The last time that Clarence Sullivan, owner of The Pharmacy Shop in Lexington, Kentucky, received a shipment of Mylan NV’s EpiPen, EpiPen Jr or equivalent generic auto-injector devices was May 24, 2018. “If somebody came in right now, they would not be able to get one from us,” he says.
Pharmacist Carter High says July 2018 is the last shipment of the Mylan devices that the Best Value Pharmacy location he manages in Rhome, Texas received. “We have several patients who are waiting for both EpiPen and EpiPen Jr to come back into stock,” he says of his store in the Dallas-Fort Worth area.
Meantime in Kansas, pharmacist-owner Dared Price says shipment to Graves Drug, an independent pharmacy in Winfield and Arkansas City, has been “sporadic” since the Mylan shortage began. “I’ve run into several times when we’ve needed it and didn’t have it,” Price told Allergic Living.
A national shortage of EpiPen, EpiPen Jr and the generic devices was announced in early May by the FDA, which called the situation “short-term”. But supply problems persist, related to continuing manufacturing delays at the Pfizer Inc. facility, which produces the auto-injectors for Mylan.
While Pfizer says that “product continues to ship and patients’ ability to readily access product has improved,” Allergic Living called several pharmacies and found that pharmacists in states such as New York, Kentucky, Kansas and Texas reporting difficulty obtaining deliveries of EpiPen, EpiPen Jr and the generic equivalent devices.
As well, a continuing online survey that Food Allergy Research & Education (FARE) began in August, by December shows that 82 percent of 821 respondents report that they could not fill or could only partially fill prescriptions for Mylan’s devices. (The survey doesn’t reveal whether earlier participants were eventually able to locate the devices.)
“I feel helpless,” says Price of Kansas about not having product when a patient comes in. “It’s not a good feeling if somebody is scared or upset about not having a life-saving device, but there isn’t a whole lot I can do about it.”
Epinephrine Alternatives in the U.S. Market
In more positive news for those who must carry life-saving auto-injectors, there are alternatives in the U.S. marketplace that are becoming increasingly popular. For instance, the AAAAI allergist organization confirms that many allergists are now prescribing the compact Kaléo’s Auvi-Q auto-injectors, which are often ordered via a directly delivery program and are also stocked at Walgreens pharmacies.
Mark Herzog, Kaléo’s vice president of corporate affairs, says the brand has no supply issues, and says Auvi-Q is now “the number one branded epinephrine auto-injector prescribed by allergists in the United States.”
However, pharmacists aren’t all aware of certain manufacturers’ programs, such as Auvi-Q’s directly delivery program.
Among the generics available, the Amneal-Impax version of the Adrenaclick auto-injector is also growing in popularity, although it too still faces manufacturing delays, according to the FDA’s site.
Teva Pharmaceutical Industries’ generic version of the EpiPen 0.3 mg is now available, at least in limited quantities, with additional distribution of this generic and the 0.15 mg (for young children) expected in 2019.
Sandoz Inc., a Novartis division, is gearing up as well for the launch of its pre-filled epinephrine syringe, called Symjepi, for the first quarter of 2019.
If patients are having problems locating Mylan branded or generic devices, Lauren Kashtan, the company’s head of communications for North America, encourages people to call its 1-800-796-9526 hotline for assistance.
Long Shortage “Unusual”: Pharmacist
Of the Mylan auto-injector shortage, Sullivan in Kentucky finds it “unusual” to see a supply problem last this long. “We used to never see things like this, drugs might be out of stock for a few days or a week, but a month would be unheard of,” says the pharmacist of 36 years. In May, Sullivan stocked up on the Mylan devices, ordering more than usual. But that stock is gone.
In Texas, pharmacist High has several patients on waiting lists for Mylan epinephrine devices. He runs one of the 14 locations of Best Value Pharmacies in the Fort Worth area and is a member of both the National Community Pharmacists Association (NCPA) and the Texas Pharmacy Association. Several of his colleagues are having similar experiences of not being able to fill prescriptions of the Mylan auto-injectors. “Our wholesaler is showing a release date of mid-December, but that has been pushed back several times.”
In New York City, a pharmacist in the Tribeca neighborhood, who preferred not to give his name, says “there is an evident drop in shipment” of branded EpiPen devices this year. He hasn’t received a shipment of Mylan’s EpiPen since June 2018 while the shipment of generic equivalent has been more frequent – with the most recent arriving on Dec. 6.
He still views this as “a huge problem,” since some school districts specify the device an allergic child is to bring. “Kids can’t go to school because the nurses require one at school for each patient. I’ve also had a patient drive two hours to upstate New York to pick up an EpiPen [set].”
Auto-injector supply is better for Ali Yasin in New York City’s East Village. “We’re getting our supply on a regular basis,” says Yasin, the supervising pharmacist at New York City Pharmacy. But he quickly notes, “there is certainly a shortage because some of the pharmacies call us and say they don’t have any in stock.”
When Will Mylan’s Shortage Resolve?
When asked about when the Mylan auto-injector shortage will resolve, neither Pfizer nor Mylan provided a timeframe other than to say they expect “further improvements over the coming months.”
In May, Steve Danehy, Pfizer’s director media relations, told Allergic Living supply issues relate to “certain third-party components” and “process changes” temporarily limited capacity at their manufacturing facility in Missouri.
When asked about current production of EpiPens and Mylan generic injectors, Danehy said, “We continue to invest in state-of-the-art manufacturing enhancements at our site.” He adds that Pfizer is working with third-party vendors to ensure that they have sufficient stock of auto-injector components.
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