During my recent bibliographic research, I came across a number of articles dealing with expired medicines. Admittedly, I’m not a specialist in the pharmaceutical field, but as a citizen I do wonder about the enormous waste involved in destroying these drugs. On the other hand, if you look a little deeper, you’ll see that the use of expired or soon-to-be-expired drugs could have many advantages (lower cost for individuals, fewer shortages, wider distribution worldwide…), but it could also lead to profitability problems for the pharmaceutical industry, regulatory problems and even ethical issues.
What are we talking about?
With this article, I’d simply like to raise awareness, at a time when ecological considerations are very much to the fore, that the outright destruction of expired medicines is certainly not an acceptable solution, but that the solutions envisaged for their reuse may not be economically viable, impacting both the manufacturers of these medicines and consumers.
These reflections are largely inspired by the article by A. Arioura & D. Shaw, Use of expired drugs: Patients benefits versus industry interest(1).
What is an expiration date?
Expiry date
The concept of shelf life originated in 1979, when the Food and Drug Administration (FDA) asked manufacturers to set an expiration date for pharmaceutical products to ensure that they functioned safely and effectively for patients. The European Medicines Agency provides guidelines for testing. The expiration date is mandatory for the granting of marketing authorization.
It is inscribed on the drug box or blister pack, and corresponds roughly to the best-before date found on certain foods. This is the date up to which drugs still contain 90% of their initial active ingredient content: in fact, drugs are considered effective as long as they still contain a minimum of 90% of their nominal active ingredient content (i.e., a loss of 10% compared to their initial state).
Every medicine contains an active ingredient that gradually degrades over time.
To determine the expiry date, stability studies are carried out to determine how long after manufacture a product will retain its therapeutic and organoleptic properties. This expiration date, generally three to five years after manufacture, is set by the manufacturer himself, who takes great care in doing so, since he alone is responsible for it.
Active ingredients degrade when exposed to heat, light and humidity. These environmental factors also favor the development of micro-organisms such as bacteria and fungi, which can also alter the drug. (3)
Moreover, the notion of an expiration date really comes into its own for fragile products that can deteriorate under poor storage conditions: syrups, ointments and other gels, eye drops, antibiotics, injectable products… come to mind.
The expiry date does not necessarily mean that the drug is no longer effective immediately after the date listed, but rather that there are no data or studies demonstrating that they can still be used beyond that date.
A study reported by the Journal of Pharmaceutical Sciences in 2006 showed that 2/3 of 122 expired pharmaceutical products tested for efficacy were still stable and safe to use for months. The expiration date has therefore been extended by one to five years for some of them, with an average extension of 66 months.(3)
In many countries, military authorities have stocks of pharmaceutical products which are chemically and physically checked every year. The results of these checks have shown that pharmaceuticals are highly resistant.
An American study (4) from 2012 analyzed eight prescription-only drugs stored between 28 and 40 years in a pharmacy. Eighty-six percent of the substances contained at least 90% of the specified activity of the pharmaceutical product. This percentage should be sufficient for the vast majority of the population, as the absorption of pharmaceutical products varies from one individual to another. Nevertheless, regulations and legislation in most countries prohibit pharmacists and healthcare providers from dispensing expired medicines. In some cases, however, the expiration date must not be exceeded, as in the case of insulin, epinephrine, tetracycline (which can produce toxic decomposition products) and other antibiotics.
Can we put medicines in the garbage can?
Medicines are not food products. If they are disposed of in household garbage cans, sinks or toilets, they risk leaking into the environment, polluting natural resources. Active ingredients can contaminate rivers and soils over the long term, and represent a real danger to the environment.
A system for recovering and recycling pharmaceutical waste resulting from household consumption of medicines was set up in 1993 by the Cyclamed association. Since 2009, France has chosen to consolidate this system of prevention and management of unused medicines for human use through a regulatory framework(5).
Every year, over 14,000 tonnes of unused medicines collected in the network of 22,500 pharmacies are recovered (sic) energetically by incineration. Only medicines are covered by the Cyclamed sorting system. Before dropping off your products at the pharmacy, remove all containers, leaflets and other packaging: they will go into a specific selective sorting garbage can.
Once expired or unexpired medicines have been returned to your pharmacist, they are taken in charge by the Cyclamed association. They are then transported to one of the 55 incineration plants in France. The energy harvested during incineration is used to generate electricity.
How much?
A massive volume of expired medicines accumulates worldwide every year, due to pharmaceutical over-prescription combined with over-production.
In addition to expired drugs, over one billion euros worth of unexpired drugs are destroyed every year in France (6). Pharmacies send medicines for destruction 3 months before their expiration date. Manufacturers, on the other hand, send them 6 months in advance, on the assumption that pharmacies will refuse them. Each pharmacy sends an average of 15,000 euros worth of medicines and parapharmaceutical products for destruction every year. Including wholesalers and laboratories, over a billion euros worth of products are destroyed each year, incinerated or buried, at a staggering ecological cost.
