PHAR250

School of Pharmacy
Pharmacy History, Practice and Ethics
PHAR 250
Spring 2016-2017
School of Pharmacy
Pharmacy History, Practice and Ethics
PHAR 250
3credits
Spring 2016-2017
Course Syllabus
Instructor Campus Sec Room Offered Time Office hours Address

Dr. Marwan Akel Beirut A 302-B TTh 8:00-9:15 TTh 11:00-12:00 marwan.akel@liu.edu.lb
Dr. Michelle Cherfan Beirut B 704-B TTh 9:30-10:45 T 11:00-12:00 michelle.cherfan@liu.edu.lb
Dr. Marwan Akel Beirut C 302-B TTh 9:30-10:45 TTh 11:00-12:00 marwan.akel@liu.edu.lb
Dr. Mohamed Hendaus Bekaa A 206-C MW 12:30-13:45 mohamed.hendaus@liu.edu.lb
Dr. Mohamed Hendaus Bekaa B 118-C TTh 12:30-13:45 mohamed.hendaus@liu.edu.lb
Dr. Lama Faddoul Saidaa A 210-B MW 8:00-9:15 lama.faddoul@liu.edu.lb
Dr. Nermine Choumane Nabatieh A 208-E MW 8:00-9:15 nermine.choumane@liu.edu.lb
Dr. Sahar Haydar Akaar A 202-A MW 8:00-915 sahar.haydar@liu.edu.lb
Dr. Nour Chamseen Tripoli A 107-B MW 9:45-11:00 nour.chamsine@liu.edu.lb
Course Coordinator: Dr. Marwan Akel
Department: Pharmacy Practice
Course prerequisite: ENGL 100, ENGL 150
Required Readings: Classroom notes and reading material
Recommended Reading: Remington, Federal Law book, Robert Veatch medical case
1
Exam Dates:
Exam Date Time Grade distribution
Exam1 Tuesday March 21, 2017 5:00-6:15 30%
Exam2 Tuesday May 2, 2017 5:00-6:15 30%
Project Scheduled during the semester TBA 5%
Final Exam Set by the university TBA 35%
Passing Grade: C
Homework solving and assignments are mandatory and may affect the final grade.
Course Description:
This course emphasizes upon the historical background and ethical principles of the profession of
pharmacy, past and future. By the end of this course, the student will become familiar with the main
events and evolution of the profession of pharmacy till the introduction of the clinical pharmacy
concept.
The practice section introduces students to the practice of pharmacy and to the different medicinal
agents and their forms. Pharmacy students will become familiarized with common medical
abbreviations used in the profession of pharmacy. Legal procedures that lead to drug marketing, drug
withdrawal or recall in the United States will be defined.
Ethical dilemmas are part of everyday routine for the pharmacist especially in the social environment we
live in. Professional conduct and a high standard of morals are required at all times. Ethical issues
relating to the practice if pharmacy will be discussed and each student will have the opportunity to
participate in a debate related to sensitive matters he/she might encounter in his/her career.
Attendance Regulations:
Attendance is obligatory.
You cannot miss more than 1/3 of the course time (even if eligible excuses), otherwise you will
be automatically receiving an AW (Academic Withdraw). For a 3-credit course, a maximum
of 10 Sessions absenteeism is allowed!
A student who wishes to stop attending must withdraw from the course to avoid an F from being
posted at the end of the semester.
No students are allowed to enter the class if they are being late for more than 5 minutes.
Cell phones are strictly prohibited from being used during classroom time. Should a mobile ring,
you will be given a warning and asked to turn off the phone immediately. Moreover, under no
circumstances should you be allowed to leave class to answer the phone.
Missing Exams
1. No make up exams are allowed at all: attending exams is obligatory.
2. Make up exams are ONLY allowed in case of:
a. Death of ONLY a first degree relative
b. Hospitalization with a valid hospital medical report: only
hospital records are allowed.
2
Cheating Regulations:
1. The following items are not allowed to be accessed during the exam: cell phones, other
electronic or digital devices including smart watches, pagers, photographic devices, and
recording devices. Any watches must be placed on the top of the desk for proctor
review.
2. Cheating in any way or form will not be tolerated during exams and will be considered
as evidence of academic dishonesty. Students will be referred to the academic integrity
committee and an F will be posted on the exam.
Class Recordings:
Photography, audio-visual recording, and transmission/distribution of classroom lectures

and discussions is prohibited. Previous lectures recordings should not be reproduced,
shared, or uploaded to publicly accessible web environments. Students who do not adhere
to this policy will be considered to be breeching SOP copyrights and will be referred to the
academic integrity committee .
Course Outline:
The course is divided into three parts
Week 1-4 Part I: History of Pharmacy
Introduction
Prehistoric pharmacy
Antiquity
Babylonian
Ancient Egypt
The Greco-Roman period
The Hebrews
The Middles Ages
The Arabs
The Renaissance period
The new era
Early modern Europe
American pharmacy and the emergence of clinical pharmacy
EXAM 1
Week 5-9 Part II: Practice of pharmacy
Common pharmacy abbreviations
Pharmacy Careers, Pharmacy Organizations
Drug development, Phases of clinical testing
Drug schedules
Pharmaceutical preparations. Introduction to Drug Dosage forms
Classification of drugs
3
EXAM 2
Week 10-14 Part III: Ethics in Pharmacy
Why pharmacy is a profession
The Pharmacist-Patient relationship: Respect, Trust, Veracity,
Privacy, Confidentiality
Pharmacy as a profession. Code of ethics. The pharmacist Oath (American and
Lebanese version). The Lebanese law regarding pharmacy ethics
Solving an ethical dilemma
Black market and counterfeit drugs
Case Studies and debate topics
Week 15 FINAL
Enjoy the course;

GOOD LUCK!!!
4
Outline
Section I
Pharmacy History & Evolution
Section II
Pharmacy Practice
Section III
Pharmacy Ethics
Section I
Introduction
1. Prehistoric pharmacy
2. Antiquity Duration: 4-5
A. Babylonian weeks
B. Ancient Egypt
Exam I
C. The Greco-Roman period
D. The Hebrews
3. The Middles Ages
A. The Arabs
4. The Renaissance period
5. Early modern Europe
6. American pharmacy and the emergence of clinical
pharmacy
2
Section II
Pharmacy Practice
1. Common medical & pharmacy abbreviations
2. Pharmacy Careers, Pharmacy Organization
Scope: Chapter 1, Remington A. Gannaro 20th edition
3. Drug development, approval process and phases of
clinical testing
The introduction of new drugs: : Chapter 48, Remington A. Gannaro
20th edition
4. Legal classification of drugs (American pharmacy)
US drug regulation: An overview. Foyers principle of medicinal
chemistry, 5th edition
5. Pharmaceutical preparations: Introduction to Drug Dosage
forms
6. Major drug groups and families
milies
Duration: 4-5 weeks
Exam II 3
Section III
Pharmacy Ethics
1. Why pharmacy is considered a profession?
2. Pharmacist/Patient Responsibilities and Duties
3. Pharmacist-patient relationship: based on: Ethical principles
A. Nonmaleficence
B. Beneficence
C. Autonomy
D. Informed consent
E. Confidentiality
F. Fidelity Duration: 4-5 weeks
G. Veracity
H. Privacy Final Exam (cumulative)
4. Ethical codes
A. APhA code of Ethics
B. Oath of pharmacist
5. Solving an ethical dilemma
6. Case Studies
7. Some Definitions
Ethics: chapter 3, Remington 20th edition
Ethical aspects of drug information practice, chapter 13. Drug information: a guide for
pharmacist 2nd edition
4
Section I
Pharmacy History
& Evolution
Section I
Introduction
2. Antiquity
A. Babylonian
B. Ancient Egypt
D. The Hebrews
3. The Middles Ages
A. The Arabs
4. Renaissance period
6. American pharmacy and the emergence of clinical
pharmacy
6
Section I
1. Prehistoric Pharmacy
Since the dawn of humanity, pharmacy has been a part
of everyday life
Healing properties of natural substances, identified by:
Trial and error
Tribe knowledge
Primitive people
Explained illness in supernatural terms
Used spells of sorcerers, sometimes with magical
substances
Prehistoric peoples gathered plants for medicinal
purposes
Shanidar (before 30,000 BC )
Shaman
8
Shanidar
Natives of Zagros
Mountains in Iraq who existed
between 30 and 60
thousands years ago
Gathered plants for medicinal
purposes and approached
diseases by the context of good
and evil spirits around them
Healed by trial and error of
natural plants and substances
9
Shanidar
When shanidar healers approached a disease
They placed it within the contest of their general
understanding of the world around them
The world around them was alive with spirits of good
and evil
10
Shaman
Intermediaries between human and
spirit worlds
In charge of all or most supernatural
things in a tribe
Tribe healers
Treat most serious and chronic illness
Diagnosis
Treatment
Preparation of the magical potions of cure
(compounding)
11
Shaman
Guarded the healing knowledge closely
Used sorcery for healing
Prepared magical potions
Using plants and spices
Used folk
Example:
Tasaday: original people of Philipines
Relied on trial and error to:

Reach healing properties
Develop knowledge concerning the collection of ingredients
12
Ancient drug definition
Special substance with nearly supernatural powers
Primitive people
Discovered only a small number of effective drugs
BUT: came up with a NEW concept:
influencing bodily functions via an outside force
Considered one of humanity's greatest advances
13
For this concept to develop further need
civilization and cultures
Writing (documentation of medicine)
Weight and measures
Without advanced tools, pharmaceutical

practices would have failed to progress
14
Section I
2. Antiquity
A. Babylonian
B. Ancient Egypt
C. Greco-Roman
D. Hebrews
15
2. Antiquity
= Ancient times
Man learned how to control aspects of
nature, by:
Farming
Lead to Permanent shelter
Large-scale buildings
Powers of gods in day-to-day life started

to decline
16
2. Antiquity
Gradual separation between
Empirical healing
Based on experience, trial & error and observation
Spiritual healing
ealing
Healing Energy
Spiritual source
ce Healer ill person
The healing energy is usually transferred to the patient

through the healer's hands
The healing does not come from the healer, but through him
17
2. Antiquity
Spiritual healing (example in modern time)
18
Section I
2. Antiquity
A. Babylonian
19
A. Babylonian
People of Babylon
Existed 2500-7000 years ago
One of the greatest cities built by Hammurabi

on the Tigris and Euphrates rivers, in Iraq
Highly fertile area
20
A. Babylonian
Two classes of practitioners
The Asipu:
Magical healers
Relied more heavily on spells and used magical stones far
more than plant materials
The Asu:
Empirical healers
Used a large collection of drugs and manipulated them into
several dosage forms still basic today:
Suppositories
Pills
Washes
Enemas
Ointments
21
A. Babylonian
Asipu and Asu
No direct competition between them
Cooperation on difficult cases
Patient went back and forth between the 2 types of
healers looking for cure
22
A. Babylonian
1 2
1. Suppositories
2. Pills
3. Washes
4. Enemas
5. Ointments
4 3
5
23
Section I
2. Antiquity
B. Ancient Egypt
24
B. Ancient Egypt
Papyri
A thick paper-like material produced from the papyrus plant
(Cyperus papyrus) that was once abundant in the Nile Delta of
Egypt
Ancient Egypt used this plant for boats, mattresses, mats, and
paper
25
B. Ancient Egypt
Greater pharmaceutical sophistication
More dosage forms compounded (inhalers, patches)
from more detailed formulas
Use of a variety of substances: plant, animal, mineral,
urine drops of a number of animals
Honey and milk were routinely prescribed by physicians for
the treatment of the respiratory system, and throat
irritations
Egyptian medicine: close connection between
supernatural and empirical healing
Medicinal recipes usually began with a prayer or spell
26
B. Ancient Egypt
Some medicinal herbs and plants used by Egyptians
Medicinal herb or plant Medicinal use
Aloe vera Worms, relieves headaches, soothes chest pains,
burns, ulcers and for skin disease and allergies
Parsley (Apium Diuretic
petroselinum)
Balsam Apple (malus laxative, skin allergies, soothes headaches, gums

sylvestris) or Apple of and teeth, for asthma, liver stimulant, weak
Jerusalem digestion
Colchicum (Citrullus soothes rheumatism, reduces swelling

colocynthus) From which they derive colchicine
Honey Natural antibiotic, to dress wounds and as a base
for healing vehicles (ointment, cream)
27
B. Ancient Egypt
Some medicinal herbs and plants used by Egyptians
Medicinal herb or plant Medicinal use
Sesame (Sesamum Soothes asthma, decrease cholesterol, antioxidant
indicum)
Thyme (Thymus/Thimbra) Pain reliever
Poppy (papaver Relieves insomnia, relieves headaches, anesthetic,

somniferum) soothes respiratory problems, reduces pain
Opium derivatives: morphine, codeine
Garlic (Allium sativa) Decrease platelet, cholesterol and blood glucose

Gives vitality
Soothes flatulence and aids digestion, mild laxative,
shrinks hemorrhoids
Frees the body of "spirits
(note, during the building of the Pyramids, the workers
were given garlic daily to give them the vitality and
28
strength to carry on and perform well)
Aloe Vera Parsley
29
Balsam Apple
Colchicum
30
Sesame
Thyme
31
Poppy (Papaver somniferum) Garlic
32
B. Ancient Egypt
Plant drugs main vehicle of healing power,
with laxatives and enemas most prominent
Medical text
The Edwin Smith Papyrus
written around1700 BC
Surgical book
Mainly about wounds, and how to treat them
The Ebers Papyrus
110 pages: the most lengthy medical papyri: 700 drugs mentioned
Contains magical spells, specific diseases (stomach, dermato,
ear/nose, migraines) and the prescriptions of cure
Emergence of individuals specialized in collection,

preparation and sale of drugs
Pharmacists are still a century away
33
Section I
2. Antiquity
34
C. The Greek period
Greek civilization
Roots of medical profession in the West
Accepted the respected medical wisdom of Egypt
Pharmakon
Similar concept of drug
Meant magic spell, remedy or poison
Found in earliest records of ancient Greece
Demiourgois
Described by Homer (800 BC) in the Odyssey epic poem
Refers to
Early Greek physicians
More advanced ways to diagnosed natural causes of illness (but without
rejecting the use of supernatural healing, in conjunction with empirical
remedies)
35
C. The Greek period

Asklepios
The temple of the god Asklepios and his
daughter Hygeia
Asklepios: god of medicine and healing in
ancient Greek mythology. Carries the serpent
Hygeia carried a magical serpent and a bowl

of healing medicine (bowl of Hygeia)
Visited by people with persistent diseases and

sufferings
People slept in the temple with the hope of

being visited during the night by the god or
his daughter, to be cured
36
Hygeia holding the snake in one
hand the bowl in the other hand
Temple of the god Asklepios and

his daughter Hygeia
37
C. The Greek period

Hippocrates (425 BC)
The Father of Medicine
Refined and codified Greek
medicine
Separated medicine from religion
Disease was not a punishment inflicted by the gods but
rather the product of environmental factors, diet and
living habits
38
C. The Greek period
Hippocrates theory
Four body humours (fluids) existing in equal
proportions in healthy individuals
Imbalance in the 4 humors disease
Therapy restore humors balance
Link between the environment and humanity
4 elements of 4 main body
environment ( )
fluids (Humors)
connection
39
C. The Greek period

iatros
Trained Greek physician
Followed the Hippocratic method
Favored conservative methods (dietary and life-style
adjustments) OVER drug use
If conservative methods failed prepared his own

medicines or gave prescriptions to family members to
compound and administer
Iatreion: an ancient Greek clinic. It was only for
outpatients because hospitals had yet to be invented
40
C. The Greek period
Major Greek medicines source:
Plants
Theophrastus (370-285 BC)

Father of botany
Conducted the first great study of plants in the
West
Combined information from scholars, midwives,
and travelling physicians
41
C. The Greek period

Theophrastus (370-285 BC) (contd)
Most famous of his books:
Enquiry into Plants:
Plants: classification, reproduction, edible seeds, useful
juices
Trees: types, locations, practical applications
Herbs
On the Causes of Plants:
Growth of plants
methods of preparing the soil
Tools to use
smells, tastes, and properties of many types of plants
42
C. The Greek period
Pedanius Dioscorides (65 AD)
Ancient Greek physician, pharmacologist and botanist
Father of Pharmacognosy
300 years after Theophrastus
Father of pharmacognasy
Copied the method of Theophrastus
Wrote the Materia Medica
Five volume book
Summary of the drug knowledge of his time
knowledge of the herbs and remedies used by the Greeks,
Romans, and other cultures of antiquity
Became the standard encyclopedia of drugs for hundreds of
years to follow
43
C. The Greek period

Galen (129 200 AD)
Greek physician practicing in Rome in the 2nd century
AD
Student of Hippocrates
It was through his teachings and writings that the
Hippocrates humoral system dominated for the next
1500 years
Rejected part of Hippocrates theory (conservative
method)
Worked by observation, deductive reasoning and
experimentation
Started physician-initiated bloodletting
44
C. The Greek period
Galen (129 200 AD) (contd)
Galen theory: Developed an elaborated system:
the Four Humors:
Is formed in
Blood Heart
Is formed in
Phlegm Brain
Is formed in
Yellow bile Liver
Is formed in
Black bile Spleen
45
C. The Greek period

Galen theory: the Four Humors
Disease: imbalance of these humours
Health: proper balance of the four humours through
Drugs of opposite nature
To treat an external inflammation
Apply cucumber, a cool and wet drug
Bloodletting
Withdrawal of blood, often in considerable quantities, from
a patient
Would cure or prevent many illnesses and diseases
Administration of laxatives to induce diarrhea
Administration of an emetic to induce vomiting
Administration of a diuretic to induce urination
46
C. The Greek period
Bloodletting practice
Hippocrates believed that menstruation functioned to "purge women of bad
humors"
Galen believed that blood was the dominant humor and the one in most need
of control
Excess of blood upsets the four humours balance
Example: High blood pressure
Symptoms: red face, protruding veins, etc.
Cure: remove some blood restore humour
Galen created a complex system for bloodletting
How much blood should be removed based on:
Patient's age
Season, weather
Diseased organ
The more severe the disease, the more blood would be removed
Fevers required large quantities of bloodletting
Similarly for other diseases
Cold has an excess of phlegm
Infection has excess of yellow bile
Coughing up blood has excess of black bile
47
C. The Greek period

