In the scramble to fill supply lists and go back-to-school shopping, this year some parents are struggling to find one other supply to send to school with their kids, one with potentially life-saving implications.
The EpiPen shortage first made news last spring when many families were unable to refill their prescriptions for weeks at a time due to manufacturing delays. EpiPen, which is owned by Mylan and manufactured at a Missouri Pfizer plant, is an epinephrine auto-injector that is routinely prescribed to children and adults who live with life-threatening anaphylactic allergies.
Melissa Tooley, a South Carolina mother whose son lives with multiple allergies, spent weeks trying to locate an EpiPen for her son. When she was able to find one, it was much closer to expiration than she preferred but, "It was better than nothing, so we took it after two weeks of trying to find one."
Fall is a pivotal time of the year for parents looking to ensure their children are adequately equipped with functioning EpiPens for the new school year. "This is the height of renewal season, and most of us need to renew multiple sets, and a lot of pharmacies are saying they are out and don't expect more until well into October or November. Parents are not thrilled about this," Erin Malawer, author of the food allergy blog "Allergy Schmallergy" and mother to a child with anaphylactic food allergies, tells WebMD.
The shortage, now closing in on its fifth month is leaving many parents high and dry, wondering how to get their hands on the life-saving medication their children need. Fort Worth pediatrician Lisa Lewis cautions parents not to panic, "If your child's EpiPen or EpiPen Jr. is not available, there are several ways to go about getting the medication." There are a few options, including an FDA-approved generic epinephrine auto-injector which should be available in pharmacies soon.
Why Is This Happening?
The shortage, which was announced by the FDA in May, comes as a result of several FDA inspection violations, including complaints about quality assurance, according to the Wall Street Journal. In response to the inspection, the facility, which is run by Pfizer, is overhauling manufacturing procedures, leading to shipping and manufacturing delays.
Last week, in response to the shortage, the FDA extended the expiration dates on some batches of EpiPen, which typically expire after 20 months. A full list of extended-use batches can be found on the FDA website as well as a list of other approved epinephrine auto-injectors. While extending expiration dates is useful, it leaves some parents wondering if their expired auto-injector will work appropriately during an emergency situation and if it does, why are the expiration dates not longer to begin with? There have also been reports of schools not allowing expired EpiPens, even with FDA approval because of the liability involved.
What Can Parents Do?
Susan Schuval, M.D., division chief of Pediatric Allergy/Immunology at Stony Brook Medicine, offers the following tips for parents and caregivers who may be struggling to find an EpiPen for their child:
1. Parents should call around to different pharmacies to see who may have the epinephrine auto-injectors in stock. Manufacturer websites (Mylan) or customer relations may also be able to provide information on locating the medication. Patients can contact Mylan customer service at 800-796-9526 for help locating Epipens and other epinephrine auto-injectors.
2. Generic epinephrine auto-injectors may be available. Although these come in different forms, they all contain the same medication, epinephrine, and are equally effective in treating severe allergic reactions.
3. Another type of epinephrine auto-injector (AUVI-Q) may be available through a central pharmacy but is not covered by all insurance.