An Interesting Commentary on Pharmaceuticals and Climate.

[NNadir]

Are We Throwing Away Medicines Too Early? Blanca De la Nogal-Fernández, Sandra Lantaron-Santamaria, Matías Nicolas Cuenca-Castillo, Vladimir Akhrimenko, Gorka Orive, and Unax Lertxundi Environmental Science & Technology 2025 59 (22), 10703-10706.

The full opinion article is short and free to read, as is, of this writing, reference 2.

Nonetheless, an excerpt:

Recent research has highlighted the healthcare sector as a significant contributor to the climate crisis. According to data from a 2019 study, the sector accounted for 4.4% of global net carbon emissions in the U.K. Furthermore, the study found that medications accounted for 25% of NHS carbon emissions, highlighting the substantial environmental impact of the pharmaceutical industry. (1) Medicine’s contribution to carbon emissions mainly arises from its production and transport (scope 3), as brilliantly illustrated in the article “The long journey of a benzodiazepine”. (2) In addition to their contribution to carbon emissions, the role of pharmaceuticals as micropollutants is of global concern. (3) For example, The Global Monitoring of Pharmaceuticals Project examined 258 rivers in 104 countries and found that concentrations of at least one active substance at 25.7% of sampling points were above concentrations considered safe for aquatic organisms or capable of selecting for antimicrobial resistance. (4)

Regulatory authorities require comprehensive stability data for marketing approval of medicines. The expiry date, which in the United States only became mandatory for pharmaceutical companies in 1979, (5) is typically between 1 and 5 years and is usually set conservatively. Short shelf lives of medicines are also a challenge for managers of hospitals, nursing homes, and national strategic stockpiles, who have to dispose of large quantities of outdated medicines each year. (6) According to one report, hospitals alone discard more than $800 million in drugs annually in the United States. (7)

The improper disposal of medicines via landfill sites or in wastewater has been linked to the contamination of ecosystems and the development of antimicrobial resistance, which is one of the top global public health and development threats according to the World Health Organization. (8) Similarly, the incineration of drug waste has been associated with harmful air pollution and increased carbon emissions. (9) In addition, there is a significant number of medicines that go unused because of their expiration date. For obvious reasons, this problem is particularly severe in resource-limited countries. (10)

Zilker et al. systematically reviewed available data of the stability of finished pharmaceutical products and drug substances beyond their labeled expiry dates. They found some extreme examples, like an ampule of metamizole that was at least 53 years old, which contained 99.7% of the claimed concentration of the active ingredient, and a 72-year-old ampule! containing sodium salicylate combined with caffeine, without any noticeable degradation...

My wife is a little bit of a "doomer." She stockpiles food and other supplies, which has, on occasion, like the Covid crisis, come in handy. On the other hand, she is always asking if I think it's safe to eat foods that have passed their expiration dates.

As I have worked for part of my career on stability testing, I am well aware that most drugs do not degrade significantly after 3 years. There are ICH protocols for drugs extending five years, but these studies are expensive to carry out, generally involving the use of controlled chambers maintaining specific temperatures and humidity levels for long periods, with samples being extracted for expensive testing at predetermined time points, including conditions that resemble ambient and conditions for accelerated testing. People generally conclude stability tests after 3 years to avoid expense. Three years is expected to cover the period from manufacture, to shipping, to shelf storage, use and home storage by the patient.

It's very rare that anything fails after 3 years, even after 5 years.

I generally don't pay any attention to expiration dates for foods and pharmaceuticals.

I didn't realize however - or didn't think about - the climate implications of declaring pharmaceuticals "waste."

Reference 2, The Long Journey of a Benzodiazepine, is here in a preprint form: The Long Journey of a Benzodiazepine

Have a nice day.