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

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.