May 11, 2019
The ongoing EpiPen shortage has hit the 1-year mark with no end in sight, leaving many families angry, confused, and struggling to get the epinephrine they rely on to stop life-threatening food allergies.
"This unexplained/under-explained shortage is ridiculous," says Cassie Hart of Normal, IL, the mother of a child with a food allergy.
"We didn't expect it to go this long," says Todd Mahr, MD, a Wisconsin-based allergist and the parent of a child with food allergies. "And that's frustrating to us and our patients."
EpiPens are just one brand of an auto-injection device that delivers set doses of epinephrine, a medicine that can help stop severe, sometimes deadly, allergic reactions. But the EpiPen has long been one of the most popular and well-known auto-injector choices, in part because it's widely accepted at schools since it's the standard most teachers and staff are trained on.
"Schools and other support networks are typically only familiar with one auto-injector: EpiPen," says Erin Malawer, a parent of a child with food allergies who also has an award-winning blog on the subject called Allergy Shmallergy. "We have a whole support system of teachers, administrators, etc., who are not trained on other epinephrine auto-injectors and even less comfortable administering epinephrine when it's so critically needed."
That's presented a lot of challenges for families in light of the supply shortage of EpiPens and EpiPen Jrs, which dates back to May 2018 and may not end any time soon.
"Despite our significant efforts, we do anticipate further supply shortages over the coming months," says Steve Danehy, director of media relations at Pfizer.
Mylan, which distributes and sells EpiPens, says problems are linked to a subsidiary of Pfizer -- Meridian Medical Technologies, which makes the devices. Danehy said in an email that the company is committed to resolving the shortage as quickly as possible, but he made it clear there is no timetable for it to end.
In fact, it could get worse before it gets better. Shortages are expected to result in tighter supplies. This could continue through the summer as peak refill season comes as parents prepare for a new school year. That's when children are required to bring extra auto-injectors to their classrooms or school offices and clinics.
"This is a big deal," Malawer says. "People are frustrated, calling all over their cities, getting on waiting lists at pharmacies. Families are worried about using their auto-injectors for fear that they might not be able to replace them. That's a dangerous thought."
What We Know About the Shortage
So why has the shortage lasted so long? The FDA's website lists the cause as "manufacturing delays."
Meridian has also reportedly had a long manufacturing shutdown for maintenance and upgrades in the winter, along with unplanned equipment downtime that made the problem worse and prevented supply reserves from building at the rate of projected demand.
"We share in the frustration over the fluctuating availability but, as with many sterile injectable medicines, EpiPen requires a highly complex and technical manufacturing and assembly process," Pfizer's Danehy said.
Mylan, the distributor, says it is speeding up shipments when it gets them from Meridian. "We appreciate how important it is for individuals with life-threatening allergies to have access to epinephrine auto-injectors and understand the frustration this ongoing situation continues to pose to patients and caregivers," Lauren Kashtan, head of North America communications at Mylan, told WebMD in a written statement.
The FDA stresses that while this is a shortage, EpiPens are still being released. "The market continues to be tight due to limited supply, and patients may experience delays, but there is product available," Nathan Arnold, an FDA spokesman, said in written comments to WebMD. He added that the agency cannot require that a manufacturer make or distribute a product.
Still, the FDA says the shortage announcement will remain on the FDA website until supply is meeting demand.
This isn't the first time Mylan and its EpiPens have been in the news. Meridian Medical Technologies voluntarily recalled a number of EpiPens and EpiPen Jrs in March 2017 for defective parts. Then in September 2017, the FDA sent Meridian a warning letter, saying it found the company had significant violations of current good manufacturing practices.
A Pfizer spokesperson says those issues are resolved and unrelated to current events.
Mylan also made headlines for reaching a $465 million settlement with federal investigators in 2017 for raising prices on its auto-injectors by about 400% between 2010 and 2016. The company violated the federal False Claims Act to avoid paying what it owed to Medicaid, the Justice Department said at the time.
While the shortage continues in the U.S., relief has come to Canada, where EpiPen is the only auto-injector on the market. Pfizer says supply issues affected that country throughout 2018, but the issue is resolved there. Representatives from Mylan and Pfizer did not respond to WebMD's question about why issues have been fixed in Canada but not in the U.S.
Impact on Families
It's estimated that 32 million Americans have food allergies, including 5.6 million children. Allergic reactions have been reported from more than 170 foods, but eight allergens are the most common: peanuts, tree nuts, shellfish, fish, milk, egg, wheat, and soy.
Avoiding an allergen is best but not always possible. Many people are exposed accidentally, through cross-contamination or even through the air. Quick access to epinephrine and knowing how to properly give it can be crucial to saving someone's life during an anaphylactic allergic reaction.
