Adverse drug reaction reporting with the Med Safety app in Uganda: a cluster-randomised, controlled trial (The Lancet Global Health, October 2025)

Summary

The 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. This study reports a large pragmatic cluster-randomised controlled trial to assess the effectiveness of the smartphone app Med Safety in improving suspected adverse drug reaction (ADR) reporting by healthcare workers to Uganda's National Pharmacovigilance Centre.

Content

• Between Aug 11, 2020 and Nov 1, 2022, 367 clusters (healthcare facilities providing dolutegravir-based combination antiretroviral therapy in Uganda) received the allocated intervention (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). 
• In the intervention group, health-care workers received pharmacist-delivered training 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 (at least 12 months) and was analysed in all sites that received the allocated intervention. 

Med Safety use was found to increase ADR reporting rates among health-care workers in Uganda, particularly non-serious and dolutegravir-related ADRs. These findings suggest that integrating digital technologies into pharmacovigilance systems could strengthen drug-safety monitoring in Uganda and other LMICs.