Translation of a-t 2023; 54: 15-6
 

a-t READERS QUESTIONS AND COMMENTS

EXPIRY DATES OF PHARMACEUTICAL PRODUCTS
... provider-driven and unsustainable

In these times of collapsing supply chains, supply bottlenecks and resource shortages due to the climate crisis, drugs have become precious commodities. Authorities and military personnel have tested the stability of a few drugs, and subsequently found that they may have shelf lives spanning decades.¹ How long can drugs actually be used, and are there any reliable lists with drug expiry dates e.g. for colleagues in conflict areas?

N.N. (name etc. stated in a-t 2/2023)
Conflict of interest: on the board of MEZIS e.V.

The shelf life of a pharmaceutical product is specified at the time of approval based on stability studies carried out by the providers. Therefore, it is the provider's decision, pricing and marketing aspects come into it as well. The specified shelf life is usually no longer than five years, often significantly less. Once the expiry date has been reached, a pharmaceutical product is no longer permitted to be marketed, and the provider's liability comes to an end (a-t 2003; 34: 78 and 86).¹ There must be a warning in the package insert, advising people against using the preparation after this date has passed.² However, the shelf life is occasionally extended subject to agreement with the authorities - to some extent, this may relate to specific batches and is temporary - to counteract any supply bottlenecks, such as in the case of FASTJECT 300 (adrenaline; a-t 2018: 49: 78-9), ACTILYSE³ (alteplase) or DACEPTON⁴ (apomorphine).

However, if pharmaceutical products are delivered to the German Armed Forces, Federal Police or to the government or states, or procured by the Federal Ministry for the purposes of civil defence or disaster prevention, expiry dates may be omitted.⁵ In this case, the competent authorities must guarantee the quality of the pharmaceutical products being stored, for example, by carrying out regular stability tests. This approach is cost-effective: According to analyses from the USA, pharmaceutical products that have been put into storage need to be procured again less often due to the fact that they are still stable. This saves many times the amount of the money that needs to be spent on carrying out quality analyses.^6,7

Based on the systematic overview of the stability of expired finished medicinal products that has already been mentioned in the reader's letter, the authors are inferring that the shelf life for a large proportion of pharmaceutical products could be extended far beyond five years.⁶* However, a list with reliable data on actual shelf life cannot be derived from the available data, and we believe this wouldn't make much sense either, given the liability issues that will arise when using drugs that have expired and can no longer be marketed. In addition, as shelf life can be influenced by factors such as temperature, humidity and light depending on composition and form of administration, findings from temperate climate zones cannot be transferred to conflict zones as a general rule.

Disposing of pharmaceutical products as a matter of routine as soon they have reached the expiry date is neither an effective use of resources, nor is it sustainable. To combat this waste, legislators and approval authorities would need to obligate providers to extend shelf life tests that are required for approval over longer periods of time. However, the EU is not currently striving to extend shelf life information in general,¹⁰ -Red.

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