Effectiveness of the modified TaWai mobile application for reporting adverse drug reaction in Lao PDR: a cluster randomized controlled trial.

Spontaneous adverse drug reactions (ADRs) reporting by health care professionals (HCPs) plays a vital role in pharmacovigilance (PV). However, under-reporting remain a major challenge worldwide, especially in low and middle-income countries, including Lao PDR. This cluster-randomized controlled trial evaluated the effectiveness of the modified TaWai mobile app for ADR reporting compared with the usual practice in hospitals. Two tertiary hospitals in Lao PDR (cluster units) were randomized into two groups: the intervention group (16 HCPs), which used the modified TaWai mobile app along with an educational workshop, and the control group (18 HCPs), which followed usual practice with the same educational workshop. The intervention group reported more ADR cases (28 vs. 3), and produced a higher number of high-quality reports (28 vs. 2) than the control group. The modified TaWai mobile app was highly rated by all participating HCPs. Questionnaire responses indicated that the tool is user-friendly, time-efficient, and well-suited for ADR reporting in hospitals in Lao PDR. In conclusion, these findings highlight the potential of the modified TaWai mobile app to enhance ADR reporting practices in hospitals, and its features make it a promising solution for strengthening PV in Lao PDR and similar settings.