The background to the EpiPen shortage
Since May this year, the EpiPen shortage has caused problems for many people with severe allergies. The epinephrine delivery system is used to counter anaphylaxis, a serious life-threatening allergic reaction that can be caused by food allergies, or reactions to insect stings or medication.
EpiPens and its authorized generic versions are marketed by Mylan and manufactured by Meridian Medical Technologies, a subsidiary of Pfizer. However, the companies have been plagued by supply disruptions and manufacturing issues in recent months, causing a shortage of the vital allergy treatment.
Back to school problems for EpiPen users
The EpiPen shortage has been further compounded by the upcoming start of the school year, a time of year that usually sees a spike in EpiPen sales.
If you are the parent of a child with severe allergies, your child’s school may require two EpiPens to keep in the nurse's office for use in the event of an allergic reaction. However, the medications expire each year, which has left many parents scrambling to find EpiPens and EpiPen Jr devices for children during the back to school season.
What is Mylan doing about the shortage?
In a press release, Mylan announced it was “actively exploring several options” to improve and stabilize supply, but warned that until Pfizer increases production and stabilizes supplies, EpiPens may not always be available in pharmacies.
What is the FDA doing to increase supply?
The US Food and Drug Administration (FDA) has already taken action to alleviate the problem, increasing the expiration date for certain existing EpiPens and its authorized generic version by four months.
Typically, the EpiPen remains has a shelf life of 20 months, but this has been extended to two years following an FDA review of stability data from Mylan. Parents should be aware that the extension does not apply to the EpiPen Jr, which is used to administer a half dose of epinephrine to smaller children.
Furthermore, on August 16th, the FDA announced the first approval of a generic EpiPen from Teva Pharmaceuticals, which could help both increase supply and reduce the cost of the allergy treatment by providing another alternative to the brand-name medication.
“This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” said FDA Commissioner Scott Gottlieb.
However, there is currently no set date for the entrance of Teva’s version of the epinephrine auto-injector into US market. The company announced the generic competitor will appear in pharmacies “in the coming months”, but until then, many patients will still be left struggling to find medication.
So what are my options?
Check EpiPen stock at alternative pharmacies
Mylan has encouraged patients to contact Mylan Customer Relations on 800-796-9526 for assistance in locating an EpiPen at alternative pharmacies if their usual pharmacy is out of stock.
Check if your child’s school is part of the EpiPen4Schools program
If your child’s school is part of Mylan’s EpiPen4Schools program, they may have an emergency stock of EpiPens. Qualifying schools are given four free EpiPen or EpiPen Jr injections, a storage unit, and EpiPen Trainers to train teachers or caregivers in administering epinephrine injections.
Check the expiration date on existing EpiPen devices
With the FDA’s extension of the expiration date on EpiPens, you may be able to continue using the expired EpiPens you currently have until stocks stabilize or your local pharmacy gets a new batch in.
Ask your physician about an EpiPen alternative
The EpiPen is not the only epinephrine delivery device available in the US. Amneal Pharmaceuticals’ Adrenaclick device also administers an emergency dose of epinephrine to treat life-threatening allergic reactions.
Another option is the Auvi-Q from Kaleo, although, with a list price of $4,500 for two, this may only be a practical option for those who can claim for the medication using their health insurance.
Be aware though, these devices function differently to the EpiPen, unlike the generic versions of the EpiPen, so should not be considered like-for-like replacements to be used interchangeably. If you are considering this option, speak to your doctor for advice before changing any allergy medication or treatment.
