Systematic Review and Meta-analysis on Effectiveness of Strategies for Enhancing Adverse Drug Reaction Reporting

Mongkhonmath N 1 , Olson PS 2 , Puttarak P 3 , Chaiyakunapruk N 4 , Sawangjit R 5

Affiliations 

  • 1 Ph.D., student, Doctor of Philosophy in Pharmacy Program, Faculty of Pharmacy, Mahasarakham University, Thailand, Khamrieng Sub-District, Kantarawichai District, Maha Sarakham Province, 44150, Thailand
  • 2 Ph.D., International Primary care Research Unit, Faculty of Pharmacy, Mahasarakham University, Kharmrieng Sub-District, Kantarawichai District, Mahasarakham, 44150, Thailand; Faculty of Pharmaceutical Sciences, UCSI University, NO.1, Jalan UCSI, UCSI Heights, Cheras 56000, Kuala Lumpur, Malaysia
  • 3 Department of Pharmacognosy and Pharmaceutical Botany, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat-Yai, Songkhla 90110, Thailand; Phytomedicine and Pharmaceutical Biotechnology Excellence Center, Prince of Songkla University, Hat-Yai, Songkhla 90110, Thailand
  • 4 Ph.D., Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, USA
  • 5 Ph.D, Assistant Professor, Clinical Trials and Evidence-Based Syntheses Research Unit (CTEBs RU), Department of Clinical Pharmacy, Faculty of Pharmacy, Mahasarakham University, Maha Sarakham, Thailand, 44150. Electronic address: [email protected]
J Am Pharm Assoc (2003), 2024 Nov 08.
PMID: 39522823 DOI: 10.1016/j.japh.2024.102293

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 EPOC 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 1,672 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 LMICs.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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