Accepted for/Published in: JMIR Human Factors
Date Submitted: Sep 5, 2023
Date Accepted: Dec 7, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Characterizing and comparing adverse drug events documented in two spontaneous reporting systems in the Lower Mainland of British Columbia, Canada: A retrospective observational study
ABSTRACT
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 two different reporting systems in the same jurisdictions, the Patient Safety Learning System - Adverse Drug Reactions (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, utilization, 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 sub-analysis focused on adverse drug reactions (ADRs) 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 3,248 ADE reports, of which 11.6% were reported in PSLS-ADR and 88.4% in ActionADE. Distribution of all events and serious events varied slightly between the two systems. Iohexol, gadobutrol, and empagliflozin were the most common culprit drugs (46.2% of events) in PSLS-ADR, while hydrochlorothiazide, apixaban, and ramipril (11.6% of events) were common in ActionADE. We included 2,728 reports in the sub-analysis of ADRs, of which 15.1% were reported in PSLS-ADR and 84.9% in ActionADE. ActionADE captured 4- to 6-fold more comparable events than PSLS-ADR over the study 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.
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