48
C. The Greek period
Galens Humoral System illustration:
49
C. The Greek period

Medicine in classic antiquity reached its peak with
Galen
Writers, who followed Galen, copied and commented
on his work (not highly original thinkers)
Medical practitioners mixed Galens method with their
folklore and superstitions to treat diseases
Recipe of the Cold Cream
Polypharmaceutical preparations
shotgun prescriptions in todays terms
Supported by Galen
Rationale: patients body would pull out of a complex
prescription the substances it need to restore its humoral
balance
50
Use of poison: like Belladonna
From which derived anticholinerigcs: atropine,
scopolamine
To lessen irritability, inflammation and pain
Gout and rheumatism
To treat corns
HR => used for bradycardia and asystole
Use of antidotes
Derived from the Greek: give against
Pharmacy viewed as an art joint to medicine
Early steps in separation of medicine and pharmacy

51
Section I
2. Antiquity
D. The Hebrews
52
D. The Hebrews
Hebrews are known today as Jews
The start of preventive medicine Prevention of disease
is the greatest contribution to hygiene
Hebrews settled in Egypt and grew a liking for
herbs and vegetables
Bitter and aromatic herbs: mustard, mint, thyme
The balsam tree: best and most expensive balsam
Cultivated Cedar tree: used its oil
Pepper, wine and honey: to treat stomach disorders
Onions for worm
53
D. The Hebrews
The ancient Jewish system does not give clues
about pharmacy profession
Drugs and physicians use declined
Treatment of dx by any means other than prayer was
inconsistent with religion and dangerous to salvation
The Hebrew religion prohibited belief in magic
and sorcery
Perfumers people who sold spices
Priests set the rules for public health
Treating dx comes from faith
54
Section I
3. The middle ages
The Arabs
55
3. The middle ages- West falling

Period from the first fall of Rome (400 AD) and
the fall of Constantinople (Istanbul today) (1453)
The dark ages

Period of cultural and economic deterioration and
disruption that occurred in Europe following the
decline of the Roman Empire
First half of the middle ages
Political and social chaos existed in the lands once
part of the western half of the Roman empire
56
The Roman Empire
West
57

The Roman Empire
58
Fall of Roman empire
Collapse of Roman civil authority in the western
half of the Roman empire (4th and 5th centuries)
Church took over cultural force
Local feudalism replaced government
Greco-Roman culture survived in the Eastern
(Byzantine) half of the empire
With significantly less creative energy
59

The use of drugs to treat illness underwent another shift
Closure of healing temples once used in Greco-Roman period
Drug therapy in the West

Rational therapy declined
Churchs teaching grew
Sin and disease closely related
Healing saints of Cosmas and Damian (Christians twins, treated
without charge)
Monks attributed their cures to the will of God, rather than their
insufficient medical resources
Curing disease: mixture of faith and miracle
60
Drug therapy in the West
Monasteries
Became centers for healing, both spiritual and corporal,
since the 2 were closely connected
Monks
Wrote epitomes
Planted gardens to grow the medicinal plants
Epitomes
Summaries of what survived from documents of the
Ancient Greek and Roman worlds
Includes: monks short versions of classical medical
texts
61
Saints of Cosmas and Damian
62
3. The middle ages- the Arabs
A new civilization arose
Brought back to life the Greek science and
medicine
Translated Greek writings into Arabic (including
medicine writings)
Arab medicine
1st: used Greek medical writings (especially those of
Galen and Dioscorides)
Later: as they grew more, they added to the writings of
the Greeks
Mainly Rhazes (860-932) and Avicenna (980-1063)
63

Arabs expending
Distant trading and conquered cities: brought new
drugs and spices (from Africa, Spain to Middle East) to the
centers of learning
Rejected old idea: foul-tasting (bitter) medicines
worked best
Instead, made their dosage forms
rms elegant and palatable:
Silvering and decoration of pills
lss
New dosage forms
Use of syrups
Sophisticated preparations by specialists - the ancestors of
todays pharmacists
Those sophisticated preparations mainly took place in Baghdad
64
Universities spread in Baghdad and Damascus
Europeans attended these universities for 4 centuries
Arabic became a universal language of learning and
science
Arak, attar, dawaa, alcohol, alkali, elixir, syrup
Paper replaced papyrus
Hospitals
More than 30 hospitals established in Cairo, Damaskus and
Baghdad
Hospitals had their own pharmacies (called treasury or
place of Potions: drugs compounded under strict
prescriptions
65

Rhazes (860-932)
Abu Bakr Muhammad ibn Zakariya Al-Razi
A physician who became the director of Baghdad hospital
Performed original chemical preparations and experiments
Discovered "allergic asthma
Wrote more than 200 works
Al-Hawa (al 7awi)
Encyclopedia of medicine and pharmacology
Separation of pharmacy and medicine
in this book
Considered pharmacy as an art
Discussed the use of mercury in medicine
and its toxicity
66
Rhazes (860-932) Contd
Considered the father of pediatrics for writing The

Diseases of Children
The first book to deal with pediatrics as an independent field
of medicine
Developed pharmaceutical apparatus

Mortars, flasks, spatulas and phials
Legend: he once selected a new hospital site through

an experiment
He hung pieces of meat at various places in the city, and
then selected the site where the least rotting occurred
67
Rhazes (860-932)
Contd
Noticed that
pupil of the eye
gets smaller
when exposed to
light
68
Pharmaceutical apparatus
Mortar and pestle Spatulas
Phials
Flasks
69

Avicenna (980-1063)
Ibn Sina in arabic
Avicenna achievements in pharmacy
included
Coating of pills with silver and Gold to
mask taste and smells of strong
remedies
The belief that noble gold purified the
blood
Oral anesthetics (inhaled morphine)
Used to iron wounds
Psychopharmacology: close relationship
between emotional states and bodily
changes
70
Avicenna (980-1063) Contd
He wrote the Canon of medicine
5-volume book
Contains the accumulated medical knowledge of the time, from
Greek and Arabic practice
The last volume: detailed instructions on the preparation and
use of drugs
Written in Arabic, translated to Latin, and served as a way to
transmit original Greek concepts to Europe
Used till 1650 in medical schools in Europe
The first book dealing with experimental medicine, evidence-
based medicine, randomized controlled trials, and efficacy tests
Set rules and principles for testing the effectiveness of new
drugs (still basic today)
See next slide
71

Avicenna rules and principles for testing the
effectiveness of new drugs
1. "The drug must be free from any inappropriate accidental quality"
2. "It must be used on a simple, not a composite, disease"
3. "The drug must be tested with two contrary types of diseases,
because sometimes a drug cures one disease by Its essential
qualities and another by its accidental ones"
4. "The time of action must be observed, so that essence and accident
are not confused"
5. "The effect of the drug must be seen to occur continuously or it was
an accidental effect"
6. "The experimentation must be done with the human body, because
testing a drug on a lion or a horse might not prove anything about its
effect on man"
72
Avicenna (980-1063) Contd
Extended the theory of 4 humours in The Canon
of Medicine to include
Emotional aspects
Mental capacity
Moral attitudes
Self-awareness
Movements
Dreams
73
Avicenna's four humours and personalities

Evidence Hot Cold Moist Dry
fevers related to loss of physical
Inflammations
Disease states serious humour, Weakness and mental
become febrile
rheumatism energy
Functional Decrease
deficient energy difficult digestion
power digestive power
bitter taste, mucoid
Subjective Lack of desire for insomnia,
excessive thirst, salivation,
sensations fluids wakefulness
burning at cardia sleepiness
diarrhea, swollen
high pulse rate, eyelids, rough
Physical signs Soft joints rough skin
weakness skin, acquired
habit
dry regimen
Foods & Hot harmful Cold harmful harmful
Moist harmful
medicines Cold beneficial Hot beneficial humectants
beneficial
Relation to
worse in summer worse in winter bad in autumn
weather 74
Ibn Zuhr (10911161)
Abu Marwan Abdal-Malik ibn Zuhr
First to describe esophagus cancer
Used practical experience and careful
observation extensively
Liber ornaments: Cosmetic
book guide for Arabic and
Muslim women
75
Ibn Rushd (Averroes) (1126-1198)

Abu el-Walid Muhammad ibn Ahmad
ibn Rushd
Friend and student of Ibn Zuhr
Kitab El-kolliyat fi al-tibb (Colliget in latin)
(General Rules of Medicine)
7-volume book
Medico-pharmacological encyclopedia
Physiology, general pathology, diagnosis, materia medica,
hygiene and general therapeutics
Discussed the topic of human dissection and autopsy,
although he never undertook human dissection
76
Abdullah Ibn Al-baitar (1197-1248)
Abu Muhammad Abdallah Ibn Ahmad Ibn al-
Baitar Dhiya
al-Din al-Malaqi
Known as Al-Bitar in Arabic
Chief inspector of pharmacies in Egypt
Discovered the earliest known herbal
treatment for cancer: "Hindiba
Has"anticancer" properties and could treat
different cancer types
Kitab al-Jami fi al-Adwiya al-Mufrada Corpus
of Simples

1800 vegetables, 145 minerals, 130 animal drugs
Became the basis for the 1st British Pharmacopeia
(pharmaceutical encyclopedia)
77

Chemistry during the Arab Era: Alchemy era
Alchemy is the pursuit of transforming common
metals into valuable gold
Alchemy: called a chemist in popular speech, and
later added the suffix "-ry" the art of the chemist as
"chemistry"
Arabian chemistry surpassed any previous one
In Europe, chemistry did not start until the Renaissance
Distillation, filtration, evaporation, sublimation,
solution and crystallization techniques were developed
78
Laboratory experiments flourished with Rhazes
Medication doses were adjusted to patient sex, age and strength
Use of modern tools: bealers, flasks, spatulas, water bassin, jars
Alchemy believed that all base metals can become Gold
Gold was a higher, purer form of metal
Copper, lead and iron were impure forms of Gold
Silver was the closest form to Gold
Surgery was poor
Lack of thermometer
Described heat by colors
79

Jabr Ibn Hayyan
One of the fathers of chemistry
Emphasized systematic experimentation
Invented over twenty types of basic chemical
laboratory equipments: alembic and retort
Discovered and described common chemical
substances and processes: hydrochloric and nitric
acids, distillation (separated acetic acid from
vinegar), and crystallization
80
Jabr Ibn Hayyan
Alembic and retort are used for distillation
Alembic Retort
81

By then, the entire Materia Medica contained

2000 items
Dosage forms
Robs
Loboch
82
The Apothecary shops: the start of pharmacy ethics
Very nicely decorated luxurious glass containers
Attar
First licensed pharmacist in the Arab times during
the region of caliph Al Mutassim ( ), i.e.
mid 800s
Pharmacology flourished
Official inspection of pharmacies started in the
19th century
Ingredient substitution was a big dilemma
83

Some herbal medicines and their uses among Arabs
Lettuce: Useful in treating scorpions and bee stings as

well as snakebites
Lemon: thought to cure fever and certain types of
diarrhea but harmful to the stomach and nerves
Aloe: the oldest medicinal plant. Known since the
Indians and Greek times. Arabs valued it for its strong
odor and used it as perfumes. Thought to clear phlegm
and eliminate blood congestion from the liver. Also
reported to strengthen the optical nerve and sharpen
the eyesight
Snake flesh: used to treat leprosy
84
Some fluids and their uses among Arabs
Milk
Used in diabetics to stop thirst as well as cool and
thicken the blood
Human milk was used to prepare pediatric
medications and to prepare mild ointments for
the eye and the wounds
Oils
Some were used in treating dental and ear pain
Caster, sesame, olive, almond, walnut and eggs oil
85

Definitions of some Arabic terms used in pharmacy practice
Rob: thick syrup purified over the fire or the sun
Loboch: thick paste
Sarab: a drink consisted of distilled fruit and herbal extract sweetened
with honey
Juleb: a light syrup consisting of rose water, sugar and water
Matbuch: a concentrated decoction of plants extract
Decoction: extract fluids from hard plant materials such as roots and bark
Soak in warm water for some time; boil for 810 minutes in water. Stew the
mixture for about 45 minutes while constantly stirring the contents. Strain into a
container
Habb: evaporated plant juices molded in the form of a pill

Gargara: gargling agents used to improve mouth odor and to treat
some head diseases such as epilepsy and facial paralysis
86
Decoction strained into a clean cup
87
3. The middle ages- West rising

Islamic world interacted with Western Europe (Spain
and southern Italy)
Highly developed Arabic culture passed over to the West
Institutions
New developments
Separation of pharmacy and medicine
By mid-13th century, Frederick II- King of Sicily
Separated pharmacy for the 1st time in Europe
puts the 1st laws governing pharmacy
State licensure
Limitation of profits
Physician not allowed to own a pharmacy or to get profits from
pharmacy
88
3. The middle ages- West rising
Medical knowledge back to Europe Through
Arabic culture
Word drug first used in the Middle Ages derived
from the word dried herbs
Greek writings translated into Latin for the use of
European scholars
Discussed the works of the great medical authorities
of
Greeks: Dioscorides, Galen
Arabs: Avicenna
Debates were based on speculation, not
observation!!!!!
89
3. The middle ages

For significant change to occur in the use of
drugs
Set aside this scholastic approach
Based on speculation
Use more skeptical observational methodologies
This new experimental age we now call the

Renaissance
90
Section I
4. Renaissance period
91
4. The Renaissance
Cultural movement that spanned roughly the 14th to
the 17th century, beginning in Florence in the Late
Middle Ages and later spreading to the rest of Europe
Beginning of the modern period
Burst of creative energy in the west
Turks conquered Constantinople (Istanbul) [1453]
Greek intellectual community left to the west, carrying
their books and knowledge with them to Europe
92
4. The Renaissance
Printing revolution
Johann Gutenberg (German)
Started an information revolution (around 1439)
By 1450, the press was in operation
Effect of printing on pharmacy
Scientists and botanists can illustrate their work
Readers can
Reproduce plant medicines easily
Do serious field work or find the drugs needed for their
practices
93
4. The Renaissance
Columbus discovered the New World
(America) (1492)
94
4. The Renaissance
Vasco da Gama found a sea route from Europe
to India (1498)
95
4. The Renaissance
Commerce based on money and banking was
established
Syphilis raged through Europe (1494)
Galen concepts were completely rejected
These changes resulted in:
Re-interpretation of old classical ideas new
ideas
Exploration of the sea
Exploration of the laboratory
96
4. The Renaissance
Andreas Vesalius (1514-1564)
Belgian physician and anatomist

Founder of modern human anatomy
Provided anatomical masterworks
Wrote one of the most influential books on
human anatomy: De humani corporis fabrica
(On the Workings of the Human Body)
97
4. The Renaissance
Andreas Vesalius Contd
Anatomy and dissection
98
4. The Renaissance
)
German physician and botanist
Printed Dispensatorium (1546)
Considered the 1st and one of the greatest
pharmacopeias
Became the official standard for the preparation of
medicines in the city of Nuremberg (in Germany)
99
4. The Renaissance
Paracelsus (1493-1541)
Philippus Aureolus Theophrastus Bombastus yon
Hohenheim
Traveling Swiss surgeon
Battled against the static ideas of Galen, Avicenna and
other traditional authorities
He was the most important supporter of chemically
prepared drugs from crude plant and mineral substances
(written in native language rather than Latin)
He adopted chemistry to make one of the humanitys most
ancient tools of drug
Eventually the efficacy of such drugs became known and
appeared in books of medicine 100
4. The Renaissance
Paracelsus (1493-1541) Contd
He started again his total faith in observation at
the same time he preached the doctrine of
signature: a belief that God had placed a sign on
healing substances indicating their use against
disease
Example: liverwort resembles a liver, thus it must be
used for liver diseases
Insisted that a specific remedy exists for a disease

(this was totally rejected by Galen)
101
Rat liver
102
4. The Renaissance
Chemistry advancements
Pharmacy prospered after discovery of chemistry
Distillation:
Isolation of the healing principles of a drug: its
quintessence (essence)
Mainly by the followers of Paracelsus
Proven effective a drug entered professional

practice
Beginning of the 19th century chemistry
emerged as a separate profession
103
4. The Renaissance
Continued explorations in chemistry laboratories
New lands discovered: new drugs brought back
Tobacco
Guaiac
Used to treat syphilis
Used in a common test for blood in human stool
Cascara Sagrada
Powerful laxative effect
Laxative effect
Ipecac
well known emetic (substance used to induce vomiting); in case of
poisoning or overdose for example
Cinchona bark
Used against malaria; cured malaria fever
Had little effect on other fevers
From which quinine was extracted in 1820
104
Guaiac Cascara sagrada
105
Cinchona
Ipecac plant
106
4. The Renaissance
Pharmacy practitioners joined together to form
groups
Sellers of spices
Physicians
Surgeons
New regulations appeared for pharmacy

practitioners:
Training requirements
Examinations
Restrictions on the number and locations of shops
107
4. The Renaissance
Conflicts grew between pharmacists and close
competitors lead to:
Government intervention
New laws which clarified the professional role of
pharmacy
apothecary word replaced by pharmacy
Eventually the separation of pharmacists into their
own organizations, in 1777
Under governmental authority, like the French College de
Pharmacie
108
4. The Renaissance
Standardization of medicines
Through the publication of books called
pharmacopeias
As pharmacy grew, physicians wanted

assurance that their prescriptions would be
prepared uniformly in their city or state
In 1499, the association of physicians and
pharmacists of Florence authorized the
Nuovo receptario as their book of standards
109
4. The Renaissance
Nuovo receptario (The New Book of Prescriptions)
First official pharmacopeia with official status, to be
followed by all apothecaries
Originated in Florence (Italy)
Collection of prescribed empirical remedies existing at that
time
Result of collaboration of the Guild of Apothecaries and
the Medical Society
One of the earliest manifestations of constructive inter-
professional relations
110
4. The Renaissance
Discoveries before the late 1700 was by trial
and error
Carl Wilhelm Scheele (1742-1786)
German-Swedish pharmaceutical
chemist
Discovered oxygen in 1773
Discovered nitrogen, chlorine,
glycerin and several inorganic acids
Extracted several plant acids,
such as citric acid (1784)
111
4. The Renaissance
Henri Moissan (1852-1907)

