SPaRCS Pharmacovigilance Systems Strengthening Workshop

The Pharmacovigilance (PV) Systems Strengthening Workshop, was held 9-11 July 2023 in Windhoek, Namibia.  The workshop, which was hosted by the Therapeutic Information and Pharmacovigilance Centre (TIPC), Namibia, marked the final in a series of capacity strengthening and mutual learning workshops in the Pharmacovigilance Systems Strengthening thematic area of the Strengthening Pharmacovigilance and Regulatory Capacities in Four Southern African Countries (SPaRCS) Project. It followed the initial trio of workshops on PV Systems Strengthening, held virtually in 2021, due to COVID-19 restrictions. A workshop on Clinical Trials Oversight (the other thematic area of the SPaRCS Project) was held in October 2022, hosted by Zimbabwe.

Fifteen participants from seven countries (Namibia, South Africa, Eswatini, Zimbabwe, Mozambique, Zambia, and Belgium) attended the workshop. The workshop was led by Anna Shimbulu from Namibia’s Therapeutics Information and Pharmacovigilance Centre (TIPC), Liberty Chirinda from the Medicines Control Authority of Zimbabwe (MCAZ), and Star Khoza and Hazel Bradley from the University of the Western Cape, South Africa (UWC).

The workshop objectives were to:

• share experiences of PV system strengthening activities within the SADC region (outside of SPaRCS Project)
• provide an update/share experiences regarding the PV system strengthening initiatives activities implemented as part of the SPaRCS Project
• discuss future PV/clinical trials projects based on the experiences of the SPaRCS Project
• conduct PV system mutual learning exchange visits to the Namibian Medicines Regulatory Authority and other relevant sites.

The first part of the workshop focused on country experiences on PV System Strengthening, with insightful presentations from the South African Health Products Regulatory Authority (SAPHRA), Autoridade Nacional Reguladora de Medicamento (ANRME, Mozambique) and the Zambia Medicines Regulatory Authority (ZamRA). They highlighted reporting systems, the use of E-reporting platforms, inspections, communication, and the value of PV activities in ensuring the safety of health products. The SPaRCS country partners (Namibia, Zimbabwe, Eswatini and South Africa) shared some of the key initiatives they have engaged with, building on insights gained through the project. Nambia, for example, increased feedback mechanisms with health care professionals through their quarterly reports, Eswatini engaged more actively with data gathered, and Zimbabwe focused on several areas but in particular on advocacy and PV communication.

A second focus of the workshop was on training of health care professionals, with updates provided on the CHW Training materials being developed as part of the SPaRCS Project.  SAPHRA also shared details on their training initiatives including partnerships to develop training materials. A representative from the Centers for Disease Control (CDC), Namibia  shared insights about the role of implementing partners in strengthening PV systems; while a representative from the University of Namibia (UNAM) highlighted collaboration between UNAM and TIPC, including journal publications which shared the experiences of the regulatory authorities to a broader audience.

The workshop concluded by identifying potential key areas of interest for future engagement:

• Improving feedback systems to healthcare professionals – essential for the success of PV activities
• PV awareness activities and how these can significantly improve ADR reporting
• Exploring the challenges to the implementating of patient ADR reporting, particularly lack of legislation
• Ways of encouraging participation of various stakeholders across the region to strengthen PV systems e.g. academia, increasing ADR reporting in the private sector.

Seven participants from the workshop remained in Namibia for a further two days and participated in guided field visits to the Intermediate Hospital Katutura, and one of the local marketing authorisation holders (MAHs), and as observers of a meeting of the Technical Working Group responsible for the active drug safety monitoring of new HIV and TB drugs.

For more information on the workshop or the project and follow-up activities please contact Hazel Bradley or Star Khoza

Acknowledgements:

The SPaRCS project is part of the EDCTP2 programme supported by the European Union (grant number CSA2018ERC-2332-SPaRCS)