Improving adverse drug event reporting by healthcare professionals

Background Adverse drug events, encompassing both adverse drug reactions and medication errors, pose a significant threat to health, leading to illness and, in severe cases, death. Timely and voluntary reporting of adverse drug events by healthcare professionals plays a crucial role in mitigating the morbidity and mortality linked to unexpected reactions and improper medication usage. Objectives To assess the effectiveness of different interventions aimed at healthcare professionals to improve the reporting of adverse drug events. Search methods We searched CENTRAL, Embase, MEDLINE and several other electronic databases and trials registers, including ClinicalTrials.gov and WHO ICTRP, from inception until 14 October 2022. We also screened reference lists in the included studies and relevant systematic reviews. Selection criteria We included randomised trials, non‐randomised controlled studies, controlled before‐after studies, interrupted time series studies (ITS) and repeated measures studies, assessing the effect of any intervention aimed at healthcare professionals and designed to increase adverse drug event reporting. Eligible comparators were healthcare professionals' usual reporting practice or a different intervention or interventions designed to improve adverse drug event reporting rate. We excluded studies of interventions targeted at adverse event reporting following immunisation. Our primary outcome measures were the total number of adverse drug event reports (including both adverse drug reaction reports and medication error reports) and the number of false adverse drug event reports (encompassing both adverse drug reaction reports and medication error reports) submitted by healthcare professionals. Secondary outcomes were the number of serious, high‐causality, unexpected or previously unknown, and new drug‐related adverse drug event reports submitted by healthcare professionals. We used GRADE to assess the certainty of evidence. Data collection and analysis We followed standard methods recommended by Cochrane and the Cochrane Effective Practice and Organisation of Care (EPOC) Group. We extracted and reanalysed ITS study data and imputed treatment effect estimates (including standard errors or confidence intervals) for the randomised studies. Main results We included 15 studies (eight RCTs, six ITS, and one non‐randomised cross‐over study) with approximately 62,389 participants. All studies were conducted in high‐income countries in large tertiar