Pharmacovigilance in South Africa

The Medicines Control Council’s obligations in terms of pharmacovigilance are delegated to the National Adverse Drug Event Monitoring Centre (NADEMC), located at the University of Cape Town [33]. This Centre is responsible for collating data on adverse drug event reports and performing assessments of causality. The Centre provides inputs to the Pharmacovigilance Expert Committee of the MCC and also submits reports to the Uppsala Monitoring Centre (UMC), for inclusion in VigiBase®, the global database of Individual Case Safety Reports (ICSRs). The NADEMC has recently implemented VigiFlow™, a web-based management system for ICSRs. The level of reporting has been low but has increased more recently, as emphasis has been placed on reporting antiretroviral-related adverse events in the public sector [34]. The authors cited data from UMC that showed an increase from 2902 reports in 2010 (58/million population) to 4088 (77/million population) in 2011. The authors also noted that ‘[t]here were other institutions following up on signals from spontaneous ADRs but they are working independently and information is not being fed into the national system. Other parallel systems exist for public health programs and NGOs but data are not being fed centrally’ [34]. Obligatory reporting of adverse events brought to the notice of the holders of marketing authorisations (manufacturers and importers) is in place. However, if providers also report directly to the NADEMC, this may result in duplication of efforts [35].

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