Pharmacovigilance Services in South Africa

Pharmacovigilance is quintessential to monitor the safety of health products and reporting of the adverse drug events plays a central role in this. The South African Health Products Regulatory Authority (SAHPRA) of the Department of Health is responsible for overseeing pharmacovigilance activities in South Africa. It monitors the safety of health products for a comprehensive understanding of possible adverse drug events and their association with the suspect drugs. Adverse events (AE) can be reported by the general public, physicians, other health professionals, medical device suppliers and pharmaceutical manufacturers via phone, fax, or email. Alternatively, adverse drug event forms can be filled which are available at National Adverse Drug Event Monitoring Centre (NADEMC) or the manufacturer ADR/ADR Report Form. Recently, a mobile application Med Safety App is developed for reporting adverse drug events related to medicines. It can be used by both public and health care professionals. The app is user-friendly and covers all the basic information required for reporting. An adverse event can be reported even if not sure about the suspicious drug. It is the responsibility of SAHPRA to assess the causality through scientific analysis and clinical to ensure that the benefits associated with the use of the suspect drug or medical device outweigh the risks for its safe use. However, the under-reporting of adverse drug events is a possible challenge faced by SAHPRA.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in South Africa that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.