EpiPen, a device containing adrenaline (ephedrine) used in allergic emergencies, has been subject to shortages since late 2017. Patients who are at risk of an anaphylactic reaction, which can be life-threatening, are advised to keep two pens with them at all times. EpiPen shortage in the UK has been covered widely by mainstream media; therefore, in this post, I will focus on the process of getting an EpiPen device and discuss alternative treatment options and supply issues around them. Recently I was surprised when a patient presented a prescription for EpiPen and traveled 20 miles as their local pharmacy could not supply EpiPen as ‘items is out of stock.’ In recent months I supplied EpiPen auto-injectors to several patients with no problems. Pharmacies need to follow the prescription validation process (outlined in the latter part of this post) in order to supply EpiPen auto-injector to patients.
Epipen is the most commonly prescribed auto-injector with over 209,510 items prescribed in the last 12 months (Nov ’18-Oct ’19), Emerade is second most prescribed with over 88,324 items prescribed and Jext third with 78,641 items prescribed (OpenPrescribing.net, 2019).
EpiPen shortage in the UK what we know so far?
- EpiPen shortage in the UK is an ongoing issue
- The prescription validation process is in place to control the supply of EpiPen auto-injectors in the UK
- Emerade auto-injector, an alternative to EpiPen is subject to disruption supply with no stock
- Jext stock is insufficient to cover demand for auto-injectors in the UK
- The exact reason for supply issues is not known, but it relates to the production of EpiPen. In The US, Meridian Medical Technologies, the company that makes EpiPen for different markets, received a warning from the Food and Drug Administration (FDA) for significant violations of good manufacturing practice such as failure to investigate compatibility issues of the device or failure to meet required specifications for the product. In total, five validations were issued by the FDA (FDA, 2017).
Use of EpiPen 0.3mg adrenaline auto-injector beyond expiry date
In response to EpiPen shortage in the UK, Mylan, the producer of the device, was given rights to extend the shelf life of specific batches of 0.3mg auto-injectors by four months. That is an additional four months after the expiry date present on the box. Only selected batches of EpiPen can be used four monhts after the expiry date. Visit Epipen.co.uk to see a full list of EpiPens affected.
The prescription validation process
Mylan announced on its website that the prescription validation process is in place for the supply of EpiPen 0.3mg and 0.15mg (EpiPen Junior). This means patients are limited to two EpiPen per each prescription, even when a doctor prescribes a different number of pens. This process is in place to ensure the best availably of the EpiPen and a steady supply of this product (Epipen.co.uk, 2020).
How to get an EpiPen 0.3mg or 0.15mg auto-injectors?
Patients need to present a valid prescription in the pharmacy. As part of the validation process, each prescription needs to be anonymised and send to Alliance Healthcare, the wholesaler which supplies EpiPen to UK pharmacies either by fax or by email (email@example.com) Pharmacy staff should include Alliance account number with each prescription sent.
Unfortunately, some pharmacy staff will not be aware of this process. The key is not to ask at the pharmacy if EpiPen is in stock because most likely, pharmacies will not have spare auto-injectors laying around for immediate supply. Patients need to ask the pharmacy staff to order the EpiPen when presenting a prescription in the chemist. If faced with the reply “EpiPen is out of stock”, patients should advise pharmacy staff about the prescription validation process.
Because of the above process, it takes longer for Alliance Healthcare to deliver EpiPen’s to a pharmacy. It takes at least an extra day or longer to get EpiPen delivered to the pharmacy.
Adrenaline auto-injectors what are the options?
In the UK, three adrenaline auto-injectors are available it the emergency of severe allergic reactions:
- Jext (available as 150 mcg or 300 mcg solution for injection in pre-filled pen)
- Emerade (available as 150 mcg, 300 mcg and 500 mcg solution for injection in pre-filled pen)
- EpiPen (available as EpiPen Junior 150 mcg auto-injector and EpiPen 300 mcg auto-injector)
- On some rare occasions, the prescriber may decide to issue a prescription for a vial of adrenaline, which is drawn by a patient and injected intramuscularly. This, however, requires specific training.
Emerade shortage the UK
Unfortunately, Emerade was subject to supply disruption alert in August 2019 and I the latest alert by Department of Health it is stated that ‘All Emerade® devices will be unavailable for the foreseeable future.’ (MHRA, 2019) Additionally The Medicines and Healthcare products Regulatory Agency (MHRA) issued two pharmacy recalls at a pharmacy level due to an error in one of the parts of Emerade auto-injector, which possibly ‘cause some pens to fail to activate and deliver adrenaline’ (MHRA, 2019). This, of course, will put more pressure on the supply of EpiPen auto-injector.
What about Jext auto-injector?
With the latest Emerade supply alert, the Department of Health & Social Care announced that there are insufficient quantities of Jext to replace Emerade stock or to meet current demand. Similarly to Epipen, ALK (the producer of Jext) was granted the right to extend the use of some Jext® 150 mcg and Jext® 300 mcg auto-injectors by four months beyond the expiry date. List of affected Jext auto-injectors can be found on Jext.co.uk
Additionally, at the end of 2019, ALK began to import Jext® 300mcg Adrenaline Auto-Injectors from Austria. Pens imported from Austria come in the Austrian German language pack. Each Austrian device will be supplied in a clear envelope containing a UK Patient Information Leaflet.
Further, advice for patients:
- It is important to avoid allergens at all times
- Check the expiry date of your EpiPen and order a new prescription in advance. Don’t wait until EpiPen expires. You can use free EpiPen Expiry alert service, Jext Expiry Alert Service, located on jext.co.uk or Emerade Reminder Service to get notifications when your pen is about to expire.
- Check the batch number of your EpiPen or Jext and see if you can use it beyond the expiry date (refer to EpiPen website or Jext website) or speak to a pharmacist to find this information for you.
- When switched from one to another auto-injector, watch training videos as each pen is used differently:
In the US, the FDA approved the production of generic EpiPen by Teva in the hope to reduce the price of the device, which has been soaring across the pond. The availability of generic EpiPen may help with shortages of this device. There is no news on generic EpiPen launch in UK/Europe. In the UK price for EpiPen auto-injectors are stable and not affected the supply issues.
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- FDA (2017). Warning letter: Meridian Medical Technologies, Inc. a Pfizer Company. MARCS-CMS 525881 — SEPTEMBER 05, 2017. Available at: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meridian-medical-technologies-inc-pfizer-company-525881-09052017 Accessed on 10/01/2020
- MHRA (2019). Class 2 Medicines recall: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (EL(19)A/39). Available at: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-emerade-150-300-and-500-microgram-solution-for-injection-in-pre-filled-syringe-mdr-57-08-19 Accessed on 11/01/2020
- MHRA (2019). Emerade 150 microgram, 300 microgram and 500 microgram adrenaline auto-injector devices. Available at: https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102938 Accessed on 11/02/2020
- OpenPrescribing.net, EBM DataLab, University of Oxford, 2017. Analyse. Available at: https://openprescribing.net/ Accessed on 11/01/2020