French chemist
Received the Nobel prize
in chemistry in 1906 for his
isolation of fluorine
112
4. The Renaissance
New chemical apparatus developed
Hydrometer
By Antoine Baume (1728-1804)
Instrument used to measure the specific gravity (or
relative density) of liquids
Improved burette
By Carl Friedrich Mohr (1806-1879)
Had a tip at the bottom and a clamp
Made it much easier to use than older burettes
Burette: allow for careful measurement; very important
to avoid systematic error
113
Chemical Apparatus
Hydrometer
Mohr Burette
114
4. The Renaissance
Documentation of the sources of plant drugs
around the globe
By pharmacists and interested physicians
Pharmacists continued the search to find pure

healing principles within medicinal plants
Isolate pure, crystalline chemicals
Measured and chemically identified accurately
Analytical chemistry had an important impact
115
4. The Renaissance
The Problem
Natural variation of active constituents in botanicals
Medicinal preparations of crude drugs fluctuated
considerably in potency
Because 2 preparations of the same AI can contain
amounts of the AI
The greatest challenge

Search
Separate
Characterize
Identify chemicals in plant drug
116
Section I
117

19th century: Golden century of Europe
Chemistry Revolution
John Dalton (1766 1844)
English chemist
He is best known for
Development of modern atomic
theory
Elements are made of tiny particles
called atoms
Research into color blindness

(Daltonism)
118
19th century: Golden century of Europe
Alkaloid chemistry
1810: Fredrich Serturner extracted morphine from
opium
Breakthrough
His method opened up the era of alkaloidal chemistry,
which resulted in the isolation of several pure drugs for
crude preparations
1820: quinine isolated from Cinchona bark
By the French pharmacists Joseph Pelletier and Joseph
Caventou
119
Alkaloids
Naturally occurring chemical compounds containing basic nitrogen
atoms
Name derives from the word alkaline, and was used to describe
any nitrogen-containing base
Produced by a large variety of organisms
Bacteria
Fungi
Plants
Animals
Are part of the group of natural products (also called secondary
metabolites)
- Local anesthetic - Nicotine - Atropine
Examples: - Cocaine - Morphine - Ephedrine
- Caffeine - Antimalarial - Theophylline
drug: quinine 120
Discovery of cocaine
1860; from coca plant
Introduced into clinical use as a local anesthetic in

Germany in 1884
Discovered its addiction properties: hyperactivity,

restlessness, increased blood pressure, increased
heart rate and euphoria
121

Francois Magendie (1783 1855)
French physiologist
Father of experimental physiology
His most important contribution to science
Number of experiments on the nervous system,
in particular verifying the differentiation between
sensory and motor nerves in the spinal cord
122
Sensory and motor nerves
Patellar test (Knee Jerk)
123
Sensory and motor nerves
124
sensory and motor nerves
NT
125

1870: synthetic drugs formulation
Increase interest in research
Narcotic plants heavily used through the century
(cannabis, cocaine, opiates)
1850: USP recognizes the cannabis extract:
marijuana
1868: 1st act regulating the sale of opium (before
that it was OTC)
First synthetic hypnotic: chloralhydrate
Discovery of iodine (thyroid disease, antiseptic)
126
Law restrictions
Number and location of pharmacies
Requirements for education and licensure
Standardization of prices decreased competition

By 19th century European pharmacists elevated
to a social position similar to that of physicians
Same happened in Britain but not until mid 19th century
127

The original class of pharmacy practitioners,
the apothecaries:
Evolved during the 1600s and the 1700s into a
second group of medical practitioners:
Treating those who could not afford the high fees
demanded by the small number of university educated
physicians
128
Apothecaries became more and more like
general practitioners of medicine
Chemists: those who manufactured drugs
Druggists: those who sold drugs
In Europe, mainly Britain, Conflicts and court

cases exploded during these years:
Between physicians, apothecaries, chemists, and
druggists shifting accordingly
What are the boundaries of each one????
129
Section I
6. American Pharmacy and the

Emergence of Clinical
Pharmacy
130
6. American Pharmacy
Was a Land of work
North America
Little to attract trained medical personnel
Central and South America
There was a lot of treasures and spices to export
18th century, colonies grew and prospered attracted ambitious
businessmen from England, including apothecaries
In the New World, British apothecaries continued to
Combine pharmaceutical and medical practices
Serve the large segment of the public who could not afford university-
trained physicians
131
No total separation between medicine and
pharmacy
Most apothecary shops were run either by an
attending physician or his apprentice, or by an
apothecary hired by the owner physician
They practiced Pharmacy either from their homes or
in a doctor shop
Doctor shops: pharmacies run by men who practice
medicine
Nonmedical practitioners of pharmacy were rare
132
Very few laws that directly involved Anglo-American
pharmacy
(Effective laws that restricted the practice of American
pharmacy appeared in 1870s)
Before that, anyone with luck, courage and sufficient
capital could open up an apothecary or druggist shop
Drugs:
Source: Britain had been the source of almost all of the
drugs prescribed and used by physicians and apothecaries
Distribution: American druggists: the distributors of dugs
Today know as wholesalers
133
BUT Americas demand increased American
druggists had to learn:
Manufacture their own chemically based drugs
Make common preparations of basic drugs obtain
form Britain
Imitate the popular British patent medicines so
much in demand by the public
Patent medicine, at that time, meant: secret remedy of
unknown composition
134
Because of the revolutionary war
American druggists greatly expanded their
production capabilities
But till that date

Pharmacy-the compounding of medicines- still
was done almost completely by physicians
135
Dr. John Morgan (1735-1789)
American physician and pioneer medical
educator
He formatted the physicians
prescriptions
Only few physicians followed Morgans Rx
format
The practice did not become Common Until
the 19th century
Wrote: A Discourse upon the Institution
of Medical Schools in America (1765)
Supported precise training and the
separation of the professions of physician,
surgeon, and apothecary
136
It was not until the early years of the 19th century that
American physicians began to view the special service
of an apothecary as distinct and essential
Hospital pharmacist
New York Hospital (1804)
Going on rounds and treating patients
By 1811, apothecary required to stay in his shop at all
times
Physicians began writing prescriptions for apothecaries

to dispense
started a concern over the compounding uniformity of
these medicines
137
Division of labor allowed pharmacists to
specialize in different areas of Pharmacy since
the 1800s:
Radio pharmacy
Clinical Pharmacotherapy
Nutritional support practice
138
1820
A national convention of physicians approved a
pharmacopeia of the United States of America (USP:
united states pharmacopeia)
Accepted nationally as the primary guide to drugs
Establishment of pharmaceutical societies

Philadelphia college of pharmacy (1821)
(established by physicians)
Massachusetts College of Pharmacy (1823)
colleges = associated colleagues
They established night schools to teach and discuss
scientific pharmacy
139
6. American Pharmacy: found its niche

Antebellum America
1820s - 1830s
Apothecary shops became more standard in their
appearance and in the stock they carried
A 19th century
apothecary in North
Carolina, USA
140
Pharmacies (mainly that of the east coast) started
to concentrate on
Drugs/medicines
Surgical supplies
Artificial tears and limbs
Dyes
Essences and chemicals
Pharmacies in small cities and towns tended to

keep in stock more general articles
Glass, paints, oils
141

Apothecary shops became the main
distributors of patent medicines
One of the most profitable lines of merchandise in
the history of American business
Boundaries of practice between physicians

and pharmacists have been drawn
And still exists today
142
Physicians
Accepted the role of pharmacists as compounders
and drug experts
Served as teachers for the 1st American Pharmacy
Schools
Supported the growth of an independent
profession of pharmacy as a necessity for a
division of labor to meet the growing demand
143

Physicians/apothecaries relationship began to
worsen in 1840s
Because: Apothecaries:
Main interest is pleasing patients not physicians
Refilled prescriptions without physician authorization
Directly treated customers: a practice called counter-
prescribing
144
Accelerate growth of American pharmacy:
Dramatic growth of pharmacy profession with
respect to the # of physicians
From 1850 to 1860
# of druggists grew by nearly 25% (from 1:3778 to
1:2850)
# of physicians did not change significantly (1:572 to
1:576)
Increase profits of pharmacists
145

late 1850s mass-manufacturers began
producing drug preparations
Large firms took over drug manufacturing
Small apothecaries had less and less role on market
Physicians had greatly supported the growth of

the pharmaceutical profession
It released them from the hard work of compounding
medicines and running a shop
146
The strong competition between pharmacists and
physicians
Threatened the boundaries that had been previously
developed to separate the 2 professions
Pharmacists conflicts with physicians; again:

Pharmacists complaint: dispensing physicians and doctors
shop
Physicians complaint: counter prescribing
After the 1865 (end of civil war)

Boundaries between the 2 professions were drawn more
clearly
147
6. American Pharmacy: The search for

professionalism
1852 : Small group of leader druggists and
apothecaries founded the American Pharmaceutical
Association (APhA) (today known as the American
Pharmacists Association)
Pharmacy students needed a voice in the professional
society of pharmacists
Drug Information Handbook (DIH) approved and
adopted by APha
Competition between apothecaries became

destructive to the profession need for
professionalism
148
6. American Pharmacy: The search for
professionalism
More and more growth of pharmaceutical
industries
Loss of the art of pharmacy (compounding)
Decrease compounding in shops
Increase pharmacy professionalism

Controlling admissions to professional schools
Raising examination standards
Applying laws and regulation
149
6. American Pharmacy: Transition to a

modern profession
From the 1870s on:
State laws: requiring examination and registration of
pharmacists
Schools of pharmacy
Schools of pharmacy joined with state colleges and
universities
(Starting with the University of Michigan in 1868)
Till then, Most of the medicines eased symptoms,

rather than treated root illnesses
Scientific pharmacology has emerged
How drugs worked on a cellular and organ system level
150
modern profession
Huge increase in drugstores, and more
importantly, the chain drugstore: increased
the economic pressure of the profession
151

modern profession
In the 1900s, United States Pharmacopeia and
the National Formulary of the APhA became
the official compendia (today known as United States
Pharmacopeia and National Formulary (USP-NF))
National drug standards for the first time
Contains drug information on:
Composition
Chemical description
Selection
Prescribing, dispensing and administration
152
modern profession
Pharmacists abandoned the in-shop
manufacturing of the ingredients of their
prescriptions
The pharmaceutical
industry
Produced cheaper and
more reliable, uniform
drugs than individual
pharmacists
153

modern profession
Pharmacy education adapted gradually to the
change
Courses shifted
Away from the identification of plant ingredients
To chemical compatibility of the ingredients within each
prescription
1932 when a 4-year BS degree became standard

for licensure
Strong professionalism of American pharmacy
Scientifically trained pharmacists
1933-1966: time of dramatic change for all the
medical care including pharmacy
154
6. American Pharmacy: The era of
dramatic change
In therapeutics the introduction of antibiotics
first significant antibiotic: discovered by Alexander
Fleming: penicillin in 1928
10 years later, a British team scaled-up the
production of the drug
Other antibiotics followed shortly
The number of prescriptions grew faster as new,
effective drugs came onto the market
First chemotherapeutic agent: Salvarsan
Introduced by Paul Ehrlich in 1910
155

dramatic change
New classes of therapeutic agents
Corticosteroids
Antidepressants
Antihypertensives
Oral contraceptives
Pharmacy evolved to include: prevention and

cure for serious disease
156
6. American Pharmacy: The era of dramatic
change
New drugs that reduced the pain and suffering of illness
Aspirin (ASA) (1853)
Acetyl Salicylic Acid
Miracle
Paracetamol = acetaminophen (APAP) (1953) drug
United states: only called acetaminophen
1955: acetaminophen went on sale in the United States under the brand name
Tylenol
Britain and countries outside US: use paracetamol more
1956: paracetamol went on sale in the United Kingdom under the trade name
Panadol
Names from same molecule:
Acetaminophen: para-acetylaminophenol
Paracetamol: para-acetylaminophenol.
APAP: acetyl-para-aminophenol
Ibuprofen (advil, profinal, brufen) (1969)

157

dramatic change
High tech, advanced American pharmaceutical industries
Shifting away from prescribing complex mixtures of
ingredients toward ready made, single-entity medicines
manufactured by large companies
158
dramatic change
Pharmaceutical industries in control
1930s about 75% of the prescriptions required
some compounding by pharmacists
By 1950 this dropped to about 25%
By 1960 only about 1 in 25 prescriptions (4%)
needed the compounding skills of pharmacist
By 1970 this dropped to about 1 in 100 (1%)
159
6. American Pharmacy: The era of dramatic

change
Change in pharmacy program:
Proposals for 6-year, Doctor of Pharmacy degrees: first
initiated at the University of Southern California in
1950
A 5-year BS in pharmacy degree was the standard
starting 1960
(in 1992, all the colleges of Pharmacy in the US voted

to make the Doctorate of Pharmacy (Pharm.D.) the
only professional Pharmacy degree; transition from BS
to Pharm D degree is complete in 2000)
160
6. American Pharmacy: The
emergence of clinical pharmacy
The concept of clinical pharmacy:
Development of hospital pharmacy in 1920s
OBRA 90
1993
Patient profile and medical file in pharmacies
Pharmacist should ask all patients if they want counseling
Growth of clinical pharmacology since the 1940s
Innovative teaching programs
Decline of pharmacology instruction in medical
schools
Expansion of the pharmacys role to include patient
instruction on proper drug utilization
161

Physicians
Overburdened by patient loads and the explosion of
new drugs
Turned to pharmacists more and more for drug
information, especially within institutional settings
Physician/patient relationship and trust declined

Pharmacist/patient relationship and trust grew
Pharmacists have become the most trusted
professionals in American Pharmacy
162
Increase in # of women in the pharmacy
profession
Year % of women in American pharmaceutical
workforce
1950 Only 4%
1959 18%
1984 36%
2000 40%
2004 52%
163

Pharmacists have adapted computer
technology to their work quickly
164
Pharmacy logos
165
Coming:
Pharmacy practice
Pharmacy ethics
166
Section II
Pharmacy Practice
1. Common medical & pharmacy abbreviations
2. Pharmacy Careers, Pharmacy Organization
Scope: Chapter 1, Remington A. Gannaro 20th edition
3. Drug development, approval process and phases of
clinical testing
The introduction of new drugs: : Chapter 48, Remington A. Gannaro
20th edition
4. Legal classification of drugs (American pharmacy)
US drug regulation: An overview. Foyers principle of medicinal
chemistry, 5th edition
5. Pharmaceutical preparations. Introduction to Drug Dosage
forms
6. Major drug groups and families
milies
Duration: 4-5 weeks
Exam II 167
Section II
Pharmacy Practice
1. Common medical &

