The University of the Western Cape (UWC) is leading efforts to strengthen understanding and reporting of adverse drug reactions to medicines in Southern Africa.

The university’s Dr Hazel Bradley from the School of Public Health and Profs Michelle Viljoen and Star Khoza of the School of Pharmacy are spearheading the “Strengthening Pharmacovigilance and Regulatory Capacities in Southern African Countries (SPaRCS) project.

This initiative is in collaboration with partners from Ministries of Health and National Regulatory Authorities from four countries - Namibia, South Africa, Zimbabwe and Eswatini (formerly Swaziland). 

The three-and-a-half-year venture commenced in April 2020, and was funded by the European and Developing Countries Clinical Trials Partnership (EDCTP2).

The aim of SPaRCS is to strengthen pharmacovigilance (PV) systems and clinical trials oversight of National Regulatory Authorities (NRAs) in South Africa, Namibia, Zimbabwe and Eswatini. The project used a participatory action learning and co-creation approach to develop personal and institutional capacities of the NRAs in the four countries. 

Key activities have encompassed:

• Mapping and review of pharmacovigilance (PV) systems across the four countries;
•  Learning exchanges and thematic workshops on topics such as strategies to strengthen adverse drug reaction reporting and analysis;
• Clinical trials oversight; and,
• The development of capacity-building initiatives for health workers.

In the three-and-a-half year duration of the project, strengths and innovative approaches have been identified in both pharmacovigilance and clinical trials oversight, alongside gaps and opportunities for further advancement.

The project’s topical webinars drew over 90 participants from across Africa and beyond, including collaborators and partners of several European and Developing Countries Clinical Trials Partnership (EDCTP)-funded projects. 

Dr Bradley reflected on the progress achieved to date, saying: “Building on the outcomes of year one, we focused our mutual learning activities in two thematic areas: strengthening pharmacovigilance systems to increase spontaneous reporting and clinical trials oversight. We have also directed our capacity-building initiative focused on community health workers (CHWs).

“In addition, tailored training materials on adverse drug reaction reporting were developed in collaboration with a Cape-Town-based non-profit organisation. This was piloted amongst CHWs in participating countries, and amended into generic, robust flexible training material that is now available for use in other countries.”