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Strengthening pharmacovigilance in South Africa
Abstract
This report outlines findings and recommendations of a national pharmacovigilance workshop held in August 2012 in South Africa (SA). A survey of current pharmacovigilance activities, conducted in preparation for the meeting, identified multiple programmes collecting drug safety data in SA, with limited co-ordination at national level. The meeting resolved that existing pharmacovigilance programmes need to be strengthened and consolidated to ensure that important local safety issues are addressed, data can be pooled and compared and outputs shared more widely. Pharmacovigilance activities should inform treatment guidelines with the goal of improving patient care. A variety of pharmaco-epidemiological approaches should be employed, including nesting drug safety studies within existing sentinel cohorts and the creation of a pregnancy exposure registry. The attendees agreed on key principles that will inform a national pharmacovigilance plan and compiled a list of priority pharmacovigilance issues facing public health programmes in SA.
Authors' affiliations
Ushma Mehta, Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa
Mukesh Dheda, Pharmacovigilance Unit, Medicines Regulatory Authority, National Department of Health, Pretoria, South Africa
Gavin Steel, Sector-wide Procurement, Essential Drugs Programme, National Department of Health, Pretoria, South Africa
Marc Blockman, Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa
Augustin Ntilivamunda, World Health Organization, South Africa
Gary Maartens, Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa
Yogan Pillay, HIV/AIDS, TB and Maternal and Child Health, National Department of Health, Pretoria, South Africa
Karen Cohen, Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa
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Date published: 2013-11-20
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