We have received the following updated statement from Mylan regarding the availability of EpiPen® 0.3mg and EpiPen® Jr 0.15mg Adrenaline Auto-Injector.
IMPORTANT UPDATE 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-ofhospital 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.
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 [email protected]
Availability of EpiPen 0.3mg Adrenaline Auto-Injectors
EpiPen 0.3mg is currently available.
To help manage product availability on an ongoing basis until a steady supply resumes, pharmacies are allocated product on a prescription-only basis and can place orders for up to a maximum of two EpiPen 0.3mg Adrenaline Auto-Injectors per prescription.
Patients should present their prescription to a pharmacy who will be able to place an order for up to a maximum of two EpiPen 0.3mg Auto-Injectors per prescription.
EpiPen 0.3mg Adrenaline Auto-Injectors – Extended Use Beyond Labelled Expiry Date for Select Lots
To address supply constraints of EpiPen 0.3mg, Mylan UK has worked with the MHRA to obtain its approval to the use of nine 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 20189.
This announcement is based on a careful review by Mylan and the MHRA of data about these specific batches provided by Pfizer. We believe the extension of the use of these nine batches beyond the labelled expiry date will temporarily improve 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.
|Lot||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 in the table above.
The extension of the use beyond the labelled expiry date does not apply to EpiPen Jr 0.15mg auto-injectors or any EpiPen 0.3mg lot numbers not specified above. Patients must continue to adhere to the manufacturer’s expiry date labelled on any EpiPen not covered by the lot numbers
- To make sure patients can access their medicines during this supply constraint, 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 data showing these nine 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.
- As with all EpiPens, patients should periodically visually inspect the adrenaline solution through the viewing window to make sure the solution is clear and colourless. If it is discoloured or contains solid particles the EpiPen should be replaced as soon as possible.
- 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 0.3mg Adrenaline Auto-Injector – with an expiry date of February 2019
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 previously outlined, 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).
Availability of EpiPen Jr 0.15mg Adrenaline Auto-Injector
Mylan has recently received supply of EpiPen Jr 0.15mg Adrenaline Auto-Injectors and our distribution partner, Alliance Healthcare, are in receipt of this supply, which is now available for pharmacies to order.
Pharmacies are able to place orders for up to a maximum of two EpiPen Jr 0.15mg Adrenaline Auto-Injectors per prescription and should follow the Instructions for Pharmacists when placing orders.
A reminder that the extension of the use beyond the labelled expiry date for the nine lots of EpiPen 0.3mg listed above does not apply to any EpiPen Jr 0.15mg auto-injectors or any EpiPen 0.3mg lot numbers not specified. Please continue to adhere to the manufacturer’s expiry date labelled on any EpiPen 0.3mg not covered by the lot numbers above and all EpiPen Jr 0.15mg auto-injectors.
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. 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: [email protected]
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
Pharmacies that are presented with a prescription for EpiPen 0.3mg or EpiPen Jr 0.15mg Auto-Injectors can place an order for up to a maximum of two EpiPen 0.3mg or EpiPen Jr 0.15mg Auto-Injectors per prescription. Please send anonymized prescriptions for EpiPen 0.3mg or EpiPen Jr 0.15mg Auto- Injectors to Alliance Healthcare’s prescription validation service, either by Fax (0330 332 8126) or email ([email protected]). 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.
Telephone: +44 (0)1707 853 000
Medical Information e-mail: [email protected]
If you are prescribed AAIs, to be well equipped during this time, we advise you to.
- Check the expiry date on your medication regularly
- If needed, get a repeat prescription from your GP well in advance
- Do not dispose of any ‘expired’ AAI devices before you have a new AAI prescription
- If necessary, revisit your GP to ask if they can prescribe an alternative medication
- If you are prescribed an alternative AAI device, ensure that you know how to use it and train others that may need to use it in an emergency
Do continue to always carry your AAIs with you and follow your usual risk management techniques to avoid your allergen and reduce the likelihood that you will experience a severe allergic reaction and need to use your adrenaline.
Frequently Asked Questions
What is anaphylaxis?
Anaphylaxis (pronounced ana-fill-ax-is) is a severe and life-threatening allergic reaction that can be fatal. Severe symptoms such as a swollen tongue, difficulty breathing or becoming unconscious usually develop suddenly, often within minutes after being exposed to an allergy trigger such as a particular food, insect stings or certain drugs. There’s no cure for anaphylaxis, so people at risk have two options: manage their condition and carry adrenaline, a potentially lifesaving emergency medication. You can find out more about anaphylaxis in our anaphylaxis factsheet: www.anaphylaxis.org.uk/our-factsheets.
What is an Adrenaline Auto-Injector?
Adrenaline is the first line treatment for severe allergic reactions (anaphylaxis) and is available on prescription in a pre-loaded injection device known as an Adrenaline Auto-Injector or AAI for self-use in an emergency. The AAIs prescribed in the UK at present are Emerade®, EpiPen® and Jext®. You can find out more about adrenaline in our adrenaline factsheet: www.anaphylaxis.org.uk/our-factsheets.
How do I check the expiry date on my AAIs?
As some of the additional stock available in the UK at present has an expiry date of October 2018, we are advising patients to check the expiry date on their Adrenaline Auto-Injectors when they receive them and not to dispose of any ‘expired’ AAI devices before they have obtained a new device.
Your AAI devices will have instructions for use printed on the outside and generally will have a shelf life of up to 18 months. The expiry date will be printed on the casing. Each of the three companies who distribute AAIs run an expiry alert service. If you register your device and expiry date with them, they will send you a reminder when it is due to expire.
Whichever devices you have been prescribed, it is important that you keep your AAIs in their original containers to prevent light exposure, do not store them above 25°C and do not freeze them. If the liquid in your AAI appears cloudy or discoloured, it should be replaced with a new device. If the liquid in the device is not cloudy or discoloured, the AAI device can still be used in an emergency.
What should I do if I have concerns about my prescription during a supply issue?
If you are worried about your prescription, we advise you to visit your GP and discuss this directly with them. If necessary, your GP can prescribe an alternative medication.
What should my pharmacist do if they are experiencing issues?
Your pharmacist should contact the supplier of your AAI through their distribution partner e.g. Alliance Healthcare, or their customer service department directly for updates regarding any issues they experience.
I have been prescribed a new brand of AAI, what should I do?
We believe your GP or pharmacist should make sure you know how to use your new brand of AAI. You should also train anyone who might be required to administer it in an emergency, such as family members and friends. You can order a trainer pen to practice with and find further help on the website relevant to the medication you carry.
An Emerade® trainer can be ordered from the Emerade® website: www.emerade-bausch.co.uk.
An EpiPen® trainer can be ordered from the EpiPen® websitehttp://www.epipen.co.uk.
A Jext® trainer can be ordered on the Jext websitehttp://www.jext.co.uk.
Can I get help with my prescription costs?
If you require support with prescription costs, prescription prepayment certificates (PPC) are available or you may be able to get help through the NHS Low Income Scheme (LIS). Find out more on the NHS Business Services Authority website here: https://www.nhsbsa.nhs.uk/nhs-help-health-costs.
I have a different question, can you help?
You can reach Bausch + Lomb UK customer services via +44 (0)208 781 2920.
You can reach Mylan UK customer services via +44 (0)1707 853 100.
You can reach ALK-Abelló customer services via 0118 903 7940.
You can contact our helpline and information team at [email protected] or call 01252 542 029 for support between Monday-Friday, 9am-5pm.