We are aware that many people across the UK are experiencing issues when seeking to obtain adrenaline auto-injectors (AAIs), despite having a prescription for these devices and appreciate that this can be very worrying.
The Anaphylaxis Campaign has been in contact with the Department of Health, the Medicines and Healthcare products Regulatory Agency, the pharmaceutical industry and other key stakeholders to raise these concerns. We have contacted Bausch + Lomb UK who distribute Emerade®, Mylan UK who distribute EpiPen® and ALK-Abelló who distribute Jext® for an update on the availability of their AAI devices in the UK. The statements below set out the latest position.
If you have any concerns about your prescription we advise you should speak with your GP or pharmacist, you may wish to take this statement along with you for reference.Availability of Emerade®
Emerade® is available in three doses; 150, 300 and 500 micrograms (adrenaline tartrate). Emerade 500 micrograms solution for injection (adrenaline tartrate) can be considered for adults in the UK for over 60kg bodyweight depending on clinical judgement. Bausch + Lomb provided us with the following information on 26th September 2018:
Bausch + Lomb is committed to helping ensure that patients have access to the medicines they need, and we are working diligently to help meet increased demand for this medicine.
Over the last 7 months we have seen a large increase in demand for our products due to the supply issues with Epipen 300mcg and in recent weeks an announcement of supply constraints on Epipen 150mcg.
We are working with our manufacturing supplier to increase production and produce as many units as possible but will not be able to supply the total demand that is normally delivered by other companies. Currently there is stock of both Emerade 300 micrograms and 500 micrograms solution for injection (adrenaline tartrate) in our UK wholesalers, and stock of Emerade 150 micrograms solution for injection (adrenaline tartrate) will be available on the 27th of September for pharmacies.
You can reach Bausch + Lomb UK customer services via +44 (0)208 781 2920.
EpiPen® is prescribed in two doses. EpiPen® 0.3mg, also known as ‘Senior’, is generally prescribed for adults and children above 25kg in body weight. EpiPen Jr® 0.15mg or ‘Junior’ is generally prescribed for children between 7.5kg and 25kg body weight. Mylan provided us with the following information on 29th October 2018:
We have received the following updated statement from Mylan regarding the availability of EpiPen® 0.3mg and EpiPen® Jr 0.15mg Adrenaline Auto-Injector.
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.
You can reach Mylan UK customer services via +44 (0)1707 853 100.
Jext® is prescribed in two doses. Adults and children over 30kg are generally prescribed 300mcg. Children between 15kg and 30kg are generally prescribed 150mcg. ALK provided us with the following information on Monday 23rd 22nd October 2018:
Supply of Jext® (adrenaline as tartrate) 150 mcg and 300 mcg Adrenaline Auto-Injector
There is currently a shortage of adrenaline auto-injectors in the UK. This shortage has been caused by intermittent supply issues of the most commonly prescribed brand and is affecting most countries in Europe. It is anticipated that supply will stabilise in the fourth quarter (October to December) of 2018. The supply status will be continuously reviewed by the Department of Health and Social Care.
ALK is working hard to help address the situation and has significantly increased production of its Jext® 150 mcg and 300 mcg adrenaline auto-injectors at its European manufacturing facility. However, due to the time needed for manufacture and the magnitude of the current deficit, it is not possible for ALK to completely meet the shortfall in supply in the short term.
ALK is working closely with its UK distribution partner Alliance Healthcare to ensure equitable distribution of supplies but it is likely that Jext® 150 mcg and Jext® 300 mcg will not be available at all times.
Extended Use Beyond Labelled Expiry Date for Selected Lots of Jext® 150 mcg and 300 mcg Adrenaline Auto-Injectors
To further ease the situation, ALK has obtained acceptance from the UK medicines regulator, MHRA, to extend the use of specific lot (batch) numbers of Jext® 150 mcg and Jext® 300 mcg auto-injectors, beyond the labelled expiry date by four months. The affected lot numbers are listed in the table below.
Affected lots (batches) for extended use of Jext® auto-injectors
|No.||Strength, mcg||Lot (batch) no.||Labelled Expiry Date (end of the month)||Extended Use by Date (end of the month)|
|1||150||T4933||Jul 2018||Nov 2018|
|2||150||T5019||Aug 2018||Dec 2018|
|3||150||T5132||Aug 2018||Dec 2018|
|4||150||T5326||Sep 2018||Jan 2019|
|5||150||T5407||Sep 2018||Jan 2019|
|6||150||T5478||Sep 2018||Jan 2019|
|7||150||T5669||Oct 2018||Feb 2019|
|8||150||T5819||Oct 2018||Feb 2019|
|9||150||T5940||Oct 2018||Feb 2019|
|10||150||T6143||Nov 2018||Mar 2019|
|11||150||T6399||Nov 2018||Mar 2019|
|12||150||T6620||Nov 2018||Mar 2019|
|13||150||T6930||Dec 2018||Apr 2019|
|14||300||T4801||Jul 2018||Nov 2018|
|15||300||T4857||Jul 2018||Nov 2018|
|16||300||T5122||Aug 2018||Dec 2018|
|17||300||T5327||Sep 2018||Jan 2019|
|18||300||T5401||Sep 2018||Jan 2019|
|19||300||T5468||Sep 2018||Jan 2019|
|20||300||T5656||Oct 2018||Feb 2019|
|21||300||T5779||Oct 2018||Feb 2019|
|22||300||T5747||Oct 2018||Feb 2019|
|23||300||T5798||Oct 2018||Feb 2019|
|24||300||T5867||Oct 2018||Feb 2019|
|25||300||T6074||Nov 2018||Mar 2019|
|26||300||T6233||Nov 2018||Mar 2019|
|27||300||T6366||Nov 2018||Mar 2019|
|28||300||T6363||Nov 2018||Mar 2019|
|29||300||T6554||Nov 2018||Mar 2019|
|30||300||T6721||Nov 2018||Mar 2019|
|31||300||T6635||Dec 2018||Apr 2019|
|32||300||T6846||Dec 2018||Apr 2019|
Important: the extended use only applies to the lots of Jext® 150 mcg and Jext® 300 mcg auto-injectors listed above. Patients can continue to use the Jext® auto-injectors of these specified lots safely until the extended use by date as stated above.
This extended use does not apply to any other lot number of Jext® auto injectors not specified. Patients must continue to adhere to the labelled expiry date on any Jext® auto injector not covered by the lot numbers above.
This extended use of 4 months beyond the labelled expiry date for the specific lots is based on supportive stability data for Jext® auto injectors and has been reviewed by the MHRA. The Jext® auto injectors of these specific lots will continue to work safely and as intended within the allowed extended use by date.
This announcement regarding the extended use of certain batches supersedes any notification that a patient may receive via the expiry alert service from www.jext.co.uk.
Information for Patients
- Lot numbers and labelled expiry dates are marked on the side of the box and on the autoinjector label itself.
- The specified lots of Jext® 150 mcg and 300 mcg autoinjectors will continue to work safely over the extended use period beyