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EpiPen Shortage Causing Concern as Schools Start

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Aug. 24, 2018 -- The EpiPen shortage is colliding with the start of the school year and causing challenges for many. That’s because families of children with allergies have to buy new epinephrine auto-injectors at the start of each school year to leave in school health clinics and classrooms, and right now, many are having trouble getting the potentially lifesaving medication their children need.

“This is the height of renewal season, and most of us need to renew multiple sets, and a lot of pharmacies are saying they are out and don’t expect more well into October or November. Parents are not thrilled about this,” says Erin Malawer, author of the food allergy blog “Allergy Schmallergy” and mother to a child with anaphylactic food allergies.

“I am still without my daughter’s full prescribed pens,” says Marlo Tremont of California. “I have two, but I need several more and am having to juggle. And I’m confused about what else I could use for her.”

Another mother in Virginia -- Claudia, who asked that her last name not be used to protect her child’s privacy -- says she’s also been unable to get the generic EpiPen she was prescribed for her daughter, who is starting kindergarten. “Only one pharmacy had them available, and only one set, so I’m on a waitlist for another. Whenever it is available, I will get a call,” she says. “It’s frustrating.”

The FDA announced this week that it is extending the expiration date on some batches of EpiPens by 4 months to try to help people struggling with the shortage. But many in the allergy community say they’re afraid to give their children lifesaving medication that is past its printed expiration date.

Others say it’s confusing to now be told they can use expired medication after long being told to stop using the devices as soon as they expire. “The expiration extension underscores how somewhat arbitrary the expiration date process has seemed from the start,” Malawer says.

Compounding the problem for many families dealing with allergies is that despite the FDA’s extension announcement, some schools are refusing to accept expired EpiPens for liability reasons. That happened to Kelley Beatty of Ohio. She says her son’s school wouldn’t take an expired set, even when she showed them the FDA announcement.

Beatty says she was told they would accept an auto-injector by a different manufacturer, but she was also warned that teachers wouldn’t be trained on it because they’ve only been taught to administer EpiPens. “It’s such a mess,” she says.

Malawer says these difficulties are more than just a minor inconvenience. An estimated 8% to 10% of children have food allergies. Immediate access to epinephrine and knowing how to properly give it is crucial to saving someone’s life during an anaphylactic allergic reaction.

“You can’t have teachers fumbling with a device and delaying the administration of this lifesaving drug. Minutes matter during a severe allergic reaction,” she says. “Allergies are a life-and-death matter, and you only have a limited amount of time to stop a deadly reaction.”

This shortage comes 2 years after EpiPen marketer and distributor Mylan made news for major price hikes on the devices. The drugmaker reached a $465 million settlement with federal investigators last year for raising prices on the auto-injectors by about 400% between 2010 and 2016.

“Here we are having another problem with this company at a crucial time for many families,” Malawer says. “It’s just not clear exactly who is to blame or what the issue is, and it is all really frustrating.”

What Caused the Shortage?

The shortage dates back to May but seems to be worsening, perhaps due to more demand as students head back to school. It affects the supply of the 0.3 milligram EpiPen, the 0.15 milligram EpiPen Junior, and the company’s generic versions of both.

A representative for Mylan, which distributes and sells the EpiPens, says it is shipping the drugs as soon as it gets them from Pfizer. But it says there are supply delays from Pfizer’s subsidiary Meridian, which manufactures the EpiPen.

A representative for Pfizer says there have been process changes, more inspections, and supply problems with certain third-party components. All have contributed to the shortages.

“We understand how important this potentially life-saving product is to patients, and are working tirelessly to increase production and expedite shipments as rapidly as possible,” a Pfizer representative said, adding that the product continues to ship and the company is hoping to stabilize supply later this year.

The company declined to provide more details on the delays.

Going Beyond Expiration Dates

The FDA has released a list of certain batches of EpiPens it says can be used 4 months beyond their printed expiration date. Patients and parents should check to see if their device is on the list. The extension does not apply to EpiPen Juniors.

