Amy Duke went to five pharmacies to fill her son’s prescription for EpiPen, and each time, she left empty-handed. At the sixth pharmacy, she was given only one dose instead of the traditional twin pack. In addition, a label was improperly placed on the device, which would have made it difficult to use.
“I looked at them like they had five heads. I don’t even understand how you are legally allowed to hand this to me,” said Duke, 41, of east Cobb.
Duke is one of many Georgia residents who have expressed concerns about the U.S. Food and Drug Administration’s response to the shortages of EpiPen, which is used for the emergency treatment of allergic reactions including those that are life-threatening. Even with use of an EpiPen, health experts still advise a visit to the emergency room.
Though EpiPen is available, the FDA has noted that several factors, including regional supply disruptions and manufacturer issues, have led to limited availability in certain parts of the country since May. Nationwide, patients and caregivers have been unable to fill prescriptions, have received partial refills or have been unable to get additional refills within a 30-day period to rebuild their stock.
The FDA approved the first generic version of EpiPen and EpiPen Jr., which will come at a lower cost to patients as well as help protect against potential drug shortages, but it will take time for manufacturer Teva Pharmaceuticals to get the drug to the market. In a statement, the company said it would apply its full resources to the launch in the coming months.
The FDA also approved extended-use dates, which allow users at least four months beyond the expiration date of specific batches of EpiPen to use the drug, but some patients and caregivers are skeptical of the change.
“It is kind of confusing because for years, we heard don’t use it past the expiration date; now they are telling us we can go four months out,” said Ashley Green, 27, of Dalton, whose 9-year-old daughter is allergic to peanuts, tree nuts and eggs.
Green has had trouble filling her daughter’s prescriptions at her local CVS, which has been out of stock for several months. “The last time I was able to get it was the beginning of July, and I had to wait three weeks for it,” Green said. The refill that she received is the only EpiPen she has that does not expire in October.
“I hope nothing happens and I have to use one (of the expired ones), but anytime anything can happen,” Green said. She wonders who would be responsible if she used an expired EpiPen and it did not work. “Is it our fault or their fault? How would that work out?” she asked.
In a statement, a spokeswoman for the FDA said pharmaceutical company Mylan submitted data to the FDA to show that specific lots of its EpiPen product remained stable, retaining its strength, quality and purity for up to 24 months when stored according to its labeled storage conditions. “The FDA reviewed the data and determined to exercise discretion to allow Mylan to extend the expiration date of specific lot numbers by four months beyond the labeled expiration date to mitigate a potential shortage of EpiPen,” the statement said.
But at the same time, the FDA clearly provides guidelines on expiration dates stating that once the expiration date of a medication has passed, there is no guarantee that the medicine will be safe and effective.
Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA), is frustrated with the consistent reports of a shortage. He suggested the issue could also be addressed by partnering with Kaleo Pharma to make its FDA-approved Auvi-Q auto-injector more accessible to patients with insurance plans that do not cover the device.
“That is what is frustrating to me: There really is no shortage,” Mendez said. “Can’t you bring these parties together to solve the short-term issue on behalf of patients?”
Kaleo Pharma, which sells Auvi-Q direct to consumers rather than through insurers, issued a statement confirming that the company is not affected by the delays other manufacturers are experiencing. Last year, the company reintroduced Auvi-Q, after it had been recalled from the market in 2015 for device malfunctions.
“We are working with all manufacturers to ensure adequate product is available to meet patient demand. Patients should work with their health care providers to identify other alternatives, if needed,” the FDA said in a statement.
With two children who have allergies, Duke has always kept multiple sets of injectors spread between school, home, on her person and with her older son on his person. Two of the four sets she currently has expire on Aug. 31. She plans to give her son one set and carry the other set with her. For Duke, Auvi-Q is not an option as her insurer does not allow it.
“I am a pretty rational person, but this is a topic that is incredulous,” Duke said. “There is no alternative for us. There is no other medication we can use. I will keep going from pharmacy to pharmacy and keep filing prescriptions one at a time.”
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