High Alert Medications:

Reliable Methods to Ensure

Safer Use

Christian Hartman, PharmD

Medication Safety Officer
Assistant Professor of Medicine
Organization Profile
• UMass Memorial Medical Center - Worcester, MA
• 834 bed academic medical center
• Multi-campus system
• Level 1 trauma center
• Level 3 NICU
• 2008 Winner – ISMP CHEERS Award
• 2008 Winner – ASHP Affiliate Pharmacy of the Year
Award
• Last Joint Commission Survey - Nov 2008
– No Medication Management RFIs
Objectives
• Define high-alert medications according to
TJC, IHI, and ISMP
• Discuss accreditation and regulatory
requirements for high-alert medications
• Outline error prevention, identification, and
mitigation strategies and best practices
• “Everybody gets so much information all
day long that they lose their common
sense.”
- Gertrude Stein
 Statistics
 1.5 million preventable adverse drug events (ADEs) occur each year
in the United States.

 Of 221,000 medication errors reported via MEDMARX 1998-2005 in

the perioperative setting:
 80% of the medication errors that result in patient harm are caused by
20% of medications administered by practitioners.

 The leading medications involved:

– Insulin – 11.3%
– Morphine – 2.3%
– Heparin – 3.5%
– Fentanyl – 2.9%
– Hydromorphone – 2.7%

Committee on Identifying and Preventing Medication Errors. Aspden P, Wolcott J, Bootman JL, Cronenwett LR, Editors.
Preventing Medication Errors: Quality Chasm Series. Washington, DC: National Academies Press; July 2006.
Alphabet Soup…
Definitions
• IHI - medications that are most likely to cause
significant harm to the patient, even when used
as intended
• TJC - medications that have the highest risk of
causing injury when misused
• ISMP - mistakes may not be more common in
the use of these medications; when errors occur
the impact on the patient can be significant
Standards: Institute for Safe
Medication Practices (ISMP)
• limit access to high-
alert medications
• auxiliary labels and
automated alerts
• standardize ordering,
storage, preparation,
and administration
employing
• redundancies such as
automated or
independent double-
checks
Standards: The Institute for
Healthcare Improvement (IHI)
• 5 Million Lives Campaign
• Goal: reduce harm from high-alert
medications by 50% by December 2008
• Aim: Anticoagulants, Narcotics and
Opiates, Insulin, Sedatives
Standards: The Joint
Commission (TJC)
• National Patient Safety Goals
– NPSG 3
• Medication Management
– MM 01.01.03
– MM 03.01.01
– MM 08.01.01
 TJC Requirements: NPSG
03.03.01
• The hospital identifies and, at a minimum, annually
reviews a list of look-alike/sound-alike medications used
by the hospital and takes action to prevent errors
involving the interchange of these medications

– EP1: The hospital identifies a list of look-alike/sound-alike

medications used by the hospital. The list includes a minimum of
10 look-alike/sound-alike medication
– EP2: The hospital reviews the list of look-alike/sound-alike
medications at least annually
– EP3: The hospital takes action to prevent errors involving the
interchange of the medications on the list of look-alike/sound-
alike medications

Joint Commission: 2009 Hospital Accreditation Manual.

 TJC Requirements:
MM 01.01.03
• The hospital safety manages high-alert and
hazardous medication
– EP1 - The hospital identifies, in writing, its high-alert
medications
– EP2 - The hospital has a process for managing
high-alert medications
– EP3 - The hospital implements its process for
managing high-alert medications
– EP4 - The hospital minimizes risks associated with
managing hazardous medications

Joint Commission: 2009 Hospital Accreditation Manual.

 TJC Requirements:
MM 03.01.01
• The hospital safety stores medications

– EP9 - The hospital keeps concentrated electrolytes

present in patient care areas only when patient
safety necessitates their immediate use and
precautions are used to prevent inadvertent
administration

Joint Commission: 2009 Hospital Accreditation Manual.

 TJC Requirements:
MM 08.01.01
• The hospital evaluates the effectiveness
of its medication management system.
– EP5 - Based on analysis of its data, as well as review of the
literature for new technologies and best practices, the hospital
identifies opportunities for improvement in its medication
management system
– EP8 - The hospital takes action when planned improvements
for its medication management processes are either not
achieved or not sustained

Joint Commission: 2009 Hospital Accreditation Manual.

