Medication Error Prevention
M. Lisa Pagnucco, BS Pharm, PharmD, BCACP
Assistant Professor, Pharmacy Practice
University of New England, College of Pharmacy
mpagnucco@une.edu
September 8th, 2013
Disclosure
I have no conflicts of interest to disclose.
Objectives
1) Discuss why a culture of safety is an important
element to improve the medication use process in
any practice setting.
2) Describe one example of an error occurring at
each stage in the medication use process.
3) Explain one or more strategies used to reduce or
eliminate errors identified at each stage in the
medication use process.
Patient Safety – Adverse Events
Medication Errors
4%
18%
Patient Care
42%
Surgery or other
procedures
36%
Infection
DHHS. Office of Inspector General. (2010) Adverse Events in Hospitals: National Incidence Among Medicare
Beneficiaries. Retrieved from http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf. Last accessed July 2012.
The Problem: Scope and Cost
Preventable Medication Errors:
• Occur in 3.8 million (inpatient admissions)
• Occur in 3.3 million (outpatient visits)
• $21 billion ($21,000,000,000)
$16.4 billion (inpatient)
 $4.2 billion (outpatient)

NEHI. (2011) Preventing Medication Errors: A $21 Billion Opportunity. Retrieved from
http://www.nehi.net/bendthecurve/sup/documents/Medication_Errors_#20Brief.pdf. Last accessed July 2012.
Estimates that
30 - 50% of
$2.7 trillion annual
US healthcare spending
is……
wasteful.
http://thinkprogress.org/health/2013/01/11/1432291/surprising-root-wasteful-spending-health-care/?mobile=nc
What is an Error?
The failure of a planned action to be completed as intended (error of
execution) or the use of a wrong plan to achieve an aim (error of planning).
An error may be an act of commission or an act of omission.
Institute of Medicine, 2004
What is a Medication Error?
…. “any error occurring in the medication use process.”
Bates DW, Boyle DL, Vander Vliet MB, Schneider J, Leape L. Relationship between medication
errors and adverse drug events. J Gen Intern Med 1995;10(4): 100–205.
Error of Commission
• An act of doing something
wrong that leads to an
undesirable outcome or
significant potential for such
an outcome.
Error of Omission
• An act of failing to do
the right thing that
leads to an undesirable
outcome or significant
potential for such an
outcome.
Example:
•
Ordering a medication for a
patient with a documented
allergy to that medication.
Example:
•
Failing to prescribe VTE
prophylaxis for a patient after
hip replacement surgery
AHRQ, Patient Safety Network (PSNet), Glossary
Where Do Medication Errors Occur (%)
38%
39%
Prescribing
Transcription
Dispensing
11%
12%
Administration
Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. JAMA. 1995;274:35-43.
Where are errors caught?
Stage of
Medication Use
Errors (%)
Interception (%)
Prescribing
39%
48%
Transcription
12%
33%
Dispensing
11%
34%
Administration
38%
2%
Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. JAMA. 1995;274:35-43.
• Established by National Academy of Sciences in 1970 to
examine policy issues related to the health of the public
• The Quality of Health Care in America project (1998)

To develop a strategy for quality improvement in next ten years
• The first report from the project was released in 1999:
“To Err is Human: Building a Safer Health System”
“To Err is Human:
Building a Safer Health System”
Landmark report, 1999
•
Examined impact of medical errors
•
Identified errors are caused by faulty system
•
Processes and conditions that lead people to
make mistakes or fail to prevent them
•
Suggested national strategy for improvement
Estimated annually in US:
•
44,000 to 98,000 patient deaths from
patient care errors
•
7,000 deaths from medication errors
Institute of Medicine. To err is human:
building a safer health system.
Washington, DC: National Academy
Press, 2000.
“To Err is Human: …1999”
Strategies for Improvement
1)
Establish a national focus to create leadership, research,
tools and protocols to enhance the knowledge base about safety.
2)
Identify and learn from errors by developing a nationwide
public mandatory reporting system and by encouraging health
care organizations and practitioners to develop and participate in
voluntary reporting systems.
3)
Raise performance standards and expectations for improvements
in safety through the actions of oversight organizations, professional
groups, and group purchasers of health care.
4)
Implement safety systems in health care organizations to ensure
safe practices at the delivery level.
Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy Press, 2000.
