Few people realise that global drug shortages occur everyday. We are talking about essential, life saving medicines that a patient or sick person is missing out on.
In Australia, the TGA have a medicines shortages information initiative and a website that provides health professionals and consumers with information about medicine shortages. Currently there are 147 medicines on the shortage list, and 7 more anticipated to be in short supply. In the US, approximately 200 drugs are in short supply, ranging from saline to complex chemotherapy drugs. This can be checked via a US FDA app.
The reasons for the global drug shortages are many, including spikes in the demand for treatments, specialised manufacturers, production problems, government/country/financial instability e.g. Venezuela. It also includes supply chain issues, discontinuation of drugs (some due to financial viability), but frequently due poor GMP compliance issues and regulatory action, i.e. plant closures.
Most GMP regulations now typically have clauses that require that when a manufacturer suspects production issues developing that will result in drug shortages, they must inform the regulator in a timely manner.
These shortages lead to unfair ethical dilemmas for the medical profession where patients requiring medicines need to be prioritised. How do they decide who to treat first? Should drugs with a limited supply be administered as a first come first served basis? Should it be based on who has the best healthcare insurance? Young vs old? How should treatment be prioritised? There are so many specific considerations before such a decision can be made, but it should not come to this.
In a recent survey in the UK, 48% of community pharmacists said they spent 21–50 hours a month dealing with medicines / drug shortages and 5% were spending over 100 hours on it.
One of the key parts of the Strategic Plan in the US to avoid shortages was to allow the US FDA to use its authority to encourage notification of shortages as early as possible. Failure to do so may now result in a non-compliance letter being issued to a manufacturer. This has helped to reduce the number of drug shortages, but has not done enough to reduce the problem. The second part of the Strategic Plan is developing long-term prevention strategies to fix the underlying reasons for the interruptions for the supply, using a risk-based analysis. This includes determining if other manufacturers can fill the gap, conducting quicker reviews of submissions and inspections, work with manufacturers on determining root causes, etc.
Other countries and agencies are following suit, but drug shortages will continue to be an issue for some time to come and unfortunately, there is no easy fix.
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