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

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.

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

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

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

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

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

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;66:1202-10. 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)

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

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

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

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

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

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

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

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)

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)

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

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

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

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

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

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

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

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)

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

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

Just Culture Whack-a-Mole by David Marx, J.D. 2009 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.

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.

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.

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

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

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

Double Check The virtues of independent double checks – they really are worth your time! ISMP December 17, 2009 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.

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.

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

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

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

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