pharmacy abbreviations
168
Medical/pharmacy Abbreviations
Abbrev. Meaning Abbrev. meaning
AOB Alcohol on breath Hx History
CA Cancer WF White female
yof
Ca Calcium WM White male
yom
SOB Shortness of breath NPO Nothing per os (mouth)
OOB Out of bed OTC Over-the-counter
PO Orally SCr Serum creatinine
SQ or SC Subcutaneously CrCl Creatinine clearance
IM Intramuscular GFR Glomerular filtration rate
sl Sublingually I/O (I&O) Input (intake)/output
169
Prn As needed; when Yr/yo/YOB Year/years old/ year of
needed birth
q Every (e.g. q6h = every q4h, every 4 hours, every 6
6 hours) q6h.... hours etc
qd Every day (i.e. once Ac Before eating
daily) c With
qh Every hour P After
qod Every other day pc After eating
qhs Every evening OR Operating room
Bid Twice per day (or q12h) ER/ED Emergency room/
emergency department
Tid 3 X/day (or q8h) OD Right eye
Qid 4 x/day (or q6h) OS Left eye
Tiw/tw Twice per week OU Both eyes
qw Every week 170
Pt Patient HEENT Head,ear, eye, nose & throat
CC Chief complaint WD/WN Well developed/well
nourished
HPI History of present illness AMA Against medical advice
PMH Past medical history U/A Urinalysis
C&S Culture and sensitivity
PERRLA Pupils Equal, Round, WNL Within normal limits
Reactive to Light and WLN Within the limits of normal
Accommodation
PE Physical exam F/U Follow up
ROS Review of system R/O Rule out
A&O X3 Alert & oriented to person, D/C or DC Discharge/discontinue
place and time
A&O X4 Alert & oriented to person, DOE Dyspnea on exertion
place, time and event
A&W Alive and well UTI Urinary tract infection
171
UTI Case
M.N is a 75 yo WF who presents to you clinic
with the chief complaint of N/V several times
today, feeling sick to her stomach and having
abdominal pain and burning when urinating
HPI:
The abdominal pain started 2 days ago but got
worse over night
This morning she developed fever and chills and
started to vomit after she had lost her appetite for
at least 48 hrs
172
UTI Case Contd
PMH:
Recurrent cystitis
HTN x 15 years
FH: father died of natural causes at age 84. mother died of kidney failure
at age 78
SH: retired secretary, ETOH occasionally
ALL: NKA/NKDA
Med: nifedipine XR (Adalat, nifedicor) 60 mg qd
PE:
M.N is an ill appearing elderly woman who appears to be her stated age
Wt: 50.5 kg Ht: 158 cm
VS: BP: 150/85 T: 39.6C P (HR): 100 bpm RR 25bpm
HEENT: dry mucus membranes
Dx: it is decided to admit M.N for UTI
173
CAD Coronary artery disease CABG Coronary artery bypass graft
surgery (= open heart)
CHD Coronary heart disease PCI Percutaneous coronary
intervention (=angioplasty:
ballon +/- stent)
PI Pulmonary insufficiency DVT Deep vein thrombosis
A-fib Atrial fibrillation PE Pulmonary embolism
V-fib Ventricular fibrillation BPH Benign prostate hyperplasia
AIDS Acquired ADHD Attention-deficit hyperactivity
immunodeficiency disorder
syndrome
HIV Human IBD Inflammatory bowel disease
immunodeficiency virus (chrohns disease (CD)/Ulceritive
colitis (UC))
CHF Congestive heart failure IBS Irritable bowel syndrome
174
(constipation/diarrhea)
DM Diabetes mellitus DNR Do not resuscitate
DMI Diabetes mellitus type 1 DOA (med) Dead on arrival
DMII Diabetes mellitus type 2 DOA Duration of action
(phar)
DKA Diabetic keto-acidosis ADL Activities of daily living
RA Rheumatoid arthritis MOA Mode (mechanism) of
action
CSF Cerebro spinal fluid ECG,EKG Electrocardiogram
CNS Central nervous system EEG Electroencephalogram
CVA Cerebro-vascular accident UTI Urinary tract infection
N/V/D Nausea/vomiting/diarrhea URI/URTI Upper respiratory
infection/ upper
respiratory tract infection
COPD Chronic obstructive
pulmonary disease 175
CBC Complete blood count BM Bowel movement
WBC White blood cells BP Blood pressure
RBC Red blood cells BS Bowel sounds
CXR Chest X-ray Bx Biopsy
CT-Scan Computed tomography Tx/Rx Treatment/prescription
MRI Magnetic resonance Dx Diagnosis
imaging
BG Blood glucose Sx symptoms
FBG Fasting blood glucose
PNC Penicillin ASAP As soon as possible
ASA Acetylsalicylic APAP Acetaminophen
acid=aspirin
NTG Nitroglycerin NSAIDs Non-steroidal anti-
inflammatory drugs 176
Abbrev. Meaning Abbrev. Meaning
ETHO Ethanol NGT Naso-gastric tube
GI Gastro-intestinal NS Normal saline (isotonic)
NaCl 0.9%
GU Genito-urinary D5W Dextrose 5% in water
H/A Headache OB-GYN Obstetrics & gynecology
IVF Intravenous fluids Pre-op Prior to surgery
L&D Labor & delivery RRR Regular rate and rhythm
MI Myocardial infarction Stat Immediately
MVA Motor vehicle accident THC Marijuana
ABG Arterial blood gases TPN Total parenteral nutrition
Td Tetanus and diphtheria Tdp Tetanus, diphtheria and
pertusis
177
Medical specialties
1. Anesthesia/Anesthesiologist
2. Cardiology/Cardiologist
3. Dermatology/Dermatologist
4. Endocrinology/Endocrinologist
5. Otalaryngology/ENT
(ear/nose/throat)/Otalaryngologist
6. Gastroenterology/Gastroenterologist
7. Geriatrics/Geriatrician
178
Medical specialties
8. Gynecology/Gynecologist
9. Hematology/Hematologist
10.Nephrology/Nephrologist
11.Neurology/Neurologist
12.Oncology/Oncologist
13.Ophthalmology/Ophthalmologist
14.Orthopedics/Orthopedist
179
Medical specialties
15. Pathology/Pathologist
Study and diagnosis of disease through examination of
organs, tissues, bodily fluids and whole bodies (Autopsy)
16. Pediatrics/Pediatrician
17. Neonatology
18. Podiatry
Diagnosis and treatment of disorders of the foot,
ankle and lower leg
19. Psychiatry/Psychiatrist
Mental disorders: affective, behavioral, cognitive, and
perceptual disorders
180
Medical specialties
20. Pulmonary/pulmonologist
21. Radiology/Radiologist
X-rays, CT-scan, MRI
22. Rheumatology/Rheumatologist
Disease of joints, soft tissues, cartilage, connective
tissues
23. Urology/Urologist
Kidneys, ureters, bladder, testes, prostates
24. Virology
Study of viruses
Considered part of microbiology or pathology
25. Microbiology/Infectious disease
Bacteria, viruses, fungi, protozoa, worms
181
F / C
To convert Fahrenheit temperatures into Celsius:
Begin by subtracting 32 from the Fahrenheit number
Divide the answer by 9
Then multiply that answer by 5
Example: Change 95F to Celsius:
1. 95-32 = 63 FYI
2. 63 9 = 7
3. 7 x 5 = 35C
To convert Celsius temperatures into Fahrenheit:

Begin by multiplying the Celsius temperature by 9
Divide the answer by 5
Then add 32
Example: Change 20C to Fahrenheit:
1. 20 x 9 = 180
2. 180 5 = 36
3. 36 + 32 = 68C
182
Cm/inches
Formula
1 cm 0.39 in
1 in 2.54 cm
1 foot = 12 inches ( 5 feet = 60 inches)
Examples
How tall is a woman in centimeters who is 5' 5" (65
in)?
5 foot x 12 inches = 60 inches
60 inches + 5 inches = 65 inches
65 inches x 2.54 = 165 centimeters
If a baby is 64 centimeters long, what is her length in
inches?
64 centimeters x 0.39 = 25 inches
183
Kilograms/pounds
Formula
lbs 2.2 = kilograms
kg x 2.2 = pounds
Examples
A man weighing 70 kilograms weighs 154 pounds
70 kg x 2.2 = 154 lbs
A woman weighing 110 pounds weighs 50
kilograms
110 lbs / 2.2 = 50 kg
184
Case 2
CC/HPI:
RJ is an 82 yo WM who presents to clinic for routine follow
up visit.
He is accompanied by his wife, SJ.
RJ stays quiet; but SJ reports that he has been acting
strange lately.
He recently went to the grocery store and returned several
hours later without many of the items on the list. He told
her he had gotten lost on the way home.
He also missed an appointment with his dentist and
completely forgot his anniversary!
She says that his behavior has been getting worse over the
past six months.
Finally, she says that she is even more frustrated because
she has not been able to sleep due to the fact that he
makes 5-6 trips to the bathroom during the night
185
Case 2 Contd
PMH:
HTN X 15 years
GERD
CHF
Occasional insomnia
SH:
Tobacco (-); EtOH (-); caffeine (+): 1 cup/day
Retired lawyer; lives at home with wife
186
Case 2 Contd
FH
Father died of MI at age 73
Mother died at 86 (she had Alzheimer disease)
Brother with Alzheimer disease died at age of 80
Sister has DMII
Medications
Enalapril (Renitec) 5 mg qd
Ranitidine (zantac) 150 mg qd
Hydroxyzine (atarax)10 mg hs prn
Furosemide (lasix) 20 mg qd
Potassium chloride 20 mEq qd 187
Case 2 Contd
PE:
GEN: WDWN elderly gentleman appearing
irritated
HEENT: PERRL
Chest: CTA
CV: RRR
ABD: no tenderness, no distention
EXT: WNL
Neuro: A&O x2 (patient does not recall the
month/season)
188
Case 2 Contd
Allergies: NKDA
VS:
BP: 102/68 HR: 78 T: 36.6C
Wt: 77 kg height: 175 cm
Labs
Chemistry: WNL
Hematogram: WNL Age (years) Prostate specific antigen
40-49 0 2.5
U/A: WNL 50-59 0 3.5
PSA: 3.9 60-69

70-79
0 4.5
0 5 or 6.5
189
Case 3
HPI/CC:
DH is a 74 yo WF who presents to the clinic
complaining of an inability to hold her urine.
She reports that she often does not make it to the
bathroom on time and she has been wearing
protective pads.
She also says: I fell down the other day when I
was trying to hurry to the bathroom. Ever since,
my wrist has been really sore. Come to think of it,
my lower back has been hurting as well
190
Case 3 Contd
PMH:
HTN
COPD (with frequent exacerbations requiring
hospitalization)
History of breast cancer with mastectomy in 1998
SH:
Tobacco (+): ppd x 40 years
EtOH (-)
Caffeine (+): about 5-6 cups coffee/day
191
Case 3 Contd
Medications
Hydrocortisone 25 mg po daily
Amlodipine (amlor, lowrac) 5 mg daily
Ipratropium inhaler (atrovent) 2 puffs qid
Salmeterol inhaler (serevent) 2 puffs bid
Enteric coated aspirin 100 mg daily
Allergies: NKDA
Vital signs:
BP: 142/78; pulse: 88 T: 36.7C
Wt: 50 kg Ht: 60 inch
192
Contd
Case 3
PE:
GEN: thin elderly woman
HEENT: PERRLA
Chest: CTA
CV: RRR
EXT: WNL
Neuro: A&O X3
193
Case 3 Contd
Labs
TSH: 3.5 (NL 5-6) 142 105 23
Iron: 65 (NL 52-169) 108
3.8 27 1.3
TIBC: 320 (NL 246-455)
Transferrin sat 20% (NL 20%-50%)
UA: WNL
Other DEXA scan:

T-score of -2.6
Z-score < -2.0
194
Case sections
SOAP
Subjective
Objective
Assessment
Plan
195
Case 4
Subjective
CC/HPI:
MM is a 58 yo WM who presents to the general medicine clinic
complaining of urinating all night.
He explains that he stopped taking his water pill but it not
helped.
Upon further questioning, he admits to have increase
drowsiness (which he attributes to interrupted sleep) and
increase thirst.
He says he has blurred vision, but he attributes that to reading
too much at work.
He complains of a tingling and burning sensations in both lower
extremities.
He denies pain upon urination. He says he has been trying to eat
less and exercise more since his doctor told him about his
diabetes.
He states he never received the glucometer that his doctor told
him he would get him, so hes not taking his blood glucose
196
Case 4 Contd
Subjective
PMH
DMII: diagnosed 2 month ago
HTN x 11 years
Seasonal allergies
Occasional constipation
FH
Mother, father, sister with DM
Father died of MI at age 62
197
Case 4 Contd
Subjective
SH:
Tobacco (+) X 5 yrs; quit 1979
EtOH (+)
Drinks when out to dinner with friends 1-2 glasses of wine
Occasionally 1-2 drinks when gets home from work after a long day
Caffeine (+)
Drinks 1-2 cups of coffee Q AM
Drinks 1-2 diet cokes per day
Allergies: NKDA
Medication history
ASA EC 81 mg PO QD
HCTZ 50 mg PO QD (stopped 1 week ago)
Colace 250 mg PO QD
MVI 1 tablet po QD
198
Case 4 Contd
Objective
PE
Gen: lethargic, obese male
HEENT: PERRLA, mild rhinorrhea, otherwise normal
Cor: RRR (cor=heart)
Chest: CTA bilaterally
Abd: moderately obese, non-tender, +ve BS
Gu: WNL
Ext: WNL
Neuro: A&O x3
VS
BP 152/92 Right arm while sitting
HR 72, T 98.9F
Wt 87 Kg, Ht 55
199
Case 4 Contd
Lab Tests
Objective
E-lytes and kidney Hematology Liver function tests Glucose/cholesterol
function (LFTs)
Na: 141 (135-145 mEq/L) Hct: 42 (M: 40-54; F: 37- AST: 18 (=SGOT) (<35 Random Glu: 212 (60-
75% ) Units/L) 110 mg/dl)
K: 4.1 (3.5-5.0 mEq/L) Hgb: 14 (M: 14-18; F: 12- ALT: 12 (=SGPT) (<35 HbA1C: 8.6% (<7%)
16 g/dL) Units/L)
Cl: 101 (98-108 mEq/L) WBC: 6,000 (4.5-11 x LDH: 56 (56-194 Units/L) Total Chol: 270(< 200
103/mm3) mg/dl)
HCO3: 25 (22-30 mEq/L) Plts: 200 (150-450x Alb: 4.2 (3.5-5 g/dl) HDL: 32 (40-60 mg/dl)
103/mm3)
BUN: 15 (7-20 mg/dl) T. Bili: 0.2 (0.1-1.2 mg/dl) LDL: 140 (< 120 mg/dl)
SCr: 1.6 (his baseline TG: 190 (< 150 mg/dl)
since 1999) (0.5-1.2
mg/dl)
U/A:
-ve: nitrite, ketones
+ve: glucose, +1 proteins, WBC 6
200
Section II
Pharmacy Practice
2. Pharmacy Careers
&
Pharmacy Organization
201
Pharmacy
Definition
The art and science of preparing and dispensing
medications as well as providing drug and related
information to the public
What does pharmacy involve

Interpretation of prescription orders
Compounding
Labeling
Dispensing of drugs and devices
Drug product selection
Drug utilization reviews (DUR)
Patient monitoring and intervention
Outpatient services (taking BP, glucose level, TG, Wt)
202
Pharmacy
So, pharmacist is one who is educated and is
licensed to do above
The pharmacist is considered the most
accessible member of todays health care
team
203
Pharmacy careers
Job opportunities are growing, due to
The increased pharmaceutical needs of a larger and older
population
Scientific advances => more drug products
The pharmacy
First place patients go with questions about medicine and
their medical care
Pharmacists
Assure safe and accurate delivery of medication to patients
Caution patients about possible side effects of their drug
therapy
204
Pharmacy careers
1. Community pharmacy (Ambulatory patient care)
2. Institutional pharmacy
1. Hospital
2. Clinics
3. Walk-In-Health centers
4. Long-term care facility: nursing home
3. Wholesalers
4. Industrial pharmacy (pharmaceutical companies)
Pharmaceutical Sales and Marketing, and CRA
5. Pharmaceutical education and universities
6. Local, State, and Federal Government and Armed Services
7. Pharmacy journalism
8. Organizational management
9. Consultant Pharmacy
10. Drug Research and Development (R&D)
11. Public Health Service
12. Mail Service/Internet Pharmacy
205
Pharmacy Careers
1. Community Pharmacists
Most persons when thinking of pharmacy they think
first for the community pharmacists
~ 70% are community pharmacists
~ 23% are hospital pharmacists
Rest: divided in the other areas of the profession
Majority of registered pharmacists (RPhs) are in the
community pharmacy
Tasks and responsibilities
Checking prescriptions
Dispensing medications
Writing labels
Counseling patients
Providing HEALTH-related services: taking BP, blood glucose,
weight
206
Prescription Label
Road Pharmacy
110 Main Street
Libertyville, Maryland
Phone 456-1234
Rx 12345 Date: July 4, 2011

Suzie Smith Dr. Mary M. Brown
Augmentin 500 mg
14 tablets
Sig: take 1 tablet in the morning with breakfast and 1 tablet in the evening with dinner
for 7 days
Refill: __1__ time Pharmacit: JK
Additional information:
-Light-resistant bottle (to protect light-sensitive products against photochemical
degradation)
-Moisture-proof closure
-Child-resistant container with safety closure
-Controlled substance 207
Community pharmacy
208
Pharmacy Careers
2. Institutional Pharmacists
The practice of Pharmacy in a private and government
Hospitals , Health Management organization (HMO)(ex:
insurance companies), clinics, WHO (world health
organization).
Mainly refers to hospital pharmacists
The number of pharmacists in the institutional
practice will increase for three principle reasons
1. There will be an increase in population &departments
2. The Pharmacists in the hospital will be given a greater role in all
aspects of the use of the drugs
1. Hospital Pharmacists
2. Clinical Pharmacists
3. Hospitalized patient often need better medical care
Hospitalization insurance ,both private and government sponsored will
foster these trends
209
Pharmacy careers
Hospital Pharmacy
Stock a larger range of medications
Provide medications for the hospitalized patients
only
Compound sterile products for patients and
medications given intravenously like neonatal
antibiotics and chemotherapy
Prepare hospital formulary
Total Parenteral Nutrition (TPN)
Chemotherapy preparation
210
Hospital pharmacy
211
Pharmacy careers
Long term facilities
It is a field of acute and episodic care integrated
closely with rehabilitative, restorative and supported
care
Many patients in these facilities are treated with long
term multiple drug therapy
APhA defines pharmacy practice as a facility or unit
which is planned, staffed and equipped to
accommodate individuals who do not require hospital
care, but who are in need of a range of medical,
nursing and related health and social services
212
Nursing home
213
Pharmacy Careers
3. Wholesale Pharmacists
Offer opportunity for a limited number of pharmacists
Pharmacists serve as a middleman between the
manufacturer & Institutional/community pharmacy
The Wholesale drug firms play a vital role in assuring the
community pharmacists and institutional pharmacists a
quick convenient source of a supplies from a multiple
manufacturer
Pharmacist work as supervisor
214
Pharmacy Careers
3. Wholesale Pharmacists
What are the benefits for the wholesalers ???
It lessens the community pharmacist's financial burden
of carrying large volumes of stock
Quick Source For a drug
Providing advisor roles to pharmacists in providing
them information and consultants on store
redecorating and remodeling
Computer assisted inventory and ordering systems
215
Pharmacy Careers
4. Industrial Pharmacy (pharmaceutical
companies)
RPhs are largely involved in marketing and
administration
Medical representatives-sales
Production and quality control
Medical communications managers and clinical
research scientists
Marketing sales and legal departments
216
Pharmacy Careers
4. Industrial Pharmacy
Pharmaceutical sales representatives
In the past: It was very hard to employ a pharmacist:
Higher Salariess Companies didnt employ always
Shortage pharmacists
Today: OPL and Ministry of Health issued a new Law

