VxMedSS is funded by the European Developing countries Clinical Trials Partnership (EDCTP) and European Union. The VxMedSS project aims to strengthen pharmacovigilance (PV) in communities starting with the Iganga and Mayuge Health Districts . To achieve this aim, collaborative support will be harnessed across several institutions in Uganda.
In the participating Districts, a uniquely designed team will lead the project. This team will consist of an intense collaboration of; National Medicine Regulatory Authority , Healthworkers and the patients / community
VxMedSS will work towards strengthening the processes of routine adverse event reporting in accordance with country policies that already exist or which will be put in place or strengthened during the course of the project. In addition, it will develop information on causality assessment, signal detection and training to support the Pharmacovigilance initiatives by the National Drug Regulatory Authorities and other Pharmacovigilance Agencies.
At the end of the project, VxMedSS will develop a blueprint for strengthening pharmacovigilance that can serve other Districts and the country at large.
The project is a population based cohort study in the Iganga Mayuge districts and will piggyback on the existing registries and health records databases through prospectively documenting occurrence of any adverse events after administration of medicines and vaccines. In addition to supporting the routine passive surveillance by the national medicines regulator, this project will implement an active pharmacovigilance system among patients administered with medicines and vaccines at public or private health facilities. Participants will be encouraged to report any adverse event (AE) occurring after their encounter with the health facility.