SPOTLIGHT OP-ED: How should medicine shortages be managed in SA?
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 regulation of medicines shortages is lacking in both clarity and enforcement. As highlighted in a recent Spotlight column by Dr Andy Gray, countries like the United States, Europe, and Australia have established robust systems for monitoring and addressing such shortages. These jurisdictions require manufacturers to report any interruptions in the manufacturing process that could significantly impact supply, along with the reasons behind these disruptions.
In contrast, South Africa's Health Products Regulatory Authority (Sahpra) does not have a similar requirement, nor does it make such data publicly available. This lack of transparency leaves health professionals and patients uninformed about product discontinuations until it's too late. Furthermore, Sahpra lacks the mechanism to receive advanced warnings of production discontinuations or the reasons for such decisions.
The South African health department's "hotlist" serves as a partial solution to this problem. This list identifies essential medicines with stock availability below 90% and total orders exceeding supplier stock on hand and provincial stock, with the list updated monthly. The list also includes the root cause of the supply challenge and proposed remedial actions. However, this list is not comprehensive, as it does not account for all medicines, including those withdrawn from the market without public notice.
The causes for these shortages are diverse, ranging from delays in quality assurance procedures to access issues for critical components. Global supply constraints and local regulatory actions are also identified as contributing factors. One potential solution suggested is the use of multiple suppliers for vital medicines, which are essential for patients' immediate health.
This approach could be facilitated by contracting split contracts for such medicines, similar to what is done with first-line antiretrovirals used to treat HIV.
Written by urgent.news from Daily Maverick's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
