With the summer winding down and the academic year in full swing, school-age severe allergy sufferers have to cope with more than just purchasing requisite school supplies and cool-weather gear. They should also be sure to have their emergency epinephrine treatment on hand and ready for use, particularly in light of its seemingly scarce availability. The Pfizer/Mylan supply shortage of brand and generic EpiPen and EpiPen Jr that was first announced in 2018 is ongoing as of September 2019, with no end in sight.
“EpiPens, especially at the beginning of school years, can be difficult to find for patients,” said Ryan Israelsen, MD, a board-certified allergist and immunologist from the Allergy and Asthma Center of Southern Oregon. “If they can’t find an EpiPen at their pharmacy, [they should] ask if there’s a generic available,” he said.
Yet, the shortage has affected both the Pfizer EpiPen and its generic alternative from Mylan.
“We share in the frustration over the fluctuating availability, but, as with many sterile injectable medicines, EpiPen requires a highly complex and technical manufacturing and assembly process,” said Pfizer spokesperson Kim Bencker. “Despite our significant efforts, we do anticipate further supply shortages over the coming months,” she said, adding, “We are committed to resolving this availability issue as quickly as possible.”
Alternatives unaffected by shortages
Kaléo, which manufactures a competitor auto-injector, Auvi-Q, has no such availability concerns. “Kaléo has not been impacted by the supply issues reported by other epinephrine auto-injector manufacturers,” said Caryn Foster Durham, director of corporate communications at Kaléo.
Kaléo partnered with Walgreens in 2018 to offer its 0.15-mg and 0.3-mg products—corresponding to the EpiPen Jr and EpiPen doses, respectively—either at no cost or via a patient assistance program. A newly approved 0.1-mg dose, the first specifically designed for use in infants and toddlers, is also included in the Walgreens collaboration.
Whether Auvi-Q use or sales have increased due to the EpiPen shortage is unknown, however. “Kaléo does not share specific sales information related to our products,” said Durham.
“It’s small … has an intuitive, user-friendly design, a smaller needle than the auto-injectors, and fits into the palm of your hand,” she said. Symjepi, which has been available in retail pharmacies since July 2019, also has a savings program that allows eligible patients to obtain it at no cost, Schneider noted.
Are beyond-expiration date products safe to use?
Patients who prefer the EpiPen brand or its generic alternative can safely use many lots of these products for 4 months beyond their expiration dates, according to research findings on their stability, Pfizer announced in a 2018 statement. Since then, Amneal, which manufactures generic EpiPen and EpiPen Jr, provided data to support the use of specific lots of both products for 2 months beyond their listed expiration dates.1
Israelsen agrees that when a patient’s preferred product is unavailable, “they can carry an old epinephrine auto-injector, and if there’s no crystallization or ‘floaties,’ it’s safer to use than nothing.” For new patients, however, “I try to show them the options and let them choose,” he said.
Kari Trotter Wall, PharmD, a director of pharmacy at both University of Southern California (USC) Pharmacy and USC Health Center Pharmacy in Los Angeles, generally recommends against using expired products.
“I don’t usually advise people [to use] past expiration dates because I like to do whatever I can to get the product for them,” Wall said. She described how staff at her pharmacies, which mainly serve college students, faculty, and staff, will call around if a prescribed product is unavailable at their location.
“The priority is that [patients] get something in hand,” she said. “Ideally I would like it to be from me, but if I don’t have it, I’m going to try to get it.”
Reference:
- http://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages
This article was previously published here.