1. Medication Error Prevention in 2014
Wendy Perry, Pharm.D.
September 28, 2013

2. Objectives Describe a Medication Safety Officer’s responsibilities.
List new safety challenges that are a result of technological advances.
Discuss the mechanisms for obtaining medication error data.
Describe a data analysis process and appropriate follow up.
Define “Just Culture.”
Discuss methods to reduce medication errors.

3. Why Medication Error Prevention in 2014?
It’s my passion story
In the news: compounding pharmacies, acetaminophen dosing, opioid warning

7. Medication Safety Officer
Job Description
Guide and coordinate the organization’s medication safety activities
Analyze data to identify trends and recommend priorities
Examine entire medication use system
Engage key stakeholders
Knowledge expert on committees
Present educational sessions
Larson CM, Saine D. Medication Safety Officer’s Handbook. ASHP;2013

8. New Technology Safety Challenge
Computer Prescriber Order Entry (CPOE) and
Clinical Decision Support (CDS)
Alert fatigue
Unforeseen challenges
Bar Code Medication Administration (BCMA)
Workarounds
Missing or incorrect barcodes
Automated Dispensing Cabinets (ADC)
Non-profile areas
Volume of barcodes
Maintenance of alerts
Override lists
Smart IV Pumps
Bypassing drug library
Robotics
System integration

9. Computerized Provider Order Entry (CPOE) and Clinical Decision Support (CDS)
Pros
Decreased number of steps in the medication process, pre-populated fields, etc. improves safety
Provision of clinical info related to allergy, dose, duplicate therapy, etc. improves safety
Cons
Complicated screens
Easier to make incorrect choice in patient, drug sentence
Alert fatigue
Almost said “should” improve safety instead
Complicated screens that include FYI, many check boxes to check or uncheck
Don’t know what you don’t know, as far as challenges with cpoe

10. Post – CPOE 1 st PSE received: Wrong Patient
Order for insulin received by pharmacist who was familiar with patient and recognized not appropriate
Wrong patient was selected by MD
Prevention methods:
Only one patient MR open at once
Create patient list
HFE for patient lists

11. Bar Code Medication Administration (BCMA)
Background
34% of all med errors occur in administration
50% of hospitals in 2011
25% of nursing time spent on med-related activities
Prospective before and after observational study
386 bed academic teaching hospital
2 medical-surgical units, 2 ICUs
Med admin errors assessed by comparing observed med administered to med intended for that patient
Helmons PJ. Effect of bar-code-assisted medication administration on medication administration errors and accuracy in multiple patient care areas. Am J Health-Syst Pharm. 2009;66:
Compared with 5% hospitals using bcma 10 years ago
Before and after bcma implemented
Observation thought to be best method, but of course knew being watched Hawthorne effect (altered behavior)

12. Results Error rate = # of errors total opportunities for error
Separated wrong time errors from other errors
Med-surg: overall 8% to 3.5% (p<0.0001)
omissions 4% to 1% (p<0.0001)
ICUs: NS, charting compliance improved
BCMA designed to prevent wrong drug, , dose, route, extra dose and omission
Wrong time error rates actually increased in med surg; probably not due to bcma
8 % to 3.5 % is a 58% decrease

14. Raising the Bar for BCMA: Addressing Pharmacy Challenges, Nursing
Engagement, and Data Analysis to Improve Practice; Beaumont Hospital; ISMP Webinar 2013.

15. BCMA Safety Opportunities
Scanning omissions
Bypass alert
Work-arounds
Barcode copies
Wrong time
Front or back scanning for convenience, patient availability
To complete documentation
Wrong reason chosen
Use barcode not scanned and scanning discrepancy reports to look for safety opportunities

16. Automated Dispensing Cabinets (ADC)
Non-profile units
Override medications
Incorrect medication fill – decreased with bar codes
Spill over
LASA medications
Replacement by nurses
Quantity to be scanned
Alert fatigue
Not feasible to scan every single product placed in machine
Monitor override lists, and audit
Alerts used for high alert, restricted etc

17. Smart IV Pumps
Override functionality – drug libraries are the core safety feature
Alert fatigue
Lack of interface
Also called computerized infusion devices, or intelligent infusion devices
Medication Safety Officers Handbook references a report that states smart IV pumps could prevent 97% of pump programming errors p234

