.
The third major innovation was the provision of primary care to ambulatory patients with both acute and chronic health problems.
This program began as pharmacists independently initiated and extended
drug therapy. The primary care program has now progressed to the extent
that pharmacists take histories, do physical assessments, and prescribe treatment, including prescription medication. These programs were developed
under the leadership of Dr. Allen J. Brands, IHS pharmacist from 1955
through 1981, and remain an important part of pharmacy practice today.
This unique primary care role has evolved due to a physician workforce
undersupply and the needs of the underserved Native American population,
and is well suited for rural areas. While the pharmaceutical care role has
14
been advocated in the ambulatory setting, most of these innovations were

first developed in the IHS.
Community Health Centers

In 1965, to stimulate societal growth and decrease poverty, Congress funded
the Neighborhood Health Center (NHC) Act to provide comprehensive
health care to low-income populations in urban and rural areas of the United
States.24 In 1973, the NHC program was transferred to the US Public Health
Service, and the freestanding ambulatory care facilities were designated
as community health centers (CHCs).25 In 1974, the Community Health
Centers Act required provision of diagnostic treatment and other services by
a physician or physician extender, laboratory services, well-child care, dental
services, social services, and pharmaceutical services. The 1978 amendments
to Sections 329 and 330 of the Public Health Services Act changed the supplemental services designation and made pharmacy a primary service. All
CHCs are required to provide or arrange for pharmacy services for their
patients; however, some CHCs provide on-site licensed pharmacies, whereas
other CHCs provide pharmaceuticals through contracted arrangements with
an off-site pharmacy. The Siouxland Community Health Center (SCHC)
provides in-house pharmacy services. Given the rising costs of drug therapy
and growing evidence of the cost of ineffectively managed drug therapy,
demonstration projects such as SCHC were funded by the Health Resources
and Services Administration (HRSA) to deliver progressive clinical services,
e.g., diabetes disease state management services to patients with diabetes at
SCHC.26 Patients with type 2 diabetes who received pharmacist-managed diabetes care demonstrated significantly improved A1c levels and quality-of-life
measures, and met treatment goals more often than patients receiving standard care.
Unemployed, uninsured, low-income America (local government

health care)
The US Census Bureau reported that a record 50.7 million residents (which
includes 9.9 million non-citizens) or 16.7 percent of the population were
uninsured in 2009.27 About one-fourth of the US population will lose health
insurance coverage for some period during the next 2 years. If fully implemented, the ACA will reduce the number with no health insurance and
those who lack adequate coverage; however, it is predicated that 16 million
Americans will not be insured. Becoming ill or living with a chronic medical
condition also can result in losing insurance coverage, or not being able to
obtain it. When uninsured Americans need health care, they often rely on
public hospitals, teaching hospitals, public health clinics, and community
health centers.
15
Medicaid
Medicaid is a jointly operated federal and state program designed to provide
health care for the poor. Medicaid recipients include the blind and disabled,
the aged poor, and families with dependent children if one parent is absent,
unemployed, or unable to work. Services for Medicaid recipients include
inpatient and outpatient hospital care, physician visits, laboratory services,
radiology services, and nursing facility care. Federal funding to states is set on
a cost-sharing basis, based on the states per capita income, so that wealthier
states get less than 50 percent and poorer states get more than 50 percent of
the federal distribution. Although an outpatient prescription program is not
mandated by federal regulations, it is an option provided by most states.
Passage of the Omnibus Budget Reconciliation Act of 1990 mandated that
pharmacists must offer to counsel Medicaid patients on outpatient prescription drugs. It also required pharmacists to document patient counseling and
drug utilization review activities. Among the objections raised by pharmacists concerning this mandate were that there is no additional compensation,
not enough time, and greater liability.28 Many states have extended this
legislative counseling mandate to include not only Medicaid patients, but
also non-Medicaid patients. Thus, some states now require that pharmacists
offer to counsel all ambulatory care patients. Very little research has been
done to measure the impact of this legislation, and boards of pharmacy have
been lax to enforce compliance with these regulations.
Medicare and Medicaid account for nearly three-fourths of public expenditures for personal health services. Medicaid expenditures have increased
rapidly in recent years, causing budget overruns for many states. Increasingly,
states are turning toward managed care programs in an attempt to control
expenditures. In theory, managed care systems reduce costs by allowing
providers to manage treatment of their patients, reducing unnecessary care,
and focusing on preventive care. In practice, this is not always the case, and
despite the growth in managed care plans, most Medicaid dollars are still
spent for traditional fee-for-service medicine. Medicaid spending is driven
by enrollment growth and by spending for seniors and individuals with
disabilities. The dual-eligible individual (i.e., one who is jointly covered by
Medicaid and Medicare) accounts for 40 percent of Medicaid spending. The
US Congress and most states are examining strategies to reduce spending
for Medicaid. While cutbacks are inevitable, the impact on access to quality
patient care is a major concern.
With the 2010 passage of the Affordable Care Act, access should improve
for most Americans without health insurance. Although the ACA was passed,
the regulations are still being developed. In addition, efforts are being made
at both federal and state levels to repeal the law entirely, to withhold funding
of various components, and to determine the legality of major components
(e.g., mandating individuals to purchase insurance) of the act. Under health
16
care reform the Medicaid program is expected to grow substantially, and

this will significantly reduce the number of uninsured, with the federal government picking up the vast majority (about 95 percent of total costs, with
5 percent for states) of the cost. Since the act is expected to add a significant
increase in enrollment in the Medicaid program, states are concerned about
how they are going to pay for their contribution of program costs. Given that
the United States has recently undergone a significant economic recession
and the majority of state budgets are in the red, most state governments
are concerned about their ability to take on more state debt. One of the
proposed solutions is to reduce Medicaid payments to providers, so that
these providers will be asked to provide more services with fewer financial
resources. As might be expected, this is receiving resistance at the provider
level.
Medicare
Medicare beneficiaries are covered by the Social Security Amendment that
was passed in 1965, and then revised in 1972, extending health care services
to all persons 65 years of age and older. Medicare Part A coverage includes
inpatient hospital care, skilled nursing facility care, hospice, and home health
care, with deductibles and limits placed on each area. Medicare beneficiaries
also are eligible for Medicare Part B coverage, which, for a relatively small
health insurance premium, allows senior citizens to obtain extended coverage for physician services, outpatient hospital services, home health care
services, and a limited number of outpatient drugs (e.g., hepatitis B vaccine,
immunosuppressant drugs, pneumococcal and influenza vaccine, and some
oral cancer drugs). Medicare Part C (Medicare Advantage) is a managed care
component that was added in 1997; it allows private companies to contract
with CMS to provide Part A and Part B services, along with other services
(e.g., optional prescription drug benefit) in either an HMO or PPO plan.
Currently, Part C plans account for a relatively small part of the Medicare
marketplace.
Medicare Part D (prescription drug) benefit was passed in 2003 as part
of the Medicare Prescription Drug, Improvement, and Modernization Act
(Public Law 108-173) (MMA 2003) and began services on January 1, 2006.
About 45 percent of funding comes from federal general tax revenue, and
the remainder comes from beneficiaries via premiums paid by participants
in the plans. The program has voluntary enrollment, so each senior citizen
decides for him- or herself whether to participate. Most prescription drugs
and insulin are covered. However, some types of prescription drugs are
excluded (e.g., barbiturates, benzodiazepines, and drugs for weight loss,
erectile dysfunction, and hair growth). Along with the additional premiums
paid for Part D, there are also deductibles and copayments that are based
on the category of benefit coverage (e.g., standard, low income, dual eligible)
17
that one is eligible to receive. The ACA Act has or will correct some of the
coverage issues with the Part D program, such as payment of drugs in the
coverage gap.
For designated Medicare gap areas, private insurance groups provide
MediGap plans that reimburse Medicare deductibles and copayments. For
a Medigap plan, the customer pays a monthly premium to the insurance
company in addition to the Medicare Part B premium. The cost of the policy
depends on the type of plan, the patients age, and the insurance company.
Most plans help pay for some of the Medicare copayments for hospital stays
and some other services. Less expensive plans have fewer benefits and higher
out-of-pocket costs.
Federal government agencies

The public health care sector also includes various agencies at the federal
level, including the Department of Health and Human Services (DHHS).
The US Food and Drug Administration (FDA) is a branch of the DHHS and
is responsible for the approval and regulation of new drug products in the
American marketplace. The HRSA is involved in providing health care to
areas with health staffing shortages, to medically underserved populations,
and to special service populations. HRSA is the administrative agency for
the National Health Services Corps Programs, and recruits practitioners for
inner-city and rural areas that are designated as health manpower shortage
areas. Another DHHS agency, the Centers for Medicaid and Medicare
Services (CMS), administers both the Medicare and Medicaid programs.
The Centers for Disease Control and Prevention (CDC), another DHHS
department, is responsible for the control and prevention of infectious and
some chronic diseases. Other agencies within the federal government also
have health-related programs, but they are too numerous to list. As the
federal government makes funding cutbacks in an attempt to produce a
balanced budget, some of these agencies are likely to be consolidated or
eliminated.
Health care: right or privilege?

Within the framework of President Lyndon B. Johnsons Great Society,
the 1965 establishment of the Medicare and Medicaid programs was done
with the belief that health care is a right and not a privilege. Since
the early 1900s, the United States has periodically examined the need for
a nationalized health care program, but each time, this type of health care
reform has been eventually defeated. The ACA Act of 2010 was proclaimed
by some as the landmark health care reform that would transform our health
care delivery system to a program that provides health care as a right. While
18
the ACA Act does much to bridge the access gap in health care, it does not
provide health care as a right. The purpose of the act is to provide access to
health care for more Americans and to improve some of the major gaps in
coverage. The passage of this ACA Act, as mentioned earlier, has provoked
substantial public debate on what should be covered and who should pay, if
at all, for this program.
Health care costs are rising much faster than other sectors of the economy.
About 17.6 percent of our GDP was spent on health care in 2009, and
a double-digit rate is expected to continue for health care spending. The
principle of universal coverage, a belief held by most American citizens, is
that every citizen should have access to health care coverage. However, the
mainstream of American society does not want to pay for other peoples
health care. With recent congressional attempts to reduce funding for both
Medicare and Medicaid, combined with reduced expenditures for other
health-related programs, the gap between right and privilege will undoubtedly become wider.
While federal legislation (i.e., ACA) did pass, both the problems of our
health care system and the efforts to reform the system continue. However,
these efforts cannot appropriately address the problems of access, quality,
and cost. Eventually, the federal government will again be faced with the issue
of health care reform, and the American people will accept major changes in
their health care system only when the conditions are right. As David Banta
and Steven Jonas concluded, the underlying problems of the US health care
delivery system are not access and cost. Those are simply outcomes of in-built
and long-standing system difficulties. . . If the money the American people are
spending on health care bought the kind of health and health care product it
easily could buy, then we would be among the healthiest people in the world,
and there would probably be little concern about the amount of money being
spent.2 The USA spends much more of its GDP on health care than any
other country in the world. One reason for this is that the USA spends huge
amounts of dollars to prolong unhealthy life at the end of the life span29 and
spends very little on health promotion.
Methods proposed to change this situation include managed care and
a Canadian-style single-payer plan. The American system prides itself on
high-quality, high-tech health care. Unfortunately, very few of the high-tech
interventions have been clearly shown to be of benefit. Brook and Lohr
estimate that 30 percent to 50 percent of US health care expenditures go to
support services that produce little or no demonstrable benefit.30 American
society will need to examine societal benefit versus individual benefit in
determining what types of technologies, new drugs, and services will be
used, and who will pay the cost. Issues of cost-effectiveness will play an
increasingly important role in health and pharmaceutical care. Decisions
regarding costs will have to be made by ethical consideration and balancing
19
individual benefit with societal benefit, so that appropriate decisions are

made for American citizens.
Conclusion
This chapter has provided a brief overview of the US health care system and
its historical evolution; the private and public health care systems; and issues
that are associated with health care utilization. While the purpose of health
care is to promote health, the American system is concerned primarily with
the diagnosis and treatment of disease, and not with the goal of promoting
health. Our health care paradigm must be changed to one that values and
rewards health promotion.31 A redesign of the US health care system will be
needed for this to happen.

1. World Health Organization. The World Health Organization: a report on the first ten
years. Geneva, Switzerland; 1958.
2. Banta HD, Jonas S. Health and health care. In: Jonas S, editor. Health care delivery in the
United States. New York: Springer Publishing Company; 1995:1133.
3. US Department of Health, Education and Welfare. Healthy people: the Surgeon Generals
report on health promotion and disease prevention. Washington, DC: DHEW Pub. No.
(PHS) 79-55071; 1979.
4. US Department of Health and Human Services. Office of Disease Prevention and Health
Promotion. Healthy people 2020. http://www.healthypeople.gov/2020/default.aspx [accessed July 5, 2011].
5. Centers for Disease Control and Prevention. National Office of Vital Statistics. Leading
causes of death, 1900-1998:67. www.cdc.gov/nchs/data/dvs/lead1900 98.pdf [accessed
July 6, 2011].
6. Centers for Disease Control and Prevention. National Office of Vital Statistics. www.cdc.
gov/NCHS/data/nvsr/nvsr60/nvsr60 03.pdf [accessed July 5, 2011].
7. Centers for Disease Control and Prevention. National Center for Health Statistics. Health,
United States, 2010:143. www.cdc.gov/nchs/data/hus/hus10.pdf [accessed July 5, 2011].
United States, 2010. Table 22. Life expectancy at birth, at 65 years of age, and at 75 years
of age, by race and sex: United States, selected years 19002007; p 27. www.cdc.gov/
nchs/data/hus/hus10.pdf#022 [accessed July 6, 2011].
9. US Department of Health and Human Services. Centers for Medicare and Medicaid
Services. National Health Expenditure Data, 2009.
www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/
NationalHealthExpendData/Downloads/highlights.html [accessed August 30, 2012].
10. Fuchs W. Who shall live? New York: Basic Books; 1974.
11. Berkman LF, Breslow L. Health and ways of living: the Alameda County Study. New York:
Oxford University Press; 1983.
12. LaLonde M. A new perspective on the health of Canadians (Lalonde Report) (1973
1974). Ottawa: Government of Canada; 1974. www.hc-sc.gc.ca/hcs-sss/alt formats/
hpb-dgps/pdf/pubs/1974-lalonde/lalonde-eng.pdf [accessed August 30, 2012].
13. Sigerist H. Medicine and human welfare. College Park (MD): McGrath Publishing Company, 1970.
14. McKeown T. The role of medicine: dream, mirage, or nemesis. London: The Nufield
Provincial Hospitals Trust, 1976.
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15. Raffel MW, Raffel NK. History of medical education and medical practice in America.
In: Raffel MW, Raffel NK, editors. The United States health system origins and functions.
Albany (NY): Delmar Publishers; 1994:135.
16. Torrens PR. Historical evolution and overview of health services in the United States.
In: Williams SJ, Torrens PR, editors. Introduction to health services. New York: Delmar
Publishers; 1993:328.
17. Flexner A. Medical education in the United States and CanadaBulletin Four. New York:
The Carnegie Foundation for the Advancement of Teaching; 1910.
18. US Department of Health and Human Services, Centers for Medicaid and Medicare
Services. National health expenditures by source of funds and type of expenditure: calendar years 20042010 [Table 4]. www.cms.gov/NationalHealthExpendData/downloads/
tables.pdf [accessed August 30, 2012].
19. Balinsky W, Starkman JL. The impact of DRGs on the health care industry. Health Care
Management Rev 1987; 12:6174.
20. Burner ST, Waldo DR, McKusick DR. National health expenditures projections through
2030. Health Care Fin Rev 1992; 14:129.
21. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J
Hosp Pharm 1990; 47:53342.
22. Paavola FG, Dermanoski KR, Pittman RE. Pharmaceutical services in the United States
Public Health Service. Am J Health Syst Pharm 1997; 54:76672.
23. Flowers L, Wick J, Figg WD, McClelland RH, Shiber M, Bitton JE, et al. US Public
Health Service Commissioned Corps Pharmacists: making a difference in advancing the
nations health. J Am Pharm Assoc 2009; 49:44652.
24. Mezey AP, Lawrence RS. Ambulatory care. In: Kovner AR, editor. Jonass health care
delivery in the United States. New York: Springer Publishing Company; 1995:12261.
25. Roemer M. Ambulatory health services in America. Rockville (MD): Aspen System Corporation; 1981.
26. Scott DM, Boyd ST, Stephan M, Augustine SC, Reardon T. Outcomes of pharmacist
managed diabetes care at the Siouxland Community Health Center. Am J Health Syst
Pharm 2006; 63(21):211622.
27. US Census. Income, poverty, and health insurance coverage in the United States: 2009:22.
www.census.gov/prod/2010pubs/p60-238.pdf [accessed July 25, 2011].
28. Portner TS, Fitzgerald WL. OBRA 90: turning a challenge into an opportunity. Am
Pharm 1993; NS33:6775.
29. Emanuel EJ, Emanuel LL. The economics of dying: the illusion of cost savings at the end
of life. N Engl J Med 1994; 330:5404.
30. Brook R, Lohr K. Will we need to ration effective health care? Issues Sci Technol 1986;
3:110.
31. Freymann JG. The publics health care paradigm is shifting: medicine must swing with it.
J Gen Intern Med 1989; 4:3139.
2
Leanne Lai, PhD
Health care financing

Finance is the branch of economics that studies the management of money
and other assets. More specifically, it is the decisions involved in collecting
financial resources and allocating these resources to providers. In health care
financing, such decisions are far beyond the fundamental forces of supply and
demand for most free-market goods and services. One of the most important
differences between the health care industry and others is that medical
customers or patients have very limited control over making decisions about
their health care spending due to uncertainty regarding the entire process
and gaps in their knowledge about medicine. Patients usually rely heavily on
their health care providersphysicians, pharmacists, dentists, nurses, physical therapists, physician extenders (e.g., Nurse Practitioners [NPs], Physician
Assistants [PAs]), chiropractors, and dietitiansto determine diagnosis or
treatment. In essence, health care financing is the process or decision on
how health care beneficiaries pay for medical expenses and how society allocates funds following demographic trends, economic development, political
climate, social value, and technological innovation over the short and long
term.
Funding sources of health care financing

In early American society, health care was paid for mainly from individual
savings, often with help from families and friends. However, savings varied
according to the individuals financial capacity, and usually were quite limited. Medical treatment or diagnosis usually was charged a fee for a service
or on a case-by-case basis. Therefore, if patients did not have cash, they
could barter (i.e., exchange medical services for vegetables, meats, fruits,
carpentry, etc.). Individual savings certainly were not a reliable form of risk
management, especially with catastrophic illnesses or accidents. In order to
spread economic risk for medical expenses, a primitive form of insurance
called contract practice evolved in the early 1800s.1 Most physicians were
22
paid a fixed fee per year to provide all health services to a family, a plantation,
or a community. Such arrangements actually placed most of the financial
burden on physicians, who had to provide unlimited services to patients with
no explicit legal boundary to secure their financial returns. The movement
from individuals savings to contract practice actually reveals an important
financing concept of risk sharing also known as risk pooling, and it is
the essential feature of all insurances. In fact, the basic principle of risk
pooling can be traced as far back as ancient Greece, where medical services
were provided by tax-supported public physicians. Centuries later, marine
services hospitals (the predecessor of the US Public Health Service Hospitals)
launched the first health insurance program in the United States in 1798.2
Today there are two types of financing sources for US health care: public
financing and private financing. The share of public and private health care
financing is almost equivalent, with private financing being slightly larger.
However, public health funding is projected to grow much faster than private
funding due to expected growth in Medicare and Medicaid spending as a
result of a continuing high rate of unemployment related to the economic
recession3 (Figure 2.1). The growing segment of the aging population has
affected and will continue to have a dramatic impact on the delivery and
financing of health care in the United States.
Public financing: Federal, state, and local government

Public financing comes from three sources: federal government, state government, and local government. In 2007, public financing accounted for almost
15
Historical
Projected
Percent
12
Public spending
Private spending
Total NHE
0
1990
1995
2000
2005
2010
2015
Figure 2.1 Growth in public and private national health expenditures (NHE) for selected calendar
years 20072019. (Reprinted with permission from Centers for Medicare and Medicaid Services,
Office of the Actuary, National Health Statistics Group, 2010.)
23
half of all health care spending and covered over 27 percent of the US population (83 million people), including the elderly, poor, disabled, children,
veterans, Native Americans, and government employees.4 The Office of the
Actuary from the CMS reported that the distribution of government health
funds has shifted from state and local government to the federal government
due to rapidly growing Medicare and Medicaid expenditures in the past
decade. In 2007, 75 percent of overall public health funds were spent on
Medicare (42 percent) and Medicaid (33 percent) programs (Table 2.1).
Unfortunately, less than 10 percent of government health funds were used to
support such research or public health projects as vaccinations, obesity treatment, diabetes treatment, smoking cessation, and health disparities. Public
health affects society in countless ways by implementing education and prevention programs, developing health policies, and conducting health-related
research. In the long run, it could be an effective approach to control rising
health care costs.
Aside from Medicare and Medicaid programs, the US government also
financed various health care programs such as Veterans Affairs Health Care
(VA), TRICARE, the Indian Health Service (IHS), the Federal Employees
Health Benefits Program (FEHBP), and the Childrens Health Insurance
Program (CHIP).
The financial flows of some important government health care programs
are outlined in the following paragraphs.
Table 2.1 Distribution of Government Health Funds

1965
2007
Medicare
42%
Medicaid
20%
33%
Veterans/Department of Defense
18%
6%
Workers compensation
8%
3%
State/local hospitals
22%
2%
Public health
8%
6%
Research
12%
4%
Construction
7%
3%
Other
5%
2%
Total (millions)
$10,799
$1,036,000
Department of Defense,
____________________
(Data from Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics
Group, 2007.)
24
Medicare
Medicare is financed from three major sources: general revenues (43 percent),
payroll tax contributions (37 percent), and beneficiary premiums (13 percent)
(Figure 2.2). Medicare benefit payments can be divided into four parts, as
follows5 :
Part A: hospital insurance (36 percent);

Part B: supplementary medical insurance (29 percent);
Part C: Medicare Advantage (23 percent); and
Part D: prescription drug benefit (11 percent).
Medicare Part A
Medicare Part A covers hospital expenses such as inpatient care in hospitals,
skilled nursing facilities, hospice, and home health care. A total of 85 percent
of Part A revenue is financed through a payroll tax that is a 2.9 percent tax on
the income earnings from both employees and employers (1.45 percent each).
Beginning in 2013, the 2.9 percent hospital insurance tax will continue to
apply to the first $200,000 of income for individuals or $250,000 for couples
filing jointly. The income exceeding this amount will be taxed at 3.8 percent.5
Those eligible for Medicare coverage are automatically enrolled in Medicare
Part A. For the other Medicare componentsParts B, C, and Ddiscussed in
the following sections, the recipient must apply and pay monthly premiums
for coverage.
Estimated Sources of Medicare Revenue, 2010
General Revenue
43%
Payroll Taxes
74%
82%
85%
37%
13%
3%
4%
1%
TOTAL
$499 billion
6%
7%
25%
PART A
$218 billion
PART B
$219 billion
Beneficiary
Premiums
Payments from
States
Taxation of Social
Security Benefits
Interest and Other
10%
1%
7%
PART D
$63 billion
Figure 2.2 Estimated sources of Medicare revenue, 2010. (From Medicare Spending and
Financing. The Henry J. Kaiser Family Foundation Fact Sheet. August 2010.)
25
Medicare Part B
Medicare Part B covers medically necessary services such as doctors services,
outpatient care, home health services, some preventive care, and others.
Part B is financed by general revenues (74 percent) and beneficiary premiums
(25 percent). Since 2007, the income-based premium schema has been incorporated into the Medicare program. A Medicare patient whose annual income is over $85,000 for an individual (or $170,000 for a couple) is required
to pay a higher monthly Part B premium. However, Medicare-deductible and
premium rates may change every year in January.
Medicare Part C
Medicare Part C, sometimes called Medicare Advantage Plans or Medicare + Choice, is offered by private companies (like HMOs or PPOs)
approved by Medicare. These private insurance plans provide coverage that
meets the standards set by the Medicare program and provide extra health
benefits through the Medicare Advantage plans to cover the items not covered by traditional Medicare (Parts A and B), such as prescription drugs,
dental care, vision care, and wellness programs. Medicare Part C is financed
through the capitation system, for which Medicare pays the private insurance
company a fixed amount every month and the patient pays an extra monthly
premium.
Medicare Part D
Medicare Part D, also called Medicare prescription drug coverage, offers
voluntary prescription drug benefits through the Medicare Prescription Drug,
Improvement, and Modernization Act.6 Beginning in 2006, everyone with
Part A or B became eligible for Part D, with substantial out-of-pocket costs
through private Medicare approved private insurance companies. There are
two ways to use Medicare Part D:
Medicare prescription drug plans (PDP): These plans add drug coverage
to the original Medicare plan; they include Medicare cost plans, Medicare private fee-for-service (PFFS) plans, and Medicare medical savings
account (MSA) plans.
Medicare Advantage Plans (like an HMO or PPO): A specific Medicare

health plan that offers Medicare prescription drug coverage. Medicare
Advantage Plans with prescription drug coverage are sometimes called
MA-PDs. As previously noted, this is a part of Medicare that requires
payment by the beneficiary on a monthly basis.
Medicare Part D is financed from general revenues (82 percent), beneficiary premiums (10 percent), and state payments (7 percent). Similar to the
Medicare Part B income-based premium schema, higher-income Medicare
beneficiaries are required to pay a larger share of prescription drug costs.6
26
As previously noted, this is a part of Medicare that requires payment by the

beneficiary on a monthly basis.
Medicaid
Medicaid is a federalstate partnership program providing health benefits to
low-income and disabled persons. Each state government determines whether
an individual residing in that state is eligible for Medicaid according to its
definition of need under federal regulations. However, in general, low-income
people who meet the following criteria qualify for the Medicaid program: the
aged (65 years or older), the blind, the disabled, and families with dependent
children. Medicaid does not pay money to the beneficiary; instead, it sends
payments directly to health care providers. Depending on each states rules,
a Medicaid beneficiary may also be asked to pay a small portion of the cost
(copayment) for some medical services.
Medicaid is financed jointly by the states and the federal government.
Federal share funding varies widely from state to state, so that low-income
states may receive much higher federal subsidies than wealthy states. State
Share Funding for Medicaid Services Section 1902(a)7 of the Act provides
that the State must ensure adequate funding for the non-federal share of
expenditures from State or local sources for the amount, duration, scope, or
quality of care and services available under the State plan. Recognized sources
of the State share of Medicaid payments include legislative appropriations to
the single State agency; intergovernmental transfers (IGTs); certified public
expenditures (CPEs); and permissible taxes and provider donations. Prior to
approval of a State plan amendment, the CMS (Federal Medicaid operational
agent) must verify that the sources of the State share meet applicable statutory
and regulatory requirements in order to authorize federal financial participation (FFP) for the covered services. The funding shared between Federal and
state government also is affected by each states Medicaid program eligibility,
enrollment, coverage, as well as per capita income.
Veterans Affairs Health Care System

The Veterans Affairs Health Care System (VA) provides medical benefits to
veterans who served in the military. Reservists and National Guard members
also may qualify for VA health care benefits if they were called to active
duty (other than for training only) by a Federal order and completed the full
period for which they were called or ordered to active duty. The VA health
care system is financed heavily by the federal government. It operates the
nations largest integrated health care system, with more than 1400 sites of
care, including hospitals, community clinics, and community living centers,
domiciliaries, readjustment counseling centers, and various other facilities.
The VA health program includes coverage for almost all medical services,
such as primary care or specialist physician office visits, immunizations,
27
hospitalizations, emergency room visits, medical and surgical supplies, as

well as prescription medications. As medical care became more expensive,
the VA health program has started initiating a small copayment for its
outpatient services and annual deductibles for its inpatient services.8
TRICARE
TRICARE provides health benefits for military personnel, military retirees,
and their dependents, including some members of the Reserve. The TRICARE program is financed and managed by TRICARE Management Activity
(TMA) under the authority of the Assistant Secretary of Defense. Unlike VA
health insurance, TRICARE does not require that services be provided by
the VA system or its physicians. TRICARE Prime, the most popular military
insurance program offered, is similar to a civilian HMO in that it stresses
preventive care and covers such routine medical expenses as office visits and
immunizations. Indemnity (fee-for-service) plans also are available through
TRICARE, offering more choices but higher costs. As a major component
of the Military Health System, TRICARE brings together the health care
resources of the uniformed services and supplements them with networks
of civilian health care professionals, institutions, pharmacies, and suppliers
to provide access to high-quality health care services while maintaining the
capability to support military operations.9
Indian Health Service

The Indian Health Service (IHS) provides a comprehensive health service
delivery system for approximately 2 million of the nations estimated 3.4 million Native Americans, including Alaska Natives. Its fiscal year 2010 appropriated budget totaled approximately $4.05 billion. Health services are
provided directly by the IHS, through tribally contracted and operated health
programs, and through services purchased from private providers. The federal
system consists of 28 hospitals, 63 health centers, and 31 health stations.
In addition, 34 urban Indian health projects provide a variety of health
and referral services. All 28 IHS-operated hospitals are accredited by the
Joint Commission or certified by the Centers for Medicare and Medicaid
Services.10 The challenge for the IHS is to continue providing access to quality
health care while dealing with the increasing costs associated with pay raises
for staff, population growth, inflation, and staffing and operating costs for
new and expanded facilities.
Federal Employees Health Benefit Plan

The Federal Employees Health Benefit Plan (FEHBP) provides health benefits
to civilian government employees and annuitants of the US government. The
employers pay one-third of the cost of insurance, and the government pays
the other two-thirds. FEHBP is financed and managed by the federal Office
28
of Personnel Management (OPM) via a managed competition system by

allowing qualified insurance companies, employee associations, and labor
unions to promote health insurance plans to governmental employees. The
financing formula for FEHBP is complex, combining two types of caps on
the government contribution: a dollar cap and a percentage cap. The dollar
cap is calculated on the basis of 72 percent of average premiums, weighted
by enrollment among about 280 plans. The percentage cap is 75 percent, so
that no matter what the premium actually is, the government will pay no
more than 75 percent of the premium. In the past 8 years, FEHBP premiums
have risen by an average of 65 percent, far faster than the average growth of
national health care costs. This out-of-control premium increase has caused
significant concerns for both the government and federal employees.11
The Childrens Health Insurance Program

The Childrens Health Insurance Program (CHIP) is financed jointly by the
state and federal governments to provide health insurance to children whose
parents earn too much to qualify for Medicaid but not enough to afford
private insurance. The program also seeks to cover uninsured children whose
parents health insurance does not cover their dependents. Through Title XXI
of the Social Security Act, state governments may design a new childrens
health insurance program (CHIP), a separate child health programs, expand
its Medicaid programs (CHIP Medicaid expansion programs), or combine
these approaches (CHIP combination programs). Under CHIP, states receive
higher federal matching dollars than they do for Medicaid. The challenge
for this program is to locate and identify children who qualify for publicly
subsidized health programs. Studies have shown that applications may be a
barrier to families applying for Medicaid for their children. Advocacy groups
and the Health Care Financing Administration (HFCA) have recommended
that states reduce the length and complexity of the application process for
CHIP to make it easier for families.12
Private financing: private health insurance

Private health insurance is the major source of health care coverage for
most Americans, accounting for approximately 40 percent of total health
care expenditures since 1990.13 It is financed by channeling funds through
multiple organizations and by contractual arrangements with both patients
and health care providers. In its complex cost-sharing system, patients are
required and obligated to pay a certain amount of out-of-pocket costs
before the insurance policy begins to pay. These include:
premiums: the amount a patient pays for insurance coverage in for a

specific period;
deductibles: the amount patients pays before the insurance starts covering
services;
29
copayments: the amount patients pays for a specific health service; and
coinsurance: the percentage amount patients pay for specific health services.
The precise amount and percentages of these out-of-pocket payments vary
with each insurance policy. Private health insurance is available to groups as
well as individuals. Group health insurance provides health benefits through
employers, professional and religious organizations, or other groups. Because
of its group purchasing power, a group health plan usually can negotiate a
better premium rate than an individual plan by reducing transaction costs.
However, private insurance also can be sold directly to individuals, especially
to those who are self-employed or work for small companies that provide
no health benefits to employees. Group and individual plans can be further
classified as either fee-for-service or managed care.
Fee-for-service
Fee-for-service plans, also called indemnity plans, pay or reimburse the
doctor, hospital, or other health care provider for all or part of the fees
charged. Because this type of plan gives patients the highest level of freedom
to choose a health care professional, it is particularly attractive to patients
who need frequent access to specialty health providers and services such as
cancer treatment. However, patients with fee-for-services plans usually have
to pay higher out-of-pocket costs than they would for other types of private
insurance plans. Fee-for-service policies also typically have annual caps which
limit the out-of-pocket expenses a patient can incur in one year.
Managed care
Managed care is a generic term for various health care payment systems that
aim to contain costs by controlling the type and level of services provided.
Managed care is an attempt to respond to the high degree of continual
change resulting from market forces, health care practices, laws or regulations (especially in Medicare and Medicaid), as well as other unpredictable
circumstances. As a result, financial and reimbursement mechanisms rarely
are found in a standard structure. Through its contractual providers, the
managed care organization monitors and controls each financial transaction
associated with medical services in the event of a patients illness or injury.
Patients are permitted to receive care only from providers inside the network.
Providers may limit services according to guidelines set by insurance policies.
Approvals are required for some services, including visits to certain health
care providers, medical tests, or surgical procedures. Evidence sometimes
is required to ensure that a procedure is medically necessary. Payment may
be subject to utilization review, sometimes with each treatment episode.
Three of the most fundamental types of managed care plans in the US are
30
health maintenance organizations (HMOs), preferred provider organizations

(PPOs), and point-of-service plans (POS).
Health maintenance organizations
Approximately 21 percent of patients in the US with private insurance
have either a contractual or organizational HMO.14 HMOs initially were
focused on preventive care by assigning a primary care physician (PCP)
from their network to each patient for early medical intervention such as
routine check-ups, immunizations, and mammograms. Ultimately, the HMO
system attempted to avoid potential high treatment costs after an illness or
injury. The primary care physician (PCP) acts as a gatekeeper and coordinates
the patients medical care with restrictive services. Two major restrictions
in HMOs are: (1) a gatekeeper policy that requires patients to receive
referrals for specialists from the PCP, who usually is the contracted doctor in
the HMO plan network; (2) mandatory authorization for hospitalization,
which requires health providers (physicians or hospitals) to obtain approval
and necessary documents before admitting the patient. Gatekeeper PCPs are
commonly paid a capitation rate, which is a fixed amount per member per
month (PMPM) for each person assigned to their practices. With the capitation payment system, PCPs may be tempted to use fewer medical services to
achieve greater profits. Even though the HMO model is the most restrictive
plan compared with other managed care plans, this type of coverage accounts
for the largest amount of managed care insurance in the US due to its
continuous success in controlling health care costs.
Preferred provider organizations
Unlike the gatekeeper system used by HMOs, preferred provider organizations (PPOs) allow their patients to see any doctor or visit any hospital without referrals, usually to in-network providers. The in-network
providers usually refer patients to pre-approved health care providers with a
contractual relationship with the insurance company. Depending on the plan
coverage and policy, patients in PPOs are required to pay more out-of-pocket
costs such as premium and coinsurance for utilizing medical services from
out-of-network providers. In addition, almost all PPO coverage includes
a deductible. PPOs are particularly attractive to patients who need greater
flexibility and accessibility to specialty physicians and medical services.
Point-of-service plan
A point-of-service (POS) plan is a hybrid of HMOs and PPOs. Like the HMO
gatekeeper physicians system, patients select a primary care physician from
the POS network as their point of service provider to oversee their medical
services in general. However, patients do not need a referral to see other
doctors in or out of network, as in a PPO. A higher premium rate and larger
31
copayment are required if patients decide to use medical services outside the
POS network.
Challenges for US health care financing

Health care spending
US health care spending grew faster than the GDP over the past 40 years.15
The Office of the Actuary (OACT) of the Center for Medicare and Medicaid
Services reported that 17.4 percent of GDP was spent on health care in
2009, for a total of $2.5 trillion, or $7960 per capita, which was more
than twice of the average of health care spending for the Organization for
Economic Co-operation and Development (OECD; Figure 2.3). The OACT
also predicted that national health expenditures would rise steadily, with
a 6.7 percent growth rate annually. At this rate of growth, it is estimated
that health care costs will be nearly $4.5 trillion in 2019, reaching up
to 19.3 percent of GDP16,17 (Figure 2.4). Even though the US economy
went into recession in the beginning of the 21st century, US health care
industry costs kept growing. Concerns about which factors play major roles
for out-of-control rising health care costs have become much more critical
in recent years. Ten important factors have been identified and are recognized consistently from study to study: (1) technology, (2) demographics,
18
Private
17.4
Public
14
12
10
8
6
12.0
11.8
11.6
11.5
11.4
11.4
11.0
10.9
10.3
10.1
10.0
9.8
9.7
9.6
9.6
9.5
9.5
9.5
9.5
9.3
9.2
9.1
8.7
8.5
8.4
8.2
7.9
7.4
7.4
7.0
6.9
6.8
6.4
6.1
16
United States
Netherlands (2)
France
Germany
Denmark
Canada
Switzerland
Austria
Belgium (1)
New Zealand
Portugal (2008)
Sweden
United Kingdom
Iceland
Greece (2007)
Norway
Ireland
OECD
Spain
Italy
Slovenia
Finland
Slovak Republic
Australia (2008)
Japan (2008)
Chile
Czech Republic
Israel
Hungary
Poland
Estonia
Korea
Luxembourg (2008)
Mexico
Turkey (2008)
Figure 2.3 Total health expenditure of OECD countries as a share of gross domestic product,
2009. OECD, Organization for Economic Co-operation and Development. http://www.oecd.org/
newsroom/healthspendingcontinuestooutpaceeconomicgrowthinmostoecdcountries.htm/.
32
U.S. healthcare spending

16.0% of GDP in 2007
2007
2005
2002
1999
1996
1993
1990
1987
1984
1981
1978
1975
1972
1969
1966
1963
1960
5.2 6
10
12
14
16
Percent of GDP
Figure 2.4 US health care spending as a percentage of gross domestic product (GDP), 1960 to
2007. (Datasource: http://stats.oecd.org/Index.aspx?DataSetCode=SHA.)
(3) health status, (4) health insurance, (5) income, (6) physician specialty
mix and supplier-induced demand, (7) productivity trends, (8) managed
care, (9) changing market structure and entrepreneurship, and (10) medical
malpractice liability.18
US health care in an international context

US health care spending is far outstripping that of all other OECD countries,
in quality, efficiency, fairness, and value of its health care system. The World
Health Organization (WHO), in its World Health Report 2000, ranked the
US health care system 37th among WHOs 191 member nations, behind almost all the industrialized countries.19 The US is the only industrialized country that does not ensure that all citizens have some kind of health insurance
coverage, resulting in a significant high uninsured rate of 16.7 percent of
the populationor 50.7 million residents in 2009.20 Expensive US health
33
care has not produced better measurable health outcomes, such as increased
life expectancy, reduced infant mortality, and reduced obesity, than other
industrialized countries that spend far less. The United Nations World Population Prospects Report ranked US life expectancy 36th in the world, well
below that of most developed countries (e.g., Japan, Switzerland, Australia,
UK, Germany) and some developing countries (e.g., Chile, Costa Rica). The
infant mortality rate in the US is 629 per 100,000 live births or 6.3 per 1000
live births, significantly higher than that in Singapore (2.31 per 1000 live
births) and Japan (2.79 per 1000 live births). The adult obesity rate in the
US (30.6%) is the highest of all the OECD countries, followed by Mexico
(24.2%), United Kingdom (23%), Slovakia (22.4%), Greece (21.97%), and
Australia (21.7%).21,22
Conclusions
The US health care system faces continuing financial challenges. As health
care costs have continued rising since the 1960s, its financial issues have
been prominent policy concerns at national, regional and local levels. These
multifaceted problems demand a well-conceived and long-term health care
reform strategy. Proposals for health care reform surfaced in the Nixon, Ford,
Carter, Clinton, and Bush administrations. In 2010, the Obama administration passed legislation that involved significant and fundamental changes in
the health care system. This new health care reform will be implemented
over much of the next decade under the Patient Protection and Affordable
Care Act (PPACA) and Health Care and Education Reconciliation Act of
2010. The primary aspects of the law are reform of both public and private
health insurance programs, to increase access to health care and reduce the
long-term costs of national health expenditures. Currently, it is too early to
assess the impact of President Obamas health reform. However, its complex
provisions have already proven to be difficult to interpret and implement.
Regardless of how well health care financing is restructured, this can only
be a means to an end. The ultimate endpoint is to provide affordable,
high-quality health services to all the US population.

1. Starr P. The social transformation of American medicine. New York: Basic Books;
1949:6078.
2. Braverman J. Health economics. London: Pharmaceutical Press; 2010:125.
3. Truffer C, Keehan S, Smith S, et al. Health spending projections through 2019: the
recessions impact continues. Health Affairs 2010; 29(3):5229.
4. DeVavas-Walt C, Bernadette P, Smith J. Income, poverty, and health insurance coverage
in the United States: 2007. Washington, DC: U.S. Census Bureau. Government Printing
Office; 2008:1927.
5. Medicare Spending and Financing. The Henry J. Kaiser Family Foundation Fact Sheet.
August 2010. www.kff.org/medicare/upload/7305-05.pdf [accessed December 12, 2012].
34
6. Medicare Prescription Drug Coverage-General Information. http://www.cms.gov/

Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/index/html?redirect=/
prescriptiondrugcovgenin/01 Overview.asp [accessed December 12, 2012].
7. United States Department of Health and Human Services, Centers for Medicare Medicaid
Services. Medicaid: financing and reimbursement. www.cms.gov/MedicaidRF/ [accessed
August 30, 2012].
8. United States Department of Veterans Affair, Federal Benefits for Veterans, Dependents
and Survivors. Chapter 1: VA health care benefits. www.va.gov/opa/publications/benefits
book/benefits chap01.asp [accessed August 30, 2012].
9. TRICARE Supplement to the Military TRICARE Health Plan. www.tricaresupplement.
us/about-tricare.pdp [accessed August 30, 2012].
10. U.S. Department of Health and Human Services, Indian Health Service. IHS Fact Sheets:
Indian Health Service: a quick look. www.ihs.gov/factsheets/index.cfm?module=dsp fact
quicklook/ [accessed February 02, 2013].
11. AFGE: proud to make America work. Federal Employees Health Benefits Program.
www.afge.org/index.cfm?page=2008ConferenceIssuePapers&Fuse=Content&
ContentIS=1410 [accessed December 12, 2012].
12. Brown JG. Department of Health and Human Services. Office of Inspector General. The
Childrens Health Insurance Program: states application and enrollment processes: an
early report from the front lines. http://oig.hhs.gov/oei/reports/oei-05-98-00310.pdf; May
1999. [accessed August 30, 2012].
United States, 2010, with special feature on death and dying. www.cdc.gov/nchs/data/hus/
hus10.pdf; 2011 [accessed August 30, 2012].
14. Miller R, Luft H. Managed care plans: characteristics, growth and premium performance.
Ann Rev Public Health 1994; 15:43759.
15. U.S. Department of Commerce. Bureau of Economic Analysis. Gross domestic product (GDP): current-dollar and real GDP. www.bea.gov/national/; 2011 [accessed August 30, 2012].
16. U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. National health expenditure data: NHE fact sheet. www.cms.gov/NationalHealth
ExpendData/25 NHE Fact Sheet.asp; 2011 [accessed August 30, 2012].
17. Keehan S, Sisko A, Truffer C, et al. Health spending projections through 2017: the
baby-boom generation is coming to Medicare. Health Affairs 2008; 27(2):w14555.
18. Ginsburg P. High and rising health care costs: demystifying U.S. health care spending.
Research synthesis report no. 16. Robert Wood Johnson Foundation; 2008.
19. World Health Organization assesses the worlds health systems. http://www.who.int/infpr-2000/en/pr2000-44.html [accessed December 12, 2012].
20. DeVavas-Walt C, Bernadette P, Smith J. Income, poverty, and health insurance coverage
in the United States: 2009. Washington, DC: U.S. Census Bureau; 2010:228.
21. Department of Economic and Social Affair. Population Division. World Population
Prospects: The 2006 Revision. C2007. www.un.org/esa/population/publications/wpp
2006/WPP2006 Highlights rev.pdf [accessed December 12, 2012].
22. OECD Health Data. How does the United States compare. 2005. http://www.eocd.org/
health/healthpoliciesanddata/34970246.pdf [accessed December 12, 2012].
3
Managed care pharmacy is the medication therapy component of the

coordinated approach to the delivery of health care services in the United
States known as managed care. This chapter describes managed care
characteristics, types of managed care models, tools used in the practice of
managed care pharmacy, and the roles pharmacists play in managed care
settings. The reader will be able to (1) define managed care, (2) explain
how and why managed care pharmacy tools are used, and (3) describe the
functions a pharmacist performs when practicing managed care pharmacy.
A bibliography for further information is included.
What is managed care?

Managed care is an organized health care delivery strategy designed to improve both the quality of and accessibility to appropriate health care services
while containing costs. It is based on integrating the services rendered by
an interdisciplinary team of health care professionals who are focused on
the care necessary for a given patient. To achieve this end, managed care
organizations focus on prevention of disease, wellness, improved quality of
life for patients, optimization of outcomes, and cost containment for both
the patient and the payer.
Managed care strategies are distinguished from fee-for-service approaches, which focus on insurance coverage for an individual service or
product a patient receives without regard to appropriateness of care or
coordination of that care.
In a managed care organization, the delivery of health care services is
driven by sound medical treatment and prescribing guidelines or protocols,
also called critical pathways or therapeutic guidelines. The protocols
are defined by assessment of evidence-based medicine findings. Protocols
recommend a series of actions concerning a specific disease or condition involving drug therapy and all other aspects of patient care, such as laboratory
tests, X-rays, and surgery. They are designed to enhance consistency, improve
36
quality of care, and improve outcomes for patients, while reducing costs.
Providers under contract with a managed care organization agree to use these
protocols as guidelines in treating their patients. Continual assessment of the
quality of health care services and their appropriateness for the patient is an
essential element of this systemized approach to delivery of services. In the
delivery of the pharmacy benefit, managed care pharmacy tools are used to
enhance patient care while containing costs.
The degree to which a managed care organization is able to engender
adherence to practice guidelines differentiates managed care models. The
greater the control a managed care organization has over the delivery of
services, the lower the cost of those services (Figure 3.1).
A broad spectrum of managed care models exists, defined by the extent of
integration of services by the practitioners treating a patient. They include:
health maintenance organizations (HMOs);

preferred provider organizations (PPOs);
point-of-service plans (POS);
integrated delivery systems (IDS); and
pharmacy benefit management companies (PBMs).
HMOs are the prototype from which other managed care organizations
spring. The characteristics intrinsic to HMOs are to be found to a greater or
lesser degree in each of the other model types. In todays competitive health
care marketplace, it is common for health plans to offer prospective clients
a variety of managed care options. It then becomes the employer-purchasers
decision as to the level of provider choice that is available to members and
the level of out-of-pocket expense the member must incur. As a general rule,
the more highly controlled a health plan is, the lower the premium is to the
employer. Conversely, the fewer benefit controls that are in place, the higher
the premium will be. Employers must balance employee choice with cost
when choosing the managed care model they will offer to their employees.
Benefit Control vs. Cost

HMO
Figure 3.1
PPO
POS Plan
IDS
Fee-forService
Greater
Lower
Control,
Control,
Lower Costs
Greater Costs
Benefit control versus cost.
37
Health maintenance organizations

HMO members must use services provided by practitioners and hospitals
affiliated with the HMO. Employers, on behalf of their workforce, pay a
premium that obligates the HMO to deliver all necessary covered services.
Members are encouraged to select a primary care physician who is responsible for coordinating all medically necessary health care services. Members
are usually assessed out-of-pocket copayments for given services. Panels of
practitioners define practice guidelines and evaluate the quality of services
rendered by benchmarking performance against defined measures.
Staff and group model HMOs employ their practitioners or have exclusive
contracts with a defined medical group. Network models and independent
practice association (IPA) model HMOs contract with practitioners and hospitals in the community who agree to treat HMO members. The practitioners
negotiate fixed reimbursement rates and are provided with HMO practice
guidelines. Contract arrangements with multispecialty group practices and
independent physician practices often entail the practitioner sharing a degree
of financial risk with the HMO.
Preferred provider organizations

Preferred provider organizations (PPOs) are organized groups of communitybased health care providers available to members. PPOs generally provide an
expansive choice of practitioners who agree to provide members with covered
services under a negotiated fee schedule. Contractual arrangements often do
not include financial risk on the part of the practitioner. Members are not
obligated to coordinate their care through a primary care physician. There
is less direct contact between practitioners and the health plan in the PPO
model than in the HMO model.
Point-of-service plans
A point-of-service (POS) plan is a combination of an HMO and a PPO. The
employer contracts with the POS plan under which covered members may
choose for any given service to receive their care from HMO providers or
from community-based PPO providers who are under contract. Because the
plan has a much closer working relationship with HMO providers who are
practicing under plan protocols than is the case with PPO providers, member
HMO copayments are lower than PPO copayments. POS plans are structured
in this way to encourage members to use the more highly coordinated HMO
system.
Integrated delivery systems

Integrated delivery systems (IDSs), also commonly referred to as physician
hospital organizations, are integrated systems of care that usually are built
38
around a broad-based hospital complex that offers a full array of services

both to those members enrolled in its health plan offerings and to the general
public within the hospitals catchment area. Employer contracts with an IDS
ensure discounts on services provided. An IDS will credential its practitioner
network and may or may not impose financial risk-sharing on those practitioners under contract. Examples of integrated delivery systems include the
Henry Ford Hospital System in Michigan and the Geisinger Hospital System
in Pennsylvania.
Pharmacy benefit management companies

Pharmacy benefit management (PBM) companies administer all aspects of
a prescription drug benefit. A PBM may be owned by or affiliated with an
insurance company, a managed care organization, or a community pharmacy
chain corporation, or it may operate as a private, independent enterprise.
PBMs may provide services directly to enrollees, as is the case under Medicare
Part D prescription drug plans. More typically, PBMs contract with health
plans or employers for the administration of their prescription drug benefit.
PBMs often operate their own mail service pharmacies.
Managed care pharmacy tools

In a managed care system, the pharmacist is an integral part of the health
care delivery team. Pharmacists practicing in managed care settings apply
their skills in areas such as assessing the appropriateness of medication
therapy, cost containment, and quality enhancement. They improve patient
care through their work in formulary system development and management,
pharmacy benefit design, disease state management, patient and provider
education, outcomes research, drug utilization management, data integration
and analysis, network management, and contract negotiations. With their
unique pharmacological and drug information knowledge, managed care
pharmacists have a critical role in assuring that the patient receives optimal results from medication therapy in a timely and cost-effective manner.
Like their counterparts in other areas of pharmacy practice, managed care
pharmacists are engaged in developing and implementing medication therapy
management programs, which are covered in Chapter 5.
The managed care pharmacy tools used to accomplish these results include:
use of generics;
formularies;
aids to formulary decision making, including:
comparative effectiveness research;
39
outcomes research; and

pharmacoeconomics
formulary management tools, including:
step therapy;
quantity limits; and
prior authorization.
drug utilization review;

contract negotiations;
provider and member education; and
quality measurement.
Use of generics
A brand-name drug is a patented drug marketed by the original drug manufacturer following the drugs approval by the US Food and Drug Administration (FDA). The manufacturer receives a patent on the drug, which gives
it the right to make and market that drug without any competition. When a
patent expires on a brand-name drug, other companies can start marketing
generic versions of the drug after receiving FDA approval.
Generic drugs are clinically equivalent to brand-name drugs. They contain
the same active ingredient(s), are of the same dosage form, have the same
route of administration, are identical in strength or concentration, and can
be expected to have the same effect and safety profile when administered to
patients under the conditions specified in the labeling. Generics usually are
available at a significant cost-savings compared to the brand-name drug.
Most managed care organizations structure their prescription drug coverage to promote the use of generic drugs because those usually offer greater
value to payers and patients. This is often achieved by using a tiered copayment structure, where the copayment for generic drugs is lower than that
for brand-name drugs, as well as by encouraging prescribers to consider
drugs in a therapeutic class that have a generic alternative instead of a newer,
single-source therapy that does not yet have a generic equivalent. (Tiered
copayments are discussed in the following section, Formularies.)
Formularies
Formulary management is an integrated patient care process that enables
physicians, pharmacists, and other health care professionals to work together to promote clinically sound, cost-effective medication therapy and
positive therapeutic outcomes. Managed care pharmacy uses the formulary
management tool to effectively use health care resources to minimize overall
medical costs, improve patient access to more affordable care, and provide
an improved quality of life.
40
The drug formulary management system is an ongoing process whereby

a health care organization, through its physicians, pharmacists, and other
health care professionals, establishes policies on the use of drug products
and therapies, and identifies drug products and therapies that are the most
medically appropriate and cost-effective to best serve the health interests of a
given patient population. These systems are used by hospitals, managed care
organizations, pharmacy benefit management companies, and government
health care programs including the Veterans Administration, the Department
of Defense, Medicaid, and Medicare.
The major component of a drug formulary management system is the drug
formulary itself. This is a continually updated list of medications and related
information representing the clinical judgment of physicians, pharmacists,
and other experts in the diagnosis and/or treatment of disease and promotion
of health. Prescription drugs that are listed on a formulary are available to
the members of a managed care organization as a covered benefit.
However, a formulary system is much more than a list of medications
approved for use by a managed health care organization. A formulary system includes the methodology an organization uses to evaluate clinical and
medical literature and the approach for selecting medications for different
diseases, conditions, and patients. Policies and procedures for the procuring,
dispensing, administering, and appropriate utilization of medications also
are included in the system.
Formulary systems often contain additional prescribing guidelines and
clinical information that help health care professionals promote high-quality,
affordable care for patients.
Finally, for quality assurance purposes, managed health care systems that
use formularies have policies in place to give physicians and patients access
to non-formulary drugs where medically necessary.
Formularies are categorized by type according to the benefit design chosen by the purchaser of a managed care organizations coverage option.
Under an open formulary, coverage typically is available for all formulary
and non-formulary drugs. Some drug classes, such as those for cosmetic use
or over-the-counter drugs, may be excluded from coverage. Physicians are
encouraged to prescribe formulary agents. Patients typically incur additional
out-of-pocket expenses for using non-formulary drugs.
Under a closed formulary, non-formulary drugs are not covered. Formulary exception policies allow patients and physicians reimbursement and
access to non-formulary medications where medically appropriate.
Most managed care organizations use tiered copayments in their pharmacy benefit design. Copayments are tiered as an incentive to both the
prescriber and the patient to use the most cost-effective medications that are
included on a formulary (Table 3.1).
41
Table 3.1 Common tiered copayment structures

Tier
Used under
Medications included
Copayment level
First
Open and closed formularies
Generics
Nominal: $58
Second
Preferred brands
Increase over first-tier level
Third
Open formularies only;

non-formulary medications are not
covered under closed formularies.
Non-formulary
Increase over second-tier

level
Specialty
High-cost specialty
products
Sizeable copayment or
coinsurance percentage
The decision to include or exclude a medication on a formulary is made by

a pharmacy and therapeutic (P&T) committee or an equivalent body. P&T
committees include physicians, pharmacists, and other professionals in the
health care field. P&T committees often include nurses, legal experts, and
administrators. When a medication or therapy under consideration warrants
focused expertise, informed specialists are asked to participate. P&T committee members are required to reveal any conflicts of interest. Most managed
care organizations choose to keep the identity of P&T committee members
confidential so that outside influence is avoided.
The P&T committee is responsible for developing, managing, updating,
and administering the formulary. The committee meets regularly to review
newly available drug therapies and treatment options. It is responsible for
the design of formulary system policies on utilization of and access to medications.
Clinical pharmacists who staff P&T committees prepare detailed
manuscripts for committee members to use in reaching their decisions. The
manuscripts include some or all of the following:
FDA-approved prescribing information and related FDA information,

including safety data;
medical and clinical literature, including:
clinical trials and treatment guidelines;

comparative effectiveness reports; and
pharmacoeconomic studies and outcomes data (The Academy of Managed Care Pharmacys Format for Formulary Submissions, available
at www.amcp.org, is the most common dossier framework used by
manufacturers to provide detailed information on their products to
P&T committees.)
relevant information on use of medications by patients and experience

with specific medications;
current therapeutic use and access guidelines and the need for revised or
new guidelines;
42
economic data, such as total health care costs, including drug costs; and
health care provider recommendations.
When two or more medications produce a similar effect and are safe for
use in patients, then business elements such as cost, supplier services, ease
of delivery, or other unique properties of the agents are considered when
determining which agent to include on the formulary.
The overall goal is to develop a list of the safest, most effective medications that will produce the desired goals of therapy at the most reasonable cost to the health care system. It is estimated that in coming years,
genetic-based medicine, also referred to as personalized medicine, will impact
formulary decision-making.
Aids to formulary decision making

Highly developed formulary decision-making involves the use of sophisticated health care tools, including the application of comparative effectiveness
research (CER) results, outcomes research, and pharmacoeconomics.
Comparative effectiveness research

In 2009, the Institute of Medicine defined CER as the generation and
synthesis of evidence that compares the benefits and harms of alternative
methods to prevent, diagnose, treat, and monitor clinical conditions or to
improve the delivery of care.1
Physicians, pharmacists, other health professionals, patients, and purchasers of health care need objective, easily accessible, evidence-based information regarding the comparative effectiveness and value of prescription
drugs in order to make knowledgeable and informed decisions. Prescribers
and patients require this information to evaluate treatment options, which
may include prescription drugs, and select the one most likely to achieve
a desired therapeutic outcome. Those entities that pay for prescription drug
benefits require this information so they can design a benefit that ensures that
patients receive the best value for the resources expended. In recent years, the
federal government has set aside substantial resources to fund CER studies.
Additionally, the 2010 Affordable Care Act established the Patient-Centered
Outcomes Research Institute to help ensure that patient interests would be a
primary focus of CER study. Countries outside the United States also conduct
similar studies. Notably, in the UK, CER is carried out by NICE (National
Institute for Health and Clinical Excellence).
Outcomes research
Outcomes research provides evidence about the benefits, risks, and results of
treatments. It can identify potentially effective strategies to implement and
improve the quality and value of care interventions. In the pharmacy arena,
43
it is used to support formulary decisions, drug use policies, clinical treatment

guidelines, and program evaluations.
Outcomes research can entail three types of outcomes analysis: economic,
clinical, and humanistic.
Economic considerations include direct medical costs for physician visits,
hospitalizations, and medication; direct non-medical costs for such items as
transportation and caregiver expenses; and indirect costs, including loss of
productivity. The economic characteristics are evaluated using an array of
economic analyses such as cost-benefit, cost-effectiveness, cost-minimization,
cost-utility, and budget impact models.
Clinical considerations include the evaluation of clinical disease markers
such as blood pressure, glucose levels, and cholesterol; the impact of the
disease on the patient; medication safety and the impact of the medication
regimen on the patient; as well as adherence trends. The clinical characteristics are evaluated using clinical trials and risk evaluation and mitigation
strategies (REMS).
Humanistic considerations include health-related quality of life; patient
satisfaction; and patient preference. The humanistic characteristics are evaluated through patient surveys such as the Consumer Assessment of Health
Plan Survey (CAHPS) series.
Pharmacoeconomics
Pharmacoeconomics is a complex analytical tool used to determine which
drug product alternative produces the best health outcome for the resource
invested. Pharmacoeconomic evaluations consider cost compared to consequences of alternatives. Sound studies are characterized by analysis of cost,
including both direct and indirect medical and nonmedical items; varying
perspectives of either the patient, the provider, the payer, or society; sensitivity
analysis; accuracy; and transparency. Its results help to inform the formulary
decision-making process.
Formulary management tools

Managed care systems use several pharmacy tools to administer a formulary.
These are designed to help the prescriber and patient choose the safest and
most cost-effective drug to treat a given condition. These tools include step
therapy, quantity limits, and prior authorization.
Step therapy
Step therapy is the process of stepping up through a sequence of alternative
drug therapies until an effective treatment regimen for the patients condition
is identified. Step therapy programs require the prescriber to start with
the simplest, safest drug. If a patient fails on the first-line medication, a
44
second-line therapy can be tried, and so on. Under step therapy protocols,
second- and third-line medications will not be covered if the prior level of
medication has not been tried. The claim will not be paid or approved, and
the dispensing pharmacist will be asked to confer with the prescriber.
Quantity limits
Quantity limits are safety edits built into a formulary management system
claims adjudication program to prevent patients from refilling prescriptions
too soon. A prescription indicates the dosage level and duration that, in
the prescribers judgment, is appropriate to treat the patients condition.
Quantity limits are based on clinical guidelines for a given medication to
ensure its proper use without causing harm to the patient. If a request to fill
a prescription is blocked by a quantity limit, the refill will not be approved
for coverage. The claim will not be paid or approved, and the dispensing
pharmacist will be asked to confer with the prescriber.
Prior authorization
Prior authorization is an administrative tool normally used by managed
care organizations that requires the prescriber to receive pre-approval for
prescribing a drug in order for the drug to qualify for coverage under the
terms of the pharmacy benefit. Prior authorization programs are intended to
approve coverage of certain specific medications when defined and specific
criteria are first met. Prior authorization programs are designed by clinical
managed care pharmacists and are approved by P&T committees. They are
commonly used when medications require specialized expertise on the part
of the prescriber to ensure patient safety or when medications are extremely
costly. The goal of prior authorization programs is to build in guaranties
that prior authorized medications are being used for only their intended
purposes.
Drug utilization review

Drug utilization review (DUR) is an authorized, structured, ongoing review
of prescribing, dispensing, and use of medication. Other terms considered
synonymous with DUR include drug use evaluation, medication use evaluation, and medication use management.
DUR encompasses a drug review against predetermined criteria that
results in changes to drug therapy when these criteria are not met. It involves a comprehensive review of a patients prescription and medication
data before, during, and after dispensing to ensure appropriate medication
decision-making and positive patient outcomes. As a quality assurance measure, DUR programs provide corrective action, prescriber feedback, and
further evaluations. DUR is classified in three categories:
45
Prospective: evaluation of a patients drug therapy before medication is

dispensed. Electronic DUR programs are used for communication between dispensing pharmacies and managed care organizations; very often
prior authorization criteria are included in these communications.
Concurrent: ongoing monitoring of drug therapy during the course of
treatment. Concurrent DUR often involves the intervention of case managers, particularly with the use of specialty pharmaceutical agents that
necessitate tightly controlled medication regimens.
Retrospective: Review of drug therapy after the patient has received
the medication. A review of medical charts, electronic medical records,
and/or claims data can assess appropriate drug use and provide analysis
of provider prescribing patterns. This type of analysis can be a tool in
advising prescribers on the constructive use of medications.
Managed care pharmacists participating in DUR programs can directly
improve the quality of care for patients, individually and as populations,
by striving to prevent the use of unnecessary or inappropriate drug therapy,
prevent adverse drug reactions, and improve overall drug effectiveness.
Contract negotiations
To administer the pharmacy benefit, managed care organizations depend on
two fundamental contract avenues: (1) establishing networks of dispensing
pharmacies and (2) contracting with pharmaceutical manufacturers for specific products. Pharmacist expertise is necessary for both.
Contracts with networks of dispensing pharmacies

Note: Staff and group model HMOs generally use in-house pharmacies.
PBMs often own their own mail service pharmacies. This discussion of
contracting with networks of dispensing pharmacies does not address either
of these alternatives.
Managed care organizations must provide the members they service with
access to pharmacies where prescriptions may be obtained. Most managed
care organizations offer the member a choice of filling a prescription either through face-to-face encounters at network community pharmacies or
through mail service pharmacies. In a network pharmacy arrangement, the
managed care organization does not receive shipments of drugs or take direct
ownership of them from the manufacturer.
Specific accessibility requirements are defined in the contract between the
managed care organization and the plan purchaser, e.g. an employer or a
government program. Those requirements typically are defined in term of
access, i.e., the distance a member must travel to reach a network pharmacy,
and/or density, i.e., the number of pharmacies available to a member within
the access requirement.
46
The managed care organization will select its network pharmacies in

order to be competitive in the community. Pharmacies view network status as
necessary to position themselves as attractive outlets to the consuming public
in order both to encourage foot traffic in their stores and to fully satisfy
customer needs. A typical network contract will reimburse the pharmacy
according to an agreed upon formula. Most commonly, the formula is the
average wholesale price of the drug less a discount, plus a dispensing fee.
In urban areas where there are numerous pharmacies in competition with
one another, the managed care organization has a contracting advantage
because numerous configurations of pharmacies can be structured to meet
accessibility requirements. In rural areas, a single pharmacy that may serve a
wide area has a contracting advantage in negotiations with a managed care
organization that must have that pharmacy in their network in order to meet
accessibility requirements.
Contracts with pharmaceutical manufacturers for product

Note: This discussion of contracting with pharmaceutical manufacturers applies only to arrangements under network pharmacies. Different contracting
mechanisms are available to staff and group model HMO pharmacies and
mail service pharmacies.
Managed care organizations concentrate their purchasing power to acquire the least expensive therapeutically safe and effective drugs that are
appropriate for the majority of patients, while allowing use of alternatives
for individual patients with special medical needs.
Rebate discounts are the most common mechanism that pharmaceutical
manufacturers use to provide lower pricing to managed care organizations,
because most prescriptions are dispensed to plan members through network
pharmacies. A rebate is broadly defined as a discount that occurs following a
purchase wherein the manufacturer of the product returns some of the money
that was paid for the product.
Various types of rebate agreements are used by pharmaceutical manufacturers based on plan and formulary design. The most common are market
share rebates and formulary access rebates.
Market share rebate arrangements offer a variable percentage of rebate
dollars based on the market share level a drug captures compared with other
similar drugs in the same class. This type of rebate is considered for use
depending on factors such as:
the number of drugs within a class of medications;

utilization levels of a particular drug; and
the ability to increase a drugs market share in the class of medications beyond what advertising or the manufacturers sales force could potentially
achieve.
47
Under formulary access rebates, manufacturers may offer a rebate to a managed care organization for placement of a drug on a formulary once the
drug has been judged clinically appropriate by a P&T committee. This is a
particularly critical decision under a closed formulary where non-formulary
drugs are not covered. In a tiered arrangement, the placement of a medication
in a tier with a lower copayment for the member can make it a more
attractive alternative to other drugs in the same class.
Provider and member education

A managed care organizations success is correlated directly with the extent
to which both its providers and its members use the features of the system
that are designed to provide medically necessary care at affordable costs.
Therefore, managed care organizations recognize the importance of educating both audiences on the rationale for the systems design and how it can
promote high quality care while reducing overall health care costs.
The goals for provider education are to enhance knowledge, align practice
patterns with established protocols, and promote the use of best practices.
Providers will be receptive to educational outreach if they perceive it will
lead to improved quality of care, reduction in adverse events, and greater
responsiveness to patient demands. Because health care practitioners time
is limited, outreach must be focused and immediate. Common topics include data on new products or pipeline agents, new treatment guidelines
or protocols, and coverage updates. Of particular usefulness are individual
practitioner utilization audits, which display a given practitioners performance against a peer group. If the practitioners practice style reveals outlier trends, there is incentive to bring that practice into conformity with
the peer group.
The goals for member education are to provide clinical counseling on
the use of medications, promote awareness and advantages of preventive
care, encourage healthy lifestyles, and increase member satisfaction. Messages that garner greatest attention are those that help members decrease
out-of-pocket costs, encourage greater self help, offer support systems, and
provide incentives for self care. Educational content must be developed so
that it is understandable based on the recipients health literacy. This factor is
vital in achieving effective messaging.
In the pharmacy benefit arena, member education programs focus on
drug information, including benefits of therapy, potential adverse events,
counseling tips, and formulary status of a given drug, as well as tools for
increasing medication adherence. Managed care organizations often use call
centers staffed by pharmacy clinicians to provide 24/7 availability to members who seek medication counseling. This avenue is commonly used in the
administration of medication therapy management programs.
48
Quality measurement
Health care observers agree: you cannot manage what you cannot measure.
Managed care organizations must be able to evaluate the quality of services
that are being provided to their members to ensure performance levels meet
targeted outcomes. Quality measurement not only can benchmark practitioner performance against specified metrics, but also can be used to indicate
areas for improvement in protocols so as to encourage the most effective
results of health care services.
Health care quality accreditation entities develop measures designed to
provide this vital management information. They include the National Committee for Quality Assurance (NCQA), the Joint Commission for Accreditation of Health Care Organizations, and URAC (previously known as the
Utilization Review Accreditation Commission). The National Quality Forum
is an umbrella organization that strives to introduce uniformity among
myriad health care quality metrics by endorsing measures that meet rigorous
standards.
Alliances dedicated to reaching consensus on quality measurement in
different areas of health care delivery operate in this environment. The
Pharmacy Quality Alliance (PQA) addresses quality measurement in the
ambulatory pharmacy arena with measures that help to assess the value
of medication-related services. PQA demonstration projects have shown a
correlation between the use of quality measures and improvement in patient
care in the pharmacy setting.
Examples of quality indicators include:
The Centers for Medicare and Medicaid Services (CMS) star rating system
NCQAs Health Plan Employer Data and Information Set
PQA measures.
Roles pharmacists play in managed care settings

The managed care setting offers a wide variety of roles for the pharmacist
to play. These roles fall under operational functions and corporate functions.
Both require clinical skills and business acumen. These managed care pharmacy tools require a pharmacists knowledge and expertise at each step in
their implementation.
Operational functions
Use of generics
Managed care pharmacists staff drug information units within managed
care organizations that provide the clinical appraisal of generic agents that
should be considered for formulary inclusion and practice protocols that
49
guide the prescribing of those generics. They must be fully familiar with the
FDAs approval processes and conversant with the peer-reviewed literature
addressing generics.
Formularies
Managed care clinical pharmacists have fundamental responsibilities within
the formulary decision-making process. Often they serve as voting pharmacy
and therapeutics committee members to determine which medications will
be included on the formulary and what administrative policies will be put in
place to make those medications available to health plan members.
Clinical pharmacists prepare detailed evidence-based manuscripts for
P&T committees to use as they either consider individual drugs or perform class reviews. The manuscripts are developed from scrutiny of available peer-reviewed literature, which is ranked according to its soundness,
manufacturer-prepared dossiers, FDA data, therapeutic guidelines, relevant
provider and patient information, and economic data.
Once a product is approved for inclusion in the formulary, managed care
pharmacists develop practice guidelines for prescribers under contract to use
as they treat patients. Consumer guides are developed to help the patient
understand how to use the medication to its best effect.
Managed care pharmacists advise on the structure of tiered copayment
arrangements. Decisions on tier placement of a medication influence its use
by both prescribers and patients. The pharmacists advice on tier placement
must consider both the clinical value of the product and its cost implications.
Aids to formulary decision making
Aids to formulary decision making include comparative effectiveness research studies, outcomes research, and pharmacoeconomics. These highly
sophisticated analyses call upon managed care pharmacists to:
identify end points for evaluation through drug use evaluation processes;
evaluate published clinical literature on the research topic to assess validity and usefulness;
assist in design, analysis, sensitivity testing, and evaluation of research

studies; and
assess results in order to design, implement, and monitor practice protocols.

Formulary management tools
A formulary management system incorporates the administrative tools of
step therapy, quantity limits, and prior authorization. Each of these mechanisms require a managed care pharmacists in-depth clinical understanding
of a given agent, its molecular structure, dosage variations, and documented
use in treatment of disease. Based on analysis of these data, the pharmacist
assists in the development of formulary management system processes.
50
Drug utilization review

All forms of drug utilization review involve the managed care pharmacist in
both their design and their implementation.
Under prospective DUR, the managed care pharmacist builds clinical edits for claims adjudication programs that will alert the dispensing pharmacist,
based on the patients medication profile, to the potential for an adverse drug
event if the prescribed item is dispensed.
Under concurrent DUR, case management for patients on complex medication regimens often is used to monitor for both patient compliance with the
therapy and adverse reactions. The managed care pharmacist may be involved
in the development of case management protocols and/or the provision
of case management services to the patient. The latter involves significant
interaction with the patient, his or her caregivers, and the treating physician.
Under retrospective DUR, the managed care pharmacist analyzes prescriber and patient activity with the goal of improving the use of medications.
The pharmacist determines criteria to be used, reviews collected data and
assess them against the criteria, uses the results to suggest interventions to
optimize outcomes, and then evaluates the effect of those interventions.
Contract negotiations
Managed care pharmacists contract with employer and health plan clients,
network pharmacies, and manufacturers to structure business arrangements
that:
establish networks of pharmacies to provide accessibility for member

populations and ensure participating pharmacy compliance with patient
safety and quality programs;
allow their clients to customize clinical and reporting requirements to
meet their individual population needs;
negotiate with manufacturers for discounts on drug prices, including
rebates, for clients in exchange for moving market share when clinically
appropriate; and
assist clients in assessing the appropriateness of new drugs compared to
existing therapeutic options.
Provider and member education

Managed care organizations use a variety of methods to communicate with
their providers and their members. Typically these include newsletters and
web-based tools designed to help both audiences be productive users of the
health care delivery systems features.
Managed care pharmacists provide academic detailing to prescribers to
help educate them on the range of uses of a given medication. Often this
involves both explanation of the rationale for a medication being included
51
on the formulary and any formulary management toolse.g., prior authorization or step therapythat might be attendant on that medication.
Additionally, managed care pharmacists will review a physicians utilization,
contrasting that physicians practice results with a peer group. The purpose
is to help the physician understand how his or her practice patterns stack up,
not only against their peers but also against clinical therapeutic guidelines.
For the member, managed care pharmacists develop messaging that is
included in mailings and explanations of benefits geared to help the member
understand the structure of his or her health benefits coverage. Clinical
managed care pharmacists work in call centers to answer member questions
about their medications, resolve adverse drug events, outline appropriate use,
and encourage compliance. The managed care call center pharmacist can be
particularly effective in helping members in this manner because he or she can
bring up on line the members individual medication profile. This overview
of the patients entire prescription drug regimen allows identification of redundant prescriptions and the potential for harmful drugdrug interactions.
The phone call interaction between the managed care pharmacist and the
patient is an ideal platform for performing medication therapy management
for patients.
Quality measurement
Development of measures for assessing the performance quality within pharmacy networks is the responsibility of the pharmacist, who works in unison
with the managed care organizations quality managers. The managed care
pharmacist provides input on what can reasonably be assessed, how feasible
it will be to implement a measure, and what potential improvements in
care can be expected. Such practitioner input is critical in order to develop
meaningful quality measures.
Once a measure is used, the managed care pharmacist can work with
network pharmacies to explain the results and indicate areas for continued
improvement in patient services.
Corporate functions
Managed care organizations employ pharmacists in roles that are less traditional. They include:
account management: consultative, day-to-day management of clinical

offerings to clients;
clinical program development: creation and implementation of utilization

management programs, both within the managed care organization and
at its client settings;
drug information, medication use policy or medication safety: provision
of internal and external customers with pertinent drug data;
52
rebate management: contracting with manufacturers;

network management: support of network design and contracting;
specialty products: management of high-cost, high-tech product offerings;
informatics: support of client reporting and complex database analyses;
product development: ongoing support for a variety of client offerings,
both internally and externally;
marketing: support of corporate initiatives to promote the organization;
and
regulatory/compliance: support government relations and legal staff in
regulatory and compliance matters related to pharmacy.

1. Initial national priorities for comparative effectiveness research. Washington, DC: The
National Academies Press; 2009.
Bibliography
Academy of Managed Care Pharmacy. AMCP Format For Formulary Submissions, Version 3.0,
October 2009. www.amcp.org/AMCPFormatforFormularySubmissions/ [accessed September 12, 2012].
National Committee for Quality Assurance. HEDIS and quality measurement. www.ncqa.org/
tabid/59/default.aspx [accessed September 12, 2012].
Navarro RP. Managed care pharmacy practice. 2nd edition. Sudbury (MA): Jones and Bartlett;
2009.
Pharmacy Quality Alliance web site. http://www.pqaalliance.org/ [accessed September 12,
2012].
4
Albert I. Wertheimer, Jr., PhD, MBA
In 2008, the US health care industry consumed about 16.2 percent of the
value of all of the goods and services produced in the United States, which
amounts to a whopping $2.34 trillion.1 It has been projected that this
consumption will double by the year 2019, to approximately $4.6 trillion.
The health care industry functions through the efforts of millions of men and
women employed in the health field; in fact, the health care industry usually
is considered the third largest industry in the United States today, following
defense and agriculture. The health care industry is an umbrella term that
includes several hundred occupations, some of which may be considered
professions. Various definitions differentiate professions from occupations.
Most definitions, though, agree that at least several characteristic activities
must be present for an occupation to receive the status of a profession. Some
of these characteristic activities are as follows:
Exercise self-regulation and policing.

Put the interests of the patients first (altruism).
Exercise judgment in the routine conduct of ones work.
Become the exclusive keeper of a body of knowledge.
There usually is a trade-off in contemporary societies by which controlled

access to the professions is granted, yielding a monopolistic situation. In
exchange, members of that professional body agree to be accountable to
the society, to pass required licensure examinations, and to maintain their
competence. Consequently, pharmacists or physicians have wide latitude in
their professional practices, based on their professional judgment and, in
exchange, agree to pass rigid licensing examinations after qualification from
specified, approved educational institutions of mandated course content and
length and, subsequently, to continue their education through attendance
at mandatory continuing education programs. Regulatory boards routinely
inspect pharmacists and physicians practice sites and receive any complaints
from consumers.2
54
Prescribing authority
When considering specific personnel roles and responsibilities, pharmacists
are interested in the controls placed on the prescribing of drugs. Those who
are permitted to write prescriptions for prescription-legend drugs are listed
in Table 4.1.3
These tabular data require a little further explanation. In North America,
the broadest prescription writing authority is granted to practicing MDs and
DOs. The conventional physician (MD) may practice, including the writing
of prescriptions, within the state or states in which he or she is licensed.
There is no major difference between the education of physicians in the
UK and the United States, but in the United States, medical study follows a
4-year undergraduate education. In the UK, medical education usually begins
immediately after completion of secondary school; therefore, in England,
the physician earns a bachelor of medicine degree (MB). This certification
is accepted in the United States as equivalent to MD when the physician
successfully completes the several US licensing examinations. Osteopathic
physicians (DOs) have, for all intents and purposes, the same education as
Table 4.1 Professions with drug-prescribing authority
Title
Abbreviations
Authority
Notes
Medical doctor (allopathic)
MD
Independent
Dentist
DDS or DMD
Independent
For appropriate use, dental related
Podiatrist
DSC, PodD, DPM
Independent
As appropriate, for extremities

(hands, feet)
Osteopathic physician
DO
Independent
Optometrist
OD
Independent
Most for ophthalmic products in a

number of states (usually office based
diagnostics only)
Veterinarian
DVM
Independent
For animals only
Nurse practitioner
NP
Dependent
Protocols, prescriptions need to be

co-signed (vary in scope)
Physician assistant
PA
Dependent
Protocols, prescriptions need to be

co-signed (vary in scope)
Chiropractor
DC
None
No prescribing authority whatsoever
Certified nurse midwife
CMW
Dependent
May prescribe only medication

specified by a practice agreement in
collaboration w/a supervising
physician.
(Data from Bureau of Health Manpower Education. Certification in allied health professions. 1971 conference proceedings. DHEW Publ. No. NIH 73-246. Washington, DC: Department of Health, Education, and
Welfare; 1971.)
55
medical doctors (MDs), but are educated in a different system with different
origins. Practice acts in most states permit MDs and DOs to undertake the
same spectrum of activities. The osteopath, to be sure, must not be confused
with the optometrist (OD). In dentistry, the DMD and DDS degrees also are
interchangeable and equal, but the academic degree is based on the traditions
at the specific professional school.
The podiatrist is legally entitled to prescribe drugs as related to his or
her practice requirements. The pharmacist should not be surprised to see
antibiotics, analgesics, and dermatologic products ordered by a podiatrist,
but must use professional judgment if a prescription for a drug such as those
used to treat hypertension or arrhythmias, or for contraception, is presented,
as these, in most cases, would be considered beyond the practice scope of
podiatry.4
As previously noted, optometrists (OD) are not the same as DO (osteopaths). The Doctor of Optometry attends a 4-year curriculum following
undergraduate study. These persons examine eyes and fit spectacles and
contact lenses. Optometrists currently are permitted to use and prescribe
prescription legend drugs after having additional training in treatment of
minor eye ailments that fall under their function domain.
Doctors of Chiropractic (DC) are educated in a 4-year curriculum. Chiropractors have no prescribing authority; however, many recommend natural
vitamins as therapies for many conditions. Chiropractors, for the most part,
consider prescription drug medications to be substances foreign to the body
and thus do not consider drugs to be appropriate interventions.
Veterinarians diagnose and treat animals. They are not permitted to write
prescriptions for humans for any reason. As an added word of caution, when
one sees DVM on the top of a prescription, one should be aware that doses
may well differ from those usually encountered in treating adult humans.
Numerous other categories of paraprofessionals have dependent
prescription-writing authority in concert with some protocols or supervisor
requirements. Among those who screen, examine, and diagnose for physicians or treat under their direct or indirect supervision are physician assistants (PAs), nurse practitioners (NPs), and medex (MX). Most have written
instructions that enable them to prescribe a specified range of drugs under
certain conditions dealing with patient status and the results of their physical
assessment of the patient. In fact, at many clinics and health maintenance
organizations (HMOs), the patient first meets a nurse practitioner. If the
problem appears to be trivial or simple, the nurse practitioner may send the
patient for tests, for bed rest at home, or to the pharmacy with a prescription
for an over-the-counter or prescription drug. Where written protocols are not
employed, some practices use a prescription pad where the physician cosigns
or initials the order, indicating that he or she has reviewed the case and
56
approves or endorses the decisions of the paraprofessional. However, greater

latitude for independent prescriptive authority is clearly gaining support.
Another group gaining support for having prescriptive privileges is psychologists, who in some states are allowed to prescribe after they obtain a
doctoral level degreeeither PhD or PsyDand a license to practice independently. In 2002, New Mexico became the first state to allow psychologists
to prescribe psychotropic drugs. Until 2009, five states in the United States
allowed psychologists to prescribe psychotropic drugs.
Currently all 50 states and the District of Columbia have legislation that
entitles certified and licensed physician assistants (PAs), Registered Nurse
Practitioners (RNPs), and Advanced Nurse Practitioners such as midwives
to prescription authority, with limitations to prescription of some controlled
drugs as identified by the Drug Enforcement Administration (DEA). The DEA
has broadly categorized the prescribing authority of health care providers as
follows:
Practitioners: physicians, dentists, veterinarians, and podiatrists who

are licensed/registered/otherwise permitted by the jurisdiction in which
he/she practices to prescribe a controlled substance in course of professional practice.
Mid-level practitioners: RNPs, midwives, PAs, optometrists, pharmacist,
clinical nurse specialists, etc. who are registered, licensed/otherwise permitted to dispense a controlled substance in course of professional practice.
The level of authority given to mid-level practitioners for prescription of
controlled substance is regulated state by state. The states where provisions
allow them to prescribe such drugs are listed in Appendix 4.1.
Pharmacist prescribing
The pharmacists role in prescribing medication has expanded greatly over
the past few decades. Most people are unaware of the role pharmacists
have in health care delivery in addition to dispensing drugs. Drug-utilization
review, administration of vaccines, patient counseling, drug-level laboratory
test monitoring and consultation, prescription of emergency contraception,
equivalent drug selection, and direct drug prescribing are among the expanded roles of pharmacists. Due to the state regulation of pharmacy licenses, the roles of pharmacists vary from state to state.
One of the first pieces of legislation to expand the role of pharmacists,
passed in 1986 in Florida, granted pharmacists the ability to prescribe drugs
that are listed on a strict formulary. This formulary has been expanded since
it was originally passed in 1986. See Appendix 4.3.
Pharmacists also have been granted prescriptive authority for vaccinations. State legislation delineates the rules and regulations of this practice in
57
addition to the formulary of vaccinations. As of 2011, all 50 states in the

United States have laws that allow pharmacists to prescribe and administer
vaccinations to their customers. To be permitted to prescribe and administer
vaccines, pharmacists has must take a 6-month course. Following successful
completion of that course, they are certified to provide vaccinations.
Recently, pharmacists have acquired the ability to prescribe emergency
contraception to patients. Pharmacists must have a physician to partner with,
but they do not have to be partnered with the specific patients physician. This
legislation has been enacted in California, Oregon, New Mexico, and Washington, to name a few. The list of states allowing pharmacists to prescribe
drugs is steadily growing as a result of the increasing physician shortage and
decreasing average American family income.
A fairly recent trend has been the drive for pharmacists to become clinical
pharmacists. Clinical pharmacists are the experts of the pharmacy field in
the use of medicines for treating diseases. In the past, clinical pharmacist
were more confined in their service to the hospitals and clinics, where they
worked in a team along with physicians, providing vital input for improving
the ongoing medical treatment in terms of obtaining better effect, reducing
side effects, and suggesting cheaper and safer options to the physicians.
Many patients have a number of chronic ailments and are already taking
half a dozen other drugs for their chronic diseases. Clinical pharmacists help
in determining what effect the introduction of new medicines would have
on the patients ongoing treatment and suggesting better and safer options
if available or necessary. They also work with patients in improving both
their understanding of their medicines and their compliance. Today, their
availability is increasing outside the hospital setting for review of the drug
to avoid medication errors for the physician and the patient. In some states
in the United States clinical pharmacists are permitted to prescribe certain
drugs if they have a collaboration with a licensed physician with an established protocol. However, in the UK, clinical pharmacists have independent
prescription authority for certain drugs.
Health manpower
A listing of the overall numbers of the major health professions and their
distribution according to industry in the United States can be found in
Appendix 4.2.5 This listing is the latest available; however, it may be dated,
because it was published in 2008.
Health care professions: terms and procedures

In 2008, more than 14 million persons were employed by the health care
industry in the United States, and by 2018 the health care industry is expected
to add more than 3 million new jobs to the U.S. economy. At this time,
58
an astounding 800 primary and alternate job titles have been identified.6
Before delving into this massive list, it is important to understand a few terms
and procedures, e.g., accreditation, certification, registration, and license or
permit.
There are essentially two types of credentialing. One recognizes the
competence of educational programs to prepare personnel. This is generally referred to as accreditation. The second recognizes the competence of
individuals to deliver services. This includes the practices of certification,
registration, or association membership and licensure.
Accreditation
Accreditation may be defined as the process by which an agency or organization evaluates and recognizes a program of study or an institution as
meeting certain predetermined qualifications or standards. It applies only to
institutions and their programs of study or their services. Accreditation of a
training program implies that the educational institution meets the standards
that have been established by the accrediting agency in collaboration with
professional groups.
There are two types of accreditation: institutional and specialized. Institutional accreditation means that the total institution has met the standards
established by the accrediting agency. Specialized or program accreditation
means that a part or parts of an educational institution have met certain criteria, relating usually to a single profession. Thus, accreditation of the whole
educational institution may not be the equivalent of specialized accreditation
for each one of its several parts or programs. This is due chiefly to the fact
that different accrediting agencies are responsible for the various programs,
and, as a result, there are variations in their criteria for accreditation, in
their definitions of eligibility, and in the procedures they use for establishing
standards.6
Certification and registration

Certification is the process by which a non-government agency or association
grants recognition to an individual who has met certain predetermined qualifications specified by that agency or association. Registration is the process
by which qualified individuals are listed on an official roster maintained by a
government or non-government agency.
Within some professions, there are specialty boards, certification boards,
and/or registries established by the profession itself for the purpose of distinguishing quality. Persons who meet set requirements of education, experience, and competency and pass an examination given by the board may use
specific professional designation. For example, MT indicates that the medical
technologist has been registered by the Board of Registry of the American
59
Society of Clinical Pathologists (ASCP). These organizations not only qualify

persons who meet their standards, but also usually know of persons working
toward qualification. They maintain lists of all persons registered to date. The
lists may appear in published form, as in the Directory of Medical Specialists,
which provides information on all physicians who are diplomates of the 22
medical specialty boards approved by the American Medical Association.7
In December 1977, 65 professional health associations formed the National Commission for Health Certifying Agencies as the result of an acknowledged need to develop and encourage high standards of professional
conduct among health certifying agencies. The commission has set nationwide standards for the certifying agencies, which attest to the competence of
the individuals who participate in the health care delivery system.
License or permit
Licensure is the process by which an agency of the government (1) grants
permission to persons meeting predetermined qualifications to engage in a
given occupation and/or use a particular title or (2) grants permission to
institutions to perform specified functions. A license or permit to practice
within a state, issued by a state agency, is a means by which some health
personnel may be identified. More than 30 occupations in the health field are
licensed in one or more states. All states and the District of Columbia require
that the following health personnel be licensed to practice: chiropractors,
dental hygienists, dentists, environmental health engineers, nursing home administrators, optometrists, pharmacists, physical therapists, physicians (MDs
and DOs), podiatrists, practical nurses, psychologists, registered nurses, and
veterinarians. Licenses are required in at least one state for another 18
occupations, and one occupation is licensed only in Puerto Rico.7
The remaining sections of this chapter provide a closer look at the
profession of medicine, followed by a similar scrutiny of the profession of
pharmacy. Finally, some current issues and trends will be examined.
Physicians
Physician specialization
In the 1930s, about 80 percent of physicians were in primary care and
general practice, with about 20 percent in specialties. Specialists earning
higher incomes received greater respect and had other advantages, including
control of hours, a more limited body of knowledge with which to remain
current, and client control. As a result, by 1970, more than 70 percent of
physicians (DOs and MDs) in the United States were in practices limited to
specialty boundaries. The result of this pendulum swing was an oversupply of
specialists and a shortage of primary care physicians. The federal government
60
aided efforts aimed at producing more primary care practitioners, with the
outcome that family practice became a specialty area, and family practice
grew in the late 1970s and 1980s. A review of MD practice types is presented
in Table 4.2.8
In the late 1960s and early to mid-1970s, there were physician shortages
in numerous areas of the country and within several medical specialties. As a
result, some clinical pharmacy activities were welcomed by some members of
the medical community. In the mid-1980s and for the foreseeable future, the
physician shortage has diminished, relatively speaking, as paraprofessionals,
greater manpower production, and the use of automation have decreased in
demand. Some argue that the self-help movement, the continued growth of
chiropractic, better public health education, prevention campaigns, improved
immunizations, and better nutrition have further reduced the demand for
physical services. Some clinical pharmacy functions may now be in jeopardy
as physicians endeavor to reclaim lost functions and to maintain their income
levels.
Looking to the future, as current baby boomers age, there will be a
sharp increase in the number of people in need of medical care. It has
been projected that currently there is a shortage of 20,000 physicians in
the US health system, and that shortage will rise to 150,000 in the coming
15 years as the population continues to age. The shortage is poised primarily
in the primary care sector. The US government has undertaken a number
of steps to counteract this shortage by allocating funding and incentive to
increasing medical education opportunities and residency training positions.
Nonetheless, the gap between demand and supply seems to be too large to be
filled by these measures, and greater roles for paraprofessionals such as PAs,
RNPs, and RPHs are likely to be seen in the coming years.
Pharmacy personnel and practice site

The Pharmacy Manpower Project Inc., established in 1989, collects, analyzes,
and distributes data regarding the size and demography of the pharmacy
practitioner workforce, their work characteristics, and their work contribution. They conduct a survey nationwide every 5 years; their last report was
for 2009. Some of the key findings of the report are:
The proportion of licensed pharmacists actively practicing pharmacy increased between 2004 and 2009. This increase was due mostly to the
increased prevalence of part-time work by actively practicing pharmacists.
The percentage of licensed pharmacists who held a PharmD degree increased from 13.9 percent in 2000 to 21.6 percent in 2009.
The overall work contribution of practicing pharmacists is broken down
in Figure 4.1.9
Table 4.2 Physicians by gender and specialty 2009 (figures in thousands)

Activity
Doctors of medicine, total
2009
Total
Office-based
972.4
560.4
720.3
421.8
Place of medical education

US medical graduates
Canadian medical graduates
International medical graduates
12.1
252.1
138.6
Male
684.7
399.1
Female
287.7
161.2
Gender
Distribution by major specialty

Allergy/immunology
4.3
3.4
Anesthesiology
42.7
31.3
Cardiovascular diseases
22.8
17.4
7.4
5.3
Child psychiatry
Dermatology
11.2
9.2
Diagnostic radiology
25.6
17.1
Emergency medicine
32.4
20.0
Family practice
86.8
68.8
Gastroenterology
13.0
10.3
General practice
9.2
7.7
General surgery
38.0
24.7
162.4
109.3
Internal medicine
Neurological surgery
5.6
4.0
Neurology
15.5
10.4
Obstetrics and gynecology
42.9
34.1
Ophthalmology
18.3
15.7
Orthopedic surgery
25.0
19.2
Otolaryngology
10.3
8.0
Pathology
19.8
10.9
Pediatrics
78.1
53.6
Physical med./rehab.
8.8
6.3
Plastic surgery
7.3
6.1
Psychiatry
40.6
26.2
Pulmonary diseases
10.9
7.7
9.2
6.8
10.5
8.7
Unspecified
9.6
3.6
Not classified
57.4
(X)
122.1
(X)
Radiology
Urological surgery
Other categories
Data from American Medical Association, Chicago, IL, Physician characteristics and distribution in the U.S.,
annual; and Anonymous, Health, United States, 2003. Hyattsville, MD: U.S. Dept. of HHS, 2003.
61
62
Work distribution
Other Activities
6%
Research
4%
Education
5%
Business/Organi
zation
Management
14%
Medicine
Dispensing
55%
Patient Care
Service
16%
Figure 4.1
Work distribution of practicing pharmacists. (Data from reference 9.)
The primary work of the pharmacist differs in different settings. Pharmacists working in a traditional (i.e., independent, chain, supermarkets)
pharmacy setting devoted 70 percent of their time to dispensing medicines
and 10 percent to patient care services, whereas hospital and patient
care pharmacists devoted 27 percent of their time to patient care and
43 percent of their time to medication dispensing.
In every practice setting, pharmacists would like to spend less time in
medication dispensing and business/organization management and more
time in patient care services, education, and research activities.
It has been projected that in the future more time will be devoted to
patient care services, including specialty pharmaceuticals, management
of people/information/organization/systems, education, and research.
The National Aggregate Demand Index (ADI) for pharmacists declined
from 4.09 in 2007 to 3.96 in 2008, to 3.79 in 2009. (ADI rates on a
scale where 1 = supply exceeds demand, 2 = some excess of supply,
3 = balance between supply and demand, 4 = moderate difficulty in
filling vacancies, 5 = difficulty in filling vacancies.)
This downward trend in the ADI for the pharmacy profession could be due
to the increase in the number of pharmacy schools or colleges opened in
recent years. This has increased the number of pharmacy graduates, who
are then added to the total census of pharmacists, after passing licensure
exams every year. Although this increase has helped in catering to the high
demands for pharmacy professionals in health and research institutes, it also
has produced a surplus of professionals, many of whom are now finding it
difficult to secure practice placement. The dwindling demand-to-supply ratio
63
could reduce the attractiveness of the field to new individuals due to reduced
job prospects and earnings, especially in these times of economic recession
where the profession of pharmacy is facing restructuring of work hours, job
layoffs, early retirement incentives, and change in service offerings.10
Specialization
The Board of Pharmaceutical Specialties (BPS), which is composed of representatives from American pharmaceutical organizations, was organized as an
independent certification body of the American Pharmaceutical Association
in 1976 (see also Appendix 4.4). Since then this organization has prepared
guidelines for specialization and certification in a number of specialties
within the profession of pharmacy. As of 2011, the BPS has recognized six
specialty areas:11
Ambulatory care pharmacy (2011): Specialists are responsible for the
provision of integrated, accessible health care services. These pharmacists

are accountable for addressing medication needs, developing sustained
partnerships with patients, and participating in the context of family and
community.
Nuclear pharmacy (1978): Specialists seek to improve and promote the
publics health through the safe and effective use of radioactive drugs for
diagnosis and therapy.
Nutrition support pharmacy (1988): Specialists promote the maintenance
and/or restoration of optimal nutritional status, designing and modifying
treatment according to the needs of the patient.
Oncology pharmacy (1996): Specialists recommend, design, implement,
monitor, and modify pharmacotherapeutic plans to optimize outcomes in
patients with malignant diseases.
Pharmacotherapy (1988): Specialists are responsible for ensuring the
safe, appropriate, and economical use of drugs in patient care and commonly serve as a primary source of drug information for other health care
organizations.
Psychiatric pharmacy (1992): Specialists address the pharmaceutical care
of patients with psychiatric disorders.
Most pharmacists who wish to obtain specialist training have earned a

Doctor of Pharmacy degree (PharmD), following which they complete 1 year
of post-graduate training in either general or specialty pharmacy residency to
become a clinical pharmacist and go on to become board certified from the
BPS.
The roles of the clinical pharmacist in the work setting often involves, but
is not limited to, providing the following:
drug information;
drug utilization;
64
drug evaluation and selection;

medication therapy management;
formal education and training program faculty positions;
disease state management; and
application of electronic data processing (EDP).11
This growth of specialization within the profession is bound to have an

impact. It could be in the form of higher salaries, intra-professional turf
battles, the greater use of pharmacist substitutes, the growth of labor union
representation, or perhaps in other areas not even envisioned today.
Pharmacy issues and trends

The issues and trends in pharmacy are essentially the same ones facing all
health professions. All health professions worry about the impact of technology and change, keeping current with new discoveries, financial security,
and the status of the profession, as well as its welfare. In pharmacy, the
full impact of the specialization trend has not yet been fully appreciated.
Varying components of specialization may be positive or negative, depending
on ones location. There is little or no evidence available for predicting
whether hospitals or extended care facilities or other large employer groups
will acknowledge specialty status or whether the specialty group itself will
be successful in convincing accreditation organizations to require the use of
board-certified specialists.
Employment of pharmacists is expected to grow by 17 percent between
2008 and 2018, which is faster than the average for all occupations. The
increasing numbers of middle-aged and elderly peoplewho use more prescription drugs than younger peoplemay continue to spur demand for
pharmacists throughout the projection period. In addition, as scientific advances lead to new drug products, and as an increasing number of people
obtain prescription drug coverage, the need for these workers will continue
to expand. The work settings that are expected to provide most of the new job
offerings for pharmacists would be nursing homes, assisted living facilities,
and home care settings. In these jobs, pharmacists would have consultation
opportunities in educating and advising patients regarding the optimum use
of medicines in terms of cost and benefit and minimizing drug interactions
and side effects. With an increasing senior population, this service is definitely
heading for a boom in job offerings. In addition, there are number of new
opportunities for pharmacists, as in managed care organizations, where they
analyze trends in medication use; pharmacoeconomics, where they calculate
the cost and benefit of different drugs and treatment modalities; research
and disease management, where they develop novel treatment methods for
preventing and treating diseases; and also in sales and marketing positions
with pharmaceutical manufacturing firms. A relatively new emerging field is
65
pharmacy informatics, which uses information technology to improve patient

care. Job opportunities for pharmacist in patient care also are expected to
increase as cost consciousness in insurance companies and health system
increases. It has been found to be more economical to prevent a disease
than to treat it. Pharmacists also can reduce the cost incurred because of
unwanted complications from drug interactions and adverse drug reaction
(Table 4.3).12
The use of auxiliary personnel also requires rigorous evaluation. Pharmacy technicians increasingly are being trained in vocational-technical
schools, at junior colleges, and on the job. Preparing for the expected growth
in the use of pharmacy technicians, the American Society of Health-System
Pharmacists created the Task Force on Technical Personnel in Pharmacy,
which prepared proposed guidelines for the use of technicians and other information for the use of hospital pharmacy directors.10,13 A number of other
entities have considered these personnel questions, but the future direction of
the overall health care system will determine the future of pharmacy practice,
for the most part, as the tail cannot wag without the dog. Their fullest
utilization appears to be limited by what some consider arbitrary or baseless
limits or ratios for their use. There is no evidence that a pharmacist cannot
effectively supervise many technicians under the appropriate circumstances.
Community pharmacies are employing more pharmacy technicians and
pharmacy aides and increasing their utilization of automated drug dispensing
systems to rapidly expand their ability to fill more prescriptions. Other,
newer cost control methods encourage the use of lower-cost prescription
drug distributors through online pharmacies and mail-order firms for dispensing certain medications. This could limit the growth of jobs among
pharmacists.
The pharmacy technicians group has organized. It has its own journal,
The Journal of Pharmacy Technology, and one can expect to hear more from
its representatives. The profession of pharmacy can expect to be called upon
Table 4.3 Degrees held by active US pharmacists
Degree
Percentage of total
BS
66.3
PharmD
21.6
MS/MBA
9.2
PhD
1.7
Others
1.2
Total
(Data from Final Report of the National Pharmacist Workforce Survey: 2009.)
100
66
to define limitations on the use of technical personnel and technician practice

constraints. Technicians, on the other hand, may argue that they are equally
competent to perform certain functions.
The jury is still out as to whether the concept of pharmaceutical care will
be accepted by payers, patients, and other health professions and HMOs. At
the moment, it is not looking promising.
Technology will continue to have a major impact in the field. It can
be expected that computers will continue to spread into every aspect of
health care activity. Artificial intelligence will further fuel this expansion
of computer involvement. Major strides in robotics may affect pharmacy
staffing, especially in routine, repetitive tasks such as repackaging, ointment
making, and other bulk compounding. Other automatione.g., counting
machines, generation of labels from the spoken word, and changes in dosage
forms and delivery systemswill surely affect personnel needs and training
requirements in the near future.
Politics and economics will also have a significant impact on pharmacy
practice. Budget pressures on HMOs and health insurers may catalyze
cost-cutting efforts in pharmacy. This may also be the case with services
rendered for the government, whether or not cost-containment activities are
continuous. How well conventional pharmacy practice fares in defending its
turf against physician dispensing, mail-order pharmacy, and other internal
and external assaults on the status quo will likewise have a major impact on
practice characteristics.
In summary, health care staffing needs form a complex web of interacting
concerns that vibrate in reaction to numerous forces: economic, political,
technical, governmental, professional, and historical, among others. These
reactions result in decisions and compromises that further result in practice
and education changes several years later. Pharmacy staffing needs are not
insulated from or immune to external forces or unpredictable events. Discussions today about the role of pharmacy in home care might be translated into
actual practice changes in a few years.
Appendix 4.1
Authority granted by the Drug Enforcement Administration to mid-level
practitioners for prescribing controlled substances, by state
State
RNP
OD
PA
RPH
Alabama
No
3,4,5 (A,P)a
3,4,5 (A)
No
Alaska
2,3,4,5
3,4,5 (P)
2(A,D) 3,4,5(P)
No
Arizona
2,3,4,5
3 (P,D,A)
2,3,4,5
No
(continued)
67
State
RNP
OD
PA
RPH
Arkansas
3,4,5 (P,D)
3,4,5
3,4,5 (P,A)
No
California
2,3,4,5 (P,D,A)
2,3,4,5,(P,D,A)
2,3,4,5 (P)
Colorado
2,3,4,5
3,4,5
2,3,4,5
No
Connecticut
2,3,4,5
2,3,4,5
2,3,4,5
No
Delaware
2,3,4,5 (P)
No
2,3,4,5 (P)
No
District Of
Columbia
2,3,4,5 (P)
No
2,3,4,5 (P,D)
No
Florida
No
No
No
No
Georgia
3,4,5
3,4
3,4,5 (P)
No
Guam(TT)
No
No
2,3,4,5 (P,D)
No
Hawaii
No
No
3,4,5 (P,D,A)
No
Idaho
2,3,4,5
2,3,4,5
2,3,4,5 (P)
No
Illinois
2,3,4,5(P,D,A)
3,4,5 (P)
2,3,4,5 (P,D,A)
No
Indiana
2,3,4,5
No
3,4,5
No
Iowa
2,3,4,5
2,3,4,5
2,3,4,5
No
Kansas
2,3,4,5
2,3,4,5,
2,3,4,5
No
Kentucky
2,3,4,5(P)
3,4,5
No
No
Louisiana
2,3,4,5
3,4,5(P,A)
3,4,5(P)
No
Maine
2,3,4,5
3,4,5
2,3,4,5(P.D)
No
Maryland
2,3,4,5
No
2,3,4,5
No
Massachusetts
2,3,4,5(P,A)
No
2,3,4,5(P,A)
2,3,4,5(P)b
Michigan
2,3,4,5(P)
3,4,5
2,3,4,5(P)
No
Minnesota
2,3,4,5
4,5
2,3,4,5
No
Mississippi
2,3,4,5
4,5(P)
2,3,4,5
No
Missouri
No
2,3,4,5
3,4,5(P)
No
Montana
2,3,4,5 (48-h supply only)
2,3,4,5
3,4,5
2,3,4,5
Nebraska
3,4,5(P); 2(72-h supply

only)
2,3,4,5
3,4,5(P); 2(72-h
supply only)
No
Nevada
2,3,4,5 (P,D,A)
2,3,4,5 (P,A)
2,3,4,5(P.D,A)
No
New Hampshire
2,3,4,5
3,4,5
2,3,4,5
No
New Jersey
2,3,4,5(P)
3,4,5(P)
2,3,4,5(P)
No
New Mexico
2,3,4,5
3,4,5
2,3,4,5
2,3,4,5
New York
2,3,4,5
No
2,3,4,5(P)
No
North Carolina
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5(P,D,Pr)
North Dakota
2,3,4,5
2,3,4,5(P)
3,4,5(P)
(continued)
68
State
RNP
OD
PA
RPH
Ohio
2,3,4,5(P,D)
3(P)
2,3,4(P)
No
Oklahoma
2,3,4,5
3,4,5
2,3,4,5(P,A)
No
Oregon
2,3,4,5
3,4,5
2,3,4,5
No
Pennsylvania
2,3,4,5
3,4,5
2,3,4,5
No
Puerto Rico
No
No
No
No
Rhode Island
2,3,4,5
3,4,5(P)
2,3,4,5
No
South Carolina
3,4,5
3,4,5
3,4,5
No
South Dakota
2,3,4,5
2,3,4,5
2,3,4,5
No
Tennessee
2,3,4,5(P,D,A)
2,3,4,5
2,3,4,5(P,D)
No
Texas
3,4,5(P,A)
2,3,4,5(P,A)
3,4,5(P,A)
No
Utah
2,3,4,5
3,4,5
2,3,4,5
No
Vermont
2,3,4,5
3,4,5
2,3,4,5
No
Virgin Islands
4,5
No
No
No
Virginia
2,3,4,5
3,4,5
2,3,4,5
No
Washington
2,3,4,5
3,4,5
2,3,4,5
2,3,4,5
West Virginia
3,4,5
3,4,5
3,4,5
No
Wisconsin
2,3,4,5
3,4,5
2,3,4,5
No
Wyoming
2,3,4,5
3,4,5
2,3,4,5
No
a Numerals 2, 3, 4, and 5 refer to drug schedules, as follows:
Schedule 2: Substances included have high abuse potential with morphine, codeine, and methadone.
Schedule 3: Substances included have abuse potential but less than those in schedule 2, e.g., nalorphine.
Schedule 4: Substances with less abuse potential.
Schedule 5: Substances with minimal abuse potential.
b Allowed only in hospital setting.
A, administering; D, dispensing; OD, optometrist; P, prescribing; PA, physician assistant; RNP, registered nurse
practitioner; RPH, registered pharmacist.
Appendix 4.2
Health care practitioners and technical occupations (Bureau of Labor statistics, 2008)
Occupation title
No. employed
Healthcare practitioners and technical occupations (total)
7 346 580
Chiropractors
26 250
Dentists, general
87 700
Oral and maxillofacial surgeons
5 330
Orthodontists
5 580
(continued)
Occupation title
No. employed
Prosthodontists
670
Dentists all other specialists
5 010
Dietitians and nutritionists
53 510
Optometrists
26 480
Pharmacists
268 030
Anesthesiologists
34 820
Family and general practitioners
97 820
Internists general
50 070
Obstetricians and gynecologists
19 940
Pediatricians general
30 100
Psychiatrists
22 690
Surgeons
43 230
Physicians and surgeons all other
293 740
Physician assistants
81 420
Podiatrists
9 310
Registered nurses
2 655 020
Occupational therapists
100 300
Physical therapists
180 280
Radiation therapists
16 590
Recreational therapists
20 830
Respiratory therapists
109 270
Speech-language pathologists
112 530
Therapists all other
16 170
Veterinarians
54 480
Audiologists
12 860
Health diagnosing and treating practitioners all other
31 390
Medical and clinical laboratory technologists
164 430
Medical and clinical laboratory technicians
156 480
Dental hygienists
177 520
Cardiovascular technologists and technicians
48 720
Diagnostic medical sonographers
53 010
Nuclear medicine technologists
21 600
Radiologic technologists and technicians
216 730
69
(continued)
70
Occupation title
No. employed
Emergency medical technicians and paramedics
221 760
Dietetic technicians
23 890
Pharmacy technicians
333 500
Psychiatric technicians
72 650
Respiratory therapy technicians
13 570
Surgical technologists
92 260
Veterinary technologists and technicians
79 870
Licensed practical and licensed vocational nurses
730 290
Medical records and health information technicians
176 090
Opticians dispensing
62 200
Orthotists and prosthetists
5 940
Health technologists and technicians all other
87 900
Occupational health and safety specialists
54 680
Occupational health and safety technicians
10 040
Athletic trainers
16 290
Healthcare practitioners and technical workers all other
55 720
Healthcare support occupations (total)
3 962 930
Home health aides
982 840
Nursing aides orderlies and attendants
1 451 090
Psychiatric aides
64 730
Occupational therapy assistants
27 720
Occupational therapy aides
7 180
Physical therapist assistants
65 960
Physical therapist aides
45 900
Massage therapists
60 040
Dental assistants
294 030
Medical assistants
523 260
Medical equipment preparers
47 310
Medical transcriptionists
78 780
Pharmacy aides
49 580
Veterinary assistants and laboratory animal caretakers
70 530
Healthcare support workers all other
193 980
Adapted from Bureau Of Labor Statistics.

