You’ve likely heard that there’s a shortage on EpiPens through the United States, Canada, United Kingdom and Australia. What began as spot shortages throughout Australia and North America has escalated into a worldwide panic. Let’s separate fact from fiction to better understand this ongoing problem and talk about interim solutions.
1. There is NO epinephrine shortage. The life-saving drug epinephrine, also known as adrenaline, is in full supply.
2. The shortage refers to pharmacy stock of Mylan’s EpiPen , EpiPen Jr. as well as its authorized generics in North America and the UK and only EpiPen 0.3 (300 mcg) in Australia. According to Mylan, this shortage is due to manufacturing delays by their partner Pfizer/Meridian.
3. There had been a shortage of Impax Laboratories’ Adrenaclick, but that appears to have been resolved.
4. Some pharmacies in the United States (including Kaiser) are reportedly rationing out only ONE pen to customers. This is not recommended. Customers should always carry two auto-injectors in case one pen malfunctions or two doses of epinephrine is required while waiting for emergency services.
5. There IS NO SHORTAGE of Auvi-Q – the innovative epinephrine auto-injector that talks you through how to administer a shot and has a retractable needle to prevent accidental injury.
While this problem affects everyone trying to refill a prescription at this time, I am particularly concerned with those trying to fill a prescription for the first time. Those patients and families who are just getting a diagnosis and hoping to find a little security in the sometimes overwhelming world of food allergies may find themselves unprepared or totally confused by the process. I’m also worried for schools and daycares, whose stock epinephrine program saves lives.
What can you do while you’re waiting for the EpiPen supplies to increase?
1. The U.S. Food and Drug Administration has extended the expiration date of Mylan’s EpiPens by 4 months. There is a list of which batches are affected and their extended expiration dates listed on FDA’s site – be sure to check your boxes.
2. Should you need a set of epinephrine auto-injectors now, there ARE alternatives to EpiPens:
- In the United States, Auvi-Q is in full supply. Please visit Auvi-Q’s website for instructions on how to arrange direct delivery.
- Adrenaclick is also in stock in the United States. Talk to your doctor and pharmacist about getting this filled in EpiPen’s place. Be reminded, you’ll need to order a free trainer from Impax Laboratories to practice on this device. It’s smaller than an EpiPen but operates just a little differently. You may call Impax Laboratories at 1-855-EPINEPH to order them directly.
- In the UK, both Jext and Emerade are available epinephrine auto-injectors.
3. Should you prefer to wait for EpiPen to become available:
- Check the expiration date on your auto-injectors. As long as they are stored at room temperature (and not, for example, in the car in the heat), you should be fine to use them past their expiration date according to the FDA. According to Dr. Baker (formerly director of FARE), EpiPens can be used up to 6 months past their expiration date.
- Check the epinephrine in your EpiPen. If you look through the window of your EpiPen and see that the epinephrine is discolored or cloudy, it is no longer good.
- Be sure to speak with your child’s school about the expiration date extension so that you will be allowed to store that set of EpiPens there.
- Make a plan (and put it on the calendar!) to replace the EpiPens and deliver a fresh set to school when they become available;
- Discuss if and how procedures will change with an expired EpiPen. Will the school use that auto-injector or will they choose to use stock epinephrine instead? Does that effect the timing of a call to emergency services? What is YOUR preference?
- As always, store your epinephrine properly. That means keeping them at room temperature as much as possible.
- Be careful about accepting a refill from a pharmacy that wants to give you only one auto-injector, splitting up a set. Heads up: We have heard reports of pharmacies charging a regular co-pay for even just ONE pen. And, again, patients at risk for anaphylaxis must ALWAYS CARRY TWO auto-injectors at all times.
- The beginning of a school year is the perfect time to review food allergy safety with your children (wash hands with soap and water before eating, no sharing food, symptoms of a reaction, what to do and who to tell). Here are some great books to use as a jumping off point for your conversations.
If you’re new to the food allergy world and getting an epinephrine auto-injector for the first time, consider one of the available auto-injectors on the market if possible. They are all equally effective and potent. You may even find that they fit your needs and lifestyle Discuss with your doctor which one may be most appropriate for you based on your age, capabilities and lifestyle.
For more information, please read WebMD’s article “EpiPen Shortage Causing Concern as School Starts”.