1. Medication Error Prevention
M. Lisa Pagnucco, BS Pharm, PharmD, BCACP Assistant Professor, Pharmacy Practice University of New England, College of Pharmacy
September 8th, 2013

2. Disclosure
I have no conflicts of interest to disclose.

3. Objectives
Discuss why a culture of safety is an important element to improve the medication use process in any practice setting.
Describe one example of an error occurring at each stage in the medication use process.
Explain one or more strategies used to reduce or eliminate errors identified at each stage in the medication use process.

4. Patient Safety – Adverse Events
DHHS. Office of Inspector General. (2010) Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries. Retrieved from Last accessed July 2012.

5. 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 Last accessed July 2012.

6. Estimates that 30 - 50% of $2.7 trillion annual US healthcare spending is……
wasteful.

7. What is a Medication Error?
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.

8. Error of Commission Error of Omission
An act of doing something wrong 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.
An act of failing to do the right thing that leads to an undesirable outcome or significant potential for such an outcome.
Example:
Failing to prescribe VTE prophylaxis for a patient after hip replacement surgery
AHRQ, Patient Safety Network (PSNet), Glossary

9. Where Do Medication Errors Occur (%)
Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. JAMA. 1995;274:35-43.

10. 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.

11. 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”

12. “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.

13. “To Err is Human: …1999” Strategies for Improvement
Establish a national focus to create leadership, research, tools and protocols to enhance the knowledge base about safety.
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.
Raise performance standards and expectations for improvements in safety through the actions of oversight organizations, professional groups, and group purchasers of health care.
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.

14. “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.

15. “Crossing the Quality Chasm:…2001” Strategies for Improvement
Six Aims for Improvement:
Safe
Effective
Patient-centered
Timely
Efficient
Equitable
Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press, 2001.

16. “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.

17. “Preventing Medication Errors” 2006 Strategies for Improvement
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
New and Improved Drug Information Resources
Improve consumer access to information about medications
Electronic Prescribing and other IT Solutions
POC references, e-prescribing, EHR, HRO focus on medication safety
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.

18. Preventing Medication Errors
Recommendation 1:
To improve the quality and safety of the medication- use 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.

19. 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.

20. Issues for Discussion with Patients by Providers
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.

21. Preventing Medication Errors
Recommendation 2:
Government agencies (AHRQ, CMS, FDA, NLM) should enhance the resource base for consumer-oriented drug information and medication self-management 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.

22. 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.

23. 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.

24. Drug Naming, Labeling, and Packaging Problems
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.

25. 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.

26. 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*.

27. 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.

28. “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:

29. 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:
©2000 by British Medical Journal Publishing Group

30. Swiss Cheese Model Active failures Latent failures
Unsafe acts by persons in direct contact with patient or system
Slips, lapses, fumbles, mistakes, procedural violations
‘Sharp end’ of process
RN, PharmD, MD, DO, RT
Administrative level decisions
Error provoking conditions
Long lasting weaknesses
‘Accidents waiting to happen’
Should review proactively
‘Blunt end’ of process

31. 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

32. 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’

33. High Reliability Organizations (HROs)
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

34. 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

35. 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

36. 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

37. 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

38. 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.

39. 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

40. Suspicion: Mindfulness: 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.

41. Where Do Medication Errors Occur (%)
Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. JAMA. 1995;274:35-43.

42. Prescribing Challenges Improvements 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
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

43. Transcription Improvements 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
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

44. ISMP Error Prone Abbreviations

45. ISMP Error Prone Dose Designations
Intended
Consequences
‘Naked’ decimal
.5 mg
0.5 mg
Missed decimal as 5 mg leading to 10-fold too high dose
Trailing zero
1.0 mcg
1 mcg
Missed decimal as 10 mcg leading to 10-fold too high dose
Missing space
Tegretol300 mg
Tegretol 300 mg
Mistaken ‘l’ as ‘1’ when medication name ends with ‘l’
100mg
100 mg
‘m’ mistaken for zero(s), leading to fold error
Adapted from

46. Dispensing Improvements Challenges Environment Drug labels, drug names
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
Process/system evaluations
Ergonomics, lighting, reduce distractions, redesign storage, work flow
Identify LASA, high-risk, use of tall-man lettering
Computer label format guidance
Resources - system maintenance
Staffing improvements
Scheduling based on workload
Technician support duties
Technology
Robotics, carousel, compounder, bar-code verification, biometrics

47. Administration Challenges Improvements Information: patient, drug
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
Better Information Access
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

48. Partnering with the Patient to Prevent Medication Errors
Invite information sharing
Use clear communication
Assess and assist with medication adherence
Identify financial barriers
Health literacy awareness
Culturally competent care
Identify interpreter needs, hearing, or visual aids
Engage care managers
Support health/wellness
Facilitate safe transition

49. IOM Report 2006 Preventing Medication Errors
Patient Education to Avoid Medication Errors

52. National Patient Safety Foundation

53. Key Elements to Prevent Medication Errors
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
Improve communication:
Between all providers, providers and patients/caregivers
Consider all communication forms for clarity and safety
Incorporate technology:
Consider highest risk error stages early
Engage expertise of end users before implementation
Revisit process change often for continual quality improvement