Interventions to improve spontaneous adverse drug reaction reporting by healthcare professionals and patients: systematic review and meta-analysis

ABSTRACT

Introduction

The aim of this study was to evaluate the effectiveness of interventions used for improving ADR reporting by patients and healthcare professionals.

Areas covered

A systematic review of literature was conducted by searching Medline, Embase and Cochrane Central Register of Controlled of Trials. Meta-analysis of randomized controlled trials (RCTs; n = 5) was conducted to estimate the pooled risk ratio for the effectiveness of interventions on ADR reporting rates. Data from observational studies were synthesized using narrative synthesis approach.

Expert opinion

A total of 28 studies were included. All except one study targeted healthcare professionals using educational, technological, policy, financial and/or mixed interventions. The results showed that financial and face-to-face educational interventions improved quality and quantity of ADR reporting when compared with interventions not involving face-to-face interactions. However, the quality of studies was generally low. Meta-analysis showed a statistically significant 3.5-fold overall increase in reporting of ADRs [RR 3.53; 95% CI (1.77,7.06)] in the intervention group compared to the control. There was a lack of consideration of theory and sustainability in the design of the interventions. There is a need to develop and test theory-based interventions and target patient reporting. More research needs to be conducted in the low- and middle-income countries.

KEYWORDS:

• Adverse drug reactions
• drug utilization
• medication safety
• pharmacovigilance

Article Highlights

• It is known that up to 94% of adverse drug reactions (ADR) are not reported. Underreporting delays drug safety signals compromising patient safety.

• There is lack of high quality interventions that aim to increase ADR reporting.

• Limited evidence suggests face-to-face education interventions combined with financial incentives tend to increase ADR reporting by healthcare professionals.

• This systematic review identifies lack of interventions targeted at patients to improve ADR reporting.

• More research studies are needed in low-and-middle-income countries.

Author contributions

VP, AA, and DS designed the study. VP, AA, MB, MAH, ZJ, and DS extracted the data and conducted quality assessment. MAH and SSH led the statistical analysis. VP and AA led the write up to which all authors significantly contributed through reviewing and editing. All authors agree to the final version of the original and revised manuscript. All authors agree to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Data availability statement

All data corresponding to this work are provided with the manuscript.

Supplementary material

Supplemental data for this article can be accessed here.

Study protocol

Protocol registration ID PROSPERO CRD42019162209 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019162209

Reporting guidelines

This systematic review and meta-analysis conforms to the PRISMA reporting guideline. A PRISMA checklist has been provided as an electronic supplementary material.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This study was funded by University of Birmingham.