*Data not inclusive of the large support staff, e.g., cleaners, housekeeping staff.
71
Percent distribution of employment and establishments in health services by

detailed industry sector 2008
Industry segment
Employment (%)
Total
100.0
Ambulatory health care services
42.6
Offices of physicians
17.0
Home health care services
7.2
Offices of dentists
6.2
Offices of other health practitioners
4.7
Outpatient care centers
4.0
Other ambulatory health care services
1.8
Medical and diagnostic laboratories
1.6
Hospitals
34.6
General medical and surgical hospitals
32.5
Other specialty hospitals
1.4
Psychiatric and substance abuse hospitals
0.7
Nursing and residential care facilities
22.8
Nursing care facilities
12.2
Community care facilities for the elderly
5.2
Residential mental health facilities
4.1
Other residential care facilities
1.3
Data from BLS Quarterly Census of Employment and Wages 2008.
Employment of wage and salary workers in health care 2008

Occupation
Employment 2008a
Number (thousands)
Percent
All occupations
14 336.0
100.0
Management business and financial occupations
614.6
4.3
Professional and related occupations
6 283.9
43.8
Counselors
171.3
1.2
Social workers
206.7
1.4
Dietitians and nutritionists
35.5
0.3
Pharmacists
67.5
0.5
Physicians and surgeons
512.5
3.6
(continued)
72
Occupation
Employment 2008a
Number (thousands)
Percent
Physician assistants
66.2
0.5
Registered nurses
2 192.4
15.3
Clinical laboratory technologists and technicians
278.8
1.9
Emergency medical technicians and paramedics
142.1
1.0
Licensed practical and licensed vocational nurses
619.1
4.3
Office and administrative support occupations
2 540.3
17.7
Billing and posting clerks and machine operators
194.8
1.4
Receptionists and information clerks
386.3
2.7
Secretaries and administrative assistants
770.7
5.4
a Columns may not add to total due to omission of occupations with small employment.
Data from BLS National Employment Matrix 2008.
Appendix 4.3
Vaccines and drugs for adverse reactions that may be dispensed by pharmacists in the state of New Mexico
Diphtheria, tetanus, and pertussis vaccine (DTP)
Diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
Diphenhydramine injection
Epinephrine injections (pre-measured syringe)
Haemophilus influenzae B vaccine (HIB)
Hepatitis A vaccine
Hepatitis B vaccine
Inactivated polio vaccine (IPV)
Influenza vaccine
Measles, mumps, and rubella vaccine (MMR)
Meningococcal vaccine
Oral polio vaccine
Pneumococcal vaccine
Tetanus toxoid
Tetanus and diphtheria toxoid (Td)
Varicella vaccine
Other vaccines as determined by the CDC or New Mexico Department of
Health that may be required to protect the public health and safety in an
established emergency.
Data from Protocol for pharmacist prescribing of vaccines in the state of New
Mexico. www.nm-pharmacy.com/Pharmacist Prescribing/Rx Rules/Vaccina
tion Protocol/vaccination protocol.htm [accessed September 12 2012].
73
Appendix 4.4
American Pharmaceutical Association
States with some form of Collaborative Drug Therapy Management
(CDTM) as of January 2003
Total number of states with some form of CDTM: 40
Total number of states with statutes authorizing some form of CDTM: 35
Total number of state with regulations (only) authorizing some form of CDTM: 5
Statutory authority (35 States)a
Arizona
Nebraska
Arkansas
Nevada
California
New Mexico
Connecticut
North Carolina
Delawareb
North Dakota
Florida
Ohio
Georgia
Oregon
Hawaii
Pennsylvania
Illinois
Rhode Island
Indiana
South Carolina
Iowa
South Dakota
Kansas
Texas
Kentucky
Utah
Maryland
Virginia
Michigan
Washington
Minnesota
Wisconsin
Mississippi
Wyoming
Montana
Board of Pharmacy Regulations (5 states)
Alaska
Tennessee
Idaho
Vermont
Louisiana
a In addition to the 40 states listed the Territory of Guam also has statutory authority for
collaborative practice.
b Delaware authority limited to immunization prescribing under protocol.
CDTM, collaborative drug therapy management.

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5
Pharmacists and US health
care
Yifei Liu, BSPharm, PhD
According to the US Department of Labor, there were 269,900 pharmacists

in the United States in 2008.1 As the third largest group of health professionals in the country,2 pharmacists play a vital role in improving patients
health outcomes related to medication therapy. This role was summarized
by Helper and Strand under the concept of pharmaceutical care.3 Such a
concept has had a profound impact on the profession in that it goes beyond
pharmacists dispensing medications and emphasizes pharmacists resolving
medication-related problems. The American Society of Health-System Pharmacists has defined the role of the pharmacist as follows: The mission of
the pharmacist is to provide pharmaceutical care. Pharmaceutical care is
the direct, responsible provision of medication-related care for the purpose
of achieving definite outcomes that improve a patients quality of life.4 In
2005, 11 US national pharmacy organizations further developed the practice
model of medication therapy management (MTM), based on the framework
of pharmaceutical care, defining MTM as a distinct service or group of
services that optimize therapeutic outcomes for individual patients.5 The
first core component of MTM is medication therapy review (MTR), which is
the process of collecting patient information, identifying medication-related
problems, and providing solutions to these problems.6
With the expanding professional roles of pharmacists, the connection
between pharmacy practice and business knowledge has become closer. A
pharmacist who wants to provide MTM services may need to perform any
or all of the following activities:
design a service workflow;

identify and target the patients who would benefit from the services; and
decide whether a medication is cost-effective.
The principles of management, marketing, and economics, respectively, can
be applied to these activities. However, the importance of business knowledge
76
in pharmacy practice may be overlooked by pharmacists. A case in point is

that the application of personal selling, a one-to-one promotional activity in
marketing, often is regarded by pharmacists as unnecessary in their practice.7
In fact, the pharmacists understanding the values of a pharmacy service alone
is not sufficient for successful service implementation, and pharmacists must
demonstrate those values to relevant parties, including patients, physicians,
and third-party payers. In implementing a cardiovascular risk management
program, my colleagues and I have identified a major barrier to service implementation the lack of consensus about a services values among relevant
parties.8 Personal selling can be the vehicle for pharmacists to present a
pharmacy service to relevant parties, especially to patients, and build rapport
with them. Personal selling is one of many ways to apply business knowledge
in pharmacy practice. To implement a pharmacy service successfully, the
pharmacist must understand and apply such knowledge.
This chapter focuses on three topics related to pharmacy practice in the US
health care system: the pharmacist workforce; MTR; and the application of
marketing in implementing MTR. The first section provides a brief overview
of the pharmacist workforce, including the shortage of pharmacists and the
practice settings, which sets the background for the other two sections.
The second section describes the process and outcomes of MTR. As the
older population grows and the prescription volume rises, MTR has become
increasingly important to address medication-relations problems. The third
section discusses the application of marketing concepts, including market
segmentation, personal selling, and relationship marketing, in providing
MTR. The application is illustrated by a case analysis.
After reading this chapter, the readers should be able to (1) explain the
major reasons for the pharmacist shortage; (2) describe the characteristics of
the pharmacy practice settings, and trends of these characteristics; (3) discuss the process and outcome of MTR; and (4) understand how to apply
marketing concepts in implementing MTR. This chapter does not intend
to cover every aspect of pharmacy practice, but selectively presents three
topics relevant to MTR. Neither does it attempt to thoroughly review the
application of business knowledge in pharmacy practice. Instead, it is an
introductory reading to explore the application of marketing in implementing
MTR. Readers who would like to learn more in the business field are
referred to three books: Pharmacy Management (2nd edition);9 Marketing
for Pharmacists (2nd edition);10 and Essentials of Pharmacoeconomics.11
The workforce of pharmacists in the United States

The shortage of pharmacists
The Pharmacy Manpower Project, Inc., a nonprofit corporation that reports
workforce data on pharmacists, has developed the Aggregate Demand Index
77
(ADI) to measure the national or regional demand for pharmacists.12 The

index uses a 5-point scale, where 5 stands for a high demand and 1 stands
for a high surplus. During the past decade, the index of national trend data
has stayed above 3.3, indicating that there was a shortage of pharmacists
nationwide. However, in many metropolitan areas, there is now a surplus
of pharmacists. In addition, the US Department of Health and Human
Services, Health Resources and Services Administration, has projected that
the number of pharmacists would reach 319,000 by the year 2030, but that
there would still be a shortage of 38,000 pharmacists at that time.13 Three
major reasons credited for this anticipated shortage are: (1) the growth of the
older population, which is associated with greater medication use; (2) the
increased number of pharmacists, especially women, who work part-time;
and (3) the expansion of pharmacy practice from dispensing prescription
medications to providing other pharmacy services.2,13
The backdrop of the changing US health care system is the increase of
the older population. In 2009, the number of those aged 65 years or greater
was 39.6 million, accounting for 12.5 percent of the total US population.14
The size of this population has increased by 4.3 million since 1999, and is
estimated that it will reach 50 million by 2020. In addition, 57 percent of
this population was women, who have a greater life expectancy than men.
The aging of the US population presents both challenges and opportunities
for health care professionals. For instance, the use of multiple medications,
i.e., polypharmacy, is common among elderly persons. About 21 percent
of people aged 65 years or greater take at least five prescription medications, and people aged 65 years or greater use seven times the number of
over-the-counter (OTC) medications as adults in general.15,16 In the Slone
survey, in the age of group of 65 years or greater, the percentage of women
using any prescription medication was 10 percent higher than men, and the
percentage of women using at least five medications was 5 percent higher.15
Polypharmacy is significantly associated with the risk of adverse drug events,
and this negative outcome is amplified for elderly persons as their physical
and cognitive conditions deteriorate.1720 MTR conducted by pharmacists
can identify and solve medication-related problems due to polypharmacy.
A clear trend in the demographic characteristics of pharmacists is the
increasing number of female pharmacists. In the past four decades, the
percentage of female pharmacists climbed, from 13 percent in 1970, to
32 percent in 1990, and to 46 percent in 2009.2,21 A similar rising trend
also was observed for the number of women earning a PharmD degree,22
which indicates that more female students have chosen pharmacy as their
major in college. In general, as the main caregiver in the family, women in
the workforce tend to work part-time. The percentage of female pharmacists
working part-time was 23 percent in 2000 and 30 percent in 2009, about
11 percent to 13 percent higher than the percentage of male pharmacists who
78
work part-time.21 Despite the increasing number of female pharmacists, the

part-time working pattern could result in a reduction of full-time equivalent
pharmacists.2 Interestingly, female pharmacists are more likely to have job
satisfaction than male pharmacist.21 Being a caregiver for patients, the stability of the profession, and the flexibility to work part-time, could be factors
attracting women to enter the pharmacy profession and to have higher job
satisfaction.
Since the inception of pharmaceutical care as the framework to guide
pharmacy practice, pharmacists have made efforts to extend their roles
beyond dispensing and provide a variety of pharmacy services. For example, in the community setting, pharmacists have provided such services as
MTM, immunization, health screenings, disease state management, weight
management, and smoking cessation.5,23 Meanwhile, pharmacy practice has
been specialized into ambulatory care, nuclear, nutrition support, oncology,
pharmacotherapy, psychiatry, and geriatric pharmacy.24,25 Moreover, employment opportunities are growing for pharmacists in the business sector,
such as pharmaceutical companies and managed care.2 The expansion and
specialization of pharmacy practice, accompanied by job opportunities from
the business sector, have increased the demand for pharmacists.
The shortage of pharmacists not only negatively affects patients access
to health care, but also imposes a high workload on the pharmacist. Over
60 percent of pharmacists working full-time have an increased workload
compared with the previous year.21 In 2009, 68 percent of pharmacists
reported that their workload level was high or excessively high, a 14 percent increase from 2004. To address the pharmacist shortage, two primary
approaches have been (1) expanding PharmD programs and (2) enrolling
more students. New PharmD programs have been established, and existing
PharmD programs have spread out to satellite locations. In 2011, the total
number of pharmacy colleges and schools in the United States reached 124,
and in the fall semester in 2010, there were 56,841 students enrolled in
PharmD programs.26 Although current estimates are that the pharmacist
shortage will continue until 2030,12 the increase of PharmD programs and
student enrollment might allow the supply of pharmacists to meet the demand sooner than expected.
Practice settings
The US health care system consists of three main practice settings: ambulatory care, hospital care, and long-term care.27 For pharmacy practice, the ambulatory care setting also is referred to as the community setting, and can be
further divided by the types of pharmacy: independent pharmacy (fewer than
four units of pharmacy under common ownership); chain pharmacy (four
or more units of pharmacy under common ownership); mass merchandiser
79
pharmacy, and supermarket pharmacy.21,23 These four groups are considered

the traditional community pharmacy or community retail pharmacy.21,28 In
2010, there were 23,117 independent pharmacies, 20,705 chain pharmacies,
8,163 mass merchandiser pharmacies, and 8,392 supermarket pharmacies.29
Compared with figures from 2006, the number of chain and mass merchandiser pharmacies increased, but the number of independent and supermarket
pharmacies declined.
Mail-order pharmacy is another type of pharmacy in the community
setting, with rapidly growing business in the past decade.28 Table 5.1 lists the
volume of prescriptions and the sales of prescriptions drugs across different
settings in 2009.28,30 Notice that although its prescription volume was the
lowest in the community setting, the sales of mail-order pharmacy were the
second highest. The average price per prescription was higher at mail-order
pharmacies, indicating that mail-order pharmacies sell high-cost medications
treating complex medical conditions. The total number of prescriptions dispensed by the five types of pharmacy in the community setting increased from
2.71 billion in 1999 to 3.61 billion in 2009.28 Compared with 1999, the
percentage of prescriptions dispensed by independent pharmacies declined
by 5.3 percent, and the percentage of chain pharmacy, mail-order pharmacy,
and mass merchandiser pharmacy increased by 2.2 percent, 2 percent, and
1 percent, respectively (see Table 5.1).
In 2009, in the community setting, 24.8 percent of actively practicing
pharmacists worked in chain pharmacies, 14.4 percent in independent pharmacies, 9.6 percent in supermarket pharmacies, 4.9 percent in mass merchandiser pharmacies, and 2.3 percent in mail order pharmacies; 26.8 percent
Table 5.1 The volume of prescriptions and sales of prescription drugs across major
settings of pharmacy practice in 2009
Setting
Volume of prescriptions (% of total

volume in community setting)a
Sales of prescriptions
drugs (% of total sales)b
Chain pharmacy
47.9
26.9
Independent pharmacy
20.3
12.7
Supermarket pharmacy
13.5
7.2
Mass merchandiser pharmacy
11.7
7.0
7.0
17.5
Ambulatory care (community)
Mail-order pharmacy
Hospital carec
Not available
22.5
Long-term care
Not available
4.7
a The total number of prescriptions was 3.61 billion.

b The total sales of prescription drugs were $300.3 billion in year 2009.
c The hospital care setting included hospitals and clinics.
(Data from IMS Health and National Association of Chain Drug Stores).
80
worked in the hospital care setting; and 3.2 percent worked in the long-term
care setting.21 Compared with 2000, there was a 1.9 percent decline of
pharmacists working in independent pharmacy, 1.7 percent decline in mass
merchandiser pharmacy, 1.3 percent increase in chain pharmacy, and 2.8 percent increase in the hospital care setting.
The practice setting is related to pharmacists work activities and their
earnings rates. For example, pharmacists in the community setting spend
over 70 percent of their time on dispensing medications and 11 percent
or less on patient care activities, whereas pharmacists in the hospital care
setting spend 43 percent of their time on dispensing and 27 percent on patient
care activities.21 Among the four types of traditional community pharmacy,
pharmacists in independent pharmacies spend the least time (70 percent)
on dispensing; and pharmacists in independent and chain pharmacies spend
the largest amount of time (11 percent) on patient care activities. Although
pharmacists in independent pharmacies spend more time on patient care
activities,21,31 their wage rate is the lowest in the community setting.32
This suggests that pharmacists in independent pharmacies value providing
pharmacy services, so they are willing to accept a lower wage rate. However, independent pharmacy has lost a share of the business of dispensing
medications, especially to chain pharmacy. As mentioned earlier, the number
of independent pharmacies, the proportion of prescriptions dispensed by
independent pharmacies, and the proportion of pharmacists working in
independent pharmacies all have declined. In spite of the loss, independent
pharmacy could use pharmacy services as a revenue source to turn around its
situation.
Medication therapy review

MTM has been implemented under the prescription drug plans of the Medicare Part D benefit, and pharmacists can obtain reimbursement by providing
MTM services.33 MTM is expected to optimize therapeutic outcomes for
patients who have multiple chronic diseases, take multiple prescription medications, and have annual prescription medication costs of more than $4000.
The MTM service model includes five core elements: medication therapy review (MTR), a personal medication record, a medication-related action plan,
intervention and referral, and documentation and follow-up.6 With a range
of services (Table 5.2), MTM brings its primary providerspharmaciststhe
opportunities to provide and improve pharmaceutical care. Because MTM
is available through Medicare, elderly patients also are likely to approach
pharmacists with their medication concerns.
In the context of an aging population and growing prescription volume,
medication-related problems inevitably will occur. For example, polypharmacy among elderly patients could be caused by inappropriate prescribing.
81
Table 5.2 The range of professional activities in medication therapy management

Item of activity
Activity description
Performing or obtaining necessary assessments of the patients health status
Formulating a medication treatment plan
Selecting, initiating, modifying, or administering medication therapy
Monitoring and evaluating the patients response to therapy, including safety and
effectiveness
Performing a comprehensive medication review to identify, resolve, and prevent

medication-related problems, including adverse drug events
Documenting the care delivered and communicating essential information to the

patients other primary care providers
Providing verbal education and training designed to enhance patient understanding

and appropriate use of his/her medications
Providing information, support services and resources designed to enhance patient

adherence with his/her therapeutic regimens
Coordinating and integrating medication therapy management services within the

broader health care management services being provided to the patient
(Data from Bluml BM. Definition of medication therapy management: development of professionwide consensus. J Am Pharm Assoc 2005;45:56672.)
One study found that over 23 percent of elderly patients received at least one
of 20 medications specified as inappropriate.34 Because physicians are busy
and may be reluctant to change prescriptions, it is difficult for physicians
alone to solve medication-related problems.35,36 As a key activity in MTM
(see Item E in Table 5.2), MTR underscores the identification, solution, and
prevention of medication-related problems by the pharmacist. MTR also
supports the pharmacists role as a medication manager, because it requires
both clinical and technical skills, and such a combination of skills is unique
to pharmacists (see Table 5.2).37
Donabedian38 outlined three aspects of health care quality: structure,
process, and outcome. The first section of this chapter has described the
structure of providing pharmaceutical care in terms of human resources and
working environment. Of note, pharmacy education in the United States also
prepares students to provide MTR. One study that compared medication
review results between practicing pharmacists and pharmacy students found
that pharmacy students made more cost-effective recommendations.39
The following section of this chapter presents the process and outcomes of
MTR. The outcomes include clinical, economic, and humanistic outcomes.40
Process of MTR
An MTR can be either a comprehensive review for all medications used by
a patient or a targeted review in response to a specific medication problem.6
82
The review can be initiated by the pharmacist if the patient is at risk for
medication-related problems. It also can be conducted in response to a
referral by the patients health plan and health care providers, or it can be
requested directly by the patient. Regardless of the type of MTR and who
initiates it, a possible process of MTR can have seven steps (Figure 5.1).
In addition to requiring clinical and technical skills, the process of MTR
highlights the importance of interpersonal communication skills. First of all,
pharmacists have face-to-face interaction with patients. When interviewing
a patient, the pharmacist must capture demographic, clinical, and medication information, as well as the patients cognition and emotion associated
with his or her medical condition and medication usage.41 When educating
patients about their medications, pharmacists need to explain the treatment
goals, and demonstrate how to use the medications appropriately.6 In addition, pharmacists interact with other health care professionals. When communicating with these colleagues, pharmacists must make the intervention
recommendations, and the recommendations are more likely to be implemented if the pharmacist has good communication skills.
A prototype of MTR is the Iowa Medicaid pharmaceutical case management (PCM) program. PCM is a state-level program that engages both
community pharmacists and physicians to review and manage medication
therapy.42 Eligible participants are Medicaid patients who take at least four
chronic medications and have at least one chronic condition. After an eligible patient is enrolled, a pharmacist performs an initial assessment, in
which he or she interviews the patient and examines the medication history,
Interviewing patients
to gather information
Assessing patients'
information
Developing a plan
for resolving each
problem
Providing
education and
training to patients
Evaluating
patients' symptoms
Identifying and
prioritizing
medicationrelated
problems
Communicating appropriate
information to other health care
professionals (e.g., physicians)
Figure 5.1 One example of the process of medication therapy review. (Data from American
Pharmacists Association and the National Association of Chain Drug Stores Foundation.
Medication therapy management in pharmacy practice: core elements of an MTM service model
(version 2.0). J Am Pharm Assoc 2008;48:34153.)
83
medication indications, and untreated illness. The pharmacist then identifies

medication-related problems, including unnecessary medication, suboptimal
medication, poor adherence, adverse drug reactions, and need for additional
medication. Next, the pharmacist sends a fax to the patients primary physician listing the identified problems and suggesting a recommended action
plan. The physician informs the pharmacist whether the plan is accepted. If
accepted, the pharmacist then performs a problem follow-up assessment to
evaluate the effectiveness of plan or modify the plan as necessary. When a
new medication-related problem is identified between the initial assessment
and problem follow-up assessment, the same process can be conducted. Both
the pharmacist and the physician are reimbursed in PCM.
A number of barriers may interfere with the implementation of MTM services, such as lack of support from insurance plans, staff, or other health care
professionals, and inefficiency and inconsistency in practice. For example,
some insurance plans were still in the preparation stage to contract pharmacies to provide MTM services.43,44 Pharmacists intended to provide MTM
services, but lacked time and sufficient staff.45 In addition, inconsistency
in MTM provision across pharmacies underscores the need to standardize
practice activities.46 Furthermore, physicians may be skeptical about MTM
services.47 With the features of insurance support, a standardized and efficient process, and pharmacistphysician collaboration, PCM can serve as a
template for MTM or MTR.
Outcomes of MTR
Clinical outcomes of MTR usually are the identification and resolution of
medication-related problems. A retrospective medication review reported
2123 medication issues for 1167 Medicare-eligible individuals.48 In another study, after a medication review, medication-related problems dropped
from 4.5 to 2.3 per elderly patient in a 6-month period.49 A randomized
controlled trial examined whether medication review by a pharmacist would
result in medication therapy changes in elderly patients with polypharmacy.36
Within 6 weeks, subjects in the intervention group had their medications
reduced by, on average, 1.5 medications. The PCM program also improved
medication appropriateness for patients.42
The term economic outcomes can refer to savings of health care costs
and to cost-effectiveness of medication review. The cost savings can result
from elimination of unnecessary medications or generic substitution for
brand-name medications. A randomized controlled trial indicated that each
elderly patient receiving medication review saved approximately $27 per
month due to medication changes.36 Cost savings also may be indirectly
achieved by solving medication-related problems that otherwise would cause
additional utilization of the health care system. A cost-effectiveness analysis
84
shows that a pharmaceutical care benefit in Medicare costs $2100 per

life-year saved, which is cost-effective from a societal perspective.50
Humanistic outcomes can refer to improvement in patients adherence,
medication knowledge, and health-related quality of life. One literature
review reported that patients who received counseling about their medications from a physician, nurse, or pharmacist had significantly better adherence than those who did not.19 This review also reported that there was a
short-term improvement in patients medication knowledge. In health-related
quality of life, however, one randomized controlled trial did not find differences in elderly patients quality of life between intervention and control
groups by the SF-36 questionnaire.36 Future studies are needed to assess
whether MTR improves health-related quality of life.
Application of marketing concepts in providing MTR

This section introduces three marketing concepts: market segmentation, personal selling, and relationship marketing. Market segmentation can be used
to select the target market, i.e., to identify patients for a comprehensive or a
targeted MTR. Personal selling can be embedded within the process of MTR,
in communication with either patients or other health care professionals.
This section focuses primarily on applying the techniques of personal selling
in communication with patients. Relationship marketing aims for establishing long-term relationship with patients or other health care professionals,
which can be achieved via personal selling. In the discussion of relationship
marketing, we focus on developing a collaborative pharmacistphysician relationship. In the process of MTR (Figure 5.1), the pharmacist can use market
segmentation before interviewing patients, personal selling during the process
to interact with patients, and strategies for developing pharmacistphysician
collaboration when communicating with physicians.
Market segmentation
In market segmentation, the market is divided into distinct customer groups,
with customers within each group sharing certain characteristics.10 Each
customer group is a market segment. Compared with a mass marketing
strategy targeting the general market, market segmentation allows the market
segments to be better served with products or services matching their specific
needs. The segmentation method can be based on differentiating geographic,
demographic, psychographic, or behavioral characteristics.10 The method
called geodemographic segmentation classifies the market using a combination of these characteristics. One example of geodemographic segmentation
is a classification of residential neighborhoods (ACORN).51
In pharmacy practice, pharmacists also can segment patients by disease
states, types of medications, or health insurance status. For instance, to
establish a cardiovascular risk management program, the pharmacist can
85
first perform a health screening to group potential participants according to

their cardiovascular risk levels.52 To implement a targeted MTR to prevent
benzodiazepine poisoning, the pharmacist can group patients by medication
usage and demographic variables.53 In the PCM program, the pharmacist
classifies patients according to health insurance status, and only Medicaid
patients are eligible.42
Market segmentation is tied to target market selection and product positioning. To select a target market, the marketer needs to assess which
market segments are desirable to match the marketing mix (i.e., product,
price, promotion, and place).10 A desirable segment should (1) be identifiable; (2) be accessible; (3) have sufficient size; and (4) be responsive to the
marketing mix. For example, in a cardiovascular risk management program,
the targeted segments should be patients at intermediate or high risk levels
for cardiovascular diseases. In a health intervention, the characteristics of
target segments often are the selection criteria to enroll patients.
Positioning is about how customers perceive the image of the product.10
After determining the target segments, the marketer should consider a positioning strategy that separates the product from competitors and equips
the product with a superior image. A positioning strategy can emphasize
any aspect of the marketing mix. Therefore, the pharmacist can position
MTR based on any of its features or benefits. The feature refers to a specific
component of the product, and the benefit is about how the product can address patients unmet needs. A thorough understanding of the target segments
should be the foundation of a positioning strategy, and the emphasized aspect
of the product should be compatible with the needs of the target segments.
Personal selling
Personal selling is a one-on-one promotional activity with customers that
involves interpersonal communication skills such as effective questioning,
active listening, and persuasion.7 Because interpersonal communication skills
also are important in MTR, personal selling fits the process of MTR to interact with patients. Personal selling of pharmacy services has six progressive
steps: gathering patient information; assessing information; asking probing
questions; presenting features and benefits; addressing concerns; and offering
the service.7 Actually, the first two steps are the same as the first two steps of a
possible MTR process (Figure 5.1), and the other three steps are linked with
positioning, and can be incorporated into the rest of the process of MTR.
In personal selling, pharmacists can ask patients four types of questions:
situation, problem, implication, and needpayoff questions.7,54 For an MTR,
the objective of situation questions is to collect patient information, the
objective of problem questions is to find out potential issues with patients
medications, the objective of implication questions is to make patients
understand the negative outcomes of the medication-related problems, and
86
the objective of needpayoff questions is to orient patients toward the

solutions for the problems. In the step of gathering patient information,
pharmacists can ask situation questions such as what medications patients
use. After assessing the information, in the step of asking probing questions,
pharmacists can (1) ask problem questions, such as whether patients have
experienced the symptoms caused by a medication-related problem; (2) ask
implication questions, such as whether patients are aware that the problem
negatively impacts their life or work; and (3) ask needpayoff questions,
such as how an MTR positively affects patients life or work. Generally, in
a stepwise manner, the four types of questions help patients to realize their
unmet needs to address medication-related problems, as well as set the stage
for pharmacists to present the features and benefits of MTR.
In the marketing step of presentation, the pharmacist should be able
to concisely describe how MTR could address patients unmet needs.7 The
description also is the positioning strategy for MTR. Although a positioning
strategy can be based on any of MTRs features (e.g., providing patient
education and training, or communicating with the patients physicians), or
benefits (e.g., to reduce adverse drug events, to reduce the cost of medications, or to improve patients adherence), it is important to highlight the
benefits, since benefits match patients unmet needs. For example, if the target segments of MTR are concerned about ensuring medication safety rather
than reducing medication cost, the MTR should be positioned as a service to
reduce adverse drug events instead of one to save cost. If patients object to
receiving an MTR, pharmacists should not give up easily, but should follow
three sub-steps: acknowledging the objection; probing for more information;
and responding to the objection.7 However, if pharmacists can help patients
realize their unmet needs during the step of asking probing questions, the
extent of objection most likely will be lessened.
Relationship marketing
In pharmacy practice, relationship marketing includes marketing activities to establish, develop, and maintain relationship with patients, physicians, or other stakeholders.7,55 The principles of relationship marketing are
one-on-one marketing, retaining customers, and taking a long-term view.55
Personal selling is in alignment with these principles. By applying the techniques of personal selling discussed earlier, the pharmacist can build rapport
with patients in MTR. Next, we discuss how to develop relationships with
physicians.
The importance of pharmacistphysician collaboration to improve medication therapy is acknowledged by both pharmacists and physicians. In
2002, the American College of PhysiciansAmerican Society of Internal
Medicine praised collaborative drug therapy as one of the best examples
of pharmacistphysician collaboration.56 Yet, barriers to collaboration exist,
87
including turf concerns, communication breakdowns, power issues, and

lack of trust.57 Even in the PCM program, which supports pharmacist
physician collaboration, some physicians did not respond to pharmacists
recommendations after being repeatedly contacted by pharmacists.42
The collaborative working relationship (CWR) model conceptualizes the
process of pharmacistphysician collaboration into five stages: professional
awareness, professional recognition, exploration and trial, professional relationship expansion, and commitment.58 These stages are progressive if
the relationship strengthens; the stages beyond professional awareness also
can be retrogressive, however, if the relationship worsens. In the stage of
professional awareness, pharmacists interact with physicians in a discrete
manner, such as dispensing prescriptions faxed from physicians or answering
physicians queries about medications. In the stage of professional recognition, pharmacists take the initiative to make physicians realize the values
of pharmacy services, such as regularly providing patients adherence information to physicians. In the stage of exploration and trial, both providers
examine their compatibility and trustworthiness in the relationship, such as
physicians assessing the quality of care provided by pharmacists. In the stage
of professional relationship expansion, bilateral communication takes place
more often between providers, such as regular face-to-face meetings. The final
stage, commitment, is symbolized by both providers signing a collaborative
practice agreement.
Three sets of factorsindividual, contexts, and exchange characteristics
are proposed to impact the overall process.58 However, pharmacists or
physicians may be in different stages of this process, and the factors affecting each collaborative stage may be different. Therefore, strategies to
promote collaboration may vary depending on which stage each provider
has reached. The logic of market segmentation can be applied here, i.e.,
to segment providers according to the collaborative stage, and target the
desirable segment with strategies tailored for the corresponding stage. From
the pharmacists side, it was found that the variable of role specification (i.e.,
clarifying each partys responsibilities) strongly affected a lower collaborative
stage, whereas the variable of internal medicine (as a physician specialty)
affected a higher collaborative stage.59 To provide MTR, a pharmacist can
perform a self-assessment to determine which stage he or she has reached,
and then consider strategies to move to the next collaborative stage.
A case analysis
The following fictional case in the community setting illustrates how to apply
marketing concepts in providing MTR.
Vincent Houston, PharmD, is the owner of Houston Pharmacy, an independent pharmacy in Trinsland, a Midwestern city with a population of
50,000. Since the 1990s, other types of community pharmacy have opened
88
business in the city, and the number of independent pharmacies has declined.
Houston Pharmacy is one of two independent pharmacies still in business.
Within a 5-mile radius of Houston Pharmacy, there is a chain pharmacy and
a mass merchandiser pharmacy. A few months ago, the chain pharmacy began to offer a reward of $25 for patients who transfer prescriptions, and the
mass merchandiser pharmacy started a program in which patients pay only
$4 for dispensing a 30-day supply of prescription drugs. This competition
has caused a drop in sales for both prescription and over-the-counter drugs
for Houston Pharmacy. However, Vincent knows that his pharmacy does
not have the financial capacity to launch a similar reward offer or lower the
dispensing cost. Therefore, he needs to locate other revenue sources to offset
the loss in sales of medications and gain an edge in the competition.
Vincent discusses this issue with Pamela Roosevelt, PharmD, who recently joined Houston Pharmacy after completing a pharmacy residency
in infectious diseases. Pamela suggests that they could provide pharmacy
services that are not available at the other two pharmacies. She observes
that about a quarter of the customers at Houston Pharmacy are elderly,
and notices that quite a few possible medication-related problems appear
in patients prescriptions, especially in regard to inappropriate selection of
antibiotics. She searches the literature as well. It is estimated that that over
40 percent of antibiotic treatments are inappropriate for respiratory tract
infections, and antibiotic-associated adverse events result in many emergency
department visits.60,61 Vincent and Pamela agree that an MTM service to
address the problem can improve patients health outcomes, and this service
has a potential market. After examining components of the MTM model,6
they also agree that once they set up the first component, MTR, the other
components will come into place without much effort. The questions are,
after the workflow of MTR has been established (Figure 5.1), as follows:
(1) how to identify and target patients who would benefit from this service;
(2) how to present the services benefits to targeted patients; and (3) how to
develop relationships with patients primary physicians.
To answer the first question, by analyzing the dispensing records at
Houston Pharmacy, Vincent and Pamela find that three risk factors associated
with the occurrence of possible medication-related problems include (1) patient age of 65 years of older; (2) patient taking at least four prescription
medications; and (3) use of at least one prescription antibiotic medication.
The results confirm Pamelas observation. Therefore, they decide to provide
a targeted MTR toward resolving inappropriate selection of antibiotics, and
the target segments are patients with all the three characteristics. They also
figure that since the targeted patients are eligible for Medicare, the patients
would be more concerned about ensuring medication safety than reducing
medication cost. So the position strategy of the service should be about
medication safety.
89
Table 5.3 Sample script between pharmacists and patients in personal selling
Step
Script
Gathering patient information
Hello, I notice from your prescription that you are going to take/are
taking [the name of the specific antibiotic medication]. Our pharmacy is
paying special attention to our patients prescribed with [the
medication], because we want to make sure that the medication is right
for our patients. For this purpose, I would like to ask you a few questions.
Asking situation questions
What medical conditions do you have?

What other medications do you take, including both prescription and
over-the-counter medications?
What are your concerns regarding your health condition or use of
medications?
Are you allergic to [the medication]?
Do you feel [the medication] works? (If it is a refill of prescription)
Assessing information
If the patient is at risk for a medication-related problem, move to the next

step.
If there is no risk, stop here.
For now, we do not see any issues related to the use of [the medication].
After using [the medication], if you feel it does not work, or experience
any antibiotic-associated adverse events (e.g., allergic reactions, side
effects, or drugdrug interactions), please do not hesitate to contact us.
Asking probing questions

Asking problem questions
Have you experienced [any antibiotic-associated adverse events]

related to [a medication identified to be problematic]?
Asking implication questions
Did you know that the symptoms you have experienced could cause an
emergency department visit, if they get severe?
Asking need-payoff questions
Would it be helpful if we thoroughly review your medications and make

recommendations to your physician to choose the right antibiotics, so
the risk of an emergency department visit will be reduced?
Presenting features and benefits
We have a medication therapy management service that is able to

reduce [the specific antibiotic-associated adverse event], and ensure
the safety of using medications. We will contact your physician and
make recommendations to optimize your use of medications.
The total cost of the service is [specific monetary amount], but you
would only have to pay [specific monetary amount]. Your insurance
would take care of the rest.
Would you like to receive the service?
(continued)
To answer the second question, Vincent and Pamela decide to apply

the techniques of personal selling. They compile a list of specific antibiotic
medications that have been identified for possible inappropriate selection.
Then, following the steps of personal selling,7 they prepare a script to practice
(Table 5.3). In particular, they would like to present the services features and
benefits to targeted patients in 15 seconds.7
By analyzing the dispensing records, Vincent and Pamela also compile a list of physicians who have prescribed medications with possible
90
Table 5.3 (continued)

Step
Script
Addressing concerns
If there is no objection, move to the next step.

If the patient objects to the offer, acknowledge the objection, and then
repeat the two steps above as necessary. If the patient agrees to receive the
offer, move the next step.
If the patient still objects after addressing concerns, stop here.
I understand [the specific concern for objection]. However, if you feel
[the medication] does not work, or experience any antibiotic-associated
adverse events, please do not hesitate to contact us.
Offering the service
The service will take [specific amount of time]. Do you have time this
morning/afternoon?
If the patient does not have time today, then schedule the service for
another day.
May I schedule a time for you to receive the service later this week?
inappropriate antibiotic selection. They sort this list by the frequency with
which possible medication-related problems have occurred. When considering communicating with these physicians in an MTR, Vincent is a little worried about how the physicians might react to pharmacists recommendations,
given that inappropriate prescribing may be revealed. Pamela argues that this
will not be an issue if they establish a good relationship with the physicians.
Among physicians who have fall into the frequent category for prescribing
drugs with possible medication-related problems, one name, George Dawson,
MD, looks familiar to Vincent. Dr. Dawson is a family physician who is
practicing in a clinic about 8 miles from Houston Pharmacy. Vincent recalls
that Dr. Dawson has phoned him a number of times, requesting information
about antibiotic medications. Therefore, Vincent considers Dr. Dawson a
good candidate with whom to establish a pharmacistphysician collaborative
relationship. After discussing the model of CWR58 with Pamela, Vincent
thinks that his relationship with Dr. Dawson currently is in the stage of
professional awareness, and he needs to carry the relationship forward. So
Vincent and Pamela decide to call Dr. Dawson to schedule a face-to-face
meeting. In the meeting, they plan to express their interest in working with
Dr. Dawson, ask about Dr. Dawsons needs to improve patient care, and
present the MTM service. According to the outcomes of the meeting, they
will plan the future strategies to promote collaboration.
Conclusions
In the US health care system, more medication-related problems are likely
to occur as the population ages and consumes more prescription medications. Although there has been a shortage of pharmacists, pharmacists have
continually made efforts to improve patients health outcomes related to
91
medication therapy. One example is the practice model of MTM. MTM services start with the core element of MTR, and MTR emphasizes pharmacists
identifying, solving, and preventing medication-related problems. Marketing
concepts such as market segmentation, personal selling, and relationship
marketing can help pharmacists with providing pharmacy services including
MTR.

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6
Much of what happens in health care is shaped or influenced by the activities

of the many organizations that represent various health care occupations or
corporations involved in health care. These organizations have such impact
on the various professions role in the health care system that the nature of an
occupations organizations and the role played by those organizations have
been used by sociologists as criteria in determining whether an occupation
is considered a profession. In fact, coming together to create formal organizations or associations has been described as essential for the existence
of a profession.1 Saunders and Wilson summarized that view by stating
that a profession is not merely a number of people performing the same
function. They asserted that a profession can only be said to exist when
there are bonds between the practitioners, and these bonds can take but
one shapethat of formal association.1 This chapter examines the nature
of the varied organizations that represent pharmacy related-groups. The
functions performed by the organizations and the ways those organizations
influence pharmacists roles in the health care system and the delivery of
pharmaceutical services will be explored.
Role of pharmacy organizations

The activities performed by professional organizations, and pharmacy organizations in particular, are of interest to individual practitionersand
future practitionersbecause the activities of the organizations help define
the profession. Many levels of society, including patients, other health care
professions, and health care insurers, are affected by the organizations
influence on the nature of health services provided, the cost of those services,
and where those services are provided. This section examines the range of
functions performed by pharmacy organizations. We first examine the role
that organizations play for individual practitioners and the profession the
organizations represent.
96
Profession and individual practitioners

The formation of an organization normally is initiated by a group of individuals who share some common interest that motivates development of some
formal structure, i.e., organization, to work toward those common interests.
It seems reasonable to begin by examining the services that organizations
provide to individuals and/or the profession in which those individuals practice. We will investigate what motivates individuals to invest their time, dollars, and other resources in forming organizations or in serving as members
of professional organizations.
Networking and professional identity

Individuals join pharmacy organizations, as well as other professional organizations, to associate and network with individuals who share like interests
and activities. The interaction with members of the same occupation helps
individuals to develop awareness of the position of the groups occupation in
society. Sharing of work accomplishments, work challenges, and professional
contributions through meetings, written materials, and other communications helps individuals to develop a view of pharmacys collective role in
society. The resulting sense of shared responsibility and accomplishment
is so valued that it motivates individuals to join and support the formal
organization.2
Educational services, publications and meetings

The meetings sponsored by pharmacy organizations are an attraction for
many individuals who join pharmacy organizations. As described previously,
meetings provide an opportunity for member pharmacists to network and
interact with other individuals in the same profession. The meetings attract
individuals to organizations for reasons other than just socializing with peers.
Most organizations meetings also include educational sessions on topics
of primary interest to organization members. The opportunity to obtain
information on new therapies, approaches to managing therapy of patients
with a specific disease, or management techniques that can be applied in
practice, are all incentives that motivate individuals to join and maintain
membership in pharmacy organizations. Members may possess a strong
motivation to learn and enhance their skills, or, at minimum, may need to
complete mandatory continuing education requirements. Some individuals
may prefer to obtain their continuing education in a live, interactive format
rather than by other means. Regardless, the annual meetings are perceived
by some individuals as an important benefit that leads to establishing and
maintaining membership in an organization. Most organizations hold series
of regular meetings and ad hoc meetings in addition to their main annual
meetings. The additional meetings may range from educational sessions on
topics of interest to members to meetings devoted to planning action in
97
advocating for some policy decision. The meetings also may serve as forums
for organization subgroups with special practice interests.
Most pharmacy organizations offer members a variety of publications
and programs that are either available only to members or are available
to members of the organization at lower cost than to nonmembers. The
range of materials provided by pharmacy organizations is very broad. Many
organizations publish a journal or magazine that is provided to members as
part of the package of services included in the membership fee. These journals
often include reports on the organizations business meeting, summaries of
issues facing pharmacy, and lobbying activities of the organization. Many
of the journals include continuing education articles and mechanisms by
which official continuing education credits can be obtained for reading and
completing examinations on the articles. The journals provide members with
a means of maintaining contact with actions of staff and elected officers of
the organization on behalf of the organizations membership.
Many organizations publish monographs on specific topics. For example,
community practice-based organizations may sponsor publication of monographs on management of the community practice or on management of
therapy of patients with a specific disease. Such publications bring together
information on a specific topic and structure it in a format that makes it more
easily accessible to the organizations members. Such publications often are
available to the publishing organizations members at discounts.
Promoting the profession

Pharmacy organizations continue to play a very active role in defining and
advancing the role of the profession in the health care system. Pharmacy
organizations often were founded in response to a perceived threat to the
profession, in response to a desire on the part of members of the profession
to advance the profession, or in response to a desire to promote greater
development of a special area of pharmacy practice. Many individuals support various organizations because of the organizations roles as advocates
for the profession. The organization acts as a collective voice for members
on issues that affect pharmacy and public health. Organizations often are
involved in communicating with legislators and regulatory agencies on laws
and regulations that affect pharmacy. The organizations help members to
develop some common viewpoint that can be consistently communicated
to policy makers and which may carry more weight than many discordant
voices speaking on an issue. Many pharmacists perceive a personal obligation
or responsibility to support efforts toward advancing the profession that
motivates them to support pharmacy organizations.
Pharmacy organizations not only work as advocates with legislators and
regulators on policy issues, but they also provide an avenue for defining the
`
professions role vis-a-vis
other health professions and for engaging those
98
professions in dialogue on such issues. In doing so, pharmacy organizations

sometimes serve as the collective voice for a group of pharmacists in interacting with organizations representing other health professionals such as
physicians.
Goal setting
If a profession is to avoid stagnation, there must be active examination of
societal changes and setting of goals for the profession. Pharmacy organizations provide opportunities for individuals involved in the profession to
review health care trends and to discuss their relevance for the future of the
profession. Such dialogue provides a means for identification of goals related
to the future of the profession. The issues addressed may vary from whether
pharmacists should be involved in administration of drugs used in capital
punishment to whether pharmacists should seek the right to independently
initiate drug therapy for patients.
Forum for policy making for the profession

Most pharmacy organizations operate on the basis of some form of representative decision making. As a result, the organizations provide a forum for
representative policy-making within the profession. Individual members of
the organization are provided a structured means of affecting the direction of
the profession. That process helps each organization to provide a collective
voice for its members. It also allows members access to influencing policy
positions of the organization as well as health policy in general.2
Society
Pharmacy organizations play an important role in protecting the social
welfare through setting standards for the profession. These functions can
be realized through a variety of approaches. In its most informal but not
necessarily ineffective form, organizations provide members with a common
concept of the roles and responsibilities of members of the profession. The
socialization of individuals that takes place through involvement in an organization can be quite influential in development of individuals personal practice philosophies, personal practice standards, and a professional ethos that
guides their practices. However, pharmacy organizations also play formal
roles in setting standards. Based on their specialized knowledge, professions
are granted a certain amount of autonomy and given authority and responsibility for self-regulation. Through their interaction with legislative bodies,
organizations provide information needed to define the realm of practice for
the profession.
We have examined the many varied services that pharmacy organizations
provide members and their contributions to society. Before discussing some
99
of the many pharmacy organizations currently in existence, it is useful to

explore the historical development of pharmacy organizations within the
United States.
Historical development of pharmacy organizations

Before the American Revolution, physicians usually were the ones who
dispensed medications to patients. Although non-physicians specializing in
drugs (druggists) existed, their main activity was to supply physicians with
drugs and chemicals. Initially, druggists primarily imported drugs and chemicals. Over time, the druggists increased their focus on manufacture of drugs
and chemicals as opposed to importation. That focus on chemistry and
the preparation of prescription orders served as the beginnings of the US
chemical and pharmaceutical industries.3 It also furthered the separation of
pharmacy activities from those of physicians and speeded development of a
separate professional identity for pharmacists.
Before the 1850s, pharmacy was not organized in any formal way to
promote education of pharmacists or to regulate the practice of pharmacy.
Pharmacy associations first formed in response to activities undertaken by
physicians to regulate the sale of drugs. The first pharmacy organizations
formed were local associations. One of the earliest and most notable groups
was the Philadelphia College of Pharmacy. (The use of the term college
was based on English custom. Only later did the term college come to refer
primarily to the schools teaching pharmaceutical subjects.) However, the first
local associations did establish schools for training individuals interested in
taking up the occupation of pharmacy. The organizations also set up legal
controls, established processes for licensing of individuals wishing to enter
the occupation, and generally sought to maintain practice at a level that
would elevate the occupation.3
Ironically, development of pharmacy organizations did not proceed from
the local associations to the next larger geographical levels, such as states
and regions. Instead, formation of a national organization, the American
Pharmaceutical Association, now known as the American Pharmacists Association, was spurred by several local associations from multiple states.
The national organization later encouraged and supported the founding of
state associations to assist in enacting state legislation and regulations that
promoted the goals of the association.3
Specific pharmacy organizations

This section examines existing pharmacy organizations. The organizations
have been grouped in the following categories: national practitioner organizations; fraternal and honorary societies; state practitioner organizations;
100
local practitioner organizations; national trade organizations; and educational, regulatory or foundation organizations. National practitioner organizations are those national organizations that primarily have pharmacists as
members. State and local practitioner organizations are the state and local
level counterparts of the national practitioner organizations. National trade
organizations are those organizations which normally have corporations as
members and represent those corporate interests. For further information,
a list of web sites for these organizations appears at the end of this chapter.

American Pharmacists Association (APhA)
The American Pharmacists Association is considered the oldest national
pharmacy association. The association was founded in 1852 and was known
as the American Pharmaceutical Association until 2003, when it changed its
name to better reflect the makeup of its membership. The impetus for its
formation was the perceived need for an organization that could represent
the opinion of pharmacists, not just a local group, in working with the
American Medical Association on efforts to control the quality of imported
drugs.3 The organization has had the goal of representing the whole of
pharmacy since its founding and has over 60,000 members. The organization
has three academies: the Academy of Pharmacy Practice and Management;
the Academy of Pharmaceutical Research and Science; and the Academy of
Students of Pharmacy. The academies contain smaller sections based on more
specialized interests. Several other national associations began as special subgroups within the APhA and later went on to become separate organizations.
The association publishes a refereed journal, newsletters, books, continuing education pieces, and a variety of other publications. The association
lobbies on pharmacy issues and works with other pharmacy associations and
organizations outside of pharmacy on pharmacy and health-related issues.
National Community Pharmacists Association

The National Community Pharmacists Association (NCPA) originally was
known as the National Association of Retail Druggists (NARD) when the
organization was formed in 1898, and separated from the APhA. The organizations name was shortened to NARD in 1987 and then changed to the
National Community Pharmacists Association in 1996. The group initially
developed to address the commercial interest of independent pharmacy owners, and it still works to represent the interests of independent community
pharmacy owners. It lobbies on issues related to pharmacy practice and other
The content in this section was influenced by and includes material adapted from Maine L.
Pharmacy organizations. In: Fincham JE, Wertheimer AI, editors. Pharmacy and the U.S. health
care system. Binghamton (NY): Pharmaceutical Products Press; 1991:288306.
101
legislative issues that impact community pharmacies. The organization publishes a journal and several specialty publications, such as one specifically for
pharmacies providing home intravenous infusion services. The organization
offers a student membership category and works to encourage development
of new independent community pharmacies.
American College of Apothecaries

The American College of Apothecaries (ACA), founded in 1940, is an organization of pharmacists with an interest in maintaining progressive professional practice and prescription compounding services. The association
describes its purpose as translation and dissemination of knowledge, research
data, and recent professional pharmacy practice developments for the benefit
of pharmacists, pharmacy students and the public. The organization publishes several periodicals. The members of ACA are designated fellows. The
organization has several membership categories:
Full fellows must be licensed pharmacists;

Associate fellows are member pharmacists employed by full fellows or
recommended by three full fellows.
A student membership category, student fellow, also exists for students

who have completed at least 2 years of pre-pharmacy curricula.
In addition to information dissemination, the organization takes positions
on policy issues related to pharmacy practice and promotes professional
pharmacy practice.
American Society of Health-System Pharmacists

The American Society of Health-System Pharmacists (ASHP) had its origin
in a subsection on hospital pharmacy that was created within the American
Pharmaceutical Association in 1932. The group became a separate association known as the American Society of Hospital Pharmacists in 1942. For
an 8-year period (1986 to 1994), the organization was known officially
as the ASHP. Its name was changed in 1994 to the American Society of
Health-System Pharmacists.
The ASHPs membership consists primarily of pharmacy practitioners,
pharmacy students, and pharmacy residents with an interest in hospital
pharmacy. The organization represents their interest in lobbying and provides a variety of services to its members. The organization sponsors an
annual meeting, known as the Mid-Year Clinical Meeting, that is perhaps the
largest pharmacy-related meeting. This meeting is held in December; ASHP
also sponsors a summer meeting in June. Like the American Pharmacists
Association, the American Society of Health-System Pharmacists publishes
a wide variety of materials, including books, continuing education pieces,
journals, and reference texts.
102
National Pharmaceutical Association

The National Pharmaceutical Association (NPhA) was founded in 1949 by
African-American pharmacists to work toward improvement of the position of African-American pharmacists within the profession. The association
works as an advocate for improvement of pharmaceutical services and health
care in general for minority and indigent populations and serves as a vehicle
for minority pharmacists to engage in collective dialogue with other pharmacy organizations and other health care organizations. The NPhA sponsors
an annual national convention of its members with continuing education
programming and organization business meetings. The association has provided scholarships for pharmacy students and works toward recruitment of
African-American and other underrepresented ethnic groups to the study of
pharmacy and to careers in pharmacy. Student chapters of the organization
exist in many schools of pharmacy and have been active in assisting with
student recruitment and retention efforts.
American Society of Consultant Pharmacists

Founded in 1969, the American Society of Consultant Pharmacists (ASCP)
grew out of the desire of a group of pharmacists to improve the use of
pharmaceuticals in extended care facilities. The ASCP describes its membership as being involved in managing drug therapy for geriatric patients and
other individuals residing in a variety of environments, including nursing
facilities, subacute care and assisted living facilities, psychiatric hospitals,
hospice programs, and home and community-based care. The organization
and its members were given a major boost in 1974, when regulations for
nursing home participation in Medicare and Medicaid required pharmacist
review of patients drug regimens. Membership has grown from just over
1000 in 1976 to over 6000. The organization sponsors an annual meeting
and a mid-year clinical meeting.
American College of Clinical Pharmacy

The American College of Clinical Pharmacy (ACCP) is a practitioner organization that works toward promoting of excellence and innovation in clinical practice, research, and education. Founded in 1979, the organization
is young relative to others. Its mission includes fostering growth of clinical services, promoting the value of clinical pharmacy services, facilitating
pharmaceutical and biomedical research, dissemination and application of
research findings, and promoting excellence in clinical pharmacy education.
The organization offers three classes of membership: full member, associate
member, and affiliate member. Students, residents, and fellows also may join
under a special member category with reduced membership fees.
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American Association of Pharmaceutical Scientists

Founded in 1986, the American Association of Pharmaceutical Scientists
(AAPS) consists primarily of pharmaceutical scientists from various segments
of the profession, including the pharmaceutical industry, government, and
academia. Its mission has been described as serving the pharmaceutical
sciences, the health professions, and the public interest by providing a forum
for free interchange and dissemination of scientific knowledge, influencing
the formation of public policy relevant to health sciences, promoting pharmaceutical sciences collectively, and fostering career growth and development of
members.4
The organization currently has approximately 12,000 members. It sponsors an annual meeting and provides members with a variety of publications, including several newsletters, several scientific journals, workshops, and short courses. The organization lobbies on pharmacy and other
health-related issues and sponsors several scholarships and grants.
Academy of Managed Care Pharmacy

As managed care grew, it was probably inevitable that an organization focusing on the specific interests of that group would develop. The national organization formed specifically to address the issues of managed care pharmacy,
the Academy of Managed Care Pharmacy (AMCP) was formed in 1989,
to address what has been described as the unique needs and interests of
managed care pharmacists. AMCP publishes a scientific journal, newsletter
and other materials, and its membership is about 6000.

Pharmacy fraternal organizations draw members based on their common
professional bond of pharmacy. They are distinguished from other professional organizations by a greater emphasis on social goals and social bonds
between members, which is consistent with the root meaning of fraternal as
brotherly. (However, the organizations use of the term in this context is
not limited by gender.)
Alpha Zeta Omega

Alpha Zeta Omega is a pharmaceutical fraternity that was founded in 1919.
The organization got its start when a group of students at the Philadelphia
College of Pharmacy and Science came together and held secret meetings
to aid each other in their studies. The organizations stated mission is to
promote the profession of pharmacy; to develop high standards of scholarship; to inculcate a spirit of fellowship amongst its members. The group has
admitted both women and men members since the 1970s.
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Kappa Epsilon
Kappa Epsilon was founded in 1921 with a goal of uniting women pharmacy students. The organization published material on women in pharmacy
and supported research on women in pharmacy. The organization promotes
womens health issues and projects related to womens health. Kappa Epsilon
supports personal and professional development and provides networking
opportunities. Its foundation also provides scholarship and fellowships to
members.
Kappa Psi
Kappa Psi, which lays claim to being the oldest and largest professional pharmacy fraternity, was founded in 1879. Although the professional fraternity
that originally grew out of the first Kappa Psi groups had both medical and
pharmacy students as members, in 1924 the group split with the pharmacy
fraternity, retaining the Kappa Psi name. The organization includes in its
objectives the development of high ideals, scholarship, and pharmaceutical
research and active support for projects that advance pharmacy.
Lambda Kappa Sigma

Lambda Kappa Sigma was founded in 1913 at the Massachusetts College
of Pharmacy. The organization states as its goal developing the intellectual,
leadership, and professional skills needed to maximize members potential.
Awards are made to members for excellence in academics, community service, leadership, and professional achievement.
Phi Delta Chi

Phi Delta Chi was founded in 1883 at the University of Michigan. Although
the organization originally accepted majors in both chemistry and pharmacy,
membership criteria were changed in the early 1930s so that only pharmacy
majors could join. The organization has accepted both women and men since
1976. The organizations stated mission is to develop leaders to advance the
profession of pharmacy.
Phi Lambda Sigma

Phi Lambda Sigma was founded in 1965 at Auburn University. Its stated
purpose is to foster and recognize leaders. It is an honorary society, and its
members are selected based on peer recognition through nominations from
members of the society.
Rho Chi
The academic honor society Rho Chi was established in 1922 with the stated
purpose of encouraging and recognizing excellence in intellectual achievement, as well as encouraging high standards of conduct and character. It seeks
105
to foster fellowship among members and to raise awareness of ethical and

social responsibilities of the profession. It also work to encourage research
and awards graduate scholarships.
State organizations
Many pharmacy organizations have memberships based within a specific
state or region within a state. Since the licensing and much of the regulation
of pharmacy and other health professions are based on state laws, the state
associations play a significant role in the health care system. Some of the organizations have several thousand members and budgets of over $1 million.
For example, in 1995 the California Pharmacists Association had more than
5000 members and an annual budget of nearly $2.5 million. Other states,
such as Florida, North Carolina, and Texas, have pharmacy associations with
over 3000 members.5
Each state pharmacy association generally publishes a journal that is distributed to its members. The journals include pharmacy continuing education
articles and analysis of general trends affecting pharmacy, but they also offer
information on legislative and policy issues specific to the associations home
state. The state associations tend to be actively involved in lobbying on state
legislation or regulations that impact pharmacy. Because government health
insurance program such as Medicaid are operated at the state level, the associations often serve as a collective voice for pharmacists on reimbursement
and other issues related to such programs. The associations also have been
very active in communicating with state legislatures and regulatory bodies on
expansion of the role of pharmacists. For example, the state associations have
worked toward passage of laws allowing pharmacists to initiate or modify
drug therapy as a means to make it possible for pharmacists to play a more
active role in managing drug therapy.6,7 States often have several associations
based on members practice interests such as hospital pharmacy, community
pharmacy, and, in some cases, long-term care pharmacy. However, some
of the state associations have explored mergers and consolidations as one
method of dealing with rapid change in the health care system.
Local organizations
Local pharmacy associations that cover a county or perhaps a city in more
metropolitan areas are common. The organizations bring together practitioners serving patients in a common geographic area, such that the pharmacists
often interact with some of the same physicians, nurses, hospitals, and other
providers of health care services. Providing a means of networking with
individuals serving that common group, the organizations often sponsor
local continuing education meetings, provide community service, and may
106
work to encourage individuals to enter pharmacy. Some of the organizations

sponsor scholarships for pharmacy students. Local associations also provide
a group that can interact with its local counterparts in the medical and other
professions.

Consumer Healthcare Products Association
The organization known as the Consumer Healthcare Products Association
(CHPA) was founded in 1881 to represent makers of cosmetics, medical
supplies, and medications for home use. Originally named the Propriety
Association, its name was changed to the Nonprescription Drug Manufacturers Association in 1989. It expanded its scope to include representation
of the nutritional supplement industry in 1998 and took on its current name
in 1999. The organization publishes a newsletter and other materials for
companies that produce nonprescription drugs or nutritional supplements.
The organization also takes an advocacy role in representing its members
interests. The organization promotes the role of nonprescription medications
and nutritional supplements and promotes responsible use of the nonprescription medications.
Generic Pharmaceutical Association

The Generic Pharmaceutical Association (GPhA) represents manufacturers
and distributors of finished generic pharmaceuticals, manufacturers and
distributors of bulk active pharmaceutical chemicals, and suppliers to the
generic pharmaceutical industry. It tracks legislative and regulation activities
for its members. The organization presents information on behalf of its
members in forums considering legislation, regulations, or policy that relates
to the pharmaceutical industry. The association also conducts meetings and
seminars on topics of interest to its members.
Healthcare Distribution Management Association

The Healthcare Distribution Management Association (HDMA) was formed
in 1876 as the Western Wholesale Druggists Association. Its name was
changed to the National Wholesale Druggists Association in 1882, and to its
current name in 2001. The association represents pharmaceutical and related
health care product distributors. It membership includes health care product
manufacturers, distributors, and service providers. International companies
may hold membership in the organization.
The association works to maintain dialogue between members of the
health care distribution chain. The association gathers data on the health care
distribution industry and publishes a variety of periodic reports with statistical data on the industry. The association works to educate customers and
107
policy makers about the services provided by health care product distributors
and the value added by distributors in the health system. The association
actively advocates for the health care product distribution industry with
legislators and regulatory agencies. The organization sponsors meetings and
programs to educate association members about issues related to the industry
and on methods to increase productivity.
National Association of Chain Drug Stores

The National Association of Chain Drug Stores (NACDS) is a trade association that represents the interests of owners of multiple pharmacies.
The organization was founded in 1933 to help improve the operations of
multiunit organizations and to represent them in interactions with other
segments of pharmacy.2 The group lobbies on issues related to pharmacy
and commercial interests of chain pharmacies, and also continues to serve
as a vehicle for interaction with other pharmacy organizations on topics of
interest to chain pharmacy companies. The organization publishes several
newsletters and holds an annual meeting each year.
National Pharmaceutical Council

The National Pharmaceutical Council (NPC) was founded in 1953. It consists of more than 20 research-based pharmaceutical manufacturers. The
organization publishes an annual comprehensive report on pharmaceutical
benefits provided under state assistance programs, primarily Medicaid. It also
sponsors a variety of research and education projects.
Pharmaceutical Research and Manufacturers of America

The Pharmaceutical Research and Manufacturers of America (PhRMA) is
an organization of U.S. pharmaceutical companies that are actively engaged
in manufacture and marketing of finished dosage-form pharmaceuticals under their own brand names and also are engaged in development of new
therapies. The organization was founded in 1958 as the Pharmaceutical
Manufacturers Association (PMA). The organization promotes the roles of
the research-based pharmaceutical industry in the prevention and treatment
of illness. PhRMA collects and disseminates data on the industry such as
industry investment in research and products being developed.
Pharmaceutical Care Management Association

The Pharmaceutical Care Management Association represents pharmaceutical benefit management companies. The association was formed under the
name National Association of Mail Service Pharmacies in 1975. It changed
its name to the American Managed Care Pharmacy Association in 1989.2
The organization added pharmaceutical benefit managers to its membership
in 1994 and changed its name again, in 1996, to the Pharmaceutical Care
108
Management Association to disassociate itself from negative connotations

attached to managed care and state-level efforts to implement legislation
regulating pharmacy benefit managers.8,9 The organization actively lobbies
on the behalf of its member companies and publishes information pieces on
mail pharmaceuticals. Companies involved in mail delivery of pharmaceuticals may be either active full members or active supporting members. Associate membership is available to pharmaceutical manufacturers that supply
prescription or nonprescription drugs to the industry. Affiliate membership is
open to other firms or to individuals engaged in business with industry firms.

United States Pharmacopeial Convention
The United States Pharmacopeial Convention (UPS) publishes the United
States PharmacopoeiaNational Formulary (USP-NF), which is recognized
by the federal government as the official compendium of drug standards.
The organization was formed in 1820 for the purpose of developing a
national pharmacopoeia.10 When the Food Drug and Cosmetics Act of 1906
was passed, the USP was recognized as an official pharmacopoeia by the
federal government. Although the USP publication is recognized as an official
document by the U.S. government, the organization is not a government
agency, and most of the work of the association is done by volunteer experts
representing other organizations in pharmacy, medicine and related areas.
The 1900 articles of incorporation for the organization describe the
purposes of the organization as encouraging and promoting
the science and art of medicine and pharmacy by selecting by
research and experiment and other proper methods and by naming
such materials as may be properly used as medicines and drugs with
formulas for their preparation: by establishing one uniform standard
and guide for the use of those engaged in the practice of medicine
and pharmacy in the United States where by the identity, strength,
and purity of all such medicines and drugs may be accurately
determined, and for other like an similar purposes; and by printing
and distribution at suitable intervals such formulas and the results of
such and similar selections, names and determinations . . .
In addition to the USP-NF, a variety of other information resources are
published. During the early 1970s, the organization began a major thrust
in publishing patient counseling information, which is now produced as a
separate publication, the USP Dispensing Information. The USP and the
American Pharmacists Association cosponsor a national patient counseling
competition for pharmacy students.10
109
American Association of Colleges of Pharmacy

Schools and colleges of pharmacy are represented in the American Association of Colleges of Pharmacy (AACP), founded in 1900. In addition to
institution memberships, individual memberships are available to administrators, faculty, and staff of the pharmacy academic institutions. The association
has two main councils, the Council of Faculties and the Council of Deans.
The organization maintains a journal that publishes articles on pharmacy
education topics and also gathers and publishes data for use by member
organizations in comparative analysis of individual programs, identification
of trends in pharmacy education and pharmacy practice, and for consideration in policy decisions related to pharmacy education. The AACP works
with other organizations in providing input on development of standards in
pharmacy education.
National Association of Boards of Pharmacy

The National Association of Boards of Pharmacy (NABP) is the organization
for State Boards of Pharmacy, i.e., the state agencies responsible for licensing of pharmacists and regulation of pharmacy practice in their respective
states. Some agencies external to the United States, such as those in U.S.
territories and Canadian provinces, also are members. A main function of the
organization is that it produces a standard pharmacy licensing examination,
the National Association Boards of Pharmacy Licensure Examination, which
is used by most of the agencies in testing pharmacists for licensure. The
organization also produces an examination on federal drug law and has
developed model pharmacy laws that the state agencies can use as guidance
and input when legislative changes are under consideration. The organization
serves a clearinghouse for pharmacist transfer of licensure from one state to
another and for pharmacy licensure information.
Working in collaboration with ACPE (see the following section), the
NABP has started administering a service known as CPE Monitor to state
boards of pharmacy that tracks continuing education credits, which are
required for pharmacist relicensure. Most state boards of pharmacy have
embraced this paperless system of electronic reporting of continuing education credits, and many require pharmacists to submit their credits only via
this mechanism. This service is free to pharmacists.
Accreditation Council for Pharmacy Education

The Accreditation Council for Pharmacy Education (ACPE) establishes standards and accredits schools and colleges of pharmacy. It is recognized as
an accreditation organization by the United States Department of Education
and the Council on Post-Secondary Accreditation. Founded in 1932, it is not
a government agency, and schools and individuals do not have membership
in the organization. However, the ACPE has considerable influence, because
110
most state licensing agencies require, with some exceptions, graduation from
an accredited school of college of pharmacy in order to sit for their licensing
examinations. Much of the ACPEs budget is provided by the tripartite member organizations and a philanthropic foundation, the American Foundation
for Pharmaceutical Education. The organization also maintains a widely
used process for review and approval of continuing education providers,
programs, and materials. Its board of directors is made up of individuals
appointed by the American Association of Colleges of Pharmacy, the American Council on Education, the American Pharmacists Association, and the
National Association of Boards of Pharmacy. The board of directors is responsible for establishing the policies and setting standards for accreditation
of pharmacy professional degree programs and for approval of continuing
pharmaceutical education providers. The organization also maintains a public interest panel, which includes at least two representatives of the public
who are not pharmacists or involved in pharmaceutical education.
American Foundation for Pharmaceutical Education

The American Foundation for Pharmaceutical Education (AFPE) was formed
in 1942 to assist in training of teachers for colleges of pharmacy and to help
in developing scientists for the pharmaceutical industry. Working to attract
individuals to the study of pharmacy and to graduate education, the organization provides fellowships for graduate students, and more recently has
provided financial support for research by new faculty members who were
AFPE graduate fellows. In addition to fellowships, the AFPE has provided
financial support for the American Journal of Pharmaceutical Education,
which is published by the American Association of Colleges of Pharmacy,
and also to the Accreditation Council for Pharmacy Education, which accredits schools and colleges of pharmacy. Other activities include financial
support for teachers seminars, student recruitment programs, and gathering
of data on pharmacy practice and pharmacy education. The organization is
supported by gifts from individuals, the pharmaceutical industry, and others.
Current issues for pharmacy organizations

Multiplicity of organizations
The profession of pharmacy has many national, state, and local organizations
that cover a region of a state, a county, or even one city. Not only are
there multiple organizations based on geographic areas, but organizations
have proliferated to represent specific interests of individuals based on varied
practice interests or varied practice sites within pharmacy.11 Each individual
is faced with a range of varied pharmacy-related organizations that he or
she might join and support. How many organizations should or must individuals support through membership fees, time, and the other resources that
111
organizations need? Does the existence of so many organizations benefit the

profession or society? Or, is the existence of so many organizations detrimental to pharmacy and/or to society? These questions have been examined
for decades, and there are, of course, competing viewpoints.
The argument often is made that the existence of multiple organizations
reduces the clout of the profession or its ability to affect the implementation
of policy decisions that would advance the profession and/or improve health
care. The fact that varied (and sometimes conflicting) positions are held
on policy issues is said to confuse policy-makers and consumers and to
cause them to question which organization really represents the views of
the profession.
Despite the concerns that have been expressed pertaining to the perceived
need for pharmacy to speak with one voice, some mechanisms do exist
for pharmacy organizations to work together. One example is the Joint
Commission of Pharmacy Practitioners (JCPP), which was formed in 1977
as a mechanism for national pharmacy organizations to discuss issues. The
JCPPs members are the following pharmacy organizations:
Academy of Managed Care Pharmacy;
American Association of Colleges of Pharmacy;
American College of Apothecaries;
American College of Clinical Pharmacy;
American Pharmacists Association;
American Society of Consultant Pharmacists;
American Society of Health-System Pharmacists;
National Community Pharmacists Association; National Association of
Boards of Pharmacy; and
National Council of State Pharmacy Association Executives.
The JCPP has organized and sponsored conferences devoted to strategic

planning for the future of pharmacy.
During a period in the early 1990s, several pharmacy organizations
formed coalitions to work on health care reform. Unfortunately, there was
not just one coalition, but several, speaking for the profession. Interestingly,
many members expressed displeasure with the lack of unity and encouraged
the organizations to work together more closely on health care reform. It
seems unlikely that many of the national pharmacy organizations will merge
in the near future. However, it does seem wise for the organizations to
continue to work toward professional unity.
Individual decisions regarding organizations

How should individuals approach the issue of personal participation in
pharmacy organizations? The large number of organizations makes decisions
112
more complex than if only one or two existed. However, the large number
of national organizations focusing on specific practice areas also means that
each pharmacist should be able to identify at least one national organization
that pursues goals consistent with his or her own interests.
Because pharmacy organizations function on a variety of levels, ranging
from the national to local, individuals desiring to influence activities affected
by pharmacy organizations should to consider joining at least one national,
one state, and one local organization.
Most pharmacy organizations offer student membership at reduced rates,
and many have student chapters, so pharmacy students should consider
becoming involved in pharmacy organizations while still in school. Involvement in the organizations offers the opportunity not only to network with
other students, but also to network with practicing pharmacists. Serving
on committees or as an officer in the organizations also provides excellent
opportunities for development of leadership skills.
Some people believe that since the profession provides an opportunity for
service and for personal reward, each individual has a duty to support the
profession by supporting pharmacy organizations. However, if most members of a profession choose not to support its organizations, the existence of
the profession and it potential contributions to society will be jeopardized.

1. Vollmer HM, Mills DL. Professionalization. Englewood Cliffs (NJ): Prentice-Hall; 1966.
2. Schondelmeyer SW. Professional association membership decisions among pharmacists.
PhD Dissertation, The Ohio State University, 1984.
3. Sonnedecker G. Kremers and Urdangs history of pharmacy. 4th edition. Philadelphia: JB
Lippincott; 1976.
4. Konnor DD. Scientists to the fore. American Druggist, May 1987:90.
5. Konnor DD. The state of state associations. American Druggist, November 1995:
282834.
6. Shefcheck SL, Thomas J III. The outlook for pharmacist initiation and modification of
drug therapy. J Am Pharm Assoc 1996; 36:597604.
7. Punekar Y, Lin S, Thomas J III. Pharmacist collaborative practice progress: state laws and
perceived impact of collaborative practice. J Am Pharm Assoc 2003; 43:50310.
8. Konnor DD. The mail service pharmacy industry: growing by meeting the needs of
managed health care. J Res Pharmaceut Econ 1990; 2:3014.
9. Managed care pharmacy association focusing on state anti-managed care. Weekly Pharmacy Reports 1996;45(46) November 11:3.
10. 170 Years of USP: the end of the beginning. Rockville (MD): United States Pharmacopeial
Convention; 1991.
11. Rappaport P. The unity issue. Can J Hosp Pharm 1992; 45(4):1334.
Web sites for organizations discussed in this chapter

Academy of Managed Care Pharmacy www.amcp.org/ [accessed September 13, 2012].
113
American Association of Pharmaceutical Scientists www.aaps.org [accessed September 13,

2012].
American College of Apothecaries. www.americancollegeofapothecaries.com [accessed September 13, 2012].
American College of Clinical Pharmacy www.accp.com [accessed September 13, 2012].
American Pharmacists Association www.pharmacist.com [accessed September 13, 2012].
American Society of Consultant Pharmacists www.ascp.com [accessed September 13, 2012].
American Society of Health-System Pharmacists. www.ashp.org/ [accessed September 7, 2012].
National Community Pharmacists Association. www.ncpanet.org/ [accessed September 7,
2012].
National Pharmaceutical Association www.npha.net.

Alpha Zeta Omega alphazetaomega.net [accessed September 13, 2012].
Kappa Epsilon http://kappaepsilon.org [accessed September 13, 2012].
Kappa Psi www.kappapsi.org [accessed September 13, 2012].
Lambda Kappa Sigma www.lks.org.
Phi Delta Chi www.phideltachi.org.
Phi Lambda Sigma www.philambdasigma.org [accessed September 13, 2012].
Rho Chi www.rhochi.org [accessed September 13, 2012].

Consumer Healthcare Products Association www.chpa-info.org [accessed September 13,
2012].
Generic Pharmaceutical Association www.gphaonline.org [accessed September 13, 2012].
Healthcare Distribution Management Association www.healthcaredistribution.org [accessed
September 13, 2012].
National Association of Chain Drug Stores www.nacds.org [accessed September 13, 2012].
National Pharmaceutical Council www.npcnow.org [accessed September 13, 2012].
Pharmaceutical Care Management Association. http://pcmanet.org [accessed September 13,
2012].
Pharmaceutical Research and Manufacturers of America. www.phrma.org [accessed September 13, 2012].

Accreditation Council for Pharmacy Education www.acpe-accredit.org [accessed September 13,
2012].
American Association of Colleges of Pharmacy www.aacp.org [accessed September 13, 2012].
American Foundation for Pharmaceutical Education www.afpenet.org [accessed September 13,
2012].
National Association of Boards of Pharmacy www.nabp.net [accessed September 13, 2012].
United States Pharmacopeial Convention www.usp.org [accessed September 13, 2012].
7
Emerging roles
Richard J. Bertin, PhD, RPh
Todays health care system offers unprecedented opportunities for pharmacists. In the not-too-distant past, pharmacy was seen as a largely undifferentiated profession, in which the vast majority of practitioners dispensed
prescriptions, written by physicians, from a traditional community or hospital pharmacy setting. A relatively small number of pharmacists deviated
from this path to pursue careers in nuclear pharmacy, research, industry, or
academia.
Now, this picture is vastly changed, with pharmacists occupying clinical
and managerial/administrative roles at many points in the health system.
Certainly, drug distribution is still an important activity which pharmacists
perform or, more commonly, supervise. Other chapters in this book have
described some of the other roles into which many of todays pharmacists
are moving. This chapter explores that phenomenon in more detail, and
highlights three topics that are of particular current interest.
The proliferation of non-traditional roles for pharmacists can likely
be traced back to the expansion of pharmacist education from the basic
chemistry-related courses of the earlier days of the profession. Courses in
business management, accounting, and related subjects became necessary
parts of the curriculum when most pharmacists were engaged in community
pharmacy or hospital pharmacy practice. In these settings, knowledgeable
budgeting, purchasing and inventory management, and staff supervision
often were markers of professional acumen, and pharmacists with these
skills commonly were selected for higher management positions in the health
industry.
It was the addition of greatly enhanced clinical training and experience
to the scientific and managerial knowledge base of pharmacists that really
opened the doors to broader roles in provision of health care for patients.
Courses in anatomy and physiology, combined with formally taught skills in
patient history taking, counseling, and physical assessment, paved the way.
The introduction and later universal adoption of the PharmD curriculum
and teaching of therapeutics courses which required that pharmacy students
interact with other health professional students proved that pharmacists
116
could hold their own in a more clinically structured environment. New

institutional drug distribution systems that required more direct participation
of pharmacists in receiving and interpreting drug orders also brought many
of these practitioners out of their cloistered enclaves. The net effect was a sea
change in pharmacy practice, beginning in institutions, but slowly spreading
across the profession. The PharmD educational curriculum and the inevitable
adoption of new clinical roles for pharmacists marked a change in pharmacy
that can never be reversed.
Community pharmacy practice has been particularly affected by the
changes in pharmacist roles. Historically, pharmacists have always served
as an important portal of entry into the health care system for patients in
the community setting, providing counseling on over-the-counter medications and frequently referring patients with serious complaints to physicians.
Ironically, however, not too long ago, ethical guidelines forbade community
pharmacists to discuss specific drug therapy with a patient or even to identify
the name of a prescribed drug on a prescription container. The pharmacists
only recourse was to refer the patient back to the physician with any questions about the drug or its effects. Obviously, this significantly curtailed the
pharmacists real utility as the drug expert in patient care.
In the 21st century, however, the situation has changed dramatically. Colleagues in the health professions are now accustomed to seeing pharmacists
playing a significant role in health care, wherever they practice. With few
exceptions, pharmacists are well accepted in these roles by colleagues as well
as patients. Although some pharmacists still in practice are uncomfortable
with these new clinical roles, the profession is clearly changing. Enthusiastic,
well-trained pharmacists have more opportunities open to them than ever
before.
Advanced practice credentialing

As pharmacists have become more clinically involved in patient care, pharmacy has taken note of the practice models that characterize other health
professions. An important example of this is the move toward the acquisition
of credentials which indicate that a pharmacist has the knowledge and skill
to perform advanced level services.
Pharmacy practice, like medicine and the other health professions, is regulated at the state level by regulatory boards with responsibility for specific
disciplines. Pharmacists are licensed to practice after having (1) graduated
from a college or school of pharmacy approved by the board; (2) spent a
minimum number of hours of experience in structured, supervised practice;
and (3) passed a licensing examination prescribed by the state.
State licensure is an indication that the individual has attained the basic
degree of competence necessary to ensure that the public health and welfare
Emerging roles
117
will be protected. Individuals who have received a license may use the abbreviation RPh (for registered pharmacist) or other designation authorized by
the board of pharmacy after their names.
Pharmacy practitioners who wish to broaden and deepen their knowledge
and skills may participate in a variety of postgraduate education and training
opportunities. Some of these are discussed in the following sections.
Academic postgraduate education and training

Pharmacists who wish to pursue a certain field of study in depth may enroll
in postgraduate masters or doctor of philosophy (PhD) programs. Common
fields of study for masters candidates include business administration and
public health. Common fields for PhD studies include pharmacology, pharmaceutics, pharmaceutical and medicinal chemistry, pharmacotherapeutics,
pharmacy practice, and social and administrative sciences.
Bachelor of Science-level pharmacists who were in the workforce when
the PharmD degree was introduced had an opportunity to return to a college
or school of pharmacy to earn that doctoral degree. Such programs, commonly tailored to the individuals background and experience, have followed
nontraditional pathways, but produced the same educational outcomes as
traditional PharmD degree programs.
Residencies
A postgraduate year 1 pharmacy residency (PGY1) training program is an organized, directed, accredited program that builds on the knowledge, skill, attitudes, and abilities gained from an accredited professional pharmacy degree
program. The first-year residency program enhances general competencies in
managing medication-use systems and supports optimal medication therapy
outcomes for patients with a broad range of disease states. The postgraduate
year 2 (PGY2) program follows a PGY1 pharmacy residency and increases
the residents depth of expertise in medication therapy management and
clinical leadership in a specialized area of focus. Pharmacy residencies occur
in a wide variety of settings and usually are 12 months in duration.
The American Society of Health-System Pharmacists (ASHP) is the recognized accrediting body for pharmacy residency programs. The ASHP Commission on Credentialing (COC), a committee of the ASHP Board of Directors, is responsible for the development of standards for residency programs,
administering the accreditation process and granting accreditation. The COC
consists of 18 appointed pharmacists, who have served as residency program
directors and who represent a variety of practice settings, as well as two
public members. ASHP partners with other organizations, including the
Academy of Managed Care Pharmacy, the American College of Clinical
118
Pharmacy, the American Pharmacists Association, and the American Association of Colleges of Pharmacy, in developing standards and/or accrediting
residency programs of a specialized or practice setting-specific nature.
Most pharmacists who pursue residency training currently do so by completing a PGY1 residency. These residencies occur in a wide variety of settings
such as hospitals, ambulatory care clinics, community or retail pharmacies,
managed care organizations, home care, or long-term care facilities.
As of mid-2012, 706 ASHP-accredited PGY1 and 381 PGY2 residency
programs were available. Interest in pharmacy residency training continues
to grow rapidly, and an additional 326 new programs currently are in the
accreditation review process. More information is available on the ASHP
web site: www.ashp.org.
Fellowships
A fellowship is an individualized postgraduate program that prepares the
participant to become an independent researcher in an area of pharmacy
practice. Fellowship programs, like residencies, usually last 1 to 2 years. The
programs are developed by colleges of pharmacy, academic health centers,
colleges and universities, and pharmaceutical manufacturers.
There is no official accreditation body for fellowship programs; however,
the American College of Clinical Pharmacys Guidelines for Clinical Fellowship Training Programs provide a framework for peer review that fellowship
programs may adopt voluntarily. Those guidelines are available at the ACCPs
web site: www.accp.com.
Several pharmacy organizations, including the American College of Clinical Pharmacy, the American Society of Health-System Pharmacists, and the
American Pharmacists Association, award the honorary title of Fellow to
selected members as a means of publicly recognizing their contributions to
the profession. A Fellow of the ASHP, for example, may write FASHP or
Fellow of the American Society of Health-System Pharmacists after his or
her name. The two uses of the word fellowone denoting an individual
participating in a postgraduate training program and the other denoting
receipt of an honorary titleshould be clearly distinguished.
Practice-based continuing pharmacy education activities

Under standards that were in place until 2008, the American Council for
Pharmacy Education (ACPE) defined a certificate program for pharmacists
as a structured and systematic postgraduate continuing education experience
that was smaller in magnitude and shorter in duration than degree programs.
When the ACPE implemented new accreditation standards for continuing pharmacy education (CPE) in 2009, the term certificate program was
Emerging roles
119
officially replaced with practice-based CPE activities. In addition to didactic

instruction, the design of practice-based CPE activities includes practice experiences, simulations, and/or other opportunities for demonstrating desired
professional competencies. The length of any such activity is determined by
its stated goals, desired professional competencies, and outcome measures,
but it requires a minimum of 15 contact hours (1.5 CEUs).
Practice-based CPE activities, often still referred to as certificate programs, are offered by national and state pharmacy organizations and by
schools and colleges of pharmacy and other educational groups. Such programs often are held in conjunction with the main educational meeting
of an organization. ACPE accredits providers of such activities, and more
information is available at the ACPE web site: www.acpe-accredit.org.
Traineeships
Traineeships, in contrast to certificate training programs, are defined as intensive, individualized, structured postgraduate programs intended to provide
the participant with the knowledge and skills needed to provide a high level
of care to patients with various chronic diseases and conditions. Traineeships
generally are of longer duration (about 5 days) and involve smaller groups of
trainees than certificate programs. Some are offered on a competitive basis,
with a corporate sponsor or other organization underwriting participants
costs. Pharmacy organizations that currently offer traineeships include the
American College of Apothecaries, the American Society of Consultant Pharmacists, and the American Society of Health-System Pharmacists Research
and Education Foundation.
Certification
Certification is a credential granted to pharmacists and other health professionals who have demonstrated a level of competence in a specific and
relatively narrow area of practice that exceeds the minimum requirements
for licensure. It is a voluntarily sought credential (in contrast to licensure),
although as acceptance of certification grows, it may be seen as a requirement
for certain positions or responsibilities. Certification is granted on the basis
of successful completion of rigorously developed eligibility criteria that include meeting initial training requirements, passing a rigorous examination,
and, in some cases, an experiential component. Completion of a certificate
program is not the same as certification, although the terms look and sound
similar and sometimes are confused.
The development of a certification program includes the following steps:
(1) defining the area in which certification is offered (role delineation);
(2) creating and administering a psychometrically valid and reliable examination; (3) identifying other criteria for awarding the credential (e.g., training
120
and experience); and (4) identifying recertification criteria for demonstrating

continued competence over time.
A professional testing consultant or firm typically assists in the development of the role delineation and the examination to ensure that the examination meets professional standards of psychometric soundness and legal
defensibility.
Certifying agencies for pharmacists only

Two organizations, the Board of Pharmacy Specialties and the Commission
for Certification in Geriatric Pharmacy, offer advanced level certification
programs exclusively for pharmacists.
Board of Pharmacy Specialties

Established in 1976 by the American Pharmacists Association, the Board of
Pharmacy Specialties (BPS) currently certifies pharmacists in six specialties:
ambulatory care pharmacy, nuclear pharmacy, nutrition support pharmacy,
oncology pharmacy, pharmacotherapy, and psychiatric pharmacy. Several
additional areas of specialty certification are currently under exploration or
development by BPS, including pediatric pharmacy, critical care pharmacy,
and palliative care pharmacy. Pharmacists who wish to retain BPS certification must be recertified every 7 years.
The recognition of each specialty is the result of a collaborative process
between the Board and one or more professional organizations, which develop a petition to support and justify recognition of the specialty. This
petition must meet written criteria established by the BPS.
An 11-member board that includes 8 pharmacists, 2 health professionals
who are not pharmacists, and 1 public/consumer member, directs the BPS.
A representative from the APhA Board of Directors and the BPS Executive
Director serve as non-voting members. A specialty council of 6 specialist
members and 3 pharmacists not in the specialty directs the certification
process for each specialty.
BPS examinations are developed and administered with the assistance of
a professional testing firm, resulting in a process that is psychometrically
sound and legally defensible. The established BPS specialty certifications
are accredited by the National Commission for Certifying Agencies, and
accreditation is sought for new specialties as soon as they are eligible for
consideration.
Each specialty has its own eligibility criteria, examination specifications,
and recertification process. All six examinations are currently given on a single day once a year at approximately 60 sites in the United States and around
the world. BPS examinations are administered using a paper-and-pencil
process, but computer-based testing incorporating a new testing schedule is
under exploration.
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121
In 1997, BPS introduced a method designed to recognize focused areas

within pharmacy specialties. A designation of Added Qualifications denotes that an individual has demonstrated an enhanced level of training and
experience in one segment of a BPS-recognized specialty. Added qualifications are conferred on the basis of a portfolio review to qualified individuals
who already hold BPS certification. The BPS currently offers Added Qualifications in Infectious Diseases and Cardiology, within the Pharmacotherapy
specialty.
As of March of 2012, nearly 13,000 pharmacists held one or more BPS
specialty certifications. More information is available on the BPS web site:
www.bpsweb.org.
Commission for Certification in Geriatric Pharmacy

In 1997, the American Society of Consultant Pharmacists (ASCP) Board of
Directors created the Commission for Certification in Geriatric Pharmacy
(CCGP) to oversee a certification program in geriatric pharmacy practice.
CCGP is a nonprofit corporation that is autonomous from ASCP. It has
its own governing Board of Commissioners which includes five pharmacist
members, one physician member, one payer/employer member, one public/consumer member, and one liaison member from the ASCP Board of
Directors.
To become certified, candidates must be knowledgeable about principles
of geriatric pharmacotherapy and the provision of pharmaceutical care to the
elderly. Pharmacists who meet CCGPs requirements are entitled to use the
designation Certified Geriatric Pharmacist, or CGP. Pharmacists who wish to
retain their CGP credential must be recertified every 5 years.
CCGP contracts with a professional testing firm to assist in conducting
the role delineation or task analysis and in developing and administering the
examination and ensuring that its exams meet high psychometric standards.
The CCGP certification process is accredited by the National Commission for
Certifying Agencies. CGP certification examinations are administered twice a
year at multiple locations in the United States, Canada, and Australia. CCGP
publishes a candidate handbook that includes the content outline for the
examination, eligibility criteria for taking the examination, and the policies
and procedures of the certification program.
As of March 2012, 1830 pharmacists held the CGP certification. More
information is available at the CCGP web site: www.ccgp.org.
Multidisciplinary certification programs

Several certification programs are open to professionals from a variety of
health disciplines, including pharmacists. Areas in which such certification is available include diabetes education, anticoagulation therapy, pain
122
management, HIV/AIDS, and toxicology, among others. These programs

have unique requirements, and interested pharmacists must obtain current
information from the providers. A partial list of those programs may be
found at the web site for the Council on Credentialing in Pharmacy: www.
pharmacycredentialing.org.
As of early 2012, fewer than 10 percent of the estimated 250 000 practicing pharmacists in the United States held advanced practice credentials such
as those described above. This indicates that there remains great potential for
growth in participation in the future. The degree of growth is likely dependent
on the extent to which employers, payers, and the public demandand are
willing to pay fordocumented knowledge and skill in their pharmacists
beyond entry-level education and licensure.
Collaborative drug therapy management

Recently, many pharmacists have developed significant expertise in identifying potential and actual drug-related problems, resolving actual drug-related
problems, and preventing drug-related problems. As their expertise in these
activities has been recognized by other health disciplines, one result has been
the development of collaborative drug therapy management (CDTM) programs. The Alliance for Pharmacist-Provided Patient Care defines CDTM as
a team approach to health care delivery whereby a pharmacist and prescriber
establish written guidelines or protocols authorizing the pharmacist to initiate, modify, or continue drug therapy for a specific patient. The Alliance is a
consortium of seven national organizations working together to educate the
public, policy-makers, and other key decision-makers about the important
role that pharmacists play in the ever-evolving health care system.
CDTM maximizes the expertise of pharmacists and physicians or other
prescribers to achieve optimal patient care outcomes through appropriate
medication use and enhanced patient care services. Authority for CDTM
is generally incorporated in state pharmacy practice acts within the section
describing pharmacists scope of practice.
The Alliance has developed information supporting the concept that
CDTM reduces delays in modifying drug regimens and unnecessary physician
office visits, and increases patient compliance and adherence to drug therapy
plans, all of which increase the likelihood that drug therapy problems will be
averted. They contend that:
When pharmacists and physicians work closely together, patients consistently achieve better results from their drug therapies, in part because they
are more likely to take their medicines and take them correctly.
When physicians and pharmacists work together to monitor a patients
reaction to a particular drug therapy, they are able to detect adverse reactions more quickly, which ultimately saves lives and unnecessary costs.
Emerging roles
123
By informing patients and prescribers of possible adverse effects and/or

drug interactions, pharmacists keep their patients healthy and safe and
also avoid unnecessary costs from complications or hospitalizations.
The main components of CDTM include a collaborative practice setting;
access to patients medical records; a demonstrated high level of pharmacist
knowledge and skill in pharmacotherapy; documentation of activities; and
reimbursement for these activities. With an established CDTM program, it
is expected that there would be an increase in efficient workflow, improved
patient outcomes, and a reduction in medication errors.
In CDTM, pharmacists are not trying to replace physicians. Physicians go
through years of training and schooling to be able to diagnose patients. Most
pharmacists do not currently possess that level of diagnostic ability. A CDTM
proposes that physicians be patients care managers, whereby they diagnose
and make initial treatment decisions, and pharmacists be the medication
experts in continuing to select, initiate, monitor, change, or discontinue
patients medications in order to reach therapeutic goals and positive patient
outcomes through cost-effective means. With a CDTM, pharmacists would
have dependent prescriptive authority, meaning that pharmacists share with
collaborating physicians the risk and responsibilities associated with the
patients overall health outcome. Pharmacists would be able to authorize
prescription renewals, adjust dosages, administer immunizations and drugs,
initiate/recommend or discontinue medications, order laboratory tests, and
schedule follow-up visits without waiting or hunting down a physician for
approval. Also, with dependent prescriptive authority, pharmacists would be
assisting physicians, not replacing them, by adding pharmacists knowledge
of drugs to make for a more efficient work environment.
Among health professionals, pharmacists are highly accessible to patients,
since many pharmacies are in minority communities, in urban centers, and
in institutions. Most patients seek out pharmacists for advice on not only
prescription medications, but also on over-the-counter medications. With the
increase in prescription medications switching to nonprescription status and
the cost of physician visits, patients often are taking their health care needs
into their own hands. Pharmacists must be part of this self-care movement to
provide information to patients on medications that are cost-effective. They
also must provide information on medications and cost to physicians, who
are the ones initially diagnosing and prescribing for these patients. Therefore, with the use of a CDTM, pharmacists would be optimizing patients
therapeutic regimens in a cost-effective way through appropriate selection of
medications and reduction in the incidence of medication errors.
Private health plans and self-insured employers have long recognized the
value of CDTM in improving health outcomes and reducing health costs.
States facing the ongoing struggle to reduce health costs while improving
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clinical outcomes should expand collaborative practice protocols to improve

patient care. As formal recognition of CDTMs develops, pharmacists are
seeking to be recognized by the federal Centers for Medicare and Medicaid
Services as providers eligible for payment for their services.
Currently, 46 states permit CDTMs between pharmacists and physicians.
Alabama, Delaware, Oklahoma, and South Carolina, and the District of
Columbia, have not yet approved such authority. As additional states recognize its value, CDTM will continue to maximize the contribution of the
pharmacists clinical expertise to the benefit of patients and health care
systems.
Other emerging practice models

Several other important initiatives are developing as emerging roles for
pharmacists in coming years. This is, of course, an evolving list, as the
pharmacy profession continues to increase its impact in the American health
system. In the previous edition of this book, immunization administration
by pharmacists was highlighted as an emerging role. Over the intervening
few years, all 50 American states have authorized pharmacists to administer
immunizations. Although not all states have uniform policies on this role, it
is clear that administering immunizations has become an established role of
pharmacists today and into the future.
An evolving role of pharmacists that has real promise for more widespread acceptance in the future is medication therapy management (MTM).
This is a distinct service or group of services that optimize therapeutic
outcomes for individual patients. These services are independent of, but can
occur in conjunction with, the provision of a medication product. MTM encompasses a broad range of professional activities and responsibilities within
the scope of practice of the licensed pharmacist or other qualified health
care provider. These services include, but are not limited to, the following,
according to the individual needs of the patient:
Performing or obtaining necessary assessments of the patients health

status;
Formulating a medication treatment plan;