“Crossing the Quality Chasm:
A New Health System for the 21st Century”
• Report released in 2001
• Health care harms patients frequently
• Chasm:

The divide between the current health
care and what health care could be like
• Study how the health system can be
reinvented to foster innovation and
improve the delivery of care
Institute of Medicine. Crossing the
quality chasm: a new health system
for the 21st century. Washington,
DC: National Academy Press, 2001.
“Crossing the Quality Chasm:…2001”
Strategies for Improvement
Six Aims for Improvement:
1) Safe
4) Timely
2) Effective
5) Efficient
3) Patient-centered
6) Equitable
Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century.
Washington, DC: National Academy Press, 2001.
“Preventing Medication Errors”
• Report released in 2006
• Adverse drug event (ADE):

Patient harm due to administration of a drug;
may be preventable (related to any error in the
medication use process) or non-preventable.
Hospitalized patients:
•
One medication error per patient per day
Estimated annually in US:
•
•
At least 1.5 million preventable ADEs
At a cost of $3.5 billion
Institute of Medicine. Preventing
medication errors: quality chasm
series. Washington, DC: National
Academy Press, 2006.
“Preventing Medication Errors” 2006
Strategies for Improvement
1) Improving the Patient-Provider Partnership
• Allow and encourage patients to take a more active role in their care
• Better communication with patients at all steps by all providers
2) New and Improved Drug Information Resources
• Improve consumer access to information about medications
3) Electronic Prescribing and other IT Solutions
• POC references, e-prescribing, EHR, HRO focus on medication safety
4) Drug Naming, Labeling and Packaging
• Industry and agency collaboration to improve drug nomenclature, labeling
and information sheets
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Preventing Medication Errors
Recommendation 1:
To improve the quality and safety of the medicationuse process, specific measures should be instituted
to strengthen patients’ capacities for sound
medication self-management.
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9.
Box S-3
Patient Rights
Patients have the right to:
• Be the source of control for all medication management decision that affect them
(that is, the right to self-determination).
• Accept or reject medication therapy on the basis of their personal values.
• Be adequately informed about their medication therapy and alternative treatments.
• Ask questions to better understand their medication regimen.
• Receive consultation about their medication regimen in all health settings and at all
points along the medication-use process.
• Designate a surrogate to assist them with all aspects of their medication
management.
• Expect providers to tell them when a clinical significant error has occurred, what the
effects of the event on their health (short- and long-term) will be, and what care they
will receive to restore their health.
• Ask their provider to report an adverse event and give them information about how
they can report the event themselves.
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Box S-5
Issues for Discussion with Patients by Providers
(Physicians, Nurses, and Pharmacists)
• Review the patient’s medication list routinely and during care transitions.
• Review different treatment options.
• Review the name and purpose of the selected medication.
• Discuss when and how to take the medication.
• Discuss important and likely side effects and what to do about them.
• Discuss drug-drug, drug-food, and drug-disease interactions.
• Review the patient’s or surrogate’s role in achieving appropriate medication use.
• Review the role of medications in the overall context of the patient’s health.
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Preventing Medication Errors
Recommendation 2:
Government agencies (AHRQ, CMS, FDA, NLM)
should enhance the resource base for consumeroriented drug information and medication selfmanagement support.
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9.
Preventing Medication Errors
Recommendation 3:
All health care organizations should make available
to providers patient information and decision
support tools.
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9.
Preventing Medication Errors
Recommendation 4:
Better labeling is needed, as are better methods
for communicating medication information to
consumers.
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9.
Box S-6
Drug Naming, Labeling, and Packaging Problems
• Brand names and generic names that look or sound alike
• Different formulations of the same brand and generic drug
• Multiple abbreviations to represent the same concept
• Confusing word derivatives, abbreviations, and symbols
• Unclear dose concentration/strength designations
• Cluttered labeling – small fonts, poor typefaces, no background
contrast, overemphasis on company logos
• Inadequate prominence of warnings and reminders
• Lack of standardized terminology
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Preventing Medication Errors
Recommendation 5:
Industry and government should collaborate to
establish standards affecting drug-related healthcare
information technology (HIT).
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9.
Preventing Medication Errors
Recommendation 6:
Congress should fund AHRQ to work with other
agencies to develop a broad research agenda on safe
and appropriate medication use, especially testing of
error prevention strategies.
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9*.
Preventing Medication Errors
Recommendation 7:
Oversight and regulatory organizations and payers
should use (tactics) to motivate the adoption of
practices that can reduce medication errors and
ensure that providers have needed competencies.
Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.
Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9.
