Project Title

Vaccines and Medicines utilisation and safety monitoring system in a Health and Demographic Surveillance System, Uganda

EDCTP Project Call

Career Development Fellowship (CDF)

Project Objectives

Overall aim is to create a community based surveillance platform for pharmacovigilance that utilises both public and private facilities for monitoring the safety and utilisation of vaccines and medicines in Uganda by piggybacking on the available community surveillance systems, linked databases of community and health facilities using technological efforts rather than creating new ones. Primary: 1. To set up a surveillance system for monitoring vaccines and medicines use within a health demographic surveillance system (HDSS) covering both public and private sector treatment centers and health facilities. 2. To characterize and profile the adverse drug reactions following use of vaccines, and drugs by patient socio-demographic characteristics. 3. To test the feasibility and practicality of available communication methods for routine monitoring of vaccines and medicines safety, and utilization practices.

Study Design

Population-based observational and surveillance studies

Project Summary

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 , health workers 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.

Host Organisation

Sites

Current Organisation

Makerere University Centre for Health and Population Research (MUCHAP)/Iganga Mayuge HDSS

Current Job Title

Executive Director & Post-Doc Researcher

Biography