Understanding the EpiPen Shortage

Due to expansive news coverage by major media outlets, many Americans are already aware of the nation-wide shortage of epinephrine auto-injectors, also known by the brand name EpiPen or EpiPen Jr. The shortage of this life-saving drug product is especially concerning during this time of year, as both bee season and back-to-school season are upon us. The EpiPen shortage is affecting many people of all ages who suffer from severe allergies to foods, insect bites/stings, medications, or other triggers that result in anaphylaxis. To better understand the issue, this article will dive into explaining the current known facts, as well as the steps that are being done to combat the EpiPen drug shortage.

What is an EpiPen?

The EpiPen is an automated injectable device that delivers epinephrine, a drug that causes blood vessels to narrow while opening the lungs of patients experiencing a severe allergic reaction. This drug can be administered by anyone to a person who is experiencing an anaphylactic reaction. Unsure what this type of reaction looks like? Anaphylaxis initially presents as a skin issue, such as itching, swelling, and redness. This reaction can also lead to respiratory problems, including wheezing, shortness of breath, and difficulty breathing, as well as dizziness and stomach upset. The largest concern with an anaphylactic reaction going untreated is the possibility of inflammation worsening to the point of the person’s airways closing, which can cause severe breathing problems and may even lead to death.

Due to other newsworthy events over the past year, this is not the first time that the EpiPen drug product has been in the spotlight. Patients, pharmacists, and doctors alike were shocked by increasing drug prices resulting in extremely high copays, reaching or extending beyond $400+ for some patients. More recently, additional news coverage centered around the discussion of a generic version of the EpiPen. Although there are other products available that deliver the same drug (epinephrine), the only generic equivalent drug on the market is also involved in this drug shortage. There is currently no release date for an additional equivalent generic drug product.

The current shortage of the EpiPen is said to be due to manufacturing and shipment delays, although there are multiple other explanations of other drug shortages. This particular shortage began in May 2018, but has been worsening as summer continues on, into the start of the school year. Although the FDA believes this will be a temporary drug shortage, many parents are worried about the safety of their children going back to school without this life-saving device. Listed below are helpful steps to take to ensure that you or your loved ones do not go unarmed without the correct tools, specifically an EpiPen, to prevent complications of severe allergic reactions.

What happens next?

  1. If you or someone you know has a history of severe allergic reactions and normally keeps an EpiPen on hand, ensure that the product is not expired. If it is expired, consider talking with both your physician and your local pharmacy to get a new prescription and check if your pharmacy has an EpiPen in stock.
  2. If you have difficulty tracking down a new EpiPen and your pharmacy doesn’t have any available, you may consider contacting the customer service division of the distributing company, Mylan, directly at 1-800-796-9526 to receive help locating alternative pharmacies who may have this medication in stock.
  3. Consider talking with your doctor and/or pharmacist about alternative epinephrine auto-injectors, including Adrenaclick and AUVI-Q. These products contain the same life-saving medication as the EpiPen, epinephrine, but have devices that inject the medication slightly different than the EpiPen. Costs of these medications may vary depending on your pharmacy and your current prescription insurance coverage.
  4. The FDA has recently announced that they are also extending expiration dates on some EpiPens to help combat this issue. This extended expiration date does not apply to all EpiPen devices, nor does it apply to other brands of epinephrine auto-injectors or the EpiPen Jr. To see if your EpiPen is one with an extended expiration date, visit the website https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm563360.htm, using your medication’s current LOT number and expiration date to identify if your EpiPen device qualifies, and the possible new expiration date.
  5. The FDA also announced on August 16th, 2018, that they have recently approved the first generic version of the EpiPen to be manufactured by Teva Pharmaceuticals. This is the first epinephrine auto-injector that will be considered equivalent, or interchangeable, with the brand-name EpiPen product. As previously stated, there is currently no release date set for this product.

Resources:

  1. DiPiro, J.T. (2017). Pharmacotherapy – a pathophysiologic approach (vol. 10e)
  2. Guinness, R. (2018, August 20). What to know about the EpiPen shortage and generic version. Retrieved from https://abcnews.go.com/Health/epipen-shortage-generic-version/story?id=57288176
  3. Extended Use Dates Provided by Pfizer to Assist with ... (2018, August 21). Retrieved from https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm563360.htm
  4. Commissioner, O. O. (2018, August 16). Press Announcements - FDA approves first generic version of EpiPen. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617173.htm