Brenda Thiel along with also also Alyssa Wachtler live on opposite sides of the country. although they’ve got at least one thing in common: both have sons with severe nut allergies. along with also also when they made their usual back-to-school trips to the pharmacy to procure their EpiPens for the fresh year, they were told the same thing.
“The pharmacist literally walked up to me along with also also said, ‘I’m definitely sorry, we do not have any epinephrine here,'” Thiel, who lives in Tucson, Arizona, told CNBC. “He said there’s a shortage, along with also also you’re not going to be able to find EpiPens anywhere.”
The lifesaving allergy medicine has had manufacturing disruptions since May, although allergy sufferers along with also also caregivers may find the idea especially hard to find today, as parents try to stock up to send their kids back to school. EpiPen prescriptions typically spike in August, when parents buy multiple packs to give to their kids’ teachers, nurses along with also also sports teams.
“In my busy pediatric clinic, we’ve noticed there are many patients calling in wondering where they can procure their EpiPens, since most pharmacies are having trouble keeping them in stock,” said Dr. Stacy Dorris, of the department of pediatric allergy along with also also immunology at the Vanderbilt University Medical Center in Nashville, Tennessee.
the idea’s a problem across the country. CNBC called two dozen pharmacies, by Boston to San Francisco, along with also also nearly each one said the idea had no EpiPens, or very few, in stock. Some said the back-order date keeps getting pushed back, while others said the idea wasn’t clear when more might be made available.
Patient advocacy group FARE, or Food Allergy Research & Education, said the idea heard by 0 people in 43 states in a survey about EpiPen availability, along with also also more than 80 percent indicated they either couldn’t fill or could only partially fill their prescriptions.
“We’ve heard there are widespread shortages of EpiPen,” said Wells Fargo analyst David Maris, who estimates the product drew $1 billion in revenue in 2016 for drugmaker Mylan. (The company today reports financial results differently, generating the idea difficult to ascertain how the EpiPen is usually performing, he said.)
“the idea’s clearly a headwind,” Maris said. “along with also also no one’s talking about how soon the idea will be cleared up.”
fresh Jersey-resident Wachtler, whose 6-year-old son, Hudson, is usually starting first grade This specific year, is usually among parents who struggled to secure an EpiPen. She said she had to call eight to 10 local pharmacies before she found one in which had a set of EpiPens in stock in which were covered by her insurance.
“I said, ‘Put the idea on hold! I will be there from the morning!'” Wachtler told CNBC. “along with also also I rushed over along with also also got the last box.”
While EpiPen is usually marketed by Mylan, the idea’s manufactured by a subsidiary of Pfizer. Mylan says the idea’s “exploring several options with Pfizer in which might help stabilize supply,” while Pfizer cites “delayed shipments due to process improvements,” along with also also the supply of “third-party components” for the disruptions.
The Pfizer subsidiary, Meridian Medical Technologies, received a warning letter by the Food along with also also Drug Administration in September, citing “significant violations of current not bad manufacturing practice requirements” at its Missouri plant. Pfizer spokesman Steven Danehy said in which the warning letter didn’t restrict supply at the time the idea was received, although in which “there has been some impact on manufacturing capacity” as a result of fresh processes the idea put into place to fix the issues the FDA cited.
The EpiPen isn’t the only option for allergy sufferers, though the idea is usually by far the most dominant. There is usually an identical authorized generic edition also sold by Mylan, although at half the cost, although the idea too faces manufacturing issues.
Amneal Pharmaceuticals makes the Adrenaclick, a similar epinephrine auto-injector, while private drugmaker Kaleo makes the Auvi-Q, a smaller, rectangle-shaped device in which talks the user through how to use the idea.
The Adrenaclick faced its own manufacturing issues earlier This specific year, although Amneal spokesman Mark Donohue said This specific week in which the epinephrine auto-injectors are available. The Adrenaclick is usually also made by Pfizer, he said.
“While we experienced intermittent supply of products by our third-party some sort of throughout the second quarter along with also also during the month of July, we are receiving shipments,” Donohue said.
The Auvi-Q hasn’t had similar manufacturing problems, although the idea has another characteristic in which may make the idea hard for some patients to procure: a list cost of $4,500 For just two auto-injectors. If the idea’s covered by insurance, many can get the device without a copay. although the idea’s not always covered.