抄録
Medicine regulation and control is not perceived as an option but a necessity in national health programmes. The investigation will embrace methods traditional healers use to diagnose and treat diabetes mellitus in the Mamelodi area Pretoria. The study assesses what these purported medications contain and their medication labels to assess whether it complies with complementary and alternative medicine (CAMs) regulations. To establish these methods is fundamental to understand in relation, the functioning of the new amended regulations of the South African Health Products Regulatory Agency (SAHPRA). The new regulatory authority (SAHPRA) and medicines Act that replaced Medicines Control Council (MCC) in 2016 needs to implement the updated and extended legal regimes that will regulate all medicines, medical devices, in vitro diagnostics (IVDs), complementary medicines, cosmetics and food stuffs. Regulations surrounding the registration and post-marketing control of (CAMs) is a crucial issue to which a solution should be found.
This study attempts to provide an overview and perspective on how traditional healers (THs) diagnose diabetes mellitus, to identify the CAMs therapies used and to provide us with an overview on CAMs therapies found in pharmacies and traditional health shops. The study assesses their compliance with the SAHPRA (MCC) regulations and attempt to assist them in better regulating these CAMs.
The study will comprise an interview and administration of a questionnaire addressed to THs to establish how they diagnose diabetes in their patients and find out CAMs they use in treating this condition. Visits with a non-structured survey will be directed to traditional health shops and pharmacies in the Mamelodi area to identify the CAMs supplied to the public in treating diabetes mellitus (DM).
This study will assist a better understanding of SAHPRA regulations regarding registration and post-marketing surveillance of CAMs. It will create awareness amongst the THs regarding the new regulations and motivate them to register and follow the requirements and procedures in supplying CAMS to their patients. This project will impact on the SAHPRA and THs and also the public concerned with this situation. The study will therefore signify an advantage regarding safety issues and trust on the CAMs.
