High-alert Medications:

Understanding System Base

Causes and Practical Error
Reduction Strategies
Hedy Cohen, RN, BSN, MS
Institute for Safe Medication Practices
www.ismp.org
hcohen@ismp.org
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 Are
medication
errors really
that bad?

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 The Institute of Medicine (IOM)
44,000 to 98,000 deaths per year from medical
errors
- more than from breast cancer or AIDS
7,000 to 16,000 deaths per year from
medication errors
- 1 out of 131 outpatient and
- 1 out of 854 inpatient deaths
To Err is Human:
Building a Safer Health System, 1999

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Agency for Healthcare Research
and Quality (AHRQ)
5 per 10,000 doses administered cause
serious harm
translates into 50 serious ADEs per month
5.3% of orders written contain a
medication error
Only 1.5% of ADEs in hospitals are ever
reported
AHRQ: www.ahrq.gov/qual/aderial/aderia.htm
Research in Action: Reducing and Preventing Adverse Drug Events
to Decrease Hospital Costs

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 TJC National
Patient Safety Goal
3. Improve the safety of using high-alert
medications
a. Remove concentrated electrolytes
(including, but not limited to, potassium
chloride, potassium phosphate, sodium
chloride >0.9%) from patient care units
b. Standardize and limit the number of drug
concentrations available in the organization

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 Verbal Order for
18 Month Old

Get this kid morphine .8

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Why do Medication
Errors Occur?
 Human Factors

The study of the interrelationships

between humans, the tools they
use and the environment in which
they live and work
Success comes with improving the
human-system interface

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 PARIS
IN THE
THE SPRING
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 Individuals
Limitation of human performance
limited short-term memory
time constraints
normalization of deviance
limited ability to multi-task
interruptions
stress
heuristics
fatigue and psychological factors
environmental factors
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 Medication System
Key Elements
Patient Information Drug Device Acquisition,
Drug Information Use, and Monitoring
Communication of Environmental Factors,
Staffing Patterns and
Information
Work Flow
Drug Labeling,
Staff Competency and
Packaging, and
Education
Nomenclature
Patient Education
Drug Storage, Stock,
Standardization, and Quality Processes and
Distribution Risk Management

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 No
Diagnosis or Ambiguous
maximum
allergy not drug order Inadequate
dose
communicated patient
warnings
education

Patient Communication Drug Info Other

Information System System systems
System
The latent failure model of complex system failure
modified from James Reason, 1991

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 High-alert Medications
Small number of medications that have a
high risk of causing injury if misused

Errors may or may not be more common

with these than with other medications, but
the consequences of errors may be
devastating

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 High-alert Medications
Adrenergic agonists
Adrenergic antagonists IV
Anesthetics agents
Antiarhythmics IV
Antithrombotic agents
Carioplegic solutions
Chemotherapeutic agents
Dextrose, hypertonic
Dialysis solutions
Epidural or intrathecal drugs
Hypoglycemics, oral
Inotropic drugs
Liposomals
Moderate sedation agents
IV, oral for children
Narcotics/opiates
Neuromuscular blocking
agents
IV heparin and oral
warfarin, thrombolytics
Radiocontrast agents, IV
Total parenteral solutions.
 Specific High-alert Medications
Colchicine injection Nitropruside injection
Epoprostenol (Flolan) IV Potassium chloride
concentrate IV
Insulin
Potassium phosphates
Magnesium sulfate injection
injection concentrate
Methotrexate tablets
Promethazine, IV
Oxytocin IV
Sodium chloride for
injection concentrate
Sterile water for injection,
inhalation and irrigation
 High-alert Medications
Collective thinking from:
Reports submitted to USP-ISMP MERP
Reports in the literature
Input from practitioners
Input from safety expertsISMP advisory board

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High Risk Patient Populations
Patients with renal/liver impairment
Pregnant/breast feeding patients
Neonates
Elderly/chronically ill
Patients on multiple medications
Oncology patients

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 Primary Principles in
Error Reduction
Reduce or eliminate possibility of errors
Make errors visible
Minimize the consequence of errors
 Rank Order of Error
Reduction Strategies
Forcing functions and constraints

Automation and computerization

Standardization and protocols

Checklists and double check systems

Rules and policies

Education / Information
Key Safeguarding Strategies

Simplify - reduce steps and number of

options
Standardize options
Externalize or centralize error prone
processes
Differentiate items (appearance,
location)
Key Safeguarding Strategies
Reminders
Improved access to information
Use of constraints that limit access or
use
Forcing functions
Failsafe
Use of defaults
Failure analysis for new products and
procedures
 Simplify
Decrease number of available sizes and
concentrations
a single heparin size/concentration is
available
reduce the number of vials available

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Standardize Order Communication
Create, disseminate and enforce ordering
guidelines
create a negative list for dangerous
abbreviations
eliminate trailing zeros; use leading zeros
standard procedure for verbal orders
standardized concentrations of critical care
drug infusions, weight-based heparin
protocol, etc

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Standardize Order Communication

Eliminate acronyms, coined names,

apothecary system, use of non-standard
symbols, etc.
TPN (IV nutrition or Taxol, Platinol,
Navelbine)
Irrigate wound with TAB

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 Externalize or Centralize
Centralize preparation of intravenous
solutions
prepare pediatric IV medications in pharmacy
outsource
Use commercially prepared premixed
products
premixed magnesium sulfate, heparin, etc.