TJC Sentinel Event Alerts

• Issue 41 – September 24, 2008: Preventing errors relating to commonly

used anticoagulants
• Issue 39 - April 11, 2008: Preventing pediatric medication errors
• Issue 34 - July 14, 2005: Preventing vincristine administration errors
• Issue 33 - December 20, 2004: Patient controlled analgesia (PCA) by
proxy
• Issue 23 - September 1, 2001: Medication errors related to potentially
dangerous abbreviations

• Issue 19 May 1, 2001: Look-alike, sound-alike drug names

Where do we begin?
• Specific medications
• General drug classes
• Specific processes
• Specific patient populations
 Specific Medications: Insulin
• MEDMARX - 9,135 errors in perioperative
setting; 4.2 % causing harm
• Problem-
– Multiple products available
– Look alike sound alike names and products
– Abbreviations (Lantus 15Units)
– Difficult dosing regimens

Hicks RW, Becker SC, Cousins DD. MEDMARX Data Report: A Chartbook of Medication
Error Findings from the Perioperative Setting from 1998-2005. Rockville, MD: USP Center for
the Advancement of Patient Safety.
 Specific Medications: Opiates
• Largest category of drugs associated with
error related deaths
• Problem-
– Name confusion (oxycodone vs oxycontin)
– Dose conversion (morphine vs. dilaudid)
– Overlapping regimens
– Multiple dosage forms (PO, IV, TD, etc)

Koczmara C, Hyland S.. Preventing narcotic associated adverse events in critical care units.
Dynamics 15:7-10, Fall 2004.
 Specific Medications:
Anticoagulants
 Bates and colleagues report that anticoagulants
accounted for 4% of preventable ADEs and 10%
of potential ADEs.
• Problem-
– Multiple products (Heparin)
– Difficult dosing regimens
– Abbreviations (Heparin 5000Units)
– Look alike sound alike names and products (Heparin
vs. Hespan)

Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse
drug events: Implications for prevention. ADE Prevention Study Group. JAMA. 1995;274:29-
34.
 Specific Medications:
Concentrated Electrolytes
• 5 to 10 patients die annually due to
concentrated KCl in the United States
• Reversal is difficult
• Problem-
– Access and storage
– Procurement

Joint Commission Resources: Reducing the risk of errors associated with concentrated
electrolyte solutions. Joint Commission: The Source 6:1-2, Mar. 2008.
 Specific Medications: Sedation
• Sedation is a continuum and often difficult to
predict patient response; types (1) minimal, (2)
moderate, (3) deep, (4) anesthesia
• Problem-
– Dosing confusion (ie midazolam onset of
action)
– Inappropriate monitoring
– Expertise, qualification, and credentialing of
staff

High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
 Specific Medications: NMB
• According to USP, there have been more
than 50 reports of significant misuse of
NMB
• Problem-
– Improper storage (ICU vs floor)
– Look alike sound alike (Vanco vs Vec)
– Inappropriate monitoring
– Medication use process

Smetzer JL. Preventing errors with neuromuscular blocking agents. Jt Comm J Qual Patient
Saf 32: 56-59, Jan. 2006.
Specific Medications:
Adrenergic Agents
• Ben Kolb - syringe that was supposed to
contain lidocaine actually contained
epinephrine
• Problem-
– Look alike sound alike names and packaging
– Multiple manufacturers
– Large vial sizes
 High Risk Processes: Oncology
• In the US, 1.2 million are diagnosed with
cancer each year; 48,000 experience
some type of adverse event
• Problem-
– Selection/procurement/storage
– Ordering and monitoring
– Transcribing
– Preparation and administration

Joint Commission Resources: Medication safety with the use of chemotherapy agents. Joint
Commission Perspectives on Patient Safety. 8:1-5, Mar. 2008
 High Risk Processes: Pediatrics
• Similar medication error rates as adults but…three times
the potential to cause harm
• Over 50% of new approved medications have not had
sufficient pedi research
• Problem-
– Complex regimens and dosing
– Medication preparation
– Immature ability to metabolize
– Lack of communication