18. Tools to Identify Safety Needs
Voluntary reporting data
Trigger tools
Culture surveys
Published literature and reporting sources
Walk around
Pharmacist clinical interventions
Med administration BCMA scan failures
Bypassed alerts and overrides
Failure mode and effects analysis (FMEA)
Voluntary is the most recognized tool, but since many not reported, need to have additional mechanisms
Literature – can be helpful to show trends in med classes or processes

20. Voluntary Reporting
Reported medication error rates are simply a measure of the ability of the organization to recognize and report medication-related problems.
Therefore, an organization with a large number of error reports may actually (and in many cases is likely to) have a lower true underlying medication error rate than an organization where few reports are received, analyzed, and acted on.
Larson CM, Saine D. Medication Safety Officer’s Handbook. ASHP;2013
Should have 2 goals: maximize number of reports, and prevent harm

22. Specific Event Type Mandatory: Yes Pick List Values (Single-pick)
Adverse Drug Reaction
Administration Technique Incorrect
Dose Incorrect
Drug With Known Allergy
Medication Administered Not Ordered
Narcotic Count Incorrect
Illegible Order
Time Incorrect/Delayed
Outdated/Unusable Medication
Drug Incorrect
Monitoring Issue
Patient Incorrect
Omission
Route Incorrect
Storage Incorrect
Drug Preparation Issue
Pump Programming Issue
Documentation Error
Other (please specify)

23. Contributing Factors Mandatory: No Pick List Values (Multi-pick):
Medication Not Available
Distractions/Interruptions Monitoring – Vital Signs Not Checked
Patient Unavailable
Incomplete/Ambiguous Order
Preparation – Delayed Delivery
Preparation – Wrong Drug/Dose/Strength
Transcription Issue – Incorrect Computer Order Entry
Transcription – Order Not Entered In Computer System
Drug Info Missing – Inadequate Medication Reconciliation Process
Patient Info Missing – Allergies
Patient Info Missing – Lab Values
Patient Info Missing – Weight
Other (please specify)
Communication/Handoff Failure
Competency of Staff
Lack of Training/Education
Insufficient Staff
Action by Family Member/Caregiver
Action by Patient
Policy/Procedure Issue
Physical Environment Condition/Design
Insufficient Monitoring/Supervision
Work Environment-Fatigue
Language Barrier
Administration Issue/Calculation Error
Drug Name Confusion(e.g. Look Alike & Sound Alike)

24. ADR vs ADE Medication Error Adverse Drug Event Adverse Drug Reaction
A preventable error occurring in any step of the medication process
Adverse Drug Event
An undesirable occurrence associated with a medication
Adverse Drug Reaction
An idiosyncratic reaction or other adverse effect of a medication that is not preventable

25. Med ADE Errors Near Miss ADR Why important :
Near misses are med errors
ADRs can’t be prevented- are not med errors

26. Interpretation Near Misses are Med Errors ADRs are not Med Errors
Caught by chance
Caught by following a safety process
ADRs are not Med Errors
All ADRs are ADEs
Not all ADEs are ADRs
Focus and follow up is different
Involves patient management
Future prevention and education
Reporting if necessary

28. Med ADE Errors C, D ADR E - I Near Miss B Why important :
Near misses are med errors
ADRs can’t be prevented- are not med errors

29. Purpose of Nomenclature and Definitions
Communication within institutions and corporations
Regulatory self-assessment
Trending and consolidation
Monitoring performance
Benchmarking
Consolidation: Some problem areas are subtle – only show up over time

30. Don’t get overwhelmed with data collection and/or analysis
The most important aspect of medication safety is to apply what has been learned to implement changes in the organization to decrease the potential for harm to patients.
We have been in a technology phase
Now it’s time to take action

31. How to Set Priorities
National Coordinating Council on Medication Error Reporting and Prevention (NCC MERP) – Categories A – I
Causes of a level where harm occurred often also seen in near misses

32. Data Analysis Departmental Interdisciplinary Committee
Event Type: Pump Programming
Contributing Factor: Hand-off Failure
Severity: E-I
Medication: Insulin
Location: 5NE
Interdisciplinary Committee
Medication Management: Nursing and Pharmacy, monthly
Hospital Committee E-I
Patient Safety Event Review: Multidisciplinary, biweekly
Quality Department
Root Cause Analysis (RCA)