Selecting, initiating, modifying, or administering medication therapy;
Monitoring and evaluating the patients response to therapy, including
safety and effectiveness;
Performing a comprehensive medication review to identify, resolve, and

prevent medication-related problems, including adverse drug events;
Documenting the care delivered and communicating essential information to the patients other primary care providers;
Providing verbal education and training designed to enhance patient understanding and appropriate use of his/her medications;
Emerging roles
125
Providing information, support services and resources designed to enhance patient adherence with his/her therapeutic regimens; and
Coordinating and integrating medication therapy management services

within the broader healthcare-management services being provided to the
patient.
Pharmacist-provided MTM services are currently authorized for eligible patients as part of the Medicare program. Payment for such services by Medicare is consistent with contemporary provider payment rates that are based
on the time, clinical intensity, and resources required. This is considered by
many to be a significant step toward greater payment for cognitive services
provided by pharmacists. As more patients and pharmacists use the Medicare
MTM benefits, the hope is that other payers will see the clinical outcome
and cost-effectiveness benefits to be reaped and similar models of care will
become the norm.
Another emerging role for the pharmacist is in the area of technology and
informatics. This topic is covered in detail in Chapter 18, but the significant
number of references to the importance of technology and/or informatics in
future pharmacy practice necessitates its mention here. Managing electronic
prescribing and its part in the provision of comprehensive pharmacy service
is cited by many pharmacists as a growing responsibility. The ability to use
technological advances properly in dispensing equipment, drug interaction
software, comprehensive electronic medical records databases, and other
applications also will be critical to pharmacists who want to remain current
and effective in meeting their patients and employers needs.
Conclusion
The Joint Commission of Pharmacy Practitioners vision of pharmacy practice in 2015 projects that pharmacists will be the health care professionals
responsible for providing patient care that ensures optimal medication therapy outcomes. In order to achieve this goal, pharmacy must move even more
rapidly to redeploy its members from medication order fulfillment to patient
care. There is no longer any doubt that the future of pharmacy as a profession
lies in its development and implementation of advanced levels of knowledge
and skills in provision of patient care.
A recent report to the US Surgeon General concluded that expanding the
role of pharmacists is supported by evidence-based outcomes and existing
innovative models. The benefits translate into improved consumer outcomes
that support many tenets of health reformenhanced access and quality of
care, cost-effectiveness, and patient safety. The emerging roles described in
this chapter and elsewhere in this book are gaining acceptance by pharmacists, patients, and the health care community throughout the country. The
advanced level credentials that document the pharmacists ability to provide
126
these services are similarly growing in strength across the profession. With
the prospect of expanded payment opportunities for pharmacists services,
all pharmacists need to ensure that they are prepared to meet the challenges
of today and tomorrow.
Bibliography
Alliance for Pharmacist-Provided Patient Care. How patients are already benefiting from
pharmacists services. www.allianceforpharmcare.com/docs/How Patients Are Already
Benefiting from Pharmacists Services.pdf [accessed September 3, 2012].
Council on Credentialing in Pharmacy. Credentialing in pharmacy: a resource paper. www.
pharmacycredentialing.org, 2011 [accessed September 3, 2012].
Council on Credentialing in Pharmacy. Scope of contemporary pharmacy practice: roles,
responsibilities, and functions of pharmacists and pharmacy technicians. (Appendices B
and C) http://www.pharmacycredentialing.org/ccp/Contemporary Pharmacy Practice.pdf,
February 2009 [accessed September 3, 2012].
Office of the Chief Pharmacist, U.S. Public Health Service. Improving patient and health
system outcomes through advanced pharmacy practice a report to the Surgeon General,
2011. www.usphs.gov/corpslinks/pharmacy/comms/sgreport2011.asp [accessed September 3, 2012].
Pharmacist Administered Vaccines: Types of Vaccines Authorised to Administer. Tables based
on APhA/NASPA survey of state immunization laws (updated June 2012). http://www.
pharmacist.com/sites/default/files/files/PharmacistIMZAuthority June18 2012%20%
5BRead-only%50.pdf [accessed February 6, 2013].
8
Robert I. Field, MPH, JD, PhD
Drugs have long mixed with controversy and politics. As far back as the
Roman Empire, Pliny the Elder warned of adulteration of the natural food
and drug supply.1 Today, pharmacy continues to confront a range of complex
political realities, whose breadth is constantly expanding. The perennial
concern over drug safety raises just one set of issues, while economics,
intellectual property, and international trade are among a host of others.
This chapter reviews the most significant political issues facing pharmacy
today. They affect the range of players in the field, from pharmacists to
manufacturers to insurers to patients. Many reflect familiar historical themes,
but others, particularly those raised by the dawning era of genomics, are
relatively new. Each issue, old and new, reflects a clash of competing interests
and conflicting values. They challenge us as a society to find the best balance.
Much of the history of food and drug regulation in America repeats a
familiar pattern.2 Well-publicized scandals engendered political controversies
that prompted new laws and new forms of regulation. The publication in
1904 of The Jungle by Upton Sinclair3 raised public awareness of unsanitary
conditions in the meat packing industry and led to the passage 2 years later
of the first comprehensive food and drug law.4 The deaths of over 100
patients, mostly children, in 1937 from an antibiotic preparation known
as elixir of sulfanilamide led to passage the following year of the federal
Food, Drug and Cosmetics Act, which forms the basis for pharmaceutical
regulation today.5 Reports from Europe in 1962 of severe birth defects linked
to the drug thalidomide gave impetus to passage of amendments toughening
that regulatory scheme later the same year.6 Severe adverse cardiac effects
linked to the widely prescribed arthritis drug Vioxx in 2004 led to legislation
enacted in 2007 to strengthen safety surveillance of drugs after they reach
the market.7
Recent political controversies, however, are different in important ways.
Americans are increasingly concerned not just with safety but also with their
ability to afford the drugs that they need. While past political controversies
led to laws that improved the quality of drugs, consumers now want, and
128
often need, guaranteed access. In a sense, the pharmaceutical industry has

become a victim of its own success. It has produced many highly effective
products that are central to treating a range of conditions, making their
cost a cause for concern. Nothing intensifies a political debate more than
discussions of the flow of money.
The issues discussed in this chapter are among the most prominent today,
but they are only some of the many that create political realities for pharmacy
in the United States. Just as they reflect an evolution from past concerns, they
will eventually be transformed into new ones. What will not change in the
foreseeable future is the central role of pharmacy in American health care.
Pharmacists, used to playing a local role in meeting community health care
needs, increasingly find themselves in the middle of a highly visible national
stage.
Growth of pharmaceutical use and spending: prelude to

intensifying political conflict
The growing role of pharmaceutical products in American health care provides the context for current political debates. Use of medications and
consequent spending on them has increased dramatically in recent years,
with particularly rapid growth occurring during the 1990s. Between 1992
and 2000, overall utilization of prescription drugs in America increased by
52 percent.8 In 1990, they accounted for just under 6 percent of health care
spending, in 2002 for just under 9 percent, and in 2008 for 10 percent.9 Just
between 1999 and 2000, prescription sales rose almost by 19 percent and
the number of prescriptions dispensed grew by 7.5 percent.10
These trends have sent ripples throughout the economy. In the business
world, General Motors spent more than $1 billion in 2001 on prescription
drugs for active and retired employees.11 In the world of government, between 1997 and 2000 Medicaid expenditures for prescriptions rose by over
18 percent, compared with 3.6 percent for hospital care.12 By 2005, they had
reached 15.6 percent of total Medicaid spending.13 Medicare began covering
outpatient prescription drugs in 2006, and by 2008 annual spending on
them had reached almost $50 billion, representing over 20 percent of the
programs budget.14
These trends present a particular burden for those who do not have
prescription insurance coverage. While the extent of coverage has grown
considerably, it is still unavailable to many.15 In 1990, about 25 percent
of all prescription spending was reimbursed through private insurance, and
60 percent was paid for out of patients pockets. In 2000, private insurance
covered almost 50 percent, but patients still paid for 27 percent directly.16 In
2008, the share of prescription drug costs paid for by patients out-of-pocket
continued to be substantial, at over 20 percent.17
129
In addition to private insurance, coverage is available for elderly persons

under Medicare and for the poor under Medicaid. However, many Americans, an estimated 50 million, do not qualify for either of these programs and
are not covered by private plans. They are uninsured and must bear the full
cost of their prescriptions. Even under the health reform enacted in 2010,
which will extend health insurance coverage to millions, a sizeable, although
smaller, number of people are expected to remain uninsured and to lack drug
coverage as a result.
Political fallout
Financial trends such as these cannot fail to have political consequences. The
cost of prescriptions has become a pocketbook issue that affects almost
everyone. Those who do not feel it themselves often experience it indirectly
through the effect on family members or through higher premiums for health
insurance.
In responding to concerns over the high cost of their products, pharmaceutical companies point to the tremendous expense involved in producing
them and to the huge benefits that many of them provide. The process
of bringing a drug from concept to market can take over 10 years, and,
according to some estimates, cost over $1 billion.18 It is estimated that for
every 250 drugs that enter initial preclinical testing, only one actually reaches
the market.19 Without an adequate return on this investment in the form of
revenues, companies could not afford the financial risk.
Drug companies also argue that when there is an adequate return for
investing in pharmaceutical drug research, the rewards for society can be
great. Pharmaceutical products are credited with playing a leading role in
recent dramatic increases in longevity.20 They may also help to hold down
other health care costs, such as hospitalization. It is not, the industry argues,
as if society does not receive great value for its pharmaceutical expenditures.
The combination of tremendous social value and potentially unaffordable costs creates a prescription for political turmoil. Political attention has
focused on a range of pharmaceutical industry practices, and in a business
this complex, attention to one issue inevitably leads to examination of many
others. Therefore, we are seeing much of American pharmacy, from research
to manufacturing to marketing to dispensing, coming under greater public
scrutiny.
Future conflicts
In coming years, the pharmaceutical industry is likely to face even more
turmoil from forces beyond economics. A fundamental scientific revolution
is transforming the very meaning of pharmaceutical products. That is the
130
advance in our understanding and use of the human genome. The field of
genomics is changing the basis of drug development, and possibly of all
health care. As a result, both the effectiveness of medicines and the cost of
their development are likely to rise significantly. A range of highly emotional
political issues can be expected in response. Our society has begun to grapple
with just a few of them, such as human cloning, stem cell research, and
genetic privacy, but the full brunt of the controversies that the genetics
revolution will engender is yet to be felt.
Regulation, patents and politics

Current political realities begin with the existing government structures that
oversee the pharmaceutical industry, two in particular. The Food and Drug
Administration (FDA) regulates the development, testing, marketing, and
manufacture of drugs. The Patent and Trademark Office (PTO) issues patents
that protect new drug products from competition for a period of time. Until
recently, these two agencies and the regulatory laws that they implement
operated largely independently. However, over the past several years, their
responsibilities have begun to overlap, creating new political pressures for
the industry and for the regulators involved.
Regulation by the FDA

The FDA is the publics guardian of drug safety and efficacy. It is the police
force that stands between consumers and products that are unsafe, useless,
or improperly manufactured. Unlike almost all other areas of consumer
regulation in which rules are enforced for products on the market, drug
regulation applies before a product even reaches consumers, in fact before it
even sees its first tests. This rigorous form of regulation is intended to protect
consumers before a disaster has a chance to occur. Some believe, however,
that the FDA overdoes its job and holds back many drugs that are safe and
needed. The battle between these competing concerns creates a fundamental,
and perennial, political reality for the agency.
In response to fears that valuable new drugs are being kept from consumers through regulatory delays, the Prescription Drug User Fee Act of
1992 directed the FDA to accelerate its review of new drug applications and
imposed fees on the companies requesting those approvals to finance the
process.21 Review times have declined since the law was implemented, but
some critics contend that reduced vigilance against hazardous products has
resulted.22 Is another thalidomide waiting to sneak through an over-stressed
review process? Or is our over-concern that there will be another such
disaster keeping lifesaving medicines from reaching patients? The agency
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faces pressure to speed up its approval of new drugs, while also facing the
prospect of condemnation if it lets a dangerous drug slip through.
This is a balancing act that the FDA will probably always face. In addition to safety, the balancing also has cost implications. A longer and more
intensive review process adds to the expense of developing new drugs. In all
sectors of health care, society juggles a perpetual trade-off between quality,
cost and access.23 We will never find the perfect equilibrium, and the FDA
perennially finds itself caught in the middle.
The FDA also faces challenges in limiting the influence of interested
parties on its decision-making process. When regulatory judgments require
particular expertise, for example when the risks and benefits of an especially
novel drug must be weighed, the agency often appoints an advisory committee of outside scientists to recommend a course of action. These committees
often include scientists who have financial ties to the manufacturer of the
drug in question through consulting fees, research support, or similar arrangements. Critics charge that such relationships create conflicts of interest
that can bias recommendations.24 Supporters of these arrangements argue
that it is only natural for the top experts on a medical condition to consult
with a company that produces treatments for it.
The FDA has grappled with the challenge of obtaining input from the
most knowledgeable experts while seeking to ensure that the advice it receives is objective. It has issued guidance on the operation of advisory committees that limits financial ties between committee members and companies
whose products they review and requires disclosure of potential conflicts of
interest, while permitting various financial relationships to continue.25 The
balance is a difficult one to achieve, and it will require continual agency
attention.26
The special status of herbal supplements

In addition to prescription drugs, other kinds of products also promise
medicinal benefits. In particular, patients have turned to herbal remedies
for thousands of years.27 Some use these remedies in the hope that they
have curative properties, others in the hope of warding off disease. There
are thousands of these substances, but few have been tested for safety and
efficacy with the same rigor that applies to prescription drugs.28
Debates have raged over the appropriate way for the government to oversee herbal medicines. Their legal status depends to a large extent on how they
are defined. If classified as drugs, FDA approval is needed before marketing,
along with the full process of clinical testing. As a result, companies that
manufacture and sell these products would prefer that they be considered as
foods, which are subject to much looser standards and for which review and
clearance are not required before they reach the market.
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In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which classified herbal remedies as similar to foods
and formally defined them as dietary supplements.29 Under the Act, these
products can be sold without pre-market approval.30 The FDA can prohibit
their sale if hazards are found, but only after they have reached the market.
Manufacturers may not make therapeutic claims for herbal supplements in
the same way as they can for FDA-approved drugs, but they may assert a
relationship between a product and health effects, if the claim is truthful and
not misleading and includes a disclaimer that it has not been evaluated by
the FDA.
Some consumer advocates maintain that this regulatory scheme still permits ineffective and unsafe products to reach the market.31 They fear that
consumers may have difficulty evaluating the general claims of benefits that
may be asserted for herbal remedies and may also fail to realize that these
products are subject to a lesser level of government scrutiny. Manufacturers
contend that the scheme implemented by DSHEA is sufficient to protect
consumers, since the FDA may act if hazards are found.32
Intellectual property
Underlying the economic foundation of the pharmaceutical industry is the
law of patents, which protects the financial interests of product innovators.
Patents give inventors the right to prevent competitors from making or selling
their inventions for a period of 20 years from the date they file an application
with the PTO. This protection applies to new drugs in much the same way as
it does to other inventions, although a large portion of the 20-year protection
period may be exhausted during pre-market testing before financial rewards
in the form of sales can be realized.
With the protection from competition that a patent affords, a manufacturer becomes a monopolist for a period of time during which it has
tremendous leeway in setting the price. Manufacturers argue that this is
essential to ensure sufficient profits to compensate for the extreme cost and
risk of developing new drugs and bringing them to market. Industry critics
contend that some companies abuse the patent laws by charging exorbitant
prices when they can.33 Prescription drugs are a necessity, they contend, and
pricing policies should take their life-saving nature into account.
The issue of pharmaceutical pricing has taken on increasing prominence
with the introduction of several new bioengineered drugs with substantial
price tags. For example, Provenge, a treatment for prostate cancer, costs
about $93,000 for a course of therapy.34 Soliris, which treats a rare immune
system disorder, costs $409,500 a year.35 Even some conventional brand
name drugs can be extremely expensive, including Lipitor, which treats high
cholesterol at a cost of $1500 a year, and Zyprexa, for schizophrenia, at
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$7,000 year. (Note: since this chapter was submitted for publication, these
drugs have become available in a generic version.)
Generic competition under the HatchWaxman Act

In a market-based economy, the answer to monopoly pricing is competition.
For pharmaceuticals, this is accomplished through the sale of generic drugs,
copies of drugs that are manufactured by competing companies once the
original patent has expired. However, bringing these products to market
raises a host of difficult questions. When should a generic manufacturer be
allowed to begin testing a copy of a patented drug? Must it go through the
entire testing and FDA review process? How much of the original product
may be copied?
In 1984, the patent rules that apply to new drugs were changed by the
Drug Price Competition and Patent Term Restoration Act (commonly known
as the HatchWaxman Act).36 This law was intended to strike a balance
between two goals: (1) to streamline the generic approval process to bring
competing forms of existing products to market faster, and (2) to maintain
sufficient economic rewards to encourage research-based companies to continue to produce new drugs.
The HatchWaxman Act implements a complex regulatory scheme. To
assist the introduction of generic drugs, it allows companies that manufacture
them to begin testing before the patent on the original drug has expired,
and applications for approval of them can reference safety data that was
filed with the FDA for the original drug. In return, manufacturers of the
original drugs are granted additional time for exclusive sales of their products
through a prohibition on FDA approval of a generic copy for up to 5 years
after the patent has expired. Other provisions permit further delays in the
marketing of generic products when the validity of patents is in dispute and
grant exclusive marketing periods for the first generic version of a drug to
obtain FDA approval.
Most observers believe that the HatchWaxman Act has fulfilled its original goals of bringing generic drugs to market sooner while protecting the
financial returns for brand name products.37 However, industry critics argue
that the patent laws are still too restrictive and that they are open to abuse
by manufacturers. They point to what they see as overuse of provisions in
the HatchWaxman Act that delay the start of generic competition and to
filings that protect inactive ingredients, metabolites, and other peripheral
aspects of drugs beyond the time when the original patent has expired.38
They also point to the high cost and consequent unavailability to many
patients of some life-saving medications that are still under patent. The
industry contends that any weakening of patent protections could jeopardize
the incentives needed for continued investment in the expensive process of
new drug development.39
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Generic competition for biotechnology drugs

While the blueprint for generic competition created by the HatchWaxman
Act has generally worked well for traditional drugs, it does not readily apply to newer medications developed through biotechnology. These products
emerge from complex processes in which microorganisms are engineered to
produce therapeutic agents. The processes require the orchestration of intricate chains of events. The methods involved are highly sensitive to changes
in conditions, making them difficult to replicate.
Manufacturing a competing biotechnology product is less a matter of
creating a chemically identical compound than of duplicating a production
protocol. In fact, at this time there is no way to demonstrate that a new
version of a biotechnology drug is exactly the same as the original.40 It is
only possible to know whether it emerged from a similar production process.
Since generic versions of bioengineered drugs may vary from the originals,
the term generic copy is not technically accurate. Therefore, they are commonly referred to instead as either biosimilars or follow-on biologics.
These products are similar, but not necessarily identical, to the original drug
that they have followed.
Biotechnology creates a particularly acute need for a generic market, as
these drugs tend to be extremely expensive. Generic competition after patent
expiration, which reduces prices for conventional pharmaceuticals, seems
an obvious remedy, if it can be implemented. However, because a generic
company must mimic a complex process in order to produce its version of
a bioengineered drug, the HatchWaxman Acts blueprint for introducing
generic competition is difficult to apply. A different regulatory mechanism is
needed that permits the exchange of production details without jeopardizing
confidential aspects of the original manufacturers operations.
Congress enacted a new blueprint for enabling competition in the market
for biosimilars as part of the Patient Protection and Affordable Care Act
(ACA), the health reform law passed in 2010.41 As under the HatchWaxman
Act, information is shared by the original manufacturer before the patent
expires, in this case information regarding manufacturing protocols. However, unlike the process implemented by the HatchWaxman Act, in which
the relevant data are available in FDA files, information for biosimilars
is provided to the generic manufacturer by the original drug maker. It is
shared under confidentiality protections, and the nature of the exchange is
subject to negotiation between the parties.42 Another important difference is
that the original manufacturer receives an additional 12 years of marketing
exclusivity after patent expiration, a notable increase over the 5 years they
receive under HatchWaxman.
This mechanism for facilitating the manufacture and sale of biosimilars
is more cumbersome than that implemented by the HatchWaxman Act for
generic drugs. It will take time to tell whether it is as effective. The high cost
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and huge therapeutic potential of biotechnology drugs mean that much is

riding on its success.
Perennial patent concerns

The appropriate length, extent and nature of patent protection are key
elements of an ongoing debate that goes to the heart of pharmaceutical
economics. Many lawsuits have been fought over the validity of individual
patents, and the flow of litigation will undoubtedly continue. Because of
the large economic implications, achieving the best balance between patent
protection and generic competition is likely to remain elusive and politically
sensitive for some time.
Insurance for prescriptions

The growth in private prescription insurance coverage during the 1990s coincided with a period of rapidly rising costs. Which was the cause and which
the effect is a matter of debate. As an array of new drugs made prescription
medications more central to the treatment of a range of diseases, the need
for assistance in affording them grew. At the same time, the availability of
financial resources to cover the cost of drugs encouraged more physicians to
prescribe expensive ones and more patients to use them. Undoubtedly, these
forces have reinforced one another. The result is that prescription coverage
has become a financial necessity for most Americans, and controlling costs
has become a primary concern for insurance plans.
The role and politics of pharmacy benefit managers

Most private prescription insurance plans are administered by companies
known as pharmacy benefit managers (PBMs) under contract with insurers.
These organizations purchase drugs in bulk from manufacturers on behalf
of millions of insured patients. This group purchasing gives them substantial
leverage to gain price concessions, which generally take the form of rebates
paid to the PBM by the manufacturer. While an individual patient may not
have the power to bargain over price, PBMs, which specialize in facilitating
group sales, do.43
PBMs also try to control unnecessary drug expenditures to further hold
down costs. Most insurance companies structure prescription benefit plans
around formularies, lists of preferred drugs that patients are encouraged to
use. A formulary generally includes a limited number of medications for
each condition, excluding other similar products as duplicative. Often, the
drugs chosen for inclusion on a formulary are those for which the insurer
or PBM has negotiated the best price. Insurers also encourage patients to use
generic substitutes for brand name drugs whenever possible. The result is that
medications fall into one of three financial categories under most insurance
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arrangements. The cheapest are generics, followed by brand name drugs on

the formulary, followed by other brand name drugs.
To translate these pricing levels into incentives for patients, most insurers structure their coverage into three tiers of reimbursement, under which
patients have the lowest copayment for the cheapest drugs, generics, and
the highest for non-formulary brand name drugs. Under some plans, this
highest copayment may be so large that it is prohibitive for many patients. In
some cases, requests for reimbursement for the most expensive drugs also are
subject to utilization review by the insurer or the PBM, and reimbursement
may be denied altogether.
PBMs, as the gatekeepers to prescription coverage, have strong opponents. Patients and physicians often resent their role in restricting coverage
through formulary development and utilization review. Some feel that they
do not effectively help to control costs, because they keep much of the savings
from manufacturer rebates for themselves. Others argue that PBMs merely
add an unneeded layer of bureaucracy to an already complex system.44
Of all the opponents of PBMs, none are more passionate than pharmacists. The drugs that PBMs purchase in bulk often are distributed to patients
through mail order, bypassing retail pharmacies entirely. When they do facilitate sales through pharmacies, PBMs often restrict the transaction through
utilization review. Those sales that are completed usually are subject to large
negotiated discounts. As a result, pharmacists are seeing some of their profits
and autonomy taken by large companies that never see patients directly.
Whatever the fate of PBMs, it seems certain that some form of large
centralized purchasing of drugs will continue to play an important role.
Group purchasing is the only form of market discipline that can create
effective price pressure, and rising costs will increasingly create demand for
the efficiencies of mail order and other forms of mass distribution. The days
when filling a prescription was a matter between a patient, a physician, and
a pharmacist are waning.
State cost control under Medicaid

State governments are active players in pharmaceutical cost debates because
of their Medicaid programs, which provide health insurance to their poorest
citizens, including, in most states, coverage for prescriptions. Medicaid is a
joint federal-state program in which states administer benefits under federal
guidelines with costs shared by both.45 Its costs have been rising rapidly.46
They reflect the largest single expense in many state budgets, even though
funding is shared with the federal government.47
A few states have been particularly aggressive in seeking to control Medicaid drug costs. Some have implemented formularies of preferred drugs
for which they pay lower prices.48 Physicians must receive prior approval
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before prescribing anything else. Some have gone even further by limiting
the total number of prescriptions they will cover under Medicaid.49 The
states involved believe that these are necessary steps in trying to control their
budgets, but some advocates for the poor fear adverse effects on the health
of vulnerable populations.
Other cost control issues

A number of other issues have received considerable political attention in the
battle over cutting costs. Two are particularly visible: reimportation of drugs
purchased outside of the United States and direct-to-consumer advertising.
Reimportation and international pricing

Some industry critics point to the lower prices charged for pharmaceuticals in
many foreign countries as evidence that Americans are being overcharged.50
Drug companies respond that virtually all developed countries other than
America directly regulate prices, so the lower prices are maintained artificially. The issue, they argue, is not so much that American prices are too
high as that foreign prices are too low.
Whatever the cause, many Americans have found that they can obtain
some medications at much lower prices outside of the country. The closest
and easiest source for these bargains is Canada, a country that controls drug
prices.51 Some residents of northern states drive across the border for pharmaceutical shopping trips, and others order drugs from Internet-based Canadian pharmacies. The price disparities have not escaped political attention.
Proponents of reimportation argue that it affords Americans the same
access to reasonably priced medications that is enjoyed by our geographically
closest foreign neighbors. Pharmaceutical manufacturers counter that selling
drugs to Americans at artificially maintained lower prices will deny them
the revenues needed to continue the expensive process of drug discovery and
development. They also warn that adulterated or contaminated drugs could
find their way back into the country.
Even though it is widely practiced, reimportation violates current law.
Congress has considered several initiatives to legalize the practice, at last
for individual purchases, but none has yet been implemented. The Medicine
Equity and Drug Safety Act of 2000 permits the FDA to let drug wholesalers
purchase American drugs at cheaper prices abroad and then bring them
back to the United States for sale at lower prices.52 However, the statutory
mechanism for reimportation is complex and cumbersome, and the FDA has
not yet put it into effect. Nevertheless, international pricing discrepancies will
continue to attract political attention. The United States market has become
the main source of profits for many pharmaceutical companies.53 This puts
a heavy financial burden on American drug buyers, and creates an ongoing
source of political friction.
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Direct-to-consumer advertising
In 1997, the FDA amended a long-standing policy that limited the ability of
drug companies to advertise their products directly to patients through television.54 Direct-to-consumer advertising, commonly referred to as DTC,
has since grown into a multibillion dollar business, with over $4 billion
spent in 2005.55 While, for the most part, only a few best-selling drugs
are promoted in this way, television commercials have been associated with
sizeable sales growth for those products that are advertised.56
Some consumer advocates and some insurance companies complain that
DTC advertising inflates utilization of drugs, adding costs for the system
overall.57 Pharmaceutical firms counter that the ultimate decision on utilization rests with each patients physician, whose professional judgment guards
against unnecessary sales. They add that DTC advertising raises awareness of
medical conditions and available treatments, resulting in timelier, and often
more effective, care.58
The FDA issued updated draft guidance on DTC advertising in 2012,
however the battle over the practice promises to continue, as the practice
shows no signs of abating. The power of television advertising to drive sales
has been clear since the dawn of the medium. It is an obvious target in the
battle to control health care costs.59
Pharmaceutical industry research and marketing

As its importance to American health care has grown, various practices of the
pharmaceutical industry have come under increasing public scrutiny. Two areas have seen particular attention: (1) the conduct of research through which
new products are created and tested, and (2) the promotion of products once
they reach the market.
Research
The lifeblood of the pharmaceutical industry is research. It is the engine
that creates new products that keep companies going. However, since drug
development research is extremely costly, time-consuming, and financially
risky, researchers face pressures not only to maintain the integrity of their
investigations but also to help facilitate the development of new drugs. In
some cases, investigators own stock or have other financial ties with the
companies whose drugs they are studying. This creates a potential conflict
for them between maintaining objectivity and achieving financial gain.
The pharmaceutical industry has adopted voluntary guidelines to reduce
the chance that conflicts of interest will distort clinical findings.60 Some
scholarly journals have adopted policies requiring that authors of articles
disclose all financial ties to research sponsors, whether or not related to the
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study in question.61 However, some critics contend that these steps are not
enough and that external government regulation is also needed.62 They feel
that the risk of compromised results is too great.
Scientific researchers are not used to being regulated. The nature of science is free inquiry without external constraints. However, effective drug regulation requires complete objectivity. Increasingly, clinical researchers must
venture out of the ivory tower into the political and legal realms to defend
arrangements with sponsors. This has turned the business of research into a
more visible and contentious area.
Marketing
Unlike other industries that manufacture consumer goods, pharmaceutical
companies do not sell most of their products directly to consumers. They
sell them to intermediaries who make the actual purchasing decisions. These
intermediaries are physicians, and occasionally other clinicians, whose approval is required before a prescription can be filled. Even DTC advertising
that appeals directly to patients asks them to consult their physician about
the decision to use a product.
The job of pharmaceutical marketers, therefore, is primarily to influence
physicians. They do this in a number of ways, some of which are controversial. Although advertising in professional journals and other media is
extensive, information about new drugs is primarily spread by sales representatives known as detailers, who meet individually with potential prescribers
to provide product data. Predictions of the demise of detailing because of
Internet marketing, managed care purchasing, and other industry changes
have so far turned out to be wrong. In 2008, there were still over 90,000 of
them in the United States.63
Physician inducements
The key to pharmaceutical product detailing is gaining access to physicians
for personal meetings.64 Often, this is facilitated with gifts. The items can
be relatively trivial, such as a take-out lunch, or can constitute significant
practice enhancements, such as a textbook or a continuing medical education
session. Some have been seen as excessive, such as trips to resorts and tickets
to sporting events. The line between information dissemination and improper
inducements can be difficult to draw. Some academic medical centers have
sidestepped it by prohibiting physicians from accepting even minimal gifts
from pharmaceutical representatives, and some even bar contact between
physicians and representatives entirely.65
Incentives to physicians to prescribe medications raise both ethical and
legal concerns. Federal law prohibits payments of any kind in return for
recommending health care products that are reimbursed by Medicare or
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Medicaid.66 The federal Department of Justice has prosecuted several manufacturers of drugs and devices for paying what are alleged to be kickbacks in
return for prescribing products, and it has obtained large recoveries in a number of cases.67 These actions have significantly raised the political visibility of
drug industry marketing practices. As public concerns about pharmaceutical
prices have led politicians to look widely for culprits, marketing inducements
have been an attractive target.
Off-label promotion
Controversy also surrounds the kinds of claims that manufacturers can make
for their products. Under FDA regulations, they may promote drugs only for
uses, known as indications, that the agency has approved. However, many
drugs have uses beyond their approved indications. For example, a drug
approved to treat one form of cancer may be effective in treating another
form, or a drug approved for adult use may also be helpful in children. In
some cases, an entirely unrelated use may be found. For example, in the early
1990s, the blood pressure drug minoxidil was found to reverse baldness in
men, a use that had not been considered in the original approval process.68
Manufacturers often are aware that a product has an alternative application
such as this, but FDA regulations do not permit them to advertise it or refer
to it in a drugs labeling until it has been subjected to clinical testing and
approved as an indication by the agency. Since these uses may not be listed
on a drugs label, they are referred to as off-label.
Although manufacturers may market drugs only for approved indications,
physicians may prescribe them for any use.69 As a result, off-label use of
FDA-approved drugs is quite common.70 This gives companies a strong
incentive to spread the word to physicians about additional applications of
their products to expand the potential market. However, in doing so, they
must avoid making direct claims for these alternative benefits.
The FDA has tried to define the boundary between permissible dissemination of information regarding off-label uses of drugs and outright promotion.
These efforts have proved controversial. The Food and Drug Administration
Modernization Act of 1997 authorized the FDA to set standards for distribution of information related to off-label uses.71 The agency issued a set of
guidelines in response,72 but they were overturned by a federal court as an
infringement of manufacturers right to free speech.73 The agency maintained
them nevertheless, not as definitive rules but as a safe harbor, a form of
advice on ways to avoid the risk of prosecution. In this context, a federal
appeals court allowed them to stand.74
The guidelines permitted sales representatives to provide physicians with
reprints of peer-reviewed journal articles and book chapters that discuss offlabel uses of a product, as long as there was disclosure that the uses have not
been evaluated or approved by the FDA. They allowed companies to support
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other activities in which information is disseminated, such as continuing

medical education programs, as long as these activities were conducted under
the auspices of independent organizations. However, they did not allow
companies to produce their own brochures or other promotional material in
which off-label uses are described. The guidelines were amended in 2009.75
Among the most significant changes, the new rules relieve companies of two
obligations that were in the original version: to make plans to apply for FDA
approval of off-label uses before distributing reprints of articles about them,
and to provide reprints to the FDA for its review before distributing them.
However, the amended rules added a requirement that positive articles be accompanied by a published paper that presents negative findings, if any exist.
Several companies have run afoul of these rules and faced enforcement
actions that have resulted in substantial penalties.76 Among the larger government recoveries, in 2009, Pfizer paid $2.3 billion and pled guilty to a
felony violation to settle allegations that it promoted off-label uses of several
drugs including the anti-arthritis mediation Bextra. The same year, Eli Lilly
paid $1.425 billion in a case involving the antipsychotic drug Zyprexa. In
2008, Cephalon entered a criminal plea and paid $425 million to resolve
charges involving off-label promotion of the pain medications Gabitril, Actiq,
and Provigil.
FDA restrictions on off-label drug promotion remain controversial.77 The
agency believes they are necessary to prevent confusion among physicians
and patients as to whether a new use of a drug has been tested and approved.
Until it has been, there can be no assurance of safety and efficacy.78 Opponents of the restrictions claim that they continue to represent infringements
on the free speech rights of pharmaceutical manufacturers.79 Because of
the possibility of expanding the markets for their products, companies will
likely remain interested in spreading information as widely as they can about
off-label uses. As a result, the question of when such efforts cross the line
into inappropriate promotion will continue to concern enforcement officials
and courts.
Medicare coverage
In 2006, Medicare for the first time offered coverage for outpatient prescription drugs under a new Part D of the program, enacted as part of the Medicare Prescription Drug, Improvement and Modernization Act.80 Coverage is
provided through private plans known as Prescription Drug Plans (PDPs) and
is subject to government guidelines under a fairly complex arrangement.81
The government provides financial support to protect the plans from large
losses and subsidizes the premiums for many low-income beneficiaries.
Participation in Part D is voluntary. Beneficiaries may enroll when they are
first eligible for Medicare, or they can wait. However, a penalty is assessed
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for those who wait, which imposes a surcharge of 1 percent on the premium
paid for coverage for each month of delay for the rest of their lives.82 The
purpose of the penalty is to discourage beneficiaries who are healthy when
they turn 65 from waiting to enroll until they need expensive prescriptions.
Upon enrollment, beneficiaries must select a plan from among those
available in their region. Plans vary according to several factors, most notably
the size of copayments and deductibles, the formularies of drugs that they
cover, and the premiums that they charge. The choice of plan can be changed
once a year.83
Most plans follow a standard benefit design mandated by Congress. It
includes multiple layers of coverage, with cut-off points that are adjusted
each year to account for inflation. In the first level, which represents annual
spending up to $320 in 2012, there is no coverage. This is a deductible that
the patient must meet before coverage begins. In the next level, up to $2,930
in 2012, the patient is responsible for a copayment of 25 percent. The level
following that offers no coverage until the beneficiary has spent $4700 (in
2012) out-of-pocket for the year. It is known as the doughnut hole. Once
a beneficiarys costs have exceeded that point, catastrophic coverage picks up
95 percent of further spending without limit.84
This structure is unique. No other health insurance plan leaves a coverage
gap between routine and catastrophic expenses. It was designed to meet
financial rather than coverage needs. The designers of the plan thought it
would be too expensive to provide continuous coverage, but did not want to
insure only routine or catastrophic costs. In effect, they split the difference by
providing some coverage for each but with a large gap between these layers
to fit the plan within budget constraints.85
The doughnut hole has been extremely controversial. Research indicates
that many beneficiaries stop taking medications when their expenses reach
the point at which it comes into play, including important preventive treatments for chronic conditions like heart disease and high blood pressure.86
In response, ACA, among its many provisions, implements a process to
gradually phase out the doughnut hole by the year 2020. If implemented
as planned, drug coverage will be continuous in subsequent years.
The structure of Medicare Part D has also engendered controversy in
its reliance on private plans to administer coverage. Architects of the law
felt that market competition among providers of the benefit would most
effectively control costs. Opponents felt that direct administration of the
benefit by the government would be more efficient.
In particular, critics of the Part D structure argued for direct negotiation
between the government and pharmaceutical companies over drug prices,
instead of multiple sets of negotiations conducted by each private plan.87 The
government, as a single huge purchaser, they contended, could extract larger
price concessions than numerous smaller insurance entities. The government
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already obtains substantial discounts in drug purchases for the health systems
of the Veterans Administration and the Department of Defense. The pharmaceutical industry has vigorously opposed direct price negotiations by the
government.88 It contends that the governments negotiating power would be
so great that it could effectively dictate prices, creating the equivalent of price
controls. Proposals have been put forward in Congress to amend the law to
permit direct government price negotiation, so far without success. However,
as health care costs continue to rise and budget cutters continue to seek ways
to control them, such proposals are likely to attract repeated attention.
Another significant issue in the design of Medicare Part D is its application to those who are dually eligible for both Medicare and Medicaid.
These are beneficiaries who meet the criteria for Medicarereaching age 65,
being totally disabled, or having end-stage renal diseaseand for Medicaid,
of having a low income and limited financial assets. Prior to the addition of
a prescription drug benefit to Medicare, they received this benefit through
Medicaid, but under Part D, they now receive it through Medicare. Under
a complex financial arrangement, Medicare assigns these beneficiaries to a
private PDP free of cost to them and then recoups the expense from their
states Medicaid program.
By law, state Medicaid programs pay among the lowest prices of any
buyer for prescription drugs.89 This is effectuated through rebates that pharmaceutical companies pay them to bring down the cost. However, the price
of drugs under Part D is determined not by this rule but by the negotiations
of each PDP. Critics of this arrangement have complained that placing dually
eligible beneficiaries under Medicare increases costs, because states lose the
ability to purchase drugs for them at the low Medicaid prices.90 Supporters
of this arrangement contend that price negotiations by PDPs represent the
best way to control costs.90
In politics as in many other areas, the level of passion tends to correlate
with the amount of money involved. For the Medicare prescription benefit, there have been a lot of both. Controversies concerning it are likely
to continue as Medicare enrollments grow, and the program increases in
importance as a purchaser of pharmaceutical products.
The role of pharmacists

There was a time when the role of pharmacists could be described fairly easily.
They filled prescriptions. Sometimes they would dispense advice to patients
along with medications, and other times they would consult with a patients
physician. However, for the most part, they turned a piece of paper with
written advice into a bottle containing a drug. Retail pharmacists worked
in a corner drugstore and hospital-based pharmacists in an institutional
pharmacy department.
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The profession is undergoing a transformation. Corner drugstores are

being replaced with national chains, and retail sales are moving toward mail
order delivery and Internet-based ordering. Some hospital pharmacists now
do rounds in intensive care units.91
The most fundamental change of all is the enhanced role of pharmacists
in providing advice and counseling, which many pharmacists and patients see
as an increasingly important part of the profession.92 Often, the pharmacist
who fills the prescription is the only readily available source of information
for patients on side effects, drug interactions, and other crucial issues. Many
states require that pharmacists offer to counsel patients when filling prescriptions.93 In some hospital settings, pharmacists help to catch medication
errors by checking dosages and other aspects of drug orders.94
Pharmacists are also seeing their administrative role growing. With most
privately insured patients covered by a pharmacy benefit plan, the majority
of prescription sales are financed through PBMs. Pharmacists must verify
coverage for each insured customer and sometimes serve as the liaison
between patient and insurer when coverage is denied because of formulary
restrictions or utilization review. Some pharmacists fear they are becoming
business agents as much as clinicians.
In a transformed profession, the old system of reimbursement may no
longer be the most appropriate. With financial margins for selling drugs
reduced by the group purchasing power of PBMs and many sales diverted
to mail order, pharmacy financial returns from filling prescriptions become
shakier. At the same time, pharmacists are increasingly providing something
more valuable than technical skill at dispensing they are providing expert
advice. Some pharmacists believe they should be explicitly compensated
for it.
The political battles over reimbursing pharmacists for cognitive services
such as patient counseling are just beginning. Who will pay for them? Will patients pay out of pocket, will insurers provide reimbursement, or will compensation be included in the cost of drugs? Recognition of patient counseling as a
reimbursable service could fundamentally change the profession of pharmacy.
It could also place pharmacists in competition with other professionals, such
as physicians and nurse practitioners, who serve similar roles. Further, it
raises the related issue of whether, and to what extent, pharmacists should be
permitted to prescribe medications on their own. The profession of pharmacy
has a tremendous amount at stake in defining its new role.
The next political realities: genetics and personalized

medicine
If the political conflicts we face today seem formidable, those we can expect
to face in the years ahead will be daunting. Genomic medicine is transforming
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the industry. We can only speculate about the political consequences of using
genetics to design and manufacture drugs, but several concerns are already
evident.
Understanding the human genome will have far-reaching consequences
throughout society. In pharmacy, there is the prospect that gene therapy will
permit physicians to alter our genetic make-up to cure defects that cause
inherited diseases. Genetics will also transform conventional pharmaceutical
products. Clinicians will be able to predict with much greater accuracy
which drugs will be most effective on which patients and which side effects
will be most likely to occur. It is hoped that drugs can then be tailored to
the individual to optimize therapeutic effectiveness and reduce adverse drug
reactions.95
The problem, as with much else in medicine, is cost. With each drug
customized to an individual or a small group of patients, the potential market
for each product shrinks to the point where it may not be economically
viable for a manufacturer to make it. Every drug almost becomes an orphan
drug. Who will be able to afford the development and production costs for
a product with such limited potential sales? Clearly, it will not be individual
patients. Insurers may find it unfeasible, as well. New financing mechanisms
may be needed.
With a revolution in therapeutic possibilities waiting to emerge and cost
pressures delaying its realization, the government has sought ways to ease
the path. The National Institutes of Health (NIH), which funds most of the
basic biomedical research conducted in the United States, has proposed a
major initiative to promote the translation of cutting edge research into commercial products. The National Center for Advancing Translational Sciences
(NCATS) is designed to support the early stages of research on new products.96 These include laboratory studies, animal tests, and in some cases the
initial phases of clinical trials. The Centers mission is to reduce the financial
risk for private investors associated with innovative products, particularly
those that rely on a revolutionary therapeutic paradigm.
Few products that enter testing actually make it to market, while the
testing that is necessary to move them toward commercialization can be
extremely expensive. The cost is huge for conventional drugs but even greater
for genomic products. The risk of large financial losses has caused many
pharmaceutical companies to hesitate about entering the field. The Centers
role is to bear the initial costs and consequent financial risks and then seek a
private partner to bring those products that appear promising to market.
Even with government support for the early risky stages of drug development, the economic hurdles to developing and manufacturing these new
therapies remain daunting. Nevertheless, it seems clear that some sort of
government support for the private market will be necessary for the genomic
revolution to achieve its potential.
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The other significant challenge posed by genomic medicine is the protection of intellectual property rights. Who owns the right to use our genes? Is it
the researchers who discover the genes and their uses, the manufacturers that
design and develop products based on them, or the people who carry them
around in all of their cells? Some argue that patent rights are essential to
encouraging research and development using genetics. Others are concerned
about the consequences of permitting ownership of the natural make-up of
individuals.
The federal Patent and Trademark Office (PTO) accepted the first applications for gene patents in 1992. However, patents granted by the PTO are
subject to challenge and invalidation in court. In 2009, such a challenge was
brought against the patent for the BRCA gene, which can indicate susceptibility to breast and ovarian cancer. In July 2011, a federal appeals court upheld
the patent, finding that genes in their isolated form are chemically distinct
from those found in nature. The case has been appealed to the Supreme
Court, where the issue can be settled definitively.97
The genetics revolution in medicine is not yet a reality. Its full clinical
promise still lies on the horizon; however, scientists are bringing us closer
each day. In the meantime, thorny legal and ethical issues, such as allocating
the high cost and determining the patentability of genes, remain unresolved.
What is certain is that as the revolution proceeds, every player in American
pharmacy will feel the effects.
Looking ahead
Within this landscape of familiar themes and emerging controversies, the
political realities for pharmacy promise to remain contentious. Drug safety
continues as a central focus, but economic concerns have added a significant
new element, and the looming prospect of genomic medicine has the potential to fundamentally change the entire industry. Looking ahead, a few trends
stand out as most likely to shape political debates.
The FDA was authorized in 1938 to aggressively protect consumers of
drugs before dangerous products reach the market where they can do harm.
Few patients could evaluate on their own the risks of the drugs that they take.
However, how far should the government go in telling us what we can and
cannot do? At what point might scientific progress be impeded and valuable
medicines denied to patients? The history of drug regulation in American
is one of scandals leading to tighter controls, with a gradual loosening of
restrictions in between, as the pendulum of regulatory fervor swings back and
forth. Congress and the FDA will always struggle to find the best balance.
Debates over the appropriate role of government intervention also play
out with regard to pharmaceutical costs. While most foreign countries believe that explicit price controls are the answer, America relies on a less
147
regulated and more market-oriented approach. However, the application of

market forces to pharmaceutical products is far from direct, with PBMs,
insurance companies, government benefit programs, pharmacies, and FDA
safety regulators all involved. Moreover, by issuing a patent, the government
effectively outlaws market-based competition for a period of time. With all
of these forces at work, the government cannot help but play some role in
the market. The hard part is defining exactly what that role should be.
If the government is to be involved in making drugs affordable for
patients, what cost should it be willing to bear? Government spending on
prescription coverage under Medicare and Medicaid combined was more
than $100 billion in 2008.98 Should we all share the cost through taxes
or should the heaviest utilizers pay more? All social programs raise similar
questions concerning the fairness of financing.
The cost issue has also forced us to examine the structure of intellectual
property protection. Most agree that patent protection is essential to encourage research and innovation, but also that at some point products should
enter the public domain to permit market competition to control prices.
As debates over the HatchWaxman Act and the extension of its model
to biosimilars have revealed, achieving the best balance is not easy. Similar
issues are arising in other areas of technology as the Internet has changed the
ability to reproduce copyrighted material. Defining ownership rights in ideas
will always pose difficult challenges, especially in a field as technologically
complex and rapidly changing as pharmacy.
Finally, there will always be conflicts between different players in the
industry. Consumers want the best products for the best price. Insurers want
to control costs and utilization. Pharmacists want to continue to play a key
role in providing patients with pharmaceutical products. Manufacturers want
to continue bringing products to market and realizing financial rewards for
doing so.
Politics is the drama of competing interests as they vie with one another.
With a range of players and interests, pharmacy and politics have long gone
hand in hand. As pharmaceuticals become increasingly essential to our health
and well being, the drama for pharmacy is certain to stay highly visible and
sensitive in the years to come.

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9
Hospital and health care
institutions
Sherilyn J. VanOsdol, PharmD, BCPS and
Charles E. Daniels, BSPharm, PhD
This chapter provides an overview of hospital structure and organization
in the US health care system. We offer a brief history of hospitals in the
United States, an overview of hospital administrative structure common to
most institutions, highlights of forces influencing change in medical practice,
and select examples of future challenges faced by hospitals in the US health
care system.
Learning objectives
After reading this chapter, the reader will be able to:
list historical events that led to the pharmacy services currently

found in US hospitals;
describe how recent patient safety movements have changed hospital pharmacy practice;
identify links between hospital executive leadership and the pharmacy department that are key to pharmacy department success;
and
describe how publicly reported hospital measures are shaping the
future of hospital pharmacy services.
History of hospitals in the United States

The concept of a hospital or a house of healing is an ancient idea. Advances
in science over the past 200 years are responsible for the evolution of the
concept of a modern hospital that we have today. Over the last 100 years,
the role of the hospital in society has greatly changed as well. Once the
154
location where the poor and diseased went to die, hospitals now serve as a
place to manage, and sometimes cure, thousands of diseases. The changes in
the science of medical practice are matched by the complexity of organization
and ownership that is seen in the modern health care setting.
Typical urban hospitals of the early 1900s were large inner-city institutions run by a religious charity or local government body. These institutions
focused on supportive care, as curative treatment for disease was rare and
usually consisted of crude surgical procedures or toxic drugs. Before the
1920s, most hospitals were charitable organizations, where physicians and,
generally, untrained nurses donated their time to provide medical care to
patients.1 As the science of medicine advanced, practitioners required more
training, and physicians, surgeons, and nurses began to get paid for their services. During the Great Depression, the distribution of charity cases shifted
from private hospitals toward public hospitals, often run by the county
or state, where patient payment for services was not required. Sufficient
government funding for these institutions was not effectively addressed.
Expenses for medical treatment further increased with advances in medical therapy seen in the 1940s, such as use of the new antibiotic penicillin.
Urban hospitals faced further financial difficulty as employed Americans
became privately insured and sought health care in suburban hospitals.1
The Hill-Burton Act in 1946 changed the face of the hospital industry by
providing federal government funds to build new hospitals.2 Acceptance of
funding through this program required that the hospital agree to provide
service to those unable to pay, irrespective of race, color, national origin,
creed, or related characteristics. Funding from the Act contributed to an
increased number and broader geographic distribution of hospitals; the funds
also paid for modernization of many older facilities. Over nearly 30 years,
new hospitals and extended care facilities were built, in part from Hill-Burton
funds.
Hospitals became more of a community resource following the HillBurtonrelated growth of the mid-20th century. There also were radical
changes in diagnostic and treatment technologies that presented the prospect
of cure or functional control for many illnesses. Medications became an integral part of patient care. Infectious disease from simple bacterial infections
could be cured with antibiotics, and chronic diseases such as hypertension
and diabetes could be managed, leading to longer, more productive lives. Patients previously institutionalized for mental disorders could be treated with
medications that allowed them to become functional members of society.
Hospital pharmacies became important components in inpatient care, but
the role of the pharmacist was mainly limited to medication dispensing.
From 1944 to 1965, visits to public hospitals increased over 300 percent; however, funding continued to prove problematic for public hospitals,
particularly those in large urban centers.1 As American employers came to
155
provide private medical insurance for virtually all employees, the elderly and
the indigent were left with disparate access to health care. The shortage
and maldistribution of trained physicians, nurses, pharmacists, and other
health care providers became apparent. Public hospital personnel struggled
to provide adequate care to growing numbers of patients in deteriorating and
commonly understaffed facilities.
In 1965, Medicaid and Medicare were established to provide access
to health care for millions of Americans without private insurance.1 This
funding proved insufficient to save failing public hospitals, and institutions
sought ways to restructure their administration to avoid full reliance on
Federal funds. The cost of inpatient care increased three-fold beyond the rise
of inflation between 1960 and 1980. Where private billing occurred, hospital pharmacies were considered revenue centers through product mark-ups
when billing for in-patient medications. In the 1970s, pharmacists started
to take on broader roles by offering expertise on medication use in clinical
settings.
By the late 1970s, the needs unique to patients receiving care in public urban hospitals were realized, and federal funding was provided to institutions
caring for disproportionately large numbers of low-income patients. These
hospitals, dedicated to serving the needs of their specific populations, would
later be designated safety net hospitals.
Rising health care costs in the 1980s placed substantial pressure on federal and state governments, and on private health care benefit organizations.
Chronic disease states became manageable in the outpatient setting, and
ambulatory surgery centers became more common; these practice shifts led
to decreased hospital admissions, shorter lengths of stay, and subsequent
reduced reimbursement. In response, rounds of significant cost-cutting efforts
led to program downsizing and the elimination of unprofitable services.
Classic and creative business concepts were applied to adapt in response to
the environment of the US health care system. Health care organizations were
merged or consolidated to optimize efficient use of resources, and to improve
bargaining power for acquiring medical equipment and drugs.
During the late 1980s and early 1990s, advances in medical technology
greatly affected medical practice. Nationwide, hospitals started to implement
electronic medical records and computerized provider order entry systems.
Some systems were designed to provide clinical decision support and immediate warnings related to patient laboratory values or drug interactions.
While they were considered advances in medical care, implementation of this
technology also increased the complexity of routine care. Many hospitals
used different computer systems for different areas of the hospital, or for the
inpatient and ambulatory care settings, often leading to access to incomplete
information.
156
Medical care advanced exponentially in the 1990s. Many medical specialty areas began to implement evidence-based treatment guidelines, leading
to standardized therapies and desired treatment goals for large patient populations. Clinical pharmacists also began to specialize, providing drug information essential to effective disease state management. Surgeries could be
completed by use of robotics, and diseases such as HIV and certain cancers,
which only a decade earlier were fatal, could in many cases be controlled
using medications. By 1999, 91 percent of surveyed hospital pharmacies
used computer systems to support daily operations.3 Despite these marked
advances, medical errors were a common cause of patient morbidity and mortality. In 1999, the Institute of Medicine released results of a groundbreaking
report that highlighted medical errors as a cause of 44 000 to 98 000 deaths
annually.4 This constituted more deaths than resulted from motor vehicle
accidents, breast cancer, or AIDS. Furthermore, these errors cost the US
health care system an estimated $17 to $29 billion annually.
The Institute of Medicine report refocused priorities for the health care
system as the 21st century began. Despite rapidly advancing knowledge
of disease states and successful, evidence-based therapies, the practice of
medicine was far more dangerous than previously believed. In addition, the
cost of medical treatment continues to grow, multi-drug-resistant organisms
have led to difficult-to-cure infections, and national drug shortages continue
to complicate the treatment of ill patients. The hospitals and health care
institutions of today are very different than those only a generation ago.
Advances in medical care and patient safety, soaring health care costs, and
complex hospital ownership and administrative structures make this a very
dynamic and complex system.
Scope of the US health care system

The hospital stands as the most physically distinguishable element of the US
health care system; however, health care in the United States is provided in
a variety of locations, not just hospitals. The traditional in-patient hospital
setting is a part of a complex web of providers and locations that are
interlinked to provide preventive and therapeutic or acute care services.
Providers may practice in a variety of sites outside of the hospital setting,
including long-term skilled nursing facilities, large and small office-based
medical practices, ambulatory surgical centers, outpatient radiology facilities,
pharmacy clinics, outpatient infusion centers, and many others (Figure 9.1).
The complexity of this web of providers influences, both positively and
negatively, patient access to service, cost of care, and quality of care. Most
recently, the focus has begun to move toward the challenges in transition
from one level of care to the next:, for example, successful discharge of a
patient from hospital to home.
157
Hospital
Long-term
skilled
nursing
Pharmacy
clinic
Patient
Outpatient
radiology
Infusion
center
Ambulatory
surgical
center
Figure 9.1
Officebased
medical
practice
The web of pharmacy providers.
Hospital organization and services

Every hospital has a leadership structure and is organized to support the
specific functions of governance, administration, and provision of care.5
The organizational structure of the hospital is intended to support hospital
performance, accomplish quality patient care, and lead to other strategic
goals and objectives. The Centers for Medicare and Medicaid Services (CMS)
Conditions of participation (CoP) address the responsibility for leadership
and governance.5 Accreditation agencies likewise address the role of organizational leadership to ensure that structure, process, and outcomes meet
standards. These standards require that the hospital clearly define lines of
accountability and authority.
The leadership standards in The Joint Commission (TJC) Accreditation
Manual for Hospitals require that the institution define who is responsible
for the governance of the organization and how the medical staff will participate.5 Importantly, TJC expects the governing structure to evaluate its
performance related to the vision, mission, and goals annually.
Many variations on the organizational structure may be seen in health
care organizations, but most are based on the prototype structure shown in
Figure 9.2, which represents a high-level picture of the organization. The first
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Executive
Office
Surgery
Cancer
Cardiology
Hospital
Operations
General
surgery
Hematology
General
cardiology
Housekeeping
Solid Organ
Transplant
Solid tumors
Interventional
Cardiology
Food Services
Neurosurgery
Radiation
Oncology
Patient Care
Services
Figure 9.2 Example of hospital organization of services with service lines. (Larger systems may
have more levels of management and greater diversification.)
critical element is the presence of a governing body (e.g., board of directors

or governors). The board of governors typically includes representatives of
the community, local business leaders, the medical staff, and other stakeholders. Ultimately, the governing body is accountable for all elements of
care. The governing body also is responsible for the planning, management,
and operations of the enterprise. Members bring expertise and perspective
on the external environment and community expectations; they also face
the challenge of meeting the mission and long-term strategic goals. These
functions are completed through the selection of executive leadership.
Hospital administration is responsible for institutional planning, management, and oversight of operational activities. The organizations chief
executive officer (CEO), or executive director, has the authority and responsibility to run the operations of the hospital system, which he or she
typically does through distribution of responsibilities to one or more senior
or junior administrator. The CEO is responsible for translating the direction
of the governing body into a functionally and financially sound organization.
The CEO hires other administrators and leadership staff, who serve defined
administrative roles in the organization. A typical organization will include
a chief medical officer (CMO) and a chief nursing officer (CNO). In some
organizations the CEO may choose to hire a chief operating officer (COO)
to run important elements of the business. Other typical members of the
hospital senior leadership include a chief financial officer (CFO) and chief
information officer (CIO). These may include titles such as vice-presidents
and associate directors. Many medical centers have also created a chief
pharmacy officer (CPO) position.
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The CMO serves in a unique role in the health system. The CMO is
the administrative liaison to the medical staff and deals with a wide range
of patient care issues, including physician competency and privileging of
medical staff members. The CMO may have a consultant relationship with
the CEO or may be a service line (discussed later) manager with specific
responsibility for some functional programs such as medical staff services,
patient care quality, and patient safety.
The CNO is a key senior administrator with substantial influence on
the organization. The CNO participates, along with the CEO, CMO, and
COO, in important decisions on how care will be organized. The single
largest group of employees in most health care institutions is the nursing staff.
Nurses are important stakeholders in the safe and effective use of medications
in the organization. An effective relationship with the nursing department
leadership is important to the success of pharmacy initiatives in improved
outcomes and efficient use of resources.
The CIO has become an important and powerful figure in most health
systems. As use of the electronic medical record and integration of all
health information and operations sources has become essential for financial
and operational reasons, information systems (IS) has become part of the
high-level organizational activities. Because of the interdependence between
an organizations information systems and the success of medication management and pharmacy operations, pharmacy leadership must develop a strong,
positive working relationship with the CIO.
One commonly controversial question is how to define supervisory relationships for pharmacists housed outside of the hospitals pharmacy department who are providing clinical IS services. Regardless of whether they
report directly to the pharmacy department or directly to the clinical IS
department, pharmacists working in the clinical IS setting must maintain a
strong knowledge of pharmacy operations and clinical workload.
CPO is a title that is now used in many health systems. The CPO
provides executive direction across the span of organizational medication
management issues by participating at an organizational strategic level.6 As
an executive officer, the CPO reports directly to a senior hospital leader
and has a collaborative role in addressing system-wide issues. The role of
the CPO, in contrast to the traditional director of pharmacy, is intended
to clarify and highlight the role of medication use and pharmacy resource
management in a broader scope. In the absence of a CPO organizational
structure, the pharmacy director often reports to a senior hospital manager
at the vice president or associate director level. Pharmacists, technicians, and
other support staff usually report to the Director of Pharmacy or a designated
pharmacy manager. Figure 9.3 shows a sample of the organizational structure
at the health system pharmacy level.
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Hospital Board of
Directors
Medical staff
(Med staff Executive
Committee)
CEO
CIO
CFO
CNO
COO
CPO
CMO
Medical staff Committees:

Pharmacy & Therapeutics;
Credentials, others
Medical Speciality
Departments
Figure 9.3 Sample hospital administration structure. CEO, chief executive officer; CFO, chief
financial officer; CIO, chief information officer; CMO, chief medical officer; CNO, chief nursing
officer; COO, chief operations officer; CPO, chief pharmacy officer.
A key element in all accredited health care organizations is the human

relations (HR) department. The HR office and staff ensure that qualified staff
are recruited and hired to meet the needs of the organization. In many cases,
the HR offices are charged with maintaining up-to-date files on all staff and
to track and record competencies, and perform personnel reviews for all staff
other than those managed by the medical staff office. Other administrative
staff and program department heads are hired to support the work of the
organization. Hospital operations include departments for medical records,
housekeeping, nutrition, maintenance, security, and information services,
among others. Other departments or programs commonly include volunteer
service and public relations.
Hospital services
Hospital organization by service line is a commonly used approach in the
organizational structure. It is designed to bring administrative, medical, and
other providers into the shared governance of the organization and to focus
on specific patient populations. Examples of service-line organizational structures might include oncology, surgery, womens health, cardiovascular, or
other related patient care categories where various providers care for patients
together in distinct organizational units. Figure 9.4 shows an organizational
chart based on service lines. The actual distribution of services will vary from
hospital to hospital; this example provides a picture of how a medium-sized
hospital might be organized.
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CEO or Vice
President
Chief Pharmacy
Officer (CPO)
Inpatient Service
Directors
Figure 9.4
Quality and Med

Safety Officer
Ambulatory Service
Directors
Pharmacy Business,
Technology Director
Drug Distribution
Manager
Discharge
Prescription
Supervisor
Pharmacy
Purchasing
Supervisor
Clinical Services
Manager
Ambulatory Clinic
Pharmacists
Pharmacy
Information Systems
Manager
Example of a health system pharmacy service organization.
The scope of services provided by each hospital is selected to allow that

hospital to accomplish its mission. They are developed to meet the unique
combination of needs of the target patient population served by the organization. Specific services to be provided by the hospital are determined, in part,
by the requirements of the various accrediting agencies, but how they are
provided is influenced by the mission, operational needs, and medical staff
composition. For instance, a county hospital with a focus on the underserved,
low-income population may provide a different menu of services than a
for-profit hospital in a wealthy suburban setting.
Hospitals and related organizations have tried to integrate several components of the system in different ways over the last 30 years to address the
three key dimensions of (1) access to service, (2) cost of care, and (3) quality
of care. Due to cost of care, these drivers have changed the nature of hospital
ownership. Changes during the 1980s and 1990s resulted in the consolidation
of the hospital industry and near extinction of the independent freestanding
single-facility hospital. Hospital systems provide value and resources that
are rarely sustainable outside of multihospital systems. Joint ownership or
other formal affiliations allow hospitals to share information technologies,
administrative support services such as human resources, purchasing, billing,
and sometimes clinical services, including radiology and pharmacy.
In the past, the segmentation of the health care industry made it difficult
to manage for improved performance on those three key dimensions. More
frequently, the hospital is owned by a larger organization that owns clinics,
laboratories, community or mobile imaging facilities, home infusion services,
162
and perhaps one or more outpatient pharmacies. Offering multiple services

to patients within a system improves patient access to auxiliary services, and
means that providers and multiple sites can use a single health records system,
improving the continuity and quality of care. Integration of providers across
the system has meant that hospitals are often not simply the traditional
stand-alone organization that was the hallmark of bygone years.
Health care staffing

Safe and effective operation of a hospital or any health care facility depends
on many individuals working as a team. Some of the key players of the
hospital team are physicians and other licensed health-care providers, nurses,
and pharmacists. Below are brief descriptions of the roles of each.
Medical staff
The health system clinical enterprise is critically linked to the medical staff.
The governance of the organization defines the relationship of the medical staff and its organizational structure. The medical staff organization is
responsible for creation and oversight of standards of care and oversight
of outcomes and quality of care. Medical staff members have privileges to
admit patients to the hospital and provide their care. They are responsible for
defined elements of oversight and direction in the hospital and are typically
represented on the governing body.
The organizations medical staff may include physicians (including osteopathic physicians), dentists, podiatrists, and several other categories of
licensed independent practitioners. The physician members of the medical staff may include generalists, intensivists, surgeons, anesthesiologists,
radiologists, pathologists, and other specialty credentialed physicians. The
medical staff may be a limited or closed staff, such as physicians at a military
hospital, or an open staff, which allows community physicians to apply for
privileges to admit patients and provide care. In most community hospitals,
the physicians who practice medicine are employed not by the hospital but
by a physician practice group or an independent practitioner. While this is the
long-standing model, it has made some aspects of the care of patients subject
to discontinuity. It also complicates standards of patient care throughout
the hospital. A recent trend in hospital personnel planning has been to
increase the number of dedicated hospital physicians on a salaried basis
to assure consistent quality care in specific areas such as the intensive care
units (intensivists), the emergency department, or for general hospital care
(hospitalists). The intent is to enhance the consistency and quality of care.
Nurse practitioners (NPs), physician assistants (PAs), and some specialty
providers (e.g. acupuncturists) are considered licensed independent practitioners by CMS and other payers. The rules that govern the rights of these
163
providers usually are determined on a state-by-state basis, with more latitude

in some places than others. While their scope of practice typically is more
limited by law than is that of the physician, these practitioners may have
significant impact in the health care organization and have rights to write
patient orders within the limits of their scope of practice. In some cases, significant amounts of hospital care are delegated to NPs and PAs by admitting
physicians to ensure that comprehensive daily medical care is provided.
The move toward more effective transition from hospital to home, or to
the next level of care, is a driving force in the health system setting. It is
reasonable to expect even greater use of non-physician intermediate level
practitioners in the future.
Nurses
Nurses are the backbone of clinical care in most hospitals. They provide and
coordinate care on a minute-by-minute basis for hospitalized patients. In the
ambulatory setting they have a similarly important function. Typically, hospitals employ more nurses than any other category of employee, and usually
by a wide margin. Nursing shortages or nursing strikes can quickly reduce
the function of an organization. New hospital wings have been completed
but not opened due to the lack of trained nurses.
Nurses in hospitals and health care organizations have a wide variety
of training and educational backgrounds, from vocational school, to nursing
diploma, to Associate, Bachelors, and Masters degrees. Recently, the doctorate in nursing degree has become more available as a method to increase the
educational qualifications. The degree of autonomy each nurse has is mandated by state laws based on the nurses education level and licensure status.
In an effort to ensure quality care, some states have passed, or attempted to
pass, laws that govern the minimum nurse-to-patient ratio for specific care
areas in a hospital. Nurses also hold key administrative positions in many
hospitals because of their in-depth understanding of the workings of the
organization.
Pharmacists
The hospital pharmacist has an expanding role on the health care team. Over
the last few decades, hospitals have increased the presence of the pharmacist
in patient care areas to provide clinical care and support broader elements of
the medication use process. The presence of a clinical pharmacist on health
care teams has been demonstrated to reduce prescribing errors, reduce cost,
and improve patient outcomes.7,8
Pharmacists are responsible for all aspects of the medication distribution
process; they are expected to review all medication orders, solve problems, and supervise medication dispensing activities. There are generally
three categories of hospital pharmacy practice models: the drug-distribution
164
centered model, the specialist model, and the integrated service model.
Pedersen et al.9 describe the drug distribution-centered model as mostly
distributive pharmacy with limited clinical services. They define a clinical
specialist-centered model as separate distributive and clinical specialist roles.
The patient-centered integrated model is defined as a clinical generalist model
with limited differentiation of rolesnearly all pharmacists have distributive
and clinical responsibilities.9 In practice, there are many ways to assemble the
people and systems to provide pharmacy services. The American Society of
Health-System Pharmacists maintains minimum standards for pharmacy services, which, in conjunction with accreditation and government regulations,
provide the pharmacist with a framework for services to be provided.10
Appropriate education and training of pharmacy personnel (i.e., pharmacists and technicians) is an important part of maintaining the quality of
pharmacy services in the health system. This includes continuing education
when in practice, and didactic and experiential training prior to entering the
workforce. All professional students entering a pharmacy school since 2000
have graduated with the PharmD degree, but there are still many practicing
pharmacists with only a Bachelors or Masters degree. As time moves on,
all practicing pharmacists ultimately will have the PharmD. Experiential
training in various health system pharmacies has become a standard part
of the curricula in accredited pharmacy schools. In the future, postgraduate
education may also become a training requirement. Residency training is
often considered a foundation for pharmacists who wish to practice in
hospitals and institutional settings. Residency experience and board certification credentials are likely to impact the scope of practice and privileges of
pharmacists in the future.
Pharmacy technician skills and roles are also closely linked to the future
of pharmacists in the hospital. Highly competent and appropriately trained
technicians affect the quality and safety of the drug distribution system. There
is substantial variation in pharmacy technician training and scope of duties
across the United States; the scope of technician functions in the pharmacy
practice model is limited by state law. Changes to minimum education and
training may be required in the future to support new duties for technicians.
After this happens, some of the current drug distribution duties conducted
by the pharmacist may be performed by less costly pharmacy technicians to
help manage the cost of health care.
Types of hospitals
Because hospitals and their related health care organizations take on such
a wide variety of roles in the medical care of Americans, it is useful to
separate them using several different metrics. Organizations are classified
by different characteristics, including type of ownership, size, location, and
165
types of services provided. The American Hospital Association (AHA) is a

non-governmental agency that represents and registers hospitals. It maintains a comprehensive database of hospitals and healthcare organizations
in the United States using the characteristics mentioned above. AHA statistics provide valuable information for health care providers, planners, and
researchers.
Hospital ownership
In the most general sense, hospitals are a community resource to relieve
pain and suffering and prolong life; however, it is important to consider
hospital ownership. While it is true that a hospital is a community resource,
each hospital has a formal ownership structure that determines many things,
most critically its vision, mission, and medical focus. The hospital industry
has historically been owned by not-for-profit corporations, which are
incorporated with the mission to provide a public benefit. Hospitals founded
by religious or faith-based organizations were the most traditional early
purveyors of hospital care, and, therefore, have become the legal owners of
many hospitals in operation today.
Table 9.1 provides more detail on the ownership characteristics of various
hospitals in the US health care landscape. Not-for-profit community hospitals
continue to dominate the hospital industry in terms of their number. The
federal government, primarily via the US Armed Forces and the Veterans
Administration (VA), owns an additional 240 hospitals that offer services
focused on the needs of their patient populations. Local, county, or state
governments are also important hospital owners.
Data from the Medical Expenditure Panel Survey in 2006 showed that
29.7 percent of the $1.03 trillion paid for health care went toward inpatient
care.11 This was the single greatest expense, followed by outpatient care, and
then prescription drug costs (Table 9.2).
Not-for-profit hospitals
Not-for-profit hospitals are incorporated as charitable organizations and
have protected ownership and tax advantages. They include hospitals
founded or built with funds from philanthropic or religious organizations.
These hospitals are the most common owners in the US hospital industry.
Many not-for-profit hospitals are now part of organized systems to provide
care to their target population. When two or more hospitals are owned,
leased, sponsored, or contract managed by a central organization, they are
An organization may be registered by the AHA if it is accredited by The Joint Commission
(TJC, described later) or is certified under federal regulations as a provider of acute care
by the Center for Medicare and Medicaid Services (CMS) under Title 18. Alternatively, an
organization may be registered if it is licensed as a hospital by state government and meets
specific requirements listed in the AHA Guide. Osteopathic hospitals which meet the other
criteria are also registered within the AHA database.
166
Table 9.1 Ownership of community hospitals

Community hospital ownership
Number
Percentage
Non-government not-for-profit
2918
58.2
Investor-owned (for-profit)
998
20
State and local governmentowned
1092
21.8
Totala
5008
100
a In 2011, there were 3011 urban and 1997 rural community hospitals.
(Data from American Hospital Association. Trendwatch: The opportunities and challenges for rural hospitals
in an era of health reform. Available online. http://www.aha.org/research/reports/tw/11apr-tw-rural.pdf.
April 2011. Accessed December 6, 2012.)
Table 9.2 Direct expenditures for US National Health Care in 2006

Expense category
Percent of expenses
Hospital in-patient expenses
29.7
Ambulatory care
23.7
Prescription medications
21.6
Hospital outpatient departments
8.7
Dental services
7.4
Othera
8.9
a Emergency room, home health care, and other medical services and equipment expenditures.
(Data from Kashihara D, Carper K. National health care expenses in the U.S. civilian noninstitutionalized
population, 2006. MEPS Statistical Brief No. 229. Available online. http://meps.ahrq.gov/mepsweb/data_
files/publications/st229/stat229.html. December 2008. Accessed December 6, 2012.)
considered to be part of a multihospital system. Single freestanding hospitals

grouped with several owned or leased non-hospital health care organizations
such as clinics, or urgent care centers, also are considered to be hospital systems. Not-for-profit hospitals may make a profit only if those funds are used
in government-specified ways, such as reinvestment in hospital operations;
the profits may not be distributed to the hospital board of trustees.12
Investor-owned hospitals
The evolutionary changes in the industry and application of business to
health care have more recently created opportunities for for profit corporations to thrive in large and small niches (Table 9.3). While not-for-profit
hospitals have been the most dominant ownership group, investor-owned
for-profit hospitals have existed for a long time. Individual physicians or
small groups of physicians often opened their own hospitals to ensure that
they would have high-quality facilities to treat their private patients in a
convenient location. Larger corporate hospital organizations have come to
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Table 9.3 Ownership of hospitals in the United States

Type of hospital
Owners
Nongovernment, not-for-profit
Religious affiliation
Examples
Independent
Other organizations
Corporate (e.g., oil companies, lumber

companies)
Philanthropic Organizations (e.g., Shriners)
Managed care organizations
Investor-owned (for profit)
Proprietorship
Partnership
Corporate
Government
Local
City
County
State
University hospital
Psychiatric
Prison
Federal
Department of Defense (e.g. Army, Navy)

Veterans Administration
Department of Health and Human Services
Department of Justice (i.e. federal prisons)
dominate the for-profit segment of the hospital industry. These corporations

typically have stockholders who have invested in anticipation of a dividend
or return on the investment.
For-profit hospital corporations often own several dozen hospitals and
manage them from a regional headquarters. The principles of economy of
scale and shared resources provide a strong base to provide a similar quality
product at the lowest cost possible. There have been several attempts to
compare the quality of care and costs between not-for-profit and for-profit
hospitals, but the published evidence provides conflicting conclusions.13,14 At
least one researcher concluded that areas where for-profit hospitals influence
the competitive market have driven down the expenditures of all hospitals
in that region.15 It is clear that investor-owned hospitals play an important
role in the provision of hospital care and have leveraged their position to
influence aspects of hospital care in all other segments of the industry.
Community hospitals
Most frequently, hospitals are classified according to services provided. Hospitals are classified by service type such as general hospitals, specialty hospitals, psychiatric hospitals, rehabilitation hospitals, chronic disease hospitals,
and teaching hospitals. Based on data from the 2010 AHA survey, there were
5754 AHA registered hospitals in the United States, with 941,995 staffed
beds. The majority of these hospitals (4985) are considered community hospitals based on the AHA definition. Community hospitals account for nearly
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95 percent of all hospital admissions, making them the dominant provider of

hospital care. The Community Hospital is defined by AHA as a nonfederal,
short-term general or other special hospital.16 Specialty hospitals include
obstetrics and gynecology; eye, ear, nose, and throat; rehabilitation; orthopedic; and other individually described specialty services. Academic medical
centers are included on the list of community hospitals if they meet the other
criteria (e.g., nonfederal, short-term). Hospitals that are not accessible to
the general public, such as college infirmaries or prison hospitals, are not
considered community hospitals. Figure 9.5 displays the changes in hospital
number and capacity over type.
Federal hospitals
Federal hospitals are numerically a small element in the provision of care
to the US public. However, the role and influence of that small group is
important. Because they are present in most major US cities in the form of VA
and military hospitals, federal hospitals influence the hospital environment in
several important ways. Army, Navy and Air Force hospitals provide care to
a large group of active and retired duty military personnel and dependents.
VA hospitals and clinics provide care to a large number of former military. In
2010, there were 1753 VA hospitals and related facilities spread in urban
and rural settings across the US and in US possessions.17 These include
several important teaching and research centers. To qualify for care in a
VA hospital, the patient must have service-related medical problems, or be
a wartime veteran unable to pay for care in a civilian facility.
Average Daily Census

Number of Hospitals
8000
1400
7000
1200
6000
1000
5000
800
600
6125
6956
7123
7156
4000
6872
6291
5756
3000
400
2000
200
1000
0
1946
Figure 9.5
9000
1955
1965
1975
1985
1995
2005
Trends in hospital numbers and daily census from 19462005.
Number of hospitals
Average Daily Census (in thousands)
1600
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Many federal hospitals are actively involved as training sites for postgraduate medical education (i.e., medical residencies). Many renowned medical
and health professions schools rely on VA hospitals for primary training
sites. It is noteworthy that the VA has led the way for other US hospitals
through its effort to improve patient safety through reduction in medical
errors in hospitalized and ambulatory patients. They have led the nation in as
early adopters of automated prescribing, and bar-coded patient identification
before medication administration. They have also demonstrated options for
developing a culture of safety and demonstrated the value of disclosure
to the patient when a medical error has occurred. In addition to military
and VA hospitals, the federal government also operates hospitals for special
populations, including the Native American and Alaska Native populations,
and federal prison systems.
Rural hospitals
There were 1,997 rural community hospitals in the United States in 2010.18
This represents 40 percent of all community hospitals. Rural hospitals have
a different character than urban hospitals. They are smaller, with 47 percent
having 25 beds or fewer, and the populations they serve are older, making them more dependent on Medicare reimbursement. Between 1990 and
1999, 186 rural hospitals closed. In 1999, 34 percent were operating with
a negative financial margin. A larger proportion of care was moved to the
ambulatory setting. These financial realities have led many rural hospitals to
make difficult choices on what services to offer and what to close. For the
small hospital, it may be necessary to close an emergency room or cardiology
unit in order to minimize losses for those small-volume services. Another
challenge in the rural setting is recruiting and retaining key physicians and
trained health care providers such as registered nurses, radiology technicians,
and pharmacists. To combat the challenges of providing service in the rural environment, many hospitals have joined into multihospital systems in
an ownership or management arrangement, which has allowed these rural
hospitals to gain some of the advantages and economies of larger urban
hospitals. It also has allowed them to offer resources that would be difficult
to install and maintain as independent facilities. Shared access to medical
technology, such as sophisticated mobile imaging and treatment facilities,
and the ability to contract with subspecialized consultants, who will come
to the rural location on a regular schedule, are feasible for small hospitals
in larger alliances. High-tech programs such as telemedicine also promise a
future for quality medicine in the rural setting.
Specialty hospitals
Specialty hospitals are a subset of the hospital population that provide
focused care for a particular subset of the population, or a special disease
170
state. There were more than 700 non-federal specialty hospitals in the United
States in 2001. Many of these specialty hospitals are affiliated with, and
may share some facilities with, general hospitals or other specialty hospitals.
Pediatric hospitals are intended to provide specialized care for children,
often including neonates. Traditional hospital settings rarely are well suited
to provide care to children. Facilities and equipment needs differ for children and newborns. Consider the difference in furniture in a kindergarten
classroom and a college classroom. This scale of variation exists in hospital
facilities, from beds and chairs to room decorations and recreation. It is also
clear that the supportive resources for a pediatric environment are different,
including social workers and teachers. Finally, the clinical expertise required
for children is different. Pediatric anesthesiologists, nurses, neonatal intensive
care unit staff, pediatric pharmacist expertise, and medication use issues are
different. All of these factors make it appropriate to create specialty hospitals
for this population.
For similar reasons several other specialty hospitals have evolved, the
most numerous of which are cancer centers; eye or ear, nose, and throat
centers; rehabilitation hospitals; and behavioral-health specialty facilities
(including alcohol and chemical dependency programs). Each of these specialty hospitals addresses the same spectrum of challenges, from facilities
to supportive care to clinical expertise and access to appropriate resources.
Pharmacy services in these specialty hospitals are all focused to meet the
needs of the particular patient populations.
Government oversight
Because health care provides services that are not easily evaluated and assessed by the general public, it is difficult for the layperson to know the
difference between a good and bad provider. For that reason, there is a need
for limits and rules on the practice of health care. Hospitals and health
care providers in general are quite heavily regulated in order to address
this dilemma. Figure 9.6 illustrates the regulatory environment in which the
hospital operates. Some of these regulatory connections are more significant
than others.
CMS, part of the federal government, provides reimbursement for health
care provided to eligible patients. In some health care organizations, federal
reimbursement accounts for over 50 percent of total revenue, but in most
hospitals the federal reimbursement is a significant component of revenue,
making their regulations critical for most hospitals. Furthermore, federal
reimbursement regulations influence many other payers; CMS decisions on
what services must be provided and how much they will pay for each service
provide a strong impact on the financial wellbeing of the hospital. Regulations from federal, state, and local agencies affect facilities design and construction, patient, staff and property security, food handling requirements,
171
Department of Health and

Human Services Centers for
Medicare & Medicaid Services
(reimbursement for federal care)
Other federal agencies
State and local

government agencies
Occupational Health and

Safety
Health Department
Drug Enforcement Agency
Medical board
Food and Drug

Administration
Hospital
Nuclear Regulatory
Commission
Figure 9.6
Nursing board
Pharmacy board
Building and safety
regulations
Regulatory interfaces for US hospitals.
waste management rules, drug use activities and many other aspects of daily
operations in the health care organization.
Other regulations that influence health care organization operations also
come from federal, state, county, and city agencies. These include health
and safety rules, such as dealing with hazardous substances, and clinical
service requirements such as required staffing ratios. State or regional facility planning regulations may determine the scope of services that must be
offered or limit development of new, resource-intensive programs to decrease
duplication of existing programs.
Hospital accreditation
Hospitals must meet state requirements to obtain and maintain licenses to
operate. Rather than each state creating their own criteria, most states license
and accredit hospitals based on broad professional standards. While this
accreditation is voluntary, it is considered to be the standard method to
demonstrate compliance with generally accepted principles for good care in
the inpatient environment. Three major accrediting bodies exist for hospital
accreditation in the United States: The Joint Commission (TJC), Healthcare
Facilities Accreditation Program (HFAP), and Det Norske Veritas Healthcare,
Inc (DNV). CMS develops CoP that health care organizations must meet to
be allowed to participate in Medicare and Medicaid programs. Accreditation
by one of the three organizations ensures that it has met the CMS conditions, and may continue to receive reimbursement for care of Medicare and
Medicaid patients.
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TJC is the largest accreditation body in the United States, accrediting approximately 15,000 health care organizations, including hospitals, long-term
care, and ambulatory care facilities. TJC has been operating since the early
1950s, at which time it was called the Joint Commission on Accreditation
of Hospitals.12 At that time, the organization existed to ensure minimum
standards for hospital operations; now TJC creates standards for meeting
the optimum achievable standards. These standards, including the National
Patient Safety Goals often exceed the CoP and are considered directly relevant
to the current delivery of health care. TJCs goals cover aspects of leadership,
ethics and patient rights, provision of care to patients, nursing care, medical
staff expectations, medication management, and performance measurement.
Participating organizations perform self-assessments routinely and receive
TJC on-site surveys every 3 years. In recent years, the TJC has also offered
certification for focused areas of care, such as stroke and chronic kidney
disease. These focused recognitions are intended to look in more detail at
standards of care at the disease level. TJC also accredits long-term and
ambulatory care elements of the health care organization, a role in which
they compete with other organizations such as the National Committee on
Quality Assurance that are more commonly used to accredit services in the
ambulatory and managed care environment.
HFAP is a not-for-profit organization that has worked to accredit health
care facilities for over 60 years. The HFAP standards required for accreditation exceed the CoP, additionally incorporating nationally recognized
evidence-based best practice standards and patient safety initiatives. Hospitals must pass an on-site survey once every 3 years to maintain HFAP
accreditation. HFAP is also authorized to survey clinical laboratories.
DNV has been operating in the United States since 1898, with the purpose
of safeguarding life, property, and the environment. CMS granted DNV
authority for hospital accreditation in 2008. The standards for DNV accreditation are in line with the CoP; the survey process focuses on individual
health care organization determined best practices and quality improvement
projects designed to comply with CMS regulations. DNV reaccredits participating institutions via an annual on-site survey.
It is the expectation of accreditation groups that pharmacy services
will include preparation of dosage forms that are in unit-of-use and
ready-to-administer forms. It is also expected that pharmacy will prepare
admixture products for intravenous administration in a controlled and sterile
environment. TJC standards additionally require that all medication orders
be reviewed by a pharmacist prior to administration of the medication,
with very few exceptions. These expectations have partially guided the scope
and content of hospital pharmacy services. While there is still substantial
diversity in how modern pharmaceutical services are provided, the role of
173
the pharmacist in the health care organization has continued to take on

substantially broader functions over the last 30 years.
Obtaining accreditation from TJC or another agency does not guarantee
that no harm can occur resulting from care; it simply provides a yardstick by
which the organization is measured and compared to similar facilities. There
is still much work to be done in the concepts and measures of quality in
health care.
Focus on patient safety

The 1999 Institute of Medicine report To Err is Human reported staggering numbers of medical errors and related patient deaths that occurred
each year.4 These data brought public awareness to the all-too-common
occurrence of patient harm inadvertently caused by health care workers.
Importantly, the report also dissected the health care environment and pinpointed ubiquitous causes of medical error. Human factors research determined that it was not safe to rely on health care workers alone to create a
safe medical system: the medical system itself was to blame for the majority
of medical errors. The Institute of Medicine recommended many changes
in health systems, including improving workplace design, changing culture
and leadership attitudes about errors, and implementing anonymous medical
error-reporting.
Of the 44,000 to 98,000 patient deaths resulting from medical errors
each year, the Institute of Medicine estimated that at least 7000 were
medication-related deaths.4 Additionally, medication errors causing harm
to patients hospitalized in the United States were estimated to cost about
$2 billion. Medication safety is an important subset of patient safety that
involves all health care providers, and is primarily supported by the pharmacy department. Medication safety officers ensure the quality and safety
of pharmacy operations, analyze medication-related error reports, and conduct investigations and process improvements related to medication-related
errors.
Following the publication of this report, many national safety organizations were formed and gained support for the changes that needed to occur
in the US health care system to increase patient safety and improve outcomes.
Some of these include the following (see Table 9.4 for more detail):
The Institute for Safe Medication Practice;

The Agency for Healthcare Research and Quality;
The National Patient Safety Foundation; and
The Institute for Healthcare Improvement.
To improve system-related processes, the health care system turned to

high-performance industries that have long-standing reputations for safety,
174
Table 9.4 National patient safety organizations

Organization
Funding
Mission
The Institute for Safe

Medication Practice (ISMP)
501c (3)
nonprofit
To advance patient safety worldwide by empowering

the health care community, including consumers, to
prevent medication errors through interdisciplinary
efforts to:
Collect and analyze reports of medication-related
hazardous conditions, near-misses, errors, and other
adverse drug events.
Disseminate timely medication safety information,
risk-reduction tools, and error-prevention strategies.
Educate the health care community and consumers
about safe medication practices.
Collaborate with other patient safety organizations,
educational institutions, governmental agencies, and
other healthcare stake holders.
Advocate the adoption of safe medication standards
by accrediting bodies, manufacturers, policy-makers,
regulatory agencies, and standards-setting
organizations.
Conduct research to provide evidence-based safe
medication practices.
The Agency for Healthcare

Research and Quality (AHRQ)
Federal
As 1 of 12 agencies within the Department of Health

and Human Services, the mission of AHRQ is to improve
the quality, safety, efficiency, and effectiveness of health
care for all Americans with information that:
reduces the risk of harm from health care services by
using evidence-based research and technology to
promote the delivery of the best possible care
transforms the practice of health care to achieve
wider access to effective services and reduce
unnecessary health care costs
improves health care outcomes by encouraging
providers, consumers, and patients to use
evidence-based information to make informed
treatment decisions.
The National Patient Safety

Foundation (NPSF)
501c (3)
nonprofit
Improve the safety of patients through efforts to:

identify and create a core body of knowledge
identify pathways to apply the knowledge
develop and enhance the culture of receptivity to
patient safety
raise public awareness and foster communications
about patient safety
improve the status of the Foundation and its ability to
meet its goals.
NPSF can make a long term, measurable difference by
serving as a central voice, and NPSF will lead the
transition from a culture of blame to a culture of
safety.
(continued)
175

Organization
Funding
Mission
The Institute for Healthcare

Improvement (IHI)
Independent,
not-for-profit
Improving the safety, effectiveness,

patient-centeredness, timeliness, efficiency and equity
of the health care system to ensure:
no needless deaths
no needless pain or suffering
no helplessness in those served or serving
no unwanted waiting
no waste
no one left out
(Data from Agency for Healthcare and Quality. About AHRQ. http://www.ahrq.gov/about/. December 2010.
Accessed December 6, 2012. Institute for Safe Medication Practices. ISMP mission and vision statement.
http://www.ismp.org/about/mission.asp. Updated 2012. Accessed December 6, 2012. Institute for Healthcare Improvement. Vision and values. http://www.ihi.org/about/Pages/IHIVisionandValues.aspx. Updated
2012. Accessed December 23, 2012. National Patient Safety Foundation. About us. http://www.npsf.org/
about-us/. Accessed December 6, 2012.)
such as the automotive and aerospace industries. Tools such as failure-mode

effects analysis, designed to anticipate errors when implementing new equipment or processes, and root cause analysis, used to determine causes of errors,
were adapted from these industries for use in medical systems. The organizational structure of many hospitals has expanded to emphasize quality of care
and patient safety.
In line with dedication to patient safety, accreditation bodies such as TJC
have redesigned their performance measures to be in line with improvement
of hospital safety and creating a positive impact on patient outcomes.
Future challenges facing hospitals

As the cost of health care continues to rise, hospitals face many challenges.
The US population is shifting from workers to retirees, and hospitals can
no longer rely on private insurance offsetting revenue lost when treating
indigent or Medicare/Medicaid patients. As of October 2008, Medicare
stopped reimbursing hospital for hospital acquired preventable conditions
such as surgical site infections and pressure ulcers. The list of preventable
conditions continues to increase, and private payers have followed suit.
Furthermore, rising costs of labor, supplies and medications, and equipment
and technology make it difficult to meet all the expectations of patients and
payers. Hospitals must implement quality improvement processes to improve
system efficiency while reducing costs to combat negative profit margins.
Another challenge faced by the health care system is the paradigm of
patient-centered care. Patient-centered care places the patient at the center
of the health care team. All providers are expected to provide care that is
tailored to the patients needs and cultural values, enabling the patient to
176
participate in care decisions.19 In addition, the Institute of Medicine states

that health systems should be safe, effective, timely, efficient, and equitable
to provide optimal individualized care.20 The treatment of an older patient
population with chronic conditions requires coordinated, team-based efforts
to provide optimal patient outcomes. These challenges together have brought
forth the need for cultural changes within hospital systems to create optimal
collaborative care environments to best serve their patients.
Health care staffing poses another concern for the health system. Hospitals face the challenge of retaining workers while attracting new workers to
replace retirees and care for the expanding elderly population. Additionally,
hospital executive positions carry high turnover rates, leading to frequent
changes in leadership.
Drug shortages have become another challenge to the health care system.
Between January 1996 and June 2002, 224 drug shortages were reported.21
In 2010, 211 drug shortages were reported. Unavailable drugs, including
anesthetic agents, chemotherapeutic agents, and antibiotics, have created
substantial barriers to safe and effective medical treatment for hospitalized
patients. The inadequate supply of raw materials necessary for drug manufacturing, decreased number of manufacturers due to consolidation of drug
companies, and factors related to drug product distribution all contribute to
national drug shortages. The 2012 Food and Drug Administration Safety and
Innovation Act includes provisions to provide early notice of unpending drug
shortages.22 The actual impact of expanded federal regulation on future drug
shortages is unclear.
As health care technology advances at a rapid pace, the gradually aging
infrastructure of US hospitals poses many problems. Older facilities will need
to dedicate more funds for remodeling or replacement. Health care organizations must address increases in regulatory burden such as environmental and
physical plant regulations, and documentation requirements (paperwork) for
many activities that are not directly related to patient care.
Conclusion
In spite of these challenges, the hospital and health care organizations in the
U.S. have shown a great resilience over the last 50 years as major changes
in the environment have arisen. For that reason it is safe to assume that the
challenges faced in the next decade will be addressed with the same creativity
and determination as the changes over the last 50 years.

