By Kristen Chandler
Australia and Canada have been dealing with an EpiPen shortage since earlier this year. At the end of April, EpiPen co-manufacturer Mylan announced that it did not anticipate the shortage to affect the United States. However, only a couple of weeks later people in the U.S. started having trouble getting their EpiPen prescriptions filled. In the beginning it was thought to be a spot shortage; however, on May 9, 2018, the Food and Drug Administration (FDA) officially declared a shortage of both the 0.15 and 0.3 doses of the EpiPen, as well as the 0.15 and 0.3 doses of the generic epinephrine auto-injector known as the Adrenaclick. According to the Food Allergy Research and Education (FARE) website, at the time the FDA declared the shortage, at least 400 people in 45 states had difficulty getting their EpiPen or generic auto-injector prescriptions filled.
Why an EpiPen Shortage is a Problem
The medication used in the EpiPen auto-injectors, epinephrine, is a life-saving drug. It is the number-one treatment for anaphylaxis, a side effect of a severe allergic reaction. If epinephrine is not administered correctly and immediately in the case of anaphylaxis, the result could be fatal. While there is not a shortage of epinephrine itself, a shortage of the auto-injectors is still not good news. There is another auto-injector available, the Auvi-Q, manufactured by Kaleo. However, some insurance plans may not cover the Auvi-Q, and a lot of people are more comfortable using the EpiPen, EpiPen Jr or their generic counterparts, because that is what they have used for so long. To put it simply, this life-saving device is just not something that we can run out of.
What Has Been Done and What You Can Expect
Shortly after the FDA declared the shortage of the devices, FARE issued a call to action asking that the FDA “act swiftly” to address and resolve the problem. The EpiPen and EpiPen Jr are manufactured by Mylan Pharmaceuticals and Pfizer. The generic epinephrine auto-injectors are manufactured by Impax Laboratories. According to Pfizer, the reason for the shortage is a manufacturing delay, which they are working to correct. In a statement released in May, Pfizer said they had surpassed their shipment expectations of the device in April. The shortage is expected to only be short-term; however, at the time of this writing the status of both the generic auto-injector and the EpiPen is listed as “currently in shortage” on the FDA website and no timeline has been given as far as how long this shortage is expected to last.
What Can You Do?
If your child has been prescribed an EpiPen or EpiPen Jr, or the generic alternatives, how does this affect you and what can you do? First, check your expiration dates. If you still have some time before the EpiPens expire, that is good news. The set I carry expires in September, and the set my son carries expires in August. I normally get his prescription refilled toward the end of July, to ensure that he has a new pack for school since he is required to carry a set that does not expire within the school year. However, if the shortage has not been declared over by the end of this month I will go ahead and start checking availability to make sure we will have them when school starts up again.
Also, if your school has stock epinephrine you may need to check on its availability as well. I spoke to our school nurse shortly before school was out, and she said her EpiPens were good but that her EpiPen Jrs were about to expire. She had ordered them at the beginning of May (around the time the shortage was announced) and was told it would be a wait, but she was assured that she would have them by the time school started again in August.
If your auto-injectors are about to expire, call ahead to the pharmacy to check on availability. If you are unable to locate auto-injectors in your area, you can call Mylan’s 800 number, 1-800-796-9526, and they can help you locate auto-injectors nearby. You can also talk to your doctor about switching to the Auvi-Q injector. But, you would also have to check with your insurance provider to make sure it would be covered. Also, keep in mind that the Auvi-Q is a different type of device than the EpiPen or the generic epinephrine auto-injector. Your doctor or pharmacist can walk you through how to use it. Additionally, the Auvi-Q does “talk,” so the device itself can walk you through how to use it.
Dr. James Baker, the CEO and chief medical officer of FARE, did state that EpiPens can be used in an emergency up to about six months after their expiration date. After that, the epinephrine may not be as effective. If the drug has become discolored, DO NOT USE IT.
Have you experienced an epinephrine auto-injector or EpiPen shortage in your area, or do you know someone who has had trouble getting their prescription filled? What did you do? We would love to hear from you in the comments.