Characterizing and Comparing Adverse Drug Events Documented in 2 Spontaneous Reporting Systems in the Lower Mainland of British Columbia, Canada: Retrospective Observational Study.

BACKGROUND: Robust adverse drug event (ADE) reporting systems are crucial to monitor and identify drug safety signals, but the quantity and type of ADEs captured may vary by system characteristics. OBJECTIVE: We compared ADEs reported in 2 different reporting systems in the same jurisdictions, the Patient Safety and Learning System-Adverse Drug Reaction (PSLS-ADR) and ActionADE, to understand report variation. METHODS: This retrospective observational study analyzed reports entered into PSLS-ADR and ActionADE systems between December 1, 2019, and December 31, 2022. We conducted a comprehensive analysis including all events from both reporting systems to examine coverage and usage and understand the types of events captured in both systems. We calculated descriptive statistics for reporting facility type, patient demographics, serious events, and most reported drugs. We conducted a subanalysis focused on adverse drug reactions to enable direct comparisons between systems in terms of the volume and events reported. We stratified results by reporting system. RESULTS: We performed the comprehensive analysis on 3248 ADE reports, of which 12.4% (375/3035) were reported in PSLS-ADR and 87.6% (2660/3035) were reported in ActionADE. Distribution of all events and serious events varied slightly between the 2 systems. Iohexol, gadobutrol, and empagliflozin were the most common culprit drugs (173/375, 46.2%) in PSLS-ADR, while hydrochlorothiazide, apixaban, and ramipril (308/2660, 11.6%) were common in ActionADE. We included 2728 reports in the subanalysis of adverse drug reactions, of which 12.9% (353/2728) were reported in PSLS-ADR and 86.4% (2357/2728) were reported in ActionADE. ActionADE captured 4- to 6-fold more comparable events than PSLS-ADR over this study's period. CONCLUSIONS: User-friendly and robust reporting systems are vital for pharmacovigilance and patient safety. This study highlights substantial differences in ADE data that were generated by different reporting systems. Understanding system factors that lead to varying reporting patterns can enhance ADE monitoring and should be taken into account when evaluating drug safety signals.

Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes.

INTRODUCTION: Adverse drug events (ADEs) are a leading cause of unplanned hospital visits. We designed ActionADE, an online ADE reporting platform, and integrated it with PharmaNet, British Columbia's (BC's) provincial medication dispensing system, to overcome identified barriers in ADE reporting and communicate ADEs to community pharmacies. Our objectives were to characterise ADEs reported in ActionADE, explore associations between patients' age, sex and ADE characteristics, and estimate the re-dispensation rate of culprit medications in community pharmacies. METHODS: We conducted a prospective observational study of ADE reporting in four BC hospitals between April 1, 2020 and October 31, 2022. We described the characteristics of ADEs reported into ActionADE, used logistic regression modelling to examine associations between age and sex and ADE characteristics, and calculated rates of avoided culprit drug re-dispensations using community pharmacists' responses to ActionADE alerts. RESULTS: In total, 3591 ADE reports were initiated by hospital clinicians, 3174 of which were included in this analysis. Serious or life-threatening ADEs resulting in permanent disability, hospitalisation, extended hospitalisation, and/or death accounted for 28.5% (906/3174; 95% CI 27.0-30.1%) of reports. Males were more likely to have non-adherence reported compared to females and experienced life threatening ADEs at a younger age than females. Of 592 patients who had ≥ 1 adverse drug reaction or allergy report (a subset of ADEs) transmitted to community pharmacies, 200 subsequently attempted to re-fill the culprit or a same class drug. Community pharmacists responded to preventative alerts by avoiding re-dispensation in 33.0% (66/200; 95% CI 26.5-39.5%). INTERPRETATION: ActionADE is the first interoperable system that communicates ADEs via a central medication database to community pharmacies. Every 10th ADE reported in ActionADE and shared to PharmaNet resulted in community pharmacists' avoiding one culprit or same class drug re-exposure. Further research is needed to understand ActionADE's impact on patient and health system outcomes.