When medicines are made outside the factory: Why pharmacovigilance matters more than ever
A high-profile court case involving a South African compounding pharmacy has highlighted the critical importance of pharmacovigilance. Experts argue that monitoring medicine safety after it reaches the public is essential, as clinical trials cannot predict every rare adverse reaction.
Why it matters
It underscores the necessity of post-market surveillance to ensure public health safety in the face of growing demand for compounded medications.
Facebook 0 Tweet 0 Email 0 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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