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20(1):610.
177
2. Dowell MA. Hill-Burton the unfulfilled promise. Journal of Health Politics, Policy and
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3. Ringold DJ, Santell JP, Schneider PJ. ASHP National Survey of Pharmacy Practice in
Acute Care Settings: Dispensing and Administration1999. Am J Health-Sys Pharmacy
2000; 57:175975.
4. Institute of Medicine. To err is human: building a safer health system. Washington, DC:
National Academy Press; 2000.
5. The Governance Institute. Leadership in healthcare organizations: a guide to Joint
Commission leadership standards. 2009. www.jointcommission.org/assets/1/18/WP
Leadership Standards.pdf. [accessed October 27, 2011].
6. American Society of Health-System Pharmacists. ASHP statement on the roles and
responsibilities of the pharmacy executive. www.ashp.org/DocLibrary/BestPractices/
MgmtStPharmExec.aspx [accessed November 7, 2011].
7. Cohen V, Jellinek SP, Motov Hatch. Effect of clinical pharmacists on care in the emergency department: a systematic review. Am J Health-Syst Pharm 2009; 66:135361.
8. MacLaren R, Bond CA. Effects of pharmacist participation in intensive care units
on clinical and economic outcomes of critically ill patients with thromboembolic or
infarction-related events. Pharmacotherapy 2009; 29:7618.
9. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice
in hospital settings: monitoring and patient education2009. Am J Health-System Pharm
2010; 67:54258.
10. American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for
pharmacies in hospitals. Am J Health-Syst Pharm 1995; 52:27117.
11. Kashihara D, Carper K. Agency for Healthcare Research and Quality, Medical Expenditure Panel Survey. Statistical Brief #229: National health care expenses in the U.S.
civilian noninstitutionalized population, 2006. http://meps.ahrq.gov/mepsweb/data files/
publications/st229/stat229.pdf [accessed November 3, 2011].
12. Raffel MW, Barsukiewicz CK. The U.S. health system: origins and functions. 5th edition.
Albany (NY): Delmar; 2002.
13. Sloan FA, Trogdon JG, Curtis LH, Schulman KA. Does the ownership of the admitting
hospital make a difference? Outcomes and process of care of Medicare beneficiaries
admitted with acute myocardial infarction. Med Care 2003; 41:1193205.
14. Devereaus PJ, Schunemann HJ, Ravindran N, et al. Comparison of mortality between
private for-profit and private not-for profit hemodialysis centers: a systematic review and
meta-analysis. JAMA 2002; 288:244957.
15. Kessler DP, McClellan M. The effects of hospital ownership on medical productivity.
Rand J Econ 2002; 33:488506.
16. American Hospital Association. Fast facts on US hospitals. Updated January 3,
2012. www.aha.org/research/rc/stat-studies/101207fastfacts.pdf [accessed December 24,
2012].
17. US Department of Veterans Affairs. Updated July 23, 2010. www2.va.gov/directory/
guide/home.asp [accessed November 5, 2011].
18. American Hospital Association. Trendwatch: the opportunities and challenges for rural hospitals in an era of health reform. April 2011. www.aha.org/research/reports/tw/
11apr-tw-rural.pdf [accessed November 4, 2011].
19. The Joint Commission. Health care at the crossroads: guiding principles for the development of the hospital of the future. 2008. www.jointcommission.org/assets/1/18/Hosptal
Future.pdf [accessed October 28, 2011].
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century. Vol. 6. Washington, DC: National Academy Press; 2001.
21. Kaakeh R, Sweet BV, Reilly C, et al. Impact of drug shortages on U.S. health systems.
Am J Health-Syst Pharm 2011; 68:18119.
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2012].
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History/A-Public-Trust.aspx [accessed October 26, 2011].
10
Pharmacist role in long-term
care
Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD and
Perhaps nowhere else have consultant pharmacists been more recognized
for their role than in the care of older adults in long-term care. Consultant
pharmacists are required by federal law to serve in oversight of medication
management in nursing homes. With the growing number of older adults and
increasing availability of medications, this role for consultant pharmacists
is growing not only in nursing homes but other long-term care settings as
well. It is estimated that by 2030 there will be a shortage of some 39,000
pharmacists as a result of this increasing need for their services.
The growing population of older adults

Since the very first census of the US population was conducted in 1790, data
on senior demographics have been available. However, it was not until 1870
that data on the senior population was first published.1 Since this first report,
we have been able to track an increased life expectancy, which has changed
the very nature of the older adult population, and the most significant effects
will soon be upon us.
Since 1900, the number of elderly persons (arbitrarily defined as those
65 years of age and older) has increased by tenfold, and since 1960 the
number of elders in the United States has grown at a faster rate than any
other segment of the population.24 In 1960, older adults accounted for
approximately 9.1 percent of the US population; today, older adults make
up approximately 12.4 percent of the population, and it is estimated that by
2030 20 percent of the nations population will be elderly.3
Because women have a longer life expectancy than men, women outnumber men in the 65-and-over population. Currently, about 21 million women
and 14 million men are aged 65 and over, yielding a male-to-female ratio
of 0.67 (i.e., there are 67 males for every 100 females). This ratio declines
steadily with age. In the 65 to 74 age range, the male-to-female ratio is
180
about 0.82; in the 75 to 84 age range, the ratio is about 0.65; and in the over
85 age group, the ratio is about 0.41.5 Two additional findings are worthy
of note. First is that diversity is less evident among the older population
than among the younger population. The percentage of non-Hispanic white
people increases with age. For example, 80 percent of those 65 to 74 years
of age, 86 percent of those 75 to 84, and 87 percent of those 85 and over
are non-Hispanic whites. Second, the living arrangements and marital status
of the older adults differ considerably between men and women as they age.
Men are more likely than women to be married and living with their spouses
(74 percent versus 50 percent, respectively). Not surprisingly, in view of these
facts, the vast majority of our oldest adults are widowed, non-Hispanic, white
females living alone.6
The main reason for the increase in the elder segment of the population
is a decrease in mortality rates. Factors contributing to that decline include
improvements in sanitation and nutrition; medical advances such as the
introduction of better diagnostic techniques and surgical procedures; the
discovery of new medications such as antibiotics and insulin and, more
recently, the development and use of chronic medications that have been
shown in clinical studies to measurably decrease mortality.4,716 A growth
spurt in the cohort of older adults is expected between 2010 and 2030, when
the first of the baby boomers will reach age 65. The baby-boom generation is
defined as the generation born between 1946 and 1964. In fact, 2000 census
data suggest that the most rapid increase in any age group was that of the
45 to 54 age bracket, due mainly to the start of the baby-boom generation.3
By 2030, the total number of persons aged 65 and older will reach 70 million.17 Meanwhile, as the older adult population grows by 75 percent during
this period, the under-65 population will increase by only 7 percent. The
fastest-growing segment of the older adult population is and will continue to
be the over-85 population. Census data from 2000 suggest that at that time
about 1.5 percent of the total national population was 85 years or older. By
the year 2050, nearly one-fourth of all seniors will be over age 85, and at
least 1 in 13 Americans will be 80 or older.
The growth rates in the number of those turning senior and those turning
old-old (defined as those 85 years and older) have staggering implications
for the delivery of health care; not only is the percentage of senior persons
growing, but also the fastest-growing segment of seniors is the old-old, or
those who tend to suffer from more disease and disability and will therefore
require more health care services. The older population is an important and
growing segment of the US population. In fact, more people were 65 years
and over in 2010 than in any previous census. Between 2000 and 2010, the
population 65 years and over increased at a faster rate (15.1 percent) than
the total US population (9.7 percent). In addition to growth in the older
population, pronounced growth in the male population 65 years and over
Pharmacist role in long-term care
181
occurred during the decade. The disproportionate increase in the older male
population not only has contributed to the growth of the overall population
65 years and over, but also has led to a narrowing of the gap between
males and females at the older ages. As larger numbers of men and women
reach age 65 years and over, it becomes increasingly important to understand
this population as well as the implications population aging has for various
family, social, and economic aspects of society.
Demand for health care services

This rapid expansion in the number of older adults is having a profound
impact on our health care system. For example, the incidence (Figure 10.1)
and cost of chronic conditions associated with long-term care such as hip
fractures and Alzheimer disease will increase dramatically. In 1990, researchers estimated that by the year 2040, the number of hip fractures would
exceed 500,000. However, since 2000, the annual number of hip fractures
has remained relatively constant.18 It is predicted that the number of patients
with Alzheimer disease will increase from 4 million to 10 million by 2040,
with a cost of treatment near $150 billion annually.19,20
By 2030, it is expected that 14 million seniors will require some type
of long-term care. Of those 14 million, just over 5 million will reside in
nursing homes, while the remaining 9 million will receive alternative forms
of long-term care.
The Pareto principle has been used to describe the demand for health care
services. This principle was first described in the 17th century by an Italian
Based on 6 possible chronic conditions*
(n = 70,688,633)
80
85.6%
Percentage
60
69.5%
56%
40
20
37.1%
23.1%
14.4%
Ages 55-64
One or more
chronic conditions
Two or more
chronic conditions
Three or more
chronic conditions
Ages 65+
Figure 10.1 Percentage of US adults aged 55 and over with chronic conditions, 2008. The six
chronic conditions illustrated are arthritis, asthma, cancer, cardiovascular disease, chronic
obstructive pulmonary disease, and diabetes. (Data from Centers for Disease Control and
Prevention. Percent of U.S. Adults 55 and Over with Chronic Conditions. (Reprinted from www.cdc.
gov/nchs/data/health_policy/adult_chronic_conditions.pdf [accessed July 16, 2012].)
182
economist who noted that 80 percent of the land was owned by 20 percent
of the population. It has been noted that similar applications apply to senior
health services. In one report it was noted that about 10 percent of the older
population incurs about 70 percent of all health care costs, which suggests
that the minority consume the majority of resources.21 The importance of
this finding is that by being better able to identify high resource utilizers, one
can potentially improve health-related outcomes and decrease cost.
One method of identifying those at high risk is a screening method
developed at the University of Minnesota called the Probability of Repeated
Admission (PRA), which is used to predict hospitalization. The PRA assigns a
numerical value of 0 or 1 to the answers from questions. A score of 0.5 means
that the individual has a 50 percent chance of being hospitalized multiple
times in the following years. In addition to predicting-hospital admission,
the PRA tool has been shown to be effective in identifying chronic illness,
risk of functional decline, nursing home use, doctor visits, and total cost of
care.22 When the items on the PRA tool were evaluated, the one question
with the highest correlation to risk of utilization was, not surprisingly,
self-description of ones own health status. Those who described their
health as poor held the highest likelihood of hospitalization within 1 year.
Pharmaceutical expenditures also have increased. This growth arguably is
largely attributable to changes in utilization rather than changes in prices.23
Increased utilization stems from an increase in demand secondary to a growing number of seniors with comorbid conditions and an increased availability
of new and effective medications. This increase in drug use and drug cost will
present several challenges in caring for older adults.
Medicare Parts A, B, C, and D in long-term care

Medicare has several parts that cover medications for older adults (Figure 10.2). Medicare Part A provides a bundled payment to acute care hospitals, subacute nursing home care, and hospice that includes those medications needed by older adults for that stay. Because these providers are financially and clinically responsible for the medications, consultant pharmacists
often are called upon to assist to ensure appropriate use.
Medicare Part B provides coverage for certain vaccines, such as pneumococcal pneumonia, influenza, hepatitis B, and tetanus under certain conditions. Part B also covers medications dispensed through a device such as
a nebulizer, as well as medications purchased by a physician for a patient.
Medicare Part C is the Medicare Advantage program, which is the program that provides services through managed care plans. These plans are
responsible for the cost of medications and, similar to the situation with
Part A, often call upon consultant pharmacists to assist in the management
of pharmaceuticals.
Part D
6% 4% 1%
Part B
28%
4%
5%
19%
Part A
5%
3%
4%
Part A and B
23%
Part C
Total Benefit Payments = $484 Billion

Does not include administrative expenses such as spending for
implementation of the Medicare drug benefit and the Medicare
Advantage program.
183
Part A
Hospital inpatient (28%)
Skilled nursing facilities (5%)
Hospice (3%)
Part B
Physicians and other suppliers (19%)
Hospital outpatient (5%)
Other Part B benefits (4%)
Part C
Medicare Advantage [Part C] (23%)
Part D
Payments to drug plans (6%)
Low-income subsidy payments (4%)
Payments to union/
employer-sponsored plans (1%)
Part A and B
Home health (4%)
Total is net of 59.4 billion in recoveries for 2009.
Figure 10.2 Where Medicare dollars go, by Parts AD, 2009. (Data from Kaiser Family Foundation.
Update on Medicare spending and financing and highlights from the 2009 Medicare Trustees
Report. Menlo Park (CA): Kaiser Family Foundation; 2009. www.kff.org/medicare/upload/7905.pdf
[accessed July 16, 2012].)
Medicare Part D is the prescription drug program that provides coverage

for medications to older adults. Most long-term care residents outside of
the subacute setting receive their medications through Medicare Part D. This
means that in the nursing home, providers must deal with many different
plans to gain access to prescribed medications for their residents. Navigation
through the prior authorization, step therapy, quantity limits, and other
utilization management restrictions is often guided by the consultant pharmacist because of his or her expertise in these areas.
Health care reform

The Affordable Care Act (ACA)24 made several changes to the care of older
adults. Perhaps most significant was the reduction of patient out-of-pocket
expenses for those Medicare beneficiaries requiring medications under Medicare Part D in the coverage gap. For those older adults falling in the doughnut hole, 50 percent of the cost of their medications is now covered through
a required rebate from the pharmaceutical companies. This previous gap in
coverage is closing, from 100 percent required out-of-pocket to just 25 percent from now through 2019. The effect of this closure is that older adults
who no longer have to pay 100 percent out of pocket are more likely to fill
their prescriptions and adhere to their treatment plans.
ACA also provided for increased coverage of preventive services, so it is
likely that a greater number of older adults will be diagnosed earlier at a
more treatable stage for their cancer, diabetes, or other condition.
184
Special considerations in the provision of health care to

older adults
Older adults are the most heterogeneous segment of the population with
respect to physical, social, and health status.25 The rate at which an individual
ages is variable; how well an individual ages is also variable and depends
on both genetic and environmental factors.25 For instance, one 70-year-old
man may be viewed as being a frail elder if he is suffering from chronic
disease and disability, whereas another 70-year-old man may be viewed
as having aged successfully if he has limited disease and disability.26,27
The term frailty refers to a loss of physiologic reserve that makes a person
susceptible to disability from minor stresses,28 whereas successful aging has
been described as a process by which deleterious effects are minimized and
function is preserved.27 Therefore, chronological age is not as descriptive as
physiological age when assessing the health status of an individual.
Older adults have the highest rate of acute illness as well as chronic illness
and disability.29,30 The prevalence of chronic disease states increases with
age, with 80 percent of the older adult population having at least one chronic
condition at any given time.31,32 Chronic conditions that lead to disability include heart disease, stroke, chronic obstructive pulmonary disease, diabetes,
arthritis, osteoporosis, and visual and hearing impairments.33
The use of medications often can accomplish prevention, cure, or palliation of disease, but those medications also can cause adverse effects. Because
older adults are often afflicted with multiple chronic disease states, they use a
disproportionate amount of medication, increasing their risk of adverse drug
events.
Medication usage in older adults

Older adults use approximately 33 percent of the nations prescription and
nonprescription medications even though they account for only about 13 percent of the US population.34 One statistic suggests the average senior uses
40 percent of all over-the-counter (OTC) medications sold in the United
States.35
Data on drug use in older adults varies with both the age of the cohort
studied and the clinical setting studied. A survey of both institutionalized
and ambulatory elderly conducted nearly two decades ago revealed that
drug use was significantly higher in the former, with 9 percent taking ten
or more drugs daily.36 The average number of agents used increases with
age, with an average of 4.4 drugs per day for those 80 years old and
above. Recent data indicate that 91 to 94 percent of ambulatory adults aged
65 and older use medications, with 44 to 57 percent using five or more
and 12 percent using ten or more medications.37 The type of medication
most commonly used by older adults also depends on the setting. Studies
185
examining community-dwelling elders found they use analgesics, diuretics,

cardiovascular medications, and sedatives often, whereas nursing home residents use psychoactive medications most often, followed by diuretics, antihypertensives, analgesics, cardiovascular medications, and antibiotics.3840
One investigation sought to examine the pharmacoepidemiology of prescription medication use in community-dwelling elderly persons living in rural Pennsylvania. The authors found that among more than 900 participants,
over 71 percent reported taking at least one prescription medication. The
old-old participants reported taking more cardiovascular agents, anticoagulants, vasodilating agents, potassium supplements, and diuretics than the
younger elderly cohort.38
Self-treatment with OTC medications is common, especially for chronic
disease states whose prevalence increases with age, such as arthritis and constipation. The most frequently used OTC medications are analgesics, such as
nonsteroidal anti-inflammatory drugs (NSAIDs), insulin, and gastrointestinal
products such as laxatives. In addition to high utilization of prescription and
OTC medications, use of dietary supplements is also increasing. Common
dietary supplements include multivitamins, vitamin E, vitamin C, calcium,
gingko, ginseng, garlic, saw palmetto, and St. Johns wort.4144 Reasons listed
for increasing popularity and utilization of dietary supplements include high
prices of medications and patient dissatisfaction with conventional medications and treatment.45,46
One study that investigated the use of dietary supplements in older veterans found that 50 percent of respondents reported using one or more such
products (vitamins, minerals, and herbals) within the past 3 months.44 Given
the large number of medications consumed by older adults, their potential
risk for adverse drug events may be significant.
Barriers to health care

Although the use of medication can benefit elders, the aged are presented
with many barriers to health care that may keep them from taking advantage
of some of these available therapies. These barriers include lack of transportation; being too ill and immobile to seek treatment; misperception that certain
symptoms and problems are normal with aging; perceived unresponsiveness
by the medical system (e.g., inadequate parking, abbreviated encounters with
clinicians, inconvenient office locations); expression; denial; isolation; and
atypical presentation of illness leading to underrecognition and underreporting of disease.
Another significant barrier to health care is the lack of adequate health
insurance. The National Institute for Health Care Management Research and
Educational Foundation estimated that in 2000 the national outpatient retail
prescription medication cost was approximately $131.9 billion,47 compared
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with data from 1991, in which a total of $36 billion was spent on both
inpatient and outpatient prescription medications.4 Even more, a significant
percentage of prescription costs is paid out-of-pocket or through cost-sharing
(e.g., deductibles, copayments, out of-pocket expenses after expenditure caps
are exceeded), so that a large burden is placed on the individual. Payment for
outpatient prescription drugs by government sources (Medicare and Medicaid) accounted for 42 percent of spending in 2008. Private health insurance
paid for 37 percent, and consumer out-of-pocket spending accounted for
21 percent.48,49
Elderly individuals with limited income and poor or no insurance are at
the greatest risk of paying large out-of pocket expenses. Moreover, these costs
are likely to continue to increase as people are living longer and with more
chronic conditions that require long-term prescription therapy.
Drug-related problems in the older adult

In addition to the general barriers to health care already mentioned, older
adults are also at risk of specific drug-related problems (DRPs). These can
include withdrawal events, medication error, overdose, therapeutic failure,
nonadherence, inappropriate medication use, drug interactions, and adverse
drug events.50,51 An adverse drug event (ADE) is an adverse event, expressed
as a sign, symptom, or laboratory abnormality, in which a drug is the
suspected and plausible cause.52 The geriatric population is at a particularly
high risk of developing ADEs for several reasons. In fact, in 1995 a statement
was attributed to geriatrician Dr. Jerry Gurwitz: Any symptom in an elderly
patient should be considered a drug side effect until proved otherwise.53
(This statement actually was first made by Dr. Gurwitzs wife Leslie Fine,
RPhD, a consultant pharmacist.)
The most consistently reported risk factor for ADEs in the literature is
polypharmacy, and the risk of ADE increases exponentially as the number
of medications increases.52,5457 Other associated or suspected risk factors
for ADEs include comorbidity history of ADE; changes in pharmacokinetics
(the way in which the body handles medication) and pharmacodynamics (the
way in which a medication affects the body); nonadherence; and fragmented
health care.52,58,59
It is controversial whether age in and of itself is a risk factor for ADEs,
though it probably is not.60,61 The prevalence rates of ADEs have been shown
to range from 2.5 percent to as high as 50.6 percent in the community, from
9.5 to 67.4 percent in long-term care, and from 1.5 to 44 percent in the
hospital setting.52,5456,59,6266 The cost of ADEs also has been studied. It
is estimated that for every dollar spent on medication in a nursing facility,
an additional $1.33 is spent treating DRPs, and in the ambulatory setting
the cost of DRPs was approximated to be $177.4 billion.67,68 Clearly, DRPs
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are common in older adults and are costly to the health care system.51 Fortunately, many ADEs are thought to be preventable. A study of hospitalized
elderly persons showed that, compared to their younger counterparts, older
adults had a higher rate of preventable ADEs (5.3 percent versus 2.8 percent
in their younger counterparts, P = 0.001). The authors suggest that this was
due to more complex medical issues in older adults rather than to less
aggressive or less appropriate care.60
Medication appropriateness
Because older adults use a disproportionate percentage of medications and
are at risk of developing a host of DRPs, several methods of assessing the
appropriateness of a medication have been proposed. The Medication Appropriateness Index (MAI) is a valid and reliable tool used to determine medication appropriateness implicitly by taking into consideration specific patient
characteristics.69 The consultant pharmacist can play a major role in reducing
medication errors, which are a significant problem. Gurwitz et al.70,71 estimated that 800,000 preventable medication-related injuries occur annually
in nursing homes across the country. Most of the medication errors in
long-term care (LTC) settings, as reported in the IOM report,72 are related to
prescribing and monitoring of medications. However, in the definition used
for the nursing home survey process, errors related to prescribing are not
considered medication errors.
One opportunity for improvement exists with the use of the Beers Criteria, developed and published in 1997 by the noted geriatrician Dr. Mark
Beers.7375 He outlined explicit criteria for use in prescribing medications
for older patients and identified several commonly used drugs that should
be considered potentially inappropriate for use in older adults. The Centers
for Medicare & Medicaid Services adopted the criteria as part of their
nursing home regulations. More recently, the criteria have been revised by
the American Geriatrics Society to take into account information that has
become available since the original publication.76
Beyond using a tool like the Beers Criteria, consultant pharmacists can
assist in reducing the errors that are all too common during transitions of
care.7780 The transitions from the nursing home to other settings are times
of high risk for adverse effects due to prescribing or transcription errors. Excluding wrong-time errors, omission of an ordered medication is, in general,
the most common type of drug administration error in nursing homes. By
ensuring appropriate medication reconciliation, missed medications can be
avoided.
Another area in the nursing home where medication errors occur is during
medication administration, or med pass. Since a typical medication pass
in LTC often exceeds 2 hours, it may be impossible for a nurse to deliver
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all medications within 1 hour of the scheduled time, making wrong-time

errors predictably high in this setting.
With drug regimen review (DRR), consultant pharmacists are required
by the facility to conduct federally mandated DRR services. This provides
comprehensive assessment of the drug regimen of a resident, which includes
preventing, identifying, and resolving medication-related problems and medication errors, and collaborating with the interdisciplinary team to promote
positive outcomes of drug therapy.
Recognizing the benefits and risks associated with medication therapy,
the goal of pharmacotherapy is to promote successful aging by maintaining functional independence, preventing disability and iatrogenic disease,
and increasing patients health-related quality of life. As mentioned earlier,
polypharmacy and changes in physiology, pharmacokinetics, and pharmacodynamics can potentially lead to the development of DRPs. The geriatric
pharmacist is well positioned to optimize utilization and to decrease expenditures associated with pharmacotherapy.
Certification of geriatric pharmacists

Given the high demand and uniquely specialized skill set of geriatric pharmacists a certification has been developed to recognize geriatric pharmacists.
The Commission for Certification in Geriatric Pharmacy (CCGP) was created
in 1997 by the American Society of Consultant Pharmacists. It is a separate
nonprofit organization with its own Board of Commissioners. CCGP offers a
board certification examination in geriatric pharmacy practice, and pharmacists who pass this examination are recognized as Certified Geriatric Pharmacists (CGP). CCGP is accredited by the National Commission for Certifying
Agencies, and the CGP examination is developed and administered according
to nationally recognized standards for certification programs.
Two years of experience as a pharmacist are required for eligibility to
take the CGP examination. Some employers provide an increase in pay for
pharmacists with board certification, and some also reimburse for expenses
related to certification.
Geriatric pharmacists are needed in almost all practice settings where
pharmacists are employed. In community pharmacy practice, at least
one-third, and possibly the majority, of patients served are aged 65 or over.
The majority of hospital in-patients also are elderly. In long-term care settings, such as nursing homes and assisted living, 90 percent or more of the
residents may be elderly.
With the advent of Medicare Part D in 2006, insurance and managed
care companies began serving vastly increased numbers of older adults. CGPs
are widely employed in this industry to assist in developing formularies
and strategies to help ensure appropriate use of medications in retirees and
Medicare beneficiaries.
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The role of the geriatric pharmacist in various geriatric health care settings
will be discussed in the following sections.
Long-term care
Long-term care is not synonymous with nursing home care. Long-term care
encompasses a wide variety of care environments that can offer improved
outcomes and use fewer resources than traditional nursing home care.81
With an increased demand from both consumers and payers for higher
quality at reduced costs, we have and will continue to see a stimulated
growth of long-term care facilities that are alternatives to nursing homes.
In addition, although long-term care can be provided to patients of all ages,
over 70 percent of patients utilizing it are elderly.82
Long-term care is simply and most appropriately defined as care that is
provided for an extended period of time. These services can be provided in a
range of settings outside of the nursing home environment and are listed in
Table 10.1.83,84
The role of the geriatric pharmacist in long-term care

Pharmacists who specialize in the care of older adults are well positioned
to provide clinical or consulting services to elderly patients in a variety of
geriatric practice settings. Pharmacists can complete a postdoctoral residency
or fellowship in geriatric pharmacy practice available through twelve institutions throughout the United States and can attain certification as certified
geriatric pharmacists (CGP) through the Commission for Certification in
Geriatric Pharmacy (CCGP). Consultant pharmacy practice is a discipline
within the profession of pharmacy that has its roots in the provision of pharmacy services to nursing homesnow referred to as nursing facilities (NFs)
and other long-term care (LTC) environments.85 Although the concept of
Table 10.1 The spectrum of long-term care
Hospital-based nursing facility

Sub-acute care
Nursing facility
Psychiatric hospital
Intermediate care facility for the mentally challenged
Community-based care
Adult day services
Home health care
Community mental health center
Hospice
Senior center
Retirement housing
Home care
Independent community living
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consultant pharmacy originated less than four decades ago, today more than
10,000 consultant pharmacists provide a broad range of services.86
Pharmacists can consult in many practice settings, including nursing
facilities (e.g., nursing homes, skilled nursing facilities, and intermediate care
facilities), subacute care and assisted living facilities; psychiatric hospitals
and intermediate care facilities for the mentally retarded; correctional facilities; adult day care; continuing care retirement communities; Program of
All-inclusive Care for the Elderly (PACE) programs; home care; and hospice.
Nursing facilities
Nursing facilities (NFs) typically are facilities in which long-term care is
provided to residents within that facility. State Medicaid programs predominantly pay for such long-term services (Table 10.2). Data from the National
Nursing Home Survey indicate that there are currently over 1.6 million
nursing home residents in the United States.87 Studies suggest that medication
use in NFs is significant and increasing.88 One such study revealed that individual nursing home residents received an average of 6.7 routine prescription
medications per day and 2.7 additional medications on an as-needed basis.
The percentage of nursing home residents using nine or more prescription
medications per day has continued to rise, from 18 percent in 1997 to
27 percent in 2000.89,90 The most commonly prescribed medications include
gastrointestinal agents, analgesics, cardiovascular medications, vitamins and
supplements, and psychoactive medications. A recent survey of pharmacists
Table 10.2 Select nursing facility characteristics, 2010
Characteristics
Reported as of June 2010
Number of residents
1,399,856
Resident payer sources

Medicaid
63.7%
Private/other
22.2%
Medicare
14.2%
Total number of beds
1,710,011
Medicare
90,682
Medicare/Medicaid
1,475,016
Medicaid
105,488
Noncertified
38,825
Total facilities
15,701
(Data from American Health Care Association. OSCAR data report: nursing facility patient characteristics
report, June 2010 update. www.ahcancal.org/research_data/oscar_data/NursingFacilityPatientCharacteris
tics/HISTORICAL_HSNF_OSCAR%20Data%20Report_2010Q2.pdf [accessed July 16, 2012]; and American Health Care Association. Nursing facility beds by certification type. CMS OSCAR data current
surveys, June 2010. www.ahcancal.org/research_data/oscar_data/Nursing%20Facility%20Operational%20
Characteristics/HIST_OPERATION_OscarDataReport_2010Q2.pdf [accessed July 16, 2012].)
191
showed that routine medication orders in nursing homes increased by 14 percent from 1997 to 2000. This trend is expected to continue, because of both
the increased disease profile acuity of residents and the increased availability
of innovative medications to treat chronic conditions. The demographic trend
is expected to significantly increase the demand for medications, while the
supply is also expected to see sizable increases. A recent survey conducted by
the Pharmaceutical Research and Manufacturers of America indicated that
there are 261 drugs in development to treat diseases of aging, as well as 122
medications for heart disease and stroke, plus an additional 402 medicines
for cancer.91
Most NF services are paid for by state Medicaid funds. In some cases,
residents who do not yet qualify financially for Medicaid use their own
private funds until they spend down to meet the Medicaid requirement.
Payment for pharmaceuticals is made separately from payment for residents
care in the NF. In all states, with the exception of New York, the risk for
medications belongs to the state Medicaid program. New York is the first
state to shift this risk to the facility, similar to the way the federal government
has shifted risk to skilled nursing facilities (SNFs), through Medicare. In New
York, most medications are lumped into the Medicaid daily rate for the NF.
As a result, the NF provider is at risk for the medication costs. Medicaid
typically reimburses institutional pharmacy providers based on the average
wholesale price (AWP) minus a percentage plus a dispensing fee. As a result
of this payment system, states (again with the exception of New York) find
that their NFs have no economic incentive to control drug utilization, and,
in fact, pharmacy providers benefit when more medications are prescribed.
Most nursing home medications are obtained from institutional pharmacy providers. Currently, more than 80 percent of US nursing home beds
are covered by institutional pharmacies.92 The remainder are served by
independent community pharmacies or retail chains. Federal and state laws
require pharmacy providers of nursing facilities to maintain extended drug
control and distribution systems that exceed the standards for pharmacies
dispensing only to outpatients. The reason for dominance in the use of
institutional pharmacy providers is that expanded services are offered by
these pharmacies to cover the special needs of NFs, including 24-hour drug
delivery, maintenance of medication profiles and drug inventory systems,
repackaging of drugs from bulk supplies into unit doses, as well as maintenance of emergency kits.
Federal law requires all nursing homes to have a contract with a consultant pharmacist. The consultant pharmacists role is to be responsible for
ensuring that resident drug use is safe and effective and that facilities are in
compliance with federal and state regulatory requirements. The role of the
geriatric pharmacist in long-term care is discussed in more detail later in this
chapter.
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Skilled nursing facilities

By definition, a skilled nursing facility (SNF) provides 24-hour skilled care
for patients who require acute care. Patients usually require assistance for
most or all of their activities of daily living (ADLs). ADLs are commonly
defined as activities such as bathing, dressing, and toileting. Skilled nursing
facilities consist of both hospital-based and freestanding enterprises that provide skilled nursing care and rehabilitative services. Certification by Medicare
is required to receive payment for the provision of these services. Approximately 75 percent of these facilities are freestanding or operate independently
of an acute-care hospital, and nearly 50 percent of all facilities are owned or
operated by nursing facility chains.93 The majority of SNF services are paid
by Medicare.
Payments to SNFs are made predominantly through the Medicare program. Medicare pays for short-term, post-acute care for up to 100 days per
benefit period per calendar year for patients who meet certain criteria and
maintain ongoing programs of rehabilitation. These services can begin only
after a 3-day acute hospital stay. In direct contrast to Medicaid, Medicare
pays for medications and the SNF services in one aggregated bundle, placing
the NF at risk for the medications. Using this approach, the SNF may benefit
when fewer medications are prescribed, shifting dollars to the SNF bottom
line from the pharmacy provider.
A paradigm shift occurred on July 1, 1998, when skilled nursing facilities
delivering Medicare-reimbursed post-acute services began operating under a
prospective payment system (PPS) using resource utilization groups (RUGs)
to calculate payments. This was a major shift for SNFs that had previously
been paid on the basis of average costs and had not been responsible for
medication costs. Under RUGs each resident falls into one of 44 specified
RUGs with a prospectively calculated reimbursement. One problem that
exists with this payment system is that although nursing home operators are
unable to directly oversee the prescribing of these medications, they are held
accountable for pharmaceutical costs.94
Skilled nursing facility providers have responded to PPS in several ways.
The Office of the Inspector General (OIG) has completed surveys demonstrating that SNFs:
increase scrutiny of a patients health status related to admission;

place renewed emphasis on utilization management once a patient has
been admitted;
develop preferential admissions policies for patients for whom they believe the PPS rate is adequate or better;
and improve internal utilization, monitoring, and documentation.95,96
One can see that the pharmacy consultant will play an important role in each
of these areas.
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The role of the geriatric pharmacist in the nursing facility

Pharmacists play a very critical role in the optimization of pharmacotherapy
in the NF. Federal law requires all nursing homes to have a contract with a
consultant pharmacist. The consultant pharmacist is responsible for ensuring
that resident drug use is safe and effective and that facilities are in compliance
with federal and state regulatory requirements. The Department of Health
and Human Services (DHHS) regulations state that NFs must employ or
obtain the services of a licensed pharmacist, who:
provides consultation on all aspects of the provision of pharmacy services

in the facility;
establishes a system of records of receipt and disposition of all controlled

drugs in sufficient detail to enable an accurate reconciliation; and
determines that drug records are in order and that an account of all
controlled drugs is maintained and periodically reconciled.97
Consultant pharmacists can be self-employed, employed by the institution,
or employed by a pharmacy provider. While currently the vast majority of
consultant pharmacists working in nursing homes are employed by the institutional pharmacy provider, the Centers for Medicare & Medicaid Services
(CMS) recently published a proposed rule in the Federal Register that would
require consultant pharmacist services for nursing facilities to be independent
from any affiliation with LTC pharmacies, pharmaceutical manufacturers,
or distributors. If implemented, consultant pharmacists could no longer be
employed by LTC pharmacies that provide medications to residents under
contract with LTC facilities. Consultant pharmacists instead would need
to be employed by LTC facilities or contract directly or indirectly with the
facilities. Currently only the state of New Jersey prohibits the consultant
pharmacist from being employed by the dispensing pharmacy. This is done
to avoid any potential conflict of interest.98,99
The drug regimen review

One of the requirements for consultant pharmacists working in nursing
homes is to perform a comprehensive drug regimen review (DRR). The DRR
is a medical chart review of each resident in the facility, and its purpose is to
ensure ongoing quality pharmaceutical care. The consultant pharmacist must
perform an on-site DRR at least monthly for every resident in the facility and
must document any actual or potential medication irregularity in the chart.
The pharmacist must assess the appropriateness of the medication regimen.
Pharmacists should therefore ensure there is an indication for each medication; that the medication is effective and safe for the condition; that the dose,
route, and directions are appropriate and practical; that the regimen is free
from clinically relevant drug interactions; that no adverse event exists; that
194
necessary laboratory measures are available to monitor the effectiveness and

toxicity of the medication; that the duration of therapy is appropriate and
that the goal of therapy is being met; and that the medication has a favorable
costbenefit ratio.99 The interpretive guidelines mandate that the pharmacist
specifically address and ensure that the residents medication regimen is free
from any unnecessary medications, and if psychoactive medications are used,
there must be frequent, documented attempts to taper and discontinue the
medication in addition to the implementation of behavioral modifications.
Evidence indicates that these regulations have been effective; the OIG found
that 85 percent of NF residents psychotropic medications were medically
appropriate under these regulations.
Federal efforts to optimize medication management in long-term care are
not limited to psychotropic medications. The DHHS currently requires that
NF residents drug profiles be free from unnecessary drugs. The definition
used for unnecessary medications is any drug used in excessive dose, for
excessive duration, without adequate indications for its use or in the presence
of adverse consequences.100
In an effort to extend regulations to optimize medication management,
the DHHS incorporated the Beers criteria into the DRR process. The Beers
criteria are a published list of medications best avoided in older adults. These
criteria have been widely accepted as a standard for appropriate geriatric
medication use. Yet despite these regulations research suggests room for
improvementsome 50 percent of nursing home residents in a study funded
by the Agency for Healthcare, Research and Quality were found to have at
least one potentially inappropriate medication prescription as defined by the
Beers criteria.101
The consultant pharmacist, in his or her DRR, is responsible for identifying irregularities regarding medication appropriateness that must then be
communicated to the attending physician and the Director of Nursing.
The performance of the DRR has evolved significantly over time. The
consultant pharmacists role in performing DRRs in the nursing home began in the 1960s with the enactment of Medicare and Medicaid, in which
supervision of pharmaceutical services by pharmacists was established.4 In
1974, the importance of pharmacy in medication oversight in long-term care
became even more evident, as pharmacists were designated the professional
health care providers responsible for evaluating and monitoring the drug
therapy of patients residing in skilled nursing facilities, and it was mandated
that pharmacists review the medication regimens of patients.4 In 1980, the
General Accounting Office developed indicators for surveyor assessment on
the DRR, and in 1982 the State Operations Manual provided surveyors
and pharmacists with specific instructions about how the DRR was to be
performed. This was also an important undertaking because the development
of the indicators gave pharmacists specific guidelines as to what must be
195
included in a DRR and held the pharmacist responsible for the content of
the DRR. In 1984 and 1986, the evaluation of medication administration
procedures and accuracy were included, as was the evaluation of drug therapy
outcomes. Now not only was a pharmacist evaluating the medical chart, he
or she was observing a nurse administer medications to the residents and assessing whether medication administration was accurate. The pharmacist was
now also responsible for ensuring through chart review that the medications
used were achieving their goal.
As a result of the landmark Institute of Medicine report in 1986 that
highlighted quality problems and the need for stronger federal regulations,
Congress passed the Nursing Home Reform Act as part of the Omnibus
Budget Reconciliation Act (OBRA) of 1987.100,102 A large portion of OBRA
1987 related to improving the provision of pharmaceutical care in the nursing
home, including limits on chemical restraints, limits on other unnecessary
or harmful drug use, efforts to discourage polypharmacy, and initiatives to
disseminate geriatric best practice information to medical providers. OBRA
1987 mandated that pharmacy recommendations made on DRR must be
followed by action. This did not mean that the physician needed to accept
the recommendation, but he or she did need to acknowledge it and address
it. The Act also provided guidelines regarding the use of unnecessary medications and antipsychotics. The result was the most far-reaching revision to
the standards, inspection process, and enforcement system since the passage
of Medicare and Medicaid in the mid-1960s. The new standards spoke
to the evolving role of the consultant pharmacist, the process of care that
is expected, and the requirement that care will promote the maximum
practicable functioning for each individual resident.
The Nursing Home Reform Act of 1987, as part of OBRA 1987, also
mandated requirements for regular resident assessment. The law mandated
that 18 areas of health assessment be conducted via the Resident Assessment
Instrument (RAI), which provided a comprehensive, accurate, standardized,
reproducible assessment of a residents medical, functional, and psychological needs.
In 1996, the Minimum Data Set (MDS) was implemented. The MDS is
a standardized instrument that health care professionals complete for each
resident, on admission and yearly thereafter. A shortened version is also
completed quarterly and when there is a change in a residents status. It
is designed to provide insight into the patients cognition, function, and
well-being, and to thereby standardize the assessment of residents and to
improve quality of care. Portions of the MDS are related to the purpose and
effects of medications. The MDS is part of the larger RAI, a form that is used
to help guide the development of individualized care plans for residents.
Today the CMS has moved to monitoring data that nursing homes report
via the MDS and administrative data from the Online Survey, Certification,
196
and Reporting System (OSCAR). The CMS can use these aggregated data
sets to provide a comprehensive view of the individual receiving care in the
nursing home. Pharmacists can use information elicited from the MDS to
identify potential or actual drug-related problems or to optimize medication.
Pharmacists can also help complete the MDS, because two sections of it
pertain directly to recent medication use, recent medication changes, and
frequency of medication administration.97,103
In 2002, the CMS implemented a new quality initiative in an effort
to provide the public with more information about the quality of nursing
homes.104 It conducted a pilot study and is now preparing for the national
launch of the nursing home quality initiative, with ten identified quality
indicators (QIs) regarding worsening of ADLs, pressure ulcers, chronic pain
and post-acute pain, new infections, physical restraints, improvements in
walking in post-acute-care patients, and delirium. Although not currently
part of the facility survey, the presence of these QIs will expand the role
of the consultant pharmacist for several reasons. First, many of these QIs
are affected by medication use, as is the case with underutilization of pain
medications, the use of medications that may contribute to weight loss, or
the use of medications that contribute to delirium. Second, the consultant
pharmacist often is part of an interdisciplinary quality assurance committee
that oversees quality of care issues in the nursing home by evaluating policies
and procedures, clinical practice guidelines, algorithms, and protocols, and
also by providing staff education.
In 2012, CMS identified 5 quality measures for short-stay NH residents
and 12 for long-stay residents.105 These 17 quality measures (QMs) fall into
just 8 major categories:
pain;
pressure ulcers;
vaccinations;
urinary issues:
infection;
Foley catheters;
incontinence (also bowel);
restraints;
weight loss;
depression; and
worsening of daily activities, including falls.
QMs for short-stay patients include:
the percentage of residents on a scheduled pain medication regimen on

admission who report a decrease in pain intensity or frequency;
197
the percentage of residents who self-report moderate to severe pain;

the percentage of residents with pressure ulcers that are new or worsened;
the percentage of residents assessed and given, appropriately, the seasonal
influenza vaccine; and
the percentage of residents assessed and given, appropriately, the pneumococcal vaccine.
QMs for long-stay patients include:
the percentage of residents experiencing one or more falls with major
injury;
the percentage of residents who self-report moderate to severe pain;
the percentage of high-risk residents with pressure ulcers;
the percentage of long stay residents assessed and given, appropriately,
the seasonal influenza vaccine;
the percentage of long-stay residents assessed and given, appropriately,
the pneumococcal vaccine;
the percentage of long-stay residents with a urinary tract infection;
the percentage of low-risk residents who lose control of their bowels or
bladder;
the percentage of residents who have/had a catheter inserted and left in
their bladder;
the percentage of residents who have been physically restrained;
the percentage of residents whose need for help with daily activities has
increased;
the percentage of long-stay residents who lose too much weight; and
the percentage of residents who have depressive symptoms.
Achieving many of these measures requires the assistance of a consultant

pharmacist. For example, many vaccination programs are led by a consultant
pharmacist to ensure that every appropriate resident is reached. Of course
there are other functions beyond DRR and QM where the consultant pharmacist also can provide assistance.
Other functions of the consultant pharmacist in the nursing facility

In addition to the DRR, the consultant pharmacist can develop and conduct
medication use evaluations; may sit on quality assurance committees or other
committees, such as the formulary committee; may work closely with the
medical team to prepare the facility for annual surveys from licensing bodies;
assesses medication distribution, delivery, dispensing, and storage; assesses
medication administration to ensure accuracy and freedom from significant
medication errors; and can also provide education to patients, families, and
staff by providing in-services, medication administration training, and other
programs.97
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Evidence of positive outcomes associated with consulting pharmacy

The literature suggests that consultant pharmacist services are associated
with positive clinical and economic outcomes.67,106108 The largest study
to date conducted to analyze the benefits of consulting pharmacy is the
Fleetwood Project, an ongoing landmark initiative begun in 1995 by the
ASCPs Research and Education Foundation, in collaboration with different
geriatric care providers during three different phases, to demonstrate the
value of consultant pharmacy services and to improve patient outcomes. The
first phase, Fleetwood I, was a pharmacoeconomic analysis of the cost of
medication-related problems and the impact of consultant pharmacy intervention on their costs. Fleetwood I found that consultant pharmacy intervention improved therapeutic outcomes and saved $3.6 billion annually.109,110
Fleetwood II tested the feasibility of a prospective DRR, which focused
on patients at highest risk of a medication-related problem. Fleetwood III
will examine the prospective DRR and the effects of consultant pharmacy
services on reducing medication inappropriateness, adverse drug events, and
under treatment of chronic diseases.109 The overall goal of the project is to
improve health outcomes, to decrease cost and medication-related problems
in nursing facilities, and to shift the focus of the consultant pharmacist from
retrospective chart review to an integral member of the interdisciplinary care
team.110
Evolving role of the consultant pharmacist

Consultant pharmacists are moving beyond their federally defined role of
reviewing resident charts in nursing facilities. They are taking on an expanded role, not only to provide the best possible care, but also to ensure
that the spending for medications supports these efforts. This is increasingly
important, given the 11 percent cut in Medicare cuts effective October 1,
2011, which is forcing NFs to operate even more efficiently and effectively.
Involvement of the consultant pharmacist in medication finances requires
knowledge in several new areas, including dialysis medication bundling, vaccine coverage, and responsibility for off-label use of medications. The financial management of medications is only the first of many opportunities for the
consultant pharmacist. Additional opportunities for consultant pharmacists
will develop as NFs become accountable for clinical outcomesincluding
readmissionsthat will affect both hospital referrals to nursing facilities and
Medicare payments.
Appreciating these opportunities and gaining knowledge and expertise is
critical to consultant pharmacists playing a lead role in the nursing facility.
Consultant pharmacists need financial management expertise to oversee these
ongoing changes.
Many facilities are using consultant pharmacists to review the medications billed to the facility to see if they are inappropriate, either because
199
of how they are prescribed or how they are billed. This financial oversight
of medications will become even more important as a result of increasingly
complex rulesand limited funds. With an 11.1 percent reduction in Medicare payments to NFs that took effect October 1, 2011, NFs will be looking
for ways to operate even more efficiently and effectively. This means ensuring
that the NF does not pay for medications that are not its responsibility
and that should be paid by another party. For example, there are several
issues that have caused significant confusion over coverage for the new
dialysis bundling of pharmaceuticals and coverage for vaccines to prevent
illnesses.
Beyond the issue of not paying for medications that are clearly someone
elses responsibility, there is a proposal on the horizon that NFs must be
aware of, one that would hold nursing facilities responsible both financially
and clinically for the off-label use of medications. The ability of consultant
pharmacists to demonstrate appropriate medication use and payment in the
facility will surely win them a greater role. The following section provides an
overview of several financial medication issues that, if not fully understood,
will result in costs to NFs that could otherwise be avoided.
The role of the geriatric pharmacist in other long-term care

settings
While consultant pharmacists are required to provide DRR in nursing homes,
their services are of significant value in other senior settings as well. These services can be provided in association with one of the elements of the Medicare
drug benefit: medication therapy management (MTM) for beneficiaries who
meet the criteria for this program. When the Medicare Part D program began
in 2006, the eligibility criteria and scope of MTM services varied widely
from one prescription drug plan to another. Over the years, the CMS, the
agency that oversees the Medicare drug benefit, has been gradually bringing
more standardization to the MTM programs of the various prescription drug
plans.
MTM programs generally have incorporated criteria that focus on specific
medications (such as encouraging use of generic over brand name drugs) or
on certain diseases, such as diabetes, heart failure, and chronic obstructive
pulmonary disease. Clinical practice guidelines for these diseases often become a point of reference, with criteria that focus on whether the guidelines
are being followed.
Geriatric pharmacists are needed to remind clinicians and Part D plans
that these guidelines and criteria may not be appropriate in elderly patients,
especially those above the age of 85, because the benefits and risks of prescription drugs in this segment of the population may be different from what
is seen in younger adults. Few adults above the age of 75 or so are included
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in clinical trials, and it may not be appropriate to generalize findings from

these trials to the frail elderly population.
Geriatric pharmacists are trained to focus on the total patient, not just
the drugs or diseases. For many older adults, quality of life and maintaining
the ability to function and live independently may be more important goals
than measures of disease status (e.g., cholesterol or A1C levels). Because the
frail elderly are the fastest growing segment of the United States population,
geriatric pharmacists are expected to play an increasingly crucial role in the
health care system of the future.
Assisted living facilities

Assisted living facilities (ALFs) are difficult to define. In fact, after several
thousand hours of committee work, the Assisted Living Workgroup could
not come up with a definition. In their most basic form, ALFs are residential
settings that offer choices in personal care and health-related services.
Assisted living is a relatively new model of care in the United States,
and, as a result, consultant pharmacy services are not currently federally
mandated in these facilities, although Congress is examining the need for
federal oversight.111 One of the main reasons residents enter an ALF is
difficulty managing their medications. Therefore, medication management is
a large issue in assisted living. State laws regarding medication administration
in the ALFs vary widely. Some allow staff to assist with self-administration
of medications, whereas others require staff to administer the medication
to patients. Some states allow unlicensed staff to administer certain medications, whereas other states mandate that a licensed nurse administer all
medications. Moreover, although quite a bit of research has focused on NFs,
little research about medication optimization has been done in the assisted
living arena.
The consultant pharmacist is well positioned to help optimize medication
prescribing and medication administration in an ALF. Although one of the
primary goals of an ALF is to optimize the health of patients and to keep
them living independently, maximizing their function is also a wise business
goal, because it allows facilities to retain these patients by delaying the
need for skilled 24-hour care. This is also desirable because it is less costly
for society to keep patients out of a NF. Therefore, maintaining patients
functional independence, including their ability to manage medications
with supervision and the aid of the pharmacist, may assist the movement
toward keeping patients in the ALF and out of a skilled NF for as long as
possible.
One study that evaluated the appropriateness of medication regimens of
588 residents in 163 ALFs found that, based on the Beers criteria, 28.8 percent of residents were receiving a potentially inappropriate medication.112
201
Several other studies have found that the use, documentation, and monitoring of psychoactive medications in ALFs was suboptimal.113116
One authors111 review of the literature on assisted living discovered
several trends:
The number of medications taken by patients in assisted living is similar
to that in NFs.
The proportion of patients on psychoactive medications in assisted living
is similar to that in NFs.
The use of potentially inappropriate medications is a problem in assisted
living.
Depression may be undertreated in assisted living.
Proper documentation of medication indication is lacking.
This list suggests that there is a role for consultant pharmacist services
in these facilities. Innovative pharmacists, often self-employed, can create a
business for themselves in assisted living. Consultants can provide services to
assisted living similar to those they provide in NFs. Chart reviews and patient
interviews can be performed and recommendations made. The evolving role
of consultant pharmacists in any setting is to focus on caring for the patient
by being an active member of the interdisciplinary care team, as opposed
to restricting ones services to retrospective chart review. The successful
consultant pharmacist will make therapeutic recommendations on behalf of
the patient and will provide ongoing monitoring and follow-up to ensure
positive outcomes are obtained. Patient, family, and staff education should
be provided as part of the pharmacists plan of care for the patient.
Adult day services

Adult day services are community-based group programs designed to meet
the needs of functionally and/or cognitively impaired adults through an
individual plan of care. These structured, comprehensive programs provide a
variety of health, social, and other related support services in a protective
setting during any part of a day, but less than 24 hours. These services
provide respite to family caregivers as well as therapeutic care for cognitively
and physically impaired older adults. Adult day centers generally operate
programs during normal business hours 5 days a week. Some programs do
offer services in the evenings and on weekends.117
Much of the recent increase in the popularity of adult day services is the
direct result of the advent of home and community long-term care Medicare
and Medicaid waiver programs, which support alternatives to institutional
long-term care and rehabilitation. Currently, the funding for adult day services is about 51 percent Medicaid and other public funds, 47 percent private
funds, and the remainder long-term care insurance.
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Medication use in the adult day service center is regulated by most

states. As one can imagine, oversight of medication in a center serving frail
elders who attend on an irregular basis and who receive a large portion
of their medications at home can lead to confusion. Since the adult day
service provider is not financially responsible for medications, it is up to
each participant to bring his or her own medications to the center if they
need to be administered during center hours. Because only one bottle and
label are given with each prescription and the original vial must be used
by the center to distribute medications in compliance with dispensing laws,
this often results in unlabeled medications left at home for administration
on non-center days and weekends. A role for the geriatric pharmacist can
easily be envisioned in this setting, given the complications of medication
management in such a subset of patients.
Intermediate care facilities for the mentally challenged or

developmentally disabled
The consultant pharmacist can perform similar functions in an intermediate
care facility for the mentally retarded as he or she does in a nursing facility.
For example, the pharmacist can participate in mandatory surveys; educate
the staff, family, and patient about drug therapy; participate in quality assurance committees; develop organizational policies and procedures; oversee
medication administration; and conduct DRRs. DRRs must be conducted by
a pharmacist at least quarterly in such facilities, and at least monthly in a
nursing facility.
Continuing care retirement communities

A continuing care retirement community (CCRC) is a community that offers
several levels of assistance, including independent living, assisted living, and
nursing home care. CCRCs are also known as life care communities in
some regions. Religious organizations, fraternal groups, and other nonprofit
agencies sponsor most CCRCs. These are different from other housing and
care facilities for seniors because they usually provide a written agreement
or long-term contract between the resident and the community that offers a
continuum of housing, health care, and other services, most commonly on
one campus or site.118
Commonly, CCRCs require a one-time entrance fee and monthly payments thereafter. Fees vary from one community to another, depending
on the type of housing and services each offers and the extent to which
long-term care is covered. Other communities operate on a rental basis, in
which residents make monthly payments but do not pay an entry fee. In still
other communities, residents own instead of rent their units in arrangements
similar to condominium ownership.119
203
Special needs plans

Special needs plans (SNPs) are another type of program working to improve
care for dual eligibles (i.e., persons eligible for both Medicare and Medicaid).
SNPs are Medicare Advantage plans limited to enrolling three types of beneficiaries: dual-eligible individuals; residents of nursing facilities; and people
with chronic conditions. Dual-eligible plans easily account for the majority
of SNPs (approximately 62.5% of the SNP plan types).120
The Medicare Improvements for Patients and Providers Act of 2008 required SNPs to contract with individual states to provide Medicaid benefits,
and it extended the SNP program through 2011. Section 3205 of the ACA
allows SNPs to continue operating through fiscal year 2013, but restricts
enrollment to individuals who have the specific special need the SNP is
authorized to cover. Beneficiaries enrolled in an SNP who do not meet
its qualifying criteria must be disenrolled by 2012. After 2013, additional
legislation will be required for the SNPs to continue operating.121
SNPs that provide coverage for dual-eligible individuals are now required
to be fully integrated and to secure contracts with Medicaid agencies for
the states in which they operate. A fully integrated dual-eligible SNP is
one that gives enrollees access to the full range of Medicare and Medicaid
benefitsincluding LTC servicesunder the umbrella of a single managed
care organization. The SNP must use aligned care management to coordinate
delivery of benefits and has to offer specialty care networks for dual-eligibles
who are considered high risk. Beginning in 2012, fully integrated SNPs designed for dual-eligible individuals may be candidates for adjusted payments
based on the overall frailty of their patient population.
Program for all-inclusive care for the elderly

In 1997, long before SNPs and the Money Follows the Person (MFP)
Rebalancing Demonstration Program (discussed in the next section) were
established to coordinate care for dual-eligibles, Congress authorized the
Program for All-Inclusive Care for the Elderly (PACE) to integrate care for
the frail elderly.143 PACE is offered as a Medicare benefit and, in some
states, as a Medicaid benefit for nursing homecertified dual-eligibles who
are 55 years of age or older and live in a PACE service area. Although PACE
enrollees are nursing homecertified, many beneficiaries are not nursing
home residents.123126
Enrollees attend an adult day health care center, where they receive medical attention and support services from an interdisciplinary team consisting
of health care providers and other professionals. For those individuals who
require nursing home care, PACE continues to pay for and coordinate their
care while they reside at the LTC facility. Because of the political desire to
204
maintain PACE, the ACA kept PACE programs exempt from the cuts being
applied to Medicare Advantage plans.
PACE is an innovative practice setting that provides comprehensive
health, social, and medical care to frail elders who are nursing home eligible
but do not wish to live in a nursing home. It is a community program
designed to serve as an alternative to nursing home living for many elders.
PACE is based on the belief that it is better for the well-being of seniors with
chronic care needs and their families to be served in the community when
possible. PACE serves individuals who are 55 or older, certified by their state
to need nursing home care, able to live safely in the community at the time
of enrollment, and live in a PACE service area. If a PACE participant does
need nursing home care, the PACE program pays for it and continues to
coordinate care. Nationally, only about 7 percent of PACE participants do
reside in nursing homes.123125
PACE programs receive a lump-sum payment from Medicare and Medicaid for delivering all needed medical and supportive services. The program
is able to provide the entire continuum of care and services to seniors with
chronic care needs while maintaining their independence in their homes for
as long as possible. These services are provided by an interdisciplinary team
and include the following:
adult day services;

medical care;
home health care and personal care;
prescription drugs;
social services;
respite care; and
hospital and nursing home care when necessary.123,124
Early in the 1970s, when the ChinatownNorth Beach community of San

Francisco realized the pressing needs of elders whose families had immigrated
to the United States, the PACE model of care was born. A community group
of leaders formed a nonprofit corporation, On Lok Senior Health Services,
to create a community-based system of care. (On Lok is Cantonese for
peaceful, happy abode.)125
PACE offers benefits to all the principal stakeholders in the following
manner:
For participants, PACE provides the following:

caregivers who listen to and can respond to their individualized care
needs;
the option to continue living in the community as long as possible; and

coordination of their health care services.
205
For health care providers, PACE provides the following:

a capitated funding arrangement, rewarding providers that are flexible
and creative in providing the best care possible; and
the ability to coordinate care for participants across settings and medical disciplines, including clinical pharmacy.
For Medicare and Medicaid programs, PACE provides the following:

cost savings and predictable expenditures;
comprehensive services emphasizing preventive care; and
a model of choice focused on keeping seniors at home and out of
institutional settings.
Outcomes from PACE programs have been positive in the areas of consumer
satisfaction, reduction in institutional care, controlled utilization of medical
services, and cost savings to public and private payers of care, including
Medicare and Medicaid.126128
Medication management in a PACE program is especially difficult to monitor, because unlike a nursing home setting, patients in the PACE program
attend the health center during the day but return home in the evening and
remain home on weekends, when they are not supervised by health staff.
Therefore, the effectiveness and toxicity of medications may not be identified
as readily, and appropriate prescribing at the outset is crucial. Currently, 33
PACE and pre-PACE programs exist in the USA, and the number of such
programs is expected to increase.130 With the advent of new PACE programs
and with the knowledge that medication monitoring in the PACE program
presents a unique challenge, it is especially important to ensure appropriate
medication prescribing at the outset. One pilot study detailed the prevalence
and consequence of potentially inappropriate medication use in a PACE program. Although the great majority of prescriptions reviewed (96.6 percent)
were considered appropriate by the Beers criteria, over one-third of patients
(36.1 percent) were prescribed a potentially inappropriate medication.131
Thus, the geriatric pharmacist can play a large role in evaluating the outcomes
of potentially inappropriate medication use by monitoring drug therapy and
bringing therapeutic issues regarding the use of these medications to the
attention of the prescribing physician.
Home health care

The American Society of Health-System Pharmacists has issued guidelines
on the pharmacists role in home care.132 They state that the pharmacist
should ensure that each patient referred to home care is an appropriate home
care candidate based on admission criteria. In doing this, the pharmacist
should assess whether the patient and family agree with the provision of
206
home health care services, that they are willing to be educated about the
patients medication, that the home environment is suitable for the provision
of services, that the medical condition and prescribed medication therapy are
appropriate for home service, that the goals of therapy are documented, and
that all components of the medication regimen are appropriate.
The pharmacist should collaborate with the health team to develop an
appropriate care plan for each patient. In doing so, the pharmacist should
maintain a complete patient database to use for ongoing monitoring of
the patients drug therapy and as an evaluation tool for measuring patient
outcomes. The database would include all pertinent subjective and objective information, including demographics, emergency contact information,
diagnoses, location and type of intravenous access, pertinent laboratory
measures, pertinent historical and physical findings, nutrition screening
test results, allergy history, a complete medication history, pertinent social
and functional limitations, and appropriate pharmaceutical assessments and
plans.
The pharmacist should collaborate with other health care providers to
select products, devices, and ancillary supplies. Common examples of the
pharmacists responsibilities would be selection of appropriate medications,
assessment of stability and compatibility of prescribed medications and infusion device reservoirs, appropriate infusion devices, fluid admixtures, and
appropriate administration sets.
The pharmacist should also consider the patients and families abilities
to learn to operate the infusion devices, and should consider patient convenience and cost in his or her recommendations. The pharmacist is responsible
for providing education to the patient, family, and staff. The pharmacist
should also work with the team to determine which medications should be
included in an emergency supply kit.
The pharmacist should also be responsible for ensuring acquisition,
proper compounding, dispensing, storage, delivery, and administration of all
medications and supplies, and for tracking adverse drug events and medication errors. The pharmacist should also be involved in developing organizational policies and procedures and be an active member of performance
improvement activities.132
Hospice care
Hospice care presents a challenging and unique opportunity for the consultant pharmacist, because the goals of therapy and, therefore, the monitoring
of therapy are different. The goal of therapy is to support terminal patients
and families and to provide comfort care, as opposed to preventive or curative care.133 The hospice pharmacist can serve on an interdisciplinary team
whose goal is to provide compassionate, comprehensive, innovative care to
207
patients and their families. In the hospice setting, probably more than any
other, the family is treated along with the patient.
The pharmacist, in collaboration with the whole hospice team, is challenged with:
quickly identifying all symptoms causing discomfort;

providing only care that serves to increase comfort;
providing all care effectively and rapidly; and
providing care that is practical, not complex, and without adverse event.
Symptoms that a pharmacist in the hospice setting will observe include

pain, weakness, fatigue, early satiety, anorexia and vomiting, and dry mouth
and constipation. Many of these can be medication-induced. For instance,
dry mouth and constipation can be secondary to the use of opioid analgesics;
and weakness, fatigue, anorexia, and vomiting can be due to many disease
states, such as cancer, as well as to too many medications. It is now recognized that pain is often undertreated; patients should not live or die in
pain. Thus, the hospice team should take great care to ensure that pain is
effectively and aggressively managed. Delirium can be due to a wide range
of causes, including pain, infection, electrolyte abnormalities, an unfamiliar
environment, and medication. The consultant pharmacist can work with the
team in identifying and treating the cause of delirium. Another common
condition in which the consultant pharmacist can play a role in management
is cachexia, which may be due to medications and may be managed with
some medications. In general, the consultant pharmacist should assess and
monitor drug therapy and develop a care plan in collaboration with the rest
of the health care team. He or she should work to prevent and manage
drug-related problems. The pharmacist may dispense and deliver drugs and
related devices such as spacers, nebulizers, or intravenous supplies; he or she
may compound medication preparations, provide analgesic dose conversions,
perform pharmacokinetic drug dosing calculations, and provide education to
the patient, family, and staff. The pharmacist should monitor the outcome of
pharmacotherapy by utilizing pain scales and other quality-of-life measures.
Conclusion
The only constant is change. Those words cannot ring any truer than with
regard to the delivery of health care, especially for older adults. The number of older adults in the United States and worldwide is growing at an
unprecedented rate. With an increased number of older adults needing health
services, our goals for managing disease have greatly changed over the years.
We are increasingly aware that illness in older adults should not be thought
of as inevitable, and we are instituting more appropriate curative, preventive,
and palliative care in elders with the goal of maximizing health and function
208
and minimizing disease and disability. Although most older adults live independently in the community, the number of those needing long-term care is
growing. Traditional nursing facilities are still an available option, but they
are no longer the only option. Many different forms of long-term care exist,
and geriatric pharmacists are finding roles in each of these settings.
Pharmacists have been providing consulting services in traditional nursing
homes for years, but change is constant, as is evidenced by the continually
expanding role of the pharmacist in the care of older adults. Now more
than ever, geriatric pharmacists have the ability to improve health outcomes
and decrease cost in many long-term care settings, where they can serve as
integral members of the interdisciplinary care team.

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214
Online resources
Administration on Aging: www.aoa.dhhs.gov.
Agency for Healthcare Research and Quality: www.ahrq.gov.
Alzheimers Association: www.alz.org.
Alzheimers Research Forum: www.alzforum.org.
American Geriatrics Society: www.americangeriatrics.org.
American Medical Directors Association: www.amda.com.
American Society of Consultant Pharmacists: www.ascp.com.
Assisted Living Federation of America: www.ALFA.org.
Centers for Medicare & Medicaid Services: http://cms.hhs.gov.
ElderWeb: www.elderweb.com.
Federal Food and Drug Administration: www.fda.gov.
Federal Interagency Forum on Aging-Related Statistics: http://www.aoa.dhhs.gov/agingstats/
default.htm.
Institute for Safe Medication Practices: www.ismp.org.
National Chronic Care Consortium: www.nccconline.org.
National Family Caregivers Association: www.nfcacares.org.
National Institute on Aging: www.nia.nih.gov.
National PACE Association: www.natlpaceassn.org.
National Parkinson Foundation: www.parkinson.org.
U.S. Census Bureau: www.census.org.
11
The research manufacturing
pharmaceutical industry
Jean Paul Gagnon, BS, PhD
The US pharmaceutical research manufacturing industry plays a significant
role in the discovery and development of innovative chemical and biological
agents used in the treatment of human and animal diseases. The industry
is distinguished from other industry sectors because its success depends on
outside organizations, e.g., the US Food and Drug Administration (FDA),
clinical research organizations, research journals, research universities, and
other entities. In addition, a successful pharmaceutical market thrives best
within societies that embrace innovation with the corresponding respect
for the protection of intellectual property, the profits received for the risks
incurred, and the contributions made to improve patient health outcomes.
The industry enjoys success in economic environments relatively free from
government price controls, with the availability of venture capital, funding
for biomedical research, and the presence of market-driven cost containment
mechanisms. The United States has exhibited these characteristics and since
2006 has accounted for a significant proportion of the worlds pharmaceutical innovations and corresponding profits.1
Another characteristic of the pharmaceutical industry is that it is not as
susceptible to usual business cycles with fluctuating yearly demand because
the demand for pharmaceuticals is disease driven. In addition, investors
traditionally consider the industry a sound investment that historically has
provided the potential for higher returns and dividends than other industries.
Finally, the industry employs highly technically competent employees who
receive higher salaries, and it is a relatively clean, environmentally friendly
industry. Many countries and states actively pursue pharmaceutical manufacturers with tax concessions, and, as a result, several regions have created
a concentration of start-up biotechnology companies.
Economic impact
The Fortune 500 pharmaceutical manufacturing companies generated
$295.7 billion in 2010 sales (Figure 11.1) and $44.5 billion in profits in
Biogen Idec
$4,716
$5,451
$15,053
Myan
$19,484
$23,076
Amgen
Wal-Mart Stores
216
$35,167
Bristol-Myers Squibb
$45,987
Eil Lilly
$421,849
Abbott Laboratories
$61,587
Merck
Johnson & Johnson

$67,809
Pfizer
Figure 11.1
Sales for nine top pharmaceutical manufacturers in 2010.
2010, earning the status of the third most profitable sector in the Fortune
500. The pharmaceutical industry ranked fourth (tied with network and
other communications equipment) in return on revenue (15 percent), and
13th (tied with one other company) in return on shareholder equity (19 percent).2 US pharmaceutical manufacturers accounted for nearly 50 percent of
worldwide pharmaceutical sales.
Additionally, the three major pharmaceutical wholesalers generated
$285.2 billion in sales with $2.5 billion in earnings, and the major retail
pharmacy chains realized $189.5 billion in sales and $5.0 billion dollars in
profits (Table 11.1). Equally significant is the $111.0 billion in sales and
$2.6 billion in profits generated by the two pharmaceutical benefit management companies. The total of all publicly traded Fortune 500 pharmacy
companies, including PBM, retail chains, wholesalers, and manufacturers,
accounted for 8.3 percent of the total Fortune 500 sales and 7.8 percent
of profits. The larger proportion of profits compared to proportion of sales
reflects the relative profitability of the industry to other industries.
Although they are large, the pharmaceutical manufacturers are relatively small compared to the leading industry sectors. Comparative financial
The research manufacturing pharmaceutical industry
217
Table 11.1 2010 Pharmaceutical sales, profits, and number of employeesa

Type of company
Revenue $ (millions)
Profits $ (millions)
No. of employees
PBM
110,958
2,608
48,050
Retail
191,502
5,011
448,050
Wholesale
300,908
2,978
78,050
Manufacturer
295,734
44,551
533,790
899,102
55,148
1,107,940
a Publicly traded companies in Fortune 500.
PBM, pharmacy benefit manager.
Table 11.2 2010 Sales, profits, and employees

Company
Rank in
Fortune 500
Revenues
($ millions)
Earnings
($ millions)
No. of Employees
Wal-Mart
421,849
16,389
2,100,000
Exxon Mobil
354,674
30,460
103,700
Chevron
196,337
19,024
82,196
Conocophillips
184,966
11,358
29,700
Fannie Mae
153,825
(14,014)
7,300
Top 5 companies
Top pharmaceutical companies

McKesson
15
108,702
1,263
32,500
CVS
21
98,413
3,427
161,500
Pfizer
31
67,809
8,257
110,600
Walgreen
32
67,420
2,091
210,500
metrics (i.e., sales, profits, and number of employees) for the top five Fortune
500 companies and the top companies in pharmaceutical development and
manufacturing and drug distribution are presented in Table 11.2.
The combined size of the Fortune 500 pharmaceutical development and
manufacturing companies measured in sales is comparable to approximately
three-fourths of the sales posted by Wal-Mart, the largest Fortune 500 company in 2010.
US pharmaceutical industry state of affairs

Historically, critics of the pharmaceutical industry have attacked its profitability, heavy promotional efforts, and pricing policies. These three Ps
have always invited criticism from various consumer, patient, and other
218
groups, who continue their efforts to modify the industrys traditional business model. Unlike other industries, pharmaceutical manufacturers are faced
with unusually high risks in the discovery and development process because
of US Food and Drug Administration (FDA) requirements for safety and
proven efficacy.
The complexity of disease processes together with the mode of action
of pharmaceutical products presents an information dissemination challenge
for pharmaceutical manufacturers, because they are expected to walk a line
between marketing hype and a rational information exchange with patients.
Consequently, manufacturers with low innovation success or relatively weak
or declining market penetration have traditionally not survived. This has
been especially true since 2006, resulting in continued consolidation and
downsizing of the industry into fewer pharmaceutical companies and a clustering of biotech companies. In addition, ongoing globalization continues to
change the makeup of the US pharmaceutical industry such that its financial
ratios, i.e., pricing and profitability, are becoming similar to large capitalized
US consumer product companies. The end result of this activity has been
smaller work forces and a research agenda that addresses worldwide health
challenges in addition to issues facing the aging population of the USA. Today
pharmaceutical companies have learned that the best size for a research team
is 20 to 40 people, and that to find new science early they must rely on
collaborations with academic research teams and licensing deals with smaller
biotech companies. They also have learned to aim at serious diseases such as
Alzheimer disease to garner higher premiums.3
A number of other segments of the pharmaceutical manufacturing industry, including generic manufacturers, biotechnology, and niche research
manufacturers, also develop, manufacture, and sell pharmaceutical agents.
These important segments offer value for providers payers, and patients.
However, products produced by these segments are becoming increasingly
expensive, which is concerning to patients and institutional purchasers. On
the other hand, some of these segments are held in high esteem because of
the potential affect they might have on patient outcomes. Biotechnology, for
example, enjoys a more favorable status with the public and congress than
large capitalized traditional pharmaceutical manufacturers. There is now a
biomedical resurgence according to Eli Lillys Chairman John Lechleiter.4
Many pharmaceutical companies are clustering their biotech research in
a handful of US cities. In 2011 construction starts in manufacture-owned
laboratory sector, which includes biotechnology, more than doubled. Today
companies feel that putting scientists in micro environment cluster locations
near top universities and competitors will increase productivity. Three areas,
Boston, New York/New Jersey and Californias Bay area are the three places
best positioned for growth in the life-science sector.5 Clustering may be good
because it will allow those involved in the quest for pioneer drugs to share
219
rather than hoard information. Unlike the current structure that encourages
the industry to protect its ideas and patents. A cluster of biotech companies
may encourage information sharing.
The unique characteristics of the industry coupled with the high level of
risk associated with aggressive marketing continue to attract considerable
attention from government officials and consumer groups. Some drug recalls
are unavoidable because untoward effects of medications are revealed only
after launch, from large-scale studies and long-term use. However, these very
visible events often are viewed by consumer groups as negative because of
the industrys profit-seeking and aggressive promotional behavior.68 The
pricing power held by manufacturers, although viewed by the investment
community as a good attribute, is a frustration to patients and the payer
community. In addition, pharmacists, insurers, employers, and consumers
chafe at prescription price increases that are percentage-wise much higher
than the average consumer price index.
The chemical and pharmaceutical industries are sensitive to the decline
in the number of actual years a company has to recoup its research and
development expenditures under US patent law. The Department of Commerce has documented the relation between pricing regulation and decreased
levels of innovation in countries with changing pricing regulations and across
countries with varying pricing regulations.9 Investors assess the value of a
pharmaceutical manufacturer based on its research pipeline and the expected
value of innovations. Consequently, Pharmaceutical Research and Manufacturers of America (PhRMA), the industry trade association, is aggressive in
addressing state and federal price control initiatives. In response, the pharmaceutical industry continues to receive increased criticism from consumers and
government officials for not apologizing for employee error and corporate
misconduct.10
Medication expenditures are driven by price increases, increases in the
number of patients treated, growing numbers of disease candidates appropriately treated with innovative pharmaceuticals, more aggressive medication
therapies involving multiple agents, and the aging demographics of the US
workforce and general population. Payers and administrators of health plans
tend to focus mainly on prescription price increases because they are visible
and measurable, and the money spent on promotional efforts is obvious.
Most pharmaceutical research and development investments continue
to be made in the United States, e.g., approximately 80 percent of global
biotech research and development in 2010 was done in the US.11 Some major
non-US manufacturers also maintain major research and development and
sales functions in the United States because of public policy and a favorable
economic environment. In the 1980s and 1990s pharmaceutical innovation
was more evenly distributed across industrialized countries. Growth in research and development in 2010 tended to exceed general inflation and
220
averages about 6.5 percent, compared to inflation, which is generally below

3.0 percent.11 This level of enthusiasm for research is driven by a society
that has embraced new technology and welcomed new therapies. Risks do
exist that affect research and development, however, including (1) policy
development shifting the economy toward restrictive price controls, and
(2) failure to respect and enforce intellectual property laws and regulations.
Payer, employer/government, and consumer reluctance to pay for specific
pharmaceuticals is growing as more of these groups begin to rely on comparative effectiveness research (CER) conducted by different groups, e.g., the
Agency for Healthcare Research and Quality (AHRQ), evidence of increased
government subsidy in the passage of the Medicare Modernization Act,12 and
the implementation of the Patient Protection and Affordable Care Act (ACA)
signed into law on March 23, 2010. This law (along with the Health Care
and Education Reconciliation Act of 2010) contains increased returns and
risks for pharmaceutical companies. For example, the ACA included a new
excise tax that is applicable to pharmaceutical companies and is based on the
market share of the company; this tax is expected to create $2.5 billion in
annual revenue for the federal government. In addition, the Medicaid drug
rebate for brand name drugs was increased to 23.1 percent, and a rebate was
extended to Medicaid managed care plans. Finally, the Medicaid rebate for
non-innovator, multiple source drugs was increased to 13 percent of average
manufacturer price.
A non-profit Patient Centered Outcomes Research Institute (PCORI) also
was established, independent from government, under the ACA to undertake
CER. This group was charged with examining the relative health outcomes,
clinical effectiveness, and appropriateness of different medical treatments
by evaluating existing studies and conducting its own. Medicare may take
the Institutes research into account when deciding what procedures it will
cover, as long as the new research is not the sole justification and the agency
allows for public input. The use of CER in decision-making increases in importance because of growing concerns about the quality of clinical trials.13,14
In response, pharmaceutical manufacturers also are starting to use health
information technology to develop virtual clinical trials.15
On the plus side, the ACA legislation increased the number of people over
65 years of age who will be eligible for coverage of prescription medications
for persons eligible for Medicare coverage. In addition to Medicare, government policies reflecting resistance to pay for some innovations or extension
of existing price controls such as the Federal Upper Limit prices for generic
pharmaceuticals are exerting downward pressure on the level of research
and development. Private payer reimbursement policies are exerting similar
pricing pressures. Such slowing in research progress is invisible, because
consumers are unaware of treatments that are delayed or not developed.
221
An example of shifting free market policies is the inclusion of provisions

for reimportation of pharmaceuticals. In effect, this action represents the
importation of de facto price controls from countries with these public
policies. Estimates are that widespread importation of pharmaceuticals from
countries with lower prices will slow innovation because of lost cash flow
generally used to finance research and development and reduced enthusiasm
for investment in innovations when the return on investment in products in
the pipelines is discounted.
Intellectual property rights are constantly being challenged in all business
sectors. Considerable interest in anti-counterfeiting technology attests to
the growing challenge to manufacturers to protect the market exclusivity
presumed to be associated with patents, trademarks, and copyrights. Niche
research manufacturers rely on the expected value of products that eventually
will be licensed to major manufacturers and attract venture capital based on
these expected values. The expectation that patents will be protected is key
to estimating the future value of innovations.
The pharmaceutical industry could become considerably less profitable
if payers are less willing to pay for innovations because products might be
priced at levels consistent with prices in price-controlled environments as
compromised intellectual property rights become more prevalent. Slower, less
profitable research pipelines will continue to exert downward pressure on
stock prices, making the industry less attractive to investors.
Accenture believes that The R&D process in the pharmaceutical industry
has reached a tipping point. As a result of a number of high-impact change
drivers and for R&D organizations to remain competitive, R&D organizations will be forced to evolve significantly or abandon traditional approaches
in favor of new R&D models.16
Future outlook for the US pharmaceutical industry

Over the last 15 years, consolidations within the US drug manufacturing and
distribution system have continued to gain momentum. In 1996 there were
approximately $10.6 billion in consolidations by US pharmaceutical-related
companies. There was more merger and acquisition activity in the biotechnology, pharmaceuticals, and health care sectors during 2008 to 2009, but
slightly less in 2010. Many large companies in the industry have completed
multi-billion dollar deals within the last 2 years alone, e.g., Merck and
Schering, Pfizer and Wyeth, Sanofi-Aventis and Genzyme, and others. Despite
the busy merger and acquisition activity in recent years, further consolidation
and joint ventures continued at a fairly moderate pace in 2011. The advent
of vertical and horizontal integration in the form of mergers and acquisitions
indicates the drug distribution system continues to form into an oligopoly,
i.e., a few large suppliers selling products and services to an oligopsony
222
consisting of a few larger purchasers. McKinsey & Co, however, believe the
pharmaceutical industry has become more fragmented because the number of
companies competing for the profit pool has more than doubled. As a result
they believe big pharmaceutical manufacturers must compete for parts of
the value chain with focused players, e.g., generic companies, life science,
service providers, clinical research organizations, and biotech companies.17
All the players in the US drug manufacturing and distribution system are
affected by continuing ongoing integrations.
Over-the-counter (OTC) companies worldwide continue to attract the
interest of brand name companies. Going forward, the prospects for the OTC
market in Europe remain good as it continues to outpace performance in the
pharmaceutical sector. Powerful market forces that cannot be ignorednew
players, new markets, new regulatory provisions, and new channels of OTC
distributionare reshaping the landscape.18
OTC drug businesses are of interest to pharmaceutical companies because
sales for these products could reach high levels by 2020 as more of the 70
million baby boomers reach age 65. More importantly, once a prescription
drug converts to an OTC product, it has an immediate place in the market
and the market expands very rapidly. One model held by a few companies
today is that the goal for a pharmaceutical company should be to manage
the whole life cycle of pharmaceutical products, i.e., continue to manage
the products as they convert from a pharmaceutical product to a branded
generic, to a generic product, and finally to an OTC drug. OTCs also will
play an important role in drug protocols developed for different diseases: i.e.,
the first drugs dispensed under capitated or value based purchasing contracts
will be inexpensive OTC drugs.
For many years, brand name pharmaceutical companies focused only on
drug research and development and ignored generic development and manufacturing. Today brand name companies are interested in generic companies
because they realize that in 2010 their market share was 78 percent of all
oral prescriptions in the US.19 As a result, some prestigious brand-name
pharmaceutical companies are now becoming major purveyors of generic
medicines. For example, the CEO of Sanofi, Christopher A. Viehbacher,
bought Medley of Brazil, which has its own brand identity. Giants such as
Pfizer, Eli Lilly, and Sanofi are pursuing a growing consumer base in emerging
markets like Eastern Europe, Asia, and Latin America, where many people
pay out of pocket for their medicines but often cannot afford expensive
brand-name drugs.20,21 Pfizer is also exploring new life for Lipitor.2224
Until recently, many brand-name drug makers invested the bulk of their
research and marketing dollars in the development of blockbuster drugs, only
to cede their intellectual property and market share to lower-priced generic
competitors once the patent life cycle began to decline. Now, however, with
an estimated $89 billion in brand-name drug sales in the United States at risk
223
to generic competition over the next 5 years, according to IMS Health some
drug makers are selling generics to offset revenue declinesas well as wring
some post-patent profits from the innovative drugs they developed.
In addition, while drug sales in developed markets such as North America
have low single-digit annual growth, emerging markets, including India,
China, Russia, and Brazil, have growth in the mid-teens.19 As a result, some
drug makers are pursuing a two-tiered strategy in developing markets: selling
their own lines of more expensive name-brand products to the more affluent,
as well as offering mid-priced branded generic lines that include prescription
and over-the-counter medicines for the broader market. Branded generics can
give prominent drug makers a way to capitalize on those markets without
having to compete with no-name generic producers whose selling point is
rock-bottom pricing. Company-branded generics can charge more for the
promise of quality. Companies also are looking at ways to differentiate their
generic products, e.g., generic companies are now describing the therapeutic
categories they specialize in or using other indicators of their brand on their
products.25
In Europe, pharmaceutical companies are experiencing pressure on drug
prices. Pressure on future prices might be exerted in one of three ways:
Other countries may mimic Portugals plan to switch to a new system of

setting drug prices based on the three EU countries with the lowest prices.
Japan and Canada use prices set by France and Germany for domestic
price decisions.
Prices vary among European member states by as much as 25 percent,
and the price in one country will affect the manufacturers ability to get
a higher price in another country. The European Parliament has recommended other ways to reduce prices.
European countries will likely follow the UKs NICE (National Institute
for Health and Clinical Excellence) pricing model starting in 2014, which
is based on evidence that new treatments offer marked benefit over
existing drugs.26
In addition, American pharmaceutical companies will continue to look
for global partnerships. For example, the Swiss drug maker Novartis, which
unified its generic business in 2003 under the name Sandoz, recognized
the consumer interest and business opportunity in generic drugs early on.
Now, with organic growth and the acquisition of branded generics such as
the German maker Hexal, Sandoz is the worlds second-largest purveyor of
generic drugs, after Teva. Eli Lilly is in talks to form a partnership with,
and potentially invest in, Turkish generic drug company Mustafa Nevzat Ilac
Sanayii AS.21
In the end, generics may not be a diversification strategy for the long
term. Some companies are moving into branded generics as a short-term
224
tactic to make up for revenue shortfalls and capture near-term growth in the
emerging market. As government health care programs and health insurers
in emerging markets develop further, consumers could be encouraged or
required to switch from mid-priced branded generics to low-cost no-name
generics. However, it would take at least a decade for that to happen.
To remain competitive, branded companies may have to sell wider product lines that include generic as well as break-through products. There will
be a very limited market for me-too type products because the only new
products allowed on a formulary will be those found to be cost- and comparatively effective versus their competitors. In response, some companies
are using high-tech recycling to repurpose their drugs. They are looking
at already approved drugs that may work against diseases they were not
originally designed to combat.27
The US pharmaceutical industry is in a quandary and is pursuing a variety
of different strategies involving vertical and horizontal consolidation. Many
large companies have hoards of cash, and will likely spend it on small to
mid-size deals/companies. The Sanofi-Aventis and Genzyme deals were the
largest in 2011. Potential takeover targets include smaller highly specialized
niche players, with good research pipelines, but also lack financial muscle or
production expertise. Specialized niche areas include such categories as vaccines (highly sought after in recent years), cancer, diabetes, gene therapy, or
rare/infectious diseases. For example, Pfizer now feels its future might be in
targeted therapies. They expect smaller generic manufacturers to be takeover
targets as larger companies try to diversify, seek downside protection from
expiring drug patents, and limit the negative financial impact of other larger
generic companies. Under the new model, the number of patients treated
using Pfizers cancer treatment drug Crizotinib is projected to be thousands
rather than millions, and the cost per month is 60 times what it is for Lipitor.
Pfizer estimates that worldwide sales will be $1 billion, not $10.7 billion as
it was for Lipitor.28
The pharmaceutical industry is an exciting and promising industry, in
spite of the criticisms and vulnerabilities discussed in this chapter. More
sophisticated pharmaceutical product screening is increasing the efficiency
of research and development. Additionally, discoveries in genomics will facilitate the identification of targets for pharmaceutical intervention. Stronger
patient advocacy will counter payer and employer resistance to payment.
Biotechnological intervention will equal or exceed traditional chemical pharmaceutical dominance in medication therapies.
A stronger partnership with health care providers and the pharmaceutical
manufacturing industry is evolving as diagnosis and treatment become more
tailored to individual patient needs and the government seeks to coordinate
health care treatment using accountable care organizations.29 More expensive medications, precise diagnosis, and cost-containment pressures bode
225
well for pharmacist intervention, ensuring the efficient and effective use
of more sophisticated treatments. Promotional efforts are shifting from the
physician to include the consumer, patient advocacy groups, and other health
providers, including pharmacists, nurse practitioners, and physicians. Pharmacy chains are gearing up to be players in the US governments accountable
care organization (ACO) initiative.
Finally, the US government committed $35 billion in the ACA to move
health care providers and hospitals into using electronic health records that
satisfy meaningfully useful standards established by the Office of the National Coordinator of Health Information Technology (ONCHIT). These
meaningfully useful systems will also be equipped with clinical decision
support systems that will assist health care practitioners in their diagnosis
and treatment regimens for patients. Physician and hospital electronic health
records (EHRs) will be analyzed to determine how well physicians and
hospitals are improving patient health outcomes. By 2015 there should be
significant increases in patient health outcomes and cost savings as physicians
and other health professionals use EHRs and comparative effective evaluations to help improve their patients health outcomes.
The demand for pharmaceuticals and biopharmaceuticals should accelerate as new technologies facilitate more discoveries. Additionally, the shifting
demographics of the world population from infrequent medication users to
frequent users of medications is significant reason to expect growth in the
pharmaceutical market in excess of growth in the general economy. Personal enhancement and cosmetic pharmaceuticals will continue to enhance
the demand outside the traditional price regulatory and cost containment
environment. Higher profitability in these areas will be associated with high
promotional efforts. The private payer and insured pharmaceutical markets
will be determined by the therapeutic class of pharmaceuticals such that individual consumers will be both insured consumers and private pay consumers
based on treatment. Today, consumers are insured or not insured based on
employment status or eligibility for government programs.
The future for the pharmaceutical manufacturing industry is promising,
and, because of its complexity, exciting. According to Mervyn Turner, a
former Merck strategist, new products will continue to be discovered and
developed as more companies begin to think of their role more broadly in
health care, not just pharmaceuticals. He predicts that future companies will
be more diversified and much more global.30

1. Daemmrich A. Where is the pharmacy to the world? International regulatory variation
and pharmaceutical industry location. Working Paper 09-118, Harvard Business School.
www.hbs.edu/research/pdf/09-118.pdf [accessed September 13, 2012].
2. The Fortune 500. Fortune, May 23, 2010:213, F-33.
226
3. Gottlieb S. Big pharmas new business model. Wall Street Journal, December 27,
2011:A13.
4. Rago J. The biomedical century. Wall Street Journal, November 19-20, 2011:A12.
5. Brown E. A biotech building boom. Wall Street Journal, November 23, 2011:C1.
6. Loftus P. Mercks marketing questioned. Wall Street Journal, August 9, 2011:7.
7. Whalen J. Novartis, J&J face EU antitrust investigation. Wall Street Journal, October 22,
2011.
8. Whalen J. Glaxo to pay US $3 billion to settle. Wall Street Journal, November 4, 2011:B3.
9. Department of Commerce. Controls in OECD countries: implications for US consumers,
pricing, research and Development, and innovation. Washington, DC: Department of
Commerce; 2004.
10. Singer N. Is sorry the hardest word in health care? New York Times, January 9, 2010.
11. PHRMA, PHRMA 2011 Profile Pharmaceutical Industry, Key Facts, Washington, D.C.,
2011.
12. Public Law No. 108-173, 21 U.S.C. 804.
13. Naik G. Mistakes in scientific studies surge. Wall Street Journal, August 10, 2011:, front
page:A1.
14. Naik G. Scientists elusive goal: reproducing study results. Wall Street Journal, December
2, 2011:A1.
15. Todd S. Drug trials the latest in virtual realities. Star-Ledger, Business Section.
16. Accenture. Shaping the future of pharmaceutical R&D: executing to a vision of high
performance. 2010.
17. Hunt V, Manson N, Morgan P. A wake up call for big pharma. McKinsey Quarterly,
December 2011.
18. Tisman A. IMS health the rising tide of OTC in Europe, 2010.
19. IMS, IMS National Prescription Audit, February 2011.
20. Singer N. Drug firms apply brand to generics. Wall Street Journal, February 15, 2010.
21. Cimilluca D. Eli Lilly explores partnership. Wall Street Journal, September 2, 2011.
22. Pfizer seeks new life for Lipitor. Wall Street Journal, September 2, 2011:B1.
23. Rockoff JD. Helping Lipitor live longer. Wall Street Journal, November 22, 2011:B1.
24. Eban K. The war over Lipitor. Fortune, May 23, 2011:205.
25. Drug makers ploy to delay generics; add a line to pill. Wall Street Journal, October 7,
2011.
26. Plumridge H. Pharmaceuticals bitter pricing pill. Wall Street Journal, May 17, 2011.
http://online.wsj.com/article/SB10001424052748703509104576327110442089104.
html [accessed September 13, 2012].
27. Dockser Marcus A. Researchers show gains in finding reusable drugs. Wall Street Journal,
August 18, 2011:A4.
28. Rockoff JD. Pfizers future: a niche blockbuster. Wall Street Journal, August 30, 2011:B1.
29. Beaulieu D. Lawmakers praise ACOs, promise to help overcome obstacles. FierceHealthcare, May 24, 2010.
30. Todd S. Mercks top strategist looks back, and ahead. Star Ledger, July 31, 2011.
12
Drug distribution
Sheryl L. Szeinbach, PhD, MS, BSPharm and
Earlene Lipowski, PhD, BSPharm
The supply chain used to distribute pharmaceuticals in the United States
represents one of the most complex systems available for medication processing in the world. The success of the supply chain for pharmaceuticals
stems from a careful analysis of the distribution network, which includes
the market dynamics for pharmaceutical products, economics, technology
use, and the location of manufacturers, distributors, and warehouses.1 This
underlying support structure for health-related products is designed to ensure
the safe delivery of pharmaceutical products to patients and health professionals throughout the United States. Within this highly regulated and safe
environment,24 manufacturers acquire raw materials to develop and produce pharmaceutical products. Distributors ensure that medications, medical
devices, health and beauty aids, and other products reach pharmacies and
retailers in the pipeline. Retailers distribute these products to end users (e.g.,
customers and patients). Regardless of the channel used for product delivery,
products gain value as they proceed through the distribution network.
As described by Porter,5 the value chain depicted in Figure 12.1 represents
a collection of activities performed by manufacturers, distributors, and retailers to produce, market, deliver, and support its products. The total package
can be broken down into core services and programs, which consist primarily
of production, delivery, and monitoring tools, while facilitative or ancillary
services relate to product marketing and support functions that create value
by linking suppliers and customers at each point in the supply chain.6
Thus, the value chain not only reflects company strategy and its success in
maintaining a competitive advantage, it also reflects value-added services that
contribute to service quality as perceived by customers. This chapter presents
the multiple functions performed by various channel members regarding the
distribution of pharmaceutical products. Specific issues addressed include the
mechanisms used within the supply chain to achieve operational efficiency,
external forces affecting the distribution network, and future directions for
the industry.
228
Core
Programs
& Services
Product
Distribution
Product
Delivery
Value
Chain
Outputs
Figure 12.1
Healthcare &
Specialty
Distributors
Pharmaceutical
Manufacturers
End
Users
ValueAdded Services
Core services, product delivery, and value chain for pharmaceutical distribution.
Distribution and marketing strategy

The target of all marketing efforts is to enhance the value of products and
services provided throughout the supply chain. Companies maintain a competitive advantage through four strategic areas known as the marketing mix:7
the product, place, promotion, and price of a product. Product considerations include physical features, packaging, and service. Distribution, or place,
is concerned with all the intermediaries involved in directing the product to
the appropriate target market. Support services, value-added programs, and
attractive packaging features are added to the product as it travels through
established channels of distribution depicted in Figure 12.1. Promotional
efforts consist of advertising, publicizing, selling, and pricing strategies that
take into account allowances, discounts, and geographic influences. Pricing
strategies are influenced by a number of factors including competition, market size, and distributor resources. Extensions to the traditional marketing
mix include the people involved in providing the service, the process for
service delivery, and the physical evidence to ensure optimal service quality.7
Each player in the distribution channel determines which marketing mix
strategy is most likely to accomplish their organizational goals as well as
meet the needs of its customers.
Pharmaceutical trends
The US pharmaceutical industry leads the world in the discovery, development, production, and sale of drugs. In 2009, manufacturer drug sales
reached $300 billion, representing 40.0 percent of the global market in
sales.8 According to the Pharmaceutical Research and Manufacturers Association (PhRMA), it takes 10 to 15 years, and an average investment of
$1.3 billion, to discover and develop a new drug and $1.2 billion to develop
Drug distribution
229
a new biological agent.8 From 2001 through 2010 333 drugs and biologics
were approved.8 Between 1983 and 2007, the US Food and Drug Administration (FDA) listed 1793 orphan drug designations (i.e., drugs used to
target diseases affecting fewer than 200,000 people) and 322 approvals.9
Retail pharmacy sales were $262.6 billion in 2009.10 Of the approximately 4 billion prescriptions dispensed in the United States in 2009, sales
represented $201.6 billion for brand-name drugs, $35.4 billion for specialty
drugs, and $20.3 billion for generics. Remaining sales were attributed to
non-prescription drugs and health-related products. Approximately 88 percent of all sales occurred through distributors.
Pharmaceutical manufacturers
Core services for manufacturers evolve from the development of innovative
products produced as medications, diagnostics, or biologics, or produced
through genomics and proteomics. Support services include well-organized
procurement systems to obtain raw materials, tracking programs, marketing
campaigns, and educational programs.11 As major participants in the value
chain, manufacturers strive to meet customer expectations by producing
high-quality and innovative products, creating positive and beneficial customer relationships, and participating in the network to improve operational
efficiency through electronic support systems and electronic data exchange.
The health care system is also influenced by regulatory and policy changes
that have a direct influence on pharmaceutical manufacturers and their
ability to produce and supply new products.
One aspect of change in health care delivery stems from the interaction
of pharmacy benefit managers (PBMs) with pharmaceutical manufacturers.
The PBMs (e.g., Express Scripts, Inc., CVS Caremark, Inc, and Medco
Health) negotiate directly with manufactures. In exchange for manufacturer
negotiated rebates for certain brand-name drugs, PBMs will shift market
share for certain drug products through managed care formularies. Other
managed-care providers, including various types of health maintenance organizations (HMOs) and preferred provider organizations (PPOs) will also negotiate directly with manufacturers. In exchange for manufacturer discounts,
these providers, along with the PBMs, use formularies, tiered copayments,
generic substitution, cost-effectiveness studies, and drug utilization review
to control costs internally. Other distributors and large chain stores gain
discounts and rebates from manufacturers through volume purchasing and
prompt payment incentives. Group purchasing organizations use competitive
bidding to obtain price concessions. If large group purchasing organizations
and manufacturers negotiate lower prices for pharmaceuticals compared to
prices negotiated between wholesalers and manufacturers, the differences in
price will result in a chargeback to wholesalers.
230
Despite a changing health care market and increasing costs to develop

new drugs, companies belonging to PhRMA continue to bring innovative
pharmaceutical products to market. In fact, approximately 64 percent of the
research on new medicines approved in the last 10 years was performed in
the United States.12 The value of pharmaceutical products to a global society
is well documented. For example, without the use of antihypertensive agents,
blood pressure would be 10 percent to 13 percent higher in the United
States.13 In addition, longevity as well as quality of life has improved for
the elderly and individuals with chronic diseases such as asthma, cancer,
and cardiovascular disease.14 The industry provides other benefits to society
such as patient-assistance programs (e.g., www.rxassist.org/) that provide
prescription medications directly to more than 4.6 million uninsured patients
in the United States.
Health care distributors in the United States

The basic function of the drug distribution industry is to consolidate the drug
distribution process to ensure smooth, safe, and cost-efficient distribution of
health care products. Distributors select, purchase, and store manufacturers
goods in close proximity to community and hospital pharmacies, clinics,
and other providers of pharmaceutical products. As shown in Figure 12.2,
88 percent of manufactured pharmaceuticals go through a distributor or
wholesaler, and a further 8 percent are distributed to physician offices, clinics, and large mail-order operations. Only a small amount of pharmaceuticals
(1 percent) are distributed directly to pharmacy warehouses or specialty
pharmacies.15
Research
Organizations
Biotechnology
Contract R&D
Firms
Supply Chain
Manufacturers
8%
1%
Chain Drug
Warehouses
1%
Specialty
Pharmacies
88%
Distributors
Direct to
Hospitals / Clinics
Mail order
Figure 12.2 Distribution network used by manufacturers (rounding differences numbers do

not total 100%). Source: HDMA Factbook 20102011.
Drug distribution
231
The core service of wholesalers consists of sorting functions and concentrating functions whereby goods produced by the manufacturer are distributed in economic quantities to retailers who dispense or sell the goods
to the end-user (Figure 12.3). By performing this function, wholesalers are
able to (1) reduce the total number of transactions required to service the
pharmaceutical distribution system, (2) enhance efficiency of distribution,
(3) protect product integrity and security through proper storage, and (4) ensure product quality and protect consumers from counterfeit and adulterated
products. In Figure 12.4, the customer market that receives pharmaceuticals
from wholesalers is substantial and includes distribution to chain warehouses
Without Distributors
Manufacturer A
Manufacturer B
Manufacturer C
Pharmacy A
Pharmacy B
Pharmacy C
Manufacturer B
Manufacturer C
With Distributors
Manufacturer A
Distributors
Pharmacy A
Figure 12.3
Pharmacy B
Pharmacy C
Value of health care distributors in reducing the number of transactions.
Percent of Sales
1%
13%
Chain drug stores
17%
Mass merchandisers
8%
5%
Chain warehouse sales

Independent drug stores
Hospitals/HMOs
17%
Clinics, long-term care

24%
15%
Figure 12.4
Mail order
Other
Distributor customers by percent of sales. Source: HDMA Factbook 20102011.
232
(24 percent) chain drugstores (17 percent), hospitals and HMOs (17 percent),
independent drugstores (15 percent), mail-order pharmacies (13 percent),
clinics and long-term care (8 percent), mass merchandisers and food stores
(5 percent), with physicians offices and specialty pharmacies accounting for
the rest of distributor sales.15
Other general offerings associated with full-service distributors and
wholesalers include a wide range of services and programs, including storage,
transportation, accounting services, financing, and bearing risk for product
integrity against theft, damage, spoilage and expiration dating. Regional
and re-packaging distributors also provide services and programs to meet
customer needs, while specialty distributors work exclusively with a limited number of manufacturers to supply products or devices, which usually have unique acquisition requirements and purchasing arrangements,
that are generally not available through traditional wholesale or distribution
channels.
In the United States, the Healthcare Distribution Management Association (HDMA) represents the firms engaged in health care distribution.
Cardinal Health, Inc., McKesson Supply Solutions, and AmerisourceBergen
Drug Company, the largest distributors, handle more than 95 percent of the
total sales. However, according to HDMA reports, more than 36 HDMA
distributor members operate approximately 189 distribution centers that
cover virtually all distribution needs in the United States.15 In 20102011,
total aggregate sales of distributed pharmaceutical products through distributors increased by 0.75 percent, from $253.31 billion in 2008 to $262.56 in
2009.15 From 2008 to 2009, the gross profit margin rose from 3.14 percent
to 3.3 percent, while the ratio of net profit before tax to net sales grew from
1.61 percent to 1.83 percent.15 Distributors placed over 428 000 orders for
health care products in 2009 from an average of 1200 manufacturers.15 In
2009, the average size for a distributor warehouse was 153 351 square feet,
roughly the size of three football fields.15 Wholesalers maximize operating
efficiency through the use of highly automated distribution and information
technologybased systems to achieve the lowest cost per unit possible (i.e.,
economies of scale).
Contributions of the distributor industry

The changing demographics of the US population together with new technological advances suggest a continued and stable role for pharmaceutical
distributors. Advances in biological research and genomics provide additional opportunities for distributors, because these products require special
handling, tracking, and maintenance procedures. As government-licensed
operations, full-line distributors adhere to stringent storage and handling
procedures designed to ensure the integrity of the medications they distribute.
Drug distribution
233
Some of these functions include (1) record keeping, (2) security, (3) temperature and humidity requirements, (4) returned goods handling, and (5) emergency planning. Examples of such materials subject to strict handling requirements include controlled substances, temperature-sensitive medications,
biologics, hazardous materials, and precursor chemicals. Distributors also
foresee growth as suppliers to residential facilities, specialty clinics, long-term
care facilities, and alternative care programs grow and expand.
Distributors offer valuable management services to their customers, including inventory control systems, staff training, facility design services, and
cooperative advertising programs. Support programs of particular value to
pharmacy operations include inventory management, on-line product descriptions, stock-keeping unit information, on-time delivery, special delivery, and private label merchandise. Distributors provide point-of sale scanning equipment to retail customers and are responsible for maintaining
the database. Distributors also interact with third-party programs to reduce
errors, improve bidding practices, and provide processing capabilities. Distributors take advantage of the latest advances in automation and technology
to improve the operational efficiency of individual pharmacies.
Packaging
The major function of repackagers is to break down bulk products into
smaller, more manageable units for distribution. Repackagers distribute medications to pharmacies, hospitals, nursing homes, mail-order pharmacy sites,
and managed care organizations. Repackagers supply products to the market
under similar guidelines as used by distributors, with some distributors
performing a dual function as repackagers. Some of the most important
functions associated with repackaged products include maintaining medication stability, providing National Drug Code numbers, supplying bar codes,
providing special packaging and containers, and labeling products with expiration dates.
Although unit-of-use packaging is used in the United States primarily for
antibiotics, corticosteroids, and oral contraceptives, this type of packaging
is commonly used in most countries in Europe and South America, as well
as Australia, New Zealand, and Canada. Unit-of-use packaging refers to a
method of preparing a legend medication in an original container, sealed
and labeled, pre-labeled by the manufacturer, and containing a sufficient
amount of medication for one normal course of therapy. If unit-of-use is
not available, medications may be prepackaged using either manual labor or
automated dispensing systems to reduce larger quantities of existing inventories from a manufacturers original bulk container, or unit-dosed drugs may
be repackaged into quantities consistent with dosing regimens commonly
234
prescribed. Unit-of-use and prepackaging have the potential to save time and
possibly reduce error and rework in the dispensing process.
Results from unit-of-use packaging studies revealed that dispensing time
was reduced by 50 percent, an average time saving of more than 27 seconds
per prescription.16 Unit-of-use studies in the United States report that automated dispensing of medications in unit dose or single unit-of use packaging
appears to exhibit similar outcomes with respect to time and efficiency, while
meeting standards of the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO).17 Another study in Canada, however, found that
the conformity in unit dose packages in hospital pharmacy practice varied
between 19 percent and 50 percent, and that a large proportion of unit
dose packages did not conform to guidelines of the American Society of
Health-System Pharmacists and the Canadian Society of Hospital Pharmacists.18
In yet another study, individuals representing State Boards of Pharmacy
were contacted and asked to participate in a packaging survey covering
unit-of use, repackaging, and remote pharmacy dispensing. Surveys were
received from 17 of the 50 states (a 34 percent response rate). When asked
about state requirements for prepackaging medication, respondents from 12
of the states indicated that prepackaging was allowed only with existing store
inventory. Most of the respondents believe that unit-of-use packaging would
reduce errors in the dispensing process, improve patient compliance, improve
patient counseling, and provide pharmacists with an average gain in time of
25 percent.19
Unit-of-use dispensing and repackaging is not totally free from challenges.
Some of these challenges include insurance barriers, physician prescribing
habits, patient acceptance, accessibility, and staff training. In a recent study of
5175 individuals who submitted reports regarding the ease-of-use of opening
medication packages, more than one-half of the respondents reported difficulties in opening blister packages (46.2 percent), with another 33 percent of
the respondents reporting various problems with package size (13 percent),
printing of information on the package, and confusing information on the
primary package (5.7 percent).20 Additional research is needed to address
how packaging (e.g., changes in prescription bottle design, use of color
codes to distinguish products and individuals, and special instructions for
use) can improve patient compliance and how to achieve a balance to ensure
child safety yet allow access to medications by elderly patients, who may
not be able to open child-resistant packaging. Distributors and repackagers
are working with companies that specialize in package design to provide
products in packages that not only improve product handling and processing, but will also provide opportunities to evaluate patient compliance.
With the potential for wider acceptance of unit-of-use packaging, trends
would indicate a greater reliance on unit-dose blisters, unit-of use packaging,
Drug distribution
235
strip packaging, and packages with special closures designed to track medication use.
Distribution in large community pharmacies

Chain pharmacies (e.g., CVS, Walgreens, and Rite Aid), having four or
more stores under the same ownership, represent the largest component of
pharmacy practice. The pathway of distribution presented in Figure 12.5
accounts for 20 500 traditional chain outlets, with an additional 14 440
pharmacies located in supermarkets and mass merchant stores.21 Of the
56 000 pharmacies in the United States, chains operate 39 000. National
Association of Chain Drug Store (NACDS) members also include more than
900 companies that supply pharmacy, health, wellness, beauty, and other
products. NACDS members include the countrys largest pharmacy organizations, including traditional chain pharmacies, supermarket chains, and
mass merchants. Chains employ more than 2.7 million employees, including
118 000 full-time pharmacists. They fill about 72 percent of all prescriptions
dispensed in the United States annually.21
Mass merchandisers such as Wal-Mart, Target, and Kmart offer lower
prices to obtain faster turnover and greater sales volume. Although prescription medications are competitively priced, the channel of distribution
for these products is primarily through a wholesaler. Large company-owned
wholesale distribution centers are reserved mostly for merchandise other than
prescription medications. However, mass merchandisers and large chains
have the capability at their main sites to repackage and supply medications
to alternate channels, including mail pharmacy services, long-term care facilities, and clinics.
Manufacturer
Chain Stores
Distribution
Center / Drug
Warehouses
Mass Merchandisers
Distributor
Wholesaler
Distribution
Center
Rx Medications
Other Merchandise
Rx Medications
Other Merchandise
Chain/Store
Mass Merchandiser
Figure 12.5
Distribution in large community pharmacies.
236
Other distribution channels

As shown in Figure 12.6, alternative distribution channels exist for hospitals
and independent pharmacies. Formation of these distribution channels for
hospitals was spurred in part by the federal governments adoption of a
prospective payment system based on diagnosis-related groups (DRGs). Hospital pharmacies shifted from profit centers to cost centers with this change.
Group purchasing started in the early 1990s as hospital administrators actively searched for cost containment strategies. Hospitals turned to buying
groups and group purchasing alliances as a strategy to centralize purchasing
and reduce costs by shifting the inventory control and management functions
to drug distributors. Although distribution channels for hospitals, in general, are specific to a hospital cluster, group purchasing organizations (e.g.,
Novation, Premier Inc., MedAssets Supply Chain Systems, and Amerinet)
form strategic alliances with hospitals in the area to contain rising health
care costs through their ability to gain pooled purchasing leverage for large
contracts. The alliances also may benefit hospitals financially by reducing
transaction costs and by providing services such as brokering, negotiating,
and consolidating supply contracts.22
Hospitals use group purchasing to gain a competitive advantage and to
reduce costs in the health care market. For certain medications, surgical
items, or medical devices, the hospital may consider contracts through a sole
source, dual sources, or a multisource that involves several manufacturers and
suppliers. The more restricted the hospitals choice of vendor and the greater
the purchasing commitment the hospital makes to that vendor, the lower
the negotiated contract price is for that product.22 In pharmacy practice,
group purchasing organizations may work with large chain pharmacies and
Re-packager
Direct
Price
Contract
Price
Buying Group
Manufacturer
Distributor
Price
Distributor
Pharmacy/Hospital
Customer
Figure 12.6
Alternative distribution channels.
Contract
Price
Prime Vendor
Direct
Price
Drug distribution
237
independently owned pharmacies to contract for multisource and brandname pharmaceuticals, durable medical equipment, diagnostic kits, optics,
and home care products. Group purchasing in a managed care organization
is accomplished through competitive bidding for the pharmacies that provide
prescription services for plan enrollees. With third parties accounting for over
90 percent of pharmacy payments, contract negotiation typically is accomplished at the corporate level through various managed care organizations
and other providers (Figure 12.7). The top four PBMs manage the drug
benefits for over 200 million people and process about 60 percent of all
community retail prescriptions in the United StatesA.23
Internet pharmacies, also known as cyberpharmacies, online pharmacies,
e-pharmacies, and virtual pharmacies/drugstores, continue to increase in
number. Despite the advantages of 24-hour availability, anonymity, online
access to personalized medication records, delivery services, and direct price
comparisons, online pharmacies are not without several concerns including
information use, system security, medication quality and integrity, and the
inability to ascertain whether licensed practitioners are dispensing drugs or
providing consultations.24 Most important, however, is the notion that some
medications, including potentially dangerous substances and controlled medications, are readily available through some rogue sites. Without appropriate
regulations, Internet pharmacies may undermine the safe and appropriate use
of medicines because the organization and support functions usually considered necessary to prevent unsafe practices (e.g., counterfeiting, improper
Distributors
Manufacturers
Contract Bids
Managed Care
Organization
Rx Contracted Services
Pharmacies / Clinics
Figure 12.7
Distribution in a managed care organization.
238
handling, and misbranding) and to ensure quality care (e.g., patient history,
assessment, and consultation) appear to be largely absent.25 Another study
revealed that appearances of disreputable sites may be obfuscated by the
use of trust-enhancing phrases such as consumer reviews, easy access, professional consultations, convenient payment options, and alternative delivery
choices.26
The National Association of Boards of Pharmacy (NABP) recently issued
a public health alert to warn Americans about the serious dangers associated
with medicines purchased through fake online pharmacies. Findings from the
report revealed that 96 percent of 8000 rogue web sites analyzed continue to
operate without being in compliance with US pharmacy laws, fuel prescription drug abuse and misuse, and provide an outlet for counterfeit medicines
to enter the US drug supply.27 The NABP has developed a program to certify
the quality of online pharmaciesthe Verified Internet Pharmacy Practice
Site (VIPPS) program.28 To meet VIPPS certification standards, a pharmacy
must comply with the licensing regulations of the state in which it is located
as well as the states to which it dispenses medications.28 As of September
2011, only 29 pharmacies had the VIPPS seal of approval. Consumers are
advised to check for this rating before using online pharmacy services. As
these sites gain in popularity, a concerted effort is needed by national and international pharmacy leaders to address issues related to the quality, integrity,
and safety of medications dispensed from online pharmacy sites.
Availability and distribution of generic drugs

With the generic drug market growing about 7 percent every year, US generic
drugs now account for about 69 percent of the total $300 billion US drug
market, and 78 percent of prescriptions are filled with generic drug products.29 Generics are drug products that compare to the pioneer reference
drug product in dosage form, strength, route of administration, quality and
performance characteristics. Sales, estimated at approximately $63 billion in
2011, continue to grow as 120 widely prescribed, brand-name drugs with
approximately $73 million in sales are expected to lose patent protection
between now and 2021.30,31 It is estimated that generic medications have
saved the US health care system over $824 billion in the last decade, with
savings of $139.6 billion in 2009 alone.30,31 The average price of a generic
drug in 2008 was about $35.22, compared with just over $137.90 for a
brand-name product.
Distribution channels for generic drugs follow similar pathways; however,
the pathways may be more dynamic and complex. Manufacturers may distribute drug products containing their own designated label, a private label,
or a label supplied from another contracted manufacturer to a distributor
who handles generics or to a manufacturer with distribution capabilities. The
Drug distribution
239
major distribution centers that receive products include warehousing chains,

wholesalers and smaller distributors.
Other trends in distribution

Regardless of the channel of distribution, the US health care market relies
extensively on new and innovative technology to transform both the business
and home environments. Broadly defined, technology in the workplace is
how an organization transforms its inputs into outputs, thereby accomplishing its goals. Technology can be classified in two broad categories: that
which relates to the organizations operations, materials, and knowledge;
and that in the category called advanced information technologies. Operations technology includes robotics, automated dispensing systems, electronic
rail systems, and pneumatic tubes. For pharmacy, this process is producing
dramatic revolutions in the way medications are processed and distributed
from point A to point Z.
Advanced information technologies use devices that transmit, manipulate,
analyze, or exploit information; digital computers that process information
integral to the users communication task of decision making; and complex
computerized programs that have appeared on the market since 1970,32 all of
which have been studied to determine their impact on health outcomes such
as quality, efficiency, and satisfaction.33 In pharmacy practice, these information technologies include the use of computer software for automated medication delivery systems, reminder systems, record keeping, financial analysis,
inventory control, drug use control, and support of clinical services. Also
included are computer-assisted communication technologies that support the
growth of telemedicine and telepharmacy (e.g., electronic mail, electronic
prescribing, computerized prescriber order entry, expert systems, information
retrieval systems, computer conferencing, videoconferencing, and devices
used to transmit images) used to support global communication.
Achieving operational efficiency through automation

Efficient distribution increasingly relies on advances in automation, bar coding, computerized inventory systems, electronic data interchange and other
information technologies. These technologies are likely to be used by group
purchasing organizations and providers to manage the distribution process
and the cost of medical therapy. These organizations will opt for more
integrated operations with connections across many departments in a hospital or managed care setting. The major advantage of automated dispensing
and monitoring systems is that these systems can monitor patients medication use proactively through advanced notification systems and through
integrated networks rather than reactively waiting until the patient enters
240
the pharmacy. Automated dispensing technologies will improve operational

efficiency, reduce the likelihood of errors, and improve opportunities for
patient interaction.34,35
Professional organizations such as the American Society of Health-System
Pharmacists encourages hospitals and health-system pharmacies to incorporate bar code scanning into inventory management, dose preparation and
packaging, and dispensing of medications to ensure that drug products distributed, deployed to intermediate storage areas, or used in the preparation
of patient doses are the correct products, are in-date, and have not been
recalled.36 There is growing evidence that the use of bar coding can reduce
errors in hospitals and increase accuracy of filled orders. For example, the bar
coding technology used to verify medication administration in an electronic
medication administration record (eMAR) revealed an 11.5 percent error
rate for hospital units not using the bar code eMAR, compared to a 6.8 percent error rate for units that did use the bar code eMAR. The relative reduction in errors was 41.4 percent (P < .001). Several professional organizations,
such as the American National Standards Institute (ANSI), the National
Council for Prescription Drug Programs (NCPDP), and the American Society
for Automation in Pharmacy (ASAP) are involved in initiatives to standardize
and protect the process for exchanging product and health planrelated data.
The use of bar coding is also widespread among pharmaceutical distributors (Table 12.1). Besides the extensive use of bar codes, distributors use
electronic data interchange (EDI) to expedite transactions with group purchasing organizations, manufacturers, and customers. Common EDI transactions include invoicing, chargeback, purchasing, product transfer, functional acknowledgment, and payment. Electronic commerce (EC) improves
interconnectivity with suppliers regarding distributor service agreements,
advance ship notices, returned goods, chargeback, vendor programs, and
collaborative planning forecasting and replenishment. Extensible markup
language (XML) allows textual data to be encoded into a form that is machine readable, while serialization enables the conversion and transmission
of those data over the Internet. Thus, the contents of each package leaving the
supplier or distributor would carry a set of unique serial numbers, as well as
an electronic pedigree to allow the contents to be monitored, tracked, and
verified throughout the distribution network. The XML system is also used
for returning goods, removing recalled pharmaceuticals, and curtailing drug
diversion.
Specialty pharmaceuticals
As discussed earlier, specialty pharmaceuticals are channeled through restricted drug distribution systems. Restricted drug distribution systems
may be established by the manufacturer, specialty pharmacies, wholesalers,
Drug distribution
241
Table 12.1 Distributor purposes for data capture through bar coding, 2009
Purposes for capturing data through bar codes
Average (%)
Order checking
100
Returned goods processing
100
Stock put-away
100
Verifying shipment
100
Stock movement (secondary to primary locations)
100
Verifying product receipt
83
Picking
67
Cycle counting
33
Product pedigree (history/tracking)
33
Complying with customer demand
33
Recalls
33
Complying with proposed FDA regulations
17
Establishing package quantity
17
Generating advanced shipment notices (ASN)
17
Checking expiration dates
Checking lot numbers
Other
17
(Data from Center for Healthcare Supply Chain Research.)
distributors, and other specialty suppliers seeking to provide services related

to the distribution and administration of drugs that require risk evaluation
and mitigation strategies (REMS) from manufacturers to ensure product
safety before they are available for distribution.37 Product characteristics of
specialty pharmaceuticals include treatment of rare diseases (e.g., Gaucher
disease), costs exceeding $5000, administration by a route other than oral,
home delivery requiring special handling, and management beyond the traditional outpatient prescription benefits for complex care, patient education,
and continuous monitoring.38 Currently, more than 600 specialty products
are under development in a market that is projected to exceed $150 billion by
2013.39 The unique aspects of the manufacturing process and supply chain
needed to produce and distribute specialty pharmaceuticals, including radiopharmaceuticals, has also led to drug shortages. Part of the problem stems
from global trade issues concerning raw materials, uncertainty about the
quality and stability of the supply of raw materials, as well as consolidation
in the pharmaceutical market. As a result of consolidation, some manufacturers have stopped making certain drugs, limited their production capacity,
242
and shifted resources to other areas.40 Although ensuing discussions among

manufacturers and distributors have been successful and should mitigate the
problem, additional research is needed to address this issue.
Another opportunity to dispense specialty products is the long-term care
market, where the demand for drug distribution to residents in a home
environment is expected to increase. These changes will create additional
challenges and opportunities for distributors as they find ways to ensure that
products reach the home in time to be administered to the patient. Future
studies are needed to assess the performance of these delivery channels for
product handling during emergencies, outside regular hours of operation, or
during system downtime.
Conclusion
In summary, drug distribution in the United States occurs through multiple
channels. Although not discussed in this chapter, drug regulations play a
major role in maintaining system integrity and ensuring that pharmaceuticals
are safe. To manage the distribution of pharmaceuticals, a highly integrated
distribution system is needed, as well as ongoing programs to evaluate
post-marketed drugs. Thus, automated dispensing systems, bar coding, and
electronic data interchange will continue to add efficiency to the distribution
system. With the emergence of more complex pharmaceuticals developed
from biologics, proteomics, and genomics, the use of radiofrequency identification systems will increase so that distributors can monitor the transportation of increasingly expensive drug products.

