Trial reportThe Lancet. Global health2025
Adverse drug reaction reporting with the Med Safety app in Uganda: a cluster-randomised, controlled trial.
Trial report in The Lancet. Global health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The trial behind it
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Who cites it
5 citing papers in PubMed.
- Article
- Sexual Dysfunction Among Males Living with HIV Receiving Dolutegravir-Based Antiretroviral Therapy in Uganda: A Cross-sectional Study.Drug safety · 2026Article
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- Strengthening pharmacovigilance in emergency care: knowledge, attitudes and barriers to adverse drug reaction reporting among nurses in Ghana.BMC nursing · 2026Article
- Pharmacovigilance in medical cannabis therapy among physicians in Poland: pharmacovigilance knowledge, ADR reporting practice and cannabis-related safety reporting.Frontiers in public health · 2026Article
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe massive roll-out of new and repurposed medicines in low-income and middle-income countries (LMICs) highlights the need for more efficient pharmacovigilance systems, including use of digital technologies. We assessed the effectiveness of the Med Safety app in improving suspected adverse drug reaction (ADR) reporting by health-care workers to Uganda's National Pharmacovigilance Centre.
methodsThis was a pragmatic, multicentre, open-label, cluster-randomised, controlled trial undertaken at health facilities (clusters), providing dolutegravir-based combination antiretroviral therapy in Uganda. Clusters were randomly assigned (1:1) to the intervention group or control group using a computer-generated simple randomisation sequence. In the intervention group, pharmacists with expertise in pharmacovigilance delivered 2 h of face-to-face training to health-care workers in clusters, regardless of their smartphone ownership, in Med Safety and traditional ADR reporting methods. The control group received the same training as the intervention group except for Med Safety training. The primary outcome was the cluster-level ADR reporting rate at the end of follow-up and was analysed in all sites that received the allocated intervention. The trial is registered with the Pan African Clinical Trials Registry (PACTR202009822379650) and is completed.
findingsBetween Aug 11, 2020 and Nov 1, 2022, 382 clusters were randomly assigned and 367 received the allocated intervention and were included in the primary outcome analysis (184 in the intervention group and 183 in the control group), with 2464 health-care workers (1211 in the intervention group and 1253 in the control group). The follow-up time for the included clusters was variable and was median 37·8 months (IQR 34·2-39·8). In the primary analysis, the intervention group had a higher mean overall ADR reporting rate of 10·6 (SD 17·4) reports per 100 000 person-months versus 5·9 (17·9) in the control group (incidence rate ratio 1·73 [95% CI 1·26-2·37]; p=0·001).
interpretationMed Safety increased ADR reporting rates among health-care workers in Uganda. Integrating digital technologies into pharmacovigilance systems could strengthen drug-safety monitoring in Uganda and other LMICs.
fundingUK Medical Research Council and the Foreign Commonwealth and Development Office; Makerere University Research & Innovations Fund; and Ugandan National Drug Authority.
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