“We cannot change the human condition,
but we can change the conditions
under which humans work.”
Reason J. Human Error: models and management.
BMJ 2000;320:768-770.
The Swiss Cheese model of how defences, barriers, and safeguards
may be penetrated by an accident trajectory.
Reason J. Human Error: models and management.
BMJ 2000;320:768-770.
©2000 by British Medical Journal Publishing Group
Swiss Cheese Model
Active failures
Latent failures
• Unsafe acts by persons in
direct contact with patient or
system
• Administrative level decisions
• Slips, lapses, fumbles,
mistakes, procedural
violations
• Long lasting weaknesses
• ‘Sharp end’ of process
• Should review proactively
• RN, PharmD, MD, DO, RT
• ‘Blunt end’ of process
• Error provoking conditions
• ‘Accidents waiting to happen’
Traditional Approach to Errors
• Person approach
• Fault of the individual
 Physician, nurse, pharmacist
 Trained for error-free practice
 Reinforced by “blame game”
• Trained to work without thinking
 Automatic
The Person Approach to Errors
• Focuses on unsafe acts by an individual
• Unsafe acts are result of aberrant mental processes
• Correction by reducing unwanted variability in
human behavior
• ‘Bad things happen to bad people’
The Systems Approach
High Reliability Organizations (HROs)
• Organizations operating in hazardous
conditions that have fewer than their
fair share of adverse events
• Preoccupied with possibility of
failure
• Study Safety rather than just Failures
• Rehearse scenarios of failure
• Workforce trained to expect errors,
recognize and recover from them
US Air Flight 1549
Hudson River January 2009
The Systems Approach - HROs
HROs:
Aviation, Nuclear Power, Space Travel
• Equally hazardous
• As complex as healthcare
Design a system for safety:
Assume things will fail
• Anticipate what should be done
• Non-punitive reporting system
• Encouraged to report
•
Organizational Safety Cultures
• Fear of legal or criminal actions after an error
 Associated with hiding or not reporting errors
 Reduced likelihood of sharing ‘close calls’; missed opportunities
to learn and prepare
• ‘Just culture’:
 Address system issues that lead individuals to engage in
unsafe behaviors
 Maintains individual accountability by establishing zero
tolerance for reckless behavior
 Based on type of behavior associated with error, not the
severity of error
Safety Culture Project
• A safety culture enables trust and quality improvement.
• A safety culture empowers staff to speak up about:
 Risks to patients
 Report errors and near misses
• Summary of knowledge, attitudes, behaviors and beliefs that
staff share about the importance of patient safety
• AHRQ survey 2010:
 1,032 hospitals, 472,397 hospital staff
 56% felt mistakes would be held against them
 54% had not reported any events in the previous 12 months
Errors are……..Opportunities
• Root Cause Analysis (RCA)
 AFTER an error has occurred – ‘Reactive’
 What DID happen, why, why, why?
 Use results for system/process improvements
• Failure Mode and Effects Analysis (FMEA)
 BEFORE errors occur; anticipation – ‘Proactive’
 What COULD happen, how and why?
 Build safeguards into process before change
Patient Safety Organizations
• Patient Safety and Quality Improvement Act of 2005
 Authorized creation of Patient Safety Organizations (PSOs) to
improve the quality and safety of U.S. health care delivery.
 Encourages clinicians and health care organizations to
voluntarily report and share quality and patient safety
information without fear of legal discovery.
 The Agency for Healthcare Research and Quality (AHRQ)
administers the Patient Safety Act and Rule for PSO operations.
Institute for Safe
Medication Practices (ISMP)
• Non-profit, 501c (3) organization
 Devoted to medication error prevention
and safe medication use
• ISMP is a certified PSO
• Expert analysis of errors
• Dissemination of medication error and
safe medication use information for over
35 years; column in Hospital Pharmacy
• Newsletters, seminars, consultant services
Michael Cohen,
President, ISMP
founder, Medication
Safety Expert,
Pharmacist
Index of suspicion:
• Awareness or concern for potentially serious underlying and unseen injuries
or illness
Suspicion:
• “the act or an instance of suspecting something wrong without proof or on very
slight evidence, or a state of mental uneasiness and uncertainty.”
Mindfulness:
• Defining characteristic of High Reliability Organizations (HROs)
• Sense of unease and preoccupation with failure that arises from admitting the
possibility of error, even with well-designed stable processes.
Where Do Medication Errors Occur (%)
38%
39%
Prescribing
Transcription
Dispensing
11%
12%
Administration
Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. JAMA. 1995;274:35-43.