There are times when you feel the urge to use, in a bit of a hurry, a box of medicine stored in your medicine cabinet, but whose expiration date has passed by a few months. All the information available to you – on the drug’s label, on the Internet, from your pharmacist and even from your neighbor – discourages you from doing so, but the reasons given are not clear: at best, the drug has become inactive, at worst it is toxic!
As we saw above, a large number of drugs are still fully active long after the expiration date. (7,8)
The question we can legitimately ask ourselves is: can these drugs be reused, and what would be the advantages and disadvantages? All the more so as certain organizations such as the Standing Committee of European Doctors (CPME) are calling on the European Commission to review the rule concerning the possibility of extending the expiration dates of pharmaceutical products(9).
The benefits of using expired pharmaceuticals
Many developing and other middle-income countries are unable to buy pharmaceuticals, and suffer acute shortages of many essential medicines, such as antibiotics and others. Sometimes, when treatment is prescribed, patients only take every other pill, so not only are they left untreated, but they often develop problems later on. Perhaps it would be more satisfactory to redirect expired drugs of proven efficacy and safety to these countries? In order not to contravene ethical rules, the donor can use expired medicines and supply fresh batches to those who need them. This avoids waste, saves money and shows solidarity.
Since 2009, expired or unused medicines can no longer be sent to developing countries, as was previously the case. For health reasons, the European Union and aid agencies prefer to send new, traceable medicines.
The financial interests of pharmaceutical companies
Understandably, the pharmaceutical industry is not in favor of this redistribution. At present, there’s no obligation to test drugs beyond their expiration dates, and they don’t share in the financial effort this would entail. On the other hand, a drug that is thrown away, even if still valid, is a drug that is sold instead. It’s true that for this type of industry, profits are used for research and development of other molecules, helping our medicines to evolve, but the obligation to extend the expiration date could have negative consequences for their performance and for the pharmaceutical industry in general. Producers no longer interested in drugs that do not renew themselves sufficiently could stop production, thereby reducing access to them and/or increasing their price.
In the late 1980s, the FDA and the U.S. Department of Defense agreed to extend the expiration date of certain drugs to reduce replacement costs. Each year, drugs from stockpiles are selected on the basis of their value and impending expiration date, and analyzed in batches to determine whether their expiration date can be safely extended. Experience has shown that the actual shelf life of many drugs is much longer than the original expiration date. No one was harmed by expired drugs in the study after they had been used.
In some cases, the FDA may authorize an Emergency Use Authorization (EUA) in case an expired product is considered unapproved, but this is limited to CBRN-related emergencies.
What’s the dilemma?
Should we put patients’ health first, or should we support the pharmaceutical industry, which is a major player in making medicines available?
The industry tells us that it’s not in patients’ interests to give them out-of-date drugs (this argument holds up less and less);
It is clearly in patients’ interests to give them access to affordable medicines by giving expired drugs a second life;
It could also save healthcare systems money.
To protect the interests of pharmaceutical manufacturers, couldn’t all pharmaceutical companies be required to carry out long-term stability tests to establish more accurate labeling? Implementing an extension program comes at a cost, but there’s no doubt that it saves a lot of money by reusing expired drugs.
It’s also worth noting that in this scenario there might be fewer drug shortages?
Conclusion
Several studies have provided further evidence of the full effectiveness of pharmaceutical products beyond their expiration date, sometimes for decades. Extending shelf life is a good way of giving these products a second life, avoiding shortages of certain drugs, and making medicines affordable for people on low incomes. Extending the safe and effective life of medicines is an ethical imperative.
Nowadays, most expired medicines are those that have not been consumed intentionally or unintentionally. If a product is proven to be safe and effective, it would be well worth putting it back on the market and making it available to the patients who need it most. But this concept must not be allowed to undermine the pharmaceutical industry’s ability to bring us new and improved formulations.
Big Pharma would be honored to make medicines accessible to all populations, avoiding the outright incineration of complex molecules that have been developed at great expense!
References
1- A. Arioua & D. Shaw, Use of expired drugs : Patients benefits versus industry interest. JMA J, 2024, 7, 1-4
2- https://www.3ssante.com/peremption-des-medicaments-demeler-le-vrai-du-faux/ [1]
3- Lyon R.C., Taylor J.S., Porter D.A., et al. Stability profile of drug peroducts extended beyond labeled expiration dates, J. Pharma. Sci., 2006, 95, 1549-1560.
4- Lee Cantrell et al. Stability of Active Ingredients in Long-Expired Prescription Medications. Archives of Internal Medicine 2012; DOI 10.1001/archinternmed.2012.4501. http://archinte.jamanetwork.com/article.aspx?articleid=1377417 [2]
5- https://www.ecologie.gouv.fr/medicaments-non-utilises [3]
7- Sandford-Smith J. Outdated drugs may be useful. BMJ., 2003, 326, 51
8- Sarla G.S., Efficacy and disposal of drugs after the expiry date, Egypt. J. Inter. Med. 2019, 31, 431-434
9- On 23 May 2015, the CPME Board adopted the “CPME position paper on rules regarding expiration dates of pharmaceuticals” (CPME 2014/074 Final)