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13
The consumers of health care
Somnath Pal, BS(Pharm), MS, MBA, PhD,
Damary Castanheira Torres, BS, PharmD, BCOP and
Maria Marzella Mantione, BS, PharmD, CGP
The transition from medical care to health care during the 1990s led Americans to view a medically oriented, physician-dominated health care system
as antiquated. An imperfect relationship exists between the need and the
demand for health care services. Many consumers who need health care
services do not consume them, whereas others with little real need consume a
large amount. Another factor that confounds our understanding of the health
care consumer relates to the existence of third-party entities that serve as
intermediaries between the health care consumer and the point of service.
To a great extent, the decision to purchase is made not by the consumer
but by a third party. Historically, this gatekeeper has been the physician
who officially declared the individual to be sick, ordered the tests, ordered
hospitalization, prescribed drugs, and scheduled follow-up visits. In a system
that has been physician-dominated, this is an important consideration. Convention held that the consumer was to trust the doctor with his or her life,
and this meant turning over most consumption decisions to this gatekeeper.
Recently, the physician has been joined by other decision makers, namely
the third-party payers. Third-party payers, such as insurance companies,
managed care programs, government health care financing agencies (e.g.,
Medicare and Medicaid), and employers have begun taking a more active
role in decision making when it comes to health care consumption. Like the
physician, these decision-makers take the process out of the hands of the end
user.
In the 21st century, health is defined as overall well-being, including
physical, mental, and social elements, rather than simply freedom from
illness. Health care is no longer viewed as an exclusive territory reserved
for physicians but is viewed as an effort in which patients and their families
continue to be involved. As a result of this broadening notion of health care,
components that formerly were of secondary importance, such as prevention,
health education, and rehabilitation, continue to gain recognition. Through
246
the decade of the 1980s, health care providers played key roles in the
transition from product-centered care to patient-centered care. Health care
providers started designing products with a specific market sector in mind,
based on the needs and wants of consumers, rather than making it one size
fits all.
The definition of the health care consumer

Since the 1970s, this country has undergone a consumer health movement.
Many factors play into this movement, and the result has been patients who
take a greater role in their care. This can translate into changing relationships
between the providers of health care (e.g., physicians, nurses, pharmacists)
and the consumers, or patients. The relationship is essentially between someone in need of a service that involves skill and sensitivity and someone who
is capable of fulfilling that need. The way in which the person in need is
labeled automatically implies how he or she is viewed by the caregiver. Do
we define these individuals as customers, patrons, clients, or patients? A
customer or patron is described as a person who purchases a product or
nonprofessional service such as groceries or a new suit. These two terms
are used interchangeably and carry a sort of nonprofessional connotation.
A client is described as a customer of professional services. Lawyers and accountants have clients, essentially customers who desire their professional
services. Patients are served by health care providers and are defined as
individuals awaiting or under medical care or treatment. The patient and the
consumer are essentially one and the same when one discusses the health
care system. As health care professionals, we have a responsibility to meet
the needs of the patient (i.e., always having the patients best interests in
mind and making decisions clinically and ethically beneficial to the patient).
However, in todays health care marketplace, one also has to keep in mind
the role of patients as consumers or customers, meaning that the services they
need can be enhanced and marketed with services they want. The health care
marketplace is growing, and more and more competition exists. In addition,
the health care marketplace has changed in that there are fewer independent
providers. Institutions are merging into health care conglomerates, physicians
are working for these conglomerates, and managed care often dictates what
services patients are eligible for and where they can go to receive them.
Because of new health care discoveries and the focus on chronic illnesses,
health care is experiencing a shift toward wellness. This trend provides health
care professionals not just with sick patients but also with consumers
seeking products and services to maintain health and prevent disease complications. The availability of products and services for disease screening
and prevention offers new options for providers and consumers. Much of
the decision-making process now depends on the consumer because of the
247
focus on prevention. Decisions about what to eat, whether to exercise, how

to exercise, whether to supplement the diet with vitamins or minerals, and
alternative medicine all come from the person seeking to maintain health, not
necessarily from the health care professional treating him or her. This shift
affects how health care professionals offer services and what services they
provide. Pharmacists are focusing their services on management of medication therapy and health, because that is what consumers are looking for. Even
consumers are realizing that the more information is available, the more they
need someone to help them sort through it. Pharmacists are attempting to fill
that void. Other services pharmacists are offering to meet the changing role
of the consumer are the sale of health foods and a focus on supplements,
as well as capitalizing on the holistic approach to healthselling candles
and aromatherapy; referring patients to services such as hypnosis, physical
therapy, and massage; and others. Pharmacies also are providing services in
the areas of health screenings and immunizations.
One of the most significant changes has been the shift from in-patient to
outpatient care, expanding the role of the patient in decision making. There
are a lot more choices for outpatient services than for in-patient services and
fewer restrictions placed by third-party payers. Doctors are likely to choose
their patients hospital, but the patients themselves choose the doctors, the
fitness programs they join, the diet programs they use, weight-reduction
programs, counseling, lifestyle management, stress management, birthing
classes, and a variety of other health services that do not necessarily involve
hospitals and physicians.
Why the shift toward consumerism?

Historically, patients followed doctors orders, but the consciousness of the
right to know all about ones body has created consumers who seek information as well as care.1 The information available to the consumer is
unending, with magazines, television, books, and the Internet bursting with
health-based information.
Every medical specialty has undergone phenomenal change over the past
two decades, leading to the evolution of the integrated health care delivery
systems, in which the hospitals have become more or less secondary in
comparison with other sectors of the health care economy.2 Opportunities
for innovation and entrepreneurship in health care during the 21st century
will exceed anything we have seen in the past. Most of the innovations so far
have been among the huge number of product- and service-oriented health
care companies.3 The Internet, telehealth, and new clinical information technology will begin to drive strategy and market structure. The Internet has
already changed health care practice and has begun to sway pharmaceutical
consumers and providers. Sophisticated database capabilities have helped
248
match market segments to the service mix. A possible negative side effect
of this process is that health care providers will be able to carefully target the
audiences they want while avoiding the ones they do not want. This could
mean that a larger number of patients will be left without easily accessible
care. For the hospitals, medical groups, physician networks, pharmacies, and
health plans to prosper, they must adopt a new character of novelty in their
service components.4
Advanced medical technology and health care consumers

Genetic research, new drugs, and medical technology will cause acceleration
in both innovation and costs. Largely because of genetic research, the number
of new drugs will grow rapidly; they will be effective, highly sought after by
consumers, and expensive. Evidences of the impact of new technology can
be seen in such inventions as laparoscopic surgery and laser eye surgery, and
dozens of other technological advances are in the pipeline. Consumers will
become better informed and more demanding.
The shift toward consumerism is accompanied by demands for higher
quality care, better access, and substantial improvements in service. More
and more, consumers will do their homework (via the Internet, through
review of direct-marketing materials, or through consumer buying groups)
before they see their health care providers. The innovative health care system
of the future will come not from a single source (such as, in the past, the
introduction of diagnosis-related groups) but from multiple sources, including growing input from consumers and technology. From the entrepreneurs
perspective, things could not be betterthe greater the number and extent
of changes, the more attractive the opportunities. Consumers, for their
part, will be pleased with the results. If technology dominates and consumers take charge, many health care leaders and their organizations will
be compelledif they are to survive and prosperto make quick changes
to keep pace with the dynamic, ever-changing health care marketplace of
the future. All these factors suggest that change is taking shape, driven by
the increasing power of consumers.5 Cost-containment pressures will coexist
with growth pressures.
Changes in consumers perception of health care

Americans have been reevaluating many standards that relate to health care.
The increasing involvement of consumers in the health care they and their
families receive is due in part to a change in their perception. Studies have revealed that Americans dislike managed care but are pleased with the services
of their health care providers, especially the physicians and the pharmacists.6
The role of health care consumer implies greater asymmetry and power differential in the relationship with a health professional. The role of health care
249
provider implies certain obligations and privileges based on the requirements

of becoming a member of a health profession. Because of the extensive
education and training period necessary to gain the specialized knowledge
required to practice a profession, society grants a great deal of autonomy
and self-regulation to the professions. Health care consumers, in turn, expect
the professional practitioner to act ethically.7 Specifically, the professional
must act in a manner that places the patients welfare above any self-interest
or benefit, that will do no harm to the patient (non-malfeasance), and that
will help the patient meet his or her needs (beneficence). The professional
is also expected to treat patients in a fair and equitable manner (justice),
be truthful with patients in providing information about their health status
and treatment (veracity), and respect the confidentiality of each patient. In
exchange for meeting these obligations of practice, the professional is granted
the authority (cultural and social) necessary to care for patients.
Americans do not hesitate to express their discontent at the spiraling costs
of health care. They have come to consider health care a right but at the same
time have become more realistic about their ability to pay for it. These health
care consumers realize that no matter what, they have to pay more, and so
in return look forward to having control over the choice of their own health
plans, physicians, hospitals, and pharmacists.8 Many have become somewhat
disenchanted with technology and, in terms of health care, are looking for
a little less high tech and a little more high touch. This goes to show that
health care consumers are progressively demanding greater freedom of choice
primarily due to the changes in their perceptions of health care.9
Consumers perception leading to incongruities

Incongruity was created when consumers were not willing to pay for health
care services for which the provider incurred cost. In response, some entrepreneurs acted aggressively to fill the void between reality and the perception of consumers by venturing into the creation of health maintenance organizations (HMOs). On the one hand, health care consumers resist HMOs
for restricting their freedom of choice; on the other hand, however, when
the plans give them an option to go outside the network for differential
copay, an overwhelming number of consumers do not exercise that option.
Health care administrators and employers (who are paying the premiums for
health care coverage for their employees) are attempting to contain costs by
monitoring drug and service utilization. Without relying on giving incentives
to the providers, some elements of motivation need to be incorporated into
the health plans so that the consumers will demonstrate more cost-effective
behavior.
Another incongruity is that, even as employers try to reduce the costs of
health care coverage for employees and their families, many consumers are
250
willing to pay significantly more for what they regard as better coverage and
more user-friendly care. Thus, the next wave of health care change may well
include premium-priced packagesofferings of very comprehensive coverage (after high deductibles) matched with accessible and attentive customer
service and high-quality providers.
Where do consumers most often get their health

information?
Direct-to-consumer advertising
Since the US Food and Drug Administration published guidelines for
direct-to-consumer (DTC) broadcast advertising in 1997, consumers have
been exposed to advertisements for prescription medications in newspapers,
magazines, billboards, and television. Spending on DTC advertising rose
from $11.4 billion in 1996 to $29.9 billion in 2005, an increase of over
10 percent per year.10 However, the consumer cannot purchase prescription
medications without authorization of a prescriber. So, in addition to detailing
physicians on the benefits of their products, manufacturers hope that by
informing the general public about the products available they will prompt
sales. Money is spent to advertise a product and create demand so that people
will have to convince a physician or other health care provider to prescribe
for them, or so that people will become convinced they are suffering from a
condition they have never been diagnosed with and require treatment with
the advertised product. This can cause deterioration in the patientprovider
relationship, as clinicians become annoyed with answering questions from
patients derived from DTC advertising.11
DTC ads also are used to dispel myths about a condition and minimize
the embarrassment associated with certain conditions through information
sharing and destigmatization. This can benefit patients who might otherwise
be too intimidated to share embarrassing symptoms with their health care
provider.
Overall, DTC has changed the way patients feel about health care. It has
created a more informed consumer, empowering patients to play more of a
role in the choice of medications they use.12
Use of the Internet by health care consumers

The Internet is a major means of patient/consumer empowerment. It provides
a wealth of information to consumers in an easily accessible format. It
increases the consumers ability to self-treat conditions, by offering information on symptoms and illness, and the ability to purchase products online.
The down side to this plethora of readily available information is the high
probability that the information is incorrect, misleading, biased, medically
251
unproven, or even dangerous. It has been reported that websites failed to

mention major safety warnings regarding medications listed on their sites in
more than 30 percent of cases.13 As health care providers, pharmacists need
to be aware of reputable medical websites so they can guide their patients
toward them when they are seeking information. The most widely trusted
sites are those that are published by the government, national organizations,
or medical universities.14
To accurately assess how the Internet affects consumerism in health care,
we need to understand who is using the Internet for health care information
and what type of information they are searching for. It has been shown that
over 60 percent of people have used the Internet to find health-related information.15 Results from the National Health Interview Survey indicate that
the people most likely to use the Internet for health-related information are
non-Hispanic white women aged 18 to 64. Use of the Internet is also higher
in those with higher incomes and those with health insurance coverage.16
The Internet also serves as a tremendous resource for providers, enabling
information sharing from all over the world, allowing remote access to
references and databases, and providing the opportunity for telemedicine
and telepharmacy. Telemedicine has been defined as the use of electronic
information and communications technologies to provide and support health
care when distance separates the participants.17 Technically, pharmacists
have been providing telemedicine services for years, by answering questions
and communicating with physicians via telephone and fax. With the Internet,
pharmacists are able to receive prescriptions electronically, to communicate with patients in a more efficient manner, and to access to up-to-date
information on a mobile device. This all serves to streamline the process
of delivering patient care, something that is highly necessary in this era of
increasing prescription volume. A limitation of using the Internet to provide
telemedicine is that patients may be reluctant to share information due to
questionable security and confidentiality practices.18
In conclusion, the Internet has empowered consumers to learn more about
the illnesses they have, the treatments that are available, and the providers
from which they can choose. We have only begun to appreciate how large an
impact the Internet will have on our practice as pharmacists, with more and
more innovations reaching us daily.
Changing demographics of health care consumers

The demographic change confronting the American health care system has
been the noteworthy increase in health care expenditures among those over
65 years of age.19,20 The aging of the population is greatly affecting home
health care, hospitals, and long-term care organizations (including assisted
living facilities and nursing homes). In turn, this provides an opportunity
252
for health care providers to be innovative in repackaging their products

and/or services to meet the specific needs and expectations of the specific
subgroups.20
Impact of aging
Human development is a continuous transition from one state to the next.
Age is a key variable in categorizing life stages when transition into a different stage occurs.21 To better comprehend the reasons why people behave
in a certain way when it comes to health care, we must understand the
theories of aging. These theories provide the background information for
observed patterns of perceptions and compliance behaviors. Since more than
one explanation is probable, more than one theory can be used to explain
age-related multifactorial health care behavior. Each person ages in a different way, so one persons behavior cannot be explained the same way as
another persons behavior just because both individuals are the same age,
have analogous experiences, or have the same disease. In order to study
health care behavior one must be familiar with individual differences in
aging: that is, chronological, psychological, and social.22
Chronological aging
Chronological aging refers to the changes in the ability to function due to
changes in cells and tissues. These changes cause wear and tear of the biological system and its subsystems and a propensity to increases in morbidity and
mortality. Thus, chronological aging can be attributed to natural changes
and/or outcome of a disease.23 Chronological aging also is likely to bring
changes to the health care needs of the individual. This, in turn, can impinge
on health care behavior, predominantly in later life.24,25 For example, with
increasing age, consumers may encounter difficulty reading the fine print on
drug labels or opening medication bottles.26
Health care providers must repackage or develop products or services to
compensate for the effects of chronological aging. For instance, medications
could be dispensed in non-child-resistant bottles, the patient could be encouraged to use a pill-box to serve as a reminder to take the medications, an
automated system for refill reminders may be set up, or the physical layout
of the pharmacy could be changed to make it easier for elderly persons to
identify and remove products from the shelves.27 Several other aspects of
health care consumption in later life can be examined from a biological or
geriatric point of view. For example, preferences for certain services and
health care products (e.g., disposable undergarments for those who suffer
from incontinence, dietary foods for those who suffer from diabetes) can be
predicted rather accurately from health statistics on the aged population.
253
Psychological aging
Psychological aging refers to constant changes in cognition (the ability to
think and reason, i.e., mental activities) and personality. Comprehending
changes in the cognitive abilities of the consumer can help the health care
provider better understand peoples capability to process information and
their responsiveness to persuasion.28 The processing-resource theorists have
concluded that our mental activities require varying amounts of cognitive
resources, which show a wide individual variation. Such resource variations
depend principally on the individuals stage of life.29 However, longitudinal
studies suggest that it is possible to continuously improve existing cognitive
skills and acquire compensatory and new cognitive skills throughout life.30,31
Such improvements may be obtained through higher education, increased
societal roles, or enhancement in the level of intellectual stimulation in ones
setting (e.g., learning to use a digital sphygmomanometer or home diagnostic
devices). Factors such as lifestyle and familiarity and interest in technological
products have been found to be good predictors of the older persons interest
in embracing of such innovations.32
The cognitive personality theory defines personality as the interaction
of the environment and the individuals perceptions of reality within social
constraints.33 Thus, it may be said that personality is the outcome of the
individuals coping strategies, the features of the environment, and social
competence or incompetence. Because the theory is concerned with the individuals way of perceiving reality and responding in a manner consistent with
his or her own perceptions, this theory comes closer to explaining behaviors
of health care consumers than other personality theories of aging.
For example, the push toward achieving consistency within ones overall conceptualization of self can be traced to publications on self-concept.
Rosenberg34 suggests that the persistence of the self-consistency motive is so
strong that it gets in the way of the change of self-views developed in early
life, even though such views are not considered acceptable by others, such
as thinking young and not acting ones age. This self-consistency motive
explains the propensity to use products and services (such as anti-aging skin
creams, health spas, and cosmetic surgery) aimed at helping the aging person
maintain his or her youthful image. The self-consistency motive can also
be held responsible for the failure of products such as Affinity shampoo
(marketed in the early 1980s to deal with the problems of over-40 hair) and
Kelloggs age 40+ cereal. One example of implications of the self-consistency
motive cited by Dychtwald and Flower35 is the packaging of products or
services to direct them to segments defined by cognitive age rather than by
chronological age. Such packaging of health care products or services can be
developed without having to deal with consumers psychological acceptance
or rejection of their chronological age. Furthermore, consumer researchers
254
could identify health care products that are associated with older age as well
as products and brand names that are age-irrelevant and promote positive
self-image. Such research could help marketers better position their products
and services to appeal to the aging population.35 What if mental decline does
not have to be a natural consequence of aging? What if part of the secret
to staying sharp lies in the foods we eat? Emerging evidence suggests that
getting enough of certain nutrientsnamely iron, zinc, and B vitaminsmay
help stave off the cognitive decline seen with aging, possibly even Alzheimer
disease and dementia.
To predict health care consumer behavior, other doctrines of the cognitive
personality theory also could be used. For example, a perceived decline
in social competence due to physiological changes may create the need to
remain independent. The motive of remaining independent as well as other
psychological motives (e.g., security) could be used to explain health care
behavior. Schewe36 shows how such information could benefit marketers and
advertisers and gives several examples of product positioning and advertising
appeals that could be developed for the older health care consumer market.
Social aging
Social aging refers to (1) changes in social relationships that define social
status within a society (e.g., married versus single) and (2) the various roles
people are expected to play at various stages in life (e.g., children. couples,
parents, grandparents). Such changes are likely to affect a wide range of
health care consumers, including the role of purchaser in later life and
normative expectations (e.g., acceptance of senior discounts).
Interrelationships among the concepts of aging

The three concepts of aging (i.e., chronological, psychological, and social
aging) are independent of one another and therefore are useful not only in directly addressing various aspects of health care behavior in later life but also
in helping us understand the indirect impact of a given type of aging on health
care behavior via its effects on other forms of aging. Chronological aging can
affect both psychological and social aging. It may limit psychological growth
(although there is no evidence of universal age-related decline of cognition, or
disintegration of the emotional system or structure of personality) and could
cause early retirement and social withdrawal, contributing to the persons
social aging.30,3739
Psychological aging can affect both chronological and social aging; for
example, depression can lead to poor eating habits, which affect the persons biological system and its ability to fight disease.40 Depression can also
lead to withdrawal and social isolation, that is, social detachment. Finally,
255
social aging has implications for chronological and psychological aging. For
example, social isolation can alter food-consumption habits, directly affecting nutrition, which relates to disease, and indirectly affecting the persons
psychological state.24
In summary, the three aging processes are relevant to the study of health
care behavior because they produce certain changes that are either directly
related to health care behavior, such as ability to process information, or
relate to factors such as personality and self-concept, which influence consumer behavior. Thus, it can be concluded that a model of aging and health
care behavior should take into account not only the various perspectives on
aging but also how the various types of aging relate to health care behavior,
directly or indirectly.
Behavioral models in the patientpractitioner relationship

For many years sociologists, psychologists, and other social scientists have
been interested in the client or patientprofessional relationship, particularly the doctorpatient interaction.4146 Three basic, generic models of the
patientprovider relationship can be placed along a continuum of responsibility for health-related decisions (Figure 13.1).
In the oldest scenario, the paternalistic model, the health professional is
viewed as the expert in medical (and often times nonmedical and moral)
matters. The paternalistic health professional knows what is best for the
patient. This model assumes that the health care provider will make all major
decisions for the patient and the patient is expected to rely on the wisdom
and beneficence of the expert, much as a young child depends on his or her
parents. Proponents of this model can often be detected by such phrases as,
speaking as your pharmacist (nurse, physician), I believe you should . . .
The engineering model is located at the opposite end of the continuum
from the expert/paternalistic model. In this model the health professional
takes no responsibility for the final health-related decisions of his or her
patients.47 Francoeur notes that health providers provide patients with the
responsibility of dealing with their own illnesses. The providers thus sacrifice
personal responsibility in favor of providing patients with control over their
ultimate health decisions.48 This model has its roots in the image of the
Expert model
Practitioner makes
decisions
Social contract model

Mutual participation in decision
making
Engineering model
Patient makes informed
decisions
Figure 13.1 Continuum of decision-making responsibility in the patientpractitioner

relationship.
256
scientist (and physician) as an objective seeker of the truth. Health professionals who subscribe to this model view themselves primarily as scientists
applying the benefits of scientific research and truth and believe that they
must ignore all issues related to personal values and deal only with the facts.
Above all else, the provider must remain impartial and objective. The goal
is to present all the facts to the patients so that they can make their own
decisions about the best course of action to take. The health professional then
carries out the patients decision, whatever that may be (e.g., to have surgery,
to discontinue treatment. to select a less costly but less efficacious option, to
modify the drug regimen). In this model, the professionals personal values
do not enter into the delivery of health care, and the major responsibility of
the health care provider is to give the patient all the information necessary
for him or her to make an informed decision.
The social contract model lies midway between the two extremes of
the continuum and focuses on the need for genuine human interaction in
the patientpractitioner relationship. This model assumes that an implied
contract comes into existence when any person seeks the advice and help of
another person who acknowledges and accepts the appeal for help. Whether
the details of such a contract are verbalized or not, the help seeker and
the helper enter a contract with each other.48 Implicitly, they accept mutual
obligations and rights. This model recognizes that the relationship is a pure
person-to-person one between practitioner and patient. In many cases, the
relationship itself is therapeutic.
Early studies of the practitionerpatient interaction have focused primarily on its conceptualization as an asymmetrical relationship in which the
physician was completely dominant and the patient was expected to comply
with medical advice and treatment. Very few of the early studies looked at the
relationship of patients with other health care providers or the relationships
of health providers with one another. Only recently have researchers become
interested in assessing the effects of the increasing numbers of women health
professionals on the practitionerpatient relationship.49
Fiduciary relationship behavioral model

Two of the early pioneers in conceptualizing the doctorpatient relationship were Thomas Szasz and Mark Hollender.50 They presented a threefold
typology of the doctorpatient relationship based on the patients level of
functioning (Table 13.1).
These researchers suggested that each of the three basic models of the
doctorpatient relationship is appropriate and necessary under various conditions and circumstances related to patient competence and health status.
In the activitypassivity model, the social prototype is one of parent to
infant. The health professionals role is to take charge and make decisions
257
Table 13.1 Three basic models of the physicianpatient relationship

Model
Physicians
role
Patients
role
Clinical application
of model
Prototype of
model
Activitypassivity
Does
something to
the patient
Recipient
(unable to
respond)
Anesthesia, acute
trauma, coma,
delirium
Parentinfant
Guidancecooperation
Tells the patient

what to do
Cooperator
(obeys)
Acute infections,
other acute illnesses
Parentchild,
parentadolescent
Mutual participation
Helps the
patient help
him- or herself
(uses expert
help)
Participant in
partnership
Most chronic
illnesses,
psychotherapy
Adultadult
necessary for the optimal care of the patient. Treatment of the patient takes
place regardless of the patients contribution or wishes, and the patient is
expected to remain dependent and passive. Often the patient is not fully
aware of what is happening to him or her, and is unable to participate in the
decision-making process. Generally this model comes into play only when
the patient is incompetent to make his or her own decisions (e.g., patient
is under anesthesia, comatose, has acute life-threatening trauma or severe
bleeding, is in a diabetic coma, delirium, has had a stroke, or is in other
such states). This model corresponds to the expert/paternalistic end of the
decision-making continuum discussed previously.
The guidancecooperation model parallels the relationship of parent to
older child or adolescent. The professionals role is that of an expert telling
the patient what to do. The patient is expected to cooperate and comply
with the advice. The patient is aware of what is going on and is capable of
following directions and of exercising some judgment. The patient is expected
to assume that the physician knows what is best for me. The clinical
application of this model is most appropriate for patients with acute medical
problems, infections, broken bones, or other non-life-threatening trauma, as
well as during the postsurgical recovery period and early stages of diagnosis
of chronic diseases.
The third model, mutual participation, corresponds to the midpoint of
the decision-making responsibility continuum and is based on the social
contract model of adult-to-adult interaction. The practitioners role is to use
his or her expertise to help patients help themselves. The patients task is to
use the expert help offered and to fully participate in partnership with the
practitioner to resolve or minimize morbidity from health-related problems.
The day-to-day treatment of illness is carried out by the patient, with only
occasional consultation with the physician; the patient takes on much of
the responsibility for his or her own welfare. This model of the relationship
258
is most appropriate for the management of patients with chronic illnesses

(e.g., diabetes, arthritis, hypertension, heart disease), rehabilitation patients
(post-acute trauma or stroke), and patients with psychological problems who
are being treated by counseling.
Problems in the doctorpatient relationship may arise if both parties do
not hold the same ideas about that relationship or if circumstances change
such that a different model is more appropriate and one party or the other
resists making the change. Definitions of good and bad patients and
good and bad doctors (or pharmacists, nurses, counselors, dentists)
may reflect the mismatch in expectations concerning appropriate role-playing
behavior.
To illustrate this point, consider the patient who presents at an emergency
room with symptoms of an acute myocardial infarction. At that point, the
physician must rather quickly determine the patients status. Certainly the
activitypassivity model of interaction is appropriate. During the patients
recovery period in the hospital, a shift to a guidancecooperation pattern of
interaction would be expected. Patients who refuse to give up the passive
dependency state and want all decisions to be made for them will he encouraged or persuaded by the hospital staff to give up some of this dependency
and become more cooperative and take more responsibility for personal
care. However, if the physician continues to act in an authoritative manner
and insists on complete control with little or no input from the patient, the
patient may become dissatisfied and resistant in some way. After discharge
from the hospital, the patient is expected to become much more active
in decision-making concerning treatment, use of medications, and making
changes in lifestyle (e.g., diet, exercise, smoking cessation, stress reduction).
If either the patient or the physician resists moving to a mutual-participation
style of interaction, dissatisfaction is likely to ensue.
Sick role behavioral model

Talcott Parsons proposed a model of the sick role as a way to understand the
social and psychological dynamics of the patientphysician relationship.51
This model was based on the premise that illness is disruptive in a society.
He further suggested that a truly sick person should be temporarily relieved
from some of his or her obligations and responsibilities while recovering
from an illness. However, without some official labeling of who is sick and
who is well, any member of society could use illness as an excuse to avoid
work or other responsibilities. Therefore, society requires experts who can
decide who is sick and who is well. The health professions, in particular
medicine, have been given the authority to diagnose and treat individuals
who are physically or psychologically unable to perform their social roles.
When an individual has defined him- or herself as ill and initiates contact
259
with a health care provider, control of the interaction is immediately shifted

to the health care professional. The diagnosis serves to legitimize or validate
the illness perceived by the patient and to initiate adoption of the sick role.
The sick role, as proposed by Parsons, imposes on the patient two obligations and grants two privileges (Table 13.2).
First, the patient is expected to seek technically competent help to deal
with the illness. The patient is also expected to trust the health care provider
and accept the power differential resulting from the competence gap in the
relationship. Second, the patient is expected to do everything that is necessary
to get well. In return, the patient is exempt from being held responsible for
becoming ill and is temporarily exempt from performing some or all of his
or her normal social role responsibilities.
The model of the sick role is the most traditional one and closely parallels the activitypassivity and guidancecooperation models proposed by
Szasz and Hollender.50 Parsons model is applicable primarily for patients
with acute and short-term illnesses that are easily diagnosed and readily
treated. This model has been criticized because it is not really appropriate
for understanding the behavior of patients with chronic illnesses, permanent disabilities, psychiatric illness, or such condition as alcoholism and
drug abuse. It would not be functional for a society to grant long-term or
permanent exemption from social role obligations to its members suffering
from a chronic condition. In addition, there appears to be a major shift in
this country in attitudes toward individuals assuming more responsibility for
chronic illnesses and conditions that are related to lifestyle decisions.52,53
Table 13.2 Parsons model of the doctorpatient sick-role system

Patients status: sick role
Doctors status: professional role
Obligations
Responsibilities
To be motivated to get well

To seek technically competent help
To trust the physician and accept the asymmetry of
the relationship (the competence/knowledge gap)
Privileges
Exemption from performance of normal social role

obligations
Exemption from responsibility for ones own state of
illness
To act for the welfare of the patient (orientation

toward the collective versus self )
To be guided by the rules of professional
behavior (universalism versus particularism)
To apply a high degree of achieved skill and
knowledge in solving problems of illness
To be objective and emotionally detached
(affective neutrality)
Professional self-regulation (to monitor
competence and ethical behavior)
Rights
Access to physical and personal intimacy

necessary for diagnosis and treatment
Professional autonomy
Professional dominance
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Individual consumer behavior: a five-stage model

A five-stage model of the consumer decision-making process from a marketing perspective is presented by Kotler and Clarke (Figure 13.2).
This model can be used to increase our understanding of the process a
consumer uses in determining which health-related product or service he or
she wants to purchase to meet an identified need. This model may also be
used to increase our understanding of what type of pharmacy setting and
which pharmacy services consumers prefer. The five steps of this model and
the questions to be addressed at each stage are as follows:
Need arousal: What needs or wants are identified by the individual that
may give rise to interest in searching for a product or service?
Information gathering: How does the individual gather information relevant to determining what product or service to select?
Decision evaluation: How does the individual evaluate the alternative

under consideration?
Decision execution: What action does the individual take after the best
alternative is selected?
Post-decision assessment: How does the individuals post-purchase experience affect his or her subsequent attitude and behavior toward the
product or service provider?
Need arousal is concerned with the initial triggering factors or cues that
signal the arousal of a particular need or want that is not being adequately
met. The cue may be internal or external. An internal cue is related to
a change in feeling state, attitude, or physiological state; appearance of a
symptom; or other such stimulus that indicates a need to take action. An
external cue is a stimulus coming from another person or other sources of
information (e.g., a newspaper article, an advertisement, a special program
on television, a self-help medical book) that signals the need to take action.
The types of specific needs or wants that are identified as being unmet vary
from basic physiological needs related to maintenance of homeostasis of the
body, to psychological needs related to connection and support or to higher
level needs related to self-development and creative activity.54
Need arousal
Information gathering
Decision evaluation
Decision execution
Post-decision assessment
Figure 13.2 Five-stage model of the consumer buying process. (Data from Kotler P, Clarke RN.
Consumer analysis: marketing for health care organizations. Englewood Cliffs, NJ: Prentice-Hall;
1987:25688.)
261
Maslow conceptualized a five-level, hierarchical model of human needs,

which includes (from lowest to highest levels):
Level I: physiological needs (e.g., hunger, thirst, warmth);
Level II: safety needs (e.g., security, protection);
Level III: social needs (e.g., sense of belonging, being loved and cared for);
Level IV: esteem needs (e.g., self-esteem, recognition, status); and
Level V: self-actualization needs (e.g., self-development, creativity, realization of goals).
Maslow proposed that people work to satisfy the lower, basic-level needs
first before directing energy toward meeting higher-level needs. As each level
of needs is satisfied, it no longer serves as a motivator for action. Thus as a
hungry person is satiated, and if he or she senses no cues that safety needs are
unmet, then the social needs would become salient and motivate the person
to seek out interaction with others. Kotler and Clarke,55 in commenting on
the applicability of Maslows hierarchy of needs, suggested:
It is easy to see Maslows hierarchy of needs at work in the health
care field. The very poor, for example, will not undertake
self-actualizing health activities, like jogging or exercise, until their
basic needs for food and shelter are met. We see that certain health
care and social services cater to physiological needs, like the Meals
on Wheels programs for the elderly, while others, like sports
medicine clinics and psychological counseling, appeal to the higher
social, esteem, and self-actualization needs.
Needs are rather generalized conditions or states requiring relief or remedy. Wants, on the other hand, are rather specific objectives that may be
expected to meet identified needs. For example, when a person senses internal
cues that indicate hunger, the hunger can be remedied by the intake of
food. What food to consume to relieve this need is a matter of wantan
ice cream cone, a broiled steak, a carton of yogurt, or a bag of potato
chips will all relieve hunger. What product does a patient want to relieve
a headacheaspirin, acetaminophen, or ibuprofen? What type of pharmacy
services should be sought from a busy chain store located in a supermarket,
one located in a medical building, an apothecary shop, or the corner drugstore? Exposure to advertisements, consumer information, investigative news
reports on television, or advice from professional caregivers and members
of a persons social network all influence the selection of alternatives (i.e.,
creation of wants) to meet identified needs.
During the information-gathering stage, a person seeks information from
many sources to increase the number of options from which to choose.
The amount of information sought depends on several factors, including
the intensity of need, the amount of information generally available, the
262
complexity, or level of risk associated with the choices and individual variation in information neediness.
Ray has proposed three models of decision-making based on the need for
information and the amount of information perceived to be available.56 For
some decisions the choices are relatively clear and risk-free, and all the information necessary to make an informed decision is readily available. General
first aid and home remedy decisions for minor ailments would fall into the
category of low-involvement decision- making. For more serious or high-risk
decisions, generally a learning model of decision making is followed. The
person experiences a fairly high level of desire for information and perceives
that sufficient information is available to evaluate the choices. A patient
who is discussing with a pharmacist the side effects experienced with a
new medication may seek information on the seriousness and permanence
of the symptoms, whether or not the symptoms will go away with continued
consumption of the medication, what will happen if the dose is reduced or
the medication discontinued, and if there are other, similar medications that
could be prescribed that would not have the same side effects. Ultimately,
the patient must decide whether to talk to the pharmacist, to return to the
physician for modification of treatment regimen, to try to self-regulate the
medication to reduce the bothersome symptom(s), to just tolerate it, to stop
taking the drug, to find another doctor, or to seek out alternative therapy.
Without adequate, readily available information, the patient might not select
the best option and might jeopardize his or her health status.
What happens when the desire for information is great and the level of
information available is perceived to be low? A dissonanceattribution model
applies in this situation. Kotler and Clarke55 have discussed the dilemma
faced by a person who views a decision to be made as high-risk or important and, at the same time, does not perceive that adequate information is
available to distinguish among the alternatives. Thus, the persons resulting
behavior appears at times to be irrational or irresponsible. The patient, faced
with an important decision and no usable information on which to base that
decision, arbitrarily decides on a course of action. Selecting a pharmacist,
primary physician, or a specialist to care for you often is difficult. Kotler and
Clarke55 illustrated this process with an example:
Many people, for example, pick a primary care physician out of the
Yellow Pages. The Yellow Pages listing gives no information other
than the physicians specialty, address, and telephone number. Given
the importance of having a competent patientphysician relationship,
this decision process seems irrational. However, it is based on two
factors: (1) there is very little information available on physicians;
(2) the information that is available does not allow meaningful
distinctions between physicians . . . Some people try to gather
263
information that will distinguish among physicians by speaking to

friends and neighbors. Assuming these information sources are not
themselves medical professionals, they will be unable to judge the
medical competence of various physicians.56
Consider an older man newly diagnosed as having prostate cancer. His
physician recommends immediate surgery. What information does he want?
Where does he go to get this information? He may wonder: Is my doctors
diagnosis correct? Will surgery save my life? Is my doctor a good surgeon?
Are there other alternative treatments? What will happen if I do not have the
surgery? Should I get a second opinion? What will be my level of incapacity
after surgery? Depending on the patients age, socioeconomic status, education, cultural background, general level of health knowledge, and a host of
other factors, he may or may not ask questions of his physician. He may go to
the library and try to find information on prostate cancer; he may talk with
friends and family or seek out other men who have had similar surgery to
learn what to expect. He may not be able to find the information he seeks. His
physician may not recognize subtle cues that indicate he needs information
but is afraid to ask. The patient may feel helpless in seeking information and
simply trust his physicians judgment and go along with whatever he or she
recommends.
Once a person has developed a list of alternatives to choose from based on
the information gathered, the process of choice narrowing occurs (decision
evaluation stage). For example, consider the case of an elderly husband
who feels he can no longer properly take care of his wife, who has been
diagnosed as suffering from Alzheimer disease. Her behavior has become
more unpredictable, and her husband is concerned about keeping her safe;
he is also exhausted by caring for her, as well as from his own failing health.
In talking with his children, his wifes physician, his neighbors, and a home
care nurse, he perceives his options to be as follows:
1
2
3
4
5
6
Move his wife into a nursing home.

Move her into their daughters home.
Make alterations in the home environment to make it safer for her (e.g.,
remove the knobs from the stove; put a fence around the property with
a locked gate to keep her from wandering).
Arrange for respite care once a month so he can get a break from his
care-giving chores.
Ask the physician to order home health care services to assist him in the
personal care of his wife on a regular basis.
Arrange for a live-in helper.
There are probably other alternatives he did not think of in making this
list. How does he make a choice among the set of alternatives he has under
264
consideration? His original list of six options is fairly generic. Initially, he

may select several of these to narrow the choices. He may outright reject
choices 1 and 2, which involve moving his wife out of the home and having
someone else care for her; he believes he and his wife should stay together
as long as possible. That leaves him with four options. Depending on his
income, he may also have to reject option 6, hiring someone to help him.
At the decision execution stage, he decides to talk with his wifes physician
to see if he can get home care services for her, such as Meals on Wheels or
housekeeping help, since his health is poor as well Also, he asks his son-in-law
to help make the house safer and to install a fence around the perimeter of
the yard. His physician recommends that he try day care for his wife several
times a week to give him a chance to get out of the house, run errands,
or visit friends. These choices are all much more specific and are made
based on personal values, cues from others, knowledge about the specific
choice attributes, and perceptions concerning the utility of each alternative
in meeting the identified need.
Once some action has been taken, the person continues to evaluate his or
her circumstances to determine whether the option selected has adequately
addressed the original need (the post-decision assessment stage). If the persons expectations, in general, have been met, then he or she will be satisfied.
If dissatisfied with the decision made, the individual will then try to reduce
the dissatisfaction by changing the focus (look at the positives, ignore the
negatives) or reconsider some of the earlier alternatives previously rejected.
If the man in the previous example is not satisfied with the result of the
options selected or if he is unable to cope with his dissatisfaction, he may
reconsider options 1, 2, or 6, or continue to gather information to develop
other alternatives not previously considered.
Consumer behavior in health and sickness

Studies that have examined the health-related beliefs and behaviors of the
American public have revealed a high level of misinformation regarding the
value of taking extra vitamins, the necessity of having daily bowel movements, and the appropriateness of home remedies and of self-diagnosis and
self-care.57,58
Becker58 has noted that nearly 16 million Americans reported selfdiagnosis for arthritis, asthma, allergies, hemorrhoids, heart trouble, high
blood pressure, or diabetes. Investigators consistently reported relatively
poor public participation in health screenings, immunization clinics, and
other preventive health programs.
Compliance with medical advice and medication regimens is notoriously
poor. Mass health education programs that focus on cessation of smoking, prevention of sexually transmitted diseases, drug and alcohol abuse,
265
seat belt use, and childhood immunizations often have minimal impact on
altering behavior. As a result, legislation has been enacted to force public
health-related behavioral changes on the population (e.g., seat belt laws,
child-restraint laws, requirement of immunizations to begin school, warnings
on tobacco and alcohol products, and random drug testing in the workplace).
These findings reveal a rather discouraging range of diverse and complex
health-related attitudes and behaviors among the public that frequently appear to be irrational, erroneous, and relatively resistant to change.
The authors of the report believe that receiving adequate health information could increase the ability of individuals to make safe and effective
health-related choices in a changing and increasingly complex health care
environment,59 in addition to reducing the risk of injury and disease. When
a person decides to seek medical advice or careand some may delay doing
so for a variety of reasonshe or she brings to the encounter a variety of
expectations, some realistic and some irrational. In addition to the technical
expertise that a person seeks from the health care provider, sympathy, empathy, understanding, compassion, and consideration are expected as well.
For many patients, these latter needs are the most important, and satisfaction
with the interaction may hinge on having these needs addressed. The quality
of this interaction is reflected in the patients satisfaction with the encounter
and resolution of the problem. If the patient deems the practitioner-patient
relationship to be unsatisfactory, then it is likely that he or she will attempt to fulfill relationship needs elsewhere (e.g., find another physician or
pharmacist, experiment with alternative or nontraditional treatments and
practitioners, or fall prey to the sellers of useless or dangerous products).
It is crucial that health care providers recognize that these covert needs exist
and convey to their patients respect, concern, and caring.60,61
Health, illness, and sick-role behavior

Three categories of behavior are related to health care, including pharmaceutical care, which are important in understanding and motivating patient
interaction within the health care system. Health behavior is defined as
any activity undertaken by an individual who believes him- or herself to
be healthy, for the purpose of preventing illness or detecting disease in the
asymptomatic stage. This would include such activities as beginning an exercise program, weight reduction, stress reduction, regular self-examination
for breast or testicular cancer, following good dental hygiene practices, or
altering ones diet to decrease fat and cholesterol consumption.
Illness behavior is any activity undertaken by a person who believes he
or she may be ill for the purpose of defining his or her state of health and
discovering a suitable treatment or remedy for the problem. Discussing a
health problem with a family member, friend, or pharmacist; making an
266
appointment to see a physician or other health care provider; reading relevant

self-help medical books; self-testing to determine ones blood pressure, blood
sugar level, or if pregnant; or experimenting with over-the-counter (OTC) or
leftover prescription medications all are examples of illness behavior.
Sick-role behavior is defined as activity undertaken by individuals who
consider themselves to be ill, or who have been diagnosed by a health professional as being ill, for the purpose of getting well. Examples of this type of
activity include following medical advice, taking medications as prescribed,
selecting an appropriate OTC product, or staying home from work or school
to rest and recuperate.
Health behavior
Of all health-related behaviors, the most difficult to predict is that of healthy
individuals. Although the person has no clear-cut symptoms to prompt the
taking of preventive and protective action, the effort and money spent on
this type of activity are potentially the most beneficial, cost-effective, and
productive of those expended on other types of health care activity.62
The health belief model (HBM) was first proposed by Rosenstock and
later modified by Becker and others to explain individual health behavior
(Table 13.3).63,64 As indicated in the model, the authors have hypothesized
that people generally do not engage in preventive health care practices or
Table 13.3 The health belief model as a predictor of preventive health behavior
Individual perceptions
Modifying factors
Perceived susceptibility to a
disease
Perceived seriousness of a
disease (severity)
Demographic variables (e.g., age,

sex, race, ethnicity)
Sociopsychological variables
(e.g., personality, social class,
peer group pressure)
Structural variables (e.g.,
knowledge about the disease:
prior contact with disease)
Perceived threat of a disease
Cues to action
Mass media campaigns

Advice from others
Reminder postcard from
physician, pharmacist, dentist
Illness of family member
Newspaper article
TV program
Likelihood of action
Perceived benefits of
preventive action
MINUS
Perceived barriers to
preventive action
Likelihood of taking
recommended preventive
health action
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participate in health detection and screening programs unless they possess a

minimal level of relevant health motivation and knowledge, view themselves
as vulnerable and the condition as threatening, are convinced of the efficacy
of the intervention or activity under consideration, and perceive few difficulties or barriers to undertaking the appropriate action. Specifically, the HBM
includes the following elements:
the individuals readiness to take action as determined by both his and

her perceived likelihood of susceptibility to a particular illness and his or
her assessment of the probable severity of its consequences (physiological,
psychological, and economic);
the individuals evaluation of the benefits versus the costs associated with
taking the proposed action, that is, weighing of the feasibility and efficaciousness of the advocated health behavior against perceptions of the
physical, psychological, social, and financial costs or barriers involved in
taking the action; and
the presence of a cue to action that would trigger the person to engage
in the appropriate health behavior; this cue can be either internal (e.g.,
a symptom or change in feeling state) or external (e.g., interpersonal
interaction, mass media campaign, or professional advice).
Although it is assumed that a range of demographic, personality, cultural, social, and structural factors affect a persons health motivations and
perceptions, in this model these factors are not viewed as direct causes of
health action; rather, they are seen as influencing the belief dimensions of the
model, which in turn directly determine health behavior.
Illness and sick-role behavior

The HBM has been modified somewhat for use in predicting the likelihood of
a person engaging in illness behavior and in sick-role behavior (Figures 13.3
and 13.4). Understanding the behavior of people when they perceive themselves to be ill can be enhanced by viewing this behavior as a sickness
career. The sickness career begins with a state of wellness. Wellness means
different things to different people, but a variety of studies have shown that
the general criteria by which people define themselves as being well include
a feeling of well-being, the absence of symptoms, or the ability to perform
normal personal and work functions and activities. Most people, even those
who feel well, are able to identify the presence of some symptoms at any
time. Often these symptoms will be viewed as normal, minor inconveniences.
These symptoms may trigger a desire for further information, however, when
they persist or affect functioning.
Ultimately, a decision must be made about the meaning and significance
of symptoms that persist, change, or become bothersome to the person.
268
Symptoms
Modifying factors
Sociodemographic variables
Health motivation
Health knowledge
Behaviors
Perceived value of action to
be taken:
BENEFITS -- BARRIERS
Perceived threat of Disease "X"

Probability of occurrence
Negatively valued
outcomes
Likelihood of engaging in
illness behavior
Number
Site
Visibility
Level of distress and/or
disability (physical or
psychological)
How defined:
self
others
Persistence
Usual coping mechanisms

Lay referral systems
Social support pressure
Relevant prior experiences
Other cues to action
Figure 13.3 The health belief model modified to explain illness behavior. (From Becker MH.
Psychological aspects of health-related behavior. In: Freeman HE, Levine S, Reeder LG, editors.
Handbook of Medical Sociology, 3rd edition. Englewood Cliffs, NJ: Prentice-Hall; 1979:25374.)
Readiness to undertake
recommended sick-role
behavior
Motivations
Concern about healthmatters
Willingness to seek or accept
counseling
Positive health activities
Value of illness threat reduction
Subjective estimates of
susceptibility or
resusceptibility (including
belief in diagnosis)
Vulnerability to illness in
general
Extent of possible bodily
harm at motivating, but not
inhibiting levels
Extent of possible
interference with social roles
at motivating, but not
inhibiting, levels
Presence of (or past
experience with) symptoms
Probability that compliant
behavior will reduce the threat
Subjective estimate of:
the proposed regimen's
efficacy (including "faith in
doctors and medical cure"
and "chance of recovery")
Modifying and enabling

factors
Sick role behaviors
Demographic
Structural i.e., cost;
duration; safety; complexity;
side effects; accessibility of
regimen; need for new
patterns of behavior
Attitudes i.e., satisfaction
with visit, physician, other
staff, clinic procedures and
facilities
Interaction i.e., length,
depth, continuity, mutuality
of expectation, quality and
type of doctorpatient
relationship, physician
agreement with patient,
feedback to patient
Likelihood of
adherence to
prescribed regimen
(e.g., drugs, diets,
exercise, personal and
work habits, follow-up
tests, referrals and
appointments, entering
or continuing
a treatment program)
Enabling i.e., prior

experience with action,
illness or regimen; source of
advice and referral
Figure 13.4 The health belief model modified to explain sick-role behavior. (From Becker MH.
Psychological aspects of health-related behavior. In: Freeman HE, Levine S, Reeder LG, editors.
Handbook of Medical Sociology, 3rd edition. Englewood Cliffs, NJ: Prentice-Hall; 1979:25374.)
269
Twaddle and Hessler have discussed a variety of factors that go into determining whether a change in health status is significant.65 They reported that
people may define themselves as ill based on one or more of the following
criteria:
Interference with normal activities and functions: e.g., change in bowel
habits, loss of strength, reduced ability to work, or loss of enjoyment of

leisure activities;
Clarity of symptoms: e.g., sharp pain, unexplained bleeding, fever, productive cough, other symptoms that are visible to family and friends, or
symptoms the person considers to be serious;
Tolerance threshold exceeded: some people can tolerate more pain or
functional incapacity than others, either because of personal characteristics, cultural factors. or the nature of their work activities;
Familiarity with symptoms: common symptoms a person has experienced
previously and recovered from are likely to be viewed as less serious than
those with which a person has no previous experience or knows to be
serious;
Assumptions about the cause of symptoms: e.g., in the case of chest pain,
it may be viewed as indigestion, muscle strain, or a heart attack;
Assumptions about prognosis of the suspected disease state: if long-term
incapacity or possible death is associated with the cause of the symptoms,
they are likely to be viewed as serious. A headache assumed to be caused
by a brain tumor is viewed more seriously than a migraine or tension
headache.
Interpersonal influences: reference groups and lay-referral network;
Other concurrent life events and crises: in some cases. symptoms that
might be viewed as normal or only a nuisance can attain greater attention
and significance in the face of other problems in a persons life; a persons
coping ability may be compromised by too many demands at one time.
The process whereby a person evaluates the significance of changes in

health status is quite complex and involves several steps, including consultation with others (i.e., support network or lay-referral system). Once a set
of symptoms is defined by the person as being important and potentially
serious, a decision must be made as to the best course of action. Is medical
help needed, and if so, what kind of help? Self-treatment is often the first
method of treatment.
Lay-referral system
The vast majority of health care decisions made by individuals in response to
symptoms are made without contact with a health care professional. Most
people depend on advice from family and friends in deciding whether or
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not to seek professional help, and if so, what kind of professional to go to.
Freidson41 has defined this process, whereby a person concerned about the
meaning of a set of symptoms or other health problem consults with family
and friends, as a lay-referral network or system. According to Freidson,
using the lay-referral system involves a series of steps, each likely to include
diagnosis, prescription, and referral.
The lay-referral system has been found to be highly developed and a
significant pathway to the health care delivery system for lower socioeconomic groups, certain cultural groups, and the elderly. It is important not
to discount the influence of the lay-referral system in determining who will
seek health care, from whom (traditional or alternative providers), and how
treatment recommendations will be followed. It has been suggested, for
example, that elderly arthritis sufferers often decide on the amount of a
prescribed anti-inflammatory drug to take, the frequency with which to take
it, and the point at which to cease taking it by soliciting opinions from
fellow arthritis sufferers who have taken the same medication.66 In addition,
information often is shared about other drugs or treatments that may have
been effective, but which the persons doctor has not prescribed. Whether
the neighborhood pharmacist is part of the lay-referral system has yet to be
studied effectively. However, this certainly seems to be an appropriate role
responsibility for pharmacists to assume.
Self-diagnosis and treatment

Self-care has alwayssince the beginning of timebeen the predominant
way in which people have dealt with health problems.67 In The Hidden
Health Care System, Levin and Idler68 describe the essential components
of self-care activities and suggest that the amount of self-care practiced in
the United States far exceeds the care delivered by health care professionals.
Levin and Idler have noted:
Self-medication is certainly the most researched aspect of self-care
for minor illness and injury, but the wide range of other such
activities deserves mention and further study: first aid for minor
injuries, cuts, scrapes, bruises, and burns; vaporizers and bed rest for
colds and flu; ointments, compresses, and astringents for skin
problems; home surgery for blisters and splinters; kisses and
Band-Aids for imaginary boo-boos; massage and hot baths for
sore muscles; chicken noodle soup and a nice hot cup of tea for
anything; hot water bottles and heating pads for menstrual cramps;
ice packs for swellings: vinegar douches and yogurt for vaginal
infections; hydrogen peroxide for ear wax; salt water garglesthe list
could go on and on. In addition to these treatments, certain
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diagnostic and monitoring equipments are increasingly found in

home use, such as thermometers, sphygmomanometers (to measure
blood pressure), otoscopes, home throat culture and urine-testing
kits, and home pregnancy test.
What is perhaps most interesting about self-care is its sheer magnitude.
Roghmann and Haggerty69 reported that over 90 percent of health-related
actions taken by 500 families in one study were based on self-decisions.
Demers and his coworkers reported that only 10 percent to 20 percent of
the health problems identified by people received professional attention.70
Reissman71 has suggested that from 65 percent to 85 percent of medical
care is provided by nonprofessionals, and he concluded that the ratio of
non-professional to professional health care for all health problems is about
7:1. Self-care is prevalent in all cultures, and the rate of self-care does not
appear to vary significantly in countries with national health programs that
remove the economic barriers to seeking care.72
Schwartz and Biederman73 have suggested that self-care is likely to increase dramatically as the number of persons suffering from chronic illnesses
increases. With the rapid aging of the US population, more people will be
suffering from such diseases as diabetes, arthritis, heart disease, and cancer.
Care of the sick

A brief examination of the history of care of the sick reveals that treatment
of the sick person, both medical and social, has changed drastically with
the level of civilization and ascription of disease causation. So, too, have
the expectations for helpers and patients. At the most primitive level of
civilization, the sick were left to fend for themselves or to die, and there
was no obligation placed on family or social group members to help. As
civilization advanced, illness often was ascribed to evil spirits, and methods
of assistance were limited to incantations and sometimes magic potions to
drive away the disease-causing spirits. At the time the Old Testament was
being written, illness was placed in a religious context as punishment for
ones own or the familys sins and transgressions. The period of the New
Testament in Western civilization brought about a sharp change in attitudes,
even to the point of allocating grace to those who associated with or aided
the sick. By the 18th century, secular authority had gained influence in health
care and, as it became obvious that providing care to keep the population
healthy contributed to the common good, care of the sick became important.
New advances in understanding disease causation removed blame from the
individual for his or her plight.74
In spite of the progress we have made in understanding disease processes, vestiges of the old attitudes remain. Many people still have difficulty
272
adopting a sympathetic attitude toward individuals suffering from a psychiatric illness or those who are severely handicapped, for example, and
still others lean toward a punishment-for-transgressions attitude regarding
people with AIDS. Many of these outdated attitudes may be seen in other
cultures as well. Understanding the behavior patterns that a society expects
of those who have officially been sanctioned as sick is important for all
health professionals. This prescribed behavior varies by culture, of course,
and depends on the severity and type of disease state present.
Diversity in the US consumer

The landscape of the American consumer has undergone significant changes
in the past 30 years, and predictions are that these changes will continue.
The largest minority group in the United States is Latinos, at 16.3 percent
according to the 2010 US Census. Latinos outnumber blacks, who represent
12.6 percent of the US population. Asian-Americans also account for a
noticeable proportion of the population in the United States, at 4.8 percent of
the population. Pacific Islanders and Native Hawaiians represent the smallest
group, at 0.2 percent, with American Indian and Alaska Natives representing
0.9 percent of the US population. At the same time, other ethnic groups
have been immigrating to the United States, including Eastern Europeans
and people from Western Asia and the Caribbean. According to the 2010
Census, the net increase in the Latino US population from 2000 to 2009 was
over 13 million people, for a total of over 48 million Latinos in the United
States. In comparison, the US white, non-Hispanic population increased by
4 million, to 244 million; blacks increased by 3.9 million, to 39.6 million;
and Asians increased by 3.4 million, to 14 million. The Latino population
also tends to be younger, with a median age of 27, compared with 41 years
of age for the white US population. Currently 48 percent of all children
in the United States belong to racial and ethnic minorities. As these children reach adulthood, the face of the American consumer will become very
different, and the power of the minority consumer will be far greater than
it is now.75
The effect these new ethnic groups will have on the United States is still
to be determined, but they introduce new challenges for those who deal with
consumers. These challenges include language barriers, lack of formalized or
legal immigration status, and expectations of the health care system from
the patients own cultural background. Challenges to the consumer include
navigating the new and often poorly understood health care system in light
of these barriers.
Several explanatory models of disease causation exist among these minorities. Humoral medicine, which focuses on maintaining balance between
opposite forces, is the most common model. In the Latino culture, these
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forces are referred to as hot and cold; in Asian cultures, these forces are
referred to as yin and yang. Other cultures, including India, Northern
Africa, and Native America, also embrace this explanation for illness. Hot
and cold refer not to actual temperatures in the body but to abstract qualities of the body state, herbs, foods, and other treatments. The treatment prescribed is meant to bring the body back into balance, usually by treating the
hot diseases with cold treatments and vice versa. Hot diseases, such as fever,
infection, diarrhea, constipation, skin problems, sore throat, liver problems,
or kidney problems, are treated with cold remedies and foods, including
tropical fruits, fresh vegetables, dairy, chicken, fish, honey, raisins, sage, milk
of magnesia, and bicarbonate of soda. Cold diseases may include cancer,
pneumonia, malaria, menstrual difficulties, tooth pain, earache, rheumatism,
cold, tuberculosis, headache, and stomach cramps, and can be treated with
hot food and herbs such as temperate-zone fruits, chocolate, cheese, eggs,
hard liquor, oils, beef, lamb, cereal grains, chili peppers, penicillin, tobacco,
ginger, garlic, cinnamon, anise, vitamins, iron, cod liver oil, and castor oil.
Many of these treatments are often used alongside Western medicine to complement the physicians recommendation. Consumers may not be aware that
some of these combinations may have detrimental interactions. In addition,
when Western medicine practitioners try to force an explanation of signs and
symptoms onto a patient, trust and compliance may be compromised, and
therefore compliance with the prescribed regimen may be quite poor.7683
Appropriate medical roles and responsibilities vary from culture to culture. Many Eastern European immigrants are accustomed to an authoritarian
style, in which the physician directs medical care and asking questions
is considered disrespectful. Some Asian immigrants expect the health care
provider to assist in the cure, not take over. In some Asian cultures, eye
contact with an elder, or someone in that role, is not polite, so patients may
bow their heads in deference and nod in acceptance, which a Western health
care provider might assume to be understanding when in fact the patient
does not understand the directions at all. In the United States, independence
and the right to make independent decisions about medical care and other
aspects of life are highly valued. Complete disclosure of health information
is also valued in the US culture. This disclosure allows patients to make
informed decisions about their health. In Latino culture, the family unit is
often involved in decision making. Therefore, it is important for health care
providers not to exclude the family unit as this may alienate the patient and
possibly affect compliance. In many cultures around the world, including
Latino, Asian, Indian subcontinent, and some European cultures, informing
patients of fatal illnesses is not the norm. Sensitivity to this issue when dealing
with the family is also important.84,85
Race discordance between the health care provider and the patient contributes to the difficulties often encountered. There may be language barriers,
274
or patients may feel that white health care providers do not share their
perception of their symptoms and disease. Many health care providers may
be dismissive of holistic medicine used by their patients, thereby alienating
patients further. Many patients do not admit to their provider that they are
using some form of alternative medicine. Patients often turn to the traditional
cultural healer initially, or when they feel Western medicine is not working.
An encompassing approach that allows the patient to use the holistic healer
and Western medicine may be best. Gender discordance may also be important, particularly for cultures where modesty in women is highly valued,
including many Muslim cultures. Race discordance does not appear to be
improving for some ethnic groups. According to the American Association
of the Colleges of Pharmacy, only 14 percent of pharmacy graduates belong
to racial or ethnic minorities, in contrast with the 25 percent of the overall
population that falls into this group.86,87
Differences in response to drugs have been identified among patients with
different ethnic backgrounds and between men and women. Differences in
metabolism rates of several compounds have been identified. Many Asian
patients are slow acetylators; therefore, levels of drugs that require this
pathway for metabolism may be higher in Asian than in white patients,
leading to increased toxicity. Also, blacks generally have different clinical
response to some antihypertensive drugs as compared with white patients. As
the body of knowledge of pharmacogenomics grows and more information
becomes available about these genetic racial differences, therapeutic regimens
will become more individualized.88 Minority patients are markedly affected
by health care conditions as compared with white patients for many reasons.
Some of these include lower socioeconomic status, poor health behaviors,
lack of access to health care, poor living and/or working environment,
discrimination, lack of health insurance, overdependence on public health
facilities, residence in locations with few health care providers, insufficient
or cumbersome transportation, and cost.87
Indian subcontinent and Middle Eastern population

Emigration from Western Asia and the Middle East has increased. These
consumers may be escaping political turmoil or religious persecution, or
seeking opportunities in the United States. The family unit usually is very
strong, and cultural differences between this population and Americans can
be pronounced. In terms of health care beliefs, this population often has
religious explanations of disease. Many Indians believe in karma, an idea
that every action a person takes has consequences that depend on not only
the action but also the persons motivation. Thus, an Indian may perceive
his or her illness primarily as a result of past action. Susceptibility based on
gender is also a common belief. These populations utilize and rely on health
275
care providers and are accepting of suggestions for change to improve signs
and symptoms.89
Eastern European population

After the collapse of the USSR, regional conflicts that ensued led to a significant increase in the number of Eastern European and Russian immigrants
to the United States. Searight90 published a study of 12 interviews with
recent Bosnian immigrants. These consumers expressed dissatisfaction with
the US health care system for several reasons. These included confusion with
insurance coverage, lack of personalization of care and access to specialty
care, and a perception of the US health care system as bureaucratic.90 The US
health care system differs significantly from the socialized medicine most of
the consumers were used to in their countries of origin. The costs associated
with health care and the myriad types of insurance also are confusing,
particularly for patients who do not speak English. Many Eastern European
immigrants are well-educated, discerning health care consumers who were
fairly well off in their country of origin and may find themselves in a very
different socioeconomic class in the United States.
Latinos
Latinos make up the fastest-growing minority in the United States; however,
to group all Latinos together is to miss the many differences among members
of this group.75 Some Latinos, such as Cubans and Puerto Ricans, have been
in the United States for several generations and behave quite differently as
consumers than recent immigrants from other countries in Central and South
America. Cubans and Puerto Ricans behave more like white Americans,
with the possible exception of more recent immigrants from these countries.
However, recent immigrants from other Latin American countries have diverse consumer behavior which may be retained for several generations. It is
therefore necessary to look at the country of origin when determining likely
consumer behaviors.
Mexicans are one of the largest Latino groups in the United States, with
11,413,000 foreign-born Mexicans currently living in the United States.75
Many Mexicans are in this country illegally and often work in jobs where
health care benefits are not offered. They often are reluctant to use the
other federally sponsored options due to fear of detection. In addition, the
use of the curandero or healer is commonplace for them and other Latino
immigrants. The curandero is from the same country, shares the beliefs and
attitudes of the patient, and is interested in all aspects of the patients life.
Often these patients will turn to these folk healers initially and present to
the physician and pharmacist only with more advanced disease. Patients
often expect a rapid response with therapy, and if this response is not seen
276
they may end the relationship with the health care provider. These patients
may also feel that health care providers are cold and indifferent and do not
want to spend time diagnosing their problem and treating them properly as
compared to the curandero. Many feel that use of the curandero is acceptable
for minor complaints or to treat complaints that were unsatisfactorily treated
with modern medicine.75,91 South and Central Americans are one of the
fastest-growing immigrant groups within the Latino immigrant population.
They often have religious or indigenous worldviews, and these views may
extend to health. Ignoring these views and explanations may compromise
the trusting relationship needed to care for these patients.92
Health care beliefs can affect mortality. Scarini and colleagues surveyed
native and immigrant Latino women in a clinic regarding knowledge and use
of the Pap smear for cervical cancer screening, an intervention with evidence
supporting a decrease in mortality from cervical cancer. They found that
Latino immigrant women in comparison with native Latino women were
less likely to have a Pap smear and had less knowledge of cervical cancer.
Their cultural beliefs and disease explanations influenced their knowledge
and willingness to get Pap smears.93 Latino-Americans have higher incidence
and mortality rates from diabetes, obesity, and hypertension, and they are
less likely than white patients to receive some interventions, such as cardiac
bypass surgery.87 Taken together, these behaviors, beliefs, and risk factors can
contribute to health disparities between Latino and white patients.
Asians
Asians and Pacific Islanders also are immigrating to the United States in
record numbers.79 Although the overall numbers in this group remain small
in comparison to other minority groups, these immigrants will become a
driving force in the future if these immigration rates are sustained. These
patients come from China, the Philippines, Cambodia, Laos, Korea, Vietnam,
Japan, Taiwan, and Thailand, among others. There is significant diversity
among all these consumers in language, religion, worldview, background,
literacy, education, and rural versus urban origin.
Many Asian-Americans subscribe to the hotcold disease explanatory
model. They often expect a rapid response to therapy and may discontinue
medication if they do not achieve that response. Asians tend to have a healthier diet and are less likely to have heart disease, diabetes, and some cancers,
such as breast and prostate cancer. However, they are more likely to have
hepatitis, tuberculosis, cervical cancer, liver cancer, and stomach cancers.87
African-Americans and blacks

Blacks and African-Americans currently represent 12.6 percent of the US
population. They were the slowest-growing minority, with a growth rate of
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21 percent, and the mean age was younger than for other races.75 A telephone
survey of white and black non-Hispanic consumers showed that black respondents were less trustful of physicians and more concerned about privacy
and unsanctioned harmful experimentation than white respondents.94
Many African-Americans have been in the United States for generations
and do not face language barriers; however, they may still have problems
accessing and utilizing the US health care system. There are many health
disparities between African-American and white patients. African-Americans
have worse outcomes for many diseases, including breast, prostate, lung, and
colorectal cancers; heart disease; diabetes; and many others. These disparities
are only partly explained by late diagnosis. Further research into the cause
and resolution of this issue is warranted.87
There has been an increase in immigration to the United States from
Caribbean and African nations. This new immigrants are quite different as
consumers from the African-Americans who have been in the United States
for generations. Some may be escaping poverty or political turmoil in their
own countries, where the health care system was poorly coordinated and
difficult to access. Many have relied on traditional healers to help with
medical problems and may be distrustful of the regimented US health care
system. A study of South African blacks by Farrand95 found that most patients preferred a combination approach to medical needs that incorporated
traditional healers and Western medicine. In another study conducted in
South Africa, 70 percent of patients interviewed consulted traditional healers
first, even for potentially life-threatening conditions.96 Incorporation of an
understanding of traditional practices into Western medicine may increase
the willingness of these consumers to utilize Western medicine and thereby
improve their health.
The role of gender

Women are more frequent consumers of health care than men, and traditionally they are the primary health care providers and decision makers
for the family. They usually are the ones who schedule appointments, take
the children to the doctor, visit the pharmacy, and administer medications.
Women also use more health care resources, both during the childbearing
years and as elderly consumers, since women are more likely to outlive men
and so will live longer with chronic illnesses.97 Women use the Internet for
health care information more often than men. Many DTC advertisements are
directed at women.
The concept of womens health as a separate area was conceived in the
1980s, and this focus of medicine has expanded tremendously since that
time.98 OTC products and vitamins are often targeted to women, such as
One-A-Day Womens with extra iron, folate, and calcium. Women increasingly work outside of the home, and in the fall of 2003 women outnumbered
278
men in many college freshman classes countrywide. These political, social,

and financial advances have given women more and more power as consumers. Also, as the large baby boom population born in the 1940s and
1950s reaches 65 years of age, older women will wield more power than the
current older generation. The implications of these changes on consumerism
in the United States remain to be seen.
Conclusion
Many changes in consumers and providers of health care occurred in the 20th
century and continue in the 21st. The provision of health care has adapted to
changes in consumers expectations and demands and changes to consumers
themselves. The health care system and the providers must continue to adapt
to the needs and demands of the consumers while maintaining the integrity
of the care provided.

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14
The drug use process
Jack E. Fincham, PhD, RPh
This chapter provides information regarding the drug use process in the
United States as influenced by patient behaviors, patient compliance, and
other variables. Patient behavior related to taking medications is the key determinant for proper drug use, or, conversely, inappropriate use. Education,
interventions, and active assistance provided to patients can help immensely
in averting negative aspects of medication use and promoting proper and
enhanced drug use.
The use of medications in the health care system provides enormous help
to many; lives are saved or enhanced, and life spans are lengthened. Many
other uses of medications lead to significant side effects, worsening states
of health, and premature deaths. So, how can we separate these disparate
pictures of drug use outcomes? Within practices and within networks in
the health care workplace, pharmacists can help promote the positive and
diminish the negative.
The use of drugs in the United States is complex, and it can certainly
be confusing for patients. The use of drugs as a form of medical treatment
in the United States is an enormously complicated process. Individuals can
purchase medications through numerous outlets. Over-the-counter (OTC)
medications can be purchased from pharmacies, grocery and superstores,
convenience stores, Internet outlets, and other sources as well. Prescription
medications can be purchased through traditional channels (community
chain and independent pharmacies), from mail-service pharmacies, through
the Internet, from physicians, from health care institutions, and elsewhere.
The monitoring of the positive and negative outcomes of the use of these
drugs, both prescription and OTC, can be disjointed and incomplete even
with sophisticated electronic monitoring systems.
Although pharmacists are the gatekeepers for patients to obtain prescription medications, patients can obtain prescription medications from any
number of pharmacies or physicians (either samples or dispensed prescriptions). Patients also can obtain medications from friends, relatives, or even
casual acquaintances. Finally, patients can obtain OTC medications through
284
prescriptions written by physicians, on advice from pharmacists, through

self-selection, or through the recommendations of friends or acquaintances.
Through all of this, it must be recognized that there is a formal (structural)
and informal (word of mouth) component at play. Pharmacists or physicians
may or may not be consulted regarding the use of medications.
In some cases, in fact, health professionals are unaware of the drugs
patients are taking. Herbal remedies or natural supplements also may be
taken without the knowledge or input of a health professional.
Consider, for example, the patient medication profiling capability of
most pharmacies. Sophisticated computerization is ubiquitous in pharmacy.
Computerization allows for ease in billing third-party programs, maintenance of drug allergy information, drug-use review, and notification of drug
interactions, and aids in various regulatory requirements. Computerization
permits drug-related information to be easily entered, retained, and retrieved.
However, as noted earlier, OTC medications are rarely entered into such
records (one exception may be OTC drugs prescribed by physicians and
dispensed through prescriptions by pharmacists). This exclusion of a whole
class of drugs from the monitoring programs of pharmacies may have a
profound effect on the ability of pharmacists to monitor the drug therapies of
their patients. If the patient purchases the OTC medication in the pharmacy,
the pharmacist may have an idea of the drugs consumed. However, if OTC
drugs are purchased in a nonpharmacy outlet, a patients pharmacist may be
completely unaware of the drugs a patient is taking. Patients may also utilize
numerous pharmacies for varying prescription products; in this case there is
no one record repository for all medications a patient may be taking.
External variables may greatly influence patients and their drug-taking
behaviors. Coverage for prescribed drugs allows those with coverage to
obtain medications with varying copayment requirements. However, many
people do not have insurance coverage for drugs or other health-related
needs. In 2010, close to 50 million uninsured individuals in the United
States were uninsured, representing between 16 percent and 17 percent of
the population.1 This dramatic number is just 10 million less than the entire
population of either France or the United Kingdom and is staggering in scope
and implications for the future collective health of the US population.
Countless other Americans are underinsured. They may have partial coverage, but for these Americans the high price of deductibles, copays, and
monthly payments for insurance create an economic dilemma each time they
seek care or pay premiums. According to the National Health Expenditure
data of the US Centers for Medicare and Medicaid Services, well over
$2.71 trillion was spent on health care in the United States during 2010. This
amounts to $8,327 per person, or 17 percent of the US gross domestic product (GDP), some of it no doubt unnecessarily spent.1 By 2020, expenditures
are projected to reach $4.64 trillion, a projected $13,709 per person, which
285
would amount to 19 percent of the US GDP. It is anticipated that with the

enhanced focus on quality of the Patient Protection and Affordable Care Act,
passed in 2009, unnecessary expenditures and duplicative health care service
may be reduced, and misspent money in parts of the health expenditures in
the United States might be decreased.
Drug use in the health care system

Spending on drugs, as a percentage of what was spent on health care in total,
increased 5.3 percent in 2009 compared to the previous year.2 Drivers for
this significant increase include increasing available technologies, increasing
numbers of patients and prescriptions per patient, and an increasing number
of seniors taking advantage of the Medicare Part D drug benefit.
Significant numbers of medications are used daily in the United States.
Over one decade (19972007), the number of prescriptions purchased
zoomed from 2.2 billion to 3.8 billion.3 The average number of prescriptions
per capita in the United States rose from 8.9 in 1997 to 12.6 in 2007.3
Problems occurring with the use of medications can include the following:
medication errors;
suboptimal drug, dose, regimen, dosage form, and duration of use;
unnecessary drug therapy;
therapeutic duplication;
drugdrug, drugdisease, drugfood, or drugnutrient interactions;
drug allergies; and
adverse drug effects, some of which are preventable.
Pharmacists often are called upon to identify, resolve, and prevent problems that occur due to undertreatment, overtreatment, or inappropriate
treatment. This is a crucial role for pharmacists, who can make a valuable
contribution in this area. As noted, individuals can purchase medications
through numerous outlets. Pharmacists and other health professionals need
to take ownership of these problems and improve patient outcomes resulting
from inappropriate drug use.
External variables may greatly influence patients and their drug-taking behaviors. Coverage for prescribed drugs allows those with coverage to obtain
medications with varying cost-sharing requirements. However, many do not
have insurance coverage for drugs or other health-related needs. With the
advent of Medicare Part D coverage for outpatient prescription medications,
we have seen more of the elderly gain access to needed therapy.4
Self-care
In some instances individuals may strive to obtain an optimal state of
health but will not look to health care providers for advice regarding health
problems. Individuals may elect to self-treat either acute or chronic health
286
conditions. In addition, through self-care, an individual might enter the

health care system only to a certain degree, perhaps to obtain a diagnosis,
but will not rely on a physician for treatment of the diagnosed condition.
Self-help or self-care may be utilized in an attempt to treat the condition. For
most appropriate self-care to occur, patients need to be able to interpret their
symptoms and understand what these symptoms actually mean.
Self-care offers many tangible benefits for many involved in health care
delivery. An active orientation toward health care on the part of the patient can serve to foster great partnerships between physicians, pharmacists,
physician extenders (e.g., nurse practitioners and physician assistants), other
caregivers, and patients. Self-limiting conditions can be and are treated by
individual patients with advice from pharmacists in many practice settings.
Self-care can be a convenient, time-saving option for patients. It also can
save individuals money, as the need for more costly types of care often can
be avoided.
Self-care may be a cause of or contributor to patient noncompliance
with recommendations, whether for prescribed medications or other recommended and/or prescribed therapeutic regimens. The individual patient may
believe that a certain prescribed medication is not necessary to treat his or
her complaint, or that a medication other than what was prescribed would
be more appropriate.
Self-medication
Self-medication can be broadly defined as a decision made by a patient to
consume a drug with or without the approval or direction of a health professional. The self-medication activities of patients have increased dramatically
in the late 20th and early 21st centuries. Many factors have continued to
fuel this increase in self-medication. There are ever-increasing ways to purchase OTC medications. Also, many prescription items have become OTC
medications in the past 40 years, and this is dramatically and significantly
fueling the rapid expansion of OTC drug usage here in the United States and
elsewhere. In addition, patients are becoming increasingly comfortable with
self-diagnosis and with self-selection of OTC remedies. In many studies,5
self-medication with nonprescribed therapies exceeds the use of prescription
medications in the patient groups assessed.
Patients use of self-selected products has the potential to provide enormous benefits.6 Some proposals to switch drugs such as statins and other
medications that currently are available by prescription only to OTC is controversial in many respects.6 Through the rational use of drugs, patients may
avoid more costly therapies or expenditures for other professional services.
Self-medication for certain conditions, even some chronic health conditions
(e.g., allergies and dermatologic conditions), if appropriately handled, allows
the patient to have a degree of autonomy in health care decisions.
287
These factors influencing self-medication in turn affect pharmacists. Certainly, pharmacists are affected economically as more OTC products become
available for purchase and more places offer them for sale. Self-diagnosis
and self-selection of products also may keep the pharmacist from being
fully aware of all drugs patients are taking. OTCs are widely used by all
age groupschildren through seniors, and all segments in between. OTCs
will continue to be popular for several reasons. Manufacturers leverage
OTCs when prescription-only products are more suitably made available
for patient self-use and when patent protection is lost on products. The US
Food and Drug Administration must approve each of these prescriptionto-OTC switches, with the major consideration being the safety of the drug
in question for self-use by patients. Retailers appreciate the profitability of
OTC products in their merchandising options. In addition, many pharmacies
sell generic OTC products that may offer a better profit option than the
brand-name originator product and also carry a reduced inventory cost. In
addition, many store brands of generics offer a competitive advantage.
These store brands are labeled with the name of the pharmacy, independent
or chain, and are meant to offer consumers a certain comfort level when they
purchase a product that that has the name of the establishment on the label.
Many patients favor OTCs as a self-treatment option in lieu of a prescribed
medication from a physician for the reasons spelled out earlier.
Pharmacists must take into consideration this important classification of
drugs when assessing patients drug therapies. As noted previously, OTCs are
seldom entered into patient profile systems. A thorough assessment of OTC
use as well as the use of supplements by patients must be made by obtaining
a thorough patient history and keeping it updated for access by pharmacists.
Patient compliance
Patient noncompliance with prescription regimens is one of the most understated problems in the health care system. The effects of noncompliance have
enormous ramifications for patients, caregivers, and health professionals.
Noncompliance is a multifaceted problem with a need for interprofessional,
multidisciplinary solutions. Interventions that are organizational (i.e., based
on how clinics are structured and how interactions can occur with patients),
educational (i.e., patient counseling, supportive approach), and behavioral
(i.e., impacting health beliefs and expectations) are necessary.
Definitions of compliance
The definitions used to categorize patients as compliant or noncompliant vary
tremendously. The variability in describing compliance behaviors has made
it difficult to assess or categorize patient behaviors. Compliance is certainly
288
not an either/or phenomenon; in this regard, the definitions of compliant

behaviors must reflect several different variables.
Figure 14.1 depicts a continuum of compliant behaviors. The four segments listed include initial noncompliance, partial compliance, total compliance, and hypercompliance.
In initial noncompliance, the patient receives a written prescription to
be filled from a prescriber, or the prescriber transfers the prescription
electronically to the pharmacy, or the prescription is phoned or faxed to
the pharmacy. The patient, however, does not pick up the prescription at
the pharmacy, and thus does not take any of the prescribed medication at
all. In many instances, the prescriber is unaware that the patient has not
actually had the prescription filled. Estimates place the number of unfilled
prescriptions at between 3 percent and 20 percent in the United States.
In partial compliance, the patient takes some of the prescribed medication, but not to the extent that the physician or prescriber has intended.
Estimates place the level of noncompliance with prescribed medications
at approximately 50 percent across all types of patients and therapeutic
agents.
In total compliance, the patient takes the medication(s) that have been
prescribed exactly as the physician or prescriber has intended.
Hypercompliance is the situation when a patient takes a prescribed and
dispensed medication or medications at a level exceeding the dosage
prescribed by the physician.
As depicted in Figure 14.1, the arrows between the categories are bidirectional. This may or may not be the case with patients, as each patient
makes these individual decisions. What is not shown in this figure is the
complexity that ensues when patients take multiple medications daily and
at differing intervals during the day, and thus have the opportunity to miss
doses, possibly due to confusion or the complexity of the regimens that have
been prescribedby numerous physicians in some cases.
Impact of noncompliance
The consequences and ramifications of patient noncompliance with medication regimens pervade all aspects of the delivery of health care. Noncompliance has the potential to deleteriously affect pharmaceutical and generic
manufacturers, prescribers, dispensers, patients, and society as a whole.
Initial noncompliance
Partial compliance
Total compliance
Hypercompliance
Figure 14.1 The compliance continuum. (Data from Fincham JE. Patient compliance with
medications: issues and opportunities. London: Informa Healthcare; 2007:80.)
289
Any number of chronic and/or acute disease outcomes are affected by

noncompliance. We will use hypertension as an example. Hypertension is
one of the chronic diseases that is most commonly affected by noncompliance
with prescribed antihypertensive medications. Noncompliance leads to lack
of control of hypertension and a high discrepancy in how patients respond
to therapies.7 Helping to identify psychosocial interventions, which engage
patients to self-manage their therapies, has proven effective.7 Acknowledging
the barriers that people perceive in complying with taking their prescribed
medications helps identify how to assist patients to overcome these obstacles.7 Compliant behavior can be enhanced through pharmacists interactions with the patients. Many times what is necessary is referral to specific
clinicians for individualized treatment and monitoring to enhance compliance. Pharmacists are ideally suited and trained to provide this specialized
monitoring and evaluation.
Whose problem is noncompliance? Although not all factors affecting
patient noncompliance have been identified, a growing body of research
and knowledge sheds light on the noncompliance problem. Potential effects
on medication adherence have been formulated, instituted, and evaluated.
Despite a steady increase of advances regarding the knowledge of noncompliance, much individual work remains to be done.
Drug manufacturers, patients, and providers have realized that the problem of noncompliance does not rest with one segment of the health care
system. Just as the problem pervades all aspects of health care delivery,
the responsibility for finding a solution to the understanding and reversal
of patient noncompliance (where it is appropriate to do so) also must be
shared. Pharmaceutical manufacturers must strive to formulate pharmaceuticals that help facilitate medication consumption. Manufacturers must follow
up the prescribing and dispensing of pharmaceuticals to ascertain if, in fact,
the formulation, packaging, or dosage form design of a product enhances
compliance with that compound. Physicians must certainly share in the
responsibility for patient compliance. Post-prescribing follow-up of patients
should be undertaken to evaluate proper drug selection for individual patient
needs, both in the therapeutic and compliance related sense of medication
requirements. Certainly the writing of a prescription must not signal the
end of physician involvement in medication compliance considerations of
patients. Patients must be given responsibility for, and input into, the medication regimens they are required to take. The patient could be the individual
most responsible for the final compliance decision. If aspects of a medication
regimen are unacceptable, patients should inform physicians and pharmacists of their wishes, desires, problems, or concerns. Pharmacists, because
of their accessibility and frequent contact opportunities with patients, can
have a dramatic impact on patient drug knowledge, understanding of patient
prescription needs, and subsequent patient compliance behaviors.
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Before patients reach the stage of being noncompliant with drug therapies, they enter the health care system at varying entry points. They may
see a physician, a pharmacist, a nurse practitioner, or a combination of
practitioners. As noted earlier, they may also bypass the formal health care
system entirely and self-medicate with drugs obtained from others. Patients
enter the health care system with varying intents and multiplicity of purposes.
Pharmacists may see patients at the beginning, midpoint, or end of their
current use of the health care system. Pharmacists should do what they can
to seek an understanding of why patients are seeking care and respond to
their individual needs accordingly.
Factors affecting compliance behaviors

Countless studies have examined various factors that may affect patient
compliance and reduce noncompliant behavior, factors including various
diseases, conditions, or types of symptoms. Studies have also tried to predict
compliance behaviors based on demographic variables (e.g., age, gender,
income levels). The complexity of maintaining the patients compliance with
his or her medication regimen has been examined. Methods to ease the
process of complying with complex regimens have been examined; these
may include packaging of drugs in a more user-friendly format such as
unit-dose packaging or monthly drug cards with prearranged medications
separated by colors or time of day as opposed to standard prescription vials.
Efforts toward educating patients about the drugs that they are taking have
been made. Predictive models have been assessed as well. Trying to predict
compliance is not as worthy a goal as is determining how best to help patients
with their drug-taking requirements.
What one can deduce from these studies is that compliance is a very
individual, specific process. Pharmacists need to assess each individual patient
to determine what method or methods might be most successful with that
patient. Reducing the complexity of regimens through simplifying how many
different dosing intervals or amounts are to be consumed has benefited
patients. Helping patients monitor their own compliance behavior has been
shown to be successful. These impacts that have been successful may seem
time consuming, but what is the alternative? Helping patients in any manner
possible should be the ultimate goal of pharmacists, so taking time to help
patients comply is a worthy outcome for consideration.
What has recently been shown to impact compliance? It is crucial at this
point to consider what approaches have been shown to positively enhance
compliance behavior and the economics of such activities. When examining
the return on investment (ROI) of improving medication adherence for costly
chronic health conditions, results identified by Sokol et al.8 were most impressive. The study, conducted several years ago, determined that the ROI for
291
compliance interventions conducted by pharmacists for patients with certain

chronic conditions was as follows:
nearly 4:1 for hypertension;

5:1 for hypercholesterolemia; and
and an impressive 7:1 for diabetes.8
A 2011 CVS Caremark study reported on by Roebuck et al.9 found that
an increase in medication adherence resulted in a large reduction in total
health care spending for studied patients. These savings were significant:
for example, the savings ranged from $1,860 per year for patients with
hyperlipidemia to over $8,880 for patients with congestive heart failure.9
In a report by Thorpe,10 which examined care coordination incorporating
health care institutions, pharmacists, physicians, and other health providers
in an enhanced communication-sharing mode, the predicted level of savings
for the most vulnerable senior population was eye opening. The individual
patients included in this model were senior patients with both Medicare and
Medicaid coverage. These individuals were classified as dual eligible because
of the coverage overlap. It is very expensive to treat this group of patients,
because of existing health problems. The model developed by Thorpe10
assumed that all such patients would be enrolled in a coordinated care effort.
Enhancing medication complianceinduced savings was one component of
this projection; other cost-saving impacts would influence hospital care,
long-term care, and outpatient services as well. Thorpe10 predicts that the
savings accruing during the first year of the coordinated care effort would
be $2.8 billion, and over the 10 years of his projection, the amount would
be $125.5 billion. This type of coordinated care approach to patients in one
component of the Patient Protection and Affordable Care Act (e.g., health
reform) that was passed by the US Congress in 2009 with a 10-year period
during which all aspects will be implemented.
Drug use by the elderly

Various components of drug use in elderly persons are worth noting. Problems with health literacy (i.e., the understanding of medical terminology and
directions from providers) are more common among the elderly.11 The burgeoning population of the elderly, coupled with their lack of health literacy,
means that this issue will become even more problematic in the future.12
Over the next decade, seniors will spend $1.8 trillion on prescription
medications. Medicare proposals to provide a drug benefit for seniors have
been estimated to cost $400 billion over a 10-year period. Thus, the most
elaborate of the current drug programs will pay only 22 percent of seniors
drug costs. Enhanced use of pharmacoeconomic tenets to select appropriate
therapy, while considering cost and therapeutic benefits for seniors and
others, will become even more crucial for clinicians in the future.
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Unnecessary drug therapy and over-medication are problems with drug

use in the elderly. A joint effort by health professionals working together
is the best approach to aiding seniors in achieving optimal drug therapy.
Evaluation of all medications taken by seniors at each patient visit can help
prevent polypharmacy.13
Confronting the problems of drug use

Medication errors
There is no more glaring issue in medication use and monitoring than the
need to reduce medication errors. Untold morbidity and mortality occur due
to the many errors occurring in medication use. Studies have shown that
reconciling the medications that patients take, with coordination by various
caregivers providing care, can help reduce medication errors in patient populations.14 Current changes in how drugs are prescribed, such as electronic
prescribing, bar code identification of patients, and electronic medication
records, can all help reduce medication errors.15,16 As these technologies are
increasingly used, the benefits will expand.
The incorporation of three key interventionscomputerized physician
order entry, additional staffing, and bar codinghas been shown in an
institutional setting to help reduce medication errors.16 Being able to track
drug ordering, dispensing, and administration electronically has been shown
to be cost effective in the long run.17 Nurses and office staff have been
proven to be valuable resources for reporting prescribing errors, especially
with ongoing reminders to scrutinize orders.18 Further studies discussed later
highlight this need for increased interdisciplinary cooperation and use of all
means to enhance care for patients admitted for institutional care.
The dramatic and negative impacts of medication errors and inappropriate use cannot be overstated. Many recent compilations and studies have
noted the severity of the problem, not only in the United States but worldwide. However, Morgan et al.,19 in a study of ethnic differences coupled with
occurrences of the ravages of inappropriate prescription drug use, determined
that US patients were at particularly high risk of forgoing care because
of costs and because of experiencing inefficient, poorly organized care, or
errors.
The issue of errors and subsequent increases in risk factors for negative
outcomes has also been a significant issue when patients are admitted to
health care facilities.20 Gleason and colleagues20 in a large-scale study of
errors in transition from outpatient to inpatient care found that 35.9 percent
of admitted patients experienced order errors at hospitalization and that
over half of the order errors were rated as potentially requiring increased
monitoring or interventions to prevent harm.
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Fick et al.21 determined that negative health outcomes due to inappropriate drug use were significantly increased in older adults. In fact, they found
the prevalence of potentially inappropriate medication (PIM) use to be at
least one prescription in 40.7 percent of the sample of seniors. In addition,
at least 13.8 percent of people in the large sample had filled more than one
PIM prescription, leading to negative outcomes.
The epidemic of prescribed drug abuse

In 2009, approximately 7 million persons were current users of psychotherapeutic drugs taken for nonmedical uses (2.8 percent of the US population).
This class of drugs is broadly described as drugs targeting the central nervous
system, including drugs used to treat psychiatric disorders. The medications
most commonly abused are:
pain relievers: 5.3 million;

tranquilizers: 2.0 million;
stimulants: 1.3 million; and
sedatives: 0.4 million.22
Prescription and OTC medications currently are the drugs most likely to
be abused in the United States. These drugs now have more first-time abusers
than the more commonly thought-of drugs of abuse, such as marijuana, and
in fact are now overtaking marijuana as the most abused drugs. The main
source for these drugs is the family medicine cabinet. Bond and colleagues,23
in their report of a large-scale database study assessing adolescent drug
misuse from the National Poison Data System of the American Association
of Poison Control Centers from 2001 to 2008, note that prevention efforts
have proved to be inadequate in the face of rising availability of prescription medications, particularly more dangerous medications such as opioids,
sedative-hypnotics, and cardiovascular agents.23 The abuse of prescription
medications by adolescents is a growing problem that all health professionals
must work together to address.
Health care reform and the drug use process

The potential for health care reform via the Patient Protection and Affordable
Care Act (PPACA) to enhance patient outcomes and the quality of care,
including enhanced drug use outcomes, for Americans, is very significant.
The inclusion of health professionals in segments of the innovative medical
homes and accountable care organizations will help physicians and primary
care providers reach more patients needing care.24
The incorporation of primary care providers, clinics, and health care
institutions will allow electronic information sharing to better reduce errors,
enhance outcomes, and help save precious dollars in the health care system.
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Health professionals have already been shown to provide savings in pilot

projects carried out to date. An average savings of $1,595 per patient was
achieved by 9 pharmacists working with 88 Medicaid patients in a pilot
project sponsored by the Centers for Medicare and Medicaid Services in a
primary care setting.25
Preventive health care made possible by the PPACA includes immunizations, screenings, and other offerings at no charge. The provision of these
preventive activities by health professionals will serve patients over the long
term and work to prevent costly care later on.
All of the preceding discussion about the potential for health care reform
to influence patient care and outcomes must be tempered by the view that
changes may occur in legislation, with the US Supreme Court this past session
affirming the constitutionality of the legislation. Also, state legislatures have
been active in negating certain components or the entire legislation as it
applies to individual states, and the outcomes of the elections of 2012 will
certainly influence the eventual scope and form of the PPACA.
Summary
Although drugs account for a relatively small component of total spending
on health care in the United States, their useproper or improperdrives
many other cost centers that include much more expensive types of care. The
numbers of outpatient prescriptions have risen by 40 percent in the past few
years,23 creating challenges for the drug delivery and drug use processes in the
United States. Technological advances, including electronic prescribing, may
stem the tide of medication errors and inappropriate prescribing and make
possible more suitable drug outcomes.15 These technological enhancements
for physician order entry (via personal data assistants or through web access
to pharmacies) have been implemented to reduce drug errors. The skills and
knowledge that enable effective use of pharmacotherapies and the attendant
challenges for enhancing drug use outcomes have never been more daunting
among the numerous health professions. Sophisticated computer technology
can further empower health professionals to play an ever increasing and
effective role in helping patients and fellow health professionals to practice
safe and effective medicine. Health care reform has the potential to dramatically impact pharmacists practices in the health care system for the length
of their careers. Regardless of practice site, pharmacists have an unparalleled
opportunity and ability to impact patient drug use and the drug use process
in the US.