33. Tools from Highly Reliable Industries
Failure Mode and Effects Analysis (FMEA)
FMEA is an ongoing quality improvement process that is carried out in healthcare organizations by a multidisciplinary team. It can be employed to examine the use of new products and the design of new services and processes to determine points of potential failure and what their effect would be – before any error actually happens. FMEA is a proactive process used to look more carefully and systematically at vulnerable areas or processes. In this regard, FMEA differs from Root Cause Analysis (RCA).
2007 several MORs with insulin over short period of time, particulary after implementation of new order sets
Performed FMEA to evaluate the processes involved in the transcription and administration of insuin
Scored each step in process for what could go wrong, potential effect, and severity of that effect
Also March 2009 infusion pump FMEA – buddy assignments for pump check; require use of library function

34. 2. Root Cause Analysis (RCA)
Usually RCA is a reactive process, employed after an error occurs, to identify its underlying causes.
Required by The Joint Commission for sentinel events, defined as “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.”
Includes an action plan, and monitoring the effectiveness of the plan.
Can also be an aggregate RCA, if trend has been identified, to address a gap
Look at what occurred and how it should have occurred
Make list of contributing factors

35. Just Culture
Whack-a-Mole by David Marx, J.D This book argues that our Whack-a-Mole approach to inevitable and often predictable human error is ineffective, inefficient, and unjust; it does nothing to enable us to learn what we might do differently next time, or what systems we might put in place to minimize the chances of causing the same adverse outcome again.

36. Just Culture
We spend far too much time looking at the severity of the adverse outcome (how bad was it?) and who was the unfortunate soul to be closest to the harm. In turn, we spend far too little time addressing the system design that got us there and the behavioral choices of the humans in those systems that might have ultimately contributed to the adverse outcome.

37. Just Culture The Behaviors We Can Expect:
Human error -inadvertent action; inadvertently doing other that what should have been done; slip, lapse, mistake.
At-risk behavior –behavioral choice that increases risk where risk is not recognized or is mistakenly believed to be justified.
Reckless behavior -behavioral choice to consciously disregard a substantial and unjustifiable risk.

38. Just Culture Console the human error. Coach the at-risk behavior.
Punish the reckless behavior.
Independent of the outcome.
Algorithm
Page 55

39. It’s About Changing Staff Expectations (from Just Culture literature)
Looking for the risks around me
• Reporting errors and hazards
• Helping to design safe systems
• Making safe choices
–Following procedure
–Making choices that align with organizational values
–Never signing for something that was not done

40. Error Prevention Strategies
Improve communication and handoff
Situation, Background, Assessment, Recommendation (SBAR)
Handoff Checklist
Catch phrases
Multidisciplinary or team safety meetings
Technology
Catch of the Month
Double Checks

41. Double Check
The virtues of independent double checks – they really are worth your time!
ISMP December 17, The average “checking error rate” (errors missed during a double-check) is about 5%. In studies where “artificial errors” were introduced into medication carts and sample pharmacy orders, 93% to 97% of such mistakes were identified during an independent double-check.

42. Double-checks work best when they are conducted independently.
The person checking has to form an independent judgment without cues from the person doing the initial work (why ISMP encourages “independent double-checks”).
It would be more effective, for example, to have two people calculate a dose separately and then compare their answers, than to have them perform the calculation together or to have one share his answer with the other before the double-check occurs.
People may be swayed by the opinions of others, even more so if the other person holds a position of authority or has more experience.

43. Heparin 25,000 units/500 ml standard solution
Store in high risk section; boxes placed below
Tech places HEPARIN sticker on bag; pharmacist initials when checks
Tech ran out of bags, placed HEPARIN sticker on additional bags that were not checked by pharmacist
Additional bags were actually Lidocaine

44. Limit checks to high-risk situations
While it’s true that independent double-checks are not as effective as system changes that make it hard for people to make mistakes, if performed properly, they can reduce the risk of an error reaching the patient
Challenge: when does technology suffice

45. Learn from captured errors.
Document mistakes discovered during double checks
Analyze to understand the reasons behind them
Identify precautions that need to be taken
Not doing so has resulted in fatal errors

46. What is your action plan?
Pharmacy director – claimed had passion; don’t all rphs
We can all document
Speak up and coach your coworkers
Recommend changes to documentation tool
Recognition – safety star, catch of the week/month
Look at what works, and use in other areas
Newsletter
Morbidity and mortality rounds
Be informed – ismp
Look at what we (rph, rn, etc) as group or individual are doing right
At minimum – complete safety reports