(Effective as of June 26, 2011)
Pharmaceutical companies are obliged to hire
only Pharmacists for the Medical
representative positions
217
217
Pharmacy Careers
4. Industrial Pharmacy
Pharmacist with masters degree in business or

additional bachelors degree in law
Find opportunities in the pharmaceutical industry in
the marketing sales and legal departments
Production and quality control supervisory
Pharmacists with the degree of doctor pharmacy
Medical communications managers
Clinical Researcher science
218
Pharmacy careers
5. Pharmaceutical education
Offers opportunities of pharmacy with more advanced degrees

in any of the professional Specialties
Masters, Pharm D or PhD (research, administrative and
teaching)
Graduate studies
Pharmaceutics
Industrial pharmacy
Medicinal chemistry
Pharmacology
Pharmacognosy
Cosmetology
Masters in business administration (MBA)
Nuclear
Toxicology
219
Pharmacy Careers
6. Governmental service
Army , Navy , and air force
FDA
United states public health service
7. Pharmaceutical Journalism
Rewarding experiences for a limited number of
pharmacists with writing and editing talent
8. Organizational Management
Officers of national and state associations and boards of
pharmacy
9. FDA and EMA
220
Pharmacy practice
Ambulatory patient care (Community pharmacy)
An ambulatory patient is he who is able to walk (not bedridden)
Ambulatory care
Health services (consultation, treatment or intervention ) provided on an
outpatient basis to those who visit a hospital or another health care
facility and depart after treatment on the same day
Examples
Minor surgical and medical procedures
Most types of dental services, dermatology services, and many types of
diagnostic procedures (e.g. blood tests, X-rays, endoscopy and biopsy procedures
of superficial organs)
Emergency visits
Rehabilitation visits
But community pharmacy serves non-institutionalized patients
The patient here is able to obtain, store and take his/her own
medications
Patient can be on a wheel chair, but still able to manage
Institutional patient care

Is mainly hospital care (Hospital and Clinical Pharmacy)
221
Pharmacy practice
Patient communication
Patient counseling
Patient compliance
Degree to which a patient correctly follows medical advice
Drug interaction
Refer to the next slide
Clinical drug literature
1, 2, and 3 literature
Poison control
Poison control centers
Drug information center (DIC)
Health accessories
Products used to aid a patient
Medical supplies 222
Pharmacy practice
Drug interaction
A situation in which a substance affects/changes another drugs
activity and/or effect
Change in effect can be
effect
effect
New effect that is not produced by the substance nor the drug alone
Interaction between the substance and drug:
Drug-drug
Food-drug
Herbs-drug
Test-drug
Vitmain-drug
Ca or iron with levothyroxine
Can occur out of an accidental misuse or due to lack of
knowledge about the active ingredients involved in the relevant
substance or dug
223
Main pharmacy organizations

1. American Pharmacists Association (APhA)
National professional organization of RPhs
Represents RPhs, pharmaceutical scientists and
pharmacy students
Founded 1852
Membership
224
2. American society of health system pharmacists
(ASHP)
RPhs in institutional settings
2 Annual meetings
Mission:
Provide high quality pharmaceutical services that
foster the efficacy, safety and cost effectiveness of
drug use
Contribute to programs and services that emphasize
the health needs of the public and the prevention of
the disease
Promote pharmacy as an essential component of the
health care team
225

3. American College of Clinical Pharmacy (ACCP)
A professional and scientific society
Purpose: to advance human health by extending the
clinical pharmacy and pharmacotherapy
By providing education, support, training, and resources
enabling clinical pharmacists to achieve excellence in
practice, research, and education
ACCP's membership:
Practitioners, scientists, educators, administrators, students,
residents, fellows, and others
Committed to excellence in clinical pharmacy and patient
pharmacotherapy
Promotes innovative science, develops successful
models of practice, and disseminates new knowledge
to advance pharmacotherapy and patient care
226
Pharmaceutical Education
227
Prior to the founding of the Philadelphia
college of pharmacy in 1821 ,Pharmacy was
taught by physicians for the physicians
At the beginning , minimal standards for

colleges of pharmacy
All were members of the American

Associations of colleges of pharmacy (AACP)
Today known as ACPE
228
Requirements
Until 1904: Grad school plus 40 weeks pharmacy
school
In 1907: Increase to 50 weeks after the grad
school
In 1918: Increase to 2 years after the grad school
In 1960: Raised to 5 years giving the BS in
pharmacy (BPharm) degree
229
Today's colleges of pharmacy offer the 5 year
program which often is so formulated that either
the
First year or the first 2 years maybe taken at Junior
colleges
In addition to the minimal degree (BPharm or BS)
for licensure and entry into the profession, some
schools offers the doctor of pharmacy (Pharm D)
as either the minimal degree (USA) or add-on
degree (Lebanon)
Pharm D
Prepares students for hospital practice, mainly clinical
practice
230
American Foundation for pharmaceutical Education (AFPE) was
incorporated in 1942
To encourage and provide improved educational standards and
facilities for the adequate training
To supply the following with technically and scientifically trained
personnel
Pharmaceutical industries
Manufacturing industries
Hospitals
Government agencies
College faculties and other professional fields
To help colleges develop strong undergraduate programs
To support graduate work in properly qualified colleges
To encourage scientific research as a necessary component of
graduate work
231
Pharmaceutical Licensure
The practice of Pharmacy in each state is
regulated by the role of that states
To practice pharmacy in the states , the
pharmacist must be a registered pharmacists
(Rph)
Also known as licensed pharmacists
A graduate of any ACPE accredited school of
pharmacy is eligible to take Naplex exam to be
registered, in addition to the state law exam
ACPE: Accreditation council of pharmacy education
Naplex: North American Pharmacist licensure examination
232
Pharmaceutical Licensure
Accreditation Council for Pharmacy Education
(ACPE)
The national agency for the accreditation of
professional degree programs in pharmacy
Providers of continuing pharmacy education
Established in 1932
233
Section II
Pharmacy Practice
3. Drug development, approval

process and phases of clinical
testing
234
What is a drug
Refers to medicines, substances that can:
Cure or stop the progression of the disease
Relief symptoms
Ease pain
Prevent diseases
Vaccines
This also includes vitamins and minerals that may be used to
correct deficiency diseases
According to US law book, a drug is defined as:
A substance which exerts an action on the structure function of the
body
By chemical action or metabolism
And is intended for use in the
Diagnosis
Cure
Improvement
Treatment
Or prevention of disease 235
Where do drugs come from?

Source of drugs
1. Plant material
Opium puppy morphine
2. Animals
Hormones, thyroid drugs, insulin, vaccines
3. Organic synthesis
In the laboratory
4. Genetic engineering
By which a certain microorganism gene(s) (which
direct a certain cell) is altered changing the
products of cell activity
Biologic drugs, or monoclonal antibodies
236
New drug approval and
development
237
Introduction
It takes more than 12 years and over $350
million to get a new drug from the laboratory
onto the pharmacy shelf.
Only 1 in 1000 of the compounds that enter

laboratory testing ever make it to human
testing
238
New drug approval and development
A. Pre-Clinical Investigation
B. Clinical Investigation: Investigational new
drug application (IND or INDA)
239

A. Pre-clinical investigation
Before testing the drug on human, it must be proven
safe and effective. This is done through
9 In vivo experiment
9 Using animals
9 In vitro
9 In laboratories
Both to determine safety and efficacy
9 No prior FDA approval is needed
9 Usually takes 1-3 years
9 When enough information and data are gathered, an INDA
application is filled to the FDA to test on humans
240
B. Investigational new drug application (IND or
INDA)
Before clinical trials, an INDA must be filed to the
FDA
Clinical investigation may take up to 12 years to
be completed
Final FDA approval of a drug can be lengthy and
expensive
241

B. Investigational new drug application (IND or
INDA)
An IRB approval is needed
9 IRB: Institutional Review Board: it reviews the trials for
ethical and rights of human test subjects & informed
consent before IND review starts by the FDA committees
An IND includes
9 Data on in-vivo and in-vitro studies that shows safety and
efficacy
9 Characterization of what a molecule looks like
9 Protocols explaining how drug will be tested
9 Qualifications of the investigators that will conduct the
clinical trials
9 IRB approval
242
Once IND is filed to the FDA, the FDA has 30
days to review it
If the sponsor has not been contacted by the 30th
day this means no problem in the IND the
study may proceed and phase 1 clinical trial starts
If the agency has contacted the sponsor by the

30th day ,the trial will not proceed legally
243
Center of Drug Evaluation and Research

(CDER)
A sponsor wishing to introduce new drug into humans for
the first time must submit an IND to the center of drug
evaluation and research (CDER):
Where it will be forwarded to one of the medical review
divisions in the office of the drug evaluation I , II:
Each review divisions consists of physicians,
pharmacologists & chemists as well as administrative
staff
Also the center has offices and divisions of
1. Statisticians
2. Biopharmaceutics (BE/GLP)
3. Attorneys & other professional staff available as
consultants to the review divisions 244
Conditions that enforce a clinical hold
1. Subjects are or would be placed at an unreasonable &
significant risk of illness or injury
2. The clinical investigators are not qualified to perform
the proposed study
3. The investigators Brochure is misleading
4. The documents dont contain sufficient information to
assess the risks to the subjects
245
The New Drug Development

Process
Steps from Test Tube to New Drug
Application Review
www.fda.gov
246
Drug Pre-clinical F Clinical studies (Human) NDA Post-
discovery research D revi market
A ew
Starts Synthesis and F F Phase
with purification of T D D IV
about 100 the molecule I A A
molecules M
Phase 1
Animal testing E
Phase 2 T T
Institutional I I
board review Phase 3 M M
E E
IND Review
submitted decision
NDA
247
submitted
Phases of clinical testing
The trials are typically conducted in

three phases
Phase I, II, III
Phase IV is the post-marketing

phase
248
Phases of clinical testing- Phase I
Consists of initial testing of a study drug in humans
Usually in normal volunteers (but occasionally in patients)
Safety evaluations are the primary and almost always

the PRIMARY objective
The attempt to establish the approximate levels of

patient tolerance for acute and usually multiple dosing
Some preliminary efficacy data may be obtained in

some studies
249
Phases of clinical testing- Phase I

These studies are designed to determine:
The metabolic and pharmacologic actions of the drug in
humans
The side effects associated with increasing doses
If possible, to gain early evidence on effectiveness
In Phase 1 studies, CDER can impose a clinical hold (i.e.,

prohibit the study from proceeding or stop a trial that
has started)
For reasons of safety, or because of a sponsor's failure to
accurately disclose the risk of study to investigators.
250
Phases of clinical testing- Phase II
Evaluate efficacy in selected population of patients for
whom the drug is intended
The first part often consists of studies, which may be

Open label
Single blinded
Double blinded
The second part consist of well-controlled studies that

usually represent the most exact demonstration of drugs
efficacy
Relative safety information is also determined in phase II

251
Phases of clinical testing- Phase III

Phase 3 studies are expanded controlled and
uncontrolled trials.
Intended to gather the additional information about

effectiveness and safety that is needed to evaluate the
overall benefit-risk relationship of the drug.
Provide an adequate basis for extrapolating the results

to the general population (due to large population
tested) and transmitting that information in the
physician labeling.
252
Phases of clinical testing- Phase III
Provide much of the information that is
needed for the package insert and labeling of
the drug
In both Phase 2 and 3, CDER can impose a

clinical hold if a study is unsafe (as in Phase 1),
or if the protocol is clearly deficient in design
in meeting its stated objectives.
253

Number of Length Purpose Percent of
patients drugs
Successfully
completing
Phase 1 20-80 Several months Mainly safety 67%
Phase 2 Up to several Several months Mainly 45%

hundred 2 years effectiveness
Phase 3 Several 1-4 years Safety, 5-10%

hundreds to effectiveness,
several dosage
thousand
254
Drug Pre-clinical F Clinical studies (Human) NDA Post-
discovery research D revi market
A ew
Starts Synthesis and F F Phase
with purification of T D D IV
about 100 the molecule I A A
molecules M
Phase 1
Animal testing E
Phase 2 T T
Institutional I I
board review Phase 3 M M
E E
IND Review
submitted decision
NDA
255
submitted

After phase III, an NDA is filed to the FDA
What is in NDA
New drug application: must contain the following
information
Pre-clinical lab and animal data
Human pharmacokinetics and bioavailability data
Any other clinical data, methods of manufacturing,
processing, packaging
A description of the drug product and substance, claims, and
proposed labeling
Risk and benefit of the new drug and all the studies of
phases I, II, and III results
256
This time, the FDA has

60 days to file the NDA: i.e. 60 days to:
Review all the data
Make sure nothing in missing or incomplete
If the application is complete the application is
accepted for review
Then, 180 days to review it and send the action

letter
257

At the conclusion of CDER's review of an
application, there are three possible action
letters that can be sent to the sponsor:
Not Approvable Lists the deficiencies in the application and explains why the
Letter application cannot be approved.
Approvable Letter Signals that, ultimately, the drug can be approved.

Lists minor deficiencies that can be corrected, often involves
labeling changes, and possibly requests commitment to do post-
approval studies.
Approval Letter States that the drug is approved. May follow an approvable letter,
but can also be issued directly.
258
FDA approval or denial takes place after NDA
testing
May be accepted and given a 20 year patent from
IND submission date
1 in 5 drugs reach the market!!!
259
Phases of clinical testing- Phase IV

(post-marketing phase)
After the drug is marketed
Studies are conducted to provide more information
about
Efficacy and safety
Different formulations
Dosages and duration of the tx
Drug interactions
Other types of patients studies can be studied
Detection and definition of previously unknown or
inadequately quantified adverse reactions and related risk
factors
Evaluation for a new indication
260
Phases of clinical testing- Phase IV
If a marketed drug is to be evaluated for
another (i.e. a new) indication, then those
clinical studies are considered as phase II
studies
Mainly: Post marketing surveillance

Observational
Non experimental in nature
261
Supplemental New drug Application

(sNDA)
A supplement is an application to allow a
company to make changes in a product that
already has an approved new drug application
(NDA).
To change a label (indication, side effects..)
Market a new dosage or strength of a drug
Change the way it manufactures a drug
CDER must approve all important NDA changes to

ensure the conditions originally set for the
product are still met.
262
ANDA
What is an ANDA and when it is filed?
abbreviated new drug application
It is filed when the brand product loses its patency and another
company wishes to market the drug in a generic form
The FDA does not require all studies to be re-done
Only chemical equivalency is required
Same absorption and probably the same effect!!!
Bioequivalency: same bioavailability in humans
Not necessary to have the same excepients
ANDA
Does not require safety and efficacy of studies
Does require proof of chemical equivalency to the drug previously
found
The FDA has 180 days to review and approve the ANDA
263
Orphan Drug Act (ODA)

Orphan drugs are used to treat rare diseases
The term "rare disease" means any disease
that:
Affects less than 200,000 persons in the United
States, or
Affects more than 200,000 in the United States
and for which there is no reasonable expectation
that the cost of developing and making available
in the Us a drug for such disease will be recovered
from sales in the US
264
Orphan Drug Act (ODA)
The four key incentives provided by the ODA
include:
Seven years of market exclusivity
Protocol assistance
Tax credits of up to 50% of research and
development costs
FDA fee waivers and research grants
265
Drugs Naming
All drugs in general use, rely on 3 names:
1. Generic name:
The official medical name for the basic active substance
2. Brand name:
Chosen by the manufacturer, usually on the basis that it
can be easily pronounced, recognized or remembered
3. Chemical name:
Is a chemical description
266
Drugs Naming
Example 1:
Generic: Paracetamol
Brand: Panadol
Chemical: N-acetyl-p-aminophenol
Example 2:
Generic: Zidovudine
Brand: Ritovir
Chemical: 3-azido-3-deoxythymidine
267
Section II
Pharmacy Practice
4. Legal classification of drugs

(American pharmacy)
268
Definitions
Addiction: obsession or excessive dependence
Physical
Showed by withdrawal symptoms
Mental/psychological
Showed by craving
Tolerance
Higher doses needed to give the same effect
Withdrawal symptoms
When the drug or substance on which someone is
dependent is suddenly removed
269
Legal Classification
Drugs upon which a person may become
dependent
Drugs range from mild stimulants to powerful
agents that alter mood and behavior
Some addictive drugs have no medical use and
can not obtained legally
Cocaine, heroin
270
Drug Schedules
Schedule I
Schedule II
Schedule III
Schedule IV
Schedule V
271
Drug Schedules
# Specifications Examples
High potential for abuse Some opiates:
Have no current accepted medical use and 9Acetylmethadol
treatment 9Alphamethadol
Lack on safety information even under medical 9Trimeperidine
I supervision 9Heroin
9Morphine-N-
All drugs in this group are prohibited oxide
Illegal users 9Marijuana?! (in
DC and CA its II)
High potential for abuse 9Codeine
Have accepted medical use but are subjects to 9Morphine
full controlled drug requirements 9Meperidine
II Abuse of these drug s may lead to severe 9Opium
physical and psychological dependence 9Amphetamine
Need prescription 9Methylphenidate
(Ritalin) 272
Drug Schedules
Potential for abuse but lower than drugs in 9Codeine: but

schedules I & II maximum 1.8 g/100
Have an accepted medical use ml or 90 mg/dosage
Abuse of these drug s may lead to moderate or unit
low physical dependence and high 9Morphine: But
III psychological dependence maximum 50 mg/100
Can be refill again ml (or per 100 mg)
Need prescription
Barbiturates
Anabolic steroids
273
Drug Schedules
Low potential for abuse than schedule III 9Chlorohydrate (Bebecal)
Have a medical use
9Zolpidem (Stilnox)
Less physical and psychological
dependence than schedule III 9Benzodiazepines
IV Need prescription Lorazepam (Ativan)
Abuse may lead to low physical or low diazepam (Valium)
psychological dependence Bromazepam (Lexotanil)
Alprazolam (Xanax)
Low potential for abuse and Less Codeine in the cough
dependence than schedule IV products (maximum 200
Used as treatment mg/100 ml or /100 mg)
V Preparations containing small amount of
narcotics
Abuse may lead to limited physical or
psychological dependence
274
What is drug abuse
Any use of the drugs that cause physical ,
psychological ,economic , legal or social harm
to the user, or to persons who may be affected
by the users behavior
Taking drugs obtained illegally
Misuse of drugs generally obtainable through
a doctors prescription only
Drugs may be re-scheduled
Ex: claritine became OTC
275
The abuse of the prescription drugs

include:
The personal use of drugs left over from
previous course of treatment
The sharing with others
Stealing the drugs from pharmacies
Intentional deception of doctors
Forgery of prescription
276
Common drugs of abuse
Sedation
Alcohol
Morphine
Heroin (is converted to morphine in the body)
Marijuana
Benzodiazepines
Excitation
Cocaine
Caffeine
Ephedrine
Nicotine
277
Section II
Pharmacy Practice
5. Pharmaceutical preparations.
Introduction to Drug Dosage
forms
278
Drug dosage forms
Most drugs are prepared in forms designed for
convenience of administration
This helps to ensure

