No, there isn’t a shortage for the moment. However, the supply of adrenaline auto-injectors (AAIs) in Switzerland has been limited recently, due to defects found last fall in one of the two available brands here. According to an official from Swissmedic—the Swiss federal agency responsible for authorizing and supervising therapeutic products—the situation may be more accurately described as “an undersupply,” and it’s improving.
The issue of a potential shortage first came to my attention in January 2014, when I picked up a new prescription for EpiPens because our son’s were expiring. I brought them home from the pharmacy to discover they would expire in May 2014—only a 5-month shelf-life. We had to request a new prescription from our son’s allergist again this spring. I wanted to know more about why this occurred, especially since a typical shelf-life for EpiPens is about 13-14-months—a fact I learned this week via email from a representative of MEDA, the company that distributes this brand in Europe. Also, I’ve been reading about similar situations in the United States via the food allergy blog, Oh Mah Deehness!, and in the United Kingdom via Anaphylaxis Campaign.
Please note: In the United States, from my experience, AAIs are more commonly referred to as epinephrine auto-injectors.
What are AAIs?
We always carry two AAIs with us because our son has severe food allergies. If he had a life-threatening allergic reaction, known as anaphylaxis, we would need to inject him with a dose (or more) of adrenaline. Some symptoms of anaphylaxis can include skin reactions and difficulty breathing. While we’ve thankfully never had to use them, we need to make sure we’re carrying AAIs that haven’t expired.
What brands of AAIs are available in Switzerland?
In Switzerland, people who need AAIs have two options: EpiPen or Jext (see the table note below). Anapen has also been licensed in Switzerland, but hasn’t been available since a product recall in 2012, and it’s not known when it will be available again, based on an email response I received from aha! Swiss Allergy Centre. Here’s a quick comparison of the two available AAIs in Switzerland:
|Types of AAI||EpiPen Jr and EpiPen||Jext 150 and Jext 300|
|Shelf-life||18 months||24 months|
|Refill reminder system||Yes (My EpiPen and My EpiPen App)||Yes (Expiry Alert Service)|
|Distributor||MEDA Pharma GmbH||ALK-Abelló AG|
*While the Jext 150 and Jext 300 haven’t been available during the first half of 2014 in Switzerland, a Swissmedic official emailed me on July 10 to report that new lots of the product are expected in July 2014.
What caused a batch recall of Jext AAIs?
In November 2013, there was a batch recall of Jext 150 and Jext 300 in Switzerland. It was discovered that in rare cases, a defect would prevent the adrenaline from being administered properly for certain batches of these products.
How did the recall affect the supply of AAIs in Switzerland?
The batch recall meant the retail sector (i.e., pharmacies) had to return their supply of Jext that could potentially have the defect. At the same time, patients with Jext were informed to keep them, since the probability of a malfunction was very low, and based on a November 2013 notice from Swissmedic, a replacement of AAIs could not be guaranteed due to a limited supply—a situation that was occurring throughout Europe.
To help alleviate the increased demand for AAI in Switzerland, Swissmedic approved the distribution of an “emergency batch” of EpiPens “with a relatively short remaining shelf-life,” according to an agency official there. It provided temporary relief and helped prevent a shortage of this medication. Patients with extremely severe and recurrent allergic reactions that had the potentially defective Jext were allowed to receive another AAI during the recall as a precaution.
What’s the situation now?
EpiPens with a more typical shelf-life are now being made available to patients in Switzerland, according to an agency official from Swissmedic. This matches our family’s experience, as the two AAIs we picked up in May 2014 had an expiration date of June 2015. Furthermore, new lots of Jext should be coming on the market yet this month, as indicated by an Swissmedic official. All of this is good news for people living with food allergies, who depend on this medication if they ever experience a severe allergic reaction.
What kind of AAI have you or your family members been prescribed? How, if at all, have you been affected by the Jext recall? Please share a comment below, when you have the chance. Thanks in advance for your help.
Updated: July 10, 2014