South Africa: How Should Medicines Shortages Be Managed in South Africa?
[spotlight] Imagine you have been taking a medicine for years. Then one day you are told at the pharmacy that supplies have run out. In his latest Spotlight column, Dr Andy Gray zooms in on how governments can monitor and plan for such shortages.
In South Africa, the issue of medicines shortages is a growing concern that requires effective management. Unlike in high-income countries such as the US, the UK or Australia, South African health law does not provide a clear definition of what constitutes a medicines shortage. While the US Federal Food, Drug, and Cosmetic Act defines a shortage as a period when demand for a medicine exceeds its supply, such metrics are not explicitly present in South African regulations.
The US approach involves manufacturers reporting any interruptions in their manufacturing process that could potentially disrupt supply, alongside reasons for these disruptions. They are also required to give advanced notice of permanent production discontinuation and must disclose the reasons behind that decision. This level of transparency and proactive reporting is not present in South Africa.
The South African Health Products Regulatory Authority (SAHPRA) does not mandate manufacturing companies to report shortages, and the regulator does not make this data publicly accessible. Consequently, health professionals and patients only become aware of product discontinuations after the fact, without any advanced warning or reasons provided for the decision.
Furthermore, there is no systematic accounting of how many medicines have been withdrawn from the market, making it difficult to monitor and manage shortages effectively.
However, the South African National Health Department has taken a proactive step by introducing a "hotlist" - a list of essential medicines with stock availability below 90% and total orders exceeding supplier stock on hand. This list also documents the root cause of supply challenges and proposed remedial actions, and is updated monthly.
While this initiative provides valuable information, it is not as comprehensive as the reporting requirements in other countries, and there is room for improvement in managing medicines shortages in South Africa.
Written by urgent.news from AllAfrica Health's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
