The Medicines and Related Substances Act, 1965 requires the South African Health Products Regulatory Authority (SAHPRA) to monitor the use of medicines in South Africa. SAHPRA is responsible for overseeing adverse drug reaction reporting in South Africa.
Adverse drug reactions (including interactions with other medicines) caused by prescribed medicines, over the counter medicines, or by complementary medicines must be reported to SAHPRA. Both healthcare professionals (including doctors, nurses, and pharmacists) and companies holding a medicine’s certificate of registration are required to report adverse drug reactions to SAHPRA but reporting requirements for a medicine’s certificate of registration are more onerous than they are for healthcare professionals.
Regulation 40(1) of the general regulations to the Act requires the holder of a medicine’s certificate of registration to establish and operate a pharmacovigilance system to monitor the use of their medicines in the market. They must appoint an appropriately qualified person responsible for pharmacovigilance (or a local pharmacovigilance officer) to oversee this system. Section 40(2) requires a holder of a certificate of registration to maintain or have access to records of the reports previously submitted to SAHPRA, and the holder must respond to any requests from SAHPRA for additional information or data.
Like healthcare professionals, the holder of a medicine’s certificate of registration must report any suspected adverse drug reactions to SAHPRA. They must also inform SAHPRA of any significant safety issues, new or existing quality, safety or effectiveness concerns, risk management activities, or changes in the risk-benefit balance of their medicines.
Regulation 40(3) places a duty on healthcare professionals to report adverse drug reactions. SAHPRA has issued guidelines to assist healthcare professionals with reporting adverse drug reactions. In terms of these guidelines, healthcare professionals should identify an adverse drug reaction by taking a proper history from the patient, conducting a physical examination, considering the time of onset of the reaction, and checking the known pharmacology of the medicine. When reporting an adverse drug reaction, a healthcare professional must include as much information as possible regarding the patient (without revealing the patient’s identity), the suspected medicine, the reaction, and provide any additional relevant information that they may have.
Besides requiring healthcare professionals and holders of a certificate of registration to provide reports, consumers are encouraged to report adverse drug reactions to SAHPRA.