Accuracy of dosages
Patient compliance (by making medicine intake as
easy as possible)
279
Drug dosage forms

Active Ingredient(s)
Therapeutic substance
Inactive ingredients (excepients, inert, adds,
pharmaceutical adjuncts) (the chemicals with
no therapeutic effect) are sometimes added
to:
Flavor
Color
Improve chemical stability (to extend the period
during which the medicine is effective)
280
Drug dosage forms
Most common dosage forms
1. Tablet
2. Capsule
3. Liquids
4. Topical preparations
5. Inhalers
6. Parenterals
281
1. Tablets
Drug compressed in a solid form, often round
in shape
282
1. Tablets
Many excepients are added before compression
Diluents (bulking agents): dissolve the drug, and add
bulk or weight if necessary
Fillers: add bulk when needed
Granulating agents & binders: allow the ingredients to
bind together to form the tablet
Lubricating agents: help the chemicals to slide easily
and not to stick on manufacturing machines
Disintegrating agents: used to dissolve medication and
medication release the drug. They highly absorb water
283
Disintegrating agents
Lubricants Ex: Cocoa butter,
Mg stearate ,purified talk, corn starch starch , veegum
(help the chemicals to slide easily and sodium bicarbonate
not to stick on manufacturing machines) (used to dissolve medication release the drug.
They highly absorb water)
Drug
Binders
Ex : acacia
gelatin
glucose
Diluents sucrose
Ex : sucrose , lactose, (allow the ingredients
sodium chloride, mannitol to bind together to
(dissolve the drug, form the tablet)
and add bulk if necessary)
Granulating agents
Ex: alcohol , gum , water, starch paste
(allow the ingredients to bind together to
form the tablet)
284
1. Tablets
The proportion or amount of each ingredient
varies from one drug tablet to another
Sustained/extended/prolonged release tablets
The active ingredient is released slowly into the body
after the tablet is swallowed
Prolonged action
Fast/immediate release
The active ingredient is released immediately into the
body after the tablet is swallowed
Fast action
Panadol Actifast
285
2. Capsules
The drug is contained in a cylindrical gelatin cover that
breaks and open after the capsule has been swallowed =>
releasing the drug
Slow-release capsule
Contains small granules(pellets) (containing the drug) that
dissolves in GI tract gradually release the drug slowly
Necessary when theres need to release drug in small amounts
into the body
Increase compliance
Example: Gastrimut
Beneficial when it is inconvenient for the patient to visit the
physician on a regular basis to receive treatment by
injection
Applies for all oral dosage forms
286
2. Capsules
287
Gel Cap
Fast/immediate release
Fast action
Advil gel
288
Caplet
A coated, oval
shaped medicinal
tablet in the shape
of a capsule
Easy-to-swallow
alternative to regular
big-size tablets
Example: Tylenol
289
3. Liquids
Active ingredient is combined
With:
Solvents
Preservatives
Flavoring agents
children
Coloring agents
In a:
Solution
Suspension
Emulsion
Elixir
Syrup
290
3. Liquids
Liquid Description
Solution Usually, a drug is dissolved in water => homogenous liquid,
clear appearance
Suspension Heterogeneous fluid containing solid particles that are
sufficiently large for sedimentation
Shake well before use (to re-disperse the particles
homogenously in the fluid)
Emulsion A mixture of two or more immiscible (unblendable)

-Oil in H2O Liquids (usually water and oils) in which the drug is suspended
-H2O in Oil An emulsifying agent is often added to stabilize the product
Elixir Solution of drug in a sweetened mixture of water and alcohol
It is usually highly flavored (cherry elixir)
Syrup Concentrated solution of sugar containing the active ingredient

and flavoring and stabilizing agents are added
291
Intended for application on:
Skin
Other surface tissues: eye, ear, anus, vagina
Local effect
Drug applied on the site of injury or disease
292
Preparation Description
Cream Non-greasy preparation
Cool and moisten the skin
In general: oil in water emulsion
Ointment Greasy preparation

Act as protector or lubricant to skin => relief of very dry skin conditions
Gels Cross linking within the fluid particles

Ranging from soft and weak to hard and tough
Lotion Emulsions (Oil-in water or water-in-oil)

Less sticky then creams ad ointments => suitable for hairy &/or large areas
To cool and dry the affected area
Suppositories Solid-bullet-shaped drug forms
Rectal (constipation, glycerin suppo) (or can be absorbed into blood for
systemic effect, like hyperthermia)
Vaginal (local fungal infections)
Dissolve at body T => release the drug
Excepient is usually cocoa butter or another type of vegetable oil 293
Sometimes drug cannot be given orally
The drug itself is destroyed by the acid in GI
The drug can cause severe GI side effect (pain,

nausea, vomiting)
The patients cannot tolerate po (N/V)

NPO
294
5. Inhalers
Aerosol inhalers contain a solution or a
suspension of a drug under pressure => when
valve opens release of drug
295
Use of an inhaler:
Use of an inhaler
Press the device while you breath in slowly
Continue to breath in slowly and deeply
Hold your breath for up to 10 seconds
Breath out slowly
296
5. Inhalers
Sometimes a mouthpiece is fixed to the device
to facilitate inhalation of the drug as it is
released from the canister
297
5. Inhalers
Diskhaler Inhaler
Serevent diskus Ventolin
298
6. Parenterals
Dosage forms intended to deliver the drug to the blood
circulation as fast as possible and bypass the GI tract
Are solutions
Sterile (microbe-free) preparations: solution or suspension
Packed in a sterile disposable vial or syringe
Reduce the chance of contamination
Injected into the body => systemic effect (most of times)
Injected for local effect: e.g. corticosteroids bone injections for
arthritis, teeth, delivery
299
6. Parenterals
Reasons for injecting drugs
Need of a rapid action
Patient cannot tolerate po
Drug destroyed by stomach acid (insulin) or liver
enzymes
Drug cannot pass through the GI wall into blood
stream
300
6. Parenterals
main types of injections
Intravenous (IV)
Injected directly in the vein (i.e. directly into blood
stream)
The fastest way of drug delivery to the blood stream
301
6. Parenterals
main types of injections
Intramuscular (IM)
Injected into muscles:
thigh, upper arm or buttock
Usually painful
302
6. Parenterals
main types
of injections
Subcutaneous
(SC or SQ)
Injected under
the surface of
the skin
Rotate site of
injection
Insulin
303
SC pre-filled syringe
304
SC injection pen
305
SC injection pen
Epipen
Anaphylactic reactions
306
SC injection pen
307
6. Parenterals
Depot: slow and

gradual release to the
blood
308
Section II
Pharmacy Practice
6. Major drug groups and

families
309
Major drug classes

1. Analgesics 8. Anti-anxiety drugs
2. Antipsychotics 9. Antihistamines
3. Anticonvulsants 10. Antibiotics
4. Antiparkinson 11. Antifungals
5. Anti-emetics 12. Bronchodilators
6. Cardiovascular drugs 13. Muscle relaxants
7. Gastro-intestinal 14. Sleeping drugs
15. Vitamins
310
1. Analgesics
A. Narcotics
- Opioids
Drugs used to relieve
pain
B. Non Narcotics
1. Aspirin
2. Paracetamol
3. Non-steroidal anti-inflammatory drugs (NSAIDs)
311
1. Analgesics
A. Narcotics
They are called opioids
Related to opium (extract of poppy seed)
They act directly on several sites in the CNS involved in pain
perception and block the transmission of pain signals
Act directly on the parts of the brain where pain is perceived
Narcotics are the most effective analgesics and are used to treat
severe pain:
surgery
serious injury & diseases
Cancer pain
Are particularly valuable for alleviating severe pain during
terminal illnesses (end-stage cancer, HIV, bone diseases)
312
Pain
Pain signals
Substance P
313
1. Analgesics
A. Narcotics (Contd)
Example
Morphine
Codeine found in solpadeine in combination with
acetaminophen and caffeine
Di-antalvic and algophene
Codeine + acetaminophen
Previousely Dextropropoxyphene + acetaminophen
Dextropropoxyphene Withdrawn from the market
Tramadol: Tramal, and found in Zaldiar in combo with
acetamonophen
Meperidine: Dolosal
314
315
Pain is present but does not

limit activities
Can do most activities with

rest periods
Unable to do SOME activities

because of pain
Unable to do MOST activities

because of pain
Unable to do ANY activities

because of pain 316
1. Analgesics
B. Non narcotic analgesics
1. Aspirin
Relieves pain (analgesic) & reduces fever (antipyretic)
Also reduces Inflammation (anti-inflammatory)
It blocks the production of chemicals called
prostaglandins (that increase inflammation, swelling &
pain at injured site), in both the brain (CNS) and the
rest of the body (periphery)
It is used to treat HA , toothache, joint pain (in
rheumatoid)
It helps to prevent abnormal clotting of the blood (anti-
platelet)
317
1. Analgesics
2. Paracetamol
Acts directly on the brain and spinal cord to decrease the
perception (or sensitivity or awareness) of pain
Acts by reducing the production of prostaglandin in the brain
only BUT unlike aspirin , it does not affect prostaglandin
production in the rest of the body => it does not reduce
inflammation
Antipyretic
Analgesic
Used for everyday pains
HA
Toothache
Joint pains
318
1. Analgesics
3. Non steroidal anti-inflammatory drugs (NSAIDs)
Can relieve pain, inflammation, and fever
Are related to aspirin
They block the production of PG in both CNS and periphery
Used to treat muscle & joint pain & menstrual period pain
Examples:
Ibuprofen (Brufen , Advil)
Ketoprofen (Profenid)
Mefenamic acid (Postan forte)
Diclofenac (Voltaren, cataflam)
319
2. Antipsychotic drugs
Psychosis
A term used to describe mental disorders that prevent
the sufferer from thinking clearly, recognizing reality
and acting rationally
Disorganized and bizarre thinking
Hypo/hyperactivity
Hostility
Social withdrawal
Confused speech..
Schizophrenia, bipolar disease
Common drugs
New generation
Risperidone (risperidal)
Quetiapine (seroquel)
Haloperidol (haldol)
320
3. Anticonvulsant drugs
Normally:
Electrical signal from the nerve cells in the brain are delicately
coordinated to produce smooth movements of arms & legs
Seizure patient
These signals can become chaotic and cause disordered
muscular activity & mental changes
Seizure
is a sudden, abnormal, excessive electrical discharge from the
neurons of the brain
Anticonvulsants suppress the rapid firing of neurons in the

nervous system (brain). Also known as Anti-epileptic drugs
and Anti-Seizure drugs
321
Seizure/epilepsy/convulsions
322
3. Anticonvulsant drugs- examples
1st (old) generation 2nd (new) generation
Phenobarbital (gardenal) Topiramate (topamax)

Phenytoin (epanutin) Levetiracetam (keppra)
Carbamazepine (tegretol) Gabapentin (neurontin)
Valproic acid (depakene) Lamotrigine (lamictal)
323
4. Antiparkinson Drugs
Parkinsonism
The general term used to describe the:
Shaking of the head+ limbs (tremor)
Stiffness or rigidity
Expressionless face
Inability to control or initiate movement
324
Parkinsonism
It is cause by an imbalance between the chemicals
dopamine and acetylcholine in the brain
These chemicals are responsible for coordinating

movements (along with other functions)
Dopamine decrease movement and is low in Parkinson
Acetylcholine increase movement and is high in
Parkinson
325
Typical Parkinson
patients
Resting tremor
326
Examples
Levodopa (sinemet)
Amantadine (symmetrel)
Bromocriptine (parlodel)
Benzhexol
327
5. Anti-emetics
Are drugs used to suppress nausea and
vomiting
What is Vomiting (emesis) ?

Is a reflex action for expelling harmful substances
It may also be a symptom of disease :
Example : GI diseases , Pregnancy ,Motion sickness
Or it may a side effect of drugs
Examples: anticancer drugs
328
5. Anti-emetics
Common anti-emetic drugs
Metoclopramide (primperan, reglan)
Domperidone (motilium)
Antihistamine (histamine 1 receptor blockers)
Promethazine (Phenergan)
Dimenhydrinate (gravol , dramamin)(also for motion sickness)
Hydroxyzine (Atarax)
Steroids
Dexamethasone (decadron)
Anti-emetics for cancer
Serotonin antagonists Mostly for
Ondansetron (Zofran) cancer
Granisetron (Kytril) patients
Aprepitant (emend) (also for post-op nausea)
329
6. Cardiovascular drugs
Since those suffering from cardiovascular
problems suffers from more than one problem,
several drugs may be prescribed:
1. Vasodilators
2. Vasoconstrictors
3. Diuretics
4. Beta blockers
5. Calcium channel blockers
6. Anti-arrhythmics
7. Digitalis drugs
8. Angiotensin converting enzyme-inhibitors (ACE-I)
and Angiotensin II receptor blockers (ARBs)
9. Combination products
330
1. Vasodilators
Dilate the blood vessel to improve blood flow
and reduce blood pressure
Nitrates: nitroglycerine, Isosorbide
331
2. Vasoconstrictors
Constrict blood vessels: narrows BV diameter =>
increase blood pressure
Example:
Epinephrine
332
3. Diuretics
Increase the bodys excretion of water
Example: furosemide (Lasix) , Hydrochlorothiazide (Esidrex)
4. Beta blockers
Decrease heart rate and contractility; cause blood vessel
dilation
Bisoprolol (concor)
Propranolol (inderal)
Also for migraine headache prevention (its lipophilic)
5. Calcium channel blockers (CCBs)

Cause blood vessels dilation, and decrease cardiac
contractility
Verapamil, diltiazem, amlodipine (amlor)
333
6. Anti-arrhythmics
Arrhythmia: Abnormal cardiac function and
contraction due to abnormalities in:
Heart rate (tachycardia or bradycardia)
Problem in heart muscles contraction
&/or
Rhythm leading
Problem in the electrical impulse generation &/or conduction
in heart
Disturbed electrical signals in the heart muscles
Treatment
Beta blockers repair normal heart rate
Bisoprolol
Anti-arrhythmics repair normal heart rhythm
Example: Amiodarone (cordarone)
334
7. Digitalis drugs
Increase cardiac contractility and is used in heart
failure
Also used for arrhythmia (because in decrease
impulse conduction)
Example: Digoxin (lanoxin)
335
8. Angiotensin converting enzyme-inhibitors
(ACE-I) and Angiotensin II receptor blockers
(ARBs)
Stop formation of angiotensin II in the kidney
(angiotensin II cause severe vasoconstriction)
Example of ACE-I: Captopril (capoten)
Example of ARBs: Losartan (Cozaar)
336
9. Combination products
Different mechanism of action
Captace: Captopril + HCTZ
Co-Diovan: Valsartan + HCTZ
Cozaar Copm: Losartan + HCTZ
Concor PLUS: Bisoprolol + HCTZ
337
7. Gastrointestinal drugs
1. Antacids
Neutralize acid => relieve heartburn and pain
Maalox, diovol, chooze, rennie
2. Anti-ulcer
Relieve symptoms
Heal the ulcer by:
Reducing the amount of acid released
PPI (or proton pump inhibitor) : Omeprazole (gastrimut),
Rabeprazole (Pariet), Esomeprazole (Nexium), Lanzoprazole
(Lanzor)
H2 blockers (or Histamine 2 receptor blockers): Ranitidine
(zantac)
Or forming a protective coating layer over the ulcer
Sucralfate
338
7. Gastrointestinal drugs
3. Antidiarrheal drugs
Diarrhea :an increase in the fluidity and frequency of bowel
movements
Loperamide (Imodium)
Diphenoxylate + atropine (lomotil)
4. Laxatives
Drugs used to relieve constipation (When the bowel does not
move as frequently as usual)
Bulk forming: Psyllium, fibers
Osmotic laxatives: Lactulose (duphalac)
Glycerin suppositories
Mineral oil
Stool softeners: Docusate sodium (colace)
Stimulant: Bisacodyl (dulcolax), Senna (prunasine), mucinum
Dependence, rebound constipation, used for limited time
alfa clyss, fleet enema
Mainly before surgeries or endoscopies/colonoscopies
339
8. Anti-anxiety
Anxiety: arises when the balance between
certain chemicals in the brain is disturbed
Used to alleviate persistent feeling of
nervousness & tension caused by stress or
other psychological problems
2 main classes
Benzodiazepines
Work on the brain chemicals
Promote relaxation
Diazepam (valium) , alprazolam (xanax),lorazepam
(ativan), bromazepam (lexotanil)
Beta blockers
Used to reduce physical symptoms of anxiety such as
shaking & palpitations (propranolol)
340
9. Antihistamine
Histamine is the 1st chemical released in
inflammatory responses
Anti-hitamines Used to treat allergic reactions
Block histamine type 1
Common drugs
1st (old generation) 2nd (new generation)
Hydroxyzine (Atarax) Cetirizine (Zyrtec)
Promethazine (Phenergan) Desloratidine (Aerius)
Fexofenadine (Telfast)
Loratidine (Claritine)
341
10. Antibiotics
These drugs are usually both safe and effective in
the treatment of bacterial disorders ranging from
minor infections (ear, throat, urine) to life
threatening diseases (blood, liver, sepsis)
Common classes/dugs
Penicillins
Amoxicillin (ospamox, amoxil)
Amoxicillin/clavulanic acid (augmentin, amoclan.)
Cephalosporin
Cefuroxime (Zinnat)
Cefpodoxime (Orelox)
342
10. Antibiotics
Common classes/drugs
Macrolides
Azithromycin (zithromax)
Erythromycin
Topical for acne
Aminoglycosides
Gentamycin
Tetracyclin
Doxcycline (vibramycin, granudoxy)
Oral for acne
343
10. Antibiotics
Common classes/drugs
Fluoroquinoles
Ofloxacin (tarivid)
Levofloxacin (tavanic)
Ciprofloxacin (ciprobay, estecina)
Norfloxacin (uroctal, noroxin)
Sulfonamides
Sulfamethoxazole/trimethoprim (bactrim)
Metronidazole (flagyl, supplin)
344
11. Antifungals
Terbinafine (lamisil)
Fluconazole (diflucan, flunazol, loitin,
myxen)
Itraconazole (sporanox, fonginox)
345
11. Antifungals
Topical
Clotrimazole (lotriderm)
Miconazole (daktarin) cream or oral gel
346
12. Bronchodilators
Are used to widen

the bronchioles
and improve
breathing
(Asthma, COPD)
347
12. Bronchodilators
Examples
Albuterol (= salbutamol) (ventoline)
SABA
Salmeterol (serevent)
LABA
Fluticasone (flixotide) (corticosteroids)
Theophylline (asmaphylline)
Some bronchodilators are combined with
corticosteroids
Seretide: Salmeterol + Fluticasone
348
13. Muscle relaxants
Used to treat
Muscle spasm
Involuntary painful contraction of a muscle
Stiffening of an arm or leg or back muscle
Common drugs that are used to treat muscle

spasm
Cyclobenzaprine (flexiban)
Orphenadrine (norflex)
Orphenadrine + acetaminophen (muscerol, norgesic)
349
14. Sleeping drugs (for insomnia)
For difficulty falling asleep or staying asleep
Causes:
Psychological problems: anxiety or depression
Pain & discomfort from a physical disorder
350
14. Sleeping drugs (for insomnia)
Types of drugs used
Benzodiazepines
Most commonly used
Barbiturates
Now rarely used high risks of abuse & dependence
Zolpidem (Stilnox)
Non-BZD hypnotics. Works on BZD receptors
Antihistamine
Used to treat allergic symptoms
1st generation antihistamines cause drowsiness and
sedation as a side effect used to promote sleeping
351
Generic Drug Suffix Chart

