Systematic review and meta-analysis on effectiveness of strategies for enhancing adverse drug reaction reporting.

Abstract

Background: Pharmacovigilance is essential for patient safety, but underreporting adverse drug reactions (ADRs) is a global challenge.

Objectives: This review evaluated the effectiveness of strategies for enhancing ADR reporting by healthcare professionals (HCPs).

Methods: This systematic review was conducted following the Cochrane and the PRISMA guidelines. Five international databases were searched from inception to December 2023 and updated search to September 2024. Randomized clinical controlled trials (RCTs) and non-RCTs on enhancing ADR reporting were included. The primary outcomes were the number of overall ADR and high-quality ADR reports. Study quality was assessed using the Effective Practice and Organization of Care risk of bias (ROB), and ROBIN-I for RCT, and non-RCT. All data were evaluated using a random-effects model, and heterogeneity was assessed using I² statistic and chi-squared tests.

Results: From 1672 studies, 13 studies (10 RCTs, and 3 non-RCTs) with 28,116 participants were included. Two of 10 RCTs had low ROB while the remaining were judged as unclear and moderate ROB. Most studies were in high-income countries, and the main strategy was educating HCPs through workshops. Meta-analysis showed significant increases in overall ADR reporting through educating HCPs with a rate ratio (RR) of 5.09 (95% CI: 3.36-7.71, I² = 84.5%, low certainty), and in high-quality reporting with 1.31 (95% CI: 1.09-1.58, I² = 0.0%, moderate certainty). Subgroup analysis indicated that educating HCPs through face-to-face workshops combined with the Tawai app (RR:10.5, 95% CI: 8.74-12.61), a face-to-face workshop alone (RR:6.69, 95% CI: 5.43-8.25, I² = 0.0%), and repeated telephone (RR:2.59, 95% CI: 1.75-3.84, I² = 8.8%) significantly increased the overall number of ADR reports with moderate certainty. Email or letter communications showed no significant effect.

Conclusion: Educating HCPs via interactive strategies like face-to-face workshops with or without a mobile app and repeated phone calls improved ADR reporting. However, long-term, high-quality studies are needed to confirm these findings before recommending widespread implementation in clinical practice, especially in low-and middle-income countries.