Epi-Pen Drug Shortages

First announced in May 2018, certain epinephrine products remain on a national shortage because of delays during the manufacturing processes. This means the drug companies are unable to make the products fast enough for the number of people who need them and the Epi-Pen may not be readily available at your pharmacy.

Epinephrine, also known as adrenaline, is a substance your body naturally releases under stress.

It is used as an injectable medication for the emergency treatment of life-threatening allergic reactions called anaphylaxis. Symptoms of anaphylaxis may include breathing problems, low blood pressure, swelling or hives, shock, or even death. Anybody with a history of severe, life-threatening allergies should always keep epinephrine on hand, and it should be given as soon as possible at the first signs of anaphylaxis.

Epinephrine is most well-known as the brand name Epi-Pen®, but several new brands and generic alternatives have come out in the past few years. The emergency epinephrine devices all were designed to be user-friendly, but not all of them are given in the same way. The brand and generic Epi-Pen® and Epi-Pen Jr.® come as a pen that automatically injects (auto-injector) the medication when pressed against a person’s thigh. Adrenaclick® and Auvi-Q® also are auto-injectors that contain epinephrine, but the pen and cartridge used to deliver the medication are different than the Epi-Pen®. Symjepi® is the newest epinephrine product and is not an auto-injector. It is a small, user-friendly syringe that is ready to be given and already contains the correct amount of medication (pre-filled). Since Adrenaclick®, Auvi-Q®, and Symjepi® are not the exact same device as the Epi-Pen®, each brand name is considered a different product and one cannot be substituted for the other without a new prescription from the doctor.

Epi-Pen Shortage

Epi-Pen Shortage

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Fortunately, some epinephrine products have not been impacted by the shortage.

The products that have not been impacted by the shortage include the brands Auvi-Q®, Symjepi®, and the generic Epi-Pen®(0.3mg) from Teva. It is important to note, if your doctor has written a prescription for the Epi-Pen® and your pharmacy does not have it on hand, the Teva generic may be substituted (if allowed by your doctor). However, while the brands Auvi-Q® and Symjepi® contain the same epinephrine medication, they are not considered different products and would require a new prescription from your doctor. Therefore, if neither the Teva generic, nor brand Epi-Pen®, is available, you may ask your doctor to write a prescription for Auvi-Q® or Symjepi®. Be sure that you understand the different ways to deliver the medication before you need to use it. There are videos and training kits available to help understand how to use each different epinephrine device.

For those who prefer the brand or authorized generic Epi-Pen® (made by the same company as the brand name), the drug makers did further research to increase access to this life-saving medication if needed.

They proved that certain lot numbers may be safely used beyond the expiration date listed on the product as long as there are no “floaties”, or crystallization, that can be seen. You can access the list of products that have been granted an expiration date extension on the FDA website (www.fda.gov/drugs/drug-shortages/ search-list-extended-use-dates-assist-drugshortages). You also can check the FDA website for updates on whether certain products are available. The most recent updates are provided in the table below.

 

 

Product, Company Drug company Availability Shortage reason Date last updated
Symjepi® (epinephrine 0.15mg or 0.3mg) pre-filled syringes Adamis Pharmaceuticals Available 7/17/2019
Auvi-Q® (epinephrine 0.1mg, 0.15mg, or 0.3mg) auto-injectors Kaleo Available 7/11/2019
Epi-Pen® and authorized generic (epinephrine 0.15mg or 0.3mg) Adamis Pharmaceuticals Available (Supplies vary pharmacy to pharmacy) Continued manufacturing delays 10/15/2019
Generic Adrenaclick® (epinephrine 0.15mg or 0.3mg) auto-injector Impax Laboratories On Allocation (Difficult for pharmacies to get) Continued manufacturing delays 8/15/2019
Generic Epi-Pen® (epinephrine 0.3mg) auto-injector Teva Pharmaceuticals Available 10/16/2019

 

Resources:
1. FDA Drug Shortages: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Epinephrine%20Injection,%20Auto-Injector&st=c&tab=tabs-1#
2. Epi-Pen® Website: https://www.epipen.com/about-epipen-and-generic/what-is-epinephrine
3. How-To Videos
Epi-Pen®: https://www.youtube.com/watch?v=FXlqSuzzrws
Adrenaclick®: https://www.youtube.com/watch?v=fK0YlWlEiWM
Auvi-Q®: https://www.youtube.com/watch?v=bZl5vXwZUOg
Symjepi®: https://www.youtube.com/watch?v=VSPPf68w3Jw
4. https://www.pharmacytimes.com/contributor/andrew-abe-pharmd/2018/10/path-to-approval-first-truly-generic-epipen
5. https://www.pharmacytoday.org/article/S1042-0991(19)31144-2/pdf

Dr. Andrea M. Jones

About Dr. Andrea M. Jones

Dr. Andrea M. Jones graduated from the University of Colorado School of Pharmacy. Dr. Jones completed post-graduate year 1 (PGY-1) residency at the Southern Arizona VA Healthcare System (SAVAHCS) in Tucson, Arizona, where she worked in multiple hospital and primary care clinic settings. She completed numerous projects like research, hospital-wide publications, and formal education presentations. Dr. Jones also worked in retail/community pharmacies for over 5 years during Undergraduate studies at the University of Kentucky and pharmacy school at the University of Colorado. Dr. Jones enjoy helping people access their medications and assist them in understanding their disease and medications. She feels passionate about managing chronic diseases (like diabetes, high blood pressure, heart failure, COPD, etc.) with both lifestyle and medications because they are the most common diseases. Some of these medical conditions are preventable; proper education and treatment can reduce hospital stays and even lead to a longer life.