When is it okay to supply or use expired medicines?
By Dr Geraldine Moses AM BPharm DClinPharm AdvPracPharm
05/05/25
It is so tempting to use out-of-date medicines, isn’t it? Especially when the expiry date is not long ago and the product looks totally fine. If it were covered in mould and oozing with slime it would be a lot easier to throw away! It can feel wasteful to throw away expired drugs, while wishfully thinking you will save money, nay, even the planet by ignoring the expiry date. And in places where medicines are scarce, such as developing countries or rural and remote clinics, the adage of “some drug is better than no drug” is often applied to expired medicines.
However, as a clinical pharmacist, I’ve learned the hard way over the years that ignoring the expiry date is a false economy. There are many reasons to respect expiry dates on pharmaceutical products, not least of which is that these dates are legally imposed by the manufacturers. So, if anything were to go wrong after using an expired medicine, the manufacturer carries no legal responsibility for the outcome and you only have yourself to blame.
How are expiry dates defined?
According to Code of Good Manufacturing Practice in Australia, an expiry date indicates the date beyond which the strength, quality, and purity of the original product can no longer be guaranteed by the manufacturer. (1) Depending on the product, the expiry date may be set as a fixed time after manufacture, after dispensing or after opening of the manufacturer’s container. Drugs are assigned an expiry date based on testing under a range of storage and handling conditions that eventually under what conditions the product best maintains its integrity over time and, eventually, its shelf-life.
Most expiry dates are given as a month and year e.g. June 2025. If you’ve been wondering what that really means, it mean the END of the given month, so if you discover it at the beginning of the month, you’ve got till the end of the month to use or throw it away. It is often presumed that the expiry date only represents decline of the active ingredient, but other factors contribute to setting of expiry dates including:
- Loss of sterility due to microbial contamination or deterioration of preservatives
- Growth of bacteria and fungi on the non-sterile medicines– e.g. mould growing on tablets and capsules
- Degradation of ingredients into toxic breakdown products
- Deterioration of the formulation e.g. dissolved ingredients crystallising out, capsules melting, tablets hardening, rubber bungs deteriorating, plasticisers leaching etc.
So even if expired pharmaceuticals do have plenty of active ingredient remaining, the formulation can spoil for other reasons making it unsafe. If a patient were harmed by use of an out-of-date product in their treatment, they would have no trouble successfully claiming that whoever supplied the medicine was professionally negligent.
Why are liquid medicines a special consideration?
Liquid medicines such as oral suspensions, eyedrops and injection fluids have special issues as they are less stable than solid formulations due to the reactive nature of the solvents used. The expiry date of some liquid formulations, such as antibiotic suspensions for children, can be prolonged by storing the drug as a dry powder, giving it a shelf-life of years. But once the powder is reconstituted with water on dispensing, the final product (a suspension) is given a new expiry of just a few days. Note that refrigeration rarely prolongs the shelf life of a medicine, so do not store drugs in a fridge unless the manufacturer specifically recommends it.
Adrenaline-containing local anaesthetics (LA’s) have a particularly short shelf-life due to the instability of the adrenaline. On exposure to heat, light and air, adrenaline is oxidised to a pink-reddish-brown substance called adrenochrome which has been linked with causing adverse psychiatric effects.[2] The evidence for these adverse effects is rather old and weak, nevertheless this is the reason adrenaline-containing LA’s contain buffers and antioxidants to protect the adrenaline from degradation, and why adrenaline-containing LA’s should be discarded when the solution looks pink, red or brown. (2)
Can expired drugs or those near expiration be donated overseas?
During domestic and international crises, supply of medicines frequently becomes compromised, and drug donations from better-supplied groups is often perceived as a pragmatic and beneficial response. Unfortunately, not all drug donations are helpful as inappropriate or expired drug donations can be dangerous, useless, and create a waste problem for the recipients. (4)
Basically, if an expired medicine is inappropriate for us to use, then it’s inappropriate for others to use too. The World Health Organization (WHO) strongly discourages donation of expired medicines to areas in crisis. (4). If delivered, the recipient country not only can’t use them, but is burdened with the responsibility of sorting the expired drugs from usable products then organising and paying for appropriate disposal.
Obviously, donations of in-date drugs are usually very welcome! To minimise the risk of donating expired medicines, the WHO guidelines recommend that donated drugs have more than one year remaining on their expiration date. (5) Drugs should also be donated in large enough quantities (generally at least several cases of product) to make the effort of receiving, sorting, and distributing cost-effective for relief organisations. Another consideration is that some countries consider dispensing of expired drugs illegal, even during a crisis. (4,5) Permission may be given by the WHO or a local regulatory authority to allow use of specific expired medicines if they are determined still safe and efficacious e.g. stockpiled Paxlovid ® had its expiry date extended in 2023 during the Covid pandemic. (6)
A personal example
I have a personal case where I thought I could get away with using an expired medicine. A few years ago I developed a severe allergic reaction to a moisturiser over my entire face. I looked like the elephant man. I had a tube of expired clobetasone 0.05% cream at home which I used as immediate treatment as I did not want to leave the house for a fresh tube! After two and half days of no effect whatsoever, I sent my husband to the pharmacy to buy a fresh tube of cream. The rash completely disappeared within 6-10 hours once I used a product that was NOT expired. I felt like such an idiot.
In summary, manufacturer-provided expiry dates reflect the shelf life of a product, during which time it will meet the specifications in the drug’s registered product information. After this date, the product may have some activity but all sorts of others things can make it substandard. So unless you are prepared to take the risk of harming your patients, expired medicines should not be used and donations of expired medicines are strongly discouraged.
References:
1) Good Manufacturing Practice. https://www.tga.gov.au/resources/publication/publications/pics-guide-gmp-medicinal-products-version-16
2) Jolowsky C. What Happens to Epinephrine After the Expiration Date? Medscape Pharmacists. August 2007 http://www.medscape.com/viewarticle/559512
3) Australian Pharmaceutical Advisory Committee. Australian guidelines for drug donations to developing countries. November 2000. http://apps.who.int/medicinedocs/documents /s20164en/s20164en.pdf
4) FDA Questions and Answers for the Public Donating Drugs to International Humanitarian Relief Efforts. http://www.fda.gov/downloads /NewsEvents/PublicHealthFocus /UCM 249617.pdf
5) WHO Guidelines for Drug Donations Revised 1999. http://www.who.int/hac/techguidance/guidelines_for_drug_donations.pdf
6) Paxlovid shelf-life extension 2023. https://cdn.npdistribution.com.au/uploads/2023/01/Paxlovid-Expiry-Date-Extension-update-January-2023.pdf