1. U.S. Centers for Medicare and Medicaid Services, National Health Expenditures. Washington, DC, January 11, 2011. www.cms.gov/NationalHealthExpendData/downloads/
proj2010.pdf [accessed September 26, 2012].
295
2. National Health Expenditure Data Factsheet. U.S. Centers for Medicare and Medicaid
Services, National Health Expenditures. Washington, DC, July 11, 2011. www.cms.gov/
NationalHealthExpendData/25 NHE Fact sheet.asp [accessed September 26, 2012].
3. Kaiser Family Foundation Washington, DC, September, 2008. Prescription drug trends.
http://kff.org/rxdrugs/upload/3057 07.pdf [accessed September 25, 2012].
4. Fincham JE. Pharmacy curricula and bellwether changes in payment for pharmacy practice services. Am J Pharm Educ 2005; 69:3923.
5. Johnson G, Helman C. Remedy or cure? Lay beliefs about over-the-counter medicines for
coughs and colds. Br J Gen Pract 2004; 54(499):98102.
6. Tinetti M. Over-the-counter sales of statins and other drugs for asymptomatic conditions.
N Engl J Med 2008; 358:272832.
7. Vrijens B, Vincze G, Kristanto P, Urquhart J, Burnier M. Adherence to prescribed antihypertensive drug treatments: longitudinal study of electronically compiled dosing histories.
Br Med J 2008; 336:11147.
8. Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence
on hospitalization risk and healthcare cost. Medical Care 2005; 43:52130.
9. Roebuck MC, Liberman JN, Gemmill-Toyama M, Brennan TA. Medication adherence
leads to lower health care use and costs despite increased drug spending. Health Affairs
2011; 30(1):919.
10. Thorpe KE. Estimated federal savings associated with care coordination models
for Medicare-Medicaid dual eligibles. September 2011. http://www.ahipcoverage.com/
wp-content/uploads/2011/09/Dual-Eligible-Study-September-2011.pdf [accessed September 26, 2012].
11. Williams A, Manias E, Walker R. Interventions to improve medication adherence in people with multiple chronic conditions: a systematic review. J Adv Nurs 2008; 63:13243.
12. Parker RM, Ratzan SC, Lurie N. Health literacy: a policy challenge for advancing
high-quality health care. Health Aff 2003; 22:14753.
13. Hajjar ER, Cafiero AC, Hanlon JT. Polypharmacy in elderly patients. Am J Geriatr
Pharmacother 2007; 5:34551.
14. Delate T, Chester EA, Stubbings TW, Barnes CA. Clinical outcomes of a home-based
medication reconciliation program after discharge from a skilled nursing facility. Pharmacotherapy 2008; 28:44452.
15. Fincham JE. e-prescribing: the electronic transformation of medicine. Sudbury (MA):
Jones and Bartlett Publishers, Inc; 2009.
16. Franklin BD, OGrady K, Donyai P, Jacklin A, Barber N. The impact of a closed-loop
electronic prescribing and administration system on prescribing errors, administration
errors and staff time: a before-and-after study. Qual Saf Health Care 2007; 16:27984.
17. Karnon J, McIntosh A, Dean J, et al. Modelling the expected net benefits of interventions
to reduce the burden of medication errors. J Health Serv Res Policy 2008; 13:8591.
18. Kennedy AG, Littenberg B, Senders JW. Using nurses and office staff to report prescribing
errors in primary care. Int J Qual Health Care 2008; 20:23845.
19. Morgan S, Hanley G, Cunningham C, Quan H. Ethnic differences in the use of prescription drug: a cross-sectional analysis of linked survey and administrative data. Open
Medicine 2011; 5(2):112.
20. Gleason KM, McDaniel MR, Feinglass J, Baker DW, Lindquist L, Liss D, Noskin GA.
Results of the Medications at Transitions and Clinical Handoffs (MATCH) study: an
analysis of medication reconciliation errors and risk factors at hospital admission. J Gen
Intern Med 2010; 25(5):4417.
21. Fick DM, Beers MH, Waller JL. Health outcomes associated with potentially inappropriate medication use in older adults. Res Nurs Health 2008; 31(1):4251.
22. National Institute on Drug Abuse. Topics in brief: prescription drug abuse. May 2011.
www.drugabuse.gov/tib/prescription.html [accessed December 2, 2012].
23. Bond GR, Woodward RW, Ho M. The growing impact of pediatric pharmaceutical poisoning. J Pediatr 2012. www.jpeds.com/article/S0022-3476%2811%2900771-2/
abstract [accessed September 25, 2012].
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24. Smith M, Bates DW, Bodenheimer T, Cleary PD. Why pharmacists belong in the medical
home. Health Aff 2010; 29:90613.
25. Smith M, Giuliano MR, Starkowski PP. In Connecticut: improving patient medication
management in primary care. Health Aff 2011; 30:64654.
15
Patient safety and
pharmacovigilance
Stephen F. Eckel, PharmD, MHA, BCPS,
Alexander T. Jenkins, PharmD, MS and
Kayla Hansen, PharmD, MS
Medication safety has always been an important issue for pharmacists and
other health care professionals, but it was never really in the public eye until
1999, when the Institute of Medicine (IOM) released its seminal report To
Err Is Human.1 This publication stated that 44,000 to 98,000 people die
in US hospitals every year due to medical errors, of which 7,000 are due to
adverse drug events. To put these figures into perspective, if the conservative
estimate of 44,000 were used, medical errors would still cause more deaths
annually than car accidents, breast cancer, and AIDS combined. Moreover,
the associated financial toll to health care from these preventable errors is
estimated to be between $17 billion and $29 billion per year.
As a result of the media attention from the IOM report, consumers are
now more attuned to the issues associated with medications and health care.
One way that organizations have responded is by creating databases that
allow for reporting and trending of both medication errors and adverse drug
reactions (ADRs). Because ADRs are instances of patient harm resulting from
medications being used in the recommended manner, they are generally considered nonpreventable.2 Most safety initiatives focus on reducing errors in
medication use, and therefore reducing the occurrence of preventable adverse
drug events (ADEs), which are instances of medication errors resulting in
patient harm. Pooling large data sets allows for systems issues in medication
use to be identified more expeditiously, enabling organizations to take steps
to minimize preventable ADEs and create a safer health care system.
This chapter will review the concepts of pharmacovigilance, the extent of
regulatory involvement with respect to safe medication use, and the overall
impact on pharmacy practice. It also discusses the safety testing that occurs
throughout the drug approval process, post-marketing surveillance, and various regulatory requirements that impact pharmacy practice.
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Overview of pharmacovigilance and medication error

reporting
Pharmacovigilance is a discipline that identifies and describes the nature,
incidence, and severity of adverse drug events.3 This is an ongoing process
that begins at drug development and continues throughout the drugs use.
To have the most complete data to evaluate and to base decisions on, this
information must be consistently followed.
Individual events present themselves as opportunities for organizational
change. It is only in recent years that medication errors have been attributed
more to systems failures than to the failure of an individual practitioner.
Historically, punitive action was the method used to address errors, and it
was directed at the practitioner deemed to be at fault. These methods led to
a culture of fear and lack of desire to report medication errors. Over time,
this punitive culture has shifted to one where it is the system that is perceived
to be at fault, not the person. The focus is on the systems failures, which
involves identifying how an underlying process contributed to the error. As a
result, individual blame is minimized, and process improvement has become
the primary focus for error prevention. As the practice of using reported
errors to track and improve systems has become commonplace, individuals
have become more engaged in reporting errors in an attempt to facilitate
change. Unfortunately, there are times when reckless behavior does occur,
and in these situations the individual should be held accountable.
The just culture methodology balances a systems-oriented philosophy
with one that focuses on holding the individual accountable.4 Just culture
has been defined as a strategy to determine the issues surrounding an adverse drug event and determining whether it was a system error or reckless
behavior on the part of an individual. While punitive cultures still exist in
some organizations, much of health care has transitioned to the adoption of
a just culture. Each event is a learning experience and a chance to improve
the underlying system involved in delivering care. However, egregious errors
cannot be tolerated, and the individual must be held accountable for that
behavior.
While reporting data can be a useful tool in the delivery of care, there
are also tremendous opportunities to evaluate patient safety both before and
after the Food Drug Administration (FDA) approves a medication.
Regulatory approval process and post-marketing

surveillance
As an agency of the US Department of Health and Human Services, the
FDA has responsibilities that include ensuring that drugs, vaccines, and
other biological products and medical devices intended for human use are
Patient safety and pharmacovigilance
299
safe and effective. Additionally, the FDA has oversight for food, cosmetics,
dietary supplements, radiation safety, and tobacco regulation. The Center
for Drug Evaluation and Research, the regulating center for drug development, houses the Office of Surveillance and Epidemiology, which conducts
risk management and pharmacovigilance activities within the agency.5 As
a requirement for drug approval, risk management procedures have been
incorporated to ensure proper assessment of risk versus benefit of marketed
products. Premarket assessment and ongoing post-market review are both
vital to risk management and have become foundational components of the
drug development process.6
As part of the risk management processes, the FDA requires a series
of specific drug evaluations during the pre-approval portion of drug development. Each phase of drug development has a specific purpose, and the
various safety assessments are interwoven into this structure. Drug discovery
and development have become increasingly more complex. As a result, the
methods for drug safety monitoring require continuous evaluation to ensure
a thorough and accurate risk assessment is completed prior to market release.
The Food, Drug and Cosmetic Act requires drug sponsors to provide
adequate testing to evaluate the safety of the drug for the labeled condition.
By assessing the pharmacology and toxicology, early pharmacokinetic and
pharmacodynamic data are obtained. These data may reveal concerns specifically related to the age, gender, metabolic, or genetic characteristics of the
patient that play a clinically significant role in the adverse effect potential of
the drug.6
Each investigational new drug undergoes a core battery of safety pharmacology, including assessment of the effects on vital organ systems. Significant concerns with QT prolonging agents have led to the requirement
for a cardiovascular assessment, including but not limited to effects on the
blood pressure, heart rate, and electrocardiogram. Evaluation of effects on
the central nervous system and respiratory system also is required. Another
standard determination is the metabolic pathway (i.e., CYP 3A4 metabolism)
and subsequent drugdrug interaction tests.7 All new drug applicants are
recommended by the FDA to conduct the following assessments for serious
adverse effects: QTc prolongation; liver, kidney and/or bone marrow toxicity;
drugdrug interactions; and polymorphic metabolism.6
In addition to laboratory assessments, premarketing processes also focus on the potential for medication errors. The reported findings have led
to premarket drug name revisions, labeling changes, and modification of
dosages. During the development phases, each medication error that occurs
with the product should be logged and analyzed. This analysis focuses on
identification of cause for the error, potential for future error in the intended
population, and how to either minimize or eliminate the risk of error in
the future.6
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Drug development has inherent limitations, including minimal volume

of exposed patients and lack of long-term use experience; co-morbid condition assessment; diversity of patients exposed; and use of a wide variety
of concomitant medications. Clinical trials will never be large enough to
detect every potential adverse effect, of course. Consequently, some drug risks
will be unknown prior to mass distribution of the drug. Instead, premarket
safety databases are rigorously reviewed for quantity of catalogued data as it
relates to novelty of treatment, safety of alternative therapies, and condition
and size of treatment population as well as duration. For example, the FDA
recommends an exposure rate of 1,500 subjects, with 300 to 600 exposed
for at least 6 months and 100 patients exposed for at least 1 year.6
The databases are expected to include a population sufficiently diverse to adequately represent the expected target population.6 Diversity
in this instance refers to a population diverse in age, comorbid conditions,
and concomitant medications. Most clinical trials are conducted through
placebo-controlled trials, and safety data often are gleaned from these or
a single-arm of the study. It is suggested that comparative safety data be
provided in instances where another medication has been established for
treatment. Such data will allow for comparison of adverse effects to determine whether they are similar to the previous product or exclusive to the
new product.6
Some adverse effects may be cumulative after a period of exposure or over
an extended period of time. Other effects may have such a low occurrence
rate that a typical premarketing study may be unable to detect the outcome.
Drug-induced liver injury is a clinical effect that occurs infrequently and
often is not observed in typical databases. Hepatotoxicity is the single most
common safety-related reason for market withdrawal in the last 50 years.
One such example occurred with troglitazone. Other drugs have avoided
market withdrawal, such as isoniazid and felbamate, but have seen a resulting
limitation in use.8
The Adverse Event Reporting System (AERS) that is mandated by the
FDA requires manufacturers to submit all adverse event data they receive.
Serious, unexpected adverse events have a required submission deadline of
15 days post-receipt. Other events (e.g., serious and expected, nonserious
and unexpected, or nonserious and expected), also must be submitted to
the agency but do not have a timeline as noted with serious, unexpected
events. In addition to reports of all serious, unexpected adverse events,
manufacturers also are required to submit quarterly periodic reports for the
first 3 years following drug approval.9 For vaccines, a Vaccine Adverse Event
Reporting System (VAERS) documentation form must be completed. VAERS
also has a public submission form that is available via the FDA website. AERS
is now a computerized system and is known most commonly as MedWatch.
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The MedWatch program includes both the mandatory manufacturer reporting and the voluntary consumer or health professional reporting.
Event reporting systems such as AERS cannot be used to define incidence,
because the true number of adverse events can never be known. Instead,
AERS is useful as a national database for a large volume of adverse events and
has been integral in the identification of safety trends with FDA-approved
products. Interrogation of event reports is part of a process known as
data mining. In combination with statistical analysis, data mining can be
useful in detecting patterns. The following safety events can trigger further
review: serious unlabeled adverse events, increase in severity of an unlabeled
event, occurrence of rare but serious events, evidence of new interactions,
new high-risk populations, and concerns related to product use. If a safety
concern arises, the FDA can conduct epidemiological inquiries, which could
result in regulatory action.10 Examples of regulatory impact from safety discoveries include labeling revisions, restrictions on drug use, and requirements
for communication of new safety information, and possibly even market
withdrawal.11
The implications of clinical trial and database limitations and a historical perspective of market withdrawals contributed to an extension of FDA
oversight in 2007. Through the Food and Drug Administrative Amendment
Acts (FDAAA) of 2007, the agency was granted considerable new authority
to require prolonged monitoring of drug use.
Before the signing of FDAAA, the agency referred to studies conducted
after drug approval as postmarketing commitment (PMC). Required studies were minimal, and PMC measure was agreed upon between the FDA and
the manufacturer. Through FDAAA, the agency was given the authority to
require postmarketing studies or clinical trials. The intent may be to learn
more about a known safety risk or to assess a safety signal that was observed
in pre-marketing. A wide variety of studies can be considered for inclusion
in a postmarketing assessment. These studies range from epidemiologic evaluations to clinical trials with safety endpoints and event safety studies in
animals. Failure to comply with FDA required study requests may result in
misbranding charges or monetary penalties. A per violation charge of up to
$250,000 can be assessed to the manufacturer.12
Historically, the FDA would encourage the development of a risk management action plan (RiskMAP). This original program laid the foundation for
the risk evaluation and mitigation strategies (REMS) program that is now in
place under FDAAA. REMS has become a separate requirement for drug
approval. The FDA has the authority not only to decide whether a drug
will require a REMS program upon approval but also to require REMS
for previously approved and currently marketed drugs. All REMS programs
must be approved by the agency, via criteria delineated in FDAAA, prior to
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release of the drug.13 A more detailed discussion on REMS is found later in

the chapter.
FDAAA also mandated an enhanced program for monitoring the safety
of drugs after the products reached the market. The introduction of the
Sentinel Initiative was the agencys response to this mandate; it was formally
launched in 2008. The system that is being implemented through the Sentinel
Initiative is the Sentinel System. Once completed, it will operate as an active
surveillance program and provide comprehensive and timely drug safety
monitoring.14
The Initiative has been designed to be a national electronic system that will
seek to link electronic health record systems, administrative and insurance
claims databases, and registries. It is meant to be a proactive surveillance
system with the goal of improving not only the ability to detect significant
safety issues but also the speed at which they are detected. The introduction
of the Sentinel System increases the breadth of the FDAs access to datafor
safety monitoring purposes only.14
The FDA will continue to operate AERS, which is known as a passive
surveillance system. Through the use of the both the Sentinel System and
AERS, the agency will have a more comprehensive monitoring program.
To ensure HIPAA compliance and minimize concerns with regulatory data
access through the Sentinel System, the FDA will send safety questions to
previously designated coordinating centers for compilation of relevant data.
In turn, the owners of the data will then be able to extract their data and
respond with de-identified results. At no time will the FDA have open access
to a data partners databases. Benefits of this system include its ability to
produce data close to real-time and also allow the FDA to send targeted data
inquires.14
All existing and newly gathered safety information is critically evaluated
by the FDA to determine whether it points to an important drug safety issue.
This evaluation can involve convening an advisory committee or consulting
the Drug Safety Oversight Board. Either group can provide recommendations
for regulatory action involving a product.15
Important drug safety issues are defined by the FDA as those that have
the potential to alter the benefitrisk analysis for a drug in such a way
as to affect decisions about prescribing or taking the drug. Examples of
important drug safety issues include: myelosuppression or other hematologic
alterations; organ toxicity; and events related to respiratory complications.
Serious adverse drug effects may be the most commonly recognized safety
issues, but these effects can also encompass adverse drug experiences in a
specific subpopulation and even medication errors.
When a potential safety risk is being investigated, information may be
released from the agency at that time to alert the public to the alleged safety
concern. All drug labeling is approved prior to marketing by the FDA and
303
is intended for use as designated. Patient package inserts and medication

guides also are FDA approved documents, as they are considered part of
the labeling.16
The FDA now uses a single communication tool for distribution of new
safety concerns and modifications, Drug Safety Communications. Implemented in early 2010, this method replaced the Early Communications,
Follow-up Early Communication, Information for Healthcare Professional
sheets, and Public Health advisory. As of July 2011, the communications
are also published in Spanish.17 The FDA website is the primary vehicle for
dissemination of new safety information for health care professionals and
patients.
Boxed warnings, commonly referred to as black box warnings, are an
important mechanism for communication of safety concerns with a drug
through the labeling. Although a drug can be released initially to the market
with a boxed warning, the warning often is added after the drug has been
approved. These warnings are most often used to highlight either serious
adverse reactions that should be considered when assessing the risks and
benefits of treatment or that could be prevented or reduced in frequency
or severity by appropriate use of the drug. Boxed warnings are found at
the beginning of the package insert and are outlined with a black box. Each
boxed warning contains a short summary of the safety information, including
any necessary restrictions on distribution or use.11
If a significant safety concern exists, the FDA also has the authority to
require withdrawal of a product from marketing and distribution to patients.
In circumstances where the safety concern is specifically associated with an
FDA-approved indication, the drug could have its approval for the indication
removed. Changes such as these occur much less frequently than product
labeling changes.
Risk evaluation and mitigation strategies

Risk management of pharmaceuticals has a become particularly complex
topic in the US health care system due to the challenges of balancing the
public demand for access to novel therapeutic options with the obligation to
ensure that those medications are safe for patients. When there is such high
demand to bring potentially life-saving medications to market without delay,
the FDA is expected to grant approval without sacrificing the integrity of the
review process.
In 1999, the FDA established the Task Force on Risk Management to
perform a complete assessment of the risk management system with respect
to FDA-approved products. The task force evaluated the overall role of the
FDA in pre-marketing risk assessment as well as postmarketing surveillance
in comparison to other government sectors, such as the role of the Federal
304
Aviation Administration (FAA) in regulating the airline industry. Based on the

results of this assessment, it was concluded that the pre- and post-marketing
risk management activities of the FDA were consistent with the design of
the system, but the system was in need of improvements through enhanced
system integration and understanding of risks.18,19 The final recommendations from the task force included structured education and competency
assessments for FDA personnel, strengthened processes for post-marketing
surveillance of new products on the market, and development of better
post-marketing safety databases that emphasized the shared responsibilities
for risk management (in addition to the FDA, successful risk management relies on contributions from health care professionals, manufacturers, patients,
and professional societies).
The idea of developing a framework for pharmacovigilance planning
throughout the life cycle of a pharmaceutical was emphasized by the release
of the E2E: Pharmacovigilance Planning guidance document in 2004 (final
version released in 2005).20,21 Risks are identified and summarized from
all pre-marketing studies to formulate a prospective pharmacovigilance plan
that can be updated as post-marketing surveillance activities promote the
availability of more robust safety information. While most FDA-approved
drugs require little more than routine pharmacovigilance activities, such as
adverse event reporting and labeling modifications, some drugs warrant more
focused efforts on risk minimization.
In 2005, the FDA released a guidance document describing the development of risk minimization action plans (RiskMAPs), which were designed to
achieve safety outcomes for specific pharmaceuticals by using certain tools:
targeted education and outreach, reminder systems, and performance-linked
access systems.22 One of the original RiskMAPs was designed for clozapine,
to ensure that patients were monitored for agranulocytosis according to a
preset schedule. The introduction of RiskMAPs through the FDA guidance
document was an important driver in the creation of a framework for more
comprehensive pharmacovigilance planning.
The impetus for congressional action on enhancing drug safety in the
marketplace was the 2006 report from the IOM that made a variety of
recommendations to facilitate the development of stronger post-marketing
surveillance.23 The key recommendations that were pertinent to pharmacy
practice are as follows:
The FDA should clarify and strengthen its regulatory authority.

Performance goals with respect to drug safety should be introduced into
the drug approval process (i.e., establish balance with the orientation
toward speed of approval).
The FDA should improve communication about safety to the public and
health care professionals.
305
In order to respond to the criticism and recommendations highlighted

in the IOM report, the FDA met with the Agency for Healthcare Research
and Quality (AHRQ) for a workshop to evaluate the use of RiskMAPs
as pharmaceutical risk management tools.24 What eventually resulted from
those discussions was the establishment of REMs.
The passage of the FDAAA in 2007 represented new momentum for
the FDA in strengthening pharmaceutical risk management by granting the
FDA the authority to require REMS. Under the new law, companies are
required to submit a REMS whenever it is determined by the FDA that
a REMS is necessary to ensure that the benefits of bringing a drug to
market outweigh the risks. In addition to pre-marketing requirements for
REMS, any drugs that are already on the market may be added to the list
of medications that require a REMS if new safety information becomes
available. While there are many similarities between RiskMAPs and REMS,
from the standpoint that both risk minimization strategies include both
pre- and post-marketing surveillance activities, one major difference makes
REMS more effective in practice. RiskMAPs were driven by an FDA guidance
document, whereas REMS is supported by congressional mandate. FDA
authority was granted by the FDAAA to require REMS and impose monetary
penalties, for any violations, up to $250,000 per violation or $1,000,000
for all violations.
To determine the whether or not a drugs benefits outweigh the risks, the
FDA must assess certain factors, including the following:
patient population;
seriousness of disease state;
expected benefit from treatment and duration of treatment; and
potential for adverse events.
Out of the 30 drugs that had RiskMAPs at the time that FDAAA was
passed into law, 16 were determined to have REMS, which meant that the
manufacturer was required to submit a REMS proposal to the FDA. Due
to the similarities between RiskMAPs and REMS, the provisions of the
RiskMAP would often continue to apply with REMS. However, one of the
major differences between REMS and RiskMAP is that a medication guide
would not have qualified as a RiskMAP on its own. Therefore, there are
currently many more drugs that require REMS (>150) than used to require
RiskMAPs.
The required elements for minimizing risk with REMS may include a
medication guide, communication plan, elements to assure safe use (ETASU),
and an implementation system. Every REMS also requires a timetable for
submission of program assessments at 18 months, 3 years, and in the seventh
year of the program. The risk management tools used in REMS are described
in Table 15.1.
306
Table 15.1 Required components of REMS

REMS component
Description
Medication guide
Information handed out to patients to make them aware of safety- or

efficacy-related information pertinent to treatment that must be approved
by the FDA
Required statement: Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.a
Communication plan
Sent from the manufacturers to providers and/or pharmacists informing

them of any associated risks and/or required ETASUs
Elements to assure safe use

(ETASUs)
Measures to ensure appropriate training of health care providers when

necessary, certifications to dispense, restricted distribution, completed
monitoring, or enrollment in a registry
Implementation system
Utilized to monitor ETASUs through a variety of means that may include

databases of certified providers or registered patients
REMS, risk evaluation and mitigation strategies.

a US Food and Drug Administration. Guidance for industry: medication guides adding a toll-free number
for reporting adverse events. June 2009. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory

Information/Guidances/UCM164669.pdf [accessed September 19, 2012].
The potential impact on pharmacists comes mostly from the requirement

for medication guide distribution and ETASUs. The FDAs position in regard
to medication guides is that patients must be provided with this critical information about their health care without placing unnecessary burden on the
health care professionals providing that care.25 Medication guides must be
dispensed when the drug is dispensed directly to the patient and/or caregiver
in the outpatient setting, at the request of the patient and/or caregiver, at
first dispensing, and whenever changes are made to the medication guide
content. In other scenarios (e.g., inpatient setting), the FDA will practice
enforcement discretion (Table 15.2). While most programs require the
distribution of medication guides, only a few include ETASUs as REMS
components. They tend to be more complex, so they are reserved for those
drugs that have the strongest evidence of risk affiliated with treatment outside
the scope of intended use.
Two of the more well-known pharmaceuticals that require ETASUs
are epoetin alfa and darbepoetin alfa (APPRISE program) and isotretinoin
(iPLEDGE program). Both of these programs require registry enrollment,
which precludes uncertified prescribers from prescribing these medications
so as to minimize the risk of unsafe use. One unique aspect of the APPRISE
(Assisting Providers and cancer Patients with Risk Information for Safe use
of ESAs) program is that it has been enforced only for the indication of
chemotherapy-induced anemia. Overall, the scope of ETASUs transcends the
health care environment to ensure that prescribers, pharmacists, and patients
alike are fully informed of a medications risk/benefit profile.
307
Table 15.2 FDA policy on enforcement discretion for medication guides

Setting
Patient or
patients agent
requests
medication
guide
Medication
guide
distributed
each time drug
dispensed
Medication
guide
distributed at
time of first
dispensing
Medication guide
distributed when
medication guide
materially changed
Inpatient
Must dispense
medication
guide
FDA intends to
exercise
enforcement
discretion;
medication
guide need not
be dispensed
FDA intends to
exercise
enforcement
discretion;
medication
guide need not
be dispensed
FDA intends to
exercise
enforcement
discretion;
medication guide
need not be
dispensed
Outpatient when
dispensed to
healthcare
professional for
administration to
patient (e.g., clinic,
infusion center)
Must dispense
medication
guide
FDA intends to
exercise
enforcement
discretion;
medication
guide need not
be dispensed
Must dispense
medication
guide
Must dispense
medication guide
Outpatient when
dispensed directly to
patient or caregiver
(e.g., retail pharmacy,
hospital ambulatory
pharmacy)
Must dispense
medication
guide
Must dispense
medication
guide
Must dispense
medication
guide
Must dispense
medication guide
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM244570.pdf.
Implementing REMS in practice presents a variety of challenges to the

profession of pharmacy. Approximately 61 percent of more than 2,000
practicing pharmacists surveyed in 2008 revealed that they believed risk
management systems have had a negative outcome on pharmacy practice
due to the complexity of the programs and associated costs.26 Moreover,
there is an increase in workload for pharmacists required to manage REMS
programs. Most importantly, though, the implementation of REMS may
potentially decrease patient access to beneficial medications due to lack of
provider participation in a registry program.27
Despite some clear challenges, there are also leadership opportunities
with the continued development of REMS programs for pharmacists. Because multidisciplinary collaboration is essential to a successful REMS program, pharmacists can take a leadership role in implementation, especially in
the inpatient setting. Incorporating REMS into practice usually would require
the approval of the Pharmacy & Therapeutics Committee and potentially
the Medication Safety Committee as well. As the FDA continues to work
toward the development of a standardized REMS solution for the future that
308
minimizes the variability between programs, pharmacists can utilize their

roles on these hospital-based committees to drive the corresponding practice
changes toward ensuring safe use of medications.
An additional benefit to enhanced post-marketing surveillance strategies
introduced by the FDAAA has been the heightened focus on new safety
information that may also de-emphasize or even disprove the existence of
suspected risks. Furthermore, the FDA has indicated a willingness to remove
REMS requirements as this new safety information becomes available.28
REMS requirements were removed for several drugs between July 2010 and
June 2011, such as ambrisentan, which was found not to cause significant
increases in liver function test abnormalities. This point validates the FDAs
stance that post-marketing pharmacovigilance monitoring in the marketplace
is critical because it demonstrates actual risk (beyond limited pre-marketing
clinical studies) and makes it possible for risk management systems to be
developed based on the most up-to-date safety information.
Regulatory requirements
Aside from striving for compliance with FDA-enforced programs, pharmacovigilance in the practice of pharmacy is also driven by the requirements set
forth by regulatory bodies such as the Centers for Medicare and Medicaid
(CMS) and the Joint Commission (TJC). Other regulatory bodies include
state-specific departments of health services and boards of pharmacy. Similar
to REMS, CMS and TJC requirements are developed using evidence-based
practice standards and are intended to promote the safe use of medications.
For this reason, the specified standards are categorized based on the different
aspects of medication management: selection, procurement, storage, ordering, transcribing, dispensing, administering, and monitoring.
To reiterate a previous statement, the common theme of pharmacovigilance is the importance of monitoring medications throughout the product
life-cycle. However, in the case of a health care organization, life-cycle means
the time from which the medication is procured and/or selected for formulary
status until the time a patient is being monitored following medication
administration. Because medication safety is a responsibility shared by all
members of the health care team (including the patient), it is critical that
standardized processes be developed to facilitate safe medication use and to
minimize the risk of error.
Medication management standards and National Patient Safety Goals
established by TJC for accreditation are the most important practice standards that affect the pharmacy profession in the acute care setting (with the
exception of some hospitals that have chosen other accrediting agencies).
Some of the elements of performance that are more heavily emphasized from
the safety perspective are related to reducing (or eliminating, if possible)
309
high-risk conditions, especially when there is an evident impact on patient

care.29 Sound-alike/look-alike drugs, high-alert medications, anticoagulants,
and chemotherapy are examples of medications that have been shown to
compromise patient safety if not managed safely. Therefore, organizations
are required to have processes in place for managing the risks associated
with these medications and sometimes also for demonstrating improved
outcomes.
In addition to routine management of medications, every health care
organization must also demonstrate that it has a process for monitoring and
reporting of adverse drug events. Adverse event monitoring may include a
variety of tools: e.g., voluntary reporting, retrospective chart review, trigger drugs, and observational data collection.30 The expectation is that an
organization is also reporting to the FDA MedWatch program when more
severe adverse events are documented and on a statewide level if there are
any state-specific reporting requirements (e.g., to the board of pharmacy).
With respect to effective management of medications, CMS has taken the
stance that reimbursement for health care organizations should be based on
evidence-based quality and safety outcome measures. Organizations not only
must remain accredited in order to continue to receive payments for care
provided to patients, but they also must demonstrate that care met certain
quality standards. Adopting a pay-for-performance methodology, CMS has
indicated that there will be a trend for the future toward increased emphasis
on paying for health care services based on the relative value of the care
provided and whether health care organizations are able to demonstrate
improved patient outcomes.3133
The regulatory approach to pharmacy practice has shown an increasing
emphasis on structured processes to improve patient safety through safe use
of medications. As with the enhanced role of the FDA in post-marketing
surveillance, it is incumbent upon organizations to design health care models
based on safety, quality outcomes and transparency of care.
Patient safety in health care organizations: the pharmacists role

One of the fundamental challenges faced by health care organizations today
is allocating resources to manage quality improvement programs with respect
to complex systems such as the medication use process. When organizations
are faced with increasing pressure to maintain compliance with a growing list
of varying regulatory requirements, it is often difficult to develop proactive
strategies using the same resources. Moreover, one cannot help but ask a few
important questions. Has the focus of medication management become so
directed toward compliance that the importance of actual patient outcomes
is now understated? Are patients experiencing better outcomes as a direct
result of improved compliance with regulatory standards? Shouldnt the most
310
critical driving force behind quality improvement be doing what is best for
the patient, not what is needed to make an organization more compliant? The
concepts of required pharmacovigilance activities and quality improvement
initiatives should be practically synonymous with respect to promoting safe
use of medications. However, the priorities often become compliance driven
based on expected improvements in patient outcomes instead of focusing
on actual patient outcomes. Because pharmacists are the medication experts,
there is a great opportunity for leadership roles in medication safety initiatives that demonstrate improved patient outcomes.
Reduction of preventable adverse drug events is a critical step in showing
improved patient outcomes. Ever since the 1999 IOM report, there has
been heightened attention to prevention of errors. However, there does not
appear to have been much success in reducing adverse drug events since then.
Recently, it was estimated that every year in 3.8 million inpatient admissions
and 3.3 million outpatient visits serious preventable medication errors occur,
resulting in approximately $21 billion in wasteful costs to the health care
system.3437 These figures illustrate a problem that must be addressed as it
has become very visible to the public eye.
Pressure to reduce preventable adverse drug events highlights an important opportunity for pharmacists to use their expertise in safe medication use
by taking on leadership roles, becoming more involved in multidisciplinary
health care teams, and taking responsibility for medication-related outcomes.
Such achievements take time and usually involve engaging key stakeholders
(i.e. physicians, nursing leadership, and hospital administration) to identify
advocates for any changes in practice. The safety-related benefits of increased
pharmacist involvement have been shown in a variety of ways, such as integration in multidisciplinary rounding teams and medication reconciliation
activities. Leape et al.38 demonstrated a 66 percent reduction in ordering
adverse drug events when a pharmacist was added to an intensive care
unit rounding team, resulting in an estimated annualized cost savings of
$270,000. In another study, patients who received follow-up calls from a
pharmacist about their medications were 88 percent less likely to experience
a preventable medication error.39 The role of the pharmacist in patient care
is critical to improved medication-related outcomes.
In hospitals and other complex health care organizations, placing a pharmacist in charge of medication safety is critical to developing an effective
system for medication management. Medication safety roles for pharmacists
may include medication safety pharmacist, medication safety officer, medication safety manager, or medication safety specialist. Regardless of the
title, placement of a pharmacist who understands the medication use process
in this role will facilitate the development of a more robust medication
safety program and better processes for tracking and preventing adverse
drug events.
311
Pharmacists in all pharmacy practice settings have the professional obligation of responsible medication management in order to promote safe
use of medications. Similar to the concept of pharmacovigilance being a
shared responsibility among all health care professionals, the responsibility
for medication-related patient safety must be shared among all practicing
pharmacists in order to improve patient outcomes.
Helpful resources
It is comforting to know that, while it is a continuing challenge to find
practical solutions that improve patient safety in health care, pharmacists
(and other health care professionals) have a plethora of patient safety resources at their disposal. Because the amount of safety information available
is overwhelming and health care is such a dynamic environment, having
access to different resources can help to identify solutions to safety-related
problems. Regardless of whether the resources used are government funded
or privately funded, having a diverse selection of information sources will
help pharmacists to have a more well-rounded understanding of patient
safety from different perspectives.
Several websites are available through the AHRQ, IOM, and similar
organizations that can provide health care professionals with access to the
most up-to-date safety information via e-mail newsletters, alerts, mailings,
podcasts, and other forms of social media.40,41 Table 15.3 lists several of
the available resources as well as a summary of what each one offers. Any
pharmacist who is seeking to stay informed on current patient safety information has a wealth of information available at his or her fingertips. The most
important thing that pharmacists need to do is to determine which sources
of information are most relevant to the respective practice environments.
In addition to current safety information, pharmacists also may find these
resources useful for networking, quality improvement tools, organizational
safety assessments (ISMP has comprehensive medication safety assessments),
and risk assessment tools. Risk assessment tools are conducted as a means of
either prospectively or retrospectively identifying vulnerabilities within the
medication use process.
Common examples of risk assessment tools include root cause analysis
(RCA) and failure mode and effects analysis (FMEA). An RCA is a process
for assessing the potential cause(s), contributing factors, and risks associated
with an error in order to ultimately identify the underlying cause. Some have
referred to the methodology of an RCA as the 3-year-old rule because the
team must ask the question why? five times in order to get to the root cause
of the problem. Another school of thought holds that beneath the root cause
is a latent condition, which is always the most difficult challenge to health
care organizations, because these conditions are imbedded in the culture.
312
Table 15.3 National safety organizations and resources

Organization
Description
Agency for Healthcare Research

and Quality (AHRQ)
www.ahrq.gov
Government organization that has accumulated a large amount of

evidence-based resources, quality measures, news, and toolkits for
pharmacists in all practice settings
Institute for Safe Medication

Practices (ISMP)
www.ismp.org
Private, nonprofit patient safety organization that offers a variety of

resources, including a biweekly newsletter, alerts, medication error
reporting, and more
Institute for Healthcare

Improvement (IHI)
www.ihi.org
Private, nonprofit organization offering safety tools, white papers, and

safety campaigns, including the 100,000 Lives Campaign and 5 Million
Lives Campaign
Institute of Medicine (IOM)

www.iom.edu
Private, nonprofit organization with a mission to improve public health

that publishes approximately 50 reports every year
Leapfrog Group
www.leapfroggroup.org
Voluntary program that engages health care organizations in order to

highlight quality, safety, and value within the US health care system
National Quality Forum

www.qualityforum.org
Private, nonprofit organization that has set out to adopt national

priorities on quality, performance improvement goals, and consensus
standards for public reporting
One might consider a latent condition to be the elephant in the room. An

FMEA uses a slightly different approach, in that it is a prospective analysis
typically performed before a significant process change is implemented. The
intent of an FMEA is to identify as many areas of vulnerability or points
of potential failure in a process as possible so that they can be managed
proactively prior to implementation.42
Overall, there is no dearth of patient safety information for pharmacists
to access. Information is available from numerous perspectives that may have
implications in every pharmacy practice setting. Once pharmacists recognize
that this information is available, the challenge becomes figuring out how to
apply the acquired knowledge, tools, networking, resources, or skill sets to
their respective practice environments. The constant pressure of regulatory
compliance and the expectations of demonstrating improved patient outcomes highlight the importance of maximizing the use of available resources
to promote safe use of medications.
Conclusions
As noted, numerous strategies are available to minimize the risks associated
with the use of medications. These strategies may be required by the FDA,
legislative mandate, and/or other regulatory bodies, but ultimately all of them
have an impact on pharmacy practice and patient safety. No matter if it is
utilizing databases, which are helpful for determining trends and detecting
signals that forecast potential adverse events, or implementing REMS in
313
practice, the feature they have in common is the importance placed on risk
minimization for the patient. By using available resources and taking responsibility for medication-related outcomes, pharmacists have an excellent
opportunity to demonstrate their unique role in improving patient safety.

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1-4. www.ama-assn.org/resources/doc/psa/guidelines4pay62705.pdf [accessed September 19, 2012].
32. Pay-for-Performance (P4P): AHRQ resources. www.ahrq.gov/qual/pay4per.htm [accessed
315
33. Centers for Medicare and Medicaid Services. Roadmap for implementing value
driven healthcare in the traditional Medicare fee-for-service program. www.cms.gov/
Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/
downloads/VBPRoadmap OEA 1-16 508.pdf [accessed September 19, 2012].
34. National Priorities Partnership. Preventing medication errors: a $21 billion opportunity.
December 2010. http://www.psnet.ahrq.gov/resource.aspx?resourceID=20529 [accessed
February 6, 2013].
35. Massachusetts Technology Collaborative (MTC) and NEHI, 2008. Saving lives, saving
money: the imperative for computerized physician order entry in Massachusetts. Updated
to 2008 figures. Cambridge (MA): New England Healthcare Institute, 2008.
36. Center of Information Technology Leadership (CITL). The value of computerized provider order entry in ambulatory settings. Updated to 2007 figures. http://www.
partners.org/cird/pdfs/CITL ACPOE Full.pdf [accessed February 6, 2013].
37. Burton MM, Hope C, Murray MD, Hui S, Overhage JM. The cost of adverse drug events
in ambulatory care. AMIA Annu Symp Proc 2007; Oct 11:903.
38. Leape LL, Cullen DJ, Clapp MD, et al. Pharmacist participation on physician rounds and
adverse drug events in the intensive care unit. JAMA 1999; 282:26770.
39. Schipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing
adverse drug events after hospitalization. Arch Intern Med 2006; 166:56571.
40. Kessler JM. Im from the government and Im here to help! North Carolina Pharmacist
2008; 88(2):18.
41. Brennan C, Donnelly K, Somani S. Needs and opportunities for achieving optimal outcomes from the use of medicines in hospitals and health systems. Am J Health-Syst Pharm
2011; 68:108696.
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analysis in health careproactive risk reduction. Oakbrook Terrace (IL): Joint Commission
Resources, Inc., 2005.
16
Provisions of care to
subpopulations: a cultural
perspective
Eucharia E. Nnadi, RPh, JD, PhD and
Tracy E. Okolo, RPh, BSN, PharmD, BCPS
Diversity is the array of physical and cultural differences that make us
different. These includebut are not limited toage, gender, ethnicity, race,
sexual orientation, and physical attributes. A simplistic view of diversity is
variety. As our country becomes more diverse, the importance of diversity
in the workplace, including the health care industry, cannot be ignored.
Achieving workforce diversity should be a priority and a concern to health
care organizations as well as educational institutions. Diversity can make
a difference between a health care organization that is merely maintaining
the status quo and one that is highly effective and successful in serving
diverse clients. Corporate America recognizes the value and the importance
of diversity. In fact, some Fortune 500 companies provide incentives for their
executives to deal successfully with workforce diversity.1
Having a diverse workforce means having people with different demographic differences, cultural differences, aptitude, personality, and ability,
all working together to achieve organizational goals. The key to successfully
managing a diverse workforce is respecting individual differences and talents
while avoiding stereotyping and discrimination in the work place. Diversity
provides a heterogeneous workforce, rather than a homogeneous one, thus
providing a wide variety of talents in handling challenges and issues in the
workplace.
A diverse workforce can enhance the performance of any organization.
For example, consumers are more likely to use the services of a pharmacy
where the pharmacist or other employees are viewed as sharing similar
characteristics. Diversity, if not managed well, can also create problems
within an organization. The key to success is to take full advantage of the
benefits of diversity while avoiding the potential downfalls.
318
According to the US Census Bureau, the general population is expected

to increase each year. Since 1970 there has been a steady increase in the
minority population. For instance, between 1970 and 1980, the minority
population increased 3.9 percent; between 1980 and 1990, it rose 4 percent
(Figure 16.1); and it is expected to continue to increase. Each year minorities
(African-American/blacks, Hispanic and Asians) make up an increasingly
larger percentage of the US resident population. If we look back to 1970,
the minority population was 16.5 percent, and by 1990 it had increased to
24.4 percent2 (see Figure 16.1). In the year 2000, the general US population
was 281.4 million; of that, African-Americans made up 12.3 percent, Hispanics 12.5 percent, Asians 3.6 percent, American Indians and Alaska Natives
0.9 percent, Native Hawaiian and other Pacific Islanders 0.1 percent, and
two or more races (a separate Census category) were 2.4 percent. Therefore,
about 30 percent of the US population in the year 2000 were minorities3
(Tables 16.1, 16.2 and 16.3).
In 2010, according to the 2010 Census report, the US population was
about 308.7 million. This is a 9.7 percent increase from the 2000 census,
which reported a population of 281.4 million (see Table 16.3). However,
this percentage growth is lower than the 13.2 percent growth of the 1990s or
the 9.8 percent growth seen in the 1980s (Figure 16.2).
The decline in the US population percentage growth rate is thought
to be caused by several factors, including increased death rates, an aging
Percent Minority: 1970-2042

60
50
50.1
2040*
2042*
39.9
40
36.3
30.9
30
20
49.2
44.5
24.4
20.4
16.5
10
0
1970
1980
1990
2000
Decennial Census
2010
2020*
2030*
Population Projections
*Projected population as of July 1.

Note: "Minority" refers to people who reported their ethinicity and race as something other than nonHispanic White alone in the decennial census.
Data from: U.S. Census Bureau, decennial census of population, 1970 (5-percent sample), 1980 to 2010,
2008 Population Projections, 2020-2042.
United States
Census
Bureau
11
Figure 16.1 Estimated US resident population by racial/ethnic category: understanding census

years 19701990 (projection).
19,175,798
20,549,505
20,528,072
20,219,890
18,964,001
39,891,724
45,148,527
37,677,952
13,469,237
10,805,447
18,390,986
12,361,180
4,239,587
35.3
59 years
1014 years
1519 years
2024 years
2534 years
3544 years
4554 years
5559 years
6064 years
6574 years
7584 years
85 years and over
Median age (years)
(X)
1.5
4.4
6.5
3.8
4.8
13.4
16.0
14.2
6.7
7.2
7.3
7.3
6.8
14,592,230
5,475,768
Unmarried partner
6,042,435
15,648,318
64,494,637
83,393,392
54,493,232
105,480,101
273,643,273
281,421,906
194,552,774
10,017,244
10,017,244
Nonrelatives
Under 18 years
Other relatives
Own child under 18 years
Child
Spouse
Householder
In households
Total population
RELATIONSHIP
White alone
Not Hispanic or Latino
Other Hispanic or Latino
1,241,685
Cuban
Under 5 years
3,406,178
20,640,711
35,305,818
281,421,906
Number
Puerto Rican
143,368,343
Female
50.9
Maxican
49.1
138,053,563
Total population
HISPANIC OR LATINO AND RACE
Male
100.0
Subject
Hispanic or Latino (of any race)
281,421,906
Total population
Percent
SEX AND AGE
Number
Subject
(continued)
1.9
5.2
2.1
5.6
22.9
29.6
19.4
37.5
97.2
100.0
69.1
3.6
3.6
0.4
1.2
7.3
12.5
100.0
Percent
Table 16.1 Profile of general demographic characteristics: 2000. Geographic Area: United States. [For information on confidentiality protection, nonsampling error, and definitions, see text]
Provisions of care to subpopulations: a cultural perspective

319
2,475,956
10,242,998
1,678,765
2,432,585
1,850,314
796,700
1,076,872
1,122,528
Asian Indian
Chinese
Filipino
Japanese
Korean
Vietnamese
0.4
0.4
0.3
0.7
0.9
0.6
3.6
0.9
Average family size
Average household size
Households with individuals 65 years and over
Households with individuals under 18 years
Householder 65 years and over
Householder living alone
Nonfamily households
With own children under 18 years
Asian
54,493,232
Married-couple family
3.14
2.59
24,672,708
38,022,115
9,772,857
27,230,075
33,692,754
7,561,874
12,900,103
24,835,505
34,588,368
71,787,347
105,480,101
3,719,594
4,059,039
7,778,633
Number
American Indian and Alaska native
12.3
75.1
97.6
7.3
Family households (families)
Total households
34,658,190
20,582,128
Female
5.1
HOUSEHOLD BY TYPE
Black or African American
14,409,625
Male
12.4
14.7
211,460,626
34,991,753
65 years and over
White
41,256,029
62 years and over
70.0
Noninstitutionalized population
Female householder, no husband present
196,899,193
21 years and over
38.4
Institutionalized population
In group quarters
274,595,678
108,133,727
Female
35.9
74.3
One race
100,994,367
Male
Subject
209,128,094
18 years and over
Percent
RACE
Number
Subject
(continued)
(X)
(X)
23.4
36.0
9.2
25.8
31.9
7.2
12.2
23.5
51.7
32.8
68.1
100.0
1.3
1.4
2.8
Percent
320
18,521,486
Some other race
6.6
0.3
Average household size of rental-occupied units.
Average household size of owner-occupied units.
2.40
2.69
35,664,348
69,815,753
(X)
(X)
33.8
66.2
100.0
(X)
(X)
3.1
9.0
91.0
100.0
Percent
Data from US Census Bureau, Census 2000. Profile of general demographics characteristics: 2000. http://www.census.gov/prod/cen2000/dp1/2khus.pdf [accessed February 15, 2013].
Represents zero or rounds to zero. (X) Not applicable.
because individuals may report more than one race.
c In combination with one or more of the other races listed. The six number may add to more than the total population and the six percentages may add to more than 100 percent
b Other Pacific Islander alone, or two or more native Hawaiian and other Pacific Islander categories.
a Other Asian alone, or two or more Asian categories.
874,414
Native Hawaiian and other Pacific Islander
4.2
Rental-occupied housing units
Owner-occupied housing units
11,898,828
6.8
105,480,101
1.7
Rental vacancy rate (percent)
3,578,718
10,424,540
105,480,101
115,904,641
Number
Homeowner vacancy rate (percent)
Asian
1.5
12.9
77.1
2.4
4,119,301
6,826,228
Two or more races
5.5
For seasonal, recreational or occasional use
American Indian and Alaska native
15,359,073
Some other race
Vacant housing units
Occupied housing units
108,914
Other Pacific Islanderb
Occupied housing units
Total housing units
36,419,434
91,029
Samoan
HOUSING OCCUPANCY
216,930,975
58,240
Guamanian or Chamoroo
0.1
Black or African American
140,652
Native Hawaiian
0.5
White
398,835
Subject
HOUSING TENURE
1,285,234
Other Asiana
Percent
Race alone or in combination with one or more other racesc :
Number
Subject

321
322
Table 16.2 Population change for the United States, regions, states and
Puerto Rico: 2000 to 2010a
Area
Population
Change
2000
2010
Number
Percent
281,421,906
308,745,538
27,323,632
9.7
Northeast
53,594,378
55,317,240
1,722,862
3.2
Midwest
64,392,776
66,927,001
2,534,225
3.9
South
100,236,820
114,555,744
14,318,924
14.3
West
63,197,932
71,945,553
8,747,621
13.8
Alabama
4,447,100
4,779,736
332,636
7.5
Alaska
626,932
710,231
83,299
13.3
Arizona
5,130,632
6,392,017
1,261,385
24.6
Arkansas
2,673,400
2,915,918
242,518
9.1
California
33,871,648
37,253,956
3,382,308
10.0
Colorado
4,301,261
5,029,196
727,935
16.9
Connecticut
3,405,565
3,574,097
168,532
4.9
Delaware
783,600
897,934
114,334
14.6
District of Columbia
572,059
601,723
29,664
5.2
Florida
15,982,378
18,801,310
2,818,932
17.6
Georgia
8,186,453
9,687,653
1,501,200
18.3
Hawaii
1,211,537
1,360,301
148,764
12.3
Idaho
1,293,953
1,567,582
273,629
21.1
Illinois
12,419,293
12,830,632
411,339
3.3
Indiana
6,080,485
6,483,802
403,317
6.6
Iowa
2,926,324
3,046,355
120,031
4.1
Kansas
2,688,418
2,853,118
164,700
6.1
Kentucky
4,041,769
4,339,367
297,598
7.4
Louisiana
4,468,976
4,533,372
64,396
1.4
Maine
1,274,923
1,328,361
53,438
4.2
Maryland
5,296,486
5,773,552
477,066
9.0
Massachusetts
6,349,097
6,547,629
198,532
3.1
Michigan
9,938,444
9,883,640
54,804
0.6
Minnesota
4,919,479
5,303,925
384,446
7.8
Mississippi
2,844,658
2,967,297
122,639
4.3
Missouri
5,595,211
5,988,927
393,716
7.0
Montana
902,195
989,415
87,220
9.7
Nebraska
1,711,263
1,826,341
115,078
6.7
Nevada
1,998,257
2,700,551
702,294
35.1
New Hampshire
1,235,786
1,316,470
80,684
6.5
New Jersey
8,414,350
8,791,894
377,544
4.5
United States
Region
State
(continued)
323

Area
Population
Change
2000
2010
Number
Percent
New Mexico
1,819,046
2,059,179
240,133
13.2
New York
18,976,457
19,378,102
401,645
2.1
North Carolina
8,049,313
9,535,483
1,486,170
18.5
North Dakota
642,200
672,591
30,391
4.7
Ohio
11,353,140
11,536,504
183,364
1.6
Oklahoma
3,450,654
3,751,351
300,697
8.7
Oregon
3,421,399
3,831,074
409,675
12.0
Pennsylvania
12,281,054
12,702,379
421,325
3.4
Rhode Island
1,048,319
1,052,567
4,248
0.4
South Carolina
4,012,012
4,625,364
613,352
15.3
South Dakota
754,844
814,180
59,336
7.9
Tennessee
5,689,283
6,346,105
656,822
11.5
Texas
20,851,820
25,145,561
4,293,741
20.6
Utah
2,233,169
2,763,885
530,716
23.8
Vermont
608,827
625,741
16,914
2.8
Virginia
7,078,515
8,001,024
922,509
13.0
Washington
5,894,121
6,724,540
830,419
14.1
West Virginia
1,808,344
1,852,994
44,650
2.5
Wisconsin
5,363,675
5,686,986
323,311
6.0
Wyoming
493,782
563,626
69,844
14.1
Puerto Rico
3,808,610
3,725,789
82,821
2.2
a (For information on confidentiality protection, nonsampling error, and definitions, see www.census.gov/
prod/cen2010/doc/p194-171.pdf.)
Data from US Census Bureau, 2010 Census and Census 2000. Population distribution and change:
20002010. http://www.census.gov/prod/cen2010/briefs/c2010br-01.pdf [accessed February 15, 2013].
population, and other factors. Despite the decrease in the population growth
percentage rates, the nations overall population increased to 308.7 million
in 2010, and it is projected to increase to 325.6 million in 2015 and to
392 million by 2050 (see Tables 16.3, 16.4 and 16.5). This means that in
2042 about 50 percent of the US population will be made up of minorities
(see Table 16.1). The population identified as white origin or race has continued to decline steadily as the minority population continues to make up a
larger percentage of the resident US population.
In 2010, Hispanics represented 16.3 percent of the total population,
African-Americans 12.6 percent, Asians 4.8 percent, American Indians and
Alaska Natives 0.9 percent, Native Hawaiian and other Pacific Islanders
0.2 percent, some other race (a separate Census category) 6.2 percent and
two or more races were 2.9 percent (see Table 16.3). The Asian and Hispanic minority populations nearly doubled, with population growth rates
of 43.3 percent and 43.0 percent, respectively, between the years 2000 and
2,475,956
10,242,998
398,835
15,359,073
American Indian and Alaska Native
Asian
Some other race

2.4
5.5
0.1
3.6
0.9
12.3
75.1
97.6
100.0
69.1
87.5
12.5
100.0
9,009,073
19,107,368
540,013
14,674,252
2,932,248
38,929,319
223,553,265
299,736,465
308,745,538
196,817,552
258,267,944
50,477,594
308,745,538
2.9
6.2
0.2
4.8
0.9
12.6
72.4
97.1
100.0
63.7
83.7
16.3
100.0
Percentage of
total population
2,182,845
3,748,295
141,178
4,431,254
456,292
4,271,129
12,092,639
25,140,787
27,323,632
2,264,778
12,151,856
15,171,776
27,323,632
Number
Change 20002010
32.0
24.4
35.4
43.3
18.4
12.3
5.7
9.2
9.7
1.2
4.9
43.0
9.7
Percent
Data from US Census Bureau, Census 2000 Redistricting Data (Public Law 94-171) Summary File, Tables PL1 and PL2; and 2010 Census Redistricting Data (Public Law 94-171) Summary
File, Tables P1 and P2. Overview of race and Hispanic origin: 2010. http://www.census.gov/prod/cen2010/briefs/c2010br-02.pdf [accessed February 15, 2013].
entirely affected race combinations involving Some Other Race. Therefore, data users should assess observed changes in the Two or More Races population and race combinations
involving Some Other Race between Census 2000 and the 2010 Census with caution. Changes in specific race combinations not involving Some Other Race, such as White and Black
or African-American or White and Asian, generally should be more comparable.
b In Census 2000, an error in data processing resulted in an overstatement of the Two or More Races population by about 1 million people (about 15 percent) nationally, which almost
a (For information on confidentiality protection, nonsampling error, and definitions, see www.census.gov/prod/cen2010/doc/p194-171.pdf.)
6,826,228
34,658,190
Black or African-American
Two or more racesb
211,460,626
White
281,421,906
274,595,678
Total population
One race
Race
194,552,774
246,116,088
Not Hispanic or Latino
White alone
35,305,818
281,421,906
Number
Number
Percentage of
total population
2010
2000
Hispanic or Latino
Total population
Hispanic or Latino origin and race
Hispanic or Latino origin and race
Table 16.3 Population by Hispanic or Latino origin and by race for the United States: 2000 and 2010a
324
325
Growth (in millions)

Percentage change
32.7
28.0
18.5
27.3
23.9
23.3
22.2
13.2
13.3
11.5
1950
1960
1960
1970
1970
1980
9.8
1980
1990
9.7
1990
2000
2000
2010
Figure 16.2 US population change, 19501960 to 20002010. Note: Change for 19501960
includes the populations of Alaska and Hawaii in the US total, although they were not US states at
the time of the 1950 census. (Data from US Census Bureau, 2010 Census; Census 2000; Hobbs F,
Stoops N. Demographic trends in the 20th century, Census 2000 Special Reports, CENSR-4, US
Census Bureau, Washington, DC, 2002; and Forstall RL. Population of states and countries of the
United States: 1790 to 1990, US Census Bureau, Washington, DC, 1996. For more information on
confidentiality protection, nonsampling error, and definitions, see www.census.gov/prod/
cen2010/doc/p194-171.pdf. Population distribution and change: 20002010. http://www.census.
gov/prod/cen2010/briefs/c2010br-01.pdf [accessed February 15, 2013].)
2010 (see Table 16.3). US population projections show that minorities will
continue to become a large segment of the total resident population (see
Table 16.4 for population projection from 2010 to 2015).
The United States is going through major demographic changes, making
it more ethnically diverse as a result of heightened immigration and higher
birth rates among minorities. In some US cities, there are no clear racial
majorities anymore, and some racial minorities are becoming the majority.
Managing diversity is, therefore, more important than ever. Some projections
suggest that while the white population may stop growing or decline, the minority population will double within the next few decades. Racial, economic,
ethnic, and demographic changes are occurring in both urban and suburban
communities.
Minorities: diversity in the health care field

Given the changes in the US population, the health care industryof which
pharmacy is an integral partalso must also diversify. To manage diversity,
one must understand diversity. Diversity, as stated earlier, involves the employers ability to accept and appreciate differences among individuals by
Total
Under 5 years
59 years
1014 years
1519 years
2024 years
2529 years
3034 years
3539 years
4044 years
4549 years
5054 years
5559 years
6064 years
6569 years
7074 years
7579 years
8084 years
8589 years
9094 years
9599 years
100 years and over
513 years
1417 years
Age group
310,233
21,100
20,886
20,395
21,770
21,779
21,418
20,400
20,267
21,010
22,596
22,109
19,517
16,758
12,261
9,202
7,282
5,733
3,650
1,570
452
79
37,123
16,994
325,540
22,076
21,707
21,658
21,209
22,342
22,400
22,099
20,841
20,460
21,001
22,367
21,682
18,861
15,812
11,155
7,901
5,676
3,786
1,856
546
105
39,011
17,019
246,630
15,944
15,888
15,560
16,570
16,731
16,544
15,711
15,674
16,610
18,202
18,049
16,134
14,087
10,446
7,867
6,331
5,093
3,290
1,423
407
69
28,273
12,941
256,306
16,563
16,412
16,467
16,143
16,976
17,125
16,915
15,946
15,763
16,561
17,998
17,691
15,582
13,285
9,511
6,780
4,957
3,374
1,674
492
92
29,577
12,937
2015
2010
2010
2015
White alone
Total
39,909
3,034
3,011
3,021
3,410
3,330
3,107
2,845
2,691
2,713
2,838
2,650
2,170
1,671
1,130
845
619
427
247
106
35
8
5,412
2,619
2010
Black or
AfricanAmerican
alone
42,137
3,191
3,084
3,080
3,096
3,449
3,374
3,158
2,872
2,690
2,679
2,765
2,545
2,042
1,528
990
690
458
271
125
40
10
5,529
2,478
2015
3,188
286
264
244
268
275
261
228
210
205
216
200
165
130
87
61
41
26
14
5
1
459
205
2010
3,472
311
292
271
252
273
279
264
230
211
204
214
196
160
123
80
53
32
17
7
2
511
204
2015
American
Indian and
Alaska
native alone
14,415
943
927
894
932
938
1,063
1,245
1,376
1,199
1,064
957
840
704
483
350
236
151
78
27
7
1
1,636
741
2010
16,527
1,004
1,018
1,034
1,030
1,047
1,106
1,305
1,413
1,476
1,272
1,115
1,001
875
717
469
310
186
99
39
9
1
1,844
818
2015
Asian alone
592
53
49
45
48
47
48
52
47
42
40
34
27
21
15
10
7
4
2
1
85
38
2010
662
56
55
52
48
50
49
52
54
48
43
40
34
27
21
14
9
5
3
1
97
39
2015
Native
Hawaiian and
other Pacific
Islander alone
5,499
840
746
631
541
459
395
319
269
241
236
219
181
145
99
69
48
33
19
8
2
1
1,259
450
2010
6,435
951
845
754
639
546
467
405
325
272
242
234
216
176
138
91
60
38
22
10
3
1
1,454
543
2015
Two or
more races
Table 16.4 Resident population projections by race, Hispanic-origin status, and age2010 and 2015a
49,726
5,053
4,888
4,513
4,473
4,010
3,887
4,039
3,868
3,431
3,002
2,425
1,862
1,417
974
710
514
354
195
78
26
6
8,501
3,595
2010
Hispanic
originb
57,711
5,622
5,452
5,401
5,040
4,873
4,311
4,166
4,236
3,979
3,491
3,036
2,450
1,867
1,387
920
637
424
257
117
35
9
9,786
4,112
2015
200,853
11,375
11,448
11,440
12,472
13,049
12,959
11,974
12,078
13,423
15,415
15,800
14,409
12,769
9,534
7,201
5,848
4,759
3,106
1,350
383
63
20,536
9,648
2010
(continued)
203,208
11,487
11,465
11,540
11,524
12,499
13,160
13,068
12,023
12,062
13,316
15,177
15,417
13,849
11,994
8,650
6,183
4,558
3,131
1,564
459
83
20,678
9,175
2015
Not Hispanic,
White alone
326
30,885
255,864
247,434
209,027
87,381
46,837
19,870
6,292
37.1
23,536
196,026
189,473
161,100
65,147
34,926
16,613
5,189
38.4
23,483
203,643
197,229
163,478
73,437
40,164
17,368
5,632
38.6
2015
2010
2015
2010
30,713
243,639
235,016
203,410
76,504
40,229
18,766
5,751
36.9
White alone
Total
4,741
30,201
28,844
26,783
7,258
3,418
1,442
397
31.7
2010
Black or
AfricanAmerican
alone
4,703
32,171
30,940
28,059
8,698
4,111
1,594
445
32.8
2015
387
2,343
2,237
2,108
531
235
87
20
29.9
2010
374
2,547
2,446
2,232
671
314
111
26
31.1
2015
American
Indian and
Alaska
native alone
1,315
11,466
11,095
10,132
2,877
1,333
500
113
36.0
2010
1,468
13,267
12,861
11,437
3,706
1,831
645
149
37.5
2015
Asian alone
66
435
416
397
87
39
14
3
30.5
2010
70
489
470
436
114
53
18
4
32.0
2015
Native
Hawaiian and
other Pacific
Islander alone
668
3,168
2,950
2,890
604
278
110
29
19.9
2010
787
3,747
3,487
3,384
755
363
133
36
20.2
2015
Two or
more races
5,788
34,372
32,576
31,515
6,136
2,858
1,173
305
27.5
2010
Hispanic
originb
2015
6,869
40,202
38,192
36,416
8,104
3,786
1,479
418
27.8
18,225
164,202
159,295
131,959
59,421
32,243
15,509
4,902
41.3
2010
Source: US Census Bureau, 2008 National population projects, August 2008, http://www.census.gov/population/www/projections/2008projections.html.
Represents or rounds to zero.
b Persons of Hispanic origin may be any race.
17,173
166,441
161,868
129,819
65,888
36,623
15,978
5,238
42.1
2015
Not Hispanic,
White alone
a [In thousands (310,233 represents 310,233,000), except as indicated. As of July 1. Projections are based on assumptions about future births, deaths, and net international migration. More information on
methodology and assumptions is available at http://www.census.gov/population/www/projections/methodstatement.html. For definition of median, see guide to tabular presentation.]
1824 years
16 years and over
18 years and over
1664 years
55 years and over
65 years and over
75 years and over
85 years and over
Median age (years)
Age group

327
328
Table 16.5 Total resident population: 19002050

(resident population, in thousands)
Year
Lowest series
Middle series
Highest series
Estimates
1900
(X)
76,094
(X)
1910
(X)
92,407
(X)
1920
(X)
106,461
(X)
1930
(X)
123,077
(X)
1940
(X)
131,954
(X)
1950
(X)
151,868
(X)
1960
(X)
179,979
(X)
1970
(X)
203,810
(X)
1980
(X)
227,225
(X)
1985
(X)
237,924
(X)
1990
(X)
249,391
(X)
1995
262,051
263,434
264,715
2000
270,259
276,241
281,957
2005
276,316
288,286
299,941
2010
281,180
300,431
319,536
2020
289,553
325,942
363,213
2030
292,902
349,993
410,991
2040
290,351
371,505
463,579
2050
285,502
392,031
522,098
Projections
Note: 1900 through 1940 excludes Alaska and Hawaii.

(X) Not applicable.
Data from current population reports. Population projections of the United States by age, sex, race, and
Hispanic origin: 19952050. http://www.census.gov/prod/1/pop/p25-1130/p251130.pdf [accessed February 15, 2013].
hiring and retaining minorities. By understanding diversity, the employer is

better able to provide a work environment that encourages employees to
reach their full potential regardless of the employees ethnic identities, in
the interest of achieving overall organizational objectives.
Definitions of racial minority sometimes vary from one publication to
another. Universally accepted definitions of racial and ethnic categories are
yet to be established. Although the Office of Management and Budget (OMB)
in 1975 issued definitions for use by federal agencies, and in 1997 revised
the standards,4 these definitions are still subject to multiple interpretations.
Sometime professional associations and academic institutions adopt their
own definition of racial/ethnic categories for their data collection on racial
and ethnic identities of individuals.
The issues of availability and accessibility of health care continue to be
of concern. Although health care services may be available, they may not
necessarily be accessible to all members of society. One of the concerns in
329
the provision of health services is access to these services by minority populations. For those who do not have health insurance or coverage, health services
often are inaccessible. Inaccessibility to health services often leads to higher
morbidity and mortality among minority populations. The more representative the mix of minorities as health care providers, the more responsive our
health care system will be to meeting the needs of our ever-growing diverse
population. It is therefore, important to examine access by minorities to the
various types of health professions programs.
Examining the status of minorities in the health fields often poses interpretation problems because of difficulties in getting comparable and commensurable data for several health occupations. Detailed, reliable, and compiled demographic data for minorities in health professions and occupations
are not very readily accessible. However, since professional education is a
prerequisite for entry into the health fields, educational data provide insight
into the admissions of minorities into the health occupations (see Tables 16.6
and 16.7).
Although enrollment into a health processional school does not guarantee
that the student will graduate from the school and then find a job in the
profession, it is the first and perhaps the most critical and necessary step in
the process of becoming a health professional. Enrollment trends, therefore,
provide insight into the expected number of minorities in the professions.
Over the past few years, the number of minorities enrolled in the health
professional schools has seen a gradual increase; however, this increase for
the most part has not kept up with the increase in the minority population.
The exception is for the Asian population; enrollment of Asian students
has either kept up with or exceeded the percentage of Asians in the population (see Table 16.6). In 1990, the US population included 11.8 percent
African-Americans, 9 percent Hispanics, 2.8 percent Asians, and 0.7 percent
American Indians (see Figure 16.1). The enrollment of racial/ethnic minorities in health professional schools in 19931994 for allopathic medicine
(MD) was as follows: only 7.4 percent were African-Americans, 6 percent were Hispanics, 0.5 percent were American Indians, and 16.1 percent
were Asians. In 19921993, enrollment for osteopathic medicine (DO) was
3.1 percent African-American, 4.0 percent Hispanic, 0.6 percent American
Indian, and 10.0 percent Asian. Enrollment for dentistry in 1992 to 1993 was
5.9 percent African-American, 7.2 percent Hispanic, 0.3 percent American
Indian, and 16.6 percent Asian. For podiatric medicine enrollment in 1992
to 1993, 9.3 percent were African-American, 6.6 percent Hispanic, 0.4 percent American Indians and 10.1 percent Asian. For optometry enrollment
in 1991 to 1992, 2.9 percent were African-Americans, 6.1 percent were
Hispanics, 0.5 percent were American Indians, and 13.2 percent were Asians.
For registered nursing baccalaureate (RN) enrollment in 1992, 9 percent
were African-Americans/blacks, 2.8 percent were Hispanics, 0.6 percent
8,628
257,983
199293
199293
199293
1992d
Pharmacy
Podiatric medicine
Veterinary medicine
Registered nursing (RN)
199293
199394
199293
199293
199192
Allied health
Chiropractic
Allopathic medicine (MD)
Osteopathic medicine (DO)
Dentistry
Optometry
Percent of students
108,084
199192g
30.0
22.8
100.0c
17.8
100.0
30.0
100.0b
596
22,675
2,433
2,899
20,227
16,679
39,805
656
669
na
100.0
6,411
11,088
23,252
Diploma
199293e
132,603
Associate
Public health
102,128
Baccalaureate
2,438
31,519
1,110
4,884c
199192
Optometry
4,794
15,980
199293
1,312
Dentistry
20,002
7,375b
199293
Minor. enroll.
9.4
13.4
7.7
13.9
302
18,650
1,754
2,248
16,540
12,713
31,499
503
397
3,524
458
2,144
569
9,250
Underrep. minora
Racial/ethnic category
66,629
199394
Osteopathic medicine (DO)
Total enroll.
Allopathic medicine (MD)
Number of students
Health profession and academic year
2.9
5.9
3.1
7.4
110
11,453
790
1,666
11,327
9,154
22,147
183
226
2,340
141
944
231
4,900
Black
6.1
7.2
4.0
6.0
168
6,700
871
534
4,237
2,896
7,667
270
162
1,088
295
1,152
293
3,986
Hispanic
0.5
0.3
0.6
0.5
24
497
93
46
976
683
1,685
50
96
22
48
45
364
Amer. Indian
Table 16.6 Total enrollment in selected health professions schools in the United States by racial/ethnic category: recent years
13.2
16.6
10.1
16.1
294
4,025
679
653
3,687
3,966
8,306
139
246
4,135
643
2,650
743
10,752
Asian
(continued)
0.2
na
na
1.3
5,061
85,409
8,655f
20,353f
112,368
85,442
21,816f
14
26
na
na
na
na
853
Other
330
100.0
100.0
100.0
199293
199293
199293
1992d
Pharmacy
Podiatric medicine
Veterinary medicine
Registered nursing (RN)
100.0
100.0
199192g
199293h
Allied health
Chiropractic
9.3
21.0
21.9
12.5
15.3
16.3
15.4
7.6
27.4
na
Minor. enroll.
4.7
17.3
15.8
9.7
12.5
12.4
12.2
5.8
16.3
11.2
Underrep. minora
1.7
10.6
7.1
7.2
8.5
9.0
8.6
2.1
9.3
7.4
Black
2.6
6.2
7.9
2.3
3.2
2.8
3.0
3.1
6.6
3.5
Hispanic
0.3
0.6
0.8
0.2
0.7
0.6
0.7
0.6
0.4
0.3
Amer. Indian
4.6
3.7
6.1
2.8
2.8
3.9
3.2
1.6
10.1
13.1
Asian
78.9
79.0
78.1f
87.5f
84.7f
83.7f
84.6f
0.2
1.1
na
Other
h Total enrollment includes data from eight reporting schools. Details does not sum to total due to missing racial/ethnic data from one school.
g Includes only programs accredited by the Committee on Allied Health Education and Accreditation (CAHEA) of the American Medical Association.
f Minority composition of total enrollment not available.
e Excludes foreign nationals.
Samoa, Guam, Puerto Rico, and the Virgin Islands.
d Estimated numbers. Detail may not sum to total due to rounding. Data for all nursing categories are based on 1,484 reporting basic registered nursing programs. Excludes American
c Includes 121 students enrolled in Puerto Rico: nonminority, 3; Black, 1; Hispanic, 117.
b Includes nine individuals for whom race/ethnicity data were not available.
a Includes Black Americans, Hispanic Americans, and American Indians.
(Data from Minorities and Woman in the Health Fields, 1994 edited. Rockville MD: US Department of Health and Human Services, Health Resources and Services Administration,
Bureau of Health Professions. August 1994.)
naData not available.
100.0
100.0
Diploma
199293e
100.0
Associate
Public health
100.0
Baccalaureate
100.0
Total enroll.
Health profession and academic year

331
198485d
198687
198889
199091
Osteopathic medicine
198485d
198687
198889
199091
Allopathic medicine
198485d
198687
198889
199091
All health fiels
Field of study and year
1,489
1,618
1,635
1,459
14,972
15,429
15,460
15,043
28,375
29,043
29,210
27,821
Total
86
109
158
163
1,881
2,141
2,567
3,054
3,106
3,739
4,332
5,035
All minor.
Number of degrees conferreda
55
64
105
80
1,298
1,336
1,423
1,514
1,964
2,320
2,316
2,514
Underrep. minor.b
29
26
40
17
730
786
793
882
1,073
1,292
1,193
1,308
Black
18
25
56
51
479
484
569
578
746
889
1,014
1,095
Hispanic
8
13
9
12
89
66
61
54
145
139
109
111
Amer. Indian
31
45
53
83
583
805
1,144
1,540
1,142
1,419
2,016
2,521
Asian
3
11
7
5
176
151
113
142
419
468
492
499
Otherc
(continued)
1,400
1,498
1,470
1,291
12,915
13,137
12,780
11,847
24,850
24,836
24,386
22,287
White
Table 16.7 First Professional degree conferred by institutions of higher education, by field of study and racial/ethnic category: Biennially,
19841991
332
198485d
198687
198889
199091
Pharmacy
198485d
198687
198889
199091
Optometry
198485d
198687
198889
199091
Dentistry
648
861
1,074
1,244
1,114
1,082
1,093
1,115
4,732
4,739
4,265
3,699
Total
139
270
296
335
121
125
140
176
620
763
824
900
All minor.
43
160
84
125
44
51
61
58
331
444
395
454
Underrep. minor.b
30
112
51
61
14
18
30
17
177
262
183
205
Black
12
42
31
58
28
29
27
34
123
169
199
235
Hispanic
1
6
2
6
2
4
4
7
31
13
13
14
Amer. Indian
96
110
212
210
77
74
79
118
289
319
429
446
Asian
53
60
45
39
14
14
17
21
84
120
158
142
Otherc
(continued)
456
531
733
870
979
943
936
918
4,028
3,856
3,283
2,657
White

333
2,661
2,493
2,890
2,640
2,177
2,230
2,157
2,032
582
591
636
589
Total
101
99
153
148
96
174
119
142
62
58
75
117
All minor.
70
69
101
90
76
150
90
110
47
46
57
83
Underrep. minor.b
22
26
24
30
36
29
32
44
35
33
40
52
Black
42
39
73
55
34
90
44
56
10
11
15
28
Hispanic
6
4
4
5
6
31
14
10
2
2
2
3
Amer. Indian
31
30
52
58
20
24
29
32
15
12
18
34
Asian
77
96
123
125
9
4
9
13
3
12
20
12
Otherc
SOURCE: US Department of Education, National Center for Education Statistics, trends in degrees conferred by Institutions of Higher Education: 198485 through 199091, NCES
93-356.
d Data for 198485 exclude awards to persons whose gender or race/ethnicity could not be imputed.
c Includes nonresident aliens.
b Includes Black Americans, Hispanic Americans and American Indians.
a Within the fifty States and the District of Columbia.
198485d
198687
198889
199091
Chiropractic
198485d
198687
198889
199091
Veterinary medicine
198485d
198687
198889
199091
Podiatric medicine
2,483
2,298
2,614
2,367
2,072
2,052
2,029
1,877
517
521
541
460
White
334
335
were American Indians and 3.9 percent were Asians. For Associate degree
enrollment, 8.5 percent were African-Americans/blacks, 3.2 percent were
Hispanics, 0.7 percent were American Indians and 2.8 percent were Asians.
For diploma degree enrollment, 7.2 percent were African-Americans/blacks,
2.3 percent were Hispanics, 0.2 percent were American Indians, and 2.8 percent were Asians. For Public Health enrollment in 1992 to1993, 7.1 percent
were African-American, 7.9 percent were Hispanics, and 0.8 percent were
American Indians, and 6.1 percent were Asians. For allied health enrollment
in 1991 to 1992, 10.6 percent were African-Americans, 6.2 percent were
Hispanics, 0.6 percent were American Indians, and 3.7 percent were Asians.
For chiropractic medicine enrollment in 1992 to 1993, 1.7 percent were
African-Americans, 2.6 percent were Hispanics, 0.3 percent were American
Indian, and 4.6 percent Asian5 (see Table 16.6). For the 1993 to 1994
school year, of the 25,653 students enrolled in Baccalaureate (BS) Pharmacy
programs, only about 6.1 percent were African-Americans, 3.6 percent were
Hispanics, 13.8 percent were Asians, and 0.4 percent were Indians. The
enrollment data in the Doctor of Pharmacy (PharmD) as the first professional
degree program for the 1993 to 1994 school year showed that 13.1 percent were African-American, 3.4 percent were Hispanics, 24.4 percent were
Asians, and only 0.3 percent were Indians.6
In 1993 to 1994 professional baccalaureate degrees in pharmacy were
awarded to only 4.9 percent African-Americans, 3.7 percent Hispanics,
0.3 percent American Indians, and 10.3 percent Asian Americans. In the
same year PharmD degrees were also awarded, of which only 6.2 percent
were awarded to African-Americans, 2.9 percent to Hispanics, 0.4 percent
were awarded to American Indians, and 25 percent to Asian Americans.6
According to data from several health professional associations, the enrollment of minorities in health profession schools in 19992000 did not
keep pace with the percentage of minorities in the general population during that period, except for Asians. The enrollment for Asians continued
to exceed their percentage in the general population. In 1999 to 2000,
25 percent of students in dentistry were Asians, compared to 4.7 percent
African-Americans, 5.3 percent Hispanics, and 0.6 percent American Indians. In allopathic medical schools, 19.5 percent of students were enrolled
were Asians, compared to 7.6 percent African-Americans, 6.5 percent Hispanics, and 0.9 percent American Indians. In osteopathic medical schools,
14.8 percent of students enrolled were Asians, compared to 3.8 percent
African Americans, 3.6 percent Hispanics, and 0.6 percent American Indians.
Those registered in nursing school consisted of 4.4 percent Asians, 9.9 percent African-Americans, 3.9 percent Hispanics, and 0.8 percent American
Indians. The enrollment in optometry consists of 24.2 percent Asians, 2.0 percent African-Americans, 5.1 percent Hispanics, and 0.6 percent American
Indians. The 19992000 minority enrollment in the schools of pharmacy
336
consisted of 19.7 percent Asians, 8.3 percent African-Americans, 3.3 percent Hispanics, and 0.5 percent American Indians. In schools of podiatry,
15.9 percent of those enrolled in 1999 to 2000 were Asians, compared to
8.5 percent African-Americans, 5.4 percent Hispanics, and 0.4 percent who
were American Indians.712
In 2003 to 2004, a total of 17 978 students were enrolled in predoctoral dental schools. The underrepresented minority dental student enrollment data is lower than the corresponding percentages in the US population. According to the American Dental Association (ADA) Survey of
Predoctoral Dental Educational Institutions, in 2003 to 2004 the percentage of total predoctoral dental school enrollment was 5.41 percent (972)
for blacks/African-Americans, 5.88 percent (1058) Hispanic/Latinos and
0.428 percent (77) for Native American/Alaska Native13 while the corresponding percentage in the US population in the same year was 12.3 percent,
12.5 percent, and less than 1 percent, respectively. Asians had the highest
enrollment, with 22.71 percent (4082) enrolled. Although the American
Dental Education Association (ADEA) has continued its programmatic efforts to increase the number of underrepresented minorities in the dental
profession, those numbers remain drastically disproportionate to their representation in the US population.13 According to the 2009 to 2010 Survey
of Dental Education by the American Dental Association, 20 052 students
were enrolled in dental schools in 2009 to 2010. Of that number, 5.7 percent
(1147) were blacks/African-American, 6.3 percent (1266) were Hispanics,
0.6 percent (126) were American Indians, and 23.9 percent (4787) were
Asians. In 2009, there were 4873 graduates, of whom 5.6 percent (274) were
black/African-Americans, 6.0 percent (290) were Hispanics, 0.7 percent (32)
were American Indians, and 24.4 percent (1191) were Asians.
Racial minority groups remain underrepresented in the population of
Registered Nurses (RN) as well, when compared with their profile in the
general population. Nurses from minority racial and ethnic groups represent only 16.8 percent of all nurses, according to the 2008 report (see
Figure 16.3).14
In that year, blacks/African-Americans, Hispanics, and American Indians/Alaska Natives were underrepresented in the RN population, while
Asians were slightly overrepresented among RNs compared to their percentage in the US population. This may be as a result of recruitment of foreign
trained nurses from Asian countries. In 2008, the registered nurse population
consisted of 5.4 percent blacks/African-Americans (while 12.2 percent of
the US population), Hispanics/Latinos 3.6 percent (while 15.4 percent of
the US population), Asian, Native Hawaiians/Pacific Islanders 5.8 percent
(while 4.5 percent of the US population), American Indians/Alaska Natives
0.3 percent (while 0.8 percent of the US population), and whites 83.2 percent (65.6 of the US population). Persons identified as two or more races,
337
100%
90%
12.5%
12.2%
16.8%
87.5%
87.8%
83.2%
80%
70%
60%
50%
40%
30%
20%
10%
0%
2000
White, non-Hispanic
2004
2008
Non-White or Hispanic
Figure 16.3 Percentage of registered nurses who are white or non-white. (Data from
reference 14.)
non-Hispanic, accounted for 1.7 percent (1.6 percent of the US population)

(see Figure 16.4).14
Minority physicians also are underrepresented in the physician workforce. According to the December 2008 report from the Health Resources
and Services Administration Bureau of Health Professions, approximately
one in four Americans is either black/African-American or Hispanic/Latino,
yet together these two minority groups constitute only 9 percent of the
physician work force (4 percent African-American/blacks and 5 percent
Hispanics).15
Increasing the number of minority physicians is not just an equity issue;
it also will improve access to care for minorities and underserved populations. Studies have shown that minority physicians tend to serve more
uninsured, Medicaid, and underserved patients than non-minority physicians. African-American/black physicians and Hispanic physicians generally
practiced in areas with relatively high populations of their own racial and
ethnic groups.1618
Moy and Bartman18 also found that minority patients tend to use
minority physicians as their usual providers, and more than a third
of minority patients were treated by minority physicians. Furthermore,
African-American/blacks and Asian physicians are more likely to care for
patients outside their own minority group than are non-minority physicians.
Since minority physicians are more likely to provide more culturally
competent care than non-minority physicians, and patients tend to prefer
to be cared for by a physician of a similar race or ethnicity, significant
338
Two or more races, non-Hispanic 1.5%

1.7%
American Indian/Alaska Native, 0.8%
0.3%
non-Hispanic
Asian or Native Hawaiian/
pacific Islander, non-Hispanic
Black/African American,
non-Hispanic
Hispanic/Latino, any race
4.5%
5.8%
12.2%
5.4%
15.4%
3.6%
65.6%
White, non-Hispanic
83.2%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
U.S.population
RN population
Figure 16.4 Distribution of registered nurses and the US population, by racial/ethnic

background. (Data from reference 14.)
increases in the number of minority physicians are greatly needed to meet

the increasingly growing minority populations.
Current trends in pharmacy and pharmaceutical degrees awarded

In 2002 a total of 7573 first professional degrees (BS [1415] and PharmD1
[6158]) were awarded to all pharmacy graduates. Out of that total, 4648
(61.4 percent) were awarded to whites; 1625 (21.5 percent) to Asians, Native Hawaiians, or Pacific Islanders; 575 (7.6 percent) to African-Americans
(blacks); 303 (4.0 percent) to Hispanics; 47 (0.6 percent) to American Indians
or Alaska Natives; 177 (2.3 percent) to foreign students; and 198 (2.6 percent) to other/unknown racial or ethnic identity. In 2002 the number of first
professional degrees in pharmacy awarded to minorities increased slightly
compared to 10 years earlier: Asians had the largest increase, while Hispanics
had the smallest increase. Although Hispanics are probably the largest racial
minority group in the general population, representing 12.5 percent, they
are poorly represented in the pharmacy profession. Only 4 percent of the
pharmacy professional degrees earned in 2002 were awarded to Hispanics,
whereas 21.5 percent of the degrees were awarded to Asians, who represent
only about 3.6 percent of the general population.19 African-Americans represent about 12.3 percent of the population and they received 7.6 percent
of the first professional degrees in pharmacy awarded in 2002. The last
B.S. degree in pharmacy was awarded in 2005 and that degree was phased
out in the United States. As a result, the PharmD became the sole professional
pharmacy degree, awarded after 2005.20
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The representation of minorities in graduate degrees in pharmacy awarded

is worse when compared to first professional degrees. In 2002 a total of
443 MS degrees in pharmaceutical sciences were awarded. Of that total,
181 (40.9 percent) were awarded to whites, 43 (9.7 percent) to Asians,
17 (3.8 percent) to African-Americans, 16 (3.6 percent) to Hispanics, none
to American Indians, 15 (3.4 percent) to other/unknown race, and 171
(38.6 percent) to foreigners. Foreigners received more MS degrees in pharmacy than all the minority racial groups combined.
Most of the PhD degrees in pharmaceutical sciences in 2002 were
awarded to foreigners. Out of the 376 PhD degrees in pharmaceutical sciences awarded in 2002, a total of 151 (40.2 percent) were awarded to whites,
27 (7.2 percent) to Asians, 8 (2.1 percent) to African-Americans, 5 (1.3 percent) to Hispanics, 2 (0.5 percent) to American Indians, 7 (1.9 percent) to
other/unknown racial groups and 176 (46.8 percent) to foreigners.
In 2010, 8 years later, a total of 11,487 PharmD1 as first professional
degrees were awarded. Of those, 6,880 (59.9 percent) were awarded to
whites, 744 (6.5 percent) to blacks/African-Americans, 489 (4.3 percent)
to Hispanics/Latinos, 2,463 (21.4 percent) to Asian/Native Hawaiians/Other
Pacific Islanders, 50 (0.4 percent) to American Indiana/Alaska Natives, 602
(5.2 percent) to those of multiple races/unknown and 259 (2.3 percent) to
foreigners.20 In 2010, racial minorities continued to be underrepresented
compared to their percentage in the general population in the awarding of
the PharmD degree as a first professional degree, except for Asians.
The total number of post-baccalaureate Doctor of Pharmacy degrees
(PharmD2) conferred in 2010 was 527. Of these, 193 (36.6 percent)
were awarded to whites, 53 (10.1 percent) to blacks/African-Americans,
33 (6.3 percent) to Hispanics/Latinos, 91 (17.3 percent) to Asian/Native
Hawaiians/Other Pacific Islanders, 2 (0.4 percent) American Indians/Alaska
Natives, 65 (12.3 percent) to those of multiple races/unknown and 90
(17.1 percent) to foreigners.20 Post-baccalaureate Doctor of Pharmacy students are pharmacists with a baccalaureate (BS Pharmacy) degree who have
decided to return to school to get the Doctor of Pharmacy degree. These
students often continue to work while continuing their PharmD degree as
adult learners.
For graduate-level degrees, the overall percentage of all racial minorities
represented is significantly lower, while a high percentage of foreigners are
represented in graduate degrees awarded.
In 2010, a total of 773 MS degrees in pharmacy were conferred.
Of these, 222 (28.7 percent) were conferred to whites, 22 (2.8 percent)
to blacks/African-Americans, 22 (2.8 percent) to Hispanics/Latinos, 78
(10.1 percent) to Asian/Native Hawaiians/Other Pacific Islanders, 1 (0.1 percent) to American Indiana/Alaska Natives, 73 (9.4 percent) to those of
multiple races/unknown and 355 (45.9 percent) to foreigners.21 In 2010, the
340
percentage of Master of Science degrees awarded was significantly worse for

racial minorities and whites compared to 2002.
In 2010, a total of 450 Doctor of Philosophy Degrees in Pharmaceutical
Sciences were awarded. Of the total degrees awarded, 162 (36.0 percent)
were awarded to whites, 13 (2.9 percent) to blacks/African-Americans, 8
(1.8 percent) to Hispanics/Latinos, 48 (10.7 percent) to Asian/Native Hawaiians/Other Pacific Islanders, 1 (0.2 percent) to American Indiana/Alaska Natives, 18 (4.0 percent) to those of multiple races/unknown and 200 (44.4 percent) to foreigners.21 Except for Asians, the number of racial minorities
receiving the PhD degree continues to be insignificant. Asians continue to
do much better than other racial minorities.
Embracing diversity in the provision of health care in the work environment offers several advantages:
It creates a work environment that is conducive to improved communica-
tion skills, and encourages individual professional growth and creativity,

which will result in enhanced patient care.
It is good business. Patients tend to be more responsive to providers they
can relate to and who can communicate to them, preferably in their own
native language. The success of some pharmacists has been attributed to
the ability of these pharmacists to tailor their services to meet the needs
of the cultural and ethnic groups in their service area.22,23
It provides a conducive environment for effective diversity training,
which will help reduce ethnic, racial, and related forms of discrimination
lawsuits.
Diversity in the health professions can play an important role in eliminating possible discrepancies in the pattern of care among different racial
groups, even after controlling for socioeconomic status.
Social good is served by having more equitable representation and diversity in all facets of society, especially in a critical area such as health
care.
Minority health professionals can serve as role models for minority youth.
These professionals, therefore, serve the unique role of being positive
images to be emulated and sought after by our young people.
Minority health professionals are more likely to provide care in disadvantaged, poor, less attractive neighborhoods because of their greater
commitment to these communities. Racial minorities make up a higher
percentage of residents in these communities. Lack of adequate health
services in such neighborhoods can result in higher morbidity and mortality compared to other neighborhoods.
Greater diversity among health professionals may improve patientprovider relationships, and result in better follow-up, better patient care,
and, ultimately, better patient outcomes and a healthier population.
341
Minority health professionals serve as a voice for minority health issues,

research, and concerns. Minorities are more likely to be more concerned,
involved, and take an active role in health issues concerning them.
Diversity cultivates better understanding and racial harmony in our
ever-growing diverse society.
Culture, race, ethnicity, and health care

Immigrants bring with them to the United States diverse cultures, attitudes,
and beliefs on illness and health care. Several factors, culture among them,
affect a patients response to health care services. The pharmacist is an integral member of the health care team in providing primary care, and, to some
extent, secondary and tertiary care to patients. As a health care provider, the
pharmacist must understand the importance of culture in providing health
care services. Epidemiology and ethnic variations, cultural sensitivity, and
treatment outcome variations are important issues in providing effective
pharmaceutical care to a culturally diverse patient population.
Cultural sensitivity
Cultural sensitivity is essential in understanding a patients cultural values
and how those values influence his or her decision to comply with recommended treatment. A patient is not likely to accept a treatment modality that
is contrary to his or her cultural values and beliefs.
Developing culturally sensitive health care requires being open to issues
surrounding patient cultural health beliefs, and the traditional medical system of that culture, which may be interwoven with spiritual belief. Some
cultures, such as those of Native Americans and Africans, have deep spiritual
foundations and family ties. To these racial minority groups, family means all
relatives. These relatives may also be influential in the patients health care
decision making. Making the US health care system culturally inclusive can
be challenging, but is necessary in light of our increasing diversity.
During patient counseling, it is important to understand that in some
cultures, direct eye contact may be a sign of aggression and disrespect to
ones senior or a person of authority. Knowing this, the pharmacist will not
misinterpret a patients lack of eye contact during counseling, and will not
attempt to force the patient to maintain eye contact. It cannot be overemphasized that the patients belief in the treatment provided by the health care
professional is one of the most important elements responsible for producing
a successful patient outcome.
The US Department of Health and Human Services, Office of Minority
Health (OMH) has published National Standards on Cultural and Linguistically Appropriate Services (CLAS). These standards are summarized in the
342
following section and also may be found at http://minorityhealth.hhs.gov/

templates.
National standards on culturally and linguistically appropriate services

The CLAS standards are primarily directed at health care organizations; however, individual providers are also encouraged to use the standards to make
their practices more culturally and linguistically accessible. The principles
and activities of culturally and linguistically appropriate services should be
integrated throughout an organization and undertaken in partnership with
the communities being served.
The 14 standards are organized by themes: Culturally Competent Care
(Standards 13), Language Access Services (Standards 47), and Organizational Supports for Cultural Competence (Standards 814). Within this
framework, there are three types of standards of varying stringency
mandates, guidelines, and recommendationsas follows:
CLAS mandates are current Federal requirements for all recipients of

Federal funds (Standards 4, 5, 6, and 7).
CLAS guidelines are activities recommended by OMH for adoption
as mandates by Federal, State, and national accrediting agencies (Standards 1, 2, 3, 8, 9, 10, 11, 12, and 13).
CLAS recommendations are suggested by OMH for voluntary adoption
by health care organizations (Standard 14).
Standard 1
Health care organizations should ensure that patients/consumers receive
from all staff members effective, understandable, and respectful care that
is provided in a manner compatible with their cultural health beliefs and
practices and preferred language.
Standard 2
Health care organizations should implement strategies to recruit, retain, and
promote at all levels of the organization a diverse staff and leadership that
are representative of the demographic characteristics of the service area.
Standard 3
Health care organizations should ensure that staff at all levels and across all
disciplines receive ongoing education and training in culturally and linguistically appropriate service delivery.
Standard 4
Health care organizations must offer and provide language assistance services, including bilingual staff and interpreter services, at no cost to each
343
patient/consumer with limited English proficiency at all points of contact, in

a timely manner during all hours of operation.
Standard 5
Health care organizations must provide to patients/consumers in their preferred language both verbal offers and written notices informing them of
their right to receive language assistance services.
Standard 6
Health care organizations must ensure the competence of language assistance
provided to limited English proficient patients/consumers by interpreters and
bilingual staff. Family and friends should not be used to provide interpretation services (except on request by the patient/consumer).
Standard 7
Health care organizations must make available easily understood patientrelated materials and post signage in the languages of the commonly encountered groups and/or groups represented in the service area.
Standard 8
Health care organizations should develop, implement, and promote a written strategic plan that outlines clear goals, policies, operational plans, and
management accountability/oversight mechanisms to provide culturally and
linguistically appropriate services.
Standard 9
Health care organizations should conduct initial and ongoing organizational
self-assessments of CLAS-related activities and are encouraged to integrate
cultural and linguistic competence-related measures into their internal audits,
performance improvement programs, patient satisfaction assessments, and
outcomes-based evaluations.
Standard 10
Health care organizations should ensure that data on the individual patients/consumers race, ethnicity, and spoken and written language are collected in health records, integrated into the organizations management information systems, and periodically updated.
Standard 11
Health care organizations should maintain a current demographic, cultural,
and epidemiological profile of the community as well as a needs assessment
to accurately plan for and implement services that respond to the cultural
and linguistic characteristics of the service area.
344
Standard 12
Health care organizations should develop participatory, collaborative partnerships with communities and utilize a variety of formal and informal
mechanisms to facilitate community and patient/consumer involvement in
designing and implementing CLAS-related activities.
Standard 13
Health care organizations should ensure that conflict and grievance resolution processes are culturally and linguistically sensitive and capable of
identifying, preventing, and resolving cross-cultural conflicts or complaints
by patients/consumers.
Standard 14
Health care organizations are encouraged to regularly make available to
the public information about their progress and successful innovations in
implementing the CLAS standards and to provide public notice in their
communities about the availability of this information.
Epidemiology, ethnic variations and access to care

Certain health problems and illnesses appear to be more prevalent among
different population groups. Differences in mortality rates, incidence, and
prevalence of disease such as sickle cell anemia are seen among different ethnic groups. Therefore, understanding the basic culture-related epidemiology
of any population will lead to improving the quality of pharmaceutical care
and other health services provided to that population.
Some diseases affect different ethnic groups disproportionately.2427
African-American patients are overrepresented among those with sickle cell
anemia, hypertension, and prostate cancer. Since hypertension is the primary
cause of heart and kidney disease, it is not surprising that African-Americans
have greater incidences of stroke, kidney failure, and heart failure related to
high blood pressure when compared to whites. Hispanic patients also have
a high incidence of diabetes, while Hispanic men have a higher incidence
of Hodgkin disease. Chinese-Americans have high rates of liver cancer. Native American women have a higher incident of cervical cancer than white
women. Native Americans appear to have one of the highest rate of diabetes.
According to the Department of Health and Human Services 2004 report
on diabetes in American Indians and Alaska Natives, the death rate due
to diabetes for American Indians and Alaska Natives is three times higher
compared with the general US population.28 Ethnic and cultural differences
also must be considered in patient response to medicine and health care.
The Institute of Medicine report Unequal Treatment: Confronting
Racial and Ethnic Disparities in Health Care in 2002 states that racial
345
and ethnic minorities tend to receive a lower quality of health care than
non-minorities, even when access-related factors, such as patients insurance,
status and income are taken into account.29 The report cites studies finding
that African-Americans and Hispanics are less likely than whites to receive
appropriate cardiac medication, undergo coronary artery bypass surgery and
receive hemodialysis and kidney transplantation and are more likely than
whites to receive a lower quality of basic clinical services, such as intensive
care.29
According to the 2010 National Healthcare Disparities Report, there
is disparity in the quality of care and access to care by racial minorities compared to whites in many measures tracked by the report.
African-Americans/blacks had poorer quality of care and worse access to
care than whites for many measures tracked in the report. For Asians, quality
of care was similar to or better than that for whites, access to care was
worse than whites for many measures that the report tracked. For Native
Hawaiians and other Pacific Islanders, the 1997 new standards for federal
data on race and ethnicity to separate information for Asians have not
yet been incorporated into all databases for more reliable information on
the various measures as other racial groups. American Indians and Alaska
Natives had poorer quality of care and worse access to care than whites for
many measures tracked in the reports. Hispanics/Latinos also had poorer
quality of care and worse access to care than non-Hispanic whites for many
measures that the report tracked.30 Out-of-pocket expenses, including high
copays and premiums and transportation, can be significant barriers to access
to needed health and preventative care. Studies have shown that racial and
ethnic minorities are more likely to face barriers and delay care because of
cost to health care compared to other groups.31,32
Ethnic and racial difference in treatment outcome variations

It is also important that we pay close attention to treatment efficacy for
different racial and ethnic groups. For several years, the typical model used
during medical training in health professional schools and studying medication efficiency was that of a white male or female. To better serve all patients,
this model must to be expanded to include all minority groups. Providing
better health care includes recognizing that responses to specific treatments
may vary from one ethnic subpopulation to another. We must realize that
what may be effective treatment for a typical white male or female may
not be equally effective for a typical African-American, Hispanic, Indian, or
Asian male or female. Genetic factors play a crucial role in drug metabolism
and response to medications,33 and there are significant differences in drug
metabolism among racial and ethnic groups. Genetic polymorphisms of certain enzymes may influence drug actions, altering pharmacokinetics and/or
346
pharmacodynamic properties and, consequently, necessitating dosage adjustments for some individuals.3436
African-Americans with hypertension treated with one agent respond
better to diuretics than to beta-blockers or ACE inhibitors.3739 People of
Chinese heritage are more sensitive to the effects of propranolol on heart rate
and blood pressure compared to whites.40 Substitution for one beta-blocker
with another may be especially problematic for African-Americans because
of clinical differences in their response to propranolol when compared to
labetalol.41 For several psychotropic drugs, such as lithium, antidepressants,
and neuroleptics, Asians require lower doses and are more likely to have
side effects at lower doses compared to whites.42 Asians also are more
sensitive to the adverse effects of alcohol such as tachycardia, palpitations,
and facial flushing. American Indians metabolize alcohol at a faster rate than
whites do.43 These studies show the serious clinical implications that might
arise from treating patients from diverse ethnic groups without regard to
their ethnic differences. Ethnic and racial considerations must be taken into
account in developing restrictive drug formularies and prescribing decisions
to avoid putting minority subpopulations at great risk. Ethnic variations in
diet also may significantly affect drug metabolism.
In recognition that one drug does not fit all adult patients with the same
illness/disease, we are beginning to see drugs that are specifically intended
for or have specific dosing for specific racial groups. For example, in 2005,
the FDA approved BiDil (Arbor Pharmaceuticals Inc.) for the treatment of
heart failure as an adjunct to standard therapy specifically for self-identified
African-American patients.44 Another example is Promacta (GlaxoSmithKline), a thrombopoietin receptor antagonist indicated for the treatment of
thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP). The recommended initial dose of Promacta depends
on the patients condition and ethnicity. It is recommended that patients of
East Asian ancestry (e.g., Chinese, Japanese, Taiwanese or Korean) take half
of the usual recommended dose.45
Cultural influences and use of health care and

pharmaceutical services
Culture influences health behavior, illness response, and attitude toward
health care. Culture influences how we explain, view, and interact with
others.4648 It is no secret that patients do engage in folk healing without
informing their health care provider. Folk or alternative medical care can
affect treatment significantly, because it can complement, interfere with, or
complicate drug therapy.
Cultural explanation of an individuals illness is also important, because
it affects the patients decision whether to seek care or not. To provide better
347
health services to patients, the health care provider should pay attention to
the patients cultural explanation of his or her health problem. This will often
provide helpful insight into the patients perception of the disease process,
ethnology, illness experience, and health belief. The ways an individual will
evaluate, respond to, or treat a symptom, and comply with recommended
treatment, is deeply embedded in the patients culture. By considering a
patients culture in providing health services, health care providers can begin
to see patients as heterogeneous, without generalizing treatment across all patients, which is central to effective clinical care. Cultural differences between
patients and providers can affect health outcomes, and paying attention to
them is directly linked to patient satisfaction and compliance.4956 For both
patients and providers, biases are embedded in their culture, which affects
how they interact with each other.
Social and cultural values greatly influence individual decisions to seek
care, even in the absence of pathological processes, or to delay health care
for a serious health condition.5760 An example of how cultural differences
affect the way people react to symptoms was provided by Zborowski61 in
his description of the response to pain by members of ethnocultural groups,
specifically Jews, Italians, Irish, and Old Americans, in New York City
hospitals in the 1960s. In this study, he reported substantial ethnic variations
in the respondents reaction to pain. Thus, symptom sensitivity seems to
have cultural correlation that affects the use of health care services, and,
consequently, compliance with recommendations. The decision to seek care
often is affected by the social and cultural values regardless of type or severity
of the illness. A patients culture influences what that patient may perceive as
a health problem and what is ignored.
As stated earlier, diversity in the workplace can be instrumental in improving patient outcomes, saving lives, and having a successful community
pharmacy practice. Pharmacists in various professional settings are recognizing the importance of having a diverse workplace and creating patient
loyalty by having a pharmacist who can speak the patients native language.
Having a diverse workforce in pharmacy practice often improves patient
satisfaction and compliance, and improves services to patients. Given current
trends, it may soon be necessary for health care professionals (especially
those in culturally diverse communities) to have at least one individual in
the workplace who can speak another language in addition to English, and
who has an in-depth understanding of a specific culture. Health professionals
who learn about cultural differences are more likely to build trust and loyalty
with their patients. A pharmacist who speaks a patients native language
is better able to emphasize the importance of complying with medication
orders, and explain the role of alternative medical care, if any, than one who
does not speak the patients language. Remember that it is not unusual for
foreign-born individuals to have less-than-adequate English communication
348
skills, and a direct word-for-word translation of the English language does

not always convey the intended meaning. As a result, even simple instructions
in English can easily be misunderstood by the patient, possibly leading to
disastrous results.
Whether pharmacists practice in ambulatory or institutional settings,
their activities are interrelated with those of other medical care personnel.
Of all the health care professionals, pharmacists often are the most easily
accessible and may serve as the gateway to health care. As a result, the patient
may first consult the pharmacist for a specific health problem because the
pharmacist is found more conveniently in the community. Pharmacists also
are very easily accessible to the patient, without a fee or protocol.
Pharmacists, therefore, play a significant role in patient self-medication.
It is estimated that for more than 70 percent of health care problems,
consumers use over-the counter (OTC) medication.62 It also has been documented that pharmacists are a very important factor in influencing a consumer to buy an OTC medication for the first time.63 People who use the
pharmacy for OTC products as the first line of defense against a health
problem are likely to have more confidence in someone who understands
their culture and can communicate effectively with them. Understanding how
some cultural and ethnic groups view health care and medication is important in counseling and improving patient outcomes. Some racial and ethnic
groups, such as the Chinese, believe in healing the whole body. Some ethnic
groups are more inclined than others to use herbal or native remedies in
combination with their OTC and/or prescription drugs. Such combinations
have greater potential for side effects or even death. Patients often believe that
a natural product means a safe product. However, several natural products
have a pharmacological effect and can be deadly. For example, imagine what
could happen if a patient on digoxin also decided to take a natural product
made from digitalis leaves.
Pharmacists, by definition, are knowledgeable about drugs and drug
therapy. However, effective and efficient drug therapy is better achieved if the
patients ethnic, racial, and cultural background are understood and taken
into consideration during patient/pharmacist interaction in the pharmacy.
The importance of the patients culture in health and illness behavior cannot
be overemphasized. From the onset of symptoms, to the time a patient arrives
at a pharmacy, to the time the patient leaves the health care system, he or
she makes several decisions and responses that are influenced by his or her
cultural background.
The patient using the services of a pharmacy or pharmacist goes through
several stages in the decision-making process. These stages can be viewed as
a process occurring over time, in which both the patient and the pharmacist
interact, each playing an important role-the patient at one time and the pharmacist at another. However, the ultimate decision to continue or terminate
349
the health utilization process is made by the patient. These stages, in order,
are as follows:
1
2
3
Perception of a need for a pharmacists advice regarding a health problem; This can occur before symptoms occur, as in preventive care, or
after symptoms appear and the patient needs treatment.
Decision and selection of a pharmacy or pharmacist for consultation:
where to seek help is often based on convenience or familiarity.
Actual consultation with the particular pharmacist or any pharmacist
at the pharmacy of a patients choice: this can occur over the phone or
in person. Most often, it occurs in person when the patient is ready to
make a purchase, but needs a recommendation.
If the patient complies with a pharmacists recommendation and is
satisfied with the outcome, the process is terminated for that health
problem or issue. If, however, the patient chooses not to comply or is
dissatisfied with the consultation and if the health problem persists, the
patient may either end the process or seek another consultation, thus
reinitiating the process (see Figure 16.5). How long it takes a patient to
go through these stages will vary from patient to patient.
To initiate the use of pharmacy services, the patient must first be able to
perceive a need. During this stage, the patient may seek advice from friends
or relatives, a process known as the lay-referral network.64 A patient is more
likely to seek advice from those within the same racial and ethnic group than
from those outside the group. Consultation with friends or relatives often is
crucial to the patients opinion about his or her own health problems and the
subsequent decision to seek advice from a pharmacist or other health care
professional.
The choice of a pharmacy is often a function of the lay-referral system.
A layperson often makes recommendations regarding where to seek health
care, sometimes based on that persons experiences with a similar health
problem or with a particular pharmacy or pharmacist. Also influencing the
selection of a pharmacy is the type of service offered and the pharmacists
ability to communicate in the patients language. Consumers do take advantage of professional services from a pharmacy if they are made aware
of them.65,66 Various studies have indicated that location, convenience, and
low cost are among the most important considerations in selecting a specific
type of pharmacy.67,68 It is possible to distinguish among pharmacy patrons
on the basis of their involvement and expertise in their choice of pharmacy.
Patient involvement with a pharmacy and expertise in pharmacy selection are
related to demographic characteristics and patient experience.69 As more of
the patient population belongs to a health care organization, such as health
maintenance organizations (HMO) or managed care organizations (MCO),
these organizations will continue to play a significant role in determining
350
Patient seeks second opinion

Patient does not
comply with
recommendations
Patient consults
with pharmacists
Patient decides
and select a
pharmacy or
pharmacist
Patient perceives
a need to consult
with pharmacist
Patient
satisfied
End of
process
Patient complies with

recommendations
(e.g., seeks a physician
uses OTC drug or other)
Patient seeks second opinion
Stage 1
Figure 16.5
Stage 2
Patient dissatisfied
Stage 3
Stage 4
Stages in the use of pharmacy (pharmacist) services. OTC, over-the-counter.
where patients receive their pharmacy services. Patients who are members of
health plans and who do not wish to pay more out-of-pocket for services
or medications can use only those pharmacies selected by their health plan
to receive benefits such as partial or full reimbursement for pharmacy services. However, where a consumer can culturally relate to a pharmacist or
pharmacy, there is a greater likelihood of increased use of that pharmacists
or pharmacys services. As competition in community pharmacy practice
increases, having diversity in the pharmacy creates an added differential
advantage to help the pharmacy to remain financially viable. Once a pharmacy is identified in the community as being very effective in meeting the
needs of an ethnic group, especially those who speak little or no English,
the lay-referral system will further promote the services provided by that
pharmacy. This may encourage the pharmacy to get into a health plan to
provide pharmaceutical care to health plan enrollees when patients learn to
use outcome data to select pharmacy services.
The next stage in the decision process involves the actual consultation with
the chosen pharmacist or pharmacy. The consultation can be over the phone
351
or face-to-face. The patient evaluates the pharmacist before and during the
consultation. Most patient-initiated consultations occur face-to-face. After
consultation, and possibly during the consultation, based on the patients
perception on how he or she was treated and the patients confidence in
the pharmacist, the patient decides whether to comply with the pharmacists
recommendations. The recommendation could be to see a physician, use an
OTC drug, or take some other course of action. Decisions at this stage also
can be influenced by the lay-referral network. If the pharmacist meets the
expectations of the patient, the patient often will comply, as long as compliance does not make an undue demand on the patients social functioning
or involve a behavioral change contrary to the patients belief and culture.
Where the recommendation is in conflict with the patients expectations or
culture, noncompliance becomes inevitable. A successful outcome after the
interaction between the pharmacist and the patient is beneficial in effective
treatment of a health problem.
It is only by understanding the patients cultural background that the
pharmacist may best be able to serve the needs of that patient effectively.
Once a pharmacist recognizes that a patient has perceived a major health
problem to be a minor one because of cultural background and belief, then
the pharmacist can more effectively communicate with the patient about the
importance of consulting a physician rather than using an OTC product. The
pharmacist can therefore emphasize the potential consequences of delaying
care and can explain that OTC products can mask the symptoms of a
potential major health problem.
As already indicated, regardless of what recommendations a health care
professional makes to a patient, these recommendations will be influenced by
a host of sociocultural and psychological factors. If the patient decides not to
comply, for whatever reason, either the process is terminated, or the patient
may decide to seek a second opinion from another health care provider,
sometimes utilizing the lay-referral system again. If the recommendations
result in a desirable outcome, the patient will very likely continue to consult
with that pharmacist as a community health care provider.
Culture and treatment compliance

The importance of culture, race, and ethnic background in the lay-referral
system must be emphasized. Each racial and ethnic group respects and
accepts certain values, attitudes, and beliefs within its culture. The value
system of an ethnic group is deep-seated, bringing strong adherence to a
set of beliefs. Different cultures use varying standards for judging normality and abnormality, so that what is regarded as illness or disease in one
cultural setting may not be so in another. The range of perceived normality
and abnormality, therefore, may vary widely from one culture to the next.
352
Mechanic70 provided a good example with a skin disorder called dyschromic

spirochetosis; it was so prevalent in a South American tribe that tribal
members who did not have the disease were regarded as abnormal. In this
instance, having the disease was perceived by tribal members as normal
rather than a disease process. Recommendation for a treatment in such a
situation would be likely to fail because it is in conflict with the patients
belief.
Cultural perspectives regarding illness and disease operate at different
periods in the illness determination process. The experience of illness and
the decision to seek help and to comply with a prescribed regimen are as
much a function of the ability to cope and adapt to ones culture as they
are a biologic phenomenon. Where the lines between health and illness are
not clear to the average person, cultural factors typically intervene before a
perception of illness and a need for health care are realized. When the need
for health care is not realized, even the recommendation to seek care will not
be complied with.
A patients social group structure, which includes ethnic exclusivity and
family tradition (i.e., the importance placed on custom and traditions), is
one of Suchmans measures of illness behavior. Suchman71 found that ethnic
exclusivity was associated with a high degree of skepticism toward medical
care, thus making effective communication with patients crucial. Stoeckles
definition of the factors that cause patients to seek health care in response to
symptoms included the following:
the patients perception, belief, and attitude about the health problem;
the patients attitude and expectation of the health care system; and
the patients definition of health and sickness, including when health care
becomes necessary.72
Because of variations in patient response to illness and in the tendency to seek
health care, several other researchers have suggested various health belief
models to summarize and explain these differences.7375
A close look at these health belief models explaining patient response to
illness shows that they appear to have one basic and essential element in
commonthe patients culture. Although culture is not emphasized in these
models, they do recognize that culture clearly influences how one handles
sickness, including the decision to comply, with recommended treatment.
Unsuccessful consultation with the pharmacist obviously has several
negative ramifications for the patient, including loss of confidence in the
pharmacist as a health care professional, increased health care expenses,
wasted time, and perhaps increased morbidity and mortality. For a successful
outcome, it usually is necessary for the patient to comply with health care
recommendations. The health care professional must understand the patient
in order to improve patient compliance.
353
The literature is rich in information and various reasons why patients

may not comply with a prescribed regimen. These reasons include side
effects, taste, cost, and attitude toward health care providers and illness. A
patients attitude is often influenced by the culture. Therefore, the health care
professional should pay more attention to the patients cultural background.
Culture not only influences the patients decision to seek care but also the
decision to comply or not comply with recommended therapeutic regimens.
Conflicting cultural beliefs across ethnic groups have been documented
to affect medication compliance and drug and placebo responses, as well as
responses to standardized clinical psychiatric and psychological tests.7678
Where culture and compliance are in conflict, the importance of an effective pharmacistpatient relationship and communication cannot be overemphasized. Reassuring the patient that the recommendation is essential for
effective treatment of the health problem will help improve compliance,
patient care, and outcomes.
Conclusion
The United States population is becoming more diversified than ever. Projections by the US Census Bureau indicate that racial minority populations
will continue to increase. Different ethnic and racial groups have different
cultures with real implications for health care and services. Although the
number of racial minority enrollments and graduations from health professional schools appear to be increasing, these minorities are still very
much under-represented compared to their proportions in the population.
Asians have made more significant progress in entering the health professions
compared to other racial minorities. In some of the health professions, the
percentage of Asians is equal to or greater than their percentage in the
overall population. There are several advantages to having a racially diverse
workforce in the provision of health services.
Certain diseases and health problems appear to be more prevalent among
certain ethnic and racial groups. Racial minorities also show different responses to different classes of drug when compared to white Americans.
Genetic factors play an important role in drug metabolism, which may
explain the difference in drug responses by different ethnic and racial groups.
Racial and ethnic minorities tend to receive a lower quality of care
than non-minorities, even when access-related factors such as income and
insurance status are taken into account. Racial and ethnic minorities are
more likely to face barriers and delays in care because of cost of health care
compared to other groups.
Ethnic and racial minorities can be subjected to greater health risks if
they receive the usual or standard doses of some drugs, because they cannot
tolerate the standard dosage of these drugs. Racial minorities should be
354
included in all clinical drug trials and metabolic studies for better determination of therapeutic efficacy, effectiveness, and side effects among minority
populations. Health care professionals should individualize treatment and
take racial and ethnic origin into consideration. The extent and nature of
cross-racial variability in metabolism and response to all classes of drugs are
not yet known. Health care providers should watch for atypical responses
or unexpected side effects in therapeutic management of persons from racial
and ethnic minorities.
Ethnic, racial, and cultural background play a significant role in patient
responses to therapy, illness, disease, and health care services.79 Different
cultures use differing standards in judging ill health. The patients culture
not only influences the patients decision to seek care, but also whether to
comply with recommended therapy. Pharmacists must consider a patients
ethnic, racial, and cultural background to provide optimal drug therapy and
professional services, especially to racial minorities.

