Mobile app improves reporting of suspected adverse drug reactions in Uganda

Results from a ground-breaking new trial published in The Lancet Global Health show that a mobile application, Med Safety, improved the reporting of suspected adverse drug reactions (ADRs) by healthcare workers in Uganda.

The findings mark a breakthrough for digital pharmacovigilance in low- and middle-income countries (LMICs) where the under-reporting of medicine-related harmful effects has long posed challenges to patient safety.

In the largest trial of its kind, researchers from Makerere University, the University of Liverpool, Uganda’s National Drug Authority, the UK Medicines and Healthcare products Regulatory Agency, Uganda’s AIDS Control Programme, and the African Union Development Agency conducted a cluster-randomised controlled trial involving 367 health facilities and more than 2,400 healthcare workers. The trial compared traditional (existing) reporting methods alone with the use of Med Safety, a smartphone app, integrated (as an adjunct to existing reporting methods) into Uganda’s national pharmacovigilance system.

Healthcare workers using Med Safety reported 73% more suspected ADRs overall and nearly double the number of suspected adverse drug reactions linked to dolutegravir (92%), a widely used HIV treatment, compared with those using only traditional pharmacovigilance methods. Reports were received of both serious and non-serious ADRs – vital for building a fuller picture of medicine safety.

Dr Ronald Kiguba, an MRC-funded African Research Leader and Chief Investigator for the trial said: “The trial’s findings demonstrate that digital tools like Med Safety can transform drug safety monitoring in real-world clinical settings in LMICs. Scaling up Med Safety and similar tools could help other low and middle income countries make data-driven regulatory decisions and better protect patients.”

Professor Sir Munir Pirmohamed, David Weatherall Chair of Medicine at the University of Liverpool said: “Under-reporting of ADRs is a major issue with all spontaneous reporting systems. The trial provides robust evidence that the mobile app achieved a 73% higher ADR reporting rate overall when compared to existing reporting methods. This highlights the value of novel tools to enhance reporting of suspected ADRs.”

Originally developed under the European Innovative Medicines Initiative-funded project, WEB-RADR, and adopted in several countries, Med Safety was launched in Uganda in 2020. This trial provides the first robust, large-scale evidence from an LMIC that a mobile app can substantially strengthen pharmacovigilance systems. By making it easier for frontline health workers to report suspected adverse drug reactions, stronger data are generated to guide regulatory decisions and ultimately improve patient care.

The study was funded by the UK Medical Research Council, Makerere University Research & Innovations Fund, and Uganda’s National Drug Authority.