Joint Commission Resources: Preventing pediatric medication errors. Joint Commission

Perspectives on Patient Safety. 7:5-6, Sept. 2007
 High Risk Processes: Elderly
• Insulin, warfarin, and digoxin were implicated in one in
every three estimated ADEs treated in ED and 41.5% of
estimated hospitalizations
• Problem-
– Altered metabolism
– Decreased renal function
– Polypharmacy
– Communication and technology

Budnitz DS, Pollock DA, Weidenbach KN, et al. National surveillance of emergency
department visits for outpatient adverse drug events. JAMA. 2006;296:1858-1866.
Strategies for Success
• "Anyone can make the simple
complicated. Creativity is making the
complicated simple."
- Charles Mingus
Strategies for Success
• General recommendations for all
medications and processes
• Specific recommendations for select
medications
• Additional recommendations
 General Recommendations
• Design processes to prevent errors and
harm.
• Design methods to identify errors and
harm when they occur.
• Design methods to mitigate the harm
that may result from the error.

5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
 Design Process to Prevent
Errors and Harm
• Standardize order sets, preprinted order forms,
clinical pathways
• Standardize concentrations and dose strengths
• Reminders about appropriate monitoring
parameters
• Consider protocols for vulnerable populations
such as the elderly, pediatric, and obese
patients

5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
 Design Methods to Identify
Errors and Harm
• Ensure that critical lab information is available to those
who need the information and can take action
• Implement independent double-checks where
appropriate
• Instruct patients on symptoms to monitor and when to
contact a health care provider for assistance

5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
 Methods to Mitigate Harm
• Develop protocols allowing for the
administration of reversal agents without
having to contact the physician
• Ensure that antidotes and reversal agents
are readily available
• Have rescue protocols available

5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
How do we make mistakes?
-Exercise
• Two teams
• Team 1 – count bounce passes for
players in WHITE shirts
• Team 2 – count chest passes for players
in WHITE shirts

http://viscog.beckman.uiuc.edu/flashmovie/15.php
Changing Practice/Behavior
• Forced Functions
• Constraints
• Check lists/pathways
• Policy
• Guidelines
• Education
 General Recommendations:
Anticoagulants
• Format anticoagulation orders to follow the patient
through transitions of care
• Use an anticoagulant dosing service or "clinic" in
inpatient and outpatient settings
• Use ONLY oral unit-dose products and pre-mixed
infusions as available
• Staff training and competency assessment
• Conduct an Antithrombotic Therapy Self-assessment or
FMEA http://www.ismp.org/selfassessments/asa2006/Intro.asp

5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
• Patient Information
• Drug Information
• Communication of Orders
• Storage
• Device Use
• Staff Competency
• Patient Education
• Risk Assessment
 Specific Recommendations:
Heparin
• Weight-based heparin protocol/nomogram
• Preprinted order forms or ordering protocols
• Account for the use of thrombolytics and GIIg/IIIa
inhibitors
• LMWH and Heparin conversion standards
• Standard concentrations
• Separate like products
• Hep-flush ordered and available in syringe
• Monitoring parameters are implemented

5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
 Specific Recommendations:
Warfarin
• Narrow therapeutic index - centralized dosing
and monitoring service
• Standardize dosing, monitoring, reversal
• Minimize available strengths; no tablet splitting
• Nutrition consult for patients on warfarin to avoid
drug/food interactions
• Patient education and follow-up

5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
 General Recommendations:
Opiate and Narcotics
• Standardize protocols
• Monitoring for adverse effects of narcotics and
opiates
• Protocols for reversal agents
• Centralized pain services
• Independent double-checks
• Minimize multiple drug strengths and
concentrations where possible
• Mutual pain assessment and toileting

5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
 Specific Recommendations:
Insulin
• Eliminate or standardize sliding scales
• Independent double-check
• Pre-printed insulin infusion orders and flowsheets
• Separate LASA; standardize manufacturer
• Prepare all infusions in the pharmacy
• Standardize to a single concentration for IV
• Safeguards on high-dose insulin concentration; reversal
protocols