Suffix Drug Class
STATIN CHOLESTEROL
(HMG CoA Reductase Inhibitor)
RAZOLE PROTON PUMP INHIBITOR
SARTAN ARB (Angiotensin 2 receptor blocker)

PAM BENZODIAZEPINES
OLOL BETA BLOCKER
PRIL ACE INHIBITOR (Angiotensin Converting Enzyme)
CILLIN PENICILLIN ANTIBIOTICS
FLOXACIN FLUOROQUINOLONE ANTIBIOTICS
CYCLINE TETRACYCLINE ANTIBIOTICS
VIR ANTI-VIRAL
352
Major Drug Groups
Fill in the Empty Cells
DRUG CLASS INDICATION EXAMPLES
Analgesics Aspirin
Paracetamol (Panadol)
Ibuprofen (Advil)
Diclofenac (Voltaren)
Codeine
Morphine
Antipsychotics Schizophrenia
Bipolar Disorders
Prevent or reduce seizures Phenobarbital (Gardenal)

Phenytoin (Epanutin)
Valproic Acid (Depakene)
Gabapentin (Neurontin)
Topiramate (Topamax)
353
Major Drug Groups

Anti-emetics Suppress nausea and vomiting Metoclopramide (Primperan)
Domperidone (Motilium)
Dimenhydrinate (Gravol)
Dexamethasone (Decadron)
Ondansetron (Zofran)
Aprepitant (Emend)
Cardiovascular Treat cardiovascular conditions
Drugs (Angina, Arrhythmia,
Hypertension, MI, CHF)
Gastrointestinal Treat GI conditions

Drugs (Heartburn, GERD,
Peptic/Duodenal ulcers,
Diarrhea, Constipation)
354
Major Drug Groups
Alleviate persistent tension, Diazepam (Valium)
nervousness and symptoms of Bromazepam (Lexotanil)
acute anxiety Propranolol (Inderal)
Fluoxetine (Prozac)
Antihistamines Treat allergic reactions
(allergic rhinitis, urticaria,
allergic conjunctivitis, hay
fever, insect bites) and prevent
motion sickness
Antibiotics Amoxicillin/clavulanic acid

(Augmentin)
Cefuroxime (Zinnat)
Azithromycin (Zithromax)
Doxycylcine (Granudoxy)
Ciprofloxacin (Ciprobay)
Mitronidazole (Flagyl)
355
Major Drug Groups

Antifungals Treat fungal infections
(Athletes foot, Tinea,
Candidiasis)
Bronchodilators Widen bronchioles and

improve breathing (Asthma,
COPD)
Orphenadrine (Muscerol)
Baclofen (Lioresal)
Dantrolene (Dantrium)
Tizanidine (Zanaflex)
Cyclobenzaprine (Flexeril)
Help in falling or staying Alprazolam (Xanax)
asleep Secobarbital (Seconal)
Zolpidem (Stilnox)
Eszopiclone (Inductal)
356
15. Vitamins
A compound is called a vitamin when it cannot be
synthesized in sufficient quantities by an organism,
and must be obtained from the diet
Vitamins should not be used as a substitute for a
balanced diet
Used in combination with a healthy diet
In humans there are 13 vitamins
Vitamins are classified in 2 categories
1. Water soluble (hydrophilic/lipophobic):
9 vitamins: 8 B vitamins and vitamin C
2. Fat soluble (lipophilic/hydrophobic):
4 vitamins: A, D, E and K
357
15. Vitamins
Fat soluble
are absorbed through the intestinal tract with the help of
lipids (fats)
The body stores them in the liver and fat tissues when not
used, and eliminate them much slowly => does not need
daily supplements
Foods that contain these vitamins will not lose them when
cooked
Water soluble
Dissolves easily in water
Are excreted in urine
Because they are not stored in body => consistent daily
intake is important
358
15. Vitamins
Fat soluble
Vitamin A (Retinol)
Vitamin D (Calciferol)
Vitamin E (Tocopherol)
Vitamin K (Phylloquinone)
Water soluble
Vitamin C (Ascorbic acid)
Vitamin B1 (Thiamine)
Vitamin B2 (Riboflavin)
Vitamin B12 (Cyanocobalamin)
Vitamin B5 (Pantothenic acid)
Vitamin B7 (Biotin)
Vitamin B6 (Pyridoxine)
Vitamin B3 (Niacin)
Vitamin B9 (Folic acid)
359
Discovery of vitamins
Year of discovery Vitamin
1909 Vitamin A (Retinol)
1912 Vitamin B1 (Thiamine)
1912 Vitamin C (Ascorbic acid)
1918 Vitamin D (Calciferol)
1920 Vitamin B2 (Riboflavin)
1922 Vitamin E (Tocopherol)
1926 Vitamin B12 (Cyanocobalamin)
1929 Vitamin K (Phylloquinone)
1931 Vitamin B5 (Pantothenic acid)
1931 Vitamin B7 (Biotin)
1934 Vitamin B6 (Pyridoxine)
1936 Vitamin B3 (Niacin)
1941 Vitamin B9 (Folic acid)
360
Vitamins use and food sources
Vitamin What the vitamin does Significant food sources
spinach, green peas, tomato
Supports energy
juice, watermelon,
B1 (thiamin) metabolism and nerve
sunflower seeds, lean ham,
function
lean pork chops, soy milk
Supports energy spinach, broccoli,
B2 (riboflavin) metabolism, normal vision mushrooms, eggs, milk,
and skin health liver, oysters, clams
spinach, potatoes, tomato
Supports energy
juice, lean ground beef,
metabolism, skin health,
B3 (niacin) chicken breast, tuna
nervous system and
(canned in water), liver,
digestive system
shrimp
Energy metabolism, fat widespread in foods
synthesis, amino acid
B7 (Biotin)
metabolism, glycogen
synthesis
361

Supports energy widespread in foods
B5 (Pantothenic Acid)
metabolism
bananas, watermelon,
Amino acid and fatty acid tomato juice, broccoli,
B6 (pyridoxine) metabolism, red blood cell spinach, acorn squash,
production potatoes, white rice, chicken
breast
Used in new cell synthesis, meats, poultry, fish,
helps break down fatty acids shellfish, milk, eggs
B12 (Cyanocobalamin)
and amino acids, supports
nerve cell maintenance
spinach, broccoli, red bell
Collagen synthesis, amino
peppers, snow peas, tomato
acid metabolism, helps iron
C (ascorbic acid) juice, kiwi, mango, orange,
absorption, immunity,
grapefruit juice,
antioxidant
strawberries
362
mango, broccoli, butternut
Supports vision, skin, bone
squash, carrots, tomato
A (retinol) and tooth growth, immunity
juice, sweet potatoes,
and reproduction
pumpkin, beef liver
self-synthesis via sunlight,
Promotes bone
D fortified milk, egg yolk, liver,
mineralization
fatty fish
polyunsaturated plant oils
Antioxidant, regulation of
(soybean, corn and canola
oxidation reactions,
E oils), wheat germ, sunflower
supports cell membrane
seeds, tofu, avocado, sweet
stabilization
potatoes, shrimp, cod
Synthesis of blood-clotting Brussels sprouts, leafy green
K proteins, regulates blood vegetables, spinach,
calcium broccoli, cabbage, liver
363
364
Food pyramid
365
Pharmacy History, Practice

And Ethics
PHAR 250
Spring 2013-2014
366
Section III
Pharmacy Ethics
367
Why Ethics?
368
Ethics
Socrates : 2000 years ago
Searched to construct ethical guides for civilization
Approached ethics as science: governed by universal
force (what applies to one, applies to all)
Situational ethics
Life events are not precisely repetitive
Different situations different analysis different
decisions
No ethical principles, no matter how well
constructed, can provide guidance to all
situations
369
Ethics
Profession
Existence of rules and standards governing the conduct of
the members of that profession
This distinguish it from occupation
Rules to which we must all submit are divided in 2

categories
1. Rules provided by law or official regulations set by
pharmacy
9 Legislative rules => vary from country to another or from period
to period
9 OPL, MOH
2. Rules of natural law (ethics)
9 Eternal
9 Depend on conscience only
370
Why pharmacy is considered a
profession?
Characteristics of a profession
1. Specialized knowledge and social utility
2. Attitudes and professional behavior
3. Social sanction
4. Desire to be a professional
371
Professional characteristics
1. Specialized knowledge and social utility
To serve society, one needs
Knowledge (by Education)
Experience (which leads to more knowledge)
Profession of pharmacy
Is NOT filling prescription only
Is knowledge about drug that allows
To advise patients about the drug
Detect DDI
Make professional judgments
372
2. Attitudes and professional behavior
Attitudes influence behavior
Basic attitude: Altruism
Unselfish concern for the welfare of others
The professional man does not work to be paid, but is
paid for his work
Every decision should be based on what is right, and
not on what is more profitable
Professional pharmacist
Concerned about health of patients
Uses highly specialized technical knowledge that the
patient does not possess
Might cause patients to be exploited!!
373
3. Social approval
Social approval
Society should view the occupation as a profession
To do that
License powered by law
Protects the public from misconduct or mistakes in
profession
Create trust between public and professionals
Society rewards
Status
Income
Power 374
4. Desire to be a professional
Several motivations:
1. Desire to serve a highly useful function in society
2. Higher incomes
Why professionals have higher incomes than occupation
practitioners?
9 Attracts the professional to his profession
9 Prevent exploitation of patients
3. Desire for power

Authoritative power over the patient
9 Pharmacist dictates what is good/beneficial for the patient and
what is bad/harmful
9 Patient has no choice but to accept the professional judgment 375
Is pharmacy a profession??
Knowledge
Experience
Serves public
Interested in patients health
Desire to serve
Commercial and retail element!!!!???
376
Rights and Duties in the Practice of
Pharmacy Profession
Patient Rights/Pharmacists Responsibilities
Patients have the right to expect their pharmacist to:
1. Be professionally competent . . . .
2. Treat them with dignity . . . .
3. Act in their best interest . . . .
4. Serve as their advocate . . . .
5. Maintain their medical records, keeping them confidential . . . .
6. Provide counseling . . . .
7. Have their prescriptions dispensed at a pharmacy of their choice
....
8. Monitor drug therapy . . . for safety and efficacy . . . .
9. Monitor their compliance and proper drug use . . . .
377
Rights and Duties in the Practice of

Pharmacy Profession
Patient Responsibilities/Pharmacists Rights
Patients are responsible for:
1. Providing personal demographics, medical history,
and payment mechanism . . . .
2. Implementing the drug therapy program
conscientiously and reporting their clinical responses
....
3. Cooperating with the pharmacist and authorizing
[the release of] medical information necessary for
the pharmacist to practice responsibly.
378
Ethical principles
Guide for pharmacist-patient relationship
1. Nonmaleficence
2. Beneficence
3. Autonomy
4. Informed consent
5. Trust
6. Confidentiality
7. Fidelity
8. Veracity
9. Privacy
379
1. Nonmaleficence
Forms the basis of the Hippocratic Oath
Famous statement: First, Do No Harm
Health care practitioners display nonmaleficence when

they act to prevent, or at least not inflict, evil or harm
to their patients.
In protecting others from harm, one may be faced with

complications:
What counts as harm?
Are there some risks worth taking?
Can lead to undue interference in patients lives
380
2. Beneficence
A moral obligation on the part of healthcare
professionals to actively do what will provide
benefit to their patients
Higher form of nonmaleficence
Like nonmaleficence, it has complications:

What counts as a benefit?
What if the attempt to confer benefit exposes patient
to risk?
Which risks are worth taking for which benefits?
381
3. Autonomy
Definition
Independency, self-chosen plan
Right for
Individual liberty
Freedom of choice, action and thoughts
In health-care, autonomy is:
The right of patients to make decisions about what
will happen to their body, what to take and what
not to take (the choice to refuse to take
medication)
Pharmacists must respect this right
382
3. Autonomy
Limitations: It fails when:
It does harm to self
It does harm to others
Patient has
Acute disease
Depression
Ignorance in the situation or illness or medicine
Discuss with the patient about the disease, drug, side effects
Will it help him make the correct decision, or will scare him and
distract him and block his thinking???
When patient willingly signs an informed consent without
reading it
Psychiatric patients with mental disorders
Decisions affected by religion, society, culture
383
4. Informed consent
Patients have a right to be
Fully informed about the benefits and risks of:
Their participation in a clinical trial
Taking a medicine
When the pharmacist counsels a patient about the risks and benefits of a
medication
he/she is obtaining an informed consent from the patient before
medical use
Choosing to have surgery
Asked for their consent/Approval
Denial of this right will be unprofessional and unethical
Protects people from manipulation and abuse during
research process
In the case of clinical research, ethics is reviewed by the
institutional review board (IRB) 384
5. Trust
Patient trust Professional
Buyer no trust Seller
Characteristics of a trustworthy pharmacist
1. Covenant
Agreement/contract/promise exchanged between the 2 parties
9 Pharmacist promises knowledge and skills
9 Patient offers the professional authority
2. Ideal of service
Safety and health of patients come first
Profit comes second
3. Conflict of interest
Pharmacist dispensing an expensive medicine to benefit his own
pocket V/S dispensing a cheaper same efficacy drug
385
6. Confidentiality
Pharmacist must keep information from
others
Unless the patient gives permission to release it
Medical confidentiality is not something to ask

permission for from the patient
ALL medical information is considered confidential
One exception
When it causes harm to others
386
7. Fidelity
Acting in a way to demonstrate loyalty & faithfulness to
patients
To keep the promise to act in the patient's best interest

is to practice fidelity in the pharmacistpatient
relationship
Two of the most important duties associated with the

principle of fidelity are veracity and confidentiality
This creates a bond between pharmacists and patients
387
8. Veracity
In the simplest terms, veracity is the duty to tell the truth
and not to lie or deceive others
Ethical principle that instructs pharmacists to be honest in

dealing with patients
Does the duty of veracity require pharmacists to tell their

patients :
The truth, the whole truth, and nothing but the truth, or
Only part of the truth, or
Just that portion of the truth that the patients canor should
"understand"?
The answer to these questions often is, "It depends."
388
8. Veracity
Placebo therapy is a case in point:
Physicians may choose to treat their patients with an
inert substance or with subtherapeutic doses of active
agents in order to prompt a nonpharmacologic
response.
In so doing, these physicians unwittingly deceive their
patients to achieve a greater good.
Unless pharmacists are aware of the physicians'
therapeutic intent in prescribing placebos, they may
inadvertently undermine this therapy by responding
frankly and truthfully to patients' questions about the
effectiveness of their medication
389
9. Privacy
Provide privacy to patients
To feel comfortable discussing his problems with
pharmacist
Separate room in the pharmacy
390
Ethical codes
First described by Hippocrates in the 4th
century BC
1. APhA code of Ethics

