When medicines are made outside the factory: Why pharmacovigilance matters more than ever
This article discusses the importance of pharmacovigilance in monitoring the safety of compounded medicines in South Africa. It highlights the legal and regulatory challenges surrounding pharmacies that produce custom medications outside of traditional factory settings.
Why it matters
Ensuring the safety of compounded drugs is critical for public health, as these medicines are often used by large populations without the same level of clinical trial oversight as mass-produced pharmaceuticals.
A high-profile court case has thrust the legalities of compounding medicines in South Africa into the spotlight. Behind the immediate legal issues, hide a series of unresolved questions about how we should ensure that compounded medicines used in South Africa are safe, argue Professor Renier Coetzee and Lara van Niekerk .
The recent court proceedings involving the Pretoria-based compounding pharmacy, iDexis, have generated considerable public interest. Much of the discussion has focused on access to medicines, intellectual property, regulatory authority and the growing demand for medicines containing semaglutide, the active ingredient used in products such as Ozempic. The legal questions are important and will ultimately be resolved through the courts and South Africa’s regulatory processes.
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