E-DRUG: South African Paediatric Hospital Level Standard Treatment Guidelines and Essential Medicines List, 2017 (5)
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Dear E-druggers
Simon Berry asked: "Many would say that this is where Zinc belongs ie as a nutrition supplement rather than a medicine. What would be the advantages/disadvantages if it were to become a 'registered medicine' in South Africa?"
The obvious advantage is to have greater surety about the quality of the product and its suitability for the intended indication. The original research which demonstrated the efficacy of zinc supplementation in the management of acute diarrhoea in children was done with a very carefully formulated product that was oro-dispersible and palatable.
Poorly taste-masked zinc preparations can result in nausea and vomiting.
South Africa has only been regulating complementary medicines for a few years, and is slowly bringing manufacturers of such products into compliance with Good Manufacturing Practice standards. Until that process is completed and well-entrenched, there will always be questions about the quality of unregistered products on the market. It may well be that the zinc products procured in South Africa are of entirely acceptable quality, but I would prefer to see them formally registered by the South African Health Products Regulatory Authority (SAHPRA), which has replaced the Medicines Control Council (MCC).
I cannot really identify an "advantage" per se to NOT having them registered, even as health supplements (which are now catered for in the Medicines and Related Substances Act). The key here is to ensure that zinc supplementation can be co-packaged with ORS or even bottled water, along the lines of the Scaling Up Zinc for Young Children (SUZY) Project in Bangladesh
https://doi.org/10.1093/heapol/czr015
That can be enabled by ensuring that zinc tablets are kept as Schedule 0, avoiding any legal barriers to access and allowing sale/supply by any retailer or community health worker.
Regards
Andy
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Andy Gray BPharm MSc(Pharm) FPS FFIP
Senior Lecturer
Division of Pharmacology
Discipline of Pharmaceutical Sciences
School of Health Sciences
Consultant Pharmacist (Research Associate)
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
University of KwaZulu-Natal
South Africa
Andy Gray <Graya1@ukzn.ac.za>