FDA spokeswoman Theresa Eisenman says that while the agency’s safety standards don’t change in a shortage situation, it can temporarily ease rules and be more flexible. Mylan gave data to the FDA to show specific lots of its EpiPen product remained stable in strength, quality, and purity for up to 24 months when stored according to instructions on their label.

This doesn’t mean expiration dates in general should be ignored. Expired medical products can be less effective because they’re not as strong as they should be, or they can be less safe because their chemicals have changed, the FDA says.

Options if You Can’t Find EpiPens

Mylan says that EpiPens are still available but are harder to find. The company says it will help patients locate pharmacies that carry their products and has extended its call center hours. Patients can call 800-796-9526 for help.

The FDA also has a list of other approved epinephrine auto-injector products on its website, including Adrenaclick and Auvi-Q.

“You can trust the FDA-approved products, and I have no problem interchanging any of these that are approved and available. Any version of epinephrine that is available is acceptable,” says Allyson Larkin, MD, an allergist at Children’s Hospital of Pittsburgh. She says she’s been getting lots of calls from worried parents trying to figure out their options.

“This creates a lot of anxiety, but I have not experienced the scenario where we can’t get anything. I have been able to get some version of epinephrine for everyone,” she says.

Larkin does caution that devices may be used differently. If you switch to a different manufacturer or delivery device, you need to educate yourself, teachers, and caregivers on how to safely use the new auto-injectors in an emergency.

She says you should read all instructions and, when possible, practice on a training device from the manufacturer.

The FDA has just approved production of the first generic versions of EpiPen and EpiPen Junior by drug maker Teva Pharmaceutical Industries Ltd., but those aren’t an option right now. The company says it will be months before the products are available.

Are Companies Rationing Devices?

EpiPens are typically dispensed in a box with two auto-injectors, because up to 25% of allergic reactions require two or more doses of epinephrine to stop life-threatening allergic reactions. Sometimes the first attempt can be improperly dispensed, or there can be a malfunction.

Larkin says she recommends that her patients keep the two-pack together when possible. If symptoms are still progressing 5 minutes into an allergic reaction, they should administer a second dose. But she adds, “It is better to have the medication available than not available.”

While it used to dispense two auto-injectors for every prescription, Kaiser Permanente says it’s had to make a change to preserve supplies for all its members who need the medication, a representative says. So, until supplies normalize, the company is providing no more than one auto-injector at a time for most patients.

“Our physician groups have endorsed the splitting of these packages to preserve supplies during the shortage. Once supplies return to normal, the one-syringe limit will be removed,” a Kaiser representative shared in a statement.

A number of Kaiser Permanente patients are concerned about the change, they say in a Facebook group for parents of children with allergies. One mom from California says she refused to accept just one auto-injector from a pharmacist. Chere Perry says she left with nothing and paid cash somewhere else.

“It is not safe, and it made me angry -- I was almost in tears,” Perry says. “The pharmacist was very understanding, but his hands were tied.”

Experts suggest you talk with your doctor to find out how best to handle this situation if it happens to you. Kaiser Permanente says pharmacists may provide  more than one prescription for high-risk patients with a documented need based on the patient’s refill history or when advised by the patient’s doctor.

WebMD Health News Reviewed by Michael W. Smith, MD on August 24, 2018

Sources

Claudia, Virginia.

Allyson Larkin, MD, Pittsburgh.

Erin Malawer, McLean, VA.

Marlo Tremont, California.

Lauren Kashtan, Mylan, Canonsburg, PA.

Food Allergy Community of East Tennessee: “Why 2?”

FARE, Food Allergy Research and Education: “Food Allergy Facts and Statistics for the U.S.”

Mylan, news release, Aug. 8, 2018.

Pfizer, representative and news releases, May 9, 2018, and Aug. 21, 2018.

Teva USA, statement, Aug. 16, 2018.

FDA representative, “FDA In Brief”: Aug. 21, 2018; “Extended Use Dates provided by Pfizer,” Aug. 21, 2018; “FDA approves first generic version of EpiPen,” Aug.16, 2018.

USA Today: “Feds finalize $465M Mylan settlement for EpiPen overcharges.”

 

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