Should medication still be used after the expiry date, Anis Arioua?
Text: Anis Arioua, Medical Ethicist
Rising healthcare costs and bottlenecks in the supply of certain medicines are leading to discussions of whether expired drugs can — and should — continue to be used. Answers from a medical ethics perspective.
The expiry date on medicines indicates the time period for which a manufacturer guarantees full efficiency and safety. This doesn’t mean that the drug is no longer effective immediately after the date listed, but rather that there are no studies yet to indicate whether it can still be used safely beyond that date.
It would, however, be useful to collect data on whether drugs can be used safely and effectively beyond their expiry date. Such medicines could then be supplied to people in need: Many developing countries are unable to afford certain drugs for their population and suffer acute shortages of many essential medicines, such as antibiotics and vaccines. It makes absolute sense to send expired drugs, whose efficacy and safety have been demonstrated, to these countries. This would avoid waste, reduce costs and also demonstrate solidarity.
Yet, the pharmaceutical industry is not on board with this idea in part due to the high costs of additional stability testing that could impact their profits. In fact, there’s no obligation to test the shelf life of drugs beyond the period defined by regulatory guidelines. Companies even rely to a certain degree on the turnover created by the need to replace medicines that have passed their expiry date. If profits on a particular drug were to decrease because it is used beyond the expiry date, manufacturers could lose interest and halt production, thereby fueling shortages and pushing up prices.
The dilemma is whether to prioritize the health of patients or the needs of the pharmaceutical industry, which plays an important role in making medicines available and developing new treatment options. The industry argues that the safety and efficacy of expired drugs are not guaranteed. At the same time, health insurance companies and healthcare providers are constantly striving to reduce overall healthcare costs. For them and for patients, access to safe and effective drugs past their expiry date at a lower price would be a great advantage.
Even if not entirely avoidable, this dilemma could be alleviated by long-term stability testing of expired products to establish a more accurate shelf life. Studies have shown full effectiveness of certain pharmaceutical products beyond their expiry date, sometimes for decades.
Drugs in solid form, in particular, such as tablets and capsules appear to remain stable. However, this isn’t the case for medicines in liquid form for injection, for example insulin and some antibiotics. These cannot be used past their expiry date. Unfortunately, these are precisely the types of medication that are in short supply in developing countries.
Programs aimed at extending the shelf life of medicines could focus on solid dosage forms and prioritize drugs most in demand. Once a more accurate shelf life is established, the drug in question could be listed as suitable for donation. The question remains as to who would finance these programs. Since there is no gain to be had for the pharmaceutical industry, the job would probably fall to NGOs.
Anis Arioua is a doctoral researcher at the Institute for Biomedical Ethics and works in the pharmaceutical and medical industries.
More articles in this issue of UNI NOVA (November 2024).