Safety in our System:

High Alert Medications

Lynn Eschenbacher, Pharm.D.
Medication Safety Officer
Duke University Hospital

Case Study
Physician ordered Norcuron (Vercuronium)
for a patient via Computerized Physician
Order Entry (CPOE)
Ordered via remote location- not at the
bedside
Accidentally prescribed for a patient on a
medical unit, meant for a patient in the ICU

Case Study
Pharmacist processed and prepared the
infusion, failing to recognize that a
neuromuscular blocking agent should
never be sent to a medical unit
Auxiliary labels placed on bag

High Alert medication

Paralyzing agent

Pharmacy technician delivered to medical

unit and didnt question why not an ICU

Case Study
Independent double check performed by
the nurses to verify

Drug
Pump settings
Patient

Infusion started and patient walked to the

bathroom
Patient fell to the floor once paralysis
began to set in

Case Study
Patient called for help
Rapid response team responded
Nurse questioned if new drug hung could
have done this
Physician immediately stopped the
infusion
Patient treated and no long-term effects

ISMP Medication Safety Alert! May 31, 2007 Volume 12 Issue 11

What Happened?
Entered on wrong patient in CPOE
No confirmation of correct patient or hardstop in
CPOE for NMB outside of the ICU
Unfamiliarity with the medication
Didnt ask for clarification or information about
the medication
Auxiliary labels not read
Multiple providers involved
6 Rights

Patient, drug, dose, route, time, response

Others?

How Do Errors Occur?

The Swiss Cheese Model

Medication Safety Defined

Adverse drug event (ADE)

Any incident in which the use of a medication (drug

or biologic) at any dose, may have resulted in an
adverse outcome in a patient (JCAHO 2001)

Adverse Drug Reaction (ADR)

A response to a drug that is noxious and unintended,

and that occurs at doses normally used in man for the
prophylaxis, diagnosis or therapy of disease, or for
the modification of physiological function (WHO 1972)

Near Miss/Close Call

Errors that have the capacity to cause injury, but fail

to do so, either by chance or because they are
intercepted (Leape 1995)

High Alert Medications

How does a medication get tagged high
alert?
1.
2.
3.
4.

A medication that is notorious for causing a lot of

medication errors.
A medication that requires an intern who has worked
for less than 10 hours in a row to write for it.
A medication that requires special care because if an
error occurs it has the potential to result in significant
patient harm.
I have no idea.

Answer
1. A medication that is notorious for causing a lot
of medication errors.
2. A medication that requires an intern who has
worked for less than 10 hours in a row to write
for it.
3. A medication that requires special care
because if an error occurs it has the potential
to result in significant patient harm.
4. I have no idea.

What Does the Evidence Tell Us?

Warfarin and insulins caused:

One in every seven estimated adverse drug events

treated in emergency departments

More than a quarter of all estimated hospitalizations

In the elderly, insulin, warfarin, and digoxin were
implicated in:
One in every three estimated adverse drug events
treated in emergency departments
41.5% of estimated hospitalizations
Budnitz DS, Pollock DA, Weidenbach KN, et al.
National surveillance of emergency department visits for outpatient adverse drug events .
JAMA. 2006;296:1858-1866.

IHI 5 Million Lives Campaign

Reducing Harm from High-Alert
Medications
The Goal:

Reduce harm from high-alert medications by

50% by December 2008

IHI 5 Million Lives Focus

Anticoagulants

Heparin and Warfarin

Narcotics/Opiates

Patient-Controlled Analgesia

Insulin
Sedatives

e.g., Midazolam

IHI Recommended Measures

ADEs:

Related to Anticoagulant per 100 Admissions with Anticoagulant Administered

Related to Insulin per 100 Admissions with Insulin Administered
Related to Narcotic per 100 Admissions with Narcotic Administered
Related to Sedative per 100 Admissions with Sedative Administered

Percent of Patients Receiving:

Anticoagulant with Treatment Appropriately Managed According to Protocol

Heparin with aPPT Outside Protocol Limits
Insulin with Blood Glucose Level Outside Protocol Limits
Insulin with Treatment Appropriately Managed According to Protocol
Narcotic Who Receive Subsequent Treatment with Naloxone
Narcotic with Treatment Appropriately Managed According to Protocol
Sedative Who Receive Subsequent Treatment with Flumazenil
Sedative with Treatment Appropriately Managed According to Protocol
Warfarin with INR Outside Protocol Limits

IHI Measure Examples

The number of adverse drug events (ADEs)
associated with an anticoagulant per 100
admissions in which the patient was
administered at least one dose of an
anticoagulant, as detected using the
IHI Global Trigger Tool (using only the
Medication Module and Care Module triggers).
The percentage of patients receiving insulin with
blood glucose levels outside the safety limits set
by the hospitals insulin protocol during insulin
administration

Duke University Hospital Approach

Identify High Alert Medications
Understand what causes harm at DUH

Data analysis

Decrease variation and standardize

Develop long lasting solutions
Involvement with front line staff up to
senior leadership
Demonstrate improvement with data

Duke High Alert Medications

Direct Thrombin Inhibitors

Neuromuscular Blocking
Agents
IT administered medications
Total Parenteral Nutrition
(TPN)
Antiarrhythmics (amiodarone
IV, lidocaine IV, dofetilide)
Vasopressors (dopamine,
dobutamine, epinephrine,
norepinephrine, phenylephrine)

Potassium IV
Heparin IV
Opiates
Chemotherapy IV and IT
Benzodiazepines
Warfarin
Insulin IV

Selection of High Alert Medications

Based on:

Previous medication errors

Sentinel Events
ISMP, USP and other national data

Increased risk of causing significant patient harm

when they are involved in medication errors.
Although mistakes may or may not be more
common with these drugs, the consequences of
an error are potentially more devastating to
patients.