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 finished files are the
result of years of scientific
study combined with the
experience of many years

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 Finished Files are the
result oF years oF
scientiFic study combined
with the experience oF
many years

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 Differentiate
Use tall man lettering
DOBUTamine
DOPamine

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 Differentiate Items by Senses
Tactile cues
tape on regular insulin vial for blind diabetics;
octagonal shape of neuromuscular blocker container
Use of color
red color to draw out warnings; appearance
of solutions, tablets, etc.; color coding
Sense of smell
useful in conjunction with check systems

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 Differentiate Similar Drugs
Purchase one of the products from another
source
hydroxyzine from company B when company As
hydroxyzine 50 mg/mL injection looks similar to their
hydralazine 50 mg/mL injection
Apply upper case lettering to dissimilar portions
of the name
Use other means to make things look different or
call attention to important information
stickers, labels, enhancement with pen or marker
Dopamine vs. Dobutamine

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 Separate Problem Products
Look-alike packaging
store hydroxyzine 50 mg tablets and
hydralazine 50 mg tablets far apart
Look-alike drug names
computer mnemonics designed so similar
names do not appear on same screen i.e.,
carboplatin/cisplatin; vinblastine/vincristine not
listed in order on preprinted chemotherapy
form
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 Reminders
Place auxiliary labels on containers for
clinical warnings and error prevention
messages
check for pregnancy, lactation
note about cross allergy between aspirin and
ketorolac
reminder on Norvasc container about Navane
confusion
maximum dose warning

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 Reminders
Incorporate warnings into computer order
processing and selection of medications
from dispensing equipment
Place labels on IV lines to prevent mix-ups
between IV lines and enteral feeding lines
Protocols, checklists, visual and audible
alarms

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Sum the digits below reading
left to right:

1000+20+1000+30+1000+40+1000+10=?
 Checklists and Double-checks
Independent double-checks
Develop checklists around the use of
high alert drugs

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 Access to Information
Use computerized drug information resources
Information at point of care
Computer order entry systems that merge
patient and drug information, provide warnings,
screen orders for safety, etc.
Readily available texts in current publication
Pharmacists presence in patient care areas
Use of medical records librarian at CME and on
rounds

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 Limit Drug Use
Peer reviewed drug approval process
Restricted therapy
attending physician cosigns chemotherapy orders;
consult to specialty required
Staff credentialing
Automatic reassessment of orders or rewrites
Prescribe autostop to limit dose or duration
Use medications with reduced dosing frequency
Parameters to change IV to PO as appropriate

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 Establish Area Specific
Guidelines for Unit Stock Medications
Assess unit-specific needs and agree on
requirements, accounting for known safety issues
Standardize and purchase pharmaceuticals in
unit dose or pre-mixed containers as much as
possible
Acquire or enhance safety in use of automated
drug distribution systems
Standardize emergency equipment and
medication storage on each unit

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 Devices

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 Forcing Functions
Makes errors immediately visible. Ensures
that parts from different systems are not
interchangeable; forces proper methods of
use (lock and key design)
oral syringe should not be able to fit onto an
intravenous line
example: preprinted order forms or computer
options that force selection from limited
number of medications, available dosages,
etc.
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 Failsafe
Use products that design error out of the
system
automatic fail-safe clamping mechanism on
intravenous infusion pumps
dangerous order cant be processed in
computer system (hard stops)
smart pumps (hard stops)

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 Redundancies
Independent checks
probability that two individuals will make the
same error is small; therefore, having one
person check the work of another is essential
calculations for pediatric patients, high alert
medications, etc., performed independently
by at least two individuals, with identical
conclusions

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 Use of Defaults
Pre-established parameters take effect
unless action is taken to modify
clinical pathways
device defaults
morphine concentration default for PCA pump
Pharmacy IV compounder defaults to drug
concentrations available in pharmacy

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 FMEA for New Products
Formal safety review (e.g., formulary
committee, risk management committee)
of new medications and drug delivery
devices
examine for ambiguous or difficult to read
labeling, error-prone packaging, sound-alike
product names, etc.
use failure analysis to determining safety of
medications and devices and to guide error
prevention methods in a proactive manner

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Insanity is doing the same
things the same way and
expecting different results

Albert Einstein