Adverse drug reaction reporting with the Med Safety app in Uganda: a cluster-randomised, controlled trial

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. 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.

This 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.

Between 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).

Med 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.

UK Medical Research Council and the Foreign Commonwealth and Development Office; Makerere University Research & Innovations Fund; and Ugandan National Drug Authority.