Data Collection
ISMP Quarterly Action Agenda
IHI Trigger Tool
Electronic Surveillance Tool
Voluntary Reports
Root Cause Analysis
Failure Mode and Effect Analysis

On-Line Reporting
Single Portal for all events: Blood Transfusion related, Falls, Patient
Visitor issues, Surgical/invasive, Treatment/testing, and Equipment

On-Line Reporting

Areas of Focus
Prescribing
Preparation
Dispensing
Administration
Monitoring

Identification and Mitigation of Risk

Analyze medication related events specific to
institution
Utilize scientific methodology to identify root
causes and opportunities for improvement
Multi-disciplinary teams to develop action
items to address the root causes
Culture and buy-in to adopt these
improvements
Mistake proof where possible to ensure long
lasting solutions

Identification and Mitigation of Risk

Analyze

RCA, FMEA

Scientific Methodology

Six Sigma, PDSA, FADE

Culture

AHRQ Culture of Safety Survey

Mistake Proofing

Elimination, Replacement, Facilitation,

Detection, Mitigation

Six Sigma
Deployed January 2004
~32 Black Belts
~62 Green Belts
DMAIC, DMADV, GE Workout, Lean,
Change Management
Six Sigma Oversight Committee with RAIL
(rolling action item list)

Multidisciplinary Participation
Official Physician champions for each effort
Report out at several physician, nursing and
pharmacy forums

Clinical Peer Review Committee

Clinical Practice Council
Performance Improvement Oversight Committee
Medication Safety Council

Knowledge experts included

Address Issues that have been identified
Share your institutions data

Example: Mistake Proofing

Insulin Examples
Standardization to one IV insulin nomogram
CPOE Insulin order sets (Subcutaneous and IV)
and can only order insulin from order set
Standardization of hypoglycemia treatment
protocol- placed in all patient charts
Nutrition and insulin

Example: Insulin administered at MN and tube feed

held at 3am due to residuals. What do you do?

Insulin Advisor

Opiate Examples
Standardized the PCA concentrations available for the
adult population
CPOE

Standardized ordering using a PCA orderset

Added critical risk factor assessment
Additional monitoring recommendations
Lean body weight for dosing
Hard stop for morphine PCA and ESRD
RT consult for patients with sleep apnea

Developed a pre-op screening electronic assessment tool

with the critical risk factors related to potential
oversedation highlighted in red at the top of the electronic
form
Developed pre-op screening education for patients to help
set realistic expectations for post-op pain management

PCA Advisor

Pre-op screening alert

Anticoagulation Examples
Standardized ordering in CPOE (10/1/07)

Direct Thrombin Inhibitors

Heparin
Warfarin

Nursing protocol to alert physicians to

returned lab results and prompts for
change in orders
Revised the pharmacist managed warfarin
monitoring form

Warfarin Monitoring Form

Look-Alike High Alert Drugs

Look-Alike Drugs

Look-Alike Drugs

Aoccdrnig to a rscheearch at Cmabrigde

Uinervtisy, it deosn't mttaer in waht
oredr the ltteers in a wrod are, the olny
iprmoetnt tihng is taht the frist and lsat
ltteer be at the rghit pclae. The rset can
be a toatl mses and you can sitll raed it
wouthit porbelm. Tihs is bcuseae the
huamn mnid deos not raed ervey lteter by
istlef, but the wrod as a wlohe.

Look-Alike/Sound-Alike Drugs
hydralazine

hydroxyzine

cerebyx

celebrex

vinblastine

vincristine

chlorpropamide

chlorpromazine

glipizide

glyburide

daunorubicin

doxorubicin

Look-Alike/Sound-Alike Drugs
TALL MAN LETTERING
hydrALAZINE

hydrOXYzine

ceREBYX

ceLEBRex

vinBLASTine

vinCRIStine

chlorproPAMIDE

chlorproMAZINE

glipiZIDE

glyBURIDE

DAUNOrubicin

DOXOrubicin

DUH Look Alike/Sound Alike Efforts

TallMan Lettering:

Smart Pumps, Automated Dispensing

Cabinets, Medication Administration Record,
bin in the central pharmacy, storeroom, IV
room and satellites
Future: CPOE, Pharmacy computer system

Posters highlighting similar products

Example: Ephedrine and Promethazine

Communication and Education

Key to Success
Often an after thought, but needs to be part of
the efforts

Staff and Faulty

Medication Safety Minutes
Flyers
Grand Rounds

Patients
Brochures
Pamphlets
Videos

Medication Safety Flyer

Medication Safety Flyer

Demonstration of Improvement
Current

Balanced Scorecard (BSC)

Reduction in ADEs resulting in harm
Reduction in ADEs resulting in harm specific to
opiates and insulin
Increase in overall reporting

Future

Incorporation of ADE-Surveillance (Triggers)

on BSC
IHI Global Trigger tool

Balanced Scorecard

Critical Success Factors

DUHS establishes priorities within each
quadrant of the Balanced Scorecard.

Clinical Quality, Customer, Finance, Work Culture

Critical Success Factors (CSFs) help to

communicate and measure these priorities.
The CSFs cascade down throughout lower level
scorecards within the organization and support
the DUHS vision and strategy.

Demonstration of Improvement
Individual projects

Process measures
Outcome measures

Unique to projects
Oversight by Core Safety Team for Clinical
Service Line or by Six Sigma Oversight
Committee

What We Know About Making

Errors
All of us make errors
Errors are not made on purpose
No one wants to admit errors if they know
punishment is the result
Error Bad Behavior
Errors happen for a reason
Lucian Leape, MD

Medication Safety
Bottom Line: If the system is not fixed
the same error will happen again