The National EpiPen Shortage
If you are like me and millions of American adults and children who suffer from potentially fatal allergies, you know your EpiPen is your lifeline.
Whether it’s shellfish, nuts, dairy or any other type of allergen that can causes a catastrophic reaction leading to anaphylaxis— which, in turn, can lead to certain death in minutes— having this emergency injection of the lifesaving drug epinephrine is critical. It is particularly important for the parents and caregivers of young children who cannot always find the exact words to articulate the changes they are experiencing in their breathing patterns and heart rates as the reaction ensues.
Also, like me, if you require an EpiPen or have a child or other relative who does, you have grown increasingly frustrated over a national shortage in the U.S. that has entered its third year now.
Most of us use the Pfizer subsidiary Mylan NV brand EpiPen, EpiPen Jr or equivalent generic auto-injector devices. Which device depends on your insurance. For unknown reasons, many insurance carriers have not approved the use of the generic versions. Some suspect it has to do with financial agreements between the pharmaceutical companies and insurers and the exorbitant costs associated with the EpiPen brand. However, none of this has been substantiated.
Studies show that anxiety over the international shortage of the life-saving medication remains high as EpiPens, the leading brand of epinephrine autoinjectors to treat anaphylaxis, have been in short supply since November, 2016 in Australia, Canada, USA, and the UK. have all reported national shortages of EpiPens, with some being entirely out of stock of both the adult and the junior versions.
In the UK, doctors and pharmacists attempted to solve the problem by recommending alternative generic brands or telling patients to keep their devices beyond the stamped expiration— a date at which it is believed the epinephrine begins to lose its potency. autoinjectors or generic alternatives, where available.
Mylan has taken to blaming the shortage on its manufacturer, Meridian Medical Technologies. Meridian explains that they experienced a supply interruption, for which they’ve offered no cause, in 2016, nor have they have offered and explanation as to why the shortage remains an unresolved issue. The medical community believes this lack of transparency will ultimately damage Mylan’s reputation in the market that they have monopolized since 2007 when they purchased the EpiPen brand.
Costs of the Mylan EpiPen injectors were initially $100 per 2-pack prescription. As the EpiPen brand became a household name, the company raised the price and by 2016, a pack of EpiPens could cost patients over $600 for a product that cost Mylan on $35 per pen to make. Consumer outrage led Mylan to authorize a generic version retailing at half the cost of their brand.
Mylan has 90% of the epinephrine autoinjector market cornered in most countries and in others, it remains the only epinephrine autoinjector available. However, the this could change, particularly in the U.S. where the ongoing shortage has allowed for more generic brands to come forward. In August 2018, Teva Pharmaceuticals generic epinephrine autoinjector was approved by the US Food and Drug Administration. The company intends to release their version of the product during their first quarter of 2019. To date, the cost is unknown.
Some hope the wide availability of a generic EpiPen will lead to the end of what the FDA called a “short-term” problem in early May, 2018. Mylan’s parent company Pfizer assures patients that their “product continues to ship and patients’ ability to readily access product has improved,” though patients and pharmacists alike disagree. There is evidence to support what patients and pharmacists believe to be an issue with no resolution.
According to a 2018 study by the organization Food Allergy Research & Education (FARE), 82 percent of respondents reported being unable to fill their prescriptions or were only able to partially fill prescriptions for the Mylan brand of EpiPens
“I feel helpless,” says Dared Price, a Kansas pharmacy owner. Telling the magazine Allergic Living about not having what his patients desperately need, “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.”
In the U.S., some doctors have moved to prescribe the order-direct compact Kaléo’s Auvi-Q auto-injectors, these can also be found at Walgreens pharmacies and the company reports no supply issues. However, this is only useful to patients whose doctors are aware of alternative programs likeKaléo’s. Another generic brand, Amneal-Impax is also available, but like Mylan, they, too, are experiencing manufacturing delays.
Novartis’ Sandoz Inc., will be launching Symjepi, an epinephrine syringe, this year.
Due to the shortage, the American Society of Hospital Pharmacists (ASHP) reports the FDA has “extended the expiration dating for certain lots of EpiPen and some generic epinephrine auto-injectors.”
The shortage isn’t the only scandal that has surrounded this medication. In 2017, the manufacturer recalled 13 lots of the drug distributed between Dec. 17, 2015, and July 1, 2016 in the U.S. In 2018, Pfizer Canada reported problems with Epipen and Epipen Jr. device mechanics that could “delay or prevent emergency treatment.” By January of this year, the FDA found the manufacturer, Meridian, knew there were problems with the injector going back to 2013, but they chose not to report it. It is unknown how many fatalities, if any, can be attributed to this malfunction.
As of this reporting, Mylan has not indicated if there will be a resolution to the U.S. Epipen shortage in the coming months. Also, the available generic alternatives that have been filling this void are seeing their stocked supplies dwindle. Canada reports their shortage has ended and in America, Teva Pharmaceuticals expects to claim 25 percent ($250 million) in profits this year from the sale of Epipens once their generic brand enters the market later this year. Until that time, Mylan, the maker of the Epipen brand tells us patients having difficulty filling their prescriptions to call their customer relations number at 800-796-9526 for assistance, but would offer no other information about the ongoing shortage.
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About the Author: Aisha K. Staggers is a writer, lecturer, and co-host and producer of “All Our Own” radio show and podcast and co-host of “Staggers State of Things” on the Dr. Vibe Show. Her work has been featured on MTV News, HuffPost, Blavity, Atlanta Blackstar, For Harriet, New York Review of Books and a host of other first-run publications and syndicated outlets. Find her on Twitter @AishaStaggers. For more of her work, check out her page here!
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