BMC Digital Health (May 2025)
Effectiveness of mobile applications in enhancing adverse drug reaction reporting: a systematic review
Abstract
Abstract Background Adverse drug reactions (ADRs) have a significant impact on the healthcare system worldwide. Underreporting of ADRs is identified as a main issue in pharmacovigilance. Mobile applications(apps) have been introduced as a solution for the underreporting of ADRs. This systematic review was conducted to assess the efficacy of the mobile applications in enhancing ADR reporting. Methodology The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The MEDLINE (via PubMed) and Google Scholar databases were used to retrieve papers published between 1983 – 2023 by using advanced search strategies and keywords in the computerized searches. A total of 1955 articles were found, and six articles that met the inclusion criteria were selected for the study. Results The six studies comprised in this systematic review showcased six distinct mobile apps designed for reporting ADRs: VigiBIP (France), My eReport France (France), MedWatcher (United States of America), ADR reporting app© (App©-India), the WEB-RADR project containing three separate apps; Yellow Card (UK), LAREB (Netherlands), HALMED (Croatia), and Med Safety (13 African countries, including Ghana, Burkina Faso, Zambia, Nigeria, Uganda, Botswana, Tanzania, Ethiopia, and others). All the apps have helped to increase the rate and magnitude of reporting ADRs. The efficacy was determined using both the quantity and quality of the reports received. The apps; MedWatcher, VigiBIP (p = 0.01), My eReport France (p = 0.002), and WEB-RADR apps {Yellow Card (p < 0.01), LAREB (p = 0.5), HALMED (p < 0.01)} revealed better reporting rates among patients compared to conventional methods. The completeness and characteristics of Med Safety App reports (missing information: 0%) were higher when compared with the paper-based ADR reporting forms {(Council for International Organizations of Medical Sciences (CIOMS) form (missing information: -29.6%)}. The average completeness score of the ADR reporting app© (App©) was significantly better than the traditional paper-based system on the Wilcoxon two-sample test (p < 0.001) and Kolmogorov–Smirnov test (p < 0.001). Furthermore, MedWatcher indicated a high vigigrade completeness score (averaging 0.80), which was considered 55.9% as well documented. My eReport France demonstrated a high clinical quality score in the ClinDoc tool and was considered 36% as well documented, indicating better quality when compared to their control groups. Conclusions Mobile apps were implemented to address the issue of underreporting. The quality of reporting was better when ADRs were reported through mobile apps compared to manual methods. However, reporting rates can benefit from further enhancement. Mobile apps hold the potential to increase ADR reporting, requiring more studies to explore a conclusive assessment of efficacy.
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