EpinephrineEpinephrine Also called adrenaline, this hormone is used in emergency situations to reverse symptoms during a severe allergic reaction (anaphylaxis). auto-injectors appear to have a substantially shorter real-world shelf life than their labeled shelf life at manufacturing release, which could increase patient burden and complicate anaphylaxisAnaphylaxis A severe allergic reaction that can turn fatal without treatment. Patients with SM are at a higher risk of developing anaphylaxis. preparedness, a Canadian study published in the Journal of Market Access & Health Policy found.
Anaphylaxis is a relatively common complication of systemic mastocytosis (SM). A 2025 study showed that 51% of patients reported at least one anaphylactic episode during the prior year. This reaction happens when the immune system overreacts to a trigger, causing a severe and potentially life-threatening response.
Epinephrine auto-injectors (such as EpiPens) are the first-line treatment for anaphylaxis and should be readily available in case of a reaction. Current clinical recommendations advise patients at risk of anaphylaxis to have immediate access to at least two in-date epinephrine auto-injectors for use during an emergency.
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At manufacturing release, epinephrine auto-injectors available in Canada have a labeled shelf life of 19 months for the 150 mcg dose and 24 months for the 300 mcg dose. However, the time spent in distribution, storage and pharmacy inventory reduces the shelf life that remains by the time the device is available for dispensing.
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To assess the real-world shelf life of epinephrine auto-injectors, researchers surveyed 50 pharmacists across Canada and asked them to verify the batch numbers and expiration dates of all the devices they had in stock. They then calculated the remaining shelf life of each device and also collected information on disposal practices.
Researchers found that the 411 epinephrine auto-injectors from 98 batches had a mean remaining shelf life of 12.8 months, while 47.4% of the devices had 12 months or less remaining.
“Patients may need to refill two epinephrine auto-injectors approximately once a year to adhere to current clinical recommendations,” the authors wrote.
Expiration also appeared to be an important reason for epinephrine auto-injector disposal. Among devices disposed of by pharmacists, expiration was cited by 100% of respondents as one of the top three reasons for disposal, followed by prior use (91%) and patient concerns about the device (67%).
The authors said the shorter shelf life may increase renewal frequency, costs and medication waste, while also raising the risk that patients carry an expired device or have no epinephrine auto-injector available during an emergency.
“Improving distribution chain practices and access to longer-shelf-life epinephrine treatment options may help reduce these burdens and enhance anaphylaxis preparedness in Canada,” they concluded.
