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Perspectives on the Emergence of Pharmacovigilance in Public Health Programmes in South Africa

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Abstract

Pharmacovigilance in South Africa was formalised in 1987 with the creation of the first pharmacovigilance centre in Africa. This pharmacovigilance centre subsequently became a full member of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring in 1992. In 2004, pharmacovigilance received a major boost with the roll-out of the South Africa antiretroviral treatment (ART) programme and the establishment of a National Pharmacovigilance Centre for Public Health Programmes (NPC) within the National Department of Health (NDOH). The NPC’s activities maintain a special focus on public health pharmacovigilance, monitoring patient safety in important treatment programmes such as TB, HIV and others. In comparison, pharmacovigilance, assessing the risk–benefit profile of registered medical products in both the pre- and post-approval periods, continues to be conducted by the Medicines Control Council (MCC). This article provides past, current and future perspectives of pharmacovigilance in the South African public health programmes. These were informed by the review of published articles, international and regional reports, health law and policy documents, as well as strategic plans and reports from within the South African NDOH. South Africa now understands that the benefit–harm ratio of medicines is a dynamic variable that has to be monitored continuously. Reconceptualising the pharmacovigilance system in South Africa to focus on treatment programmes and individual patients has gradually set the stage for a holistic system and established a decentralised but structured and highly participative national pharmacovigilance programme that significantly benefits public health and patient care.

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Acknowledgments

The author would like to acknowledge all the healthcare providers and administrators who have contributed to the successful evolution of the pharmacovigilance field in South Africa, and in particular to the success of decentralised pharmacovigilance as the new approach to managing ADRs in patients.

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Authors and Affiliations

  1. National Department of Health, National Pharmacovigilance Centre for Public Health Programmes, Pretoria, South Africa

    Mukesh Dheda

  2. School of Health Sciences, Pharmaceutical Services, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa

    Mukesh Dheda

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  1. Mukesh Dheda
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Correspondence to Mukesh Dheda.

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This work was not funded.

Conflict of interest

Mukesh Dheda is the Director of the National Pharmacovigilance Centre for Public Health Programmes based at the National Department of Health in South Africa.

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Dheda, M. Perspectives on the Emergence of Pharmacovigilance in Public Health Programmes in South Africa. Pharm Med 30, 213–219 (2016). https://doi.org/10.1007/s40290-016-0150-x

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