Mobile App Improves Reporting Of Suspected Adverse Drug Reactions In Uganda

Results from a ground-breaking caller proceedings published in The Lancet Global Health show that a mobile application, Med Safety, improved nan reporting of suspected adverse supplier reactions (ADRs) by healthcare workers successful Uganda.

The findings people a breakthrough for integer pharmacovigilance successful low- and middle-income countries (LMICs) wherever nan under-reporting of medicine-related harmful effects has agelong posed challenges to diligent safety.

In nan largest proceedings of its kind, researchers from Makerere University, nan University of Liverpool, Uganda's National Drug Authority, nan UK Medicines and Healthcare products Regulatory Agency, Uganda's AIDS Control Programme, and nan African Union Development Agency conducted a cluster-randomised controlled proceedings involving 367 wellness accommodation and much than 2,400 healthcare workers. The proceedings compared accepted (existing) reporting methods unsocial pinch nan usage of Med Safety, a smartphone app, integrated (as an adjunct to existing reporting methods) into Uganda's nationalist pharmacovigilance system.

Healthcare workers using Med Safety reported 73% much suspected ADRs wide and astir double nan number of suspected adverse supplier reactions linked to dolutegravir (92%), a wide utilized HIV treatment, compared pinch those utilizing only accepted pharmacovigilance methods. Reports were received of some superior and non-serious ADRs – captious for building a fuller image of medicine safety.

Dr Ronald Kiguba, an MRC-funded African Research Leader and Chief Investigator for nan proceedings said: "The trial's findings show that integer devices for illustration Med Safety tin toggle shape supplier information monitoring successful real-world objective settings successful LMICs. Scaling up Med Safety and akin devices could thief different debased and mediate income countries make data-driven regulatory decisions and amended protect patients."

Professor Sir Munir Pirmohamed, David Weatherall Chair of Medicine astatine nan University of Liverpool said: "Under-reporting of ADRs is simply a awesome rumor pinch each spontaneous reporting systems. The proceedings provides robust grounds that nan mobile app achieved a 73% higher ADR reporting complaint wide erstwhile compared to existing reporting methods. This highlights nan worth of caller devices to heighten reporting of suspected ADRs."

Originally developed nether nan European Innovative Medicines Initiative-funded project, WEB-RADR, and adopted successful respective countries, Med Safety was launched successful Uganda successful 2020. This proceedings provides nan first robust, large-scale grounds from an LMIC that a mobile app tin substantially fortify pharmacovigilance systems. By making it easier for frontline wellness workers to study suspected adverse supplier reactions, stronger information are generated to guideline regulatory decisions and yet amended diligent care.

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