Medication Expiry Date: What Does It Imply

The most common misconception among people is that the medications become unsafe immediately after their expiry date. From the consumer’s end, it is reasonably acceptable as the same rule applies for most of the food items or consumer goods they purchase from the market. However, that is not always the case with drugs and medicines. The expiry date is usually assigned by the manufacturer based on specific tests to check the stability of their products. Based on the results, they assign a date to indicate that it is safe and effective to be used within that particular time period.

Effectiveness of Drug

Although it is commonly believed that expired drugs become unfit for use after expiry, studies have revealed that more than 90% of both prescription and over-the-counter drugs were safe to use even 15 years post their expiry date. Also, it depends upon various factors such as the type of medicine (liquid suspension or solid tablets), storage conditions, and medication handling. Many companies often advise storage under cool and dry conditions, and away from sunlight, as the drug’s chemical composition and stability may change under certain conditions. With time, certain chemical components lose their strength or may eventually degrade from their original form into ineffective or toxic substances.

Not all drugs turn toxic beyond their expiry date; some medicines lose their effectiveness and strength to treat the intended ailment or condition. Mostly, medicines in the form of solutions or liquid suspensions tend to lose their effectiveness after expiry. Whereas tablets or capsules in solid form have appeared to be more stable and unaffected over the mentioned time. Overall, the date printed on crimp conveys the duration until which the drug remains safe and effective for use, guaranteed by the manufacturer.

Global Health Context

Since many developing nations like Africa face a shortage of essential drugs, the military suggested extension of shelf life for existing drugs as many were tossed out unused, every year. In 1986, SLEP (Shelf-Life Extension Program) was initiated in collaboration with FDA to evaluate the stability of expired drugs and relabel dates with a longer duration in order to reduce cost wastage and provide for unprivileged nations where storage and affordability are a challenge.

Pharmaceutical companies are not required to extend shelf-life for all their products except for providing the initial expiration date along with data obtained from stability tests. Tests conducted for evaluating and extending dates may incur high costs to companies and they do not normally opt for shelf-life extension. It is likely considered in case of emergencies like a pandemic, where there is an urgent need for medication and new batches cannot be made immediately.

Advantages & Disadvantages of Expiry Date Extension

During the SLEP program, a study revealed that none of the participants were affected by consuming drugs past their expiration date. So, extending shelf-lives proves to be beneficial when there is shortage of drugs, during emergency conditions, and whenever there is a need to provide for people who cannot afford the medication, rather than dumping expired stockpiles as waste.

Besides these advantages, companies may decide to extend dates only under special conditions such as government requests for emergencies or special needs, as the process may result in loss due to higher costs linked to further testing and evaluation. Moreover, if they choose to evaluate and extend shelf-life for certain products, it may eventually stop them from manufacturing due to lack of business interest and cost constraints could hinder them from developing new formulations.

Safety Considerations

·       This article is for informational purposes only, and it is strictly not recommended to use the expired medication in your cabinet.

·       Certain drugs like antibiotics lose their strength to fight infections beyond the stamped date, and consuming them may not only fail to treat, but can also make the drug ineffective due to bacterial resistance.

·       Take necessary precaution during disposal of expired drugs. Return it to a reliable, designated place such as a pharmacy or dispose carefully as per instructions provided on the label.

·       Do not flush all outdated medications down the drain, as some of them may have a hazardous impact on the environment.

References

1.       U.S. Food and Drug Administration. (n.d.). Don’t be tempted to use expired medicines. https://www.fda.gov/drugs/special-features/dont-be-tempted-use-expired-medicines

2.       Iserson, K. V. (2021). Should we use expired drugs when necessary? Journal of Emergency Medicine, 60(5), 669–673. https://doi.org/10.1016/j.jemermed.2021.02.002

3.       Gikonyo, D., Gikonyo, A., Luvayo, D., & Ponoth, P. (2019). Drug expiry debate: the myth and the reality. African Health Sciences, 19(3), 2737–2739. https://doi.org/10.4314/ahs.v19i3.49

4.       Burungale, S. D., Patil, R. N., & Delonix Society’s Baramati College of Pharmacy. (2024). Comparative study of expired and non-expired medicine. International Journal of Innovative Research in Technology, 11(3), 1474–1475. https://ijirt.org/publishedpaper/IJIRT167535_PAPER.pdf

5.       Arioua, A., & Shaw, D. (2024). Use of Expired Drugs: Patients Benefits versus Industry Interest. JMA Journal, 7(1), 1–4. https://doi.org/10.31662/jmaj.2022-0209

Assessed and Endorsed by the MedReport Medical Review Board