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 storyIn the news: compounding pharmacies, acetaminophen dosing, opioid warning
7 Medication Safety Officer Job DescriptionGuide and coordinate the organization’s medication safety activitiesAnalyze data to identify trends and recommend prioritiesExamine entire medication use systemEngage key stakeholdersKnowledge expert on committeesPresent educational sessionsLarson CM, Saine D. Medication Safety Officer’s Handbook. ASHP;2013
8 New Technology Safety Challenge Computer Prescriber Order Entry (CPOE) andClinical Decision Support (CDS)Alert fatigueUnforeseen challengesBar Code Medication Administration (BCMA)WorkaroundsMissing or incorrect barcodesAutomated Dispensing Cabinets (ADC)Non-profile areasVolume of barcodesMaintenance of alertsOverride listsSmart IV PumpsBypassing drug libraryRoboticsSystem integration
9 Computerized Provider Order Entry (CPOE) and Clinical Decision Support (CDS) ProsDecreased number of steps in the medication process, pre-populated fields, etc. improves safetyProvision of clinical info related to allergy, dose, duplicate therapy, etc. improves safetyConsComplicated screensEasier to make incorrect choice in patient, drug sentenceAlert fatigueAlmost said “should” improve safety insteadComplicated screens that include FYI, many check boxes to check or uncheckDon’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 appropriateWrong patient was selected by MDPrevention methods:Only one patient MR open at onceCreate patient listHFE for patient lists
11 Bar Code Medication Administration (BCMA) Background34% of all med errors occur in administration50% of hospitals in 201125% of nursing time spent on med-related activitiesProspective before and after observational study386 bed academic teaching hospital2 medical-surgical units, 2 ICUsMed admin errors assessed by comparing observed med administered to med intended for that patientHelmons 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 agoBefore and after bcma implementedObservation 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 errorsMed-surg: overall 8% to 3.5% (p<0.0001)omissions 4% to 1% (p<0.0001)ICUs: NS, charting compliance improvedBCMA designed to prevent wrong drug, , dose, route, extra dose and omissionWrong time error rates actually increased in med surg; probably not due to bcma8 % 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 omissionsBypass alertWork-aroundsBarcode copiesWrong timeFront or back scanning for convenience, patient availabilityTo complete documentationWrong reason chosenUse barcode not scanned and scanning discrepancy reports to look for safety opportunities
16 Automated Dispensing Cabinets (ADC) Non-profile unitsOverride medicationsIncorrect medication fill – decreased with bar codesSpill overLASA medicationsReplacement by nursesQuantity to be scannedAlert fatigueNot feasible to scan every single product placed in machineMonitor override lists, and auditAlerts used for high alert, restricted etc
17 Smart IV PumpsOverride functionality – drug libraries are the core safety featureAlert fatigueLack of interfaceAlso called computerized infusion devices, or intelligent infusion devicesMedication 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 dataTrigger toolsCulture surveysPublished literature and reporting sourcesWalk aroundPharmacist clinical interventionsMed administration BCMA scan failuresBypassed alerts and overridesFailure mode and effects analysis (FMEA)Voluntary is the most recognized tool, but since many not reported, need to have additional mechanismsLiterature – can be helpful to show trends in med classes or processes
20 Voluntary ReportingReported 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;2013Should have 2 goals: maximize number of reports, and prevent harm
22 Specific Event Type Mandatory: Yes Pick List Values (Single-pick) Adverse Drug ReactionAdministration Technique IncorrectDose IncorrectDrug With Known AllergyMedication Administered Not OrderedNarcotic Count IncorrectIllegible OrderTime Incorrect/DelayedOutdated/Unusable MedicationDrug IncorrectMonitoring IssuePatient IncorrectOmissionRoute IncorrectStorage IncorrectDrug Preparation IssuePump Programming IssueDocumentation ErrorOther (please specify)
23 Contributing Factors Mandatory: No Pick List Values (Multi-pick): Medication Not AvailableDistractions/Interruptions Monitoring – Vital Signs Not CheckedPatient UnavailableIncomplete/Ambiguous OrderPreparation – Delayed DeliveryPreparation – Wrong Drug/Dose/StrengthTranscription Issue – Incorrect Computer Order EntryTranscription – Order Not Entered In Computer SystemDrug Info Missing – Inadequate Medication Reconciliation ProcessPatient Info Missing – AllergiesPatient Info Missing – Lab ValuesPatient Info Missing – WeightOther (please specify)Communication/Handoff FailureCompetency of StaffLack of Training/EducationInsufficient StaffAction by Family Member/CaregiverAction by PatientPolicy/Procedure IssuePhysical Environment Condition/DesignInsufficient Monitoring/SupervisionWork Environment-FatigueLanguage BarrierAdministration Issue/Calculation ErrorDrug 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 processAdverse Drug EventAn undesirable occurrence associated with a medicationAdverse Drug ReactionAn 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 errorsADRs can’t be prevented- are not med errors
26 Interpretation Near Misses are Med Errors ADRs are not Med Errors Caught by chanceCaught by following a safety processADRs are not Med ErrorsAll ADRs are ADEsNot all ADEs are ADRsFocus and follow up is differentInvolves patient managementFuture prevention and educationReporting if necessary
28 Med ADE Errors C, D ADR E - I Near Miss B Why important : Near misses are med errorsADRs can’t be prevented- are not med errors
29 Purpose of Nomenclature and Definitions Communication within institutions and corporationsRegulatory self-assessmentTrending and consolidationMonitoring performanceBenchmarkingConsolidation: 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 phaseNow it’s time to take action
31 How to Set PrioritiesNational Coordinating Council on Medication Error Reporting and Prevention (NCC MERP) – Categories A – ICauses of a level where harm occurred often also seen in near misses
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 setsPerformed FMEA to evaluate the processes involved in the transcription and administration of insuinScored each step in process for what could go wrong, potential effect, and severity of that effectAlso 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 gapLook at what occurred and how it should have occurredMake list of contributing factors
35 Just CultureWhack-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 CultureWe 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.AlgorithmPage 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 handoffSituation, Background, Assessment, Recommendation (SBAR)Handoff ChecklistCatch phrasesMultidisciplinary or team safety meetingsTechnologyCatch of the MonthDouble Checks
41 Double CheckThe 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 belowTech places HEPARIN sticker on bag; pharmacist initials when checksTech ran out of bags, placed HEPARIN sticker on additional bags that were not checked by pharmacistAdditional 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 patientChallenge: when does technology suffice
45 Learn from captured errors. Document mistakes discovered during double checksAnalyze to understand the reasons behind themIdentify precautions that need to be takenNot doing so has resulted in fatal errors
46 What is your action plan? Pharmacy director – claimed had passion; don’t all rphsWe can all documentSpeak up and coach your coworkersRecommend changes to documentation toolRecognition – safety star, catch of the week/monthLook at what works, and use in other areasNewsletterMorbidity and mortality roundsBe informed – ismpLook at what we (rph, rn, etc) as group or individual are doing rightAt minimum – complete safety reports