Risk-Informed Interventions in Community Pharmacy: Implementation and Evaluation

1. Risk-Informed Interventions in Community Pharmacy: Implementation and Evaluation Michael R. Cohen (Principal Investigator) Judy L. Smetzer (Project Manager) Institute for Safe Medication Practices September 14, 2009

2. Current Research Project Risk-informed Interventions in Community Pharmacy: Implementation and Evaluation Three interventions • Scripted mandatory patient counseling for targeted high-alert medications • Readiness assessment for bar-coding technology • Risk assessment/intervention scorecard

3. Prior Study Aims Using Risk Models to Identify and Prioritize Outpatient High-Alert Medications • Identify a list of high-alert medications dispensed from community pharmacies • Available error data, ISMP surveys, review of literature, litigation data, • Develop comprehensive risk models for four high-alert medications (ST-PRA) using model building teams with facilitators • Warfarin, fentanyl transdermal, insulin analogs, methotrexate oral • Identify error pathways that have the highest probability of causing harm (fault trees) • Identify and determine the impact of approaches for eliminating or reducing the risk of harm

4. High-Alert Medications Individual Drugs • carbamazepine • chloral hydrate liquid • sedation of children • heparin • unfractionated/low-molecular weight • methotrexate • non-oncologic use • midazolam liquid • sedation of children • propylthiouracil • warfarin Drug Class/Category • Antiretroviral agents • Chemotherapy, oral • Hypoglycemic agents, oral • Immunosuppressant agents • Insulin • Opioids, all formulations • Pregnancy category X drugs • Pediatric liquid medications that require measurement

5. Socio-Technical Probabilistic Risk Assessment (ST-PRA) • Models combinations of failures that lead to undesirable consequence (Relex software) • Used in other industries • Differs from FMEA, which analyzes each failure separately, never in combination (pharmacy dispensing process) • Begins by defining the “top-level event” (PADE) • Medication dispensed to wrong patient at point of sale • Patient given wrong dose of warfarin • Uses experienced modeling team to yield probability estimates of “basic events”

6. Socio-Technical Probabilistic Risk Assessment (ST-PRA) • Risk model includes effects of: • Human error • Socio-technical aspects • At-risk behaviors and procedural deviations • Mechanical/technology failures • Some data readily available in community pharmacies • Rx volume, exposure rates, technologies and percent of use, computer alerts followed, presence of certain steps or processes like use of drive through window, availability of 24 hr pharmacy, opening bag at P.O.S.

7. Example of ST-PRA Fault Tree Risk Model Medication dispensed to wrong customer at the point-of-sale Top Level Event Gate1 And Gate Q:0.0014 Medication given to wrong Wrong customer not detected customer at the point-of-sale Gate2 Gate3 OR Gate And Gate Q:0.0034 Q:0.41 Wrong customer's medications selected by pharmacy Medication was placed in Pharmacy staff do not detect Customer does not catch at point-of-sale when dispensing medication wrong customer's bag identification error at point-of-sale identification error at point-of-sale Event1 Event2 Gate6 Event3 Initiating Errors OR Gate Basic Event Q:0.003 Q:0.0004 Q:0.45 Q:0.9 Identification error not caught when Identification error not caught when customer following customer identification process identification process not followed Gate4 Gate5 And Gate And Gate Q:0.0005 Q:0.45 Exposure rate of following Pharmacy staff fail to detect the error when Exposure rate for not following Pharmacy staff fail to detect the error when customer identification process following customer identification process customer identification process customer identification process does not occur Event4 Event5 Event6 Event7 Q:0.5 Q:0.001 Q:0.5 Q:0.9 Exposure Rate Basic Event Exposure Rate Basic Event

8. Unfamiliar task performed at speed/no idea of consequences 5:10 Task involving high stress levels 3:10 Complex task requiring high comprehension and skill 15:100 Select ambiguously labeled control/package 5:100 Failure to perform a check correctly 5:100 Error in routine operation when care required 1:100 Well designed, familiar task under ideal conditions 4:10,000 Human performance limit 1:10,000 Human Error Probabilities ST-PRA uses probability estimates to quantify risk

9. Performance shaping factors that impact on probability of error in community pharmacy • Task complexity • Information complexity • Work environment • Stress • Time urgency • Training/experience • Familiarity with task • Design of labels • Clarity of handwritten prescriptions • Look-alike drug names or packages

10. Insulin Analog Data Entry Error (wrong drug) • Start • 1 data entry error per 100 prescriptions • Capture • 96% errors captured • Risk (PADEs that reach patients) • 3 wrong drug errors per 10,000 prescriptions • 2,200 errors annually (chains in study) • 6,400 errors annually (national)

11. Insulin Analog Data Entry Error (wrong drug) • Interventions • Use of tall man letters to distinguish products • 50% improvement • Increase patient counseling from 30% to 80% • 67% improvement • Conduct a second redundant data entry verification during product verification • 50% improvement • All three interventions • 95% improvement • 3/10,000 to 1/1 million errors that reach patients

12. Fentanyl Patches Prescribing Errors(wrong dose) • Start • 1 dose error per 1,000 prescriptions • Capture • 27% errors • Lack of information about opioid tolerance, indication • Risk (PADEs that reach patients) • 7 dose errors per 10,000 prescriptions • 1,000 errors annually (chains in study) • 3,400 errors annually (national)

13. Fentanyl Patches Prescribing Errors(wrong dose) • Interventions • Increase in patient counseling from 10% to 80% and increase ability to detect inappropriate doses during counseling session • 64% improvement • Conduct an intake history of opioid use at drop-off • 40% improvement (tested with 20% implementation) • Both interventions • 78% improvement • 7/10,000 to 1/10,000 errors that reach patients

