Improving the spontaneous reporting of suspected adverse drug reactions: An overview of systematic reviews

Author:

Routledge Philip Alexander1ORCID,Bracchi Robert2

Affiliation:

1. School of Medicine Cardiff University Cardiff UK

2. All Wales Therapeutics and Toxicology Centre University Hospital Llandough Llandough UK

Abstract

AimTo conduct an overview of systematic reviews examining interventions to stimulate spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals (HCPs) and/or patients/carers.MethodsSystematic reviews published since 1 January 2000 were identified and the included publications categorized in relation to the 4Es (education, engineering, economics and enforcement).ResultsAlmost all studies were aimed at HCPs. Educational initiatives were most often used and, in most studies, were associated with improvements in quantity and/or quality of reports, at least in the short term. Lectures/presentations and regular reminders (eg, verbal or by e‐mail) were the educational methods most often identified by systematic reviews. Engineering initiatives were also generally effective, including improving the availability of reporting forms, electronic ADR reporting, modification of reporting procedures/policies or the reporting form and assistance to complete the form. Evidence for the benefit of economic incentives (eg, monetary rewards, lottery tickets, days off work, “giveaways” and educational credits) was often clouded by the potential effects of other concomitant initiatives, and any possible associated improvements often disappeared rapidly after incentives were discontinued.ConclusionEducational and engineering strategies appear to be the interventions most often associated with improvements in reporting rates by HCPs, at least in the short to medium term. However, the evidence for sustained impact is weak. The available data were insufficient to clearly identify the separate impact of economic strategies. Further work is also needed to examine the effects of these strategies on reporting by patients, carers and the public.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference56 articles.

1. Medicines and Healthcare products Regulatory Agency.2020.Contribution of Yellow Cards to identifying safety issues.https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/856409/Contribution_of_Yellow_Cards_to_identifying_safety_issues.pdf(Accessed 15/05/2023)

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