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17
Professionalism and ethics
Dean L. Arneson, PhD
Eve Hendersen, PharmD, owner of Delta Pharmacy, was amazed when Alex
Bishop returned six bottles of Copegus 200 mg and Pegasys syringes with an
estimated cost of over $8000. He said that he and his girlfriend had a huge
fight and she left a week ago and he didnt know where she is. He is moving
away and didnt want to throw away the medications in the trash.
Eve knew that she had several other patients on the same medication and
that one of them was due for another round of treatment next week. Because
the medication was so expensive she would only order it just in time to fill it
for the next patients prescription.
Eve knew that state law did not allow redispensing of medications once they
had left the pharmacy, but the medications still appeared to be untouched.
Delta Pharmacy had been struggling financially ever since a large discount
merchandise store that had a pharmacy had opened about a year ago. Eve
knew that she could make $8000 in profit if she used the medications to fill
the next patients prescription. This would help her though the next month
of payroll and utility bills.
This type of legal or ethical dilemma is not one that a pharmacist would
face on a daily basis, but it is an example of the type of ethical decision that a
pharmacist may face at some point in his or her career. This situation has the
added element of involving a legal issue: if Eve were to be caught reselling
the medications she could lose her license.
This type of situation depicts the conflict that sometime exists between
ethics and the laws governing the practice of pharmacy, where ethics is defined as the study of how we make judgments in regard to what is considered
right and wrong. In the context of ethics, decisions are based on a persons
morals, which are those things people believe to be right and good. In certain
situations, a pharmacist may have to decide between what is ethically the
right thing to do and following the law. This can be seen as a continuum and
balance between ethics and law. This continuum can be visualized as four
quadrants (Figures 17.1 and 17.2). In these figures, the upper right quadrant
represents the situation where the act would be considered both legal and
360
Legally Right
Morally
Right
Immoral
Illegal
Figure 17.1
Ethical versus legal continuum.
Legally Right
Fill a Legal
Prescription
Refuse a patient
treatment because
they can't pay
Morally
Right
Immoral
Refill a prescription
without authorization
Sell narcotics to an
addict without a prescription
Illegal
Figure 17.2
Ethical versus legal continuum for pharmacists.
ethical: for example, the pharmacist calling the prescribers office to request
refill authorization on a pain management prescription that had not indicated
any refills. This is the legally correct process and also the ethically appropriate
thing to do for a patient who is still in pain.
A pharmacist may be faced with a situation where he or she is asked
to refill a prescription and cannot obtain authorization for the refill. If the
pharmacist decides to refill the prescription anyway, without authorization,
361
he or she may have ethically served the patient but violated the letter of the
law. An example would be refilling an antibiotic for a child whose parents
had lost the medication. By the letter of the law, the prescription should
not be refilled without authorization; however, to prevent the interruption of
therapy, filling the prescription is in the best interest of the patient and by
most accounts the ethical thing to do. This situation would fall in the lower
right quadrant.
The upper left quadrant represents circumstances where the situation
would be considered unethical but legal. An example of this would occur
when a pharmacist refuses to provide a law enforcement office information
on a persons prescription records without a warrant, even though that
office is claiming that it is a medical emergency. Since the person asking for
the information is not another health care provider, legally the pharmacist
should not give out the information without the permission of the patient.
If it is truly a medical emergency, however, ethically they should provide the
information to help benefit the patient.
The last quadrant (lower left) represents situations where the pharmacists
actions would be both illegal and unethical. An obvious example would
be were a pharmacist is shorting a patients prescription for a controlled
substance and selling it to someone else without a prescription.
Balancing decisions between legal and ethical issues has been a challenge
for pharmacist. Generally, the issues are very clear cut as what is the right
thing to do, but as societys values change and laws may become more
prescriptive, the decisions may be harder to make. The advancement of
technology has altered societys viewpoint of many issues. One example
would be the increased ability to detect brain function, which has allowed
a better definition of brain death.
A pharmacist may be presented with dozens of decisions on a daily basis,
and, depending on the situation, he or she may have dozens of choices on
what to do. Whenever a pharmacist is confronted with the need to make
a decision concerning a patients health, interactions with other health care
professionals, and personal matters, they can choose only one response out
of many possibilities for each issue. The right response may be a matter
of opinion, but many factors can influence the decision as to what is the
correct choice for that particular situation. The question that comes up is who
determines what the correct decision is? Is it the pharmacist, the profession,
or society? One may ask why the patient him- or herself is not also a choice
as far as who determines if the decision is correct, since the decision generally
affects them. The patient does have the final decision whether or not to accept
the decision of the health care professional, but he or she does not have the
education and background to weigh the consequences of ethical decisions of
this type. The influences that will determine whether the decision is seen as
correct are the values and beliefs of the pharmacist, which are based on his
362
or her religious beliefs, the environment in which he or she was raised, and
the one he or she currently lives in.
The most common types of ethical interactions that may occur are (1) between the patient and the pharmacist; (2) between one pharmacist and
another pharmacist; and (3) between a pharmacist and a physician or other
health care provider. Such ethical dilemmas generally occur when the values
of one of the parties conflict with those of the other party. For example, the
physician is insisting on prescribing a particular product to treat a patient that
has no scientific basis for treatment of that condition and the pharmacist is
trying to persuade the physician change to a medication that has been proven
to be safe and effective. The dilemma exists because the pharmacist does not
know the rationale behind the physicians decision, and the ethical choice is
to use the treatment that is scientifically proven.
Pharmacy code of ethics

History of the code
To help guide pharmacists with their interactions with patients, other health
care providers, and society, a pharmacy code of ethics has been developed.
These guidelines or codes of behavior for many different professionals have
been around since ancient times. One of the earliest is the Code of Hammurabi (1780 BCE), which is one of the earliest codified set of laws governing
peoples behavior. Also, often cited in the health care field, are the Oath and
Prayer of Maimonides and the Hippocratic Oath (400 BCE).
The history of the code of ethics for pharmacy in America dates back
to 1852, when the American Pharmaceutical Association adopted a code
modeled after a code developed by the Philadelphia College of Pharmacy
4 years earlier. This version has been modified several times over the years
to reflect the change in societys values and expectations of the profession of
pharmacy. At times, over the years, the code addressed more business-related
activities of pharmacy, and at one point even indicated that it would be
unethical for a pharmacist to discuss the medications being dispensed with
the patient. The 1922 version concentrated on the compounding and selling
of safe products, which was a major concern during that era. The next
revision, in 1952 and deemed it to be unethical for the pharmacist to talk to
the patient about their medication, because that which would be interference
in the physicianpatient relationship. The 1969 revision acknowledged that
it was unethical for pharmacies to advertise, especially prices. This claim was
later challenged in court and was overturned, which lead to a minor revision
in 1975. The most recent version was adopted in 1994 by the American
Pharmacist Association.1 This one is patient centered, but also includes a
broader vision on public health and society (Box 17.1).
363
Box 17.1 Code of ethics for pharmacists (1994 version).

Preamble
Pharmacists are health professionals who assist individuals in making
the best use of medications. This Code, prepared and supported by
pharmacists, is intended to state publicly the principles that form
the fundamental basis of the roles and responsibilities of pharmacists. These principles, based on moral obligations and virtues, are
established to guide pharmacists in relationships with patients, health
professionals, and society.
I. A pharmacist respects the covenantal relationship between the
patient and pharmacist.
Considering the patientpharmacist relationship as a covenant means
that a pharmacist has moral obligations in response to the gift of trust
received from society. In return for this gift, a pharmacist promises to
help individuals achieve optimum benefit from their medications, to
be committed to their welfare, and to maintain their trust.
II. A pharmacist promotes the good of every patient in a caring,
compassionate, and confidential manner.
A pharmacist places concern for the well-being of the patient at the
center of professional practice. In doing so, a pharmacist considers
needs stated by the patient as well as those defined by health science.
A pharmacist is dedicated to protecting the dignity of the patient. With
a caring attitude and a compassionate spirit, a pharmacist focuses on
serving the patient in a private and confidential manner.
III. A pharmacist respects the autonomy and dignity of each patient.
A pharmacist promotes the right of self-determination and recognizes
individual self-worth by encouraging patients to participate in decisions about their health. A pharmacist communicates with patients
in terms that are understandable. In all cases, a pharmacist respects
personal and cultural differences among patients.
IV. A pharmacist acts with honesty and integrity in professional
relationships.
A pharmacist has a duty to tell the truth and to act with conviction of
conscience. A pharmacist avoids discriminatory practices, behavior or
work conditions that impair professional judgment, and actions that
compromise dedication to the best interests of patients.
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V. A pharmacist maintains professional competence.

A pharmacist has a duty to maintain knowledge and abilities as new
medications, devices, and technologies become available and as health
information advances.
VI. A pharmacist respects the values and abilities of colleagues and
other health professionals.
When appropriate, a pharmacist asks for the consultation of colleagues or other health professionals or refers the patient. A pharmacist acknowledges that colleagues and other health professionals may
differ in the beliefs and values they apply to the care of the patient.
VII. A pharmacist serves individual, community, and societal needs.
The primary obligation of a pharmacist is to individual patients. However, the obligations of a pharmacist may at times extend beyond the
individual to the community and society. In these situations, the pharmacist recognizes the responsibilities that accompany these obligations
and acts accordingly.
VIII. A pharmacist seeks justice in the distribution of health resources.
When health resources are allocated, a pharmacist is fair and equitable, balancing the needs of patients and society.
(Adopted by the membership of the American Pharmacists Association, October 27, 1994. Reprinted from American Pharmacist Association. Code of ethics for pharmacist (1994). www.pharmacist.com/
AM/Template.cfm [accessed August 1, 2011].)
Why do we have a code?

The code of ethics exists to provide guidance to the members of the profession
regarding expectations of how they should act in their involvement with
patients and society. It outlines what is expected from the interactions a
pharmacist would have on an individual basis with a patient. For example,
section II addresses the aspect of treating a patient in a caring, compassionate,
and confidential manner. This relates to the pharmacist being concerned with
the well-being of the patient and serving them in the fullest capacity that they
can.
What does it mean?

Virtually all health care professions have adopted a code of ethics to provide
guidance for the members of their respective professions. Besides providing
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the profession with guidelines, having a code of ethics serves as a commitment or covenant of the profession to serve the public in the manner that
best serves the interest of patients and society. It allows the public to be able
to read and understand the commitment that the profession is making to the
highest standard of care that can be offered by the health care profession.
Understand and accept the crucial role of ethics as related to

professionalism
What is the relationship?
A profession generally sets forth ethical guidelines for its members. The most
recent version of the Pharmacy Code of Ethics, just discussed, was adopted in
1994. The code of ethics gives the pharmacist guiding principles to deal with
situations concerning patients. Although the code does not dictate specifically
how a pharmacist must act, it provides general guidelines for what is expected
of a pharmacist in dealing with patients and the health care system.
Why is it critical?
The foundation of professionalism is developing standards in dealing with
patients and other health care providers based on current social values. As a
professional, the pharmacist must be committed to making the right decision
for each patient. Due to improvements in technology and changing social
norms, what is considered ethical conduct by a pharmacist changes over
time. The ability to sustain the lives of premature babies at earlier and earlier
gestational time periods is an example of an advancement in technology
that brings up the ethical dilemma of justice in the allocation of health care
dollars.
Distinguish the difference between professional and unprofessional

acts
Examples and explanations
Examples of professional behavior are generally easy to identify, such as
taking the time to counsel a patient on a very complicated dosage regimen.
Some examples of unprofessional behavior also are easily identifiable, such
as refusing to fill a prescription for a patient based on their race or perceived
sexual orientation. Many states have sections in their pharmacy professional
practice act that outline unprofessional activities of pharmacists. Box 17.2
lists the activities considered unprofessional by the state of Wisconsins
Board of Pharmacyas cited in the states rules and regulations. There are
unprofessional acts that are harder to distinguish in real life, howeverfor
example, when there is a conflict of interest such as a pharmacist insisting on
using a particular brand-name product because he or she owns stock in the
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company. Other unprofessional behavior includes, but is not limited to, the
following:
Judgmental acts in which the pharmacist may attempt to impose his or her
values on the patient. An example would be the pharmacist instructing

a young unmarried woman who is buying birth control pills that it is
immoral to have sexual intercourse outside of marriage.
Being rude to a bothersome patient. Even though a patient may have lots
of questions at a very busy time or just wants to talk to the pharmacist,
the pharmacist must handle the situation in a professional manner and
use communication methods that he or she has learned to the address the
patients needs while still being able to do their job.
Showing up late to work or other appointments. Not arriving when
scheduled for work or being late for meetings and other appointments
with patients or other health care workers is inconsiderate and unprofessional.
Leaving work for others to do when the pharmacist is capable of completing the work. An example would be leaving prescriptions to be filled
for the next shift when the pharmacist had the time and capability to fill
them even though the patients were not waiting at that time.
Being unprepared for meetings or presentations. An example would be
not having reviewed all the patients information when rounding with the
hospital team so that when questions come up concerning the patients
medications, the pharmacist does not have an answer.
A situation that may be difficult to handle would arise if a patient were to
ask the pharmacist his or her opinion of the abilities of their physician.
The pharmacist should avoid any criticisms of the persons ability; such
criticism generally is considered being unprofessional, because the pharmacist does not know all the circumstances concerning the interactions
between that patient and the physician.
Box 17.2 Unprofessional conduct.

Phar 10.03 Unprofessional conduct. The following, without limitation
because of enumeration, are violations of standards of professional
conduct and constitute unprofessional conduct in addition to those
grounds specified under Wisconsin legislation s. 450.10 (1), Stats.:
(1)
(2)
Administering, dispensing, supplying or obtaining a drug other

than in legitimate practice, or as prohibited by law;
Engaging in any pharmacy practice which constitutes a danger
to the health, welfare, or safety of patient or public, including
(3)
(4)
(5)
(6)
(7)
(7m)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
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but not limited to, practicing in a manner which substantially

departs from the standard of care ordinarily exercised by a
pharmacist which harmed or could have harmed a patient;
Dispensing a drug which the pharmacist should have known
would harm the patient for whom the medication was prescribed;
Dispensing or causing to be dispensed a drug which is outdated
or contaminated or known by the pharmacist to be unsafe for
consumption;
Falsifying patient records;
Disclosing to the public information concerning a patient without the consent of the patient unless the information is requested
by the pharmacy examining board or the department of regulation and licensing or unless release is otherwise authorized by
law;
Failing to report to the pharmacy examining board any pharmacy practice which constitutes a danger to the health, safety
or welfare of patient or public;
Failing to report to the board information that reasonably suggests there is a probability that a prescription drug or device
dispensed by a pharmacist has caused or contributed to the
substantial bodily injury or death of a customer or patient;
Providing false information to the pharmacy examining board
or its agent;
Refusing to render professional services to a person because of
race, color, sex, religion, or age;
Aiding or abetting the unlicensed practice of pharmacy;
Advertising in a manner which is false, deceptive or misleading;
Dispensing sample drug products for any financial consideration;
Exercising undue influence on or taking unfair advantage of
a patient in the promotion or sale of services, drugs or other
products for the financial gain of the pharmacist or a third party;
Participating in rebate or fee-splitting arrangements with health
practitioners or with health care facilities;
Furnishing a prescriber with any prescription order blanks imprinted with the name of a specific pharmacist or pharmacy;
Using secret formula or code in connection with prescription
orders;
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(17) Having a pharmacist license revoked or suspended in another

state or United States jurisdiction or having been subject to other
disciplinary action by the licensing authority thereof;
(18) Violating or attempting to violate any formal disciplinary order
of the board.
(19) Practicing without a current license.
History: Cr. Register, January, 1980, No. 289, eff. 2180; renum.
from Phar
(Reprinted from Wisconsin Administrative Code. Rules of the Pharmacy Examining Board. Phar 10: standards of professional conduct.
http://docs.legis.wisconsin.gov/code/admin code/phar/10
[accessed
September 23, 2012].)
List, explain and give examples of ethical theories

Several overarching frameworks or theories for ethics are used to determine
what is morally right or wrong when considering human behavior. These theories generally are categorized into one of two basic groups: consequentialist
and deontological.2 Consequentialist theories hold that we ought always
to act in the way that brings about the best consequences. It doesnt matter
what those acts are; the end justifies the means. All that matters for ethics is
making the world a better place. Deontological theories2 concentrate on the
act being performed. According to deontological theories, certain types of act
are intrinsically good or bad. These acts ought or ought not to be performed,
irrespective of the consequences.2
Using the scenario at the beginning of the chapter as an example of
consequentialism, the pharmacist would justify the selling of the returned
medication to help support the pharmacy because keeping the pharmacy
open benefits the rest of the patients who come to the pharmacy. The
consequence, or overall good, of keeping the pharmacy open to be able to
serve more patients is justifiable under this theory, even though the means of
getting to the end may be viewed as questionable. In comparison, using the
deontological theory, the act of reselling the medications with the possible
chance of them not working or even being harmful is not considered good
and therefore should not be done. (The word deontological comes from the
Greek word deon, which means binding duty.) The pharmacist in this case
has a duty to benefit patients that come to the pharmacy and not potentially
harm someone by dispensing adulterated medication.
Two newer theories recently have emerged that relate to health care: the
ethics of care3 and feminist ethics.4 The two are similar in their emphasis
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on empathy, the concern for the needs of others, and the importance of the
relationships and responsibilities that arise with providing care. The feminist
ethics theory also addresses issues of oppression, inequalities, women, and
other disadvantaged groups. As these develop, they may become more and
more pertinent to the practice of pharmacy. Definitions and descriptions of
the other ethical theories can be found in Box 17.3.
Box 17.3 Ethics theories: utilitarianism versus deontological ethics.

Natural law
The system of natural law, often attributed to Aristotle, posits that
man should live life according to an inherent human nature. It can be
contrasted with man-made, or judicial, law, but they are similar in that
both may change over time, despite the frequent claim that natural law
is immutable, often tying it to particular religious beliefs.
Deontology
Deontology holds that the most important aspects of our lives are
governed by certain unbreakable moral rules. Deontologists hold that
these rules may not be broken, even if breaking them may improve an
outcome. In other words, they may do the right thing, even though
the consequences of that action may not be good. The famous
philosopher, Immanuel Kant is often identified with this theory. One
example of a list of unbreakable rules is the Ten Commandments.
Utilitarianism
One of the more functional and commonly used theories, utilitarianism, sometimes called consequentialism or teleology, basically promotes good or valued ends, rather than using the right means. This
theory instructs adherents to work for those outcomes that will give
the most advantage to the majority of those affected in the most impartial way possible. (Simplistically, this theory advocates achieving the
greatest good for the greatest number of people.) It is often advocated
as the basis for broad social policies.
Virtue Theory
The virtue theory asks what a good person would do in specific
real-life situations. This recently revived theory stems from the character traits discussed by Aristotle, Plato, and Thomas Aquinas. They discuss such timeless and cross-cultural virtues as courage, temperance,
wisdom, justice, faith, and charity.
(Reprinted from Moral philosophy. www.moralphilosophy.info/
normativeethics.html [accessed August 1, 2011].)
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List, define and give examples of ethical principles

The ethical theories provide a framework for a broad level understanding
of how and why decisions are made, but on a more elemental level, there
are ethical principles which pharmacists would use to base and defend their
position concerning a particular decision. These principles are the basis of
all of the decisions that the pharmacist will make. The individual situation
will determine what ethical principles are involved, and then the pharmacists
decision will depend on his or her own values. If, for instance, the dilemma
involves the principle of the patients autonomy, then the pharmacists beliefs
about how much autonomy a patient can exercise in the situation would
determine the decision they would make.
One of the first principles that may come to mind is when a health professional interacts with a patient in a paternalistic5 manner (Box 17.4). The
health care professional may act as a parent in making decisions for the patient concerning that patients health care. Just as a parent may need to make
decisions that are in the best interest of their child, the health care professional will decide the best treatment for the patient. They assume the power to
make the decision based on the training and expertise that they possess and
the patient does not. Under normal circumstances, an oncology patient would
not know the most current treatment of choice for their disease, and therefore the oncologist would choose the appropriate therapy to treat the disease.
However this may come into conflict with the patients autonomy (Box 17.4).
Box 17.4 Ethical principles.

Autonomy: existence as independent moral agent: personal independence and the capacity to make moral decisions and act on
them.
Beneficence: the doing of good; active goodness or kindness; charity.
Confidentiality: The ethical principle or legal right that a physician or other health professional will hold secret all information
relating to a patient, unless the patient gives consent permitting
disclosure.
Fidelity: loyalty to an allegiance, promise, or vow.
Informed consent: permission for operation or treatment; agreement by a patient to undergo an operation or medical treatment
or take part in a clinical trial after being informed of and having
understood the risks involved.
Justice: fairness or reasonableness, especially in the way people are
treated or decisions are made.
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Nonmaleficence: The ethical principle of doing no harm, based on

the Hippocratic maxim, primum non nocere, first do no harm.
Paternalism: telling people what is best: a style of government or
management, or an approach to personal relationships, in which
the desire to help, advise, and protect may neglect individual choice
and personal responsibility.
Veracity: the truthfulness or honesty of somebody.
Autonomy (Box 17.4) is probably one of the most controversial and

complicated issues of any of the principles a pharmacist may face. Autonomy is the patients power to make his or her own decisions about his
or her health care. Usually, a patient willingly takes the responsibility for
making the decisions about his or her care. However, the person can only
make such decisions if he or she is provided all the information needed to
make the decision. This brings in the principle of informed consent, which
is discussed later in this section. The controversy and conflict come from
the principle of paternalism, which puts the responsibility for making the
decision about the patients health on the health care provider. The issue is
that by doing this, the health care provider often may not give the patient
all the pertinent information, thereby directing the treatment in the way the
provider wants it to gohopefully the treatment that is in the best interest
of the patient.
Beneficence (Box 17.4) generally is considered the ultimate goal of the
health care professional. The treatment that the health care professional
provides should, in some way, benefit the patient. The care that the health
care professional provides must not cause additional harm to the patient.
A controversy may develop when there is a decision on end-of-life issues.
When, for example, a terminal cancer patient is in the final stages of life,
what treatment should be offered? Would providing adequate narcotic analgesics, even though that may cause the cessation of respiration, be harmful
because it would end the patients life or beneficial because it would end their
suffering? This may be considered in conflict with another ethical principle,
nonmaleficence (Box 17.4), which is to do no harm. The consideration of
what treatment to offer to a patient, especially in end-of-life issues, may
come down to this: if the health care professional cannot provide benefit
to the patient, he or she should at least do no further harm. These two
principles may be considered to be at the opposite ends of a spectrum. At
one end is nonmaleficence, which is to do no harm, and at the other end is
beneficence, which is to bring about a positive good. Along the line would
be preventing harm, e.g., not submitting a terminally ill patient to a painful
procedure which may only provide marginal benefit, or removing harm when
372
it is being inflicted, e.g., withdrawing a painful treatment when it is obviously

not providing any benefit to the patient.
Fidelity (Box 17.4) is defined as being faithful. In this context, the pharmacist must be faithful to two entities: both the patient and the profession.
Being faithful to the patient means that once the pharmacist has accepted that
he or she is going to treat a patient, he or she will maintain the commitment
to treat them until the treatment is complete or the patient terminates the
commitment. For example, if a pharmacist began treating a patient for a
chronic disease and then learned that patient is an ex-convict and then wants
to stop treating him or her, that choice is not an option.
Pharmacists must be faithful to the profession. This means that they
will do everything in their power to uphold and protect the honor of the
profession. They will always present themselves in a professional manner
and maintain a commitment to do the best they can for a patient. One of
the most challenging aspects of this principle could arise when a pharmacist
is confronted with unprofessional, unethical, or illegal acts by another pharmacist or health care provider. It is the pharmacists responsibility to report
these types of activities to the appropriate authority to prevent harm coming
to patients and the profession.
Veracity (Box 17.4) is the act of telling the truth. For a patient to be able to
make an informed decision, the pharmacist must disclose all the information
in a truthful manner in a form the patient can understand. For the most
part this does not cause an issue; however, there are times when the truth
may need to be withheld from the patient. The deception of the patient is
justifiable if, in the health care providers opinion, it is in their best interest.
Informed consent (Box 17.4) is given by the patient at two different
levels, active and passive; however, both require the patient be given the
most complete and accurate information available. The first level of informed
consent is the one most people are familiar with if they have had any surgery
or major treatments. This is an active form, in which the physician or his or
her agent reviews the procedure in detail with the patient so they understand
everything that will take place and the risks involved with the procedure. At
this time the patient can ask any questions or clarify any points. The patient
is then asked to sign a statement indicating that the procedure has been
presented and discussed, and that the risks have been identified. An example
would be the pharmacist discussing the side effects of cancer chemotherapy.
Passive informed consent is what is experienced in community pharmacies
where the patient brings in the prescription to have it filled. The pharmacist
counsels the patient on the medication, educating him or her on the appropriate way to take the medication and, in the process, reviews the side
effects and other risks associated with taking the medication. However, the
patient is never asked to sign any form acknowledging their acceptance of the
treatment; he or she gives consent by following the directions and taking the
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medication. Both active and passive forms require that the patient receive the
most accurate and complete information possible so they can exercise their
autonomy in proceeding with the treatment.
Confidentiality (Box 17.4) must be maintained to create trust between the
patient and the health care provider. The provider must keep all information
confidential. The best way for a patient to be willing to provide all the
information needed by the pharmacist is if they know the information they
provide will not be shared with anyone who is not directly involved with
their treatment.
Most states have laws that protect a persons medical information and
prohibit the dispersement of the information to anyone not directly involved
in the patients treatment without the patients permission, generally in written form, even the patients spouse. The Health Insurance Portability and
Accountability Act of 1996 (HIPPA) requires health care providers to inform
patients of how their medical information will be used by that provider and
receive an acknowledgement of this notification.
Pharmacists must be careful when discussing patient information, even
with colleagues or other health care professionals, in public areas where
friends or family members may overhear. Patient information should only
be discussed in areas where only the health care providers involved with the
case can hear.
When considering the distribution of limited medical resources, the health
care profession must consider the principle of justice (Box 17.4). The amount
of health care resources available is not unlimited, and there will be times
when the health care profession will have to make a decision as to how they
will be distributed. An example would be in the case of an influenza epidemic
and a limited amount of vaccine, where a decision would have to be made
to prioritize who would receive it first. Most likely would be given to health
care providers and public servants such as police and firemen.
Distinguish the difference between virtues, values, morals

and rights
Ethics come from various sources and influences. They are formed during the
growth and maturation of the individual and come from the persons virtues
and values they develop during this process. Some of the major influences
on the formation of these virtues and values come from the persons parents,
peers, and religious instruction.
Virtues6 are commendable qualities or traits that a person may posse or
find desirable in other human beings. Examples of virtues include courage,
wisdom, temperance, commitment, compassion, conscientiousness, cooperativeness, discernment, fairness, fidelity, and honesty. Values7 can be defined
as the accepted principles or standards of a person or a group. They may be
374
viewed as virtues that the person holds as the most important to themselves
and they see as being significant in other people. Morals8 are standards of
behavior that are based on principles of right and wrong as they govern
standards of general behavior.
Rights7 are claims that a person can make on others or on society, as
in saying that a person has the right to die. There has been much debate
in the United States as to whether health care is a right or a privilege. In
other countries, health care is seen as a right that should be available to all
humans, and, therefore, health care is paid for by society and an individual
is not charged on a per visit basis. The present predominant philosophy in
the United States is that health care is more of a privilege that should be paid
for by the individual, either out of pocket or through insurance programs.
List and explain a decision process for determining solutions

to ethical dilemmas
Various processes for making decisions concerning ethical dilemmas, ranging
anywhere from three to six steps, have been published. A four-step approach
is commonly used, and that is what is used in this chapter. The process
outlined here is adapted from the process used by Weinstein.9
1
2
3
4
Identify the dilemma and determine the facts.

Identify the ethical principles that are involved.
Find the options available to you.
Test the options and choose the best one, based on steps 1 and 2.
The first step is to identify the problem and the facts related to the
dilemma. According to Buerki and Vottero,10 it is important to identify
the technical facts, moral parameters, legal constraints, and relevant human
values. This helps in establishing a clear identification of the problem, and
makes it possible to determine that it is an ethical issue and not rooted
in a legal issue. The influence of legal issues may change how the process
is handled; therefore, the ethical principles that come into play must be
identified and must be the primary issues involved with the dilemma.
The second step is to determine what ethical principles are involved. In
the scenario at the beginning of this chapter, the pharmacist is faced with
reselling medications that may have become adulterated due to improper
storage by the patient. The pharmacist has no way of knowing whether
the medications are no longer useable, and they should be disposed of. By
reselling them, she could help her financially struggling pharmacy stay in
business, but legally and ethically there are problems. The ethical issues in
this dilemma are nonmaleficence and fidelity. She potentially could harm
the patient that she resells the medications to if they are adulterated. She
also could be considered in violation of fidelity to both the patient and the
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profession by doing something that could harm the patient and something
that the profession would consider to be wrong. The legal issues do complicate this scenario and may actually override the ethical dilemma and influence
the pharmacists decision.
The third step is to develop and consider what alternatives are available. When developing the alternatives, many different possibilities may
be considered. When forming the list of possible alternatives, all possible
feasible solutions should be considered. The list may contain solutions the
consequences of which will be unacceptable to the person making the choice,
but they should be included for consideration all the same.
In the final step, one solution will be chosen based on the morals and
values of the individual making the choice. The alternative chosen may be
the best one for that person and may be unique for that individual. After he
or she has have chosen the alternative, they should also consider objections
to their alternative, because they may have to defend their actions. If their
actions are based on their morals and values, however, they should feel
confident in their decision.
Discuss ethical dilemmas in process of providing patient

care
In this section we briefly review three possible scenarios that present ethical
dilemmas.
Case 1
Mr. Perkins drops off a new prescription for Reservital, a medication use to
treat prostate cancer, usually when no other medication would work because
of the severe damage it can cause to the liver. Beverly, the pharmacist, asks
Mr. Perkins when he was diagnosed with cancer. He states that he does
not have cancer but that his physician had heard that it can be used to
treat erectile dysfunction, although there is no documented indication for the
medication. Beverly can see from Mr. Perkins profile that he has tried several
other medications for this condition, and when she asked how the others had
worked he said they had no effect. Beverly asked Mr. Perkins what the physician had told him about the medication, and he said only that a colleague
had told him that is had produced good results for his patients. Beverly tries
to contact the physician but the office is closed. What should she do?
1

This case has two obvious ethical dilemmas. The first dilemma is that
the prescriber did not inform Mr. Perkins about the adverse effects of
the medication and, therefore, he may not have had the opportunity to
exercise his autonomy to decide if he is willing to risk possible liver
376
damage. The second dilemma is whether or not Beverly should tell

Mr. Perkins about the possible adverse effects and interfere with the
physicianpatient relationship.
The ethical principles involved are autonomy, informed consent, and
nonmaleficence.
One possible option is to call Mr. Perkins physician and ask for permission to discuss the possible adverse effects on the medication with
him.
or
Fill the prescription without telling Mr. Perkins anything except how to
take the medication and what side effects to watch for.
The first option would seem to be the better choice in this case, because
if the physician gave permission, then Mr. Perkins could receive the
information that he would need to make an informed decision.
Case 2
Dylan, the pharmacy intern, asked to speak with Bob, the pharmacist, in
private. When they got back to Bobs office and closed the door, Dylan told
Bob that Nick had told him to fill out 3 hours of a continuing education
(CE) course for him because he was short the credits and needed them for
his license renewal and didnt have time to do it. Bob knows that they have
been short-staffed at the hospital pharmacy and that Nick has been helping
out a lot by covering extra shifts when needed. Bob also knows that if Nick
does not renew his license, the pharmacy will not be able to keep the 24-hour
service that is required.
1

Nick is attempting to fulfill the requirements for pharmacist licensure
in the state in which he is practicing by having a pharmacy intern
complete the continuing education that is required to be completed by
the pharmacist.
The ethical principle involved is, depending on the type of CE that Nick
is not doing, nonmaleficencebecause it might be that the knowledge
that Nick would have received by completing the CE would have prevented harm to a patient. Veracity also may be cited in that Nick would
be submitting work that he did not do.
Bob could allow Dylan to complete the CE and, after it was submitted,
inform the board of pharmacy of what Nick and Dylan had done.
or
377
Bob could talk to Nick and Dylan and ask if it was true. If it was, he
could give Nick time to complete the CE he needs to renew his license.
The second option would seem to address the dilemmas in a better
manner, because Nick would both obtain useful knowledge and submit
his own work.
Case 3
Jake realized that his neighbors daughter was only 14 and had brought
in a prescription for birth control pills (BCP). He knew that Lloyd was
very involved in his church and would not approve of Julie having sexual
intercourse at that age. However, she had paid for the prescription in cash
and had asked to make sure her prescription files were separate and would
not be given to her parents.
1
2
3

The daughter of Jakes neighbor is starting on BCPs and Jake knows that
her father would not approve of her being sexually active at age 14.
The confidentiality of the daughters prescription information.
Tell the father.
or
Counsel the daughter on the risks of birth control pills and encourage
her to discuss this with her parents.
The second option would not violate the patients confidentiality, and
might aid in developing a dialog between the daughter and her parents.
These are very brief examples of the process of determining actions that
may be ethically defensible for these circumstances. They are by no means an
in-depth analysis of the cases or the alternatives for solutions.
What is professionalism?
In a white paper on pharmacy student professionalism,11 the authors defined
professionalism as the active demonstration of the traits of a professional,
which share ten common characteristics:
prolonged specialized training in a body of abstract knowledge;

a service orientation;
an ideology based on the original faith professed by members;
an ethic that is binding on the practitioners;
a body of knowledge unique to the members;
378
a set of skills that forms the technique of the profession;

a guild of those entitled to practice the profession;
authority granted by society in the form of licensure or certification;
a recognized setting where the profession is practiced; and
a theory of societal benefits derived from the ideology.
They further identify the traits of a professional as including:
knowledge and skills of the profession;

commitment to self-improvement of skills and knowledge;
service orientation;
pride in the profession;
a covenantal relationship with the client;
creativity and innovation;
conscience and trustworthiness;
accountability for his or her work;
ethically sound decision making; and
leadership.
The definition and traits of a professional outline the responsibility that must
be embraced by the health care provider. The ideology and philosophy by
which the profession was created must be adhered to by all its members.
Most entities recognize that what separates a professional from a regular
employee is a specific set of knowledge and skills that must be learned and
developed for that particular career. Pharmacy requires that a person obtain
this knowledge and skills by attending and completing an accredited educational program. The program requirements generally are in the range of 140
credit hours to 150 credit hours of professional college course work leading
to a Doctor of Pharmacy (PharmD) degree. Then the individual must pass
an examination to be allowed to practice pharmacy. This examination also
is also seen as a barrier to entry into the profession, although just having the
degree allows myriad career opportunities. What must be taught/learned over
the 3 years or 4 years of coursework is the commitment that an individual
must make to improve his or her skills and knowledge over the remainder of
his or her career. It is a lifelong commitment, because the information and
techniques used in any medical field change continuously. The obligation
to stay abreast of the most up-to-date information is a commitment to the
patient to provide the best care possible. Pharmacists do receive recognition
from society, which puts its trust in the profession to provide the highest
possible care, and they are held in esteem by the public for the unique services
they provide.
A professional is committed to serving her constituents above most other
matters, even those that may concern family issues. The pharmacist will not
necessarily work on an hourly basis but will have to do what is necessary
379
to complete the task. This may mean spending extra time with patients
so they understand a complicated medication administration technique or
researching the right drug treatment for an obscure disease. This may be
come at the expense of spending time with family and friends, because the
patients needs come first.
It is a covenant with society. Society recognizes pharmacy as a profession,
and with this recognition come the responsibility of being accountable for
the health of the patient. The pharmacist is the advocate of the patient in
drug therapy management. Society will grant this status of being a profession
to the pharmacist and put its trust in him or her to take responsibility
for providing the highest level of care possible. The pharmacist must earn
and maintain the trust of the patient so that the patient will listen to the
pharmacists teaching concerning their medication and then follow his or her
advice.
The pharmacist must document and be held accountable for the educational materials and training they give to the patient. The purpose of
the documentation of this information is twofold; (1) it verifies what the
pharmacist did, so that if there is a problem it can be referred to; and
(2) it allows other health care professionals to see what medication therapy
management plans are addressed. This makes the pharmacist accountable for
his or her work.
Professional development would, then, be the process in which a person
develops these traits. As medication therapies become more complicated and
as pharmacy careers become more intricate, pharmacist must focus more
on long-term career development. This continuous professional development
involves long-term goals and objectives that will allow the pharmacist to
advance particular career paths, which could lead to more involved patient
care. Examples of this type of career development would be, for example,
in states that allow the pharmacist to work with practitioners in developing
drug therapy protocols that can be managed by the pharmacist.
Several additional attributes are recognized as essential to being a professional. One is service to the public, in that the knowledge and skills that
the professional offers to society are recognized as being unique, vital, and
beneficial. An example would be counseling a patient on the appropriate
administration of their medication. Another attribute that is considered a
part of being a professional is having the autonomy to make professional
decision without the influence of patients, employers, or other nonprofessionals. As a pharmacist, when acting on behalf of the patient, if the pharmacist
discovers that there is a potential adverse interaction between a medication
that a patient is already on and a new one that is prescribed, they have the
responsibility to make the decision not to administer or provide the medication. One of the most important attributes is the belief that a profession
must be self-regulating. The profession itself sets the standards as to what
380
is acceptable and what is not when dealing with society. Every state has a
board of pharmacy that regulates the licensure of pharmacists who practice
in that state. These boards regulate the entry into the profession by setting
the requirements for licensure, and they also can rescind licenses if the pharmacist performs in an unprofessional manner. Individuals of the profession
must report unprofessional acts performed by colleagues; this, too, is part
of self-regulation. This is probably one of the most difficult requirements,
because the pharmacist will have to report the unprofessional activity of a
colleague, who may be a friend. However, the pharmacist must hold the
safety and well-being of the patient paramount, and if the unprofessional
activity jeopardizes that well being, the person doing it must be reported.
List and discuss the characteristics of professionalism

A more general look at what may be considered the behavioral attributes of
a professional or behavioral professionalism12 is outlined below:
Specialized knowledge based on extensive preparation. Being a profes-
sional does not happen overnight. It requires many hours of study and
preparation. Professionals are expected to maintain a high knowledge
level and expertise. Organizations compensate professionals for their
knowledge.
Participates in ongoing training and development. A professional firmly
believes in staying current in his or her field. This means that a professional is committed to continued training and development.
Accepts responsibility. Professionals seek and accept responsibility. They
can be trusted and given high levels of responsibility within the organization. A professional is handed tasks at such a high level that poor
performance can reflect poorly on the entire organization, not just the
individual.
Have a sense of ownership of their work. Professionals feel a sense of
ownership and pride in everything they do. Professionals work, not to just
meet organization standards, but, most importantly, to meet the standards
of their own pride in their work. Professionals work for the organization
as if they were working in their own business.
Maintain a collective networking spirit outside of the organization. Professionals understand that their work is not limited to their organization.
They understand the importance of professional relationships outside of
work with others in the same field.
Maintains high standards of ethics and integrity. Professionals are driven
by a code of ethics. They have a strong sense of right and wrong. Their
integrity ensures that they adhere strongly to a set of values about how
they do their work. Integrity leads management and others to trust the
professional. They say what they will do and do what they say.
381
Maintains high standards of performance. Professionals have high levels

of expectations, both of themselves and of others. They are determined
to always do the right thing and do it well. Doing a job well is more
important to a professional then the number of hours that they log
on the clock. A true professional is unsatisfied with poor performance.
While money may be important, it is not the driving force behind the
professionals desire to put forth exemplary work.
This list outlines the behaviors that may be considered the behaviors of a
pharmacist. The fact that it takes an extended preparation period (usually
6 years) to become a pharmacist indicates a considerable amount of information to master, and new material is introduced at an ever-increasing rate.
The pharmacist must dedicate him- or herself to learning and maintaining
his or her level of knowledge to the benefit of the patient and society. As
a professional, there must be a commitment to lifelong learning to be able
to best serve the patient. As a result, the pharmacist is well compensated
for their command of this knowledge and its use to benefit society. With
the trust that patients and society gives to pharmacist comes accountability
for providing a high level of care and this accountability is recognized by
society. The courts have become more aware of this responsibility and have
made more rulings that hold the pharmacist responsible for direct patient
care. Pharmacists are being held liable, especially in the areas of counseling
of patients and checking for drug interactions. Until recently the courts have
not recognized the responsibility of the pharmacist to educate the patient on
the appropriate way to take their medication; it was seen as the responsibility
of the physician or prescriber, and the pharmacist was not to interfere in that
relationship. The courts also did not recognize the pharmacists responsibility in identifying possible interactions with medications that patients were
taking, both prescription and over-the-counter. Formerly, it was something
the patient was to make the prescriber aware of and then allow them to
determine the appropriate medication to prescribe. The courts are now more
aware that the pharmacist has the knowledge and opportunity to prevent
the harm caused by these interactions. For the most part, pharmacists have
embraced these responsibilities and make the public aware that they should
expect this level of professional care. The profession as a whole expects that
the level of care be of the same high standard, no matter where it is provided
and to whom it is provided.
Discuss the concept of professionalism

What does it mean to be a professional? It means providing a level of care
that is the best a person can provide. This will require that the pharmacist
maintain his or her level of competence at its maximum. The pharmacist will
have to commit him- or herself to a process of lifelong learning. This process
382
will require them to continuously read and study the literature to maintain
a mastery of the information on the most up-to-date medication therapy. It
also means that the pharmacist puts their patients needs ahead of his or her
own.
What is caring?
What does it mean to care for patients? Reich13 discusses different aspects
of care and the implications for the practice of pharmacy. He explores the
concept of care as a burden or as devotion. As a profession, it must be seen
as devotion to the patient that is embraced by the pharmacist and not as a
burden that a pharmacist has to bear. By considering it to be devotion to
the patient, it is seen something that the pharmacist accepts and is willing to
provide for the patients needs on a proactive basis rather than just providing
the basic necessities. He further discusses the difference between taking care
of the patient versus caring about the patient. The act of taking care of the
patient addresses the physical needs of the patient as it pertains to the disease.
The caring about the patient goes beyond or even separates the patient and
the disease. As health care professionals, pharmacists need to start caring
about the patient and addressing their needs in a more holistic manner. This
is a moral obligation that pharmacists must accept, just as physicians have
incorporated it into their medical practice.
Conclusion
Societys expectations of pharmacists have changed over the years, and, with
them, what is deemed to be right and wrong activities that represent the
profession of pharmacy. The profession of pharmacy has developed a code
of ethics to help guide the pharmacist in such situations and to help society
understand what types of actions they should expect from pharmacy. Ethical
principles are the guidelines for making decisions when confronted by ethical
dilemmas, and, depending on the morals and values of the pharmacist, will
dictate how the pharmacist responds when confronted with each predicament.
Being a health care professional carries a responsibility to care for patients
at the highest level possible. This is expected of the pharmacist by both the
field of pharmacy and the individual patient. This means providing a higher
level of care than just delivering the right medication to the right patient. It
means putting the needs of the patient and caring about them at the forefront
and making a commitment to that covenant.

1. American Pharmacist Association. Code of ethics for pharmacist (1994). www.
pharmacist.com/AM/Template.cfm [accessed August 1, 2011].
383
2. Moral philosophy. www.moralphilosophy.info/normativeethics.html [accessed August 1,

2011].
3. New World Encyclopedia: ethics of care. www.newworldencyclopedia.org/entry/Ethics
of care [accessed August 1, 2011].
4. Stanford Encyclopedia of Philosophy: feminist ethics www.plato.stanford.edu/entries/
feminism-ethics [accessed August 1, 2011].
5. Websters Ninth New College Dictionary. Springfield (MA): Merriam-Webster Inc.; 1990.
6. Websters New World Dictionary. New York: Simon & Schuster; 1997.
7. Glossatist.com. www.faculty.erau.edu/schliepr/ethics/glossary.html [accessed August 1,
2011].
8. Dictionary.com. 2011. http://dictionary.reference.com/browse/moral [accessed August 1,
2011].
9. Weinstein B. What should I do? 4 simple steps to making better decisions in everyday life/
New York: Berkley Publishing Group; 2000.
10. Buerki RA, Vottero LD. Ethical responsibility in pharmacy practice. 2nd edition. Madison
(WI): American Institute of the History of Pharmacy; 2002.
11. White Paper on Pharmacy Student Professionalism. J Am Pharm Assoc 2000; 40:96102.
12. Walker D. The seven characteristics of a professional. Career Training Site. BellaOnline,
2010 Web. 5 May 2010 www.bellaonline.com/article/art48951.asp [accessed].
13. Ethical dimensions in pharmaceutical care. Binghamton (NY): Pharmaceutical Products
Press; 1996:117.
14. Wisconsin Administrative Code. Rules of the Pharmacy Examining Board. Phar 10:
standards of professional conduct. http://docs.legis.wisconsin.gov/code/admin code/phar/
10 [accessed September 23, 2012].
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18
Health information
technology: emerging
challenges for pharmacy*
Mark Brueckl, RPh, MBA, Norrie Thomas, PhD, MS, RPh
and Abigail Stoddard, PharmD, MBA
The health care industry has used information technology (IT) since the
beginning of the computer age. Until recently, the primary focus has been
to streamline communications and data management, improve revenue and
accounts receivable performance, and manage health services utilization. For
decades, community pharmacies have used IT to process enrollment and
manage drug claims. Hospitals first installed information systems to admit
and track patients, streamline the billing process, and increase the efficiency
of other tasks such as the ordering of tests, procedures, and prescriptions.
In ambulatory physician offices, IT was first used to bill patients, process
claims, and manage scheduling via practice management systems (PMSs).
Recognizing the value of automating the clinical aspects, some companies
began to develop electronic medical records (EMRs), which were effectively
computerized versions of paper charts. Some of those systems integrated with
PMSs, and some of the PMSs evolved their technology to help manage the
clinical aspects of therapy.
Electronic prescribing (e-prescribing) was one of the earliest applications
of health information technology (HIT). Pharmacies realized the countless
hours of interpretation and reentering of data that could be saved by the
transformation of a paper prescription into an electronic prescription, while
managed care recognized the increased ability to influence the prescribing process at the point of prescribing. Although e-prescribing has been
around for decades, often functioning as an electronic prescription writer,
e-prescribing is now much more than that, often including eligibility-driven
formulary information as well as clinical input.
*We acknowledge the generous contributions of the Academy of Managed Care Pharmacy and
the Foundation for Managed Care Pharmacy in supporting the authors and providing valuable
information in writing this chapter.
386
This expanded influence of HIT and e-prescribing is evident now, as

e-prescribing becomes mainstream, and will even be more apparent in a few
years as e-prescribing becomes the predominant form of prescribing.
Today, unlike just a few years ago, most e-prescribing occurs within the
context of an electronic medical record (EMR). While EMRs have been established in hospitals for some time, (more than 68 percent were using EMRs
by 2006), only 15 percent of medical groups had EMR systems installed.1,2
Even now, we are in the midst of another HIT transition as electronic health
records (EHRs) become the successor to EMRs.
A convergence of forces is driving a significant increase in the growth
trajectory for HIT applications, especially those used by clinicians at the
point of care. A new generation of Web-based health care applications is
making systems more accessible and affordable. Quality and usability is
improving, and the federal government is providing unprecedented levels of
funding to promote HIT innovation and adoption.
This chapter provides an overview of the important topics in the HIT
arena. We start with a brief overview of the basic concepts, such as
e-prescribing, EMRs, and health information exchanges (HIEs), followed
by a discussion of what is driving the industry. Then we take a look at
interoperability and the standards development organizations (SDOs) that
help make everything work. We will finish with a look to the future.
Key health IT concepts

Electronic health records and electronic medical records
Although the terms electronic health record (EHR) and electronic medical record (EMR) tend to be used interchangeably, they are not the same.
The EMR contains clinical data, clinical decision support, computerized
provider order entry (CPOE), pharmacy, and clinical documentation applications, and is used by health care practitioners to document, monitor,
and manage health care delivery within a single practice. EMR data is not
typically exchanged with other practitioners or health care organizations.
In todays health care arena, EHRs are the cornerstone of medical practice. In addition to performing clinical functions, they may also contain
administrative and financial functions. EHRs also serve as the legal document for a practitioner. EHRs typically conform to nationally recognized
interoperability standards and can be created, managed, and shared across
more than one health care organization (interoperability).
Although the advantages of EHRs are many, there are costs and concerns
associated with implementing an EHR system in a practice. First there is the
cost of the system itself, which can run into hundreds of thousands of dollars,
based on the size of the practice. Then there is the decreased productivity
during the training and implementation phase. Finally, there is the concern
Health information technology: emerging challenges for pharmacy
387
about the privacy and security of the patient data contained in EHRs. No
one wants unauthorized individuals to have access to their personal health
information; therefore data security must be enforced.
However, in the long run, the benefits outweigh the disadvantages. EHRs
improve productivity by creating more efficient work processes, such as
medication ordering (e-prescribing), improved intra-office communication,
and reduction of repetitive, tedious tasks. Care coordination also improves,
as EHRs typically provide clinical decision support and information on
treatment guidelines, ensuring that appropriate care is provided. The ability
to share patient data among inpatient and outpatient systems and providers,
making all pertinent patient information available to the treating practitioner
at the point of care, is perhaps the greatest asset of EHRs.
Personal health records

A personal health record (PHR) is an EHR that is initiated and maintained
by an individual. There are nationally recognized standards for PHRs. One
distinction between an EHR and PHR must be madea PHR is controlled
by, and can be edited by, the patient, whereas an EHR is controlled and edited
by health care practitioners. A physician may provide information from the
EHR to the patient, allowing that patient to populate his or her PHR.
Patients typically use PHRs to help manage their medications and medical
history. Most individuals have access to PHRs through their health plan,
but there are companies that market PHRs directly to patients, such as
Microsofts HealthVault. One of the goals in the use of PHRs is to make
patients more involved in their own health care. It is believed that patients
who use PHRs pay more attention to their own health and become partners
with their health care practitioners in the process of providing appropriate,
quality cost-effective care.
Computerized physician or provider order entry

Computerized physician (or provider) order entry (CPOE) systems allow the
prescriber to enter clinical orders directly into a health care systems electronic health record. Such systems are primarily found in hospitals, as physicians typically use e-prescribing systems in their private offices (e-prescribing
is covered later in this chapter). The P in the acronym originally denoted
physician, but today, these systems are used by many health care professionals, including physicians assistants, nurse practitioners, and others.
Orders entered into the system are not limited to medications only, and
include almost any item/service/test/therapy that can be obtained within
the health care system, such as laboratory tests, special diets, consultation
requests, oxygen requirements, and others.
388
The primary advantage of CPOE is increased patient safety. Handwritten

orders must be interpreted, transcribed, and delivered to the appropriate
department. CPOE eliminates the handwritten orders, thus there is no chance
for misinterpretation of the providers handwriting. The system then electronically transmits the orders to the correct department. In addition, most
CPOE systems have additional safety checks built in, such as checks for
drugdrug interactions, dosage too low or too high, and patient allergies.
More complex systems include clinical decision support, which provides
evidence-based guidelines for treatment and will provide suggestions to the
prescriber about appropriate medications, tests, and other therapies.
Electronic prescribing
Electronic prescribing (e-prescribing, eRX) systems are becoming more common in physicians offices today, for many of the same reasons that CPOE
systems are implemented in hospitals. Patient safety is, again, the primary
benefit. Handwritten prescriptions are eliminated, thus removing a major
source of medication errors, as there is no need for the pharmacist to
interpret and transcribe a handwritten prescription. Modern e-prescribing
systems also are typically connected to a patients pharmacy benefit data,
providing the physician with information about the patients eligibility, formulary, and medication history.
Until recently, one of the barriers to implementation of e-prescribing was
the inability to transmit electronic prescriptions for controlled substances.
Controlled substances typically entail about 10% of all prescriptions written
by a prescriber, but the deterrent to e-prescribing is the interruption of
the workflow when ordering controlled substances. In July of 2010, the
federal Drug Enforcement Administration (DEA) published rules allowing
physicians to prescribe and pharmacies to receive electronic prescriptions
for controlled substances. The rules focused on increased security of the
e-prescribing systems, and a certification process for those systems before
they would be allowed to be used. Slowly, systems vendors are upgrading
their e-prescribing systems, and electronic prescriptions for controlled substances are trickling in to pharmacies.
HIT drivers
HIT provides greater access to health care information for all parties
involvedpatients and health care professionals alike. An EHR allows health
care practitioners access to patients medical records at the click of a mouse.
Gone are the file folderssome several inches thickthat contain the patients records and the tedious process of sifting through pages and pages of
paper to find lab work, consultation notes, or other test reports. Physicians
389
now have easy access to the patients important medical information at their
fingertips.
Patients also have greater access to their own medical information through
PHRs. This typically leads to patients becoming more involved with their
medical conditions and treatment. Patients who are more involved are more
likely to work with their medical professionals in choosing the best treatment
plan for their condition, leading to a greater understanding of their diseases
and treatments, better adherence and compliance, and more positive outcomes.
Greater access to medical information leads to increased quality in the
medical services provided. Having full access to a patients medical record
and the increased use of clinical decision support systems available in most
EHR systems allows practitioners to provide higher quality health care.
HIT reduces medical errors. Nowhere is this more apparent than in
e-prescribing. Countless errors are avoided by eliminating the interpretation
and transcription of a prescribers handwriting. HIT also reduces duplication
of therapy. Prescribers are able to view tests, x-rays, laboratory work, and
everything else ordered by themselves and other practitioners, eliminating
duplication.
Although it is widely believed that use of HIT will reduce the cost of
health care, the current literature on the subject is inconclusive. However,
uptake and use of HIT is still in its infancy, and as more practitioners
implement HIT systems, the numbers should become clearer. The health
care industry appears to be convinced of the utility and cost-effectiveness
of HIT, as many health plans have developed incentive programs to assist
practitioners in the implementation of HIT.
The federal government has also become a major driver in the effort to
implement HIT. Several laws passed in recent years all have implications for
HIT, including the Health Insurance Portability and Accountability Act of
1996 (HIPAA), the Medicare Drug Improvement and Modernization Act of
2003 (MMA), the Medicare Improvements for Patients and Providers Act
of 2008 (MIPPA), the Health Information Technology for Economic and
Clinical Health Act (HITECH)a component of the American Recovery and
Reinvestment Act of 2009 (ARRA), and the Patient Protection Affordable
Care Act and the Health Care and Education Reconciliation Act of 2010
(collectively referred to as the Affordable Care Act or ACA). HIPAA set the
standards for privacy and security within HIT and also mandates certain
standards for health care transactions. Sections within MMA and MIPPA
define the standards for e-prescribing and the incentive program for use
of e-prescribing in the Medicare Part D prescription drug program. The
HITECH Act and the ACA laid the ground work for the meaningful use of
electronic health records, heath information exchanges and Beacon Communities. HITECH and ACA combined provide up to $27 billion in incentives
390
for HIT implementation. Our next section will describe these legislative
events in more detail and provide context for each HIT advancement.
Key hit events and legislation

The federal government has been a significant and, until recently, largely
unrecognized driver of IT development and adoption (Figure 18.1). In 1996,
the Health Insurance Portability and Accountability Act (HIPAA) was signed
into law and established privacy regulations around patient data. What is less
known is that HIPAA mandated the use of standardized electronic transactions. Consequently, there was an explosion in electronic claims and data.
Health care entities seized the opportunity by leveraging their data to better
monitor and manage their business.3
The next landmark piece of legislation profoundly impacting HIT was the
Medicare Drug Improvement and Modernization Act of 2003 (MMA). Most
widely known for providing a federally funded prescription drug benefit
for Medicare recipients (Medicare Part D), it also contained a number of
provisions that advanced HIT. Some of the game-changing events either
written into the MMA or derived from it include the following4 :
exceptions to the Stark Safe Harbor and Anti-Kickback laws permitting

entities, such as hospitals, physician organizations and health plans to
provide e-prescribing and EMR solutions to physicians, thereby increasing adoption;
requirements that health plans accommodate e-prescribing and adhere to
certain standards when an eligible professional e-prescribes for Medicare
ARRA/HITECH
1995
MIPPA
MMA
HIPAA
2000
2005
Meaningful Use
Incentives Start
2010
PQRI
2015
Meaningful Use
Penalties Start
Affordable Care Act
Figure 18.1 Timeline of pivotal health information technology events. ARRA/HITECH, American
Recovery and Reinvestment Act/ Health Information Technology for Economic and Clinical Health;
HIPAA, Health Insurance Portability and Accountability Act; MIPPA, Medicare Improvements for
Patients and Providers Act; MMA, Medicare Drug Improvement and Modernization Act; PQRI,
Physician Quality Reporting Initiative. (Data from Health information technology primer. Academy
of Managed Care Pharmacy, 2011. www.amcp.org/HITPrimer.)
391
patients (note: The legislation did not require that eligible professionals
prescribe electronically); and
funding of pilot studies on transaction and terminology standards for

key e-prescribing components: medication history, formulary and benefit
status, fill status, patient instructions, drug name standardization, and
electronic prior authorization.
The Physician Quality Reporting Initiative (PQRI) was established by
the Tax Relief and Health Care Act of 2006.5 This program allows eligible
professionals to earn additional Medicare Part B income by reporting on
various quality measures related to patient treatment and conditions. As it
relates to HIT, it established quality measures for e-prescribing. Originally,
the program required an e-prescription to be issued at 50 percent of Medicare
visits that resulted in a prescription. In 2009, the e-prescribing measure
was removed from the PQRI, and was made into an independent program
known as the CMS e-prescribing Incentive Program. Under this program,
providers are eligible for a 2 percent e-prescribing incentive payment, which
can combine with PQRI for a 4 percent total. The recently passed Affordable
Care Act dictates another changethat these incentives will be integrated
into Meaningful use in 2012.
In 2008, provisions within the Medicare Improvements for Patients and
Providers Act (MIPPA) created both incentives (carrots) and penalties (sticks)
around e-prescribing use. Eligible professionals who electronically transmit
at least 50 percent of their prescriptions would receive up to an additional
2 percent per year on their Medicare Part B claims for 5 years, starting
in 2009. Eligible professionals who do not achieve 50 percent will start
incurring penalties in 2012, with penalties escalating to 2 percent in 2014.
In 2009, the federal government set aside up to $29 billion dollars
to encourage the adoption and use of EHRs in the Health Information
Technology for Economic and Clinical Health (HITECH) component of the
American Recovery and Reinvestment Act (ARRA), making the term health
information technology more prominent. This unprecedented investment is
driven by the Federal governments belief that HIT is critical to the transformation of health care in the United States, and represents a watershed event
whose impact on HIT cannot be overstated. With it, the Federal government
provided both a blueprint for the future of health care and HIT, and financial
incentives (Table 18.1), up to $63,750 for each eligible provider and millions
to each hospital that qualifies as a meaningful user. The rationale behind
Meaningful use and the foreseeable future of HIT was made quite clear by
the HIT Policy Committee:
We recommend that the ultimate goal of Meaningful Use of an
Electronic Health Record is to enable significant and measurable
392
improvements in population health through a transformed

healthcare delivery system. The ultimate vision is one in which all
patients are fully engaged in their healthcare, providers have
real-time access to all medical information and tools to help ensure
the quality and safety of the care provided while also affording
improved access and elimination of health care disparities.
This north star must guide our key policy objectives, the advanced
care processes needed to achieve them, and lastly, the specific use of
information technology that will enable the desired outcomes, and
our ability to monitor them.6
Subsequent governmental actions have reinforced the belief that health
care must transform and that HIT will play a pivotal role in that transformation. The Office of the National Coordinator for Health Information
Table 18.1 Meaningful use incentives
Medicare incentives
Certified
meaningful user
2010
2011
2011
2012
2013
2014
2015
$18,000
$12,000
$8,000
$4,000
$2,000
$18,000
$12,000
$8,000
$4,000
$2,000
$44,000
$15,000
$12,000
$8,000
$4,000
$39,000
$12,000
$8,000
$4,000
$24,000
2012
2013
2014
2015+
2016
Total
incentive
$44,000
$ Penalties
Medicaid incentives
Cap on net average allowable
costs, per the HITECH Act
Maximum yearly
incentive (up to 85%)
Maximum cumulative
incentive over 6-year
period
For most eligible professionals

$25,000 in year 1
$21,250
$63,750
$10,000 in years 26
$8,500
For pediatricians with 2030% medicaid patient volume

$16,667 in year 1
$14,167
$6,667 in years 26
$5,667
$42,500
Data from Health information technology primer. Academy of Managed Care Pharmacy, 2011. www.amcp.
org/HITPrimer/.)
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Technology (ONC or ONCHIT) has laid out a clear conceptual framework

for meaningful use with five public policy priorities:
Improve quality, safety, efficiency and reduce health disparities.

Improve population and public health.
Ensure adequate privacy and security protections for protected health
information.
Engage patients and families.
Improve care coordination.
These priorities are addressed in three stages: stage 1data capture and
sharing; stage 2clinical processes; and stage 3improved outcomes (Figure 18.2).
To achieve meaningful use in each stage, a number of criteria must
be met, including a minimum threshold for e-prescribing, interoperability,
clinical decision support (CDS), and quality metrics.7 One criterion is the
inclusion of formulary information, which, for managed care pharmacy, is
critically important. Surprisingly, the requirement for verifying formulary
was made optional, and verifying insurance eligibility was dropped from the
requirements going into effect in 2011. At this time, it is believed that the
formulary requirement will be mandatory for 2013, though the status of the
insurance eligibility check is unknown.
For eligible professionals and hospitals to qualify for meaningful use
incentives, they must use a certified EHR.8 Not every system will qualify as
an EHR certified for meaningful use, nor will every version of an application.
Meaningful Use Stages
Stage 3
2015
Stage 2
2013
Stage 1
2011
Data Capture
& Sharing
Figure 18.2
Improved
Outcomes
Advanced
Clinical
Processes
Stages for meaningful use of health information technology.
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While certification is primarily a responsibility of the HIT vendor, those wishing to qualify for incentives need to ensure that their versions are certified.
As of the time this manuscript was submitted, six entities were recognized
as certifying entities: InfoGard Laboratories, the Certification Commission
for Health IT (CCHIT), the Drummond Group, ICSA Labs, SLI Global
Solutions, and Surescripts.
The ARRA incentives, which provide an estimated $27 billion to eligible
professionals Meaningfully Using certified EHRs, will certainly boost EHR
adoption beyond what might have occurred in their absence.9 However, not
all providers will readily adopt EHRs, for several reasons. First, although the
$44,000 that providers receive in incentives is a considerable sum of money
(Figure 18.2), it must be earned over 5 years and only partially offsets the cost
of EHR implementation and ongoing support. Second, some practitioners,
accustomed to years of practicing medicine without EHRs, will be unwilling
to change. Nevertheless, the front-loaded incentives are expected to stimulate
EHR adoption in 2010 and 2011, with a second wave of adoption in 2015
fueled by the penalties, starting at 1 percent of Medicare reimbursement and
increasing annually. Furthermore, it appears that many commercial insurers
are starting to align their provider incentive programs with meaningful use,
thereby reinforcing the vision that meaningful use of EHRs will be a standard
of care in the very near future.
Before the incentives start, ONC will allocate $2 billion through various
Department of Health and Human Services (HHS) agencies to fund EHR
adoption and connectivity of local HIT initiatives and HHS agencies. A
portion of these funds is also slated for promoting telemedicine, the use of
HIT by public health agencies, and the development of best practices for
integrating HIT into care delivery and protecting patient health information.
The vision is that adoption will be facilitated through regional extension
centers (RECs). The primary goal of these not-for-profit resource centers is to
accelerate EHR adoption in small practice groups (<10 eligible professionals). Relatively few of these small practice groups currently have EHRs in
place. By offering technical and purchasing assistance, education, guidance
and best practice information to small practices, RECs are expected to
provide additional impetus for the adoption and use of EHRs.
While the meaningful use incentives will certainly motivate some, the services offered by RECs to overcome implementation issues, often the biggest
reason for HIT adoption failure, will raise the value threshold significantly.
If constructed and managed correctly, RECs have the opportunity to dramatically improve EHR adoption and use.
The 2010 passage of the Patient Protection and Affordable Care Act and
Health Care and Education Reconciliation Act, collectively referred to as the
Affordable Care Act (ACA), further strengthened the federal governments
influence on HIT. The legislative intent was to ensure that all Americans
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have access to high-quality, affordable health care through structural changes

intended to significantly reduce long-term health care costs. Three major
elements of the legislation stand out because of HITs central role in the
provisions: (1) the promotion and support of new care delivery models;
(2) the expansion of coverage and use of quality measures and reporting;
and (3) the provision of incentives to health care providers and payers to
improve health outcomes. With these three areas of focus, the ACA builds
upon the central tenet of ARRAs HITECH provisions: HIT as the means to
health care transformation. Included in the ACA are numerous provisions
that will shape HIT:
integrating meaningful use reporting with quality reporting;

conducting a study examining methods to increase EHR usage;
requiring EHR usage in most demonstration projects;
requiring the Center for Quality Improvement to align best practices with
meaningful use;
providing grants to long-term care facilities to acquire EHRs;
providing grants to provide HIT training to primary care residents;
providing bonus payments to Medicare Advantage plans that incorporate
HIT to help manage and coordinate patient care; and
requiring the Center for Quality Improvement and Patient Safety to expand demonstration projects for improving the quality of childrens health
care and the use of HIT.
Within the ACA are numerous provisions that indicate the Federal governments intention to evaluate new ways of delivering and paying for health
care, improve quality and decelerate rising costs. At the forefront are the
accountable care organization (ACO) and patient-centered medical home
(PCMH). Taken together the two are intended to replace the uncoordinated
fee-for-service care model with a quality- and care-based model predicated on
treating the whole patient, and with alternative payment models, including
capitation. Central to the success of ACOs and PCMHs will be HIT, specifically the use of EHRs to manage coordination of care as well as providing the
data necessary to perform macro-level organizational analysis of how best to
deliver care.
In summary, there is a national consensus that our health care system
needs to be transformed that the cost of health care exceeds the value and
quality of the care delivered. While there is significant debate surrounding
many of the elements of that transformation, there is consensus that advancing from paper to computerized technology is critical to transformation. The
Federal government has been leading that effort for more than a decade.
An evolutionary path for HIT has been laid out in legislation from HIPAA
through the HITECH component of ARRA and the Affordable Care Act.
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While this transformation is complex and roadblocks remain, these transformational elements bear watching because of the profound potential impact
they are likely to have on stakeholders involved in health care.
Future challenges: interoperability, HIT standards, and HIT

organizations
While health care systems are continuing forward with HIT innovations,
these advancements are not without significant challenge. Any industry that
has introduced radical change has experienced similar growing pains, particularly in the areas of interoperability and the development of standards for
new technology. Participation in the resolution of these challenges is critical
for all stakeholders, including pharmacy, as the solutions will permanently
shape the delivery of patient care.
Interoperability
Interoperability is a property referring to the ability of diverse systems and
organizations to work together (inter-operate). The term is often used in
a technical systems engineering sense, or, alternatively, in a broad sense,
taking into account social, political, and organizational factors that affect
system-to-system performance.10 With respect to HIT, the term is commonly
used to describe the ability of different EHR systems to exchange information
between them. Interoperability is the key to the connected health care system,
and the vision of the national health information network (NHIN).
EHRs exchange information via an electronic document called the continuity of care record (CCR). The CCR is an example of a data standard,
and the exchange of information would not be possible without data and
transmission/exchange standards.11 The CCR contains various sections, such
as patient demographics, insurance information, diagnosis and problem list,
medications, allergies, and care plan. These represent a snapshot of a
patients health data that can be useful or possibly lifesaving, if available at
the time of clinical encounter. A CCR can potentially be created, read, and
interpreted by any EHR or EMR software application. A CCR can also be
exported in other formats, such as PDF and Microsoft Word.11
Health information exchange (HIE) funding was included in the HITECH
Act. HIEs are responsible for creating the data exchange infrastructure, and
will knit together disparate information sources to provide health care professionals with a more comprehensive view of a patients medical information.
HIEs tend to be very geocentric in nature, offering services to the majority
of health care professionals in a defined geographic area. HIEs will be the
means by which a patients medical information can be shared electronically
between physicians in different groups and/or the local hospital.
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However, medical providers in one HIE are limited in their electronic

communications to only those local providers that are also connected to their
HIE; that is, HIEs are not currently interoperable with other HIEs. Thus, the
health information of an individual who spends summers in New York is
not readily available to the physician who treats that same patient during the
winter months in Florida.
The ability to exchange health care information beyond the regionally
focused HIE is the realm of the NHIN. Specifically, ONC is advancing
the NHIN as a network of networks which will connect diverse entities
that need to exchange health information, such as state and regional health
information exchanges (HIEs), integrated delivery systems, health plans that
provide care, and with personally controlled health records.
Although the reality of the NHIN remains a few years away, it will be
an environment that promotes a more effective marketplace, greater competition and increased choice through accessibility to accurate information on
health care costs, quality, and outcomes. It also represents the final piece in
HIT interoperability, which is the ability for an individuals complete health
care information to be accessed from anywhere in the country at any time.
HIT standards
Not only must standards be developed, but the industry must then agree
to use the specific standards and implement them in the various systems.
How then are standards developed? Typically, the industry identifies a gap
in capabilities for a particular system. For example, a transaction involving
billing information or the exchange of clinical information may be needed.
People within the industry form a working group to define what is needed to
close the gap. The first step is to research whether a current standard can be
modified or if a new transaction standard is needed.
As the use of computers became more prevalent in the mid- to late 20th
century, these industry insiders saw the need to formalize these types of
working groups, and created standards development organizations (SDOs).
The primary purpose of such organizations is to create and maintain standards for various electronic transactions. They typically are nonprofit organizations that have representative membership from all aspects of the industry
in which they are involved: e.g., health care, telecommunications, and other
categories. These members come together to create and maintain standards
for the greater good of the industry. As standards are developed, members
of the SDO have the opportunity to comment on and vote for or against
acceptance of the standard, and a standard will not be released for public use
until it has been approved by the members of the SDO that developed it.
Many SDOs are recognized in legislation. HIPAA recognizes the following SDOs for the health care sector:
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The Accredited Standards Committee X12 (ASC X12). Chartered by the

American National Standards Institute (ANSI) more than 30 years ago,
ASC X12 develops and maintains standards that drive business processes
globally. Its diverse membership includes technologists and business process experts, encompassing health care, insurance, transportation, finance, government, supply chain, and other industries.12 Among its wide
array of standards, ASC X12 has developed the electronic standards for
the billing of medical claims. ASC X12N, Version 5010, is referenced in
HIPAA for the billing of medical claims.
The National Council for Prescription Drug Programs (NCPDP). A

not-for-profit, ANSI-accredited, Standards Development Organization
representing virtually every sector of the pharmacy services industry,
the diverse membership provides leadership and health care business
solutions through education and standards, created using a consensus
building process.13 NCPDP has focused primarily on pharmacy-related
transactions including e-prescribing and claims processing. Several of its
standards are referenced in HIPAAfor example, Telecommunication
Standard, Version D.0, for the billing of pharmacy claims, and SCRIPT
electronic prescribing standard, Version 10.1, for the transmission of
electronic prescriptions.
Health Level Seven (HL7). HL7 is a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive
framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical
practice and the management, delivery and evaluation of health services.
HL7s members represent more than 90% of the information systems
vendors serving health care.14 HL7 has developed standards for EHRs
and PHRs (called functional profiles) and many standards for the transfer
of clinical information in hospitals and medical practices.
Maintenance of current standards is as important as the development of
new standards, and follows a similar path to the creation of new standards.
Users of the standard identify a gap in the standard, or develop a new use case
for the standard. That information is shared with the work group in charge of
the standard, and the group develops methods to close the gap. Those methods could include adding new data fields, changing the data requirements for
particular fields, or developing new codes that identify a specific data point.
Most updated standards are designed to be backward-compatible, meaning
that the updated standard retains all of the functionality of the old standard
and adds new features. This allows early adopters of the updated standard the
flexibility to use the updated version and still be able to communicate with
systems that have not updated. Modifications to standards are also voted on
by members of the SDO, and, if approved, are released for public use.
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Implementation of new or updated standards is not always automatic,

and may take 2 years or more to complete. Many issues must be resolved
before any new or updated standard is implemented. Systems developers need
time to program the systems that will use them. Standards must be tested
prior to implementation to ensure that they are useable and problem-free.
Some standards, such as the pharmacy telecommunication standard (NCPDP
Telecommunication Standard Version D.0) and the standard for electronic
medical claims (ASC X12N Version 5010) are named in HIPAA, and may
be updated only through the legal and regulatory process. This typically
delays implementation and further increases the amount of time required
to complete the upgrade.
Recently, members from both HL7 and NCPDP teamed up to form a
work group to develop a functional profile for a pharmacist EHR, entitled
the Pharmacist/Pharmacy Provider Electronic Health Record (PP-EHR). The
joint work group met weekly for over a year to develop the functional profile.
Members of the work group included pharmacists from all areas of practice,
along with representatives from systems vendors and other interested parties.
The members of the work group reviewed all aspects of pharmacy practice to
ensure that all necessary functionality was included in the PP-EHR functional
profile. Once implemented, the PP-EHR will be able to exchange data with
other EHRs, and will enhance the pharmacists ability to perform all aspects
of his or her duty, including medication dispensing and clinical services, such
as MTM and collaborative drug therapy management (CDTM).
HIT organizations
In addition to the SDOs, associations focused on HIT issues have formed.
Some are specific to the medical specialty, such as the following:
The American Medical Informatics Association (AMIA). AMIA aims to

lead the way in transforming health care through trusted science, education, and the practice of informatics. AMIA connects a broad community
of professionals and students interested in informatics. AMIA is the
bridge for knowledge and collaboration across a continuum, from basic
and applied research to the consumer and public health arenas.15
The American Nurses Informatics Association and the Capital Area
Roundtable on Informatics in Nursing (ANIA-CARING). The purpose
of ANIA-CARING is to advance the field of nursing informatics through
communication, education, research, and professional activities.16
Others are open to all stakeholders, such as the following:
The Healthcare Information and Management Systems Society (HIMSS).

HIMSS is a cause-based, not-for-profit organization exclusively focused
on providing global leadership for the optimal use of information
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technology (IT) and management systems for the betterment of health

care. HIMSS represents more than 38,000 individual members, of whom
more than two-thirds work in health care provider, governmental, and
not-for-profit organizations. HIMSS frames and leads health care practices and public policy through its content expertise, professional development, research initiatives, and media vehicles designed to promote
information and management systems contributions to improving the
quality, safety, access, and cost-effectiveness of patient care.17
The American Health Information Management Association (AHIMA).
AHIMA is the premier association of health information management
(HIM) professionals. AHIMAs more than 63,000 members are dedicated
to the effective management of personal health information required to
deliver quality health care to the public. Founded in 1928 to improve
the quality of medical records, AHIMA is committed to advancing the
HIM profession in an increasingly electronic and global environment
through leadership in advocacy, education, certification, and lifelong
learning.18
The eHealth Initiative (eHI). eHI represents the multiple and diverse
stakeholders who are improving health care through the use of HIT. eHIs
mission is to drive improvement in the quality, safety, and efficiency of
health care through information and technology. It is the only national
organization that represents all of the stakeholders in the health care
industry.19
There are also regulatory/certification organizations, such as:
The American National Standards Institute (ANSI). ANSI oversees the

creation, promulgation, and use of thousands of norms and guidelines
that directly impact businesses in nearly every sector: from acoustical
devices to construction equipment, from dairy and livestock production
to energy distribution, and many more. ANSI is also actively engaged
in accrediting programs that assess conformance to standardsincluding
globally recognized cross-sector programs such as the ISO 9000 (quality)
and ISO 14000 (environmental) management systems.20
The Certification Commission for Health Information Technology
(CCHIT). A nonprofit organization with the public mission of accelerating the adoption of health IT, CCHIT was founded in 2004, and has
been certifying EHRs since 2006. The certification criteria were developed
through a voluntary, consensus-based process engaging diverse stakeholders, and the Certification Commission was officially recognized by the
federal government as a certifying body.21
Several bodies within the federal government provide leadership and/or oversight of HIT:
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The Office of the National Coordinator for Health Information Technology (ONC). ONC provides leadership for the development and nationwide implementation of an interoperable health information technology
infrastructure to improve the quality and efficiency of health care and
the ability of consumers to manage their care and safety. The National
Coordinator for Health Information Technology serves as the principal
advisor on the development, application, and use of health information
technology; coordinates the Department of Health and Human Services
(HHS) health information technology programs; ensures that HHS health
information technology policy and programs are coordinated with those
of other relevant executive branch agencies; develops, maintains, and
directs the implementation of a strategic plan to guide the nationwide
implementation of interoperable health information technology in both
the public and private health care sectors that will reduce medical errors,
improve quality, and produce greater value for health care expenditures;
and coordinates outreach and consultation by the relevant executive
branch agencies with the public and private sectors.22
The National Committee on Vital and Health Statistics (NCVHS).
NCVHS is a statutory public advisory body on health data, statistics and
national health information policy. The Committee assists and advises
the Secretary of the Department of Health and Human Services (HHS)
on health data, statistics, privacy, national health information policy,
and the Departments strategy to best address those issues. The Committee monitors the nations health data needs and current approaches
to meeting those needs, identifies strategies and opportunities to achieve
long-term consensus on common health data standards, and makes recommendations regarding health terminology, definitions, classifications,
and guidelines.23
These are but a few of the organizations that have an interest in the HIT
arena. Given the increasing importance of HIT, the number and diversity of
organizations devoted to aspects of HIT will continue to grow.
Implications for pharmacists

Automated dispensing
The ACA will undoubtedly affect all aspects of health care delivery, but it
has particular implications for pharmacists. Imbedded within the ACA is
legislation that will allow HIT to enhance the two core functions of the
pharmacy profession: medication dispensing and patient care.
As of January 1, 2012, skilled nursing facilities are required to adopt
dispensing techniques such as weekly, daily, or automated dispensing by
the ACA.24 Although this change affects only a subset of facilities, it is likely
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that the innovation will spread to other inpatient facilities, clinic medication
administration systems, and emergency medication dispensing models.
This piece of legislation has significant implications for in-patient pharmacy operators. These pharmacists may now be called upon to become the
experts in various medication dispensing technology and automation and
institute novel operations methods for this new technology. Indeed, health
systems will look for leaders to ensure their pharmacy operations evolve from
manual dispensing, punch cards and multi-dose strip packaging to the newest
and most efficient techniques. Properly applied automated dispensing has the
potential not only to increase efficiency, but also to improve patient safety
and reduce medication waste that is costly not only to our payers but to our
environment.
Automated dispensing systems will be expensive and will require large
investments from long-term care facilities. Pharmacy operators and managers
must educate themselves on the costs and benefits of each innovation and
be able to help decision makers determine the best investment. Participation
by pharmacists in organizations such as the American Society of Consultant Pharmacists, the National Council of Prescription Drug Plans, and the
National Association of Boards of Pharmacy will be crucial to creating and
updating resources on dispensing models for pharmacies across the nation.
Telemedicine
Synergistic with the development of HIT is telemedicinethe electronic
exchange of medical information from one site to another to improve patient
health.25 This broad patient care area concept includes tools such as videoconferencing, remote monitoring of vital signs, and decentralized patient
portals connected to provider networks.
The federal government recognizes the potential of telemedicine and has
enacted several programs to foster its growth. In 2011, the Senate introduced
the Fostering Independence Through Technology (FITT) act to create pilot projects for Medicare patients and provide incentives for home health
agencies to adopt more home monitoring technologies.26 That same year
the US Department of Agriculture dedicated more than $30 million for 100
telehealth projects in 34 states.26 These projects included linking hospitals
and installing mobile medical carts, digital stethoscopes, and telemonitoring
systems to support health care teams in remote areas of the USA.
Pharmacists are already involved in telemedicine services and provide
clinical pharmacy care to patients and provider groups throughout the rural
United States. In 2010 the American Pharmacist Association highlighted several programs through the United States that brought pharmacy services to
underserved areas of Nebraska, Arizona, and North Dakota.27 Pharmacists
were able to fulfill vital clinical roles remotely, such as reviewing patient
profiles, providing dose adjustments, and even rounding with physicians via
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telephone.27 As pharmacists expand these services, they will become an integral part of a patients telehealth team, further emphasizing the professions
clinical and patient care value to the interdisciplinary team.
Research
Today pharmacists must understand and use health care technology in ways
to improve patient care by participating in the design and execution of
cost effectiveness research (CER). CER and other major initiatives based
on health care reform legislation give pharmacists a unique opportunity to
create information systems that report and define better ways to use medications to obtain better care at a lower cost, based on real-world assessments.
Information systems that track medication experience at the level of patient
effects, including safety, effectiveness, and cost, will consistently adapt and
change based on legislation and technology advancements. Pharmacists can
play an important role in expanding their scope of influence by leading the
advances in information technology. Several health care reform initiatives are
underway. One initiative, the Patient-Centered Outcomes Research Institute
(PCORI; www.pcori.org), was established in 2010 and is focused on helping
people make informed health care decisions.28 PCORI will not conduct CER
but, rather, address questions from patients such as these:
Given my personal characteristics, conditions, and preferences, what

should I expect will happen to me?
What are my options and what are the benefits and harms of those
options?
How can the health care system improve my chances of achieving the
outcomes I prefer?
Information technology will play an increasing role in tracking, recording, and interpreting the role medications play in improving patient care.
Pharmacists who understand HIT will become the professional leaders of a
new and expanded role for the pharmacy profession.29
Central not only to outcomes research but to all facets of HIT is the use
of uniform standards for clinical data. Access to uniform and precise data
by clinicians and researchers alike is essential to provide continuous patient
care and track outcomes. Although the use of clinical data standards is not
currently required for ACAs meaningful use incentives, organizations such
as the American Health Information Management Association (AHIMA)
and the National Council for Prescription Drug Programs (NCPDP) are
encouraging its inclusion as a requirement for federal incentives.30
A major development for clinical data standards will be the transition to
the International Classification of Disease version 10 (ICD-10). The tenth
version of the ICD codes greatly expands the number and complexity of
diagnosis and procedure codes, allowing for the collection of precise and
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comprehensive data.31 This increased granularity of data will have vast utility
for researchers, as the study population increases with the use of standardized data on interoperable systems. Interoperability and data standards will
enable initiatives like PCORI to expand evidence-based medicine and allow
providers to make informed decisions for the most efficient improvement of
patient health.
The Pharmacy E-Health Information Collaborative

The practice of pharmacy has formed its own organization devoted to HIT.
The Pharmacy e-Health Information Technology Collaborative (referred to
henceforth as the Collaborative) was formed in 2010 by four associations, the Academy of Managed Care Pharmacy (AMCP), the American
Pharmacists Association (APhA), the American Society of Health-Systems
Pharmacists (ASHP), and the National Community Pharmacists Association
(NCPA).32 These four organizations have since been joined by five other
pharmacy associations and several associate member organizations. The Collaborative will address the professions needs and functionality to provide,
document, and bill for pharmacist-provided patient care services in all care
settings, influence HIT policy, and facilitate the provision and enhance the
quality of patient care services provided by pharmacists. Furthermore, the
Collaborative will ensure that resources, technical standards, and provider
knowledge are aligned with the nations growing need for pharmacists
services.32
The first output from the Collaborative is The Roadmap for Pharmacy
Health Information Technology Integration in U.S. Health Care (Roadmap).
The document, released in December 2011, describes the priorities of the
pharmacy profession in relation to HIT to ensure that optimal use of EHRs
contributes to providing safe and effective medication use. It guides provider
organizations, policymakers, vendors, payers, and other stakeholders involved in the integration of pharmacy HIT into the national HIT infrastructure.33
The Roadmap states that the Collaboratives goals include defining the
pharmacists role in the health care delivery system, e-prescribing, immunizations, medication therapy management, and the meaningful use of EHRs.33
The Roadmap also outlines the strategies it will employ over the next 5 years
to achieve these goals. Many of these strategies involve interdisciplinary advocacy by pharmacists and other providers at the state and federal levels. The
creation of grants and funding opportunities for pharmacists to demonstrate
their value in drug therapy management projects, HIEs, and HIT-related
outcomes research is another way the Collaborative will drive the profession
forward into HIT.33 The Collaborative recognizes the importance of participation in the discussion and creation of policy and regulation and seeks to
motivate pharmacists to be active advocates for their profession.
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The Roadmap is available on the Collaboratives website: www.

pharmacyhit.org.
The future of HIT

What is ahead for HIT? Although no one can predict with absolute certainty,
the future for HIT is quite promising. HIT is a step in modernizing the
delivery of health care; it is critical for efficiency, safety and cost-effectiveness;
and its implementation should continue until we reach the goal of the
fully connected health care system. The amount of money being invested
by federal, state and local governments and the health care industry itself
is enormousa recent survey indicates that federal spending will grow to
$6.5 billion by 2016.34 That amount of money makes it a high-priority area,
and it will continue to be one for the foreseeable future.
The meaningful use of EHRs will dominate the push for HIT implementation for the next few years, as the incentive program pushes more
practitioners to implement EHR systems. To assist practitioners with their
EHR implementation, the federal government has funded 62 regional extension centers (RECs). The RECs will provide outreach, education, and EHR
support and assistance to aid providers in the meaningful use of EHRs.35
The push will also continue for the development of health information
exchanges (HIEs) and interoperability, the goal of which is to develop the national health information network (NHIN). Challenges to this effort include
privacy and security concerns and ownership of the data. Great progress
has already been made. The Direct Project, for example, is helping small
providers in rural areas send clinical data in a secure, standardized way that
meets meaningful use stage 1 requirements.36 With the expansion of federal
funding, more organizations like this will continue to expand HIEs and the
National Health Information Network.
One of the most exciting developments, the use of mobile devices and the
development of mobile health apps, is just starting to make noise in the HIT
arena. These should become more prevalent, and eventually replace many of
the technologies currently in use. To be always connected to the health care
system and to have continuous monitoring of physical functions holds great
promise for health care. Although we are still a long way from having a Star
Trek tricorder, it is not out of the question that as HIT advances we will see
gadgets like this being used in the near future.
Questions for study

Short Answer
1. Explain the difference between an electronic medical record (EMR) and a

personal health record (PHR). What is an implementation issue common
to both tools?
406
2.
3.
4.
5.
A: An electronic medical record is a computer record that practitioners

use to document, monitor and manage health care delivery within a single
practice. A personal health record is a health record that is maintained by
an individual patient to manage medications and record medical history.
Concerns of data security and access by unauthorized individuals are
implementation issues for both tools.
Name two requirements stated in the Medicare Drug Improvement and
Modernization Act of 2003 (MMA) that advanced the adoption of health
information technology.
A: Any of the following two requirements advanced the adoption of
health information technology: 1. Exceptions to anti-kickback laws permitting entities such as hospitals, physician organizations, and health
plans to provide e-prescribing and EMR solutions to physicians. 2. Requirements that health plans accommodate e-prescribing. 3. Funding
of pilot studies on transaction and terminology standards for key
e-prescribing components.
The Office of the National Coordinator for Health Information Technology (ONCHIT) has five public policy priorities. What are these priorities
and how are they addressed in EMR implementation?
A: The priorities of ONCHIT are to improve quality, safety, efficiency
and reduce health disparities, improve population and public health,
ensure privacy and security of health information, engage patients and
families, and improve care coordination. These priorities are addressed
in EMR implementation by the creation of three meaningful use stages.
Thresholds of e-prescribing, interoperability, clinical decision support
and quality metrics must be met to achieve incentives in each stage.
Describe the relationship between the continuity of care record (CCR),
health information exchange (HIE), and the National Health Information
Network (NHIN).
A: The CCR is a standard set of patient data that can be read and
edited by multiple electronic medical record software packages. A health
information exchange is the infrastructure across which patient data on
a CCR can be accessed by multiple providers. The NHIN is the larger
network that knits together regional health information exchanges.
Automated dispensing systems have been adopted by many retail, mail
order, and inpatient pharmacies. What role do pharmacy managers play
in organizations adopting these technologies? Where can pharmacists find
resources on the advancement of robotic dispensing products?
A: Pharmacy managers can be experts in dispensing operations and
workflow efficiency. They can also help an institutions decision makers chose the best technology for their needs. Organizations like the
American Society of Consultant Pharmacists, the National Council of
407
Prescription Drug Plans, and the National Association of Boards of Pharmacy offer resources and education on dispensing models and robotic
technologies.
Essay
1. CPOE systems have been shown to reduce certain types of prescribing

errors and provide a more efficient workflow than traditional prescribing.
However, CPOE systems often introduce new types of error via their
implementation and use. What are the mechanisms (if any) in place to
monitor EHR systems for these types of errors and correct them before
they reach the national health information
Suggested readings
Ammenwerth E, Talmon J, Ash JS, Bates DW, Beuscart-Zephir MC,
Duhamel A, et al. Impact of CPOE on mortality ratescontradictory
findings, important messages. Methods Inf Med 2006; 45:58693.
Bates D. Computerized physician order entry and medication errors:
finding a balance. Journal of Biomedical Informatics 2005; 38(4):
25961.
Campbell EM, Sittig DF, Ash JS, Guappone KP, Dykstra RH. Types of
unintended consequences related to computerized provider order entry.
J Am Med Inform Assoc 2006; 13:54756.
Sidrov J. It aint necessarily so: the electronic health record and the
unlikely prospect of reducing health care costs. Health Affairs 2006;
25:107985.
2. As the private sector continues to provide innovative solutions to expand

health information exchanges state and federal regulations and incentives
become increasingly important, how can private sector companies develop
HIE solutions that leverage and strengthen existing Medicaid infrastructure? How can these HIEs be spread across state Medicaid programs?
Suggested readings
Bates M. After the gold rush: a path to sustainable HIE development.
NHIN Watch, March 7, 2011. www.nhinwatch.com/perspective/aftergold-rush-path-sustainable-hie-development [accessed September 23,
2012].
Bates M. HIE insights: Medicaid and state health information exchanges. A Thomson Reuters white paper. November 2010. http://
healthcare.thomsonreuters.com/hie/assets/Insights2%20FINAL.pdf
Toussaint JS, Queram C, Musser JW. Connecting statewide health
information technology strategy to payment reform. Am J Manag Care
2011; 17(3):e80e88.
408
Re: Federal Funding for Medicaid HIT Activities. Letter from CMS
to State Medicaid Directors sent on Aug. 17, 2010. www.ncdhhs.
gov/healthit/HITECH %20SMD final 081710.pdf [accessed September 23, 2012].
Bates M, Kheterpal V. Statewide health information exchange: best
practice insights from the field. A Thomson Reuters white paper. http://
healthcare.thomsonreuters.com/hie/assets/HIE Best Practices WP.pdf
McKathan, et al. An early status report on the Beacon Communities
plans for transformation via health information technology. Health
Affairs 2011; 30(4):782788.
3. Pharmacists providing patient care services are not currently considered

eligible professionals who qualify to receive funding by the Medicaid
and Medicare Electronic Health Records Incentive Programs under the
HITECH provisions of the American Recovery and Reinvestment Act
(ARRA) of 2009. How can the profession amend this issue? How will
we move our professional agenda forward when left out of ARRA and
meaningful use incentives?
Suggested readings
Government Affairs Issue Briefs by the American Pharmacists Association. Accessible at http://www.aphafoundation.org/AM/Template.cfm?
section=Government Affairs/.
Hogin E, Daniel J. The many meaningful uses of health information technology. May 18, 2011. Published at HealthITBuzz.gov.
www.healthit.gov/buzz-blog/meaningful-use/meaningful-healthinformation-technology/ [accessed September 23, 2012].
Pharmacy e-Health Information Technology Collaborative. www.
pharmacyhit.org/ [accessed September 23, 2012].
American Pharmacists Association. www.pharmacist.com [accessed
4. The ONC will soon be launching its Consumer e-Health Program to

equip patients with the tools needed to take part in their own health IT
through PHRs. How can stakeholders encourage patients to participate
in these programs? How can we make sure our most vulnerable and
underserved populations arent left behind in the digital divide?
Suggested readings
Goldberg L, Lide B, Lowry S, Massett HA, OConnell T, Preece J,
et al. Usability and accessibility in consumer health informatics current trends and future challenges. Am J Prev Med 2011; 40(5 Suppl
2):S18797.
409
Botts NE, Horan TA, Thoms BP. HealthATM: personal health cyberinfrastructure for underserved populations. Am J Prev Med 2011; 40(5
Suppl 2):S11522.
Horan TA, Botts NE, Burkhard RJ. A multidimensional view of personal health systems for underserved populations. J Med Internet Res
2010; 12(3):e32.
Raisinghani MS, Young E. Personal health records: key adoption issues
and implications for management. Int J Electron Healthcare 2008;
4(1):6777.
5. The transition from the use of ICD-9 to ICD-10 codes will allow for
the captures of more precise and comprehensive morbidity reporting.
Who are the stakeholders who will benefit from the availability of this
data? Where would a requirement of standardized data fit among the
meaningful use incentive stages?
Suggested readings
AMCP HIT primer. http://amcp.org/HITPrimer
NCPDP website www.ncpdp.org
World Health Organization. International Classification of Diseases.
www.who.int/classifications/icd/en/ [accessed September 23, 2012].
CAQH, NCPDP join to boost data exchange standards. Government
Health IT News, June 16, 2011. http://govhealthit.com/news/caqhncpdp-join-boost-data-exchange-standards [accessed September 23,
2012].