14. Warfarin Filling Errors (drug/dose) • Start • 1 drug selection error per 1,000 prescriptions • 1 dose selection error per 10 prescriptions • Capture • 99.9% errors • Consistent use of bar-coding technology • Risk (PADEs that reach patients) • 9 wrong drug errors/1 billion prescriptions • 1 error every 14 years (chains in study only) • 9 wrong dose errors/10 million prescriptions • 7 errors annually (chains in study only)

15. Warfarin Filling Errors (drug/dose) • Interventions • Increase patient counseling from 30% to 80% • 67% improvement • 9/1 billion to 3/1 billion errors reach pt (drug) • 9/10 million to 3/10 million errors reach pt (dose) • Eliminate bar-coding technology • (95,340%) reduction in safety • Eliminate pill image on the product verification screen • (334%) reduction in safety • Eliminate bar-coding and pill image • (445,000%) reduction in safety • 9/1 billion to 4/100,000 errors that reach pt (drug) • 9/10 million to 4/1,000 errors that reach pt (dose)

16. All Medications Point of Sale Error(wrong patient) • Start • Due to bagging error (4 per 10,000 prescriptions) • Due to misidentification of bag or patient (3 per 1,000 prescriptions) • Captured • 64% errors captured • Risk (PADEs that reach patients) • 1 error per 1,000 prescriptions • 1.3 million errors annually (chains in study) • 4 million errors annually (national)

17. All Medications Point of Sale Error(wrong patient) • Interventions • Increase patient counseling from 30% to 50% • 27% improvement • Open the bag at the POS • 56% improvement • Increase compliance with ID process from 50% to 80% • 34% improvement • All three interventions together • 86% improvement • 1/1,000 to 2/10,000 errors that reach patients

18. Current Research Project Risk-informed Interventions in Community Pharmacy: Implementation and Evaluation • Scripted mandatory patient counseling • Warfarin • Fentanyl patches • Methotrexate • Insulin analogs • Low-molecular weight heparin* • Hydrocodone and oxycodone (with acetaminophen) – top 200* • Readiness assessment for bar-coding technology • Risk assessment/intervention scorecard using risk models from first study: HAMERS tool * Added to increase frequency of observation of counseling sessions

19. Intervention 3: HAMERS(High-Alert Medication Error Risk Scorecard) • ST-PRA models translated into practical assessment tool and scorecard • Tool Kit will include: • Introduction • Key learning from risk models (prior study) • User instructions • HAMERS tool • Scorecard with qualitative (distribution of risk) and quantitative (PADE rates) information • Tool calculations driven by reports from original risk models

20. Intervention 3: HAMERS Inputs • Set-up questions • Relevance: Would the step provide capture opportunity? • System attributes: Require data entry verification for pharmacists? • Availability: Use bar-coding technology? Specific computer alerts? • Prescription volumes? • Exposure rates • Frequency of pharmacists/technicians entering prescriptions? • Capture opportunities • What percent of errors will be caught during this step? • At-risk behaviors • Frequency of choosing not to ask patient for second identifier? • Human errors • Frequency of forgetting to read back an oral prescription?

21. Intervention 3: HAMERS Outputs • Scorecard that quantifies the risk of specific PADEs • Bar-graph that shows distribution of risk • Which elements contribute most to the PADE? • Menu of interventions to reduce risk • Pharmacy chooses from the menu of interventions • Pharmacy makes changes to inputs based on the planned interventions • Pharmacy receives a revised scorecard that quantifies improvements based on planned interventions • “If (intervention) is implemented, then risk that the PADE will reach the patient is ___%.” • If risk factor is (increased/decreased) by __%, risk that the PADE will reach the customer is reduced to __%.”

22. Intervention 3: HAMERS • Tool can be used to measure risk within dispensing system for any medication or most types of errors/ PADEs • Focus on high-alert medications • Can measure risk of not capturing prescribing errors • Cannot measure risk of patient self-administration • Limited menu of interventions • General in nature • Specific to high-alert medications • Include all tested interventions from prior study and others

23. Intervention 1: Patient Counseling • Pre-intervention observation in pharmacies • 50 observations completed • 4 states • 2 states with mandatory counseling • 2 states with mandatory offer to counsel • Preliminary findings • No counseling in states with “offer” to counsel • Counseling for OTCs more common than for prescription drugs • More frequent counseling in states with mandatory counseling • Differences between state enforcement of counseling • Not covering information linked to PADEs

24. Intervention 1: Patient Counseling • Implementation Tool Kit • Scripted counseling materials, checklists, health questions • Consumer handouts about targeted drugs • Specifically targets known causes of PADEs • Consumer outreach materials to promote counseling • Availability on http://www.consumermedsafety.org • Model state regulations for requiring/limiting mandatory counseling for high-alert drugs

29. Intervention 1: Patient Counseling Measures • Self-administered surveys to patients • Perception of counseling encounter/value of handouts • Increase understanding? • Result in new information? • Result in changed behavior? • Reduce risk of self-administration error? • Treatment for PADE? • Toll-free number to call research team • Incentives to send back survey • Self-administered surveys to pharmacists • Perceived value and impact of counseling

30. Intervention 1: Patient Counseling Measures (cont’d) • Post-implementation observation • Detection of prescribing or dispensing errors • Detection of potential self-administration errors • Barriers to counseling • Factors that facilitate counseling • Quality of counseling sessions

31. Intervention 2: Bar-coding Readiness Assessment • 46-50% of community pharmacies in the US do not use barcode technology for product verification • 100 pharmacies participating in the study • Survey to determine why non-users are still non-users • Phase 1 • 100 pharmacies will complete the assessment and submit findings • Pharmacies will complete survey to measure perceived value • Phase 2 • Pharmacies from Phase 1 that have since implemented bar-coding will complete survey to measure actual value