EpiPens

Heather Bresch, CEO of EpiPen manufacturer Mylan, points to data during a House Oversight and Government Reform Committee hearing in Washington, D.C., on Sept. 21, 2016.

A shortage of Mylan’s EpiPen anti-allergy epinephrine injectors is forcing patients and pharmacists to go to great lengths to get their hands on the lifesaving device.

EpiPens, which can help stop a severe or life-threatening allergic reaction, have been hard to get since at least May 2018, when the Food and Drug Administration said the device was in short supply.

While other options are available, including a lower-priced version of the device from Mylan, consumers have struggled to secure these alternatives thanks to uneven distribution, uneasiness with unfamiliar products, and the reluctance of insurers to pay for them. The generic injector made by Mylan isn’t officially in shortage, according to the FDA.

Even patients who live near pharmacies have been scrambling. Boston resident Justin Klaassen said he drove 45 minutes outside the city earlier this year to find EpiPens for his 7-year-old daughter. Everywhere he called within 10 miles of Boston was out of stock of the device. The device carries a list price of more than $600 for a two-pack, and has been scarce because of manufacturing problems.

“My family has enough money to buy one with insurance, you know, and even two because you want one at school and you want one at home,” Klaassen said. “But there are families out there who can’t even afford one, and then you have the problem finding them.”

EpiPens can be especially difficult to track down at the start of a new school year, when sales tend to peak. Teachers and staff in school districts across the U.S. have been trained to use the devices, while few have been shown how to use rival products such as Adrenaclick and Auvi-Q. Some parents say they worry that the few moments needed to get familiar with a new injector could be costly in an emergency.

Pharmacists are racing to keep EpiPens on their shelves, scooping up fresh supply whenever they can. Ashley Seyfarth, the owner of New Mexico pharmacy Kare Drug, said she “plays the back-order game,” ordering from her wholesaler as soon as a shipment comes in, regardless of whether she has prescriptions that need filling.

Steps taken by U.S. regulators in recent weeks suggest that they expect the deficit of EpiPen brand injectors to linger, meaning more headaches likely await parents of students returning to school next month. In June, the FDA said expiration dates for some devices would be extended by four months.

Mylan has been providing information about EpiPen production, and any distribution shortages, to the FDA on a weekly basis, said FDA spokesman Nathan Arnold. The FDA can’t say when the shortage will end, he said.

“The FDA looks at drug shortages on a national scale,” Arnold said. “There may be local shortages in any given area of the United States even when there are not national shortages.”

So far this year, Mylan’s stock price has fallen by 32%.

The problem of finding EpiPens can be traced back to September 2017, when Pfizer Inc.’s Meridian Medical Technologies division, which makes the EpiPens for Mylan, received a warning from the FDA. The warning referred to allegations that the division had failed to investigate hundreds of complaints about faulty devices.

Pfizer spokesman Kim Bencker said the company itself is frustrated by the unsteady supply and that EpiPens involve a “highly complex and technical” manufacturing process.

“Despite our significant efforts, we do anticipate further supply shortages over the coming months,” Bencker said. The “product is routinely shipping, and we are committed to permanently resolving this availability issue as quickly as possible.”

EpiPens

Mylan's EpiPen auto-injection epinephrine pens can be life-saving for severe allergy sufferers.

Mylan spokesman Lauren Kashtan said the company is sending shipments as soon as it receives them from Meridian and encourages people to call customer relations for assistance in locating other pharmacies.

Pharmacists say that nailing down when they can get more EpiPens has been difficult. Carter High, owner of Best Value Rhome Pharmacy in Texas, said his wholesaler has several times pushed back the date of when more injectors would be available.

“As a parent, I look at that and think, God, I wish I could help them,” High said. “I can’t. There’s nothing to give them because I just can’t get it.”

High said he has also had difficulty obtaining Mylan’s generic EpiPens. At times, he said he gave patients epinephrine the “old-school way,” with a syringe. He said he tells patients to keep expired EpiPens because it’s “better to have something than nothing.”

In the meantime, brand-name EpiPen prescriptions have fallen. After peaking at more than 580,000 in August 2016, there were just 27,000 in May 2019, according to data compiled by Bloomberg Intelligence.

Going without an EpiPen can be dangerous for patients like Ashley Spencer, 29. She was eating a strawberry when she went into anaphylaxis on June 23. Her skin was bright red and itchy. Her throat was closing.

Spencer, who suffers from a rare autoimmune disease, didn’t have an EpiPen. She’d been waiting for a refill for more than a week when her body developed the new allergy.

“I can’t go a week and a half without it because my disease also can cause me to go into anaphylaxis at any time,” Spencer said. EpiPens “are crucial to my life.”

While some large pharmacy chains have struck agreements with EpiPen competitors to try to alleviate the shortage and reduce patients’ costs, others have struggled as insurance companies have sometimes balked at paying for pricier alternatives.

High said wholesalers “have plenty of Auvi-Q, but at $5,000 a whack, I can’t even get insurance to pay for that.”

“Though there are other things out there, we can’t use them even if we can get our hands on them,” said Seyfarth.

Additionally, a new generic product made by Teva Pharmaceutical Industries Ltd. has been difficult to track down, some pharmacists say. “I’ve never actually seen Teva’s product in the marketplace,” said Hamilton, N.J., pharmacist Eklavya Lalwani.

In an earnings call in May, Teva Chief Executive Officer Kare Schultz said the company is “ramping up the volumes” and is distributing its injector to Anda Inc., a supplier the drugmaker owns. “Any pharmacy who needs (an injector) can just call Anda, and they will get it within 24 hours,” Schultz said in May.

Teva spokesman Kelley Dougherty said the company has no back orders for the product, but both High and Lalwani said it was indicated as out of stock in Anda’s ordering system on July 8.

Elsewhere, Sandoz, a division of Swiss drug giant Novartis, said on Tuesday that Symjepi epinephrine injections, previously only given in hospitals and clinics, will now be available at pharmacies.

Even when insurance covers another brand, some parents like Klaassen have trained their family and friends on Mylan’s device and don’t want to switch.

Others, such as Erin Malawer, who lives near Washington, D.C., switched her 14-year-old son to Auvi-Q but still tries to find at least one EpiPen, because she fears that his friends or teachers might not recognize an alternative device in an emergency.

“If you’re looking for an EpiPen, blue and orange tube, and it’s not there, you’re wasting precious seconds that could save a life,” Malawer said.

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