1. American Hospital Association. Continued progress: hospital use of information technology. www.aha.org/aha/content/2007/pdf/070227-continuedprogress.pdf [accessed May
16, 2011].
2. Gans D, et al. Medical groups adoption of electronic health records and information
systems. Health Aff 2010; 24:132333.
3. HIMSS. Introduction to healthcare information enabling technologies. Introduction.
www.himss.org/content/files/INTROHITEXCERPT1.pdf [accessed May 16, 2011].
4. Health information technology primer. Academy of Managed Care Pharmacy, 2011.
www.amcp.org/HITPrimer/ [accessed September 23, 2012].
5. Physician quality reporting system. www.cms.gov/PQRS/ [accessed January 6, 2012].
6. United States Department of Health and Human Services, The Office of the National
Coordinator for Health Information Technology. Meaningful use preamble, June 16,
2009. http://www.healthit.hhs.gov/portal/server.pt/gateway/PTARGS 0 11113 872720
0 0 18/Meaningful%20Use%20Preamble.pdf [accessed February 15, 2013].
7. Meaningful use criteria. Federal Register, July 28, 2010. Vol 75(144). http://edocket.
access.gpo.gov/2010/pdf/2010-17207.pdf [accessed September 23, 2012].
8. Certified health IT product list. The Office of the National Coordinator for Health
Information Technology. http://onc-chpl.force.com/ehrcert [accessed January 6, 2012].
410
9. EHR incentive programs. www.cms.gov/ehrincentiveprograms/ [accessed January 6,

2012].
10. ONCs Office of Interoperability and Standards. http://healthit.hhs.gov/portal/server.pt/
document/953731/onc office of interoperability and standards pdf [accessed January 6,
2012].
11. U.S. Department of Health and Human Services. What is a CCR? www.hrsa.gov/healthit/
toolbox/HealthITAdoptiontoolbox/PersonalHealthRecords/aboutccr.html [accessed January 6, 2012].
12. The Accredited Standards Committee. About ASC X12. www.x12.org [accessed September 23, 2012].
13. National Council for Prescription Drug Programs. www.ncpdp.org/about.aspx [accessed
February 15, 2013].
14. Health Level Seven International. www.hl7.org [accessed September 23, 2012].
15. The American Medical Informatics Association. www.amia.org [accessed September 23,
2012].
16. The American Nurses Informatics Association and the Capital Area Roundtable on Informatics in Nursing. www.ania-caring.org [accessed September 23, 2012].
17. The Healthcare Information and Management Systems Society. www.himss.org [accessed
18. American Health Information Management Association. www.ahima.org [accessed
19. The eHealth Initiative. www.ehealthinitiative.org [accessed September 23, 2012].
20. American National Standards Institute. www.ansi.org [accessed September 23, 2012].
21. Certification Commission for Health Information Technology. www.cchit.org [accessed
22. U.S. Department of Health and Human Services. The Office of the National Coordinator
for Health Information Technology. healthit.hhs.gov [accessed September 23, 2012].
23. U.S. Department of Health and Human Services. The National Committee on Vital Health
Statistics. www.ncvhs.hhs.gov [accessed September 23, 2012].
24. Talyst Whitepaper: The impact of healthcare reform on LTC pharmacy. www.talyst.com/
ltc-pharmacy/ [accessed January 6, 2012].
25. Telemedicine defined. The American Telemedicine Association. www.americantelemed.
org [accessed January 7, 2012].
26. The Telehealth year in review. Government Health IT. December 29, 2011. http://
govhealthit.com/news/telehealth-year-review [accessed January 7, 2012].
27. Creating a virtual team: the future for medical homes? Tammy Worth. The American
Pharmacist Association. January 11, 2010. www.pharmacist.com [accessed January 7,
2012].
28. The Patient-Centered Outcomes Research Institute. www.pcori.org [accessed January 7,
2012].
29. FMCP 2011 Research Symposium Meeting Proceedings. www.amcp.org/WorkArea/
DownloadAsset.aspx?id=14938.
30. Rode D. Letter to the Office of the National Coordinator for Health Information Technology Re: solicitation of commentsmeaningful use stage 2. February 25, 2011. www.
ahima.org [accessed January 7, 2012].
31. International classification of diseases. The World Health Organization. www.who.int/
classifications/icd/en/ [accessed January 7, 2012].
32. The Pharmacy e-Health Information Technology Collaborative. www.pharmacyhit.org/
33. The roadmap for pharmacy health information technology integration in U.S. health care.
The Pharmacy e-Health Information Technology Collaborative. www.pharmacyhit.org/
pdfs/11-392 RoadMapFinal singlepages.pdf [accessed February 15, 2013].
34. Miliar M. Federal health IT market set to grow to $6.5B by 2016. HealthcareIT News,
December 20, 2011. www.healthcareitnews.com/news/federal-health-it-market-set-grow65b-2016 [accessed September 23, 2012].
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35. Get the facts about regional extension centers. The Office of the National Coordinator
for Health Information Technology. healthit.hhs.gov/portal/server.pt/document/953727/
get the facts about regional extension centers pdf [accessed January 7, 2012].
36. Overview. The Direct Project. http://directproject.org/ [accessed January 7, 2012].
19
Unresolved issues in
pharmacy: imagining the
future*
William A. Zellmer, BS (Pharmacy), MPH
Pharmacy practice in the United States is in the midst of a transformation
from an occupation that is product focused to a health profession that is patient focused.1 This transformation, which is further along in some sectors of
practice than in others,2 is following a haphazard course, leading to a variety
of practice models that have core traits in common with the early concept
of clinical pharmacy. The pace of change in the coming years may fluctuate
between exhilarating advances and disappointing setbacks, depending on
forces in the environment and the quality of the professions leadership.
The themes of this chapter are transformation, diffusion, and imagination. After a brief reflection on the current state of pharmacy practice in the
United Statesthe foundation for the futureclinical pharmacy is discussed
from the perspective of knowledge about the diffusion of innovations. The
chapter concludes with thoughts about monitoring progress in the transformation of the profession.
Transformation: letting go of old dreams

Clinical pharmacy entails what Thomas Kuhn3 called a perceptual transformationa paradigm shift. The traditional paradigm of pharmacy practice
could be stated like this:
The pharmacist is responsible for ensuring that a patient receives the
medicine ordered by the physician and that the medicine is safe to
use.
*Note: This chapter has been adapted, with the permission of the original publisher, from the
following publication: Zellmer WA. Pharmacys future: transformation, diffusion, and imagination. In: Elenbaas RM, Worthen DB, editors. Clinical pharmacy in the United States: transformation of a profession. Lenexa (KS): American College of Clinical Pharmacy; 2009:17582.
414
The new paradigm is this:

The pharmacist is responsible for helping a patient make the best use
of medicines.
This deceptively simple statement implies that the pharmacist (1) knows the
patient (including the patients health status, literacy level, health-related
values, living conditions, and social support systems) and (2) acts in collaboration with the patients other health care providers. That the pharmacist
should be concerned about anything other than filling an order safely and
accurately was a revolutionary idea. Revolutions are always resisted, so it is
not surprising that the professions transformation is not yet complete more
than 40 years after the introduction of clinical pharmacy.
The pioneers in clinical pharmacy education had hoped that the professions general practitioners would integrate the precepts of clinical pharmacy
into their existing practices. The dream was that frontline pharmacists would
take responsibility for ensuring that the patient is using the most appropriate
medicine in the most appropriate way. While this dream is being realized in
some exemplary community and institutional pharmacies, it is still far from
reality in the vast majority of practice sites.
Most pharmacists in community pharmacies and outpatient pharmacies
limit their activities to the rudiments of dispensing. In the hospital inpatient
setting, most pharmacy departments are driven by a production culture
rather than a patient care culture.4 Even in hospitals at academic health
science centers, which have offered some of the most fertile ground for the
adoption of clinical pharmacy, the order review and dispensing functions still
consume a significant portion of pharmacists time.5
In contrast with pharmacy educations thorough embrace of clinical pharmacy, grassroots pharmacy practice seems to have suffered from a lack of
vision and will. If there had been an authentic perceptual transformation
among pharmacistsif clinical pharmacy had penetrated their hearts and
mindssurely they would have reformed their practices to include much
deeper engagement with the patient.
The inertia of the past notwithstanding, many pharmacy practice leaders
recognize that the old paradigm for pharmacy practice is not sustainable.
This awareness is demonstrated most prominently in support for the 2004
vision statement for pharmacy practice developed by the Joint Commission
of Pharmacy Practitioners (JCPP).6 National pharmacy organizations are collaborating in projects designed to achieve the JCPP vision. Other independent
initiatives are designed to transform particular segments of practice.7,8
Both the retail drugstore industry and the hospital industry are devising
new ways of preparing and delivering prescription medicines that do not
necessitate the hands-on involvement of a high-priced pharmacist. Among
the innovations that are setting the stage for reducing pharmacist involvement
Unresolved issues in pharmacy: imagining the future
415
in dispensing are electronic prescribing, clinical decision support systems,

technician certification and licensure, robotics, and various telepharmacy
applications (including remote order review9 and remote pharmacist supervision of technicians10 ).
It may be time to let go of the dream of integrating or blending the
old and new paradigms of pharmacy practice and concentrate the efforts of
pharmacists on clinical practice. There is certainly abundant need in health
care for pharmacists who are dedicated to ensuring optimal medication
therapy outcomes.11
Diffusion: steps toward the future

Research on the diffusion of innovations offers insights into what the coming
years may hold for the transformation of pharmacy. In that field of research,
innovation is defined as an idea, practice, or object that is perceived
as new by an individual or other unit of adoption.12 As summarized by
Rogers,13 this research shows that the following attributes of a new idea or
conceptsuch as clinical pharmacyinfluence its rate of adoption:
relative advantage: the degree to which an innovation is perceived as

being better than the idea it supersedes;
compatibility: the degree to which an innovation is perceived as consistent with the existing values, past experiences, and needs of potential
adopters;
complexity: the degree to which an innovation is perceived as relatively
difficult to understand and use;
trialability: the degree to which an innovation may be experimented with
on a limited basis; and
observability: the degree to which the results of an innovation are visible
to others.
Those who are in a position to foster the adoption of clinical pharmacy can
attempt to modify its individual attributes to make the innovation overall
more attractive to potential adopters.
There are two ways to think about adopters of clinical pharmacy. Internally, within the profession, the adopters are pharmacists themselves; they
have latitude to choose how they practice pharmacy. Externally, outside
the profession, adopters are the employers of pharmacists (who influence
or dictate how their pharmacists practice) and those who pay for health
care services, whether individual patients, companies that offer a health
insurance benefit for their workers, or taxpayers. These external potential
adoptersemployers of pharmacists and payers of servicesare particularly
relevant to this discussion because they are the ones who will determine if
clinical pharmacy practice is sustainable economically. It is one thing for a
416
pharmacist to want to practice clinically; it is something altogether different

for someone to be willing to pay a pharmacist for clinical services. (It could
be argued that the external group of adopters also includes physicians,
because the degree to which they expect pharmacists to help their patients
manage their drug therapy is a very important factor in the diffusion of
clinical pharmacy.)
The external group can be stratified and analyzed based on the strength
of the incentives for adopting clinical pharmacy, which relate directly to the
various methods of financing health care in the United States. Consider, for
example, a hospital that gets most of its revenue from fixed payments linked
to patients diagnoses and severity of illnesses. The hospitals executives have
an incentive to ensure that the use of medicines is as safe, effective, and cost
conscious as possible, and they may be willing to incur the added cost of
hiring clinical pharmacists if they believe that doing so will improve the hospitals overall financial margin. On the other hand, in a retail chain drugstore
corporation whose revenue is related directly to the number of prescriptions
it dispenses (with no reward for improving health outcomes), the executives
have an incentive to minimize operating costs; they are not likely to include
clinical pharmacy as a value-added service for the corporations prescription
customers.
Table 19.1 speculates about the perceptions of various external
adopters toward the attributes of clinical pharmacy. The scores in the table
reflect the judgments of the author based on his assumptions about each type
of adopter; different assumptions would yield different scores. The authors
intent is not to peg precisely a particular type of employer or payer but, rather,
to illustrate the value of stratifying adopters for the purpose of understanding
their varying perceptions of clinical pharmacy.
Pharmacy is fortunate to have a number of groups that are working hard
to foster the professions transformation, including national pharmacist associations, some state associations, research-oriented foundations, and some
schools of pharmacy. They pursue this noble objective through a combination
of push and pull tactics. Examples of push tactics are (1) advocacy of
laws, regulations, accreditation standards, and reimbursement requirements
that mandate or induce pharmacists to perform certain clinical functions;
and (2) creation of peer pressure, such as through a highly publicized
consensus-seeking conference or a motivational talk by a pharmacy leader.
Pull tactics include (1) public relations programs designed to elevate
consumer expectations and (2) publicity about the results of research that
demonstrates the value of clinical pharmacy services. Some pharmacy groups,
taking lessons from the public health field,14 are beginning to apply social
marketing techniques in this endeavor. (Social marketing is the application
of commercial marketing strategies to the diffusion of a social good such as
smoking cessation.)
417
Table 19.1 Conjectures about perceptions of attributes of clinical pharmacy

among various external adopters
Potential adopter
Perceptions of attributes of clinical pharmacya
Total score
Relative
advantage
Compatibility
Complexity
Trialability
Observability
Hospital, reimbursement
primarily case-based,
fixed-rate
23
Physician group in
drug-intense specialty
practice (e.g., organ
transplantation)
23
Specialty pharmacy,
manages use of high-risk,
high-cost drugs
22
Employer, self-insured,
high incidence of chronic
illness in workforce
20
Physician-based medical
home
19
Patient, multiple drugs,

self-pay for clinical
pharmacy services
18
Independent pharmacy
owner
18
Medicare
14
Employer, health
insurance plan, young
healthy workers
12
Chain drugstore
corporation
Physician, primary care,

fee-based payment
a Scale: 05, where 0 = highly negative perception, 5 = highly positive perception. Attribute categories based
on Rogers.12 A higher total score suggests more readiness to adopt clinical pharmacy. Attribute scores
reflect the judgment of the author. The intent of the table is to show that perceptions of the attributes of
clinical pharmacy vary widely among potential external adopters of clinical pharmacy.
Diffusion-of-innovations research suggests that highly targeted changeagency methods are more effective than diffuse, generalized approaches.15
The groups in pharmacy that are trying to shape the professions future
would do well to stratify the potential types of external adopters of clinical
pharmacy according to their importance, analyze the perceptions of each
important type, and customize their tactics accordingly.
418
Leadership is always a critical factor in the rate of adoption of an innovation. In any practice setting, without a champion, clinical pharmacy will be a
nonstarter. An extremely important step in spreading clinical pharmacy is the
nurturing of practice leaders, which is a key function of pharmacy residency
training and various leadership-development programs in pharmacy.
Imagination: measuring progress

Because we are living through the zigzagging transformation of pharmacy,
rather than observing the process from a distance that offers perspective, it
is difficult to discern whether progress is being made. This will not be any
easier in the years ahead. Imagine if we had the benefit of a dashboard with
several gauges, each of which measured a critical facet of the professions
transformation. Relevant data (which might have either positive or negative
implications) could feed into an algorithm that would yield a numeric value
for each gauge. The dashboard readings, which would permit continuous
assessment of the direction, rate, and sustainability of the transformation
process, would give the professions leaders a rational basis for staying the
course or for making course corrections. The metrics would also be of
interest to practicing pharmacists who are concerned about the future of
their profession.
What are some candidates for the gauges or indicators in this imaginary
dashboard? What data would be relevant, directly or indirectly, for calculation of the gauge readings? The following sections offer some ideas.
Indicator 1hearts and minds of pharmacists

Definition: The estimated proportion of pharmacists, including practice
managers, who conduct their professional lives by the precepts of clinical
pharmacy.
Comment: There cannot be a true revolution in pharmacy unless its practitioners believe in the new paradigm and are committed to live it in their
professional practice.
Types of data used to calculate the indicator:
the proportion of pharmacy students who were selected by schools that

give heavy weight to applicants ability and desire to lead change;
the proportion of pharmacy students who accept scholarships
(pre-employment agreements) from retail drugstore corporations that
limit pharmacists to dispensing;
the proportion of new pharmacy graduates who pursue residency training
in clinical practice;
the vacancy rate for positions in traditional pharmacy practice versus
clinical practice; and
419
the proportion of practice managers in health care institutions who deploy their pharmacist resources preponderantly to clinical activities.
Indicator 2public demand

Definition: The extent to which people who use medicines seek the advice
and consultation of pharmacists.
Comment: Public demand is the ultimate test of the viability of clinical
pharmacy.
Data types:
out-of-pocket consumer expenditures for clinical pharmacist consultation;

the degree of correlation between overall satisfaction of hospitalized
patients and pharmacist communication encounters;
the degree of correlation between changes in community pharmacy patronage with the availability of pharmacist consultation; and
the number of listings in Yellow Pages in major cities for clinical pharmacist consultation services.
Indicator 3competency matters

Definition: Emergence of a process to help the public identify specific pharmacists who have demonstrated they are qualified to provide medication-use
consultation services.
Comment: Although pharmacys egalitarianism is causing it to resist making an explicit differentiation between old- and new-paradigm pharmacists,
doing so could be a critical step in hastening the transformation of the
profession during the period in which the public is exposed to both types
of pharmacists. A related point is that as the adoption of clinical pharmacy
expands, the profession may find it necessary to further upgrade pharmacy
education in order to prepare pharmacists for a deeper level of drug therapy
consultation.
Data types:
the number of states that license pharmacists for two different types of
practice, supply chain integrity and clinical practice;
the number of states that require pharmacists to prove clinical competency periodically before licensure renewal;
the number of hospitals and health systems that require advanced credentials (such as residency training and board certification) for clinical
pharmacy practice;
dollars spent by pharmacist organizations on public information campaigns that explain how to find a pharmacist qualified to provide
medicine-use consultation; and
420
the number of messages in the pharmacy blogosphere that call for better
educational preparation of pharmacists.
Indicator 4provider status

Definition: The extent to which (a) health-benefit plans reimburse pharmacists for drug therapy management services and (b) physicians expect
pharmacists to provide this service.
Comment: For several years, a major goal of pharmacy has been to obtain
provider status under Part B of Medicare, which would allow pharmacists to
bill for drug therapy management services provided to Part B beneficiaries.
Before that legislative victory is achieved, other third-party payers and health
benefit plans will accord pharmacists provider status in their programs.16,17
Physicians have very low expectations of pharmacists, and it will be an
immense challenge to get them to expect pharmacists to be involved in
helping manage their patients drug therapy.18
Data types:
the number of public health benefit programs that pay pharmacists for
drug therapy management services;
the number of self-insured employers who pay pharmacists for drug
therapy management services;
the number of medical homes,19,20 accountable care organizations,21
and physician group practices22 that employ pharmacists or contract with
pharmacists for drug therapy management services; and
the results of periodic assessments of the physician pharmacistexpectation index.
Indicator 5the leading edge

Definition: Strength of the continuing evolution of clinical pharmacy practice.
Comment: One measure of the vibrancy and sustainability of clinical pharmacy is the extent to which it continues to refine and reinvent itself, which
would be expected to occur especially in academic health science centers and
in integrated health care systems such as the Veterans Health Administration,
often through the leadership of faculty members of schools of pharmacy.
Data types:
the number of articles published on innovative pharmacist services related

to personalized medicine and other breakthroughs in the diagnosis and
treatment of disease;
the number of articles published on expanded pharmacist chronic-care
services in integrated health care systems;
421
the number of published articles on new models for clinical pharmacy

practice in acute care;
the number of favorable economic analyses of clinical pharmacy published in the peer-reviewed biomedical literature;
the number of schools of pharmacy that have formal programs for developing economically sustainable, real-world clinical pharmacy practice
models; and
support for new clinical pharmacy services by health care accreditation
and quality-improvement bodies.
Indicator 6pharmacist salaries

Definition: Mean annual compensation of licensed pharmacists.
Comment: Any significant change in the pharmacist supply and demand
balance will affect pharmacist salaries. Over the past 40 years, primarily
because of regulated pharmacy-staffing requirements and growth of the retail
chain drugstore industry, pharmacist salaries have increased at approximately
twice the rate of general inflation. Pharmacist salaries, or the rate of growth
in their salaries, may decline if a reduction in dispensing positions is not
matched by growth in clinical opportunities. Moderation of pharmacist
`
salaries could help put pharmacists in a more favorable position, vis-a-vis
nurse practitioners and other physician extenders, for leadership of drug
therapymanagement clinics in hospitals and health systems.
Data type: salary survey results.
Indicator 7private practice

Definition: The proportion of pharmacists who earn their living primarily
through private clinical practice serving a multiplicity of clients, including
individual patients and health benefit plans.
Comment: A potential barrier to this development is a movement away
from fee-for-service reimbursement, as part of health reform, toward the
payment of capitated rates to a health care provider organization for the
care of enrolled patients, along with payment incentives related to quality
of care. However, even in such a system, it will be necessary to have a
mechanism to pay specialists for episodic care, which suggests that there will
be an opening for contractual relationships with clinical pharmacists. Also,
pharmacists may be able to persuade health benefit plans that the cost of
regular pharmacist consultations with patients who use many medicines will
be offset by improved outcomes, including reduced overall cost of care.
Data types:
the number of hospitals, hospitalist groups,23 medical homes, accountable care organizations, and physician group practices that contract with
clinical pharmacists who are in independent practice;
422
the number of independent pharmacist group-practice organizations; and

the number of clinical pharmacists who advertise their services to the
public.
Indicator 8pharmacy technicians

Definition: The extent to which pharmacy technicians have autonomous
responsibility for managing dispensing systems in drug stores and health care
institutions.
Comment: It has been generally accepted in pharmacy for some time that
it is necessary to develop a well-defined category of technical workers in
order to free pharmacists for clinical practice. A logical extension of this
line of thinking is to expect that technicians will eventually practice without
the supervision of pharmacists, particularly if their education and training is
upgraded and standardized.
Data types:
the number of states that require pharmacy technicians to have completed

nationally standardized education and training;
the number of states that allow qualified technicians to control the pharmacy dispensing process; and
the number of members in professional organizations for pharmacy technicians.
Indicator 9corporatization
Definition: The extent to which some type of big business (e.g., retail chain
drugstores, drug wholesalers, pharmacy benefit management companies)
captures clinical pharmacy.
Comment: The corporatization of community pharmacy has reduced it to a
faint shadow of its potential. This has also occurred in the highly consolidated long-term care industry in which the autonomy and professional rigor
of consultant pharmacists have been eroded.24,25 When clinical pharmacy
begins to flourish economically, it, too, may become subject to the forces of
corporatization and thereby become sapped of its vigor.
Data type: mergers and acquisitions of clinical pharmacy group practices.
Indicator 10wild cards

Definition: Unanticipated game-changing events.
Comment: This gauge, which is simply a flashing yellow light in the center
of the dashboard, is a cautionary signal about unexpected events that may
propel or stymie the professions transformation. History is replete with
examples of unforeseen events that bolstered or dashed the prospects of a
423
group. A few examples of wild-card developments that could affect pharmacys future, positively or negatively, include:
sustained global economic decline;

the Oprah effect (i.e., celebrity endorsement of the profession following
some heroic feat by a pharmacist);
scientific breakthroughs that make medicine use exquisitely safe and
effective without the need for a medication-use expert; and
widely publicized pharmacist perfidy that brings long-lasting disgrace to
the profession.
Summary
This discussion of 10 gauges for a pharmacy-transformation dashboard is, of
course, fanciful. Nonetheless, imaginative thinking of this nature can have
concrete value if it stimulates pharmacists and pharmacy students to (1) visualize new possibilities for the profession, (2) ponder collective actions that
need to be taken in order to achieve pharmacys potential, and (3) identify
indicators of change that they will monitor personally.
Conclusion
The odds seem excellent that over the next 40 years there will continue
to be a need for a health expert who is competent and eager to help
people make the best use of medicines. Whether pharmacists will, in fact,
satisfy this need on a broad scale may have more to do with eagerness
than competencepharmacy education already equips pharmacists with the
basic tools for clinical practice. Will some combination of fear (fueled by
diminished opportunities in traditional practice), imagination (fueled by
vision, altruism, and compassion), ambition (fueled by a desire for greater
prestige), and incentives (fueled by dollars) propel pharmacists toward a
genuine transformation in self-perception? Even if pharmacy continues to
be blessed with wise and assiduous leaders, its full promise will be realized
only if individual pharmacists perceive deeply that their primary professional
mission is to help patients make the best use of medicines.

1. Elenbaas RM, Worthen DB. Clinical pharmacy in the United States: transformation of a
profession. Lenexa (KS): American College of Clinical Pharmacy; 2009.
2. Schommer JC, et al. Pharmacist contributions to the U.S. health care system. Innovations
in Pharmacy 2010:111. www.pharmacy.umn.edu/innovations/prod/groups/cop/@pub/
@cop/@innov/documents/article/cop article 247054.pdf [accessed December 28, 2011].
3. Kuhn TS. The structure of scientific revolutions. 2nd edition, enlarged. Chicago: University of Chicago Press; 1970:112.
4. Pierpaoli P. Creatively using our intellectual capital. Am J Health-Syst Pharm 2009;
66:1087.
424
5. Pedersen CA, et al. ASHP national survey of pharmacy practice in hospital settings:
prescribing and transcribing2010. Am J Health Syst Pharm 2011; 68:66988.
6. Joint Commission of Pharmacy Practitioners. Vision statement. www.aacp.org/
resources/historicaldocuments/Documents/JCPPFutureVisionofPharmacyPracticeFINAL.
pdf [accessed June 11, 2009].
7. Project Destiny Executive Summary. http://www.pharmacist.com/sites/default/files/files/
mtm project destiny summary.pdf [accessed December 7, 2012].
8. American Society of Health-System Pharmacists. ASHP Pharmacy Practice Model Initiative. www.ashpmedia.org/ppmi/overview.html [accessed December 28, 2011].
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Health-Syst Pharm 2002; 59:71621.
10. Young D. Telepharmacy project aids North Dakotas rural communities. Am J Health-Syst
Pharm 2006; 63:1776.
11. Knapp DA. Professionally determined need for pharmacy services in 2020. Am J Pharm
Educ 2002; 66:4219.
12. Rogers EM. Diffusion of innovations. 5th edition. New York: Free Press; 2003:12.
14. Centers for Disease Control and Prevention. Gateway to health communication & social marketing practice. http://www.cdc.gov/HealthCommunication/index.html [accessed
December 7, 2012].
16. Daigle L, Chen D. Pharmacist provider status in 11 state health programs. ASHP policy analysis paper, September 2008. www.ashp.org/DocLibrary/Advocacy/ProviderStatus
Programs.aspx [accessed May 4, 2009].
17. Fera T, et al. Diabetes ten city challenge: final economic and clinical results. J Am Pharm
Assoc 2009; 49:e5260.
18. Smith WE, et al. Physicians expectations of pharmacists. Am J Health-Syst Pharm 2002;
59:507.
19. Daigle L, Banek K. Pharmacists MTM services key to health care homes success.
ASHP policy analysis paper, March 2009. www.ashp.org/DocLibrary/News/Health Care
Home.pdf [accessed May 4, 2009].
20. Bates DW. Role of pharmacists in the medical home. Am J Health-Syst Pharm 2009;
66:11168.
21. Fisher ES, et al. Creating accountable care organizations: the extended hospital medical
staff. Health Affairs 2007; 26:w4457.
22. Devine EB, et al. Strategies to optimize medication use in the physician group practice:
the role of the clinical pharmacist. J Am Pharm Assoc 2009; 49:18191.
23. Wachter RM. An introduction to the hospitalist model. Ann Intern Med 1999;
130:33842.
24. Berwick DM, Sebelius K. Considering changes to the Conditions of Participation for
Long Term Care Facilities (independence of LTC consultant pharmacists). Fed Register
2011 (Oct 11); 76:6303841.
25. Udesky L. Nursing home investigation finds errors by druggists. January 27, 2012. www.
nytimes.com/2012/01/27/health/nursing-homes-in-california-confront-pharmacistserrors.html? r=1&scp=1&sq=laurie%20udesky%20nursing%20home&st=cse [accessed
January 30, 2012].
20
The future
Eleanor L. Olvey, PharmD, PhD and
J. Lyle Bootman, PhD, ScD
Change is the law of life.
And those who look only to the past or present are certain to miss
the future.
John F. Kennedy
The ever-changing economic and health care climates in the United States
require pharmacy professionals to reevaluate their roles in the health care
system continually. Looking ahead to the future of the field is necessary to
ensure pharmacists will be able to maintain optimal health care delivery and
be provided with opportunities to expand practice even further. Paraphrasing
the words of John F. Kennedy, change is inevitable, and those not considering
or preparing for the future may miss it altogether. Thus, recognizing the
possible directions pharmacy practice could take in the foreseeable future
is critical so the profession can prepare to face new challenges head-on and
not be left behind.
Long regarded as one of the most highly trusted professionals, pharmacists have been providing increasing value to the communities and patients
they serve, as well as the health care system as a whole, by becoming more
active participants in the health care team. However, demonstrating that
value in terms of improved clinical, economic, and humanistic (i.e., quality
of life, satisfaction) outcomes and determining how to pay for this value
must be at the forefront of efforts. This is significant given the rapidly
aging baby-boomer population, who have begunand will continueto
increase the demand for a variety of health care resources and services, including pharmaceutical care. Technological innovations aimed at increasing
efficiency and streamlining care can aid pharmacists in meeting this growing
demand. Specifically, it has been suggested that the time is right for disruptive innovations in health carethose innovations that force traditional
innovations out of the market that are accessible to a larger consumer base.1
To prepare the current and the future workforce for these changes and
426
challenges, educating and training students and practicing pharmacists with

the knowledge and skill sets necessary for future success will be critical.
This chapter is not intended to delineate the absolute course for pharmacy
but to offer suggestions as to areas where the profession has begun to
explore or potentially can explore, moving toward addressing current and
impending health care issues. First, we highlight the value pharmacists and
the pharmacy profession provide in a variety of settings, with explanations
as to how these efforts can be clearly demonstrated to the system, including
policy-related efforts. This discussion encompasses how pharmacists must expand their contributions to the changing health care scene by participating in
policy-related forums more than ever before. Second, we review the ways the
aging population will influence the role and direction of pharmacy. Third, we
examine examples of technological innovations that could be instrumental
in helping pharmacists move the profession forward. Finally, we discuss the
areas in which pharmacy education and training should focus and prepare
students entering this profession.
Providing, demonstrating, and paying for value

What defines value in health care has been an ongoing topic of debate.25
However, it is generally agreed that value is achieved where better outcomes
are obtained for every dollar spent. The concept of value additionally encompasses components of access, cost, and quality, all of which center around
attaining optimal outcomes whether those outcomes are economic, clinical,
or humanistic. In essence, it means providing more, safer, and better care to
more people for less money. There are many examples from other industries
(e.g., cellular phones, wireless Internet) that have achieved increased value
for the dollar spent. Health care is on the path to achieving increased
value. The pharmacy profession is a key participant in attaining value in
health care.
Providing value
In what ways do pharmaceuticals and pharmacists provide added value to
the health care system? Treating chronic conditions with medications can
aid in avoiding costly events due to disease progression. For example, a
patient taking prescribed inhaled corticosteroid treatment for asthma may
avoid visits to the emergency room or hospitalization due to acute exacerbations of the disease. Medications may offset other more expensive events,
prevent disease recurrence or progression, and improve the patients quality
of life, all which are valued by one stakeholder or another. However, this
can occur only if the medications are properly prescribed, dispensed, and
consumed, and pharmacists play an integral role in each of these steps,
The future
427
regardless of the practice setting. First, before a medication is dispensed, the

pharmacist must ensure the correct drug, dose, and directions for the correct
patient are prescribed, along with checking for any drugdrug interactions
or contraindications to therapy (e.g., allergy) to the best of their ability. In
addition, the pharmacist in many cases is involved in resolving insurance
coverage issues or recommending medications that may be less expensive
(i.e., generics). Next, the drug must be dispensed to the correct patient with
adequate counseling about what the medication is for, how it is to be taken,
and any side effects or interactions patients should be made aware of. Finally,
pharmacists can influence the optimal and appropriate consumption of the
medication, again, with counseling emphasizing the directions for use and
the important benefits of taking the medication. Lack of persistence or suboptimal use deters the full value of medications, which may not necessarily
be cost-driven. As such, pharmacists have an opportunity to influence patient
behavior or beliefs by educating and empowering the consumer, which could
lead to better adherence and outcomes.
In every part of the drug delivery process, pharmacists are pivotal in
identifying and preventing drug-related problems (DRPs). DRPs include
untreated indications, improper drug selection, subtherapeutic dosage, failure to receive drugs, overdosage, adverse drug reactions, drug interactions,
and drug use without indication.6 A 1995 study estimated the cost of
DRPs to be $76.6 billion, with a 2000 study update estimating those
costs rising to $177.4 billion.6,7 An example of how pharmacy professionals have been instrumental in helping to monitor and prevent DRPs has
been with clinical pharmacy services (CPS), including the development of
pharmacist-administered medication therapy management (MTM) programs
as a mandate by Medicare Part D (MPD) legislation. Clinical pharmacy
is defined by the American College of Clinical Pharmacy as that area of
pharmacy concerned with the science and practice of rational medication
use.8 Clinical pharmacy services apply the specialized therapeutic knowledge and expertise of pharmacists to provide pharmaceutical care in an
effort to achieve optimal outcomes. All health care settings utilize clinical
pharmacists in a variety of ways. Common CPSs include disease management
programs (e.g., diabetes monitoring), general pharmacotherapeutic monitoring (e.g., drug regimen and utilization review), target drug therapy (e.g.,
anticoagulation with warfarin), immunization, and pharmacokinetic services
(e.g., aminoglycoside dosing).9 The Medicare Modernization Act (MMA)
of 2003 mandated medication therapy management (MTM) programs to
be established by MPD sponsors targeting enrollees who meet eligibility
criteria, including those with multiple chronic diseases and taking multiple
chronic medications, in addition to incurring total annual costs above a
certain threshold ($3100 in 2012).10 These services and programs have been
administered by a variety of health care providers, including pharmacists,
428
and are considered under the umbrella of CPS, but targeted to a specific
subpopulation. A systematic review and meta-analysis of studies evaluating
pharmacist-provided direct patient care was conducted to determine the
impact of these services on therapeutic, safety and humanistic outcomes.11
The results indicated favorable and significant improved therapeutic and
humanistic outcomes for pharmacist-based interventions in regard to management of hemoglobin A1c, blood pressure, low-density lipoprotein (LDL)
cholesterol, medication adherence, patient knowledge, and quality of life.
Additional examples are available as to how pharmacists have broadened
their scope of practice and have continued to redefine their roles in innovative
ways, which should be expanded into the future. The patient-centered medical home (PCMH) model is an approach to providing patient-centric primary
care that is based on sustained relationships among the patient, physician,
and other health care providers.12 The PCMH rests upon interdisciplinary
collaboration and coordination in order to deliver a comprehensive continuum of quality care to individuals. As DRPs are prevalent and result in
negative outcomes incurring significant costs, it is critical for pharmacists
to become integrated as part of the PCMH team, because their expertise in medication management can significantly contribute to reductions
in DRPs and successful outcomes.12,13 The Patient-Centered Primary Care
Collaborative, highlighting the importance of pharmacist inclusion in this
model, drafted a document specifically focusing on pharmacists as part of
the PCMH in order to provide comprehensive medication management.12
This guidance delineates the steps required in successful medication management, implementation, evaluation, and payment for pharmacist services
within a PCMH initiative. The potential value that pharmacists can bring
to patients, physicians and the medical home team as a wholein terms of
improved outcomes, satisfaction, and even costsprovides a rationale for
further development and pursuit of this opportunity for pharmacists to be
actively engaged in this capacity.
Collaborative practice agreements in which an established physician
pharmacist relationship exists that permits pharmacists to monitor, adjust,
and prescribe treatments is an even more expanded role of MTM.14 As part
of a PCMH model, pharmacists who additionally may be operating within
a collaborative practice agreement could provide even greater efficiencies
and enhanced value to the team. However, many challenges to the idea of
pharmacists assuming a larger prescribing role have been discussed, with
reimbursement strategies and potential for conflict of interest proving to be
two examples of key issues.15,16
Although there are many potential opportunities for pharmacists to grow
into different roles within the health care system, the diffusion of these
practice innovations has been slow. The diffusion of an innovation is the
process in which an innovation is communicated through certain channels
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429
over time among the members of a social system.17 An innovation can

be anything: a medication, device, program, or intervention. The diffusion
process is complex. The attributes of the innovation or technology itself
have to be communicated to and assessed by those in the system who are
the end-users or adopters of the innovation. Many barriers to diffusion of
pharmacy services exist, including methods for reimbursement (discussed
further later in this chapter). However, one issue cited as preventing these
innovations from becoming widely accepted practices has been difficultly
in demonstrating their value convincingly to stakeholders: that is, the cost
benefits for the outcomes achieved.
Demonstrating value
To demonstrate value, pharmacist-provided services have to show they improve outcomes, either in conjunction with saving money or by proving
the outcomes achieved are worth additional expenditures. Methodologies
incorporating costs and consequences (i.e., outcomes) of alternative therapies, innovations, or programs are appropriate to demonstrate value fully
to a stakeholder. The primary evaluation methods that may be used include cost-effectiveness analyses (CEA), cost-utility analyses (CUA), and
cost-benefit analyses (CBA).18 Using these methods, inferences can be drawn
as to whether an intervention provides improved outcomes at lower costs or
improved outcomes but with higher costs, both of which may be considered
to be value-added.
Several reviews of the literature for studies evaluating the economic
impact of pharmacy services have been published.9,1922 Overall, the
studies supported the idea that economic benefits accrue from using
pharmacist-based services. However, the robustness of published economic
evaluations of these services has been questioned. Of note, most of the
studies have been reported to be only partial analyses, not full analyses
that appropriately incorporate costs and outcomes, such as CEAs, CUAs
and CBAs. These partial evaluations either assume that outcomes between
interventions are equal, thus reducing the analysis to a cost comparison; list
the costs and outcomes without attempting to draw a conclusion about the
comparative effectiveness of competing alternatives; or fail to measure all
relevant costs and outcomes. While partial analyses may be appropriate in
some situations, they rarely are adequate without the full incorporation of
all health care resources and outcomes. In addition, the lack of a comparison
group and poor methodological quality or rigor in published economic
evaluations is problematic.9,19 Continued efforts to evaluate the economic
impacts of pharmacy services should be at the forefront of efforts to demonstrate the value stakeholders seek. During times when resources are scarce,
establishing cost-effectiveness is critical. However, robust methodologies and
430
high-quality study designs must be used to encourage stakeholder buy-in.

Incorporating a researcher into the team who has experience conducting
economic evaluations or referring to resources and good-practice guidelines
for conducting such analyses is recommended to avoid the pitfall of previous
studies.2325
Despite internally valid economic analyses demonstrating value, some
hesitation or resistance to adopting pharmacist services still exists. Typically,
pharmacy interventions are vastly different in terms of setting, service provided, and patient population. Thus, the external validity, or generalizability,
of these evaluations to a variety of pharmacy practice settings may be limited.
It becomes necessary, then, to evaluate internally the possible costs and
consequences of implementing a program or to perform pilot programs to
demonstrate the value at that practice site. If value can be demonstrated,
then the program or service may receive continued funding, or resources
may not be revoked. However, the current fee-for-service environment of
health delivery is not one that supports value-based health delivery, which,
additionally, explains much of the variance in the adoption of value-driven
technologies.
The recent enactment of the Patient Protection and Affordable Care Act
(PPACA) of 2010, the most comprehensive changes to health care since the
1965 legislation establishing Medicare and Medicaid, has the potential to
change the system to one where value-based services and technologies will be
valued by the health care system. The overall goals of this legislation include
expanding access to coverage, controlling health care costs, and improving
quality and health system performance.26 There exist provisions within this
act that will establish and develop quality and performance measures that
must be achieved within hospitals, skilled nursing facilities, home health
agencies, and ambulatory surgical centers in order to qualify for Medicare
reimbursement.26 For these goals to be attained, the health care professionals,
services, and technologies that are deemed to contribute significantly to
these outcome measures will be retained and valued. Therefore, it is critical
during this time that pharmacists and the services they provide demonstrate
value to the system in which they operate and to the stakeholders involved,
so pharmacists can continue to advance the profession into an even more
integral part of high-quality health care delivery.
Demonstrating value scientifically is an important first step. However,
participating in endeavors that support these value-added services or interventions through advocacy and policy-related activities also is important.
This will require pharmacists at local, state, and national levels from each
practice setting to become involved in a variety of ways. A number of
professional pharmacy organizations are actively involved in lobbying for
and representing the interests of the pharmacy profession in Washington,
DC, including communicating pharmacists interest to agencies such as the
The future
431
Department of Health and Human Services, the Institute of Medicine (IOM),

and the Centers for Medicare and Medicaid Services. The American Pharmacists Association is one such organization with diverse pharmacy interests
and constituency, including the largest student body of any professional
organization. The American Association of Colleges of Pharmacy (AACP)
supports the interests of pharmacy educators and is additionally instrumental
in advocacy and legislative endeavors.
At the state and local level, pharmacists, as part of their local colleges of
pharmacy or state pharmacy associations, can become involved in legislative
days to meet with members of congress where concerns and ideas about state
and community issues in health care can be communicated. That level of
local advocacy can influence legislation, which ultimately could set the stage
for larger national calls to action. Volunteering as preceptors for students
at health fairs is another way for individual pharmacists to become involved.
Participation in policy and advocacy for the profession from members of such
organizations should not only be encouraged, but should be considered a
duty to ensure the voice of all pharmacists is heard and the profession is
propelled forward into the future.
Even while these services may be valued because of the outcomes
achieved, and their value effectively communicated to stakeholders and
policy-makers, the ability to pay for these services and the potential sustainability of these programs, whether in the public or private sector, is an area
of growing concern.
Paying for value

Pharmacists continue to play an integral role in health care, demonstrating
their value in terms of improvements in economic, clinical, and humanistic
outcomes. However, how do we achieve that value and still keep the sector
alive? In 2009, the US spent $2.5 trillion for health care, approximately 17%
of the gross domestic product.27 Even though the USA spends more per capita
on health care than any other country in the world, citizens do not enjoy
superior longevity or health as compared to other industrialized countries.
Determining inefficiencies in the system and reallocating dollars to truly
value-added endeavors is required within the entire health care system. While
value-added services or technologies may only slow, but not reduce, health
care expenditures, they would provide increased access, quality, and safety
without increasing spending. In an effort to slow rising health care expenditures while still maintaining or improving outcomes, pay-for-performance
has been suggested for implementation, where reimbursement for provider
services is dependent on achieving specific patient outcomes. Under a PCMH
approach, quality metrics reached as part of pharmacist activities in the team
may demonstrate that value to the patients and other professionals within
432
that model to demonstrate value. However, a large complication remains as

to how pharmacists can be reimbursed for that value and who will pay for it.
Currently, pharmacists do not have provider status under Medicare, so they
cannot be directly reimbursed for patient care.28 Current procedural technology codes exist to bill for pharmacists cognitive services, but have yet to be
routinely adopted by payers.29 One of the barriers to reimbursement may be
the lack of understanding, knowledge, and demonstration as to the role of
pharmacists providing clinical services and research supporting the value of
that role to payers. In the Asheville project, where pharmacists provided and
were reimbursed for diabetes management services by employers, improved
short- and long-term outcomes were realized with decreases in costs due to
avoidance of other medical events.30,31 This, and other examples, show the
beginnings of utilization and reimbursement by payers for these services, but
they are still far from broad acceptance.
Additional issues relating to payment for the value pharmacists provide
to the health care system is the willingness-to-pay (WTP) threshold of those
ultimately paying for it. Improving outcomes can be cost-saving; however, in
many cases, better outcomes come at a cost. The question is how much would
payers be willing to spend for those outcomes? It will depend on the service
or intervention, how much that payer values the benefits, and competing
resources. WTP is not easily determined and varies from payer to payer. If
the benefits of pharmacist services do come at a cost, then being able to
justify those costs to external groups will be of the utmost importance.
Pilot programs for innovative pharmacist services may be funded initially
by internal or external sources. However, the sustainability of programs
in the long term is another factor to be considered.15 These services and
programs may be self-sustaining, where downstream cost savings pay for
the programs operation. Additionally, internal to an organization, revenues
from one area may support those pharmacy services. Reimbursement by
third-party payers might be sought for patients utilizing these services. However, payment reform for pharmacist services by increasing awareness of
pharmacist value to the health care system will ultimately be responsible for
the sustainability of such endeavors.
Population dynamics
Providing, demonstrating, and paying for the value pharmacy professionals
contribute to health care is becoming more important with the growing and
aging population, who will require more health care services and utilize
more medications. US Census Bureau projections estimate that 20.7% of
the population will be over 65 years of age by 2050, whereas in 2010 it
was estimated at only 13.0%.32 Moreover, starting in 2011, the first of the
baby-boomer generation became eligible for Medicare, where the last of
The future
433
the generation will be reaching the age of 65 by 2029. This baby-boomer

population is projected to significantly contribute to increases in Medicare
spending over the next decade.33
Many diseases that at one time were terminal now can be managed
chronically with a variety of treatments, including pharmacotherapy. The
result is increased health care resource utilization and expenditures, because
a larger number of individuals with multiple chronic diseases live longer. This
affects not only the sustainability of programs such as Social Security, but
also the affordability and capacity to provide sufficient health care resources,
such as long-term care and Medicare benefits. There is an expectation by
patients that pharmacists take a more active provider role to manage and
monitor polypharmacy. The supply of primary care physicians is not currently adequate to meet demand. As pharmacists are generally more visible
and accessible to patients, particularly in the community, they will be an
important resource for patients and should be valued by other practitioners
as a partner in providing pharmaceutical care for their growing and aging
patient populations.
Beyond contributing to the increasing number of older individuals who
will need more health care in the coming decades, the baby-boomer generation has additionally had an impact on almost every business sector they have
encountered, from entertainment to communications to real estate. As other
sectors have not been immune to this generations influence, health care will
likely be no different. Now, at the edge of health care reform and at a time
when the baby-boomers will require more health care services, it is predicted
they will drive home notions of increased convenience, ownership of patient
information, demand for transparency, increased quality, guarantee of safety,
and lower costs. This demand will require more health care professionals,
including pharmacists, to step into roles meeting these needs.
Technology
In order for the pharmacist to assist in managing the increasing demand for
health care resources, lead in patient-centered care, and provide services that
achieve desired economic, clinical, and humanistic outcomes, use of advances
in health information technology (HIT) will be necessary.
As integrated health care teams evolve, as in the PCMH model, communication and continuity of care are central. Efficiencies in these areas can be
realized with HITs, which electronically exchange patient information, such
as clinical and administrative information, among health care settings and
providers.34 Electronic health records (EHRs) and electronic personal health
records, where pharmacists would have access to records generated by other
health care providers or the patient, are two such examples of HIT.13,35 It
has been estimated that EHRs could save over $81 billion annually due to
434
increases in efficiency, and decreased inpatient and ambulatory adverse drug

events.36
The use of telecommunications technologies to provide health care is
being explored in a variety of settings. Telehealth may be one method
to provide cost-effective care, particularly for rural patients and providers.
Pharmacists, in addition to physicians and nurses, are using this technology
to remotely monitor and care for patients. Although rural settings have been
the model for this innovation, it is also being used in urban hospital and
community settings. For example, pharmacists have used remote technologies to monitor therapy and adherence to guidelines for adult intensive care
unit patients on sedation overnight while on-site staffing was limited.37 In
the community setting, telepharmacy has been used for remote medication
processing and dispensing, medication counseling via webcam, authorization
for refills, and referrals.38 Telehealth technologies have even been integrated
successfully into existing telephone MTM programs to monitor patients with
uncontrolled diabetes.39 Other technologies, including electronic prescribing
and computerized provider order entry, which have been shown to prevent
prescribing errors, are additionally making their way into pharmacy practice.40
While careful implementation of all these technologies is necessary to
ensure no detrimental effects of their use occur, all health care providers must
be open to educating themselves and using these technological advances as
they are adopted by the system. However, questions remain as to whether
and at what rate these innovations will diffuse into routine practice.
Advances in pharmacogenetics and pharmacogenomics may provide insights to more accurate prescribing and dosing of medications shown to be
influenced by genetic factors. Personalizing medicine in this manner not only
conforms to patient-centric models of care but also calls for those with the
skills and knowledge to appropriately implement and monitor such pharmacotherapies. This is an opportunity for pharmacists to, again, extend the
bounds of traditional pharmacy practice and provide value-added services.
As pharmacists begin to move beyond dispensing responsibilities, which
may be performed increasingly by technicians or automated technologies,
they will be asked to use their expertise in drug selection and dosing for
individual patients where the utilization of genomic information may be
necessary. The challenge with pharmacogenomic technologies, as with the
others discussed, is not only in adoption, but also demonstrating clinical and
economic value to all stakeholders.41 The application of genomic information
in delivering personalized medicine, in addition to other critical factors such
as timely health information exchange and interprofessional collaboration,
may greatly facilitate the optimal goal of truly providing therapy specific to
the individual.42 In addition, efforts toward educating students and practicing
The future
435
pharmacists in all of these areas are important in moving the profession

forward.
Education
The dynamic nature of health care requires pharmacy education to keep
pace by continually evaluating and revising professional curricula to prepare
the pharmacists of tomorrow with the skills and knowledge required to
be productive and effective health care providers into the future. Formal
continuing education and training programs also will have to be implemented
at practice sites for those already working in the field.
Several recommendations have been made as to where current pharmacy
education and training need further expansion and refinement.43 Introduction to interprofessional collaboration and communication in an interdisciplinary health care team early in pharmacy school education is one such
recommendation.43 The World Health Organizations (WHO) definition of
interprofessional education is when students from two or more professions
learn about, from and with each other to enable effective collaboration and
improve health outcomes.44 It is essential that education in interprofessional
teamwork be incorporated into early in pharmacy training: once in practice,
health care professionals are asked to work together in teams to provide
comprehensive care to patients. However, a distinction between a team
and a group is required, as unfortunately, most teams function not as a
team but, rather, as a working group. Katzenbach and Smith45 defined the
attributes of a team versus group and the necessity of true team dynamics to
achieve good performance; the differentiating characteristics are delineated
in Table 20.1.
Subsequent to the publication of the IOMs Crossing the Quality Chasm:
A New Health System for the 21st Century series in 2001, the IOM released Health Professions Education: A Bridge to Quality, which includes
recommendations for health care education reform, with an emphasis on
developing interprofessional practice.46,47 The vision the committee developed centers around five core elements, listed in this statement: All health
professionals should be educated to deliver patient-centered care, as members
of an interdisciplinary team emphasizing evidence-based practice, quality
improvement approaches, and informatics.47 Continued efforts to educate
and train the future and current pharmacy workforce in each aspect of this
shifting health care paradigm will be paramount in making this vision a
reality.
As health care begins to embrace the PCMH model, education regarding
interprofessional collaboration becomes particularly important. To that end,
the Interprofessional Education Collaborative (IPEC) group, consisting of
panel members from six professional societies, including the AACP, has
436
Table 20.1 Characteristics of working groups versus teams

Working group
Team
Strong, clearly focused leader
Shared leadership roles
Individual accountability
Individual and mutual accountability
The groups purpose is the same as the broader

organizational mission.
The team has a specific purpose that the team itself

delivers.
Individual work products
Collective work products
Runs efficient meetings
Encourages open-ended discussion and active

problem-solving meetings
Measures its effectiveness indirectly by its

influence on others
Measures performance directly by assessing collective

work products
Discusses, decides, and delegates
Discusses, decides, and does real work together
(Data from Katzenbach JR, Smith DK. The discipline of teams. Harv Bus Rev 1993;71[2]:11120.)
developed core competencies for interprofessional collaborative practice.48

Interprofessional collaborative practice, as defined by the WHO, is when
multiple health workers from different professional backgrounds work together with patients, families, carers, and communities to deliver the highest
quality of care.44 The key competency domains for interprofessional collaborative practice developed by the IPEC panel include focus on values/ethics,
roles/responsibilities, interprofessional communication, and teams and teamwork.48 The future of science, education, and practice will most likely be a
result of the success of teamwork; therefore, emphasizing and integrating
these concepts into formal education and practice for students and veterans
of the pharmacy profession, alike, must be a priority.
Scholarly activities and integration of research content into professional
programs has been emphasized as well.43,49 As the value provided by pharmacists interventions has to be demonstrated into the future, pharmacists
must be armed with the ability to conduct such research, including economic
evaluations. Additional recommendations include, but are not limited to,
expanding HIT familiarly, use of simulation-based learning, global health
education, and leadership and advocacy.43
Conclusion
A continued focus and goal of the pharmacy profession should be to provide pharmaceutical care and services that demonstrate value (i.e., improve
quality, access, and cost) to the system and to key stakeholders within
the system: patients, payers, purchasers, other providers, and policy-makers.
Community-based pharmacists have direct access to ambulatory patients,
usually on a routine basis, where, aside from their medication monitoring
The future
437
and dispensing roles, they play a key role in educating patients. Pharmacists
working within a medical center or health system can intervene to reduce
medication and medical errors, in addition to working within interdisciplinary teams to deliver optimal care. Insurance companies and pharmaceutical benefits managers also employ pharmacists to help facilitate access
and reimbursement, as well as perform drug utilization reviews, research and
MTM. Regardless of the practice setting, pharmacists are valued members of
the health care team.
As a greater demand for pharmaceuticals and related services has
emerged, due, in recent years, to the aging baby boomer population, there
is an expectation for pharmacists to step into even larger provider roles in
patient-centered care to monitor medications and provide additional chronic
disease management services. Technological innovations may aid pharmacists
in achieving greater work efficiency and improved outcomes. Pharmacy curricula will need to be relevant and dynamic in response to changes in skill
sets and knowledge required for current practice.
No one can predict with certainty the future of the pharmacy profession.
The only certainty is that change will occur. Those already practicing must be
prepared to adapt to challenges and changes, which might entail reinventing
and redefining the roles of pharmacists and pharmacy professionals in the
US health care system. We should encourage all to work directly with the
development of clinical decision support systems; implementation of personalized medicine programs; development of value-based, patient-centered
delivery models and telehealth systems in terms of creating such personalized
programs; and working in organizations that will use these tools and approach the prevention, monitoring, and treatment of disease using different
paradigms from how most were trained. We are just at the beginning of
dramatic change in health care.

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Index
Note: page numbers in italics refer to figures and tables.
abuse of medication 293
Academy of Managed Care Pharmacy
(AMCP) 103
access to care 8, 1278
minority populations 3289,
3445
older population 1856
accountability 379, 381
adverse drug events 298
accountable care organizations (ACOs)
395
accreditation 58
geriatric pharmacists 188
hospitals 1723
see also training of pharmacists
Accreditation Council for Pharmacy
Education (ACPE) 10910
Accredited Standards Committee X12
(ASC X12) 398
active informed consent 372
activities of daily living (ADLs) 192
activitypassivity model,
patientpractitioner relationship
2567
adolescents, abuse of prescription
medications 293
advanced practice credentialing 11617
academic postgraduate education
and training 117
certification programs 11920
multidisciplinary 1212
certifying agencies for pharmacists
only 1201
fellowships 118
practice-based continuing
pharmacy education 11819
residency programs 11718

traineeships 119
adverse drug events (ADEs) 297
monitoring procedure 309
prevention 310
risk in older population 1867
see also medication errors;
pharmacovigilance
Adverse Event Reporting System
(AERS) 3001, 302
advertising see direct-to-consumer
advertising
advisory committees, use by FDA 131
Affordable Care Act (ACA), 2010 8,
17, 38990, 391, 430
impact on HIT 38990, 391,
3945
impact on Medicaid program 15
impact on older population 183
impact on pharmaceutical industry
220
implications for dispensing 4012
African-American population 2767,
323
access to care 345
attainment of First Professional
degree 3324
enrollment into health professional
schools 329, 335, 336
growth 324
projections 3267
medication responses 346
as percentage of registered nurse
population 336, 337
pharmacy graduation, trends
33840
Agency for Healthcare Research and
Quality (AHRQ) 175, 312
Aggregate Demand Index (ADI) 767
442
Index
pharmacists 62
aging 252
chronological 252
individual variation 184
interrelationships among the three
concepts 2545
psychological 2534
social 254
aging population 77, 17981, 2512,
4323
implications for self-care 271
alcohol, ethnic variations in response
346
allopathic medicine training
degree by ethnic category 332
enrollment of ethnic minorities
329, 330, 335
Alpha Zeta Omega 103
alternative therapies 346
ethnic minorities 273, 274
Alzheimer disease, increasing incidence
181
ambrisentan 308
ambulatory care 63
expenditure 166
private sector 9
American Association of Colleges of
Pharmacy (AACP) 109
American Association of
Pharmaceutical Scientists (AAPS) 103
American College of Apothecaries
(ACA) 101
American College of Clinical Pharmacy
(ACCP) 102
American Council for Pharmacy
Education (ACPE), continuing
education programs 11819
American Foundation for
Pharmaceutical Education (AFPE) 110
American Health Information
Management Association (AHIMA)
400
American Hospital Association (AHA)
165
American Indian and Alaskan
population
access to care 345

schools 3301, 335, 336
growth projections 3267
population 336, 337
33840
American Medical Informatics
Association (AMIA) 399
American National Standards Institute
(ANSI) 400
American Nurses Informatics
Association and the Capital Area
Roundtable on Informatics in Nursing
(ANIA-CARING) 399
American Pharmacists Association
(APhA) 100
formation 99
American Recovery and Reinvestment
Act (ARRA) incentives 394, 408
American Society of Consultant
Pharmacists (ASCP) 102
American Society of Health-System
Pharmacists (ASHP) 101
residency programs 11718
antibiotics, medication therapy review
8890
apothecaries 56
APPRISE program 306
Asheville project 432
Asian-American population 272,
2745, 276, 323
access to care 345
degree 3324
schools 329, 3301, 335, 336
growth 324
health care culture 273
population 336, 337
33840
assisted living facilities (ALFs) 2001
automated dispensing 4012, 4067
automation technologies
impact on health care 66
role in drug distribution 23940
autonomy 370, 371
professional 379
Index
baby-boom generation 180, 4323

bar coding technology 240
distributor purposes 241
barriers to health care, older population
1856
Beers Criteria 187
incorporation into DRR 194
beneficence 370, 371
beta-blockers, ethnic variations in
response 346
BiDil 346
biosimilars 1345
biotechnology drugs, generic
competition 1345
biotechnology segment, pharmaceutical
industry 218
black box warnings 303
black population 272, 2767
access to care 345
degree 3324
schools 329, 3301, 335, 336
growth 324
projections 3267
population 336, 337
33840
blister packages, ease of use 234
Board of Pharmacy Specialties (BPS)
1201
boards of pharmacy 380
boxed warnings 303
branded generics 2234
brand-name drugs 39
BRCA gene, patenting 146
business knowledge 756
cachexia 207
call centers, managed care systems 47,
51
capitation payment systems 30
care, ethics of 368
caring 382
causes of death, changes between 1900
and 2007 34
443
Centers for Disease Control and

Prevention (CDC) 17
Centers for Medicare and Medicaid
Services (CMS) 17, 171
Conditions of Participation 157
pay-for performance methodology
309
Certification Commission for Health
Information Technology (CCHIT)
400
certification of individuals 589
certification programs 11920
multidisciplinary 1212
certified nurse midwives (CMWs),
prescribing authority 54
certifying agencies for pharmacists only
1201
chain pharmacies 78
distribution of drugs 235
National Association of Chain
Drug Stores (NACDS) 107
work activities 80
charities
not-for-profit hospitals 1667
role in early medical care 154
chief executive officer (CEO), hospitals
158
chief information officer (CIO) 159
chief medical officer (CMO) 159
chief nursing officer (CNO) 159
chief pharmacy officer (CPO) 159
child-resistant packaging 234
children, ethnic diversity 272
Childrens Health Insurance Program
(CHIP), funding sources 28
chiropractic training
enrollment of ethnic minorities 335
chiropractors (DC), prescribing
authority 54, 55
choice, patients 247, 249
chronic conditions
age-related prevalence 181
growing importance 78
patient responsibilities 259
provision of value 4267
chronological aging 252, 254
Civilian Health and Medical Program
of the Uniformed Services
(CHAMPUS) 12
CLAS Standards 3414
444
Index
clinical outcomes, medication therapy

review 83
clinical outcomes analysis 43
clinical pharmacy 57, 164, 4278
adopters 41516
perceptions of external
adopter 417
adoption
influencing factors 415
tactics 41618
American College of Clinical
Pharmacy (ACCP) 102
evaluation 42931
Indian Health Service 13
indicators of progress
competency matters 41920
corporatization 422
hearts and minds of
pharmacists 41819
leading edge 4201
pharmacist salaries 421
pharmacy technicians 422
private practice 4212
provider status 420
public demand 419
wild cards 4223
and physician shortages 60
reimbursement 4312
roles 64
transformation of pharmacy
practice 41315
see also consultant pharmacists
clinical specialist-centered model,
hospital pharmacy practice 164
clinical trials, premarket assessment of
drugs 299300
closed formularies 40
clustering, pharmaceutical industry
21819
CMS e-prescribing Incentive Program
391
coalitions, pharmacy organizations 111
cognitive abilities, psychological aging
253
cognitive personality theory 2534
collaborative drug therapy management
(CDTM) 1224
participating states 73
collaborative practice 867, 428, 436
collaborative working relationship

(CWR) model 87
case analysis 90
Commission for Certification in
Geriatric Pharmacy (CCGP) 121, 188
Commission on Credentialing (COC)
117
communication skills 82
Language Access Services 3423
language issues 3478
in personal selling 856
Community Health Centers (CHCs)
1314
community hospitals 168
medical staff 163
ownership 166
rural hospitals 16970
community pharmacies 67, 7880
changing roles 116
National Community Pharmacists
Association (NCPA) 1001
use of pharmacy technicians 65
comparative effectiveness research
(CER) 42, 220
compliance 287, 351
continuum of behaviors 288
cultural issues 3523
definitions 2878
enhancement of 289
noncompliance 28890
relationship to packaging 234
role of self-care 286
computerized physician (provider)
order entry (CPOE) systems 3878,
407
concurrent DUR 45, 50
confidentiality 370, 373
conflicts of interest 365
pharmaceutical industry research
1389
consent see informed consent
consequentialist theories of ethics 368
consolidation, pharmaceutical industry
218, 2212, 224
consultant pharmacists 18990
American Society of Consultant
Pharmacists (ASCP) 102
certification 188
employment opportunities 188
Index
evidence of associated positive

outcomes 198
evolving role 1989
role in error reduction 1878
role in home health care 2056
role in hospice care 2067
role in long-term care 179
adult day services 2012
in assisted living facilities
2001
continuing care retirement
communities 202
intermediate care facilities 202
in nursing homes 191, 1937
PACE programs 205
reduction of medication errors
187
consultations, patient decision-making
351
Consumer Healthcare Products
Association (CHPA) 106
consumerism
drivers of 2478
changed perception of health
care 2489
technology 248
incongruities 24950
consumers of health care 2467
behavior 2656
health behavior 2667
in health and sickness 2645
illness and sick-role behavior
2679
individual consumer behavior
model 2604
demographic change 2512
chronological aging 252
impact of aging 252
interrelationships among the
concepts of aging 2545
psychological aging 2534
social aging 254
ethnic minorities 2724
2767
Asian-American population
2745, 276
Eastern European population
275
445
Latino population 2756

gender issues 2778
information sources
direct-to-consumer advertising
250
Internet 2501
see also patientpractitioner
relationship
consumption of health care,
decision-makers 245
continuing care retirement communities
(CCRCs) 202
continuing pharmacy education (CPE)
activities 11819
continuity of care records (CCRs) 396,
406
continuous professional development
378, 379, 380, 3812
contract negotiations, role of managed
care pharmacists 50
contract practice 212
contracts
with networks of dispensing
pharmacies 456
with pharmaceutical
manufacturers 467
controlled drugs
electronic prescribing 388
prescribing authority 56, 668
coordinated care
impact on compliance 291
medication error reduction 292
corporatization of pharmacy practice
422
cost control strategies 78
cost effectiveness research (CER) 403
cost reduction, role of CDTM 1234
cost savings, medication therapy review
834
cost-benefit analysis (CBA) 429
cost-effectiveness analysis (CEA) 429
costs of drug-related problems 186
costs of healthcare 18, 53
comparison with other OECD
countries 31, 32
growth 312
hospital spending 7
impact of aging population 433
impact of health care reform 2934
impact of health information
technology 389
446
Index
impact of medication adherence

291
pharmaceutical pricing 1323
trends 4, 17, 1289, 2845
impact of genomics 130,
1456
political fallout 129
see also drug costs
counseling information, USP
Dispensing Information 108
counseling mandate, Medicaid patients
15
CPE Monitor service 109
critical pathways see protocols
Crizotinib, projected sales 224
Cuban population 275
cues, need arousal 260, 267
cultural differences 341
277
Asian-American population
2745, 276
Latino population 2756
in use of health care services
34651
Cultural and Linguistically Appropriate
Services (CLAS), National Standards
3414
cultural sensitivity 341
Culturally Competent Care, CLAS
Standards 342
curandero use, Mexican population
275, 276
darbepoetin alfa, APPRISE program
306
data standards 396, 4034
death, causes of, changes between 1900
and 2007 34
decision evaluation, individual
consumer behavior model 260, 2634
decision execution, individual
decision-making
ethical dilemmas 3745
case studies 3757
ethics 3612
gatekeepers 245
importance of information 265
patients 2467
see also patientpractitioner
relationship
decision-making models 2623
decision-making process 3489, 350
delirium 207
demographic change 77, 17981,
2512, 31921, 325, 4323
population projections by race and
age 3267
see also aging
dental services, expenditure 166
dentistry training
329, 330, 335, 336
dentists, prescribing authority 54
deontological theories of ethics 368,
369
Department of Health and Human
Services (DHHS) 17
Det Norske Veritas Healthcare Inc.
(DNV) 173
determinants of health 2
diabetes, ethnic variations 344
diabetes care, Community Health
Centers 14
Dietary Supplement Health and
Education Act (DSHEA), 1994 132
dietary supplements, usage by older
population 185
diffusion of innovations 41518, 4289
Direct Project 405
direct-to-consumer (DTC) advertising
250
cost implications 138
dissonanceattribution model of
decision-making 2623
distribution of drugs
automation 23940
contributions of distributor
industry 2323
customers of wholesalers 2312
distribution network 230
generic drugs 2389
healthcare distributors 2302
to hospitals 236
internet pharmacies 2378
Index
in large community pharmacies

235
in managed care organizations 237
marketing mix 228
packaging 2335
from pharmaceutical
manufacturers 22930
specialty pharmaceuticals 2402
supply chain 227
trends 239
diversity 317, 3534
in the health care industry 325
advantages 3401
see also ethnic minorities
doctorpatient relationship see
documentation 379
doughnut hole, Prescription Drug Plans
142, 183
drug costs 219
effect of direct-to-consumer
advertising 138
impact of genomics 130, 1456
Medicaid 1367
Medicare coverage 1823
private prescription insurance
1356
reimportation and international
pricing 1378
role of government 1467
drug development 1389
benefits to society 230
costs 129, 2289
impact of genomics 145
new drug applications
advisory committees 131
review times 1301
pre-approval drug evaluations
299300
drug distribution see distribution of
drugs
drug distribution-centered model,
Drug Enforcement Administration
(DEA), categorization of prescribing
authority 56
drug recalls 219
drug regimen review (DRR) 188, 1934
447
historical evolution 1945

in intermediate care facilities 202
drug-related problems (DRPs)
in hospice setting 207
preventive role of pharmacists
4278
see also adverse drug events
drug responses, ethnic differences 274,
3456
Drug Safety Communications 303
Drug Safety Oversight Board 302
drug shortages 176, 2412
drug use 2835
abuse of prescribed drugs 293
compliance 287
definitions 2878
noncompliance 28890
potential problems 285
medication errors 2923
self-medication 2867
decision-making process
34851, 350
influence of pharmacists 348
trends 1289
drug utilization review (DUR) 445
role of managed care pharmacists
50
druggists 99
dual eligibles 15
care coordination 291
program for all-inclusive care for
the elderly 2035
special needs plans 203
dyschromic spirochetosis 352
Eastern European population 275
economic outcomes analysis 43, 834,
429
education 1645, 378
advanced practice credentialing
11622
degree, by racial/ethnic category
3324
329, 3301, 3356
ethnic minorities 330, 333, 335
448
Index
expansion 11516
first established pharmacy college 6
future directions 4356
in geriatric pharmacy 189
in managed care systems 47
medical education 545
role of federal hospitals 169
pharmacy organizations 10910
websites 113
preparation for clinical practice
41920
501
role of pharmacy organizations
967
eHealth Initiative (eHI) 400
elderly population see older population
electronic commerce (EC) 240
electronic data interchange (EDI) 240
electronic health records (EHRs) 225,
3867, 3889
certification 3934
cost savings 4334
facilitation of adoption 394
future developments 405
interoperability 3967
meaningful use 3913
Pharmacist/Pharmacy Provider
Electronic Health Record 399
electronic medical records (EMRs) 385,
386, 406
electronic prescribing 3856, 388
associated legislation 3901
elements to assure safe use (ETASUs)
306
emergency contraception, pharmacist
prescription 57
emerging roles 56, 78, 11516, 1246,
247, 4201, 4269
advanced practice credentialing
11622
advocacy 4301
collaborative drug therapy
management 1224
demonstration of value 42930
political aspects 1434
reimbursement 4312
see also consultant pharmacists
employment trends, pharmacy 645
end-of-life care, ethical issues 371

engineering model, patientpractitioner
relationship 2556
environmental factors in disease 5
epidemiology, ethnic variations 344
epoetin alfa, APPRISE program 306
errors see medical errors
esteem needs 261
ethical decision-making 3612, 3745
ethical dilemmas 359
case studies 3757
ethical interactions 362
ethical practice 249
ethical principles 36973
ethical theories 3689
ethical versus legal continuum 35961,
360
ethics 380
definition 359
pharmacy code of ethics 3634
history of 362
purpose 3645
professional behavior 3658
relationship to professionalism 365
virtues, values, morals and rights
3734
ethnic minorities 272, 3534
access to care 3445
2767
Asian-American population 2745,
276
degree 3324
compliance 3523
Cultural and Linguistically
Appropriate Services (CLAS),
National Standards 3414
definitions 328
differences in health care service
use 34651
drug responses 274
Eastern European population 275
employment in health care industry
325
schools 329, 3301, 3356
epidemiological variations 344
health care cultures 2734
infant mortality 4
Index
Latino population 2756, 319

life expectancy 4
models of disease causation 2723
as percentage of physicians 336,
338
as percentage of US population
318, 3201, 323
trends 318
33840
population growth 324, 325
population projections by race and
age 3267
preference for ethnic minority
physicians 338
treatment outcome variations
3456
workforce diversity, advantages
3414
evidence-based care 156
expanded roles, pharmacists 56, 78
expenditure on health care 166
extensible markup language (XML)
system 240
eye contact, cultural differences 341
failure mode and effects analysis
(FMEA) 312
fatal illness, disclosure to patients 273
Federal Employees Health Benefit Plan
(FEHBP), funding sources 278
federal government-provided care
Community Health Centers 1314
military medical care 12
federal hospitals 1689
fee-for-service plans 29, 35
fellowships 118
female pharmacists, increasing numbers
778
feminist ethics 368
fidelity 370, 372
fiduciary relationship model,
2568
financial management, role of
consultant pharmacists 1989
financing of health care 21
challenges
449
health care spending 312

international context 323
conclusions 33
see also funding sources
Fleetwood Project 198
Flexner Report, 1910 6
follow-on biologics 1345
Food and Drug Administration (FDA)
17, 1301, 146, 2989
Adverse Event Reporting System
3001, 302
definition of important drug safety
issues 302
Drug Safety Communications 303
and herbal remedies 1312
and off-label promotion of drugs
1401
requirements for premarket
assessment 299300
RiskMAPs 304
Task Force on Risk Management
3034
Food and Drug Administrative
Amendment Acts (FDAAA), 2007
3012, 305
Food, Drug and Cosmetic Act, 1906 6
formularies 3942, 135
aids to formulary decision-making
423
responsibilities of managed care
pharmacists 49
formulary access rebates 47
formulary information, inclusion in
meaningful use criteria 393
formulary management tools 434, 49
for-profit hospitals 1678
Fostering Independence Through
Technology (FITT) act 2011 402
fragmentation, pharmaceutical industry
222
frailty 184
fraternal organizations 1034
websites 113
functional profiles, EHRs 398, 399
funding sources 212
private health insurance 289
fee-for-service plans 29
managed care systems 2931
public financing 223
Childrens Health Insurance
Program 28
450
Index
Federal Employees Health

Benefit Plan 278
Medicaid 26
Medicare 246
TRICARE 27
Veterans Administration (VA)
system 267
see also financing of healthcare
future directions 4256, 4367
education 4356
population dynamics 4323
providing, demonstrating, and
paying for value 42632
technology 4335
gatekeepers 245
gender differences
in health care consumption 2778
in life expectancy 4
generic drugs
availability and distribution 2389
branded 2223, 2234
competition for biotechnology
drugs 1345
HatchWaxman Act 133
over-the-counter products 287
use in managed care 39, 489
Generic Pharmaceutical Association
(GPhA) 106
genetic factors in disease 5
genomics 42, 130, 434
political issues 1446
geodemographic segmentation 84
geriatric pharmacy
certification 188
Geriatric Pharmacy 121
employment opportunities 188
role in error reduction 1878
role in long-term care 18990,
199200
role in nursing homes 193
drug regimen review 1935
quality assurance 1967
see also consultant pharmacists;
older population
goal setting, role of pharmacy

organizations 98
governing bodies, hospitals 158
government drug price negotiations
1423
group purchasing organizations
alliances with hospitals 236
alliances with pharmacies 2367
interaction with pharmaceutical
manufacturers 229
guidancecooperation model,
patientpractitioner relationship 257
guidelines see protocols
HatchWaxman Act 133
health, definitions 1, 245
health behavior 265, 2667
health belief models 2667, 3523
explanation of illness behavior 268
explanation of sick-role behavior
268
health care reforms 1718, 33, 430
impact on drug use process 2934
impact on older population 183
legislation 3906
health care services
historical evolution 89
18501900 56
19001945 67
19452010 78
2010 and beyond 8
use, cultural differences 34651
health care system, web of providers
1567
health education see education
health habits 45
health information exchanges (HIEs)
3967, 405, 406, 4078
health information technology (HIT)
3856, 4335
computerized physician (provider)
order entry systems 3878
drivers of implementation 38890
electronic health records and
electronic medical records 3867
electronic prescribing 388
future developments 405
implications for pharmacists
automated dispensing 4012
telemedicine 4023
interoperability 3967
key events and legislation 3906
organizations 399401
Index
personal health records 387

Pharmacy e-Health Information
Technology Collaborative 4045
questions for study 4059
research roles 4034
standards 3979
Health Information Technology for
Economic and Clinical Health Act
(HITECH) 38990, 391
health insurance 7
benefit control vs. cost 36
coverage 911
see also private prescription
insurance
Health Insurance Portability and
Accountability Act 1996 373, 389,
390
Health Level Seven (HL7) 398
health levels, improvements since 1900
4
health literacy problems 291
Health Maintenance Organization
(HMO) Act, 1973 8
health maintenance organizations
(HMOs) 10, 30, 36, 37, 249
health professionals 53
accreditation 58
certification and registration 589
employment percentages by
industry sector 71
employment percentages by
occupation 712
licenses and permits 59
numbers and distributions 578
numbers by specialty 6870
pharmacists
personnel and practice sites
60, 623
specialization 634
physicians, specialization 5960,
61
controlled drugs 668
pharmacists 567
Health Professions Education: A
Bridge to Quality, IOM 435
health promotion 1, 5
451
Health Resources and Services

Administration (HRSA) 17
Healthcare Distribution Management
Association (HDMA) 1067, 232
Healthcare Facilities Accreditation
Program (HFAP) 1723
Healthcare Information and
Management Systems Society
(HIMSS) 399400
Healthy People 2020 (DHHS) 13
objective areas 2
hepatotoxicity 300
herbal remedies
regulations 1312
use by ethnic minorities 348
use by older population 185
high-tech care, limited benefits 18
Hill-Burton Act, 1946 7, 154
hip fractures, increasing incidence 181
Hispanic population see Latino
population
holistic approach 247
home health care
drug distribution 242
role of consultant pharmacists
2056
honorary societies 1045
websites 113
hospice care, role of consultant
pharmacists 2067
hospital acquired preventable
conditions 174
hospital services 1612
hospital types 165
community hospitals 168
federal hospitals 1689
investor-owned hospitals 1678
specialty hospitals 170
hospitals
accreditation 1723
drug distribution channels 236
future challenges 174, 1767
growth period 7
health care staffing
medical staff 1623
nurses 1634
pharmacists 1645
history of 1536
organizational structure 15761,
160
452
Index
ownership 162, 1656, 167

patient safety issues 1734
pharmacy services, expectations of
accreditation groups 173
private sector 9
regulatory environment 1712
hotcold disease explanatory model
273, 276
human relations (HR) department,
hospitals 161
humanistic outcomes analysis 43, 84
hypercompliance 288
hypertension
ethnic variations 344
in treatment response 346
noncompliance 289
illness
attitudes towards 2712
defining factors 269
ethnic models of disease causation
2723
illness behavior 2656, 267, 269
health belief model 268
immunizations
pharmacist prescription and
administration 567, 72, 124
implication questions 856, 89
important drug safety issues 302
indemnity (fee-for-service) plans 29
independent pharmacies 78
competition 88
work activities 80
Indian Health Service (IHS) 1213
funding sources 27
individual consumer behavior, five stage
model 2604
infant mortality rate (IMR) 33
improvement since 1900 4
infectious disease mortality, influencing
factors 5, 6
informatics 125
information, importance for
health-related decision-making 265
information gathering, individual
information sources, health care

consumers
direct-to-consumer advertising
250
Internet 2501
informed consent 370, 3723
initial noncompliance 288
innovations, diffusion of 41518,
4289
in-patient care expenditure 166
Institute for Healthcare Improvement
(IHI) 176, 312
Institute of Medicine (IOM) 312
recommendations on reduction of
medical errors 173
Institute for Safe Medication Practice
(ISMP) 175, 312
institutional accreditation 58
institutional pharmacies 191
insulin, discovery 6
integrated delivery systems (IDSs) 378
integrity 380
intellectual property 147, 221
regulations 1323
biotechnology drugs 1345
HatchWaxman Act 133
International Classification of Disease
(ICD) codes 4034, 409
Internet, impact on health care 247,
2501
interoperability, health information
technology 3967, 405
interpreter services, CLAS Standards
3423
interprofessional education 435
Interprofessional Education
Collaborative (IPEC) group 4356
investor-owned hospitals 1678
Iowa Medicaid pharmaceutical case
management program 823
iPLEDGE program, isotretinoin 306
Joint Commission of Pharmacy
Practitioners (JCPP) 111
journals 97
state pharmacy organizations 105
judgmental acts 367
just culture strategy, adverse drug
events 298
justice 370, 373
Index
Kappa Epsilon 104

Kappa Psi 104
karma 274
knowledge, role in professionalism 380,
381
Lambda Kappa Sigma 104
Language Access Services, CLAS
Standards 3423
Latino population 272, 2756, 319,
323
access to care 345
degree 3324
schools 329, 3301, 335, 336
growth 324
projections 3267
health care culture 273
population 336, 337
33840
lay-referral system 26970, 349
cultural issues 352
Leapfrog Group 312
learning model of decision-making 262
legal dilemmas 359
legal versus ethical continuum 35961,
360
legislation
application to hospitals 1712
Food and Drug Administration
1301
of health-related behavior 265
herbal remedies 1312
HIT-associated 38996
intellectual property 1323
HatchWaxman Act 133
off-label promotion of drugs
1401
pharmacovigilance 3089
license to practice 59, 11617
licensing examination 109
life care communities (CCRCs) 202
life events, interaction with symptoms
269
life expectancy 33
453
improvement since 1900 4

lifestyle practices 45, 7
Lipitor
cost 132
sales 224
local government-provided care 1416
local pharmacy organizations 1056
long-term care 10
adult day services 2012
assisted living facilities (ALFs)
2001
continuing care retirement
communities 202
definition 189
nursing facilities 1901
Program for All-Inclusive Care for
the Elderly (PACE) 2035
role of consultant pharmacists 179,
18990
settings 189
mail-order pharmacy 79
managed care pharmacists 645
Academy of Managed Care
Pharmacy 103
corporate functions 512
operational functions
contract negotiations 50
drug utilization review (DUR)
50
formularies 49
provider and member
education 501
quality measurement 51
use of generics 489
managed care pharmacy tools 389
aids to formulary decision-making
423
contract negotiations 457
drug utilization review 445
formularies 3942
formulary management tools 434
provider and member education 47
use of generics 39
managed care systems 8, 1011, 2931,
356
drug distribution 237
health maintenance organizations
37
integrated delivery systems 378
454
Index

manufacturers 229
Medicare Advantage program 182
pharmacy benefit management
companies 38
point-of-service (POS) plans 37
preferred provider organizations
37
public health care sector 15
TRICARE 12
market segmentation 845, 87
market share rebate arrangements 46
marketing 76
pharmaceutical companies 139
off-label promotion 1401
physician inducements 13940
marketing mix 228
mass merchandiser pharmacies 789
meaningful use, health information
technology 3913
medex (MX), prescribing authority 55
Medicaid 7, 1416
drug costs 128, 1367
foundation 155
funding sources 26
payment for nursing facility
services 191
prospective payment system 8
waiver programs 201
role of federal hospitals 169
medical errors 156, 1734, 297
patient safety organizations 1756
reduction strategies 169
bar coding 240
health information technology
388, 389
see also medication errors
medical staff, hospitals 1623
Medicare 7, 16
distribution of spending 183
drug costs 128
coverage of 1823
foundation 155
funding sources 246
growing expenditure 22, 23
MTM services 125
payment for nursing facility

services 191
payment for skilled nursing
facilities 192
Prescription Drug Plans 1413
prospective payment system 8
waiver programs 201
Medicare Drug Improvement and
Modernization Act (MMA) 2003
389, 3901, 406
Medicare Improvements for Patients
and Providers Act (MIPPA) 2008 389,
391
Medication Appropriateness Index
(MAI) 187
medication counseling 47
medication errors 2923, 294
reduction strategies 310
premarket revisions 299
role of consultant pharmacists
1878
reporting of 298
see also adverse drug events;
medical errors
medication guide distribution 306
enforcement discretion 307
medication management standards
3089
medication passes, wrong-time errors
1878
medication response, ethnic variations
3456
medication safety 174, 310
medication therapy management
(MTM) 75, 801, 1245, 4278
professional activities 81
suitability for older population
199200
medication therapy review (MTR) 75,
813, 82
application of marketing concepts
84
market segmentation 845
personal selling 856
relationship marketing 867
case analysis 8790
outcomes 834
medication use evaluation/
management see drug utilization
review (DUR)
Medicine Equity and Drug Safety Act,
2000 137
Index
MediGap plans 16
MedWatch 3001
meetings, sponsorship by pharmacy
organizations 967
member education, managed care
systems 47
mental health services 10
mentally challenged, intermediate care
facilities 202
mergers and acquisitions,
pharmaceutical industry 2212
metabolism, ethnic variations 274,
3456
Mexican population 2756
midwives, prescribing authority 54, 56
military medical care system 12, 1689
Minimum Data Set (MDS) 1956
monographs 97
morals 374
mortality rates, decreasing 180
multidisciplinary approach,
multidisciplinary certification programs
1212
multihospital systems, rural hospitals
170
mutual participation model 2578
National Association of Boards of
Pharmacy (NABP) 109
National Association of Chain Drug
Stores (NACDS) 107
National Center for Advancing
Translational Sciences (NCATS) 145
National Commission for Health
Certifying Agencies 59
National Committee on Vital and
Health Statistics (NCVHS) 401
National Community Pharmacists
Association (NCPA) 1001
National Council for Prescription Drug
Programs (NCPDP) 398
national health information network
(NHIN) 397, 405, 406
National Patient Safety Foundation
(NPSF) 175
National Pharmaceutical Association
(NPhA) 102
455
National Pharmaceutical Council

(NPC) 107
national practitioner pharmacy
organizations 1003
websites 11213
National Quality Forum 312
national trade organizations 106,
1068
websites 113
Native Hawaiian and Pacific Islander
population
growth, projections 3267
population 336, 337
33840
natural law 369
need arousal, individual consumer
behavior model 2601
needpayoff questions 86, 89
needs
hierarchical model 261
of patients 265
Neighborhood Health Centers (NHCs)
13
network pharmacies, contract
negotiations 456
networking 96, 380
local pharmacy organizations 105
new drug applications
advisory committees 131
review times 1301
niche areas, pharmaceutical industry
224
noncompliance see compliance
nonmaleficence 370, 371
nuclear pharmacy 63
nurse practitioners (NPs) 163
prescribing authority 54, 55, 56
nurses
employment in hospitals 1634
training 164
nursing facilities (NFs) 1901
medication finances 1989
Minimum Data Set (MDS) 1956
quality indicators 196
quality measures 1967
role of geriatric pharmacists 193,
197
skilled 192
456
Index
Nursing Home Reform Act, 1987 195

nursing homes, medication errors
1878
nutrition support pharmacy 63
obesity rate 33
Office of the National Coordinator for
Health Information Technology
(ONCHIT) 401, 406
off-label use of drugs
in nursing facilities 199
promotion by manufacturers
1401
old-old 180
medication usage 185
barriers to health care 1856
Geriatric Pharmacy 121
drug costs, Medicare coverage
1823
drug errors 2923
drug-related problems 1867
health care usage 1812, 184
medication usage 1845,
2912
increasing size 77, 17981
Medicare 16
medication appropriateness 1878
packaging issues 234
see also geriatric pharmacy;
long-term care
Omnibus Budget Reconciliation Act
(OBRA), 1987 195
oncology pharmacy 63
online pharmacies 2378
Online Survey, Certification, and
Reporting System (OSCAR) 1956
open formularies 40
optometrists (OD), prescribing
authority 54, 55
optometry training
329, 330, 335
Organizational Supports for Cultural
Competence, CLAS Standards 3434
orphan drugs 229

osteopathic medicine training 545
329, 330, 335
outcomes research 423
outpatient care
choices 247
expenditure 166
over-the-counter (OTC) drug market
222
over-the-counter (OTC) drug usage
283, 284, 2867
decision-making process 34851,
350
older population 184, 185
ownership of work 380
packaging of drugs 2335
impact on compliance 290
for older population 252
pain management, in hospice setting
207
pain relievers, abuse of 293
pain response, cultural differences 347
Pap smears, cultural issues 276
paradigm shift in pharmacy practice
41315
see also clinical pharmacy
Pareto principle 1812
partial compliance 288
part-time working, role in pharmacist
shortage 778
passive informed consent 372
patent laws 130, 1323, 147, 221
HatchWaxman Act 133
219
perennial concerns 135
paternalism 255, 370, 371
patient-centered care 176, 246
patient-centered integrated model,
patient-centered medical homes
(PCMHs) 395, 428, 4312
Patient Centered Outcomes Research
Institute (PCORI) 220
Index
patient counseling information, USP

Dispensing Information 108
patient medication profiling, limitations
284
causes of problems 258, 265
continuum of decision-making
responsibility 255
fiduciary relationship model 2568
individual consumer behavior
model 2604
sick role behavioral model 2589
patient safety 1734, 297
pharmacists role 30911
post-marketing surveillance
3003
premarket assessment of drugs
299300
regulatory requirements 3089
resources 31112
risk management 3038
role of health information
technology 388, 389
see also medical errors; medication
errors
patient safety organizations 1756
pay-for performance methodology,
CMS 309
pediatric hospitals 170
penicillin, discovery 6
permits to practice 59
personal health records (PHRs) 387,
389, 406, 4089
personal selling 76, 84, 856
case analysis 8990
personalized medicine 42, 434
political issues 1446
pharmaceutical care 11, 75
role expansion 78
see also emerging roles
Pharmaceutical Care Management
Association 1078
pharmaceutical case management
(PCM) program 823, 87
pharmaceutical industry 215
benefits to society 230
clustering 21819
457
consolidation 218, 2212, 224

criticisms of 21718
developing markets 223
economic impact 21517
future prospects 2245
generic drug manufacturing 2223,
2234
global partnerships 223
high-tech recycling 224
impact of pricing regulations 219
marketing 139
off-label promotion 1401
physician inducements 13940
over-the-counter drug market 222
pressure on drug prices 223
public attitudes towards 219
rebate agreements 467
research and development 21921
costs 129
segments 218
Pharmaceutical Research and
Manufacturers of America (PhRMA)
107
pharmaceutical sales, trends 2289
pharmacist prescribing 567
vaccines and drugs for adverse
reactions 72
pharmacist shortage
contributing factors 768
impact 78
responses to 78
Pharmacist/Pharmacy Provider
Electronic Health Record 399
pharmacistphysician collaboration
867
case analysis 90
collaborative drug therapy
management (CDTM) 1224
pharmacists
personnel and practice sites 60,
623
practice settings 7880
specialization 634
see also consultant
pharmacists
pharmacists role, political aspects
1434
pharmacoeconomics 43, 65
458
Index
pharmacotherapy 63
pharmacists role 30911
post-marketing surveillance 3003
299300
regulatory requirements 3089
resources 31112
Pharmacovigilance Planning, E2E 304
pharmacy and therapeutic (P&T)
committees 41
pharmacy benefit managers (PBMs) 11,
38
manufacturers 229
role and politics 1356
history of 362
purpose 3645
Pharmacy e-Health Information
Technology Collaborative 4045
pharmacy graduates, ethnic minorities,
trends 33840
pharmacy informatics 65
pharmacy issues and trends
auxiliary personnel 656
employment 645
impact of technology 66
political and economic impacts 66
Pharmacy Manpower Project Inc. 60
Aggregate Demand Index (ADI)
767
education, regulatory, and
foundation organizations 10810
historical development 99
individual participations decisions
11112
local organizations 1056
multiplicity of organizations
11011
national practitioner organizations
1005
national trade organizations 1068
role 95
for the profession and
individual practitioners 968
for society 98
state organizations 105

Pharmacy Quality Alliance (PQA) 48
pharmacy selection, influencing factors
34951
pharmacy services, Community Health
Centers 14
pharmacy technicians 656, 165
responsibilities 422
pharmacy training see education
PharmD degree 117
PharmD programs, expansion 78
PhD studies 117
Phi Delta Chi 104
Phi Lambda Sigma 104
Philadelphia College of Pharmacy 99
physical fitness, Healthy People 2020
objectives 23
physician assistants (PAs) 163
prescribing authority 54, 55, 56
physicianhospital organizations see
integrated delivery systems (IDSs)
Physician Quality Reporting Initiative
(PQRI) 391
physician training, Flexner Report,
1910 6
physicians
gatekeeper role 245
inducements from pharmaceutical
companies 13940
percentage in ethnic minorities
336, 338
specialization 5960
physiological needs 261
podiatric medicine training
329, 330, 335
podiatrists, prescribing authority 54, 55
point-of-service (POS) plans 301, 37
policy-making, role of pharmacy
organizations 98
political issues 1278, 1446
cost control 12930
effect of direct-to-consumer
advertising 138
Medicaid drug costs 1367
reimportation and
international pricing 1378
Index
genetics and personalized medicine

1446
legislation
Food and Drug
Administration 1301
herbal remedies 1312
intellectual property 1325
looking ahead 1467
Medicare coverage, Prescription
Drug Plans 1413
pharmaceutical industry research
1389
pharmaceutical company
marketing 13941
private prescription insurance 135
pharmacy benefit managers
1356
role of pharmacists 1434
polypharmacy
adverse drug events 186
nursing home residents 190
older population 77, 184
population demographics 31921,
4323
population growth 325, 328
projections by race and age 3267
proportion of ethnic minorities
318, 323
trends 318
by region and state 3223
positioning strategies 85, 86
case analysis 88
post-decision assessment, individual
postgraduate education and training
117
postmarketing commitment (PMC) 301
postmarketing surveillance 3003, 308
practice-based continuing pharmacy
education 11819
practice management systems (PMSs)
385
practice settings, pharmacists 7880
practitioner utilization audits 47
preferred provider organizations
(PPOs) 1011, 30, 37
299300
premium-priced packages 250
459
prepackaging 2334
controlled drugs 668
pharmacists 567
prescription benefit programs 11
Prescription Drug Plans (PDPs) 1413
Prescription Drug User Fee Act, 1992
130
prescription insurance coverage 1289,
284, 285
Medicare Part D 183
prescription medicines, expenditure
166
prevention 2467
preventive services
participation levels 2645
pricing regulations
European countries 223
219, 221
pricing strategies 228
primary care physicians (PCPs) 30
prior authorization programs, managed
care systems 44
private health care sector 9
long-term care 10
managed care 1011
mental health services 10
pharmaceutical care 11
prescription benefit programs 11
private health insurance 289
fee-for-service plans 29
managed care systems 2931
private prescription insurance 135
pharmacy benefit managers 1356
Probability of Repeated Admission
(PRA) 182
probing questions 86, 89
problem questions 86
processing-resource theory 253
professional fidelity 372
professional identity 96
professional status 53
professionalism 365, 3678
behavioral characteristics 3802
caring 382
definition and traits 37780
relationship to ethics 365
unprofessional conduct 3667
460
Index
prognosis, patients perceptions of 269

program (specialized) accreditation 58
Program for All-Inclusive Care for the
Elderly (PACE) 2035
Promacta 346
promotion of pharmacy, role of
promotion of products 228
prospective DUR 45, 50
prospective payment systems 8
skilled nursing facilities 192
protocols 356
Provenge, cost 132
provider education, managed care
systems 47
psychiatric pharmacy 63
psychological aging 2534
psychologists, prescribing authority 56
psychotherapeutic drug abuse 293
psychotropic medications
ethnic variations in response 346
public financing 223
Childrens Health Insurance
Program 28
distribution of government health
funds 23
Federal Employees Health Benefit
Plan 278
Medicaid 26
Medicare 246
TRICARE 27
Veterans Administration (VA)
system 267
public health care sector 9
federal government agencies 17
federal government-provided care
Community Health Centers
1314
military medical care 12
local government-provided care 14
Medicaid 1416
Medicare 16
Public Health training, enrollment of
public service 379
publications 97
Puerto Rican population 275

reducing numbers 323
quality indicators (QIs), nursing
facilities 196
51
quality measures (QMs), nursing
facilities 1967
quantity limits 44
racial minorities see ethnic minorities
regional extension centers (RECs) 394
registered nurses, percentage of ethnic
minorities 336, 337
registered nursing training, enrollment
of ethnic minorities 329, 330
registration of individuals 589
regulation of pharmaceuticals, origins
127
regulations see legislation
reimbursement of pharmacists,
compensation for extended role 144,
421, 4312
reimportation 137, 221
relationship marketing 84, 867
repackaging 2334
research and development 21920, 436
impact of reimportation 221
intellectual property rights 221
use of health information
technology 4034
research pharmacists 65
residency programs 11718, 165
Resident Assessment Instrument (RAI)
195
resource distribution, justice 373
resource utilization groups (RUGs),
skilled nursing facilities 192
responsibilities, professional 3789,
380, 381
restricted drug distribution systems
2401
retrospective DUR 45, 50
return on investment (ROI),
compliance interventions 2901
Rho Chi 1045
right to health care 1718
rights 374
risk assessment tools 31112
Index
risk evaluation and mitigation strategies

(REMS) 3012, 3056
impact on pharmacists 3067
risk factors 1, 4, 45
risk minimization action plans
(RiskMAPs) 301, 304
comparison with REMs 305
risk sharing (risk pooling) 22
Roadmap for Pharmacy Health
Information Technology Integration
in U.S. Health Care 4045
robotics, impact on health care 66
role of pharmacists
political aspects 1434
see also emerging roles
root cause analysis (RCA) 31112
safety concerns
see also patient safety; patient
safety organizations
safety needs 261
safety net hospitals 155
salaries 421
screening, Probability of Repeated
Admission (PRA) tool 182
sedatives, abuse of 293
segmentation see market segmentation
self-actualization needs 261
self-care 123, 2701, 286
self-consistency motive 253
self-diagnosis 264
self-medication 2867
decision-making process 34851,
350
self-regulation, pharmacy profession
37980
senior citizens see older population
Sentinel Initiative 302
service organization, hospitals 161
sick, care of 2712
sickness career 267, 269
sick-role behavior 2589, 266, 267,
269
461
situation questions 85, 89

skilled nursing facilities (SNFs) 192
social aging 254, 255
social contract model,
social needs 261
social welfare, role of pharmacy
organizations 98
Soliris, cost 132
special needs plans (SNPs) 203
specialization
pharmacists 634
physicians 5960, 61
specialized (program) accreditation 58
specialty hospitals 168, 170
specialty pharmaceuticals, distribution
2402
standards, professional 381
standards development organizations
(SDOs) 3978
state pharmacy organizations 105
step therapy 434
stimulants, abuse of 293
sulfanilamide, elixir of 127
supermarket pharmacies 79
supply chain 227
symptoms, patients perceptions of 269
target market selection 85
Task Force on Risk Management 3034
Tax Relief and Health Care Act 2006
391
teams, comparison with working
groups 436
technology 4335
application in hospitals 155, 156
automation 23940
electronic health records (EHRs)
225
impact on health care 66, 248
reduction of drug errors 292, 294
role in pharmacy practice 125, 239
as source of ethical dilemmas 361,
365
see also health information
technology
telemedicine 251, 4023, 434
thalidomide 127
The Joint Commission (TJC) 172
The Joint Commission (TJC)
Accreditation Manual for Hospitals
157
462
Index
therapeutic guidelines see protocols

tiered copayments 401, 47, 136
advisory role of pharmacists 49
To Err Is Human, Institute of
Medicine, 1999 173, 297
tolerance, individual variations 269
total compliance 288
traineeships 119
training of pharmacists see education
tranquilizers, abuse of 293
transformation of pharmacy practice
41315
see also clinical pharmacy; future
directions
treatment outcome variations, ethnic
minorities 3456
TRICARE 12
funding sources 27
tuberculosis, reduced mortality 5, 6
uninsured
health care provision 14
Medicaid 1416
prescription costs 1289
United States Pharmacopoeia-National
Formulary 108
Unites States Pharmacopeial
Convention (UPS) 108
unit-of-use packaging 2334
universal coverage 17
unprofessional conduct 3658
reporting of 380
utilitarianism 369
vaccinations
pharmacist prescription and
administration 567, 72, 124
Vaccine Adverse Event Reporting
System (VAERS) 300
value chain 227, 228
value in health care 426
demonstration of 42931
paying for 4312
provision of 4269
values 3734
veracity 371, 372
Verified Internet Pharmacy Practice Site
(VIPPS) program 238
Veterans Administration (VA) system
12
VA hospitals 1689
Veterans Affairs Health Care System
(VA) system, funding sources 267
veterinarians (DVM), prescribing
authority 54, 55
veterinary training
enrollment of ethnic minorities 330
Vioxx 127
virtue theory of ethics 369
virtues 373
vitamin supplements, usage by older
population 185
wage rates, relationship to practice
setting 80
wants, distinction from needs 261
wellness 267
wholesalers, role in drug distribution
2302
willingness-to-pay (WTP) 432
withdrawal of products 300, 301, 303
women, older population 179
womens health concept 277
womens interests, Kappa Epsilon 104
work activities, relationship to practice
setting 80
workforce diversity 317, 325, 353
advantages 3401
in pharmacy practices 347
working groups, comparison with
teams 436
wrong-time errors 1878
Zyprexa, cost 1323
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Pharmacy and the US Health Care System

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Pharmacy and the

Published by Pharmaceutical Press

Health and health care in the United States

Health and disease

Financing US health care

Health care financing

Managed care pharmacy

What is managed care?

The health professions

Pharmacy personnel and practice site

Pharmacists and US health care

The workforce of pharmacists in the United States

Role of pharmacy organizations

Advanced practice credentialing

Political realities of pharmacy

Growth of pharmaceutical use and spending: prelude to intensifying

Regulation, patents and politics

Hospital and health care institutions

History of hospitals in the United States

10 Pharmacist role in long-term care

The growing population of older adults

11 The research manufacturing pharmaceutical industry

13 The consumers of health care

14 The drug use process

15 Patient safety and pharmacovigilance

16 Provisions of care to subpopulations: a cultural perspective

Minorities: diversity in the health care field

17 Professionalism and ethics

18 Health information technology: emerging challenges for

Key health IT concepts

19 Unresolved issues in pharmacy: imagining the future

Transformation: letting go of old dreams

models should be viewed not as endpoints but rather as part of a continuum

Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD

Pharmacy and the US Health Care System

Health problems: impact of public health and lifestyle

Health and health care in the United States

Table 1.1 Healthy People 2020 objective areas

Immunization and infectious diseases

Arthritis, osteoporosis, and chronic back conditions

Injury and violence prevention

Blood disorders and blood safety

Lesbian, gay, bisexual, and transgender health

Maternal, infant, and child health

Chronic kidney disease

Medical product safety

Dementias, including Alzheimer disease

Mental health and mental disorders

Nutrition and weight status

Disability and health

Occupational safety and health

Early and middle childhood

Educational and community-based programs

Public health infrastructure

Sexually transmitted diseases

Health communication and health information

Health careassociated infections

Social determinants of health

Health-related quality of life and well-being