PURPOSE OF THE STUDY.
To determine if EpiPens are still potent up to 50 months after the labeled expiration date.
Unused, expired EpiPens were collected from patients and practitioners at a community clinic.
Patients and practitioners provided unused, expired EpiPens over a 2-week period. All units were examined for color changes and expiration date. The concentration of epinephrine in two aliquots from each unit was quantified by liquid chromatography and tandem mass spectrometry. Epinephrine-d6 was used as an internal standard.
Thirty-one expired EpiPen and 9 EpiPen Jr autoinjectors were analyzed. All medications were between 1 to 50 months past the labeled expiration date. None were discolored. Sixty-one percent (19 out of 31) of the EpiPen and 56% (5 out of 9) EpiPen Jr devices contained at least 90% of the stated amount of epinephrine. All the devices had at least 80% epinephrine remaining at the time of testing.
EpiPen and EpiPen Jr autoinjectors retain a majority (at least 80%) of the labeled quantity of epinephrine up to 50 months after the written expiration date.
Although there appeared to be a trend for the concentration of epinephrine to slightly decrease over time in the devices tested, the authors of this study demonstrate that most of the drug is still present after several years. The limitations of this study include the small number of devices and the unknown number of lots analyzed, and the authors did not assess how the units were stored or handled before and after they were expired. Considering the recent controversy regarding the skyrocketing prices of prescribed self-injectable epinephrine devices, more attention among prescribers and patients has been directed toward the use of expired epinephrine, particularly when it is cost prohibitive or no other alternative is readily available in an emergency situation. Future studies should be focused on outcomes in cases in which expired epinephrine and the minimum dose content that would be needed to deliver a therapeutic effect are used. In the meantime, the authors suggest that, in the event of a severe allergic reaction, it would be more prudent to use an expired EpiPen rather than no EpiPen at all.
- Copyright © 2017 by the American Academy of Pediatrics