Pilot testing of checklists to discern adverse drug reactions and adverse drug events.

OBJECTIVES: To estimate the prevalence of patient-reported adverse drug events (ADEs)/adverse drug reactions (ADRs) in the community pharmacy setting and determine the prevalence relative to pharmacist judgment. DATA SOURCES: The 2009 version of the Pharmacy Times top 200 drugs was used to identify the prescription medications most commonly used within the ambulatory population during 2008. All ADEs/ADRs for each medication were obtained by combining the ADEs/ADRs listed in Drug Facts and Comparisons, Lexi-Comp, and Micromedex. METHODS: Checklists for each pharmacologic class within the top 200 medications (n = 51) were developed, with questions about the five most common ADEs/ADRs in each class. Ten community pharmacies administered the checklists. Patients requesting a prescription refill for a medication listed in the top 200 were asked to complete a class-specific checklist to determine ADEs/ADRs experienced in the previous 4 weeks. Upon completion, pharmacists engaged in routine counseling procedures, including a discussion of patient-reported ADEs/ADRs. Pharmacists indicated if they believed, based on their clinical judgment, whether the ADE/ADR reported was related to the medication. RESULTS: 2,057 checklists were completed, with a total of 10,285 potential ADEs/ADRs. Patients reported 2,185 ADEs/ADRs (21.24%), with 755 (7.3%) definitively confirmed by the pharmacist as being related to their medication. CONCLUSION: Use of these checklists resulted in the identification of previously unrecognized ADEs/ADRs in the community setting. Routine use of these short, patient-completed checklists may assist pharmacists in earlier identification of ADEs/ADRs, which can have a positive impact on patient safety across settings.