Recent data show cases of several allergic reactions, known as anaphylactic reactions, rose 377% from 2007 to 2016, says Lisa Gable, CEO of Food Allergy Research & Education (FARE), the world's largest nonprofit organization dedicated to food allergy awareness, education, and advocacy. "We believe no individual should be without this lifesaving drug due to lack of access or affordability."
But many families say they are struggling as this EpiPen shortage stretches on, and they're trying many different ways to navigate the challenging shortage. In August 2018, the FDA announced it was extending the expiration date on some batches of EpiPens. Nine months later, an FDA spokesperson says people should refer to its website to check the current extended expiration dates for specific lots of epinephrine auto-injectors.
Kristy Lane of Jersey Shore, PA, says she relied on expired EpiPens for 8 months while looking for replacements at pharmacies in her area. "I was on eggshells. I was uber vigilant with my son and the situations we were in and everything he ate," says Lane, whose 9-year-old son is allergic to tree nuts and dates. "I felt like I was committing child neglect because I couldn't provide the one thing that keeps him safe. It was awful."
Jennifer Dantzer, MD, an allergist at Johns Hopkins Medicine in Baltimore, says if an expired EpiPen is all you have, hold on to it. "I would rather you use an expired EpiPen than not have any medicine available," she says.
Other families say they're trying out alternatives to brand-name EpiPens. Options include a generic from EpiPen, Auvi-Q, and Adrenaclick. In August 2018, the FDA also approved the first generic version of EpiPen and EpiPen Jr by another company, Teva Pharmaceuticals, which are now commercially available. Sandoz recently announced, too, that it would be bringing Symjepi, another epinephrine injector, to the retail market, soon. It is currently available at hospitals and clinics.
Jessica Johnson, an Arizona mother of 5-year-old twins with peanut, tree nut, and egg allergies, says this shortage was the last straw for her, and she decided to try a new device. "We've jumped ship completely and have Auvi-Qs now."
Some families say they are so frustrated that they're paying out-of-pocket now for other brands on principle. "We pay out-of-pocket for Adrenaclick because Mylan has put our family through so much grief with their inflated pricing and shortage," says Jennie Fura of Sinking Spring, PA, whose 4-year-old son needs epinephrine because of his allergies to peanuts, tree nuts, green peas, and chickpeas.
Allergists say it is common now for many patients to try multiple pharmacies before finding their life-saving medication. "I talked with a family this morning who called seven pharmacies before she could locate one," Dantzer says.
"We don't have a brand preference," the allergist adds. "We think they will all be equally effective, and the most important thing is you have some type of epinephrine auto-injector. So our biggest goal has been working to get access to any kind possible. Some people have had to limit the number they get dispensed, too."
That's because devices can be expensive, especially when multiple sets are needed for home, school, and caregivers. Having insurance can help with the cost but can also present new challenges when carriers say that families must switch to other devices that not all schools and caregivers are trained on.
"Insurance steers us to different devices at times, and it is very frustrating," says Mahr, president of the American College of Allergy, Asthma and Immunology. "There are alternative devices available, but we need to teach people how to use them. They can be extremely different in how many steps are involved and what you remove first."
What Can Patients Do?
While all prescribed epinephrine auto-injectors on the market do contain the same epinephrine, understanding the differences in how the devices dispense that medicine could be important during a potentially life-threatening allergic reaction.
If your patient has switched to a new brand of auto-injector, experts say, it's important for them to practice on a training device from the manufacturer to become familiar with the differences in how to give the potentially life-saving medication.
Check how long is needed to hold the needle against the skin to dispense the medication, because it varies between devices:
- EpiPen brand-name and generic devices have a 3-second needle hold time.
- Auvi-Qs have a 2-second hold time.
- Adrenaclick has a 10-second needle hold time, and trainers aren't automatically included with prescriptions. They must be requested by phone, mail, or through the company's website.
- Teva injections have a 3-second hold time.
If your patients need to find new devices as the shortage stretches on, the FDA says people can look into other devices on its website. Mylan says its customer relations team continues to be "highly successful" in helping patients or families find where their products are available. Patients can call the company at 800-796-9526 during what it calls "extended" hours of operation: Monday through Friday, 8 a.m. to 7 p.m. ET.
Gable, the FARE CEO, says the nonprofit is encouraging families who need help filling their prescriptions to contact an independent pharmacy rather than a national chain, ask their doctor for a prescription for another brand, and keep expired epinephrine auto-injectors in case of emergency. More information for families affected by the epinephrine auto-injector shortage can be found on the group's website.
Dantzer, the Johns Hopkins allergist, says she is also encouraging families to start thinking early about what they'll need for the next school year so everyone isn't trying to stock up at the same time.
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SOURCE: WebMD, May 11, 2019.