Updated Aug. 21, 2018: An online survey of epinephrine auto-injector access, conducted by the Food Allergy Research & Education (FARE), reveals widespread issues across America trying to fill prescriptions for EpiPen and equivalent generic auto-injector devices during the back-to-school season.
The non-profit says the survey, which began on Aug. 3 and continues, to date shows 80 percent of 600 survey participants reporting that they either could not fill at all, or could only partially fill, prescriptions for Mylan NV’s EpiPen, EpiPen Jr or generic devices. The supply issues relate to continuing manufacturing delays at a Pfizer Inc.-owned facility, which produces the auto-injectors that Mylan distributes.
Survey participants were food allergy families and individuals from 43 states. In a sample of anonymous survey comments FARE provided to Allergic Living, one parent said the family’s doctor “won’t even write a new prescription given the shortages.” Another said of the auto-injectors, “there are none available. The pharmacist at my clinic said every date Mylan tells them they’ll be able to order comes and goes with no availability.”
Another participant reports purchasing just one EpiPen from a two-pack set that a pharmacy broke up. “I was told to try again to get the other one in two to three weeks,” the person wrote.
Dr. Susan Bailey, an allergist in Dallas-Fort Worth, told Allergic Living that most of her patients have been able to fill their auto-injector prescriptions. However, she recently saw a patient who was admitted to hospital for anaphylaxis and then couldn’t find a pharmacy that had epinephrine auto-injectors. “She had to order the Mylan generic by mail,” says Bailey. “It took two weeks to arrive and, meantime, she was completely defenseless if she had another reaction.”
Alternative Options on the Rise
In the U.S., it appears the epinephrine shortage of Mylan’s branded and generic devices, which began in May, has many patients turning to an alternative auto-injector.
Dr. Robert Wood, president of the AAAAI allergists’ organization, is hearing of many allergists avoiding epinephrine supply problems by prescribing the compact Auvi-Q auto-injector. In his own Baltimore clinic, he’s found a parent and patient preference for Auvi-Q during the busy back-to-school refill and school form season.
In fact, Kaléo, the makers of the Auvi-Q, tell Allergic Living that their device is now “the number one branded epinephrine auto-injector prescribed by allergists in the United States.” (This would not factor in sales of Mylan’s generic device.) Kaléo stresses that it has no supply issues with its compact Auvi-Q auto-injector and is able to fill all Auvi-Q orders received through its direct delivery service.
While Mark Herzog, Kaléo’s vice president of corporate affairs, declined to give Auvi-Q’s precise market share, being the brand leader would represent a huge change in the epinephrine marketplace. Consider that in 2016, Mylan’s branded EpiPen and EpiPen Jr accounted for 95 percent of the epinephrine auto-injector market.
Another U.S. auto-injector option, the Amneal-Impax generic version of the Adrenaclick auto-injector, which has a cost-effective program with CVS, has also faced some shortage issues, but has a smaller share of the marketplace. In the FARE survey, about 2 percent of respondents had trouble locating an Adrenaclick generic.
On Aug. 16, the FDA granted long-awaited approval to Teva Pharmaceuticals to market a generic version of the EpiPen and EpiPen Jr. The company said it is applying its “full resources to this important launch in the coming months and is eager to begin supplying the market.”
Pfizer Inc. released a statement on Aug. 8 about the Mylan auto-injector shortages, saying its facility continues to “experience manufacturing constraints affecting U.S. supply.” The statement spoke of efforts to increase production, but said: “Currently, supplies will vary from pharmacy to pharmacy, and we cannot guarantee that product will be available at all pharmacies.” (Mylan says to call 1-800-796-9526 for assistance in locating the devices.)
Expired Epinephrine and the School
Given the supply shortages, many food allergy families are asking about the safety of carrying auto-injectors past expiration. A University of California study in 2017 did find that epinephrine retained potency for at least two years beyond the expiration date. FARE is recommending keeping expired epinephrine auto-injectors to use as backup in case of an emergency if an unexpired auto-injector set cannot be immediately located. (It’s recommended to follow the usual protocol of dialing 911 and going to hospital for follow-up assessment and/or treatment).
But Wood says trying to register at school with an expired set of EpiPens would not normally be acceptable. “School health systems and school nurses are bound by very strict guidelines, and first and foremost is requiring medication within the expiration date.”
FARE’s clinical advisory board executive wrote to FDA commissioner Dr. Scott Gottlieb on Aug. 14, requesting that the FDA issue official guidance on the safety of using epinephrine auto-injectors past expiration dates. “This is important because the public – and schools in particular – must be informed that expired epinephrine can be kept on hand for emergencies, especially during a time when current devices may be difficult to obtain,” the FARE medical advisors wrote.
On Aug. 21, the FDA did issue a statement extending the expiration date on EpiPens and equivalent generic by several months. See full details here. However, Pfizer says the extension does not apply to EpiPen Jr and the junior generic.
As well, FARE’s medical advisory committee repeated its request for the FDA “to permit importation of approved EAIs [epinephrine auto-injectors] from other developed countries,” as a means to provide more options for epinephrine.
Stock Epinephrine Programs
Both Mylan and Kaléo run programs that provide schools with “stock” epinephrine auto-injectors, for use in case a student experiences an anaphylactic reaction to a food or sting and doesn’t have their own medication available.
Mylan’s EpiPen4Schools program, which offers four free epinephrine auto-injectors to qualifying schools across the United States, is running for the 2018-2019 academic year, according to Lauren Kashtan, the pharmaceutical company’s head of communications for North America. However, in May, Mylan alerted schools in the program that, given the supply shortage, “there may be delays in order fulfillment until supply levels stabilize,” said Kashtan.
Kaléo’s Q Your School program provides up to four free epinephrine auto-injectors and trainers per elementary school across the United States. (Replacements are offered if a school has to administer these devices.) Herzog says the application process for schools remains open and the company is able to fill all orders.
In the 2017 academic year, nearly 58,000 schools participated in Mylan’s program, while Kaléo donated more than 17,000 auto-injectors to 2,500 elementary schools across 45 states.