2. Oath of pharmacist
391
1. APhA code of Ethics (1994)

A pharmacist:
Respects the covenantal (based on agreement and promise)
relationship between the patient and pharmacist
Promotes the good of every patient in a caring, compassionate, and
confidential way
Respects the autonomy and dignity of each patient
Acts with honesty and integrity in professional relationships
Maintains professional skills
Respects the values and abilities of colleagues and other health
professionals
Serves individual, community, and societal needs
Seeks justice in the distribution of health resources 392
2. Oath of pharmacist
By the American Association of College of
Pharmacy (AACP)
At this time, I vow to devote my professional life to the service of all
humankind through the profession of pharmacy
I will consider the welfare of humanity and relief of human suffering my
primary concerns
I will apply my knowledge, experience, and skills to the best of my ability
to assure optimal drug therapy outcomes for the patients I serve
I will keep abreast (updated) of developments and maintain professional
competency in my profession of pharmacy. I will maintain the highest
principles of moral, ethical and legal conduct
I will embrace and advocate change in the profession of pharmacy that
improves patient care
I take these vows voluntarily with the full realization of the responsibility
with which I am entrusted by the public
393
Ethical Dilemmas
394
Dilemma!! What is it?
An ethical dilemma is typically described as a
complex situation that involves a conflict
between different morals or ethical principles.
Eg: Autonomy Vs Beneficence
Ethical dilemmas are commonly found in

medical field.
395
Solving a dilemma
First most critical step: understanding the facts
ALL parties understand the facts of the specific case or dilemma
Misunderstanding lead to misinterpretation
Each party identifies the moral rule under which he
believes the case should be solved
Confidentially rule
Consent rule
Controversy still exists
Example:
Patient has the right to be informed on the risks of medications ALL
V/S THE TIME
Patient has the that right EXCEPT when it might upset him and make
him refuse to take the drug
396
Solving a dilemma
Refer to some ethical theories
Consequentialism
Moral value of an action is determined by its outcome
The ends justify the means
Acts or rules are right if they produce good
consequence (benefit)
Acts or rules are wrong if they produce wrong
consequence (harm)
This involves protecting patient from harm
Following this line of reasoning, lying to a patient would
be permissible, even laudable, if it resulted in some
benefit to the patient or others.
397
Solving a dilemma
Non-Consequentialism
The nonconsequentialist, looks at the action itself as
either right or wrong, without regard to outcome.
Following this line of reasoning, lying to a patient is

wrong by definition, whether or not the lie might
ultimately "benefit" all concerned parties.
Pharmacists who deeply believe in

nonconsequentialism are devoted to being faithful to
the patient above all other considerations and are
therefore disposed to tell the truth in even the most
sensitive situations.
398
Consequentialism Vs. Non-
consequentialism
Non-conesquentialist pharmacists would speak frankly, but kindly,
to terminal cancer patients who are apparently unaware of the
seriousness of their condition, confident that they are being faithful
to them.
In contrast, pharmacists who believe in consequentialism must

struggle deciding whether the false serenity resulting from lying to
these same patients would be more beneficial than any anguish
resulting from telling the truth.
To the pharmacist guided by nonconsequentialism, this dilemma is

simply not an issue.
Telling the truth becomes a "good" that outweighs the

consequences associated with telling the truth or the patient's
ability to handle the truth
399
Solving a dilemma
Utilitarianism
Moral value is determined by the resulting good among
ALL parties involved (and not only the patient itself)
Total net good = total good consequences total bad
consequences
For ALL people involved in and affected by the act
If total net good is +ve => its a beneficial act
400
Solving a dilemma- Four Box System
When you are seeing patients in the outpatient or inpatient
setting and a dilemma arises as to how to best resolve an
ethical question, use the following "four box" system
401
Solving a dilemma- Four Box System
402
Ethical dilemmas- Examples
Case 1:
A pharmacist receives a prescription for a
fertility drug from a Medicaid recipient with
four young dependents. The pharmacist
grudgingly fills the prescription, but counsels
the patient on the advisability of submitting to
a tubal ligation.
403

Case 2:
A pharmacist working at a student health center
pharmacy on a large campus refuses to fill a
prescription for four oral contraceptive tablets
once he realizes that the tablets are intended to
be used for morning-after therapy, explaining
that his religious beliefs do not condone abortion.
You may have a right to your religious beliefs,
the young woman counters, but you dont have
a right to refuse to fill my prescription.
404
Case 3:
Pharmacist asked to falsify insurance records
or payment bills, for patients who cannot
afford the cost of the medicine
Case 4:
Pharmacist asked to give placebo to an addict
to trick him into recovery
405

Case 5:
A doctor telephones a prescription for a powerful
tranquilizer, but directs you to label the
prescription with the name of a mild sedative
because the patient is frightened by the idea of
taking tranquilizers. The drug prescribed is the
only effective therapy for this condition. Your
state pharmacy practice act includes a strong
prohibition against mislabeling.
406
Case 6:
Jon Swift, a 45-year-old paraplegic patient, was prescribed
several months' supply of a tricyclic antidepressant to help him
cope with a divorce from his wife and the alienation of his
teenaged son. While being counseled in the use of this drug, Jon
asked the young pharmacist Jack a direct question: "How
dangerous could this prescription be?" Jack carefully revealed
that tricyclics may pose a problem of toxicity, as they are not
easily removed from the body in cases of emergency. Soon after
the discussion, Jon ingested a large amount of the drug and
died, the result of an apparent suicide. Upon hearing of the
incident, Jack felt guilty and somehow partially responsible.
Knowing of his serious depression, what duty did Jack have to
inform Jon about his drug?
407
Definitions
408
1- Placebo: drugs, tests, surgeries 2- Off label use
A placebo drug is a fake Off-label use for
medication, a medication with prescription drugs,
no pharmacological action, or biologics, and approved
active ingredient. It looks, medical devices means any
smells, and feels the same as use that is not specified in
the active drug. It is used in the labeling approved by
research to increase the the U.S. Food and Drug
strength of the study Administration (FDA)
Placebos can be drugs or tests Many physicians prescribe

drugs in their off-label use
Placebo surgeries have been based on evidence based
done but are considered medicine
unethical ways to trick
insurance companies Off label use of drugs is a
debatable issue in court
409
3- Palliative care
Care to ease the end-of-life of the terminally ill patient
Pain (Usually the drugs used are strong analgesics (often
narcotics))
Depression, anxiety, SOB, fatigue, severe weakness,
activity intolerance
The Lebanese Center for Palliative Care Balsam

Non-governmental organization that works to relieve
patient suffering and improve quality of life
Support to patients dealing with life-threatening illness by
providing medical services as well as psychological, social,
practical, and spiritual support within the family and home
environment
410
4- Euthanasia (Mercy killing)
Word origin is Greek and it means easy or good death,
from euthanatos (eu + thanatos)
Painless killing or withholding life support of a person who has a
painful, incurable disease or incapacitating disorder.
Most legal systems consider it murder, though in many jurisdictions,
a physician may lawfully decide not to prolong the patient's life, or
may give drugs to relieve pain even if they shorten the patient's life
Voluntary Euthanasia
Was legalized in the Netherlands in 2001 and in Belgium in 2002.
In 1997 Oregon became the first state in the U.S. to decriminalize
physician-assisted suicide
Non-voluntary
Involuntary
Any of the above can be
Active
passive
411
5- Do Not Resuscitate (DNR) code

In medicine, a "do not resuscitate" or "DNR",
sometimes called a "No Code", is a legal order
written either in the hospital or on a legal form
to respect the wishes of a patient not to
undergo CPR or advanced cardiac life
support (ACLS) if their heart were to stop or
they were to stop breathing
412
6- MedWatch
MedWatch is the Food and Drug Administrations
reporting system for adverse events, founded in 1993
Serious Adverse Event
An adverse event is any undesirable experience associated
with the use of a medical product in a patient. The event is
serious and should be reported to FDA when the patient
outcome is:
Death
Life-threatening
Hospitalization (initial or prolonged)
Disability or Permanent Damage
Congenital Anomaly/Birth Defect
Other Serious (Important Medical Events)
413
7- Bioavailability/Bioequivalence
Bioavailability
Rate and extent to which the AI is absorbed form a
drug product and became available at the site of
action
Used to determine whether one drug product has the
same effect as a generic equivalent
Pharmacokinetic parameters are between 80% and
125%: if the generic product shows 20% less
absorption or up to 25% more absorption, the
products will be deemed bioequivalent
Bioequivalence
Similar bioavailability in vitro, or in some cases in vivo,
or both 414
8- Therapeutically equivalent products
(FDA classification)
Meet all the following criteria Can have differences in

Pharmaceutical equivalents Shape
Contain identical amounts of Color
the same active ingredient in
the same dosage form, route of Packaging
administration,
strength/concentration
Inactive ingredients/excipients
(colorings, flavorings, and
Bioequivalents
preservatives)
Adequately labeled
Expiration date/time
Manufactured in compliance
with current Good Minor aspects of labeling
Manufacturing Practice (GMP) (presence of specific
regulations pharmacokinetic information)
Standards of strength, quality, Storage conditions
purity, and identity
415

(FDA classification)
Can be substituted with the full expectation
that the substituted product will produce the
same clinical effect and safety profile as the
prescribed product
The FDA takes the position that when these
mentioned differences are important in the
care of a particular patient, it may be
appropriate for the prescribing physician to
require that a particular brand be dispensed
("dispense as written") as a medical necessity
("brand medically necessary") 416
Orange Book
Called Approved Drug Products with Therapeutic
Equivalence Evaluations
Created in 1980
Electronic Orange Book
Online version
Updated daily as new generic approvals occur
FDA publication that lists many drug products and
contains indications as to whether generic versions of
medications are considered to be "equivalent" to the
brand names
Only includes NDA drugs
417
9- Generic Drug Substitution Law

All pharmacists are permitted or obliged to substitute a
generic version of the prescribed product
Some states provide, in addition to the orange book, a
Sate drug Formulary
Positive formulary: drugs are equivalent and interchangeable
Negative formulary: drugs are Not equivalent and Not
interchangeable
Most states require patient consent for, or notification of,
substitution
Most states require that the substitute be less or no more
expensive than the drug prescribed
A generic drug can cost 30-70% less than the brand drug
Narrow therapeutic window drugs should not be
substituted 418
9- Limitations of generic substitution
Large studies certify efficacy and safety for brand
drugs, while for generics efficacy and safety is only
presumed
Might be less effective and/or more toxic
If bioequivalent not necessary therapeutic equivalent
Bioequivalence testing
Manufacturer has the right to choose their own
production lot for testing and even the lot from a local
pharmacy where from to be taken the original comparative
drug
For ethical reasons, BE studies are performed on healthy
volunteers
It is conventionally accepted that the similar bioavailability found
in these people is a solid proof of a similar bioavailability in sick
people!
Not necessarily true 419
9- Limitations of generic substitution

Brand to generic substitution for drugs with high-
medium therapeutic index is acceptable
Brand to generic substitution for NTI drugs is not
applicable
Drugs with narrow therapeutic index present small
differences between the effective and toxic doses. Small
variations in concentration of these drugs can result in an
insufficient therapeutic response or toxic appearance
Generic-generic substitution is not acceptable
Difference in bioavailability between 2 generics can be up
to 45%
After the patient clinically responds to a specific generic
drug, patient should be instructed about the need not to
change it by his will or by the pharmacist will. This rule is
often violated. 420
FDA list
of
NTI drugs
http://www.uspharmac
ist.com/content/s/44/c
/9787/
421
10- Drugs expiry date

Stability (USP definition)
The extent to which a product retains, within
specified limits, and throughout its period of
storage and use, i.e., its shelf life, the same
properties and characteristics that it possessed at
the time of manufacture
No or minimal chemical degradation
Shelf life
The time the manufacturer guarantees the full
potency and safety of a drug
Minimum acceptable potency: Drug concentration
90% of the amount indicated on the drug label
422
Expiry date
Point in time when a pharmaceutical product is no
longer within an acceptable condition to be
considered effective
The medication reaches the end of its shelf life
Expired products
The active drug becomes chemically unstable
The effectiveness of the drug may change
The break down of the drug may be toxic and
harmful to the patient
Increased risk of contamination 423

All these factors are set during the clinical trial of
the drug
Depending on the product, the expiry date may
be set as a fixed time:
after manufacture
after dispensing
after opening of the manufacturers container
Not all drugs deteriorate at the same rate
Some products now show a symbol
for expiry date after opening
424
Formulation and packaging Suggested expiry after opening Rationale
unless otherwise stated by
manufacturer and still within
manufacturers expiry date
Tubs of creams / ointments 1 month The contents are exposed and can become
contaminated
Tubs of creams/ ointment 1 month or seek community As above, and pouring from bulk container
poured from bulk container pharmacy advice into another container could introduce
contamination
Tubes of creams/ ointments 3 months Closed container, contents not openly
exposed to environment
Tablets/ capsules in monitored 2 months No batch number or expiry printed on
dosage systems MDS
Tablets/ capsules/ liquids Variable Dependant on stability of product
poured into pharmacy bottle
Oral liquids in original 6 months unless otherwise Exposure of liquid to environment when
container specified by manufacturer dose is measured can introduce
contamination
Eye, Ear, Nose drops/ 1 month Manufacturers recommendation
ointments
Inhalers Manufacturers expiry Closed container, contents not openly
exposed to environment
Insulin 4 weeks for insulin vials and pens The sterile seal has been broken and may
unless otherwise stated be stored outside the fridge 425
Examples of different wording of

expiry dates
Wording on packaging Definition
Best before January 2011 Discard 31/12/2010
Use by January 2011
Use before end January 2011 Discard 31/01/2011

Discard after January 2011
Expires January 2011
Use within one month of opening explanatory

Discard 7 days after opening explanatory
426
11- Proper drug storage
All medicines should be stored in a cool (below
25C) dry place, unless refrigeration is required (
between 2C-8C), Or as recommended by
manufacturer
Keep away from
Moisture (not in the kitchen or bathroom cabinet!),
Light (Furosemide)
Temperature
From children
Avoid contamination of sterile products
In the safe, in its original bottle
427
12- Monitored Dosage Systems (MDS)

It is recommended that medicines dispensed in a MDS are
discarded after 8 weeks if they have not been used.
NOT all medicines are suitable for inclusion in MDS; for
example :
Medicines that may be harmful when handled (cytotoxic products
like methotrexate)
Medicines that are sensitive to moisture (effervescent tablets)
Light-sensitive medicines (chlorpromazine)
Medicines that should only be dispensed in glass bottles (glyceryl
trinitrate (GTN))
Medicines that should only be taken when required or PRN
(painkillers)
Medicines whose dose may vary depending on test results
(warfarin)
The foil packing around individual tablets must NOT be cut and
place in MDS, doing so has potential to cause harm if
inadvertently swallowed by patient 428
429
Black market
and
Counterfeit drugs
430
Black market
From collectors of chemical manufactures
wholesalers pharmacists
Sell medicines that are
Expired
Contaminated
Placebo
Forbidden (addictive drugs)
Stolen formulas from companies
Falsely labeled
Deal with all types of drugs: antibiotics, hormones,

stimulants, antidepressants, vitamins
Deal with all types of dosage forms: from IV to po 431
Counterfeit drugs
Definition
Drugs with are exact physical copies (same appearance)
of trade-market drugs
Have the same
Labels, package insert, paper, bottle
So close to the legitimate drug that physicians, pharmacists
and patient cannot on sight distinguish any difference
It is necessary to compare them microscopically
Chemically in specialized labs
Ingredients may or may not be the same
They may be adulterated or contaminated
Pirated compounds may have been used in their
manufacturing
432
Counterfeit drugs
Production under the worst conditions
Sewer pipes into drug mixing machines
Compressing tablets in machines immediately
after using them to make poisonous pills
Storage in unclean bottles and containers
No studies, no research, no quality control
Offers
Better prices
433
Term definition
Term Description
Adulterated Drugs may include a substance that is not part of the
ingredients. Usually a cheaper material is added
Contaminated Contain impurities or traces from other drugs
Pirated Stolen formulas (of a drug still patent) manufactured
abroad from the original company product is sold in
the country of the patent drug, or other countries where
the patent drug is being sold in the market
Misbranded When the label of the drug is false or misleading in any
way
Look-alike or Drugs manufactured to resemble is size, shape and color
imitation the products of other companies
434
Legal drugs
Term Description
Brand drug The original drug that received the patent
Generic drug 1. Refers to the chemical name of the drug

(ciprofloxacin is the generic name of the brand
ciprobay)
2. Refers to the copy drug (estecina is the generic
product of the original brand ciprobay) (produced by
legal companies after expire of the ciprobay patent)
Generic Drug product selection = Generic substitution = generic

Substitutes drug interchange
Generic drugs to replace what the physician prescribed
435
Thank You
436

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School of Pharmacy

Pharmacy History, Practice and Ethics

Instructor Campus Sec Room Offered Time Office hours Address

Course Coordinator: Dr. Marwan Akel

Department: Pharmacy Practice

Course prerequisite: ENGL 100, ENGL 150

Required Readings: Classroom notes and reading material

Photography, audio-visual recording, and transmission/distribution of classroom lectures

Enjoy the course;

Relied on trial and error to:

Without advanced tools, pharmaceutical

Powers of gods in day-to-day life started

The healing energy is usually transferred to the patient

Existed 2500-7000 years ago

One of the greatest cities built by Hammurabi

Balsam Apple (malus laxative, skin allergies, soothes headaches, gums

Colchicum (Citrullus soothes rheumatism, reduces swelling

Poppy (papaver Relieves insomnia, relieves headaches, anesthetic,

Garlic (Allium sativa) Decrease platelet, cholesterol and blood glucose

Poppy (Papaver somniferum) Garlic

Emergence of individuals specialized in collection,

C. The Greco-Roman period

C. The Greek period

Hygeia carried a magical serpent and a bowl

Visited by people with persistent diseases and

People slept in the temple with the hope of

Temple of the god Asklepios and

C. The Greek period

C. The Greek period

If conservative methods failed prepared his own

Theophrastus (370-285 BC)

C. The Greek period

C. The Greek period

C. The Greek period

C. The Greek period

C. The Greek period

Pharmacy viewed as an art joint to medicine

Early steps in separation of medicine and pharmacy

3. The middle ages

3. The middle ages- West falling

The dark ages

3. The middle ages- West falling

3. The middle ages- West falling

Drug therapy in the West

Saints of Cosmas and Damian

3. The middle ages- the Arabs

3. The middle ages- the Arabs

Considered the father of pediatrics for writing The

Developed pharmaceutical apparatus

Legend: he once selected a new hospital site through

3. The middle ages- the Arabs

3. The middle ages- the Arabs

Avicenna's four humours and personalities

3. The middle ages- the Arabs

Ibn Rushd (Averroes) (1126-1198)

3. The middle ages- the Arabs

3. The middle ages- the Arabs

3. The middle ages- the Arabs

By then, the entire Materia Medica contained

3. The middle ages- the Arabs

Lettuce: Useful in treating scorpions and bee stings as

3. The middle ages- the Arabs

Habb: evaporated plant juices molded in the form of a pill

3. The middle ages- West rising