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Sunday, August 26, 2018

Generic versions of EpiPen may ease a national shortage


The EpiPen shortage facing the country has worsened in recent weeks, but a Watertown, NY pharmacy has found a way around it.
Bolton’s Pharmacy, with locations on Main and Washington streets, has been using generic epinephrine auto-injectors for its prescriptions.
Supervising pharmacist Shawn M. Signor said the only real difference is the name brand. While the formulas vary, the results and functionality are practically the same.
“We have been frequently dispensing alternative versions of EpiPens for patients,” Mr. Signor said. “There is no backstock on them, so we haven’t had any trouble having them supplied at our pharmacy.”
By comparison, EpiPen is the trademark Pfizer associated with the product, just like Kleenex is associated with a facial tissue — it doesn’t mean the other versions aren’t effective.
Until the shortage is over, this may be the best option for consumers to consider.
The shortage
The limited availability is related to both pharmacy-level supply disruptions and manufacturing constraints, Pfizer stated in a recent release.
Sales of the EpiPens also spike during back-to-school season, as parents attempt to refill expiring prescriptions to keep in children’s backpacks, at school and at home.
Pharmaceutical company Mylan stated it’s “expediting shipments upon receipt from Pfizer” and that officials “are working closely with Pfizer to stay informed of anticipated shipments and are maintaining a regular dialogue with health authorizers to provide frequent updates on supply status.”
Expanded expiration dates
On Tuesday, the U.S. Food and Drug Administration said people can use some expired EpiPens for a few months longer, to help cover spot shortages. This can only be applied to EpiPens and its authorized generic version.
Certain batches of the devices, which inject lifesaving medication to stop severe allergic reactions, can be used for four months beyond their expiration, the FDA said.
“We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” the FDA’s Dr. Janet Woodcock stated. “We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring.”
Combatting the problem
On Aug. 16, federal regulators approved the first generic version of EpiPen, developed by Teva Pharmaceuticals. This version will be interchangeable with the original epinephrine auto-injector sold by Mylan. Pharmacists will soon be able to substitute this version when doctors prescribe the original EpiPen, but it’s not available yet.
This version may not launch in time for families urgently searching for supply now, so Mylan is encouraging patients to call its customer relations department at 800-796-9526 for help locating alternative pharmacies.
Alternative options include changing to a generic epinephrine auto-injector that is not the same formula as an EpiPen.
If a patient is interested in a generic version, they should talk with a health care provider about different options.
Also, be sure the prescription states “epinephrine auto-injector” instead of “EpiPen.” If not, pharmacies may not be able to provide the available alternative.
What is an EpiPen?
EpiPen refers to the brand-name version of an epinephrine auto-injector, which injects epinephrine, a chemical that narrows blood vessels and opens airways in the lungs. The pen is a quick self-injection system that can be used by anyone to deliver medicine to someone in allergic shock, or anaphylaxis.
Typical allergic reactions to treat with an EpiPen include insect stings or bites, food, drugs and other allergens, according to the American Academy of Allergy Asthma and Immunology.
The EpiPen is marketed by Mylan and manufactured by Pfizer. Other companies have made different types of epinephrine auto-injectors, most common being Adrenaclick and Auvi-Q, and can vary drastically in price. A consumer who switches from EpiPen to a generic auto-injector could be saving up to $430 per prescription.

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