Generic Epinephrine Injector May Cause Confusion
Epinephrine is a cornerstone medication in the treatment of anaphylaxis. As allergists we routinely prescribe this medication for many of our patients. For years we only had to remember the name EpiPen (http://www.epipen.com/) as it was the sole product available for our patients to safely and easily use. Recently we added new injectors, the latest being the Adrenaclick (http://www.adrenaclick.com/).
In May 2010 a "generic" epinephrine auto-injector was released for distribution. This epinephrine auto-injector (http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=16934) has no trade name currently (it is distributed by Greenstone, a generic division of Pfizer). It has been authorized by Shionogi, the maker of the Adrenaclick, as a generic of the Adrenaclick. This is somewhat confusing as all of the auto-injectors are considered by the FDA as BX rated indicating that the FDA has determined that there is insufficient data showing that epinephrine auto-injector products are therapeutically equivalent and safe to substitute. Normally to be generically equivalent a drug would have an AB rating.
The EpiPen does not currently have a generic auto-injector and the Greenstone generic epinephrine auto-injector cannot be substituted for the EpiPen.
In an informal survey of patients and pharmacists in Missouri, there is some concern about what products the patients may receive. Patients report they would like to continue to receive the same auto-injector they had previously and are concerned they might not know how to use a new injector if a substitute is given to them without instruction. Pharmacists have yet to see the new auto-injector and most were unaware of its existence. One pharmacist was very concerned that EpiPen prescriptions might get substituted in less scrupulous pharmacies. Other pharmacists freely admit that they do not always take the time to instruct the patients in the use of the auto-injectors. When asked the pharmacists agree that this a formula for confusion and potentially a reason for delay or error in administration of the epinephrine.
Here are a few tips to decrease the confusion. For the prescriber: Write for the exact product that you and the patient agree upon and sign dispense as written on the prescription. Make sure that the patient has been instructed in your office in the use of the specific injector. Empower your patient to check out their epinephrine auto-injector BEFORE they leave the pharmacy.
For the patient: Make sure you know how to use your auto-injector before you leave your doctor’s office. Check your auto-injector IN the pharmacy and make sure you are getting the product your doctor prescribed and trained you on. If you determine that a legitimate substitution has been made, make sure you are trained in its use and comfortable with the new injector before leaving the pharmacy. Epinephrine is life saving and you should be able to competently use this for yourself or a loved one.
You can view each type of injector and review the instructions for their administration at the websites listed above.
Janna Tuck, MD, FACAAI
Allergy Partners of Cape Girardeau
Cape Girardeau, Missouri