19 OCTOBER 2018
EpiPen® 0.3mg and 0.15mg Adrenaline Auto-Injectors
Our manufacturing partner Meridian Medical Technologies, a Pfizer company, continues to experience interruptions in the production of EpiPen 0.3mg and EpiPen Jr 0.15mg Adrenaline Auto-Injectors (AAIs).
We appreciate how important it is for individuals with life-threatening allergies to have access to adrenaline auto-injectors and understand the challenges this situation continues to pose for patients.
We will continue to proactively and diligently update pharmacies, healthcare professionals and patient advocacy groups across the country regarding any changes in stock availability.
The manufacturer, Pfizer, anticipates that supply of EpiPen 0.3mg will stabilise in the fourth quarter of 2018. The supply status will be continually reviewed by the manufacturer and the Department of Health and Social Care.
Essential Facts About EpiPen®
EpiPen has been available in the UK since 1996 and has been used to provide emergency treatment to those at risk of anaphylaxis.
The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care in the United Kingdom, is responsible for ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy. The MHRA reviewed and approved EpiPen as a fit for purpose self-administration adrenaline auto-injector device for allergic emergencies, which includes approval of the product's needle length and dosage.
We are aware that questions have recently been raised around the needle length and strength of adrenaline contained with an EpiPen auto-injector. The Resuscitation Council (UK) guidelines for "Emergency treatment of anaphylactic reactions". were quoted in respect of the needle length and adrenaline dose for treating anaphylactic reactions. These guidelines state that they are for healthcare providers who are expected to deal with an anaphylactic reaction whilst working in a hospital or out-of-hospital setting. They are not intended to provide guidance to patients or carers when self-administering adrenaline through AAIs.
[As with all medicinal products, safety data are collected in respect of EpiPen. These data are submitted to the MHRA. These data is kept under constant review and if there was evidence data to suggest there was a concern with either the needle length or the strength of the adrenaline in EpiPen they would be reconsidered. To date, no such evidence exists.]
In conjunction with the administration of an AAI to a patient, the emergency services should be called immediately. The controller should be informed that they or the patient is suffering from anaphylaxis and their guidance followed.
Training and education of patients, carers and healthcare professionals in respect of EpiPen is of paramount importance to ensure appropriate administration. Read the user guide and visit the EpiPen website to find practical advice to using your EpiPen, including a demonstration video.
If you need any further information, please contact our Medical Information team on +44 (0)1707 853 000 or email info@. mylan.co.uk
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- Extended Use Beyond Labelled Expiry Date for Select Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors
Extended Use Beyond Labelled Expiry Date for Select Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors
To address supply constraints of EpiPen 0.3mg, Mylan UK have obtained acceptance from the MHRA to extend the use beyond labelled expiry date for specific lot (batch) numbers of EpiPen 0.3mg auto-injectors, beyond the labelled expiry date by four months. The affected lot numbers are listed in the table below.
Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth quarter of 2018.
This announcement is based on a careful review of product stability data provided by Pfizer. We believe the extension of use beyond the labelled expiry date will temporarily address patients’ access to and use of EpiPen 0.3mg Auto-Injectors.
The affected lots, which have labelled expiry dates between July 2018 and November 2018 are listed in the table below.
Labelled Expiry Date
(end of the month)
Extended Use by Date
(end of the month)
Important: the extended use only applies to the lots of EpiPen 0.3mg auto-injectors listed above.
The extension of use beyond the labelled expiry date does not apply to EpiPen 0.15mg auto-injectors or any lot numbers not specified. Patients must continue to adhere to the manufacturer’s expiry date labelled on any EpiPen not covered by the lot numbers above
- Further information
· To make sure patients can access their medicines during this shortage, the period that the nine specific lots of EpiPen 0.3mg (listed above) can be used has been extended by a further four months beyond the labelled expiry date on the pack.
· 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, please talk to your pharmacist.
· This extension of use beyond the labelled expiry date is based on stability data showing these batches of EpiPen 0.3mg auto-injectors will work just as well for this period. This has been reviewed by the UK medicines regulator, MHRA. EpiPen auto-injectors should continue to be stored as labelled on the pack.
· At the end of the extended use beyond the labelled expiry date period (the end of the month listed in the right column above), you will still need to obtain a new auto-injector by the usual means.
· Please note that the information provided in this letter supersedes any other communication that you may receive from the Expiry Alert Service.
EpiPen Jr 0.15mg Adrenaline Auto-Injector
EpiPen Jr 0.15mg Adrenaline Auto-Injectors continue to be temporarily unavailable. During this period of temporary unavailability, we encourage patients to speak to their healthcare provider about alternate adrenaline auto-injectors.
EpiPen 0.3mg Adrenaline Auto-Injector
Pfizer recently made available to Mylan a limited volume of single and twin-pack EpiPen 0.3mg Auto-Injectors that will expire in February 2019.
This supply is not subject to the current prescription validation process, as outlined above, and will be available for pharmacists to order and hold in stock. Pharmacies wishing to order EpiPen 0.3mg Adrenaline Auto-Injectors with an expiry date of February 2019 should refer to the “Instructions for Pharmacists” section below. The product meets all required quality standards and remains valid through the last day of the month (28 February 2019).
- Information for Patients
Information for Patients
Mylan is unable to make any specific treatment recommendation to individual patients. Patients should speak to their healthcare provider for appropriate actions to be taken.
- Information for Prescribers
Information for Prescribers
To support patient access to the product during this supply constraint, we are encouraging healthcare professionals to manage prescription renewals diligently. 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 February 28.
- Instructions for Pharmacists
Instructions for Pharmacists
Pharmacies that are presented with a prescription for EpiPen 0.3mg Auto-Injectors can place an order for up to a maximum of two EpiPen 0.3mg Auto-Injectors per prescription. Please send anonymized prescriptions for EpiPen 0.3mg Auto-Injectors to Alliance Healthcare’s prescription validation service, either by Fax (0203 044 8996) or email (EOHotline@alliance-healthcare.co.uk). Please include your Alliance Healthcare account number when placing your order.
Pharmacies wishing to order stock of EpiPen 0.3mg Adrenaline Auto-Injectors with an expiry date of February 2019 can do this through the usual channels. There are currently two presentations available; a single device with a pip code: pip 8133308 EPIPEN 0.3mg (EXP 02/2019) and a twin pack with a pip code: pip 8001000 EPIPEN 0.3mg (EXP 02/2019). Please ensure you specifically reference these codes when placing your order.
- Contact Information
If you require additional information or have any questions, please contact Mylan Customer Services: +44(0) 1707 853 100.
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