5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
 Specific Recommendations:
Concentrated Electrolytes
• Eliminate storage on patient care units when
possible
• Segregate bulk supplies within the pharmacy
• Secure after hours access to medication
supplies
• Utilize premix/pre-packaged where feasible
• Auxiliary labeling and packaging
• Pop-up warnings/alerts in ADM

High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
 Specific Recommendations:
Sedation
• Stock only one concentration of moderate sedation
agents
• Preprinted order forms/sets
• Monitor all children on chloral hydrate
• Age/size appropriate resuscitation equipment
• Adequately trained personnel
• Fall prevention program

High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
 Specific Recommendations:
NMB
• Secure/segregate storage
• Restrict access to ICU, ED, OR only
• Auxiliary labeling and packaging
• Alerts and pop-up warnings
• Do not store on unit dose cart/ADM matrix
drawer; ADM single item only
• Standardize formulary and prescribing
• Prompt removal of product after D/C

High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
http://www.ismp-canada.org/download/caccn/CACCN-Spring07.pdf
 Specific Recommendations:
Adrenergic Agents
• Premixed solutions and prefilled syringes when
feasible
• Standardize concentrations
• Apply LASA standards
• Standardize ordering (ie do not use “titrate to
effect”)
• Extravasation policy and kit
• Utilize different manufacturers when feasible to
ensure packaging looks different

High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
 Specific Recommendations:
Oncology
• Procurement/Dispensing - standardize
• Storage - physical separation, negative pressure room,
LASA
• Ordering - standard order sets, CPOE, ordering policy,
dose limits, pair with protocols, forced - weight, blood
counts
• Transcribing - prohibit verbals if possible, transcription
policy, independent verification

High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
 Specific Recommendations:
Oncology
• Preparation/Dispensing - independent verification, check offs, staff
protection (USP 797, closed systems, etc), labeling
• Administration - independent verification of new starts/rate
changes/etc, smart pumps, clearly marked catheters
• Monitoring - interdisciplinary monitoring, standard orders for
laboratory monitoring, cumulative dose

High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
 Specific Recommendations:
Pediatric
• Segregate medications from adult storage areas
• Standardize concentrations
• Compounding and dilutions should occur within the
pharmacy
• Oral syringes for oral liquids
• Patient specific unit dosing provided by pharmacy
• Mandatory weights and ongoing assessment
• Pediatric P&T Committee and formulary
• Ordered using weight based formula (mg/kg)
• Visual cues for pediatric orders and records

High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
 Specific Recommendations:
Elderly
• Polypharmacy assessment
• Concurrent renal dosing monitoring
program
• Comprehensive falls risk assessment
• Adoption of Beers criteria and mitigation
strategies

High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
 Beers List

Donna M. Fick, James W. Cooper, William E. Wade, Jennifer L. Waller, J. Ross Maclean, and Mark H. Beers. Updating the Beers
Criteria for Potentially Inappropriate Medication Use in Older Adults: Results of a US Consensus Panel of Experts. Arch Intern Med,
Dec 2003; 163: 2716 - 2724.
Additional Recommendations:
Dedicated Teams
• Anticoagulation management team
• Interdisciplinary pain management team
• Dedicated pediatric and oncology
coverage
• Annual risk assessment team - Failure
Mode and Effect Analysis
Additional Recommendations:
Patient Education
• Engage patient involvement
– Pain management
– Anticoagulation
• Simple, visual information
– Example: warfarin education
Additional Recommendations:
Technology
• Computerized Practioner Order Entry/ePrecribing
• Bar Coded Medication Administration (BCMA)
• Dispensing verification
• RFID
• Smart Pumps
• Medication carousel
• Electronic, real-time surveillance of trigger drugs, labs,
etc
Clinical Surveillance
A Robust Program…
• Analyzes medications and processes
• Applies standards and regulations
• Develops strategies to prevent, Identify,
and mitigate errors and harm
• Utilizes technology when feasible
• Engages the patient and family
• Design is not just what it looks like and
feels like. Design is how it works.”
- Steve Jobs
Contact Information

Christian.Hartman@asmso.org

The American Society of Medication Safety Officers

www.asmso.org

www.twitter.com/ChrisHartman