Prescribing
Challenges
• Missing information
 References, patient, history,
labs, home meds
 Medications unfamiliar
• Distractions
 Patient cases, missing charts
 Office hours and on- call
 Pagers
• Ordering process
 NCR, verbal orders,
telephone, hand written
Improvements
• Improved information access
 Remote computer system access
 Clinical decision support systems
(CDSS)
 Electronic drug, disease information
• Electronic Health Record (EHR)
• Use of checklists, care plans
• Improved communication
 Reduced phone time; less pager use,
increased messaging and in person
 Legibility, abbreviations strategies
• Computerized Provider Order Entry
(CPOE), E-prescribing
Transcription
Challenges
• Order appearance
 Legibility, abbreviations, decimals,
spaces
• Order clarifications
 Verification of calculations
 Incomplete orders, paging
 Pertinent labs, allergies, patient
history
 Wrong patient
• Order transmission
 Verbal, facsimile, NCR
Improvements
• Safety – written and printed
 “Do Not Use Abbreviations”
 Pre-printed order forms/sets
 QI/credentialing for legibility
• Improved information access
 Computer system interfaces
 CDSS and informatics
 Improved patient demographics
• Scanning or CPOE
 Minimize use of verbal orders
 E-prescribing
ISMP Error Prone Abbreviations
http://ismp.org/Tools/errorproneabbreviations.pdf
ISMP Error Prone Dose Designations
Error Prone
Intended
‘Naked’ decimal
.5 mg
0.5 mg
Missed decimal as 5 mg leading
to 10-fold too high dose
1 mcg
Missed decimal as 10 mcg
leading to 10-fold too high dose
Trailing zero
1.0 mcg
Missing space
Tegretol300 mg
Mistaken ‘l’ as ‘1’ when
Tegretol 300 mg medication name ends with ‘l’
Missing space
100mg
Consequences
100 mg
‘m’ mistaken for zero(s), leading
to 10-100 fold error
Adapted from http://ismp.org/Tools/errorproneabbreviations.pdf
Dispensing
Challenges
• Environment
 Distractions, workload, stress,
workflow, storage, poor lighting
• Drug labels, drug names
 Look-alike, sound-alike
 Poor labels from Rx computer
 High-risk medications
• Rx system issues
 Problematic drug database
 Updates not timely
• Medication shortages
Improvements
• Process/system evaluations
 Ergonomics, lighting, reduce
distractions, redesign storage, work
flow
 Identify LASA, high-risk, use of tallman lettering
 Computer label format guidance
 Resources - system maintenance
• Staffing improvements
 Scheduling based on workload
 Technician support duties
• Technology
 Robotics, carousel, compounder, barcode verification, biometrics
Administration
Challenges
• Information: patient, drug
Improvements
• Better Information Access
 Missing age, ht/wt, allergies,
diagnoses, home medications
 Reference books outdated




• Dose admixtures and rates
 IV admixture, calculate IV rate
 Dose preparation from bulk
• Order verification
 Right order, med, patient
 Maintain manual MAR
• Distractions
 Phones, pagers, call buttons
 Missing or misplaced doses
Computer system interfaces
Point-of-Care current drug info.
CDSS pertinent lab verification
Patient identification verification
• USP 797, unit dose and TJC
• SMART pumps
•
•
•
•
•
Electronic MAR
Bar Code Medication Administration
Automated Dispensing Cabinets
Reduced interruptions/distractions
Patient engagement
Partnering with the Patient
to Prevent Medication Errors
• Invite information sharing
• Culturally competent care
• Use clear communication
• Identify interpreter needs,
hearing, or visual aids
• Assess and assist with
medication adherence
• Engage care managers
• Identify financial barriers
• Support health/wellness
• Health literacy awareness
• Facilitate safe transition
IOM Report
2006
Preventing
Medication
Errors
Patient Education
to Avoid
Medication Errors
National Patient
Safety Foundation
Key Elements to
Prevent Medication Errors
1) Create a culture of safety:




Empower staff, patients, caregivers to speak up
Report errors, near misses for process improvement
Share information about problems and solutions
Raise awareness of errors
2) Improve communication:
 Between all providers, providers and patients/caregivers
 Consider all communication forms for clarity and safety
3) Incorporate technology:
 Consider highest risk error stages early
 Engage expertise of end users before implementation
 Revisit process change often for continual quality improvement