Are EpiPens Still Good After Their Expiration Date?

In response to the ongoing furor surrounding Mylan’s large increase in the price of EpiPen, one pharmacist wondered what could be done to help.

F. Lee Cantrell, PharmD, Director of the California Poison Control System in San Diego, conducted a study to find out if EpiPens could still be used after their expiration date.

Cantrell told Drug Topics that he was interested in researching the topic because of the recent price hikes and questions from patients. He would often receive calls at the Poison Control Center from parents wondering if they could use an expired EpiPen or not. In the recent upheaval over EpiPen price increases, many patients said they worried that their insurers would not cover the price increase, he added. This resulted in a rush to buy EpiPens and created a shortage, potentially leaving patients only with expired EpiPens.

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Extending the “use by” date could potentially save patients hundreds or thousands of dollars. EpiPens carry an expiration date of 18 months after their manufacture, but it may be several months before the devices are actually sold and in the hands of the people who may need them.

Along with a team of researchers, Cantrell gathered expired EpiPens from patients and practitioners. Cantrell said that the team gathered 40 expired EpiPens in just two weeks from a single clinic, indicating that a large number of expired EpiPens are out there. The team then analyzed the EpiPens for concentrations of epinephrine.

Reuters reported that even 50 months after the listed expiration dates, EpiPens still retained 84% of epinephrine concentrations, which is still enough to prevent anaphylactic shock.

These expiration dates are the “the final day, based on quality control tests, that a product has been determined to be safe and effective when stored under the conditions stated in the package insert,” Mylan told Reuters. “Given the life-threatening nature of anaphylaxis, patients are encouraged to refill their EpiPen Auto-Injector upon expiration, approximately every 12 to 18 months.” Mylan has reportedly filed a patent application for an EpiPen that will have a 24-month shelf life.

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However, Cantrell isn’t satisfied with the current printed expiration dates, and is pushing for a change in how expirations are formulated. He told Drug Topics that he doesn’t “see any longitudinal testing of medications seeing how long they can retain potency, to see how medications can be kept in optimal or even suboptimal conditions.”

As to whether or not he would recommend an expired EpiPen to a patient, Cantrell stressed that he could not tell a patient to use an expired EpiPen. However, he said, “If that’s the only product you have, and you or a loved are having a reaction,” then it could potentially be lifesaving. He added, “If that was my child, I absolutely would.”

The results of the study were published in the Annals of Internal Medicine. DOI: 10.7326/L16-0612