Latest statement on availability of EpiPen® 0.3mg and 0.15mg Adrenaline Auto-Injectors
- 14 February 2020
- News
The Anaphylaxis Campaign has received the following updated statement from Mylan regarding the availability of EpiPen. This includes information for patients, prescribers, pharmacists, hospitals and schools.
Mylan’s manufacturing partner Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen®, has experienced manufacturing challenges which has resulted in interruptions in the production of EpiPen 0.3mg and EpiPen Jr 0.15mg Adrenaline Auto-Injectors (AAIs).
To help manage product availability on an ongoing basis until a steady supply resumes, Mylan assigned a prescription validation process for EpiPen 0.3mg, meaning patients can obtain up to a maximum of two EpiPen 0.3mg AAIs per prescription.
There is no prescription validation process in place for EpiPen 0.15mg.
Patients should follow the Instructions for Patients detailed below to fulfil their prescriptions and pharmacies should follow the Instructions for Pharmacists outlined below when placing orders.
Instructions and Information for Patients
Patients requiring EpiPen 0.3mg AAI should present their prescription to a pharmacy where an order will be placed for up to a maximum of two EpiPen 0.3mg AAIs per prescription.
Patients requiring EpiPen Jr 0.15mg AAI should present their prescription to a pharmacy to fulfil their prescription. Please check with your pharmacy to ensure that supply has been received and is available.
Mylan is unable to make any specific treatment recommendation to individual patients. Patients should speak to their healthcare provider for appropriate action to be taken. However, if you have a question about your EpiPen device please contact our Medical Information team who will be able to help you: +(0) 1707 853 000 or email: info@mylan.co.uk.
Information for Prescribers
Please note, when validating the expiry date of an adrenaline auto-injector, the product expires on the last day of the month indicated. For example, if it expires in February, it remains valid (not expired) until 29 February.
Instructions for Pharmacists
Pharmacies that are presented with a prescription for EpiPen 0.3mg Adrenaline Auto-Injectors can place an order for up to a maximum of two devices per prescription. Please send anonymized prescriptions to Alliance Healthcare’s prescription validation service, either by fax (0330 332 8126) or email (scriptvalidation@alliance-healthcare.co.uk).
Please include your Alliance Healthcare account number when placing your order.
Orders from schools should be sent to Alliance Healthcare’s prescription validation service on the fax number or email address above. Please note that the purchase of EpiPen 0.3mg is currently limited to two devices per order.
Pharmacies can place orders and hold supply of EpiPen® Auto-Injector Jr 0.15mg. Please request supply through Alliance Healthcare, stating your account number when placing your order.
Instructions for Hospitals
Hospitals and healthcare institutions requiring supply of EpiPen 0.3mg Adrenaline Auto-Injectors for emergency use should contact Mylan Customer Service on +44 (0) 1707 853 100.
Instructions for Schools
To support children and young adults who may be at risk of anaphylaxis whilst away from home, the Human Medicines (Amendment) Regulations 2017 allows schools, without the need for a prescription, to purchase and hold supply of adrenaline auto-injectors. Regulations allow the purchase of a reasonable number of adrenaline auto-injectors for use on an occasional basis and as required.
Schools requiring a supply of adrenaline auto-injectors to be used in emergency situations are now able to order EpiPen 0.3mg and EpiPen Jr 0.15mg through Mylan’s distributor, Alliance Healthcare.
To place your order, please provide your local pharmacy with a letter, written on your school’s headed paper and signed by the principal or headteacher. The pharmacy will then send the request to Mylan’s distribution partner, Alliance Healthcare.
Please be reminded that the purchase of EpiPen 0.3mg is currently limited to two devices per order.
Extended Expiration Dates for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors
Extended Use Beyond Labelled Expiry Date for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors
In August 2019, Mylan was granted approval to a variation to permanently extend the shelf life of EpiPen 0.3mg auto-injectors from 20 months to 24 months.
Mylan UK have obtained acceptance from the MHRA to extend the use of specific lot (batch) numbers of EpiPen® 0.3mg auto?injectors already on the market, 4 months beyond the labelled expiry date. The affected lot numbers are listed in the table below.
EpiPen® 0.3mg (single pack)
LOT Original Expiry Date Extended Expiry Date
8FA273E 11/2019 03/2020
8KB332M 02/2020 06/2020
8FA366K 02/2020 06/2020
8FA367B 02/2020 06/2020
8KB478B 04/2020 08/2020
8KB474B 04/2020 08/2020
8KB481B 04/2020 08/2020
8KB510G 05/2020 09/2020
8KB523G 05/2020 09/2020
8KB648B 06/2020 10/2020
8KB587B 06/2020 10/2020
8KB630C 06/2020 10/2020
8KB587F 06/2020 10/2020
8KB671R 07/2020 11/2020
9KB087B 10/2020 02/2021
9KB148B 10/2020 02/2021
9KB177AE 11/2020 03/2021
9KB262B 12/2020 04/2021
EpiPen® 0.3mg (twin pack)
LOT Original Expiry Date Extended Expiry Date
8KB558C 05/2020 09/2020
8KB630D 06/2020 10/2020
8KB671F 07/2020 11/2020
9KB148J 10/2020 02/2021
9KB177E 11/2020 03/2021
9KB252P 11/2020 03/2021
9KB301J 12/2020 04/2021
Important: the extended use only applies to the lots of EpiPen 0.3 mg auto-injectors listed above.
This extended use does not apply to EpiPen® 0.15mg Auto?Injectors or any lot number of EpiPen 0.3 mg auto-injectors not specified. It is important that patients must continue to adhere to the labelled expiry date on any EpiPen® not covered by the lot numbers above.
Further information
You can find the lot number on the end-flap of the box and on the EpiPen® itself. If you’re unsure whether your EpiPen® is affected, talk to your pharmacist.
The 4 months extended use beyond the labelled expiry date for the specific lots listed above is based on supportive stability data for EpiPen® 0.3mg auto-injectors and has been reviewed by the MHRA.
The EpiPen® 0.3mg auto-injectors of these specific lots will continue to work safely within the extended use by date. The EpiPen® auto-injectors should continue to be stored as labelled on the pack.
At the end of the extended use period (the end of the month listed under “Extended Expiry Date” in the table above), you will still need to obtain a new auto-injector by the usual means.
Please note that the information provided in this communication supersedes any other communication that patients receive from the Expiry Alert Service.
Contact Information
Telephone: +44 (0)1707 853 000
Medical Information e-mail: info@mylan.co.uk
The Anaphylaxis Campaign would like to reinforce the following advice;
- Always carry two adrenaline auto-injectors with you at all times.
- Ensure you have registered the expiry date of your devices on the relevant manufacturers websites to give you ample warning when a new prescription is required.
- Ensure you gain a replacement device prior to disposing of any out of date devices.
- Always make sure you have a trainer device which can be ordered from the manufacturer’s websites for free:
- Make sure that your family and friends are familiar with the device you have and how to use it.
- In an emergency call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna-fill-axis’).
If you have any questions, you can contact our helpline at info@anaphylaxis.org.uk or call 01252 542029 for support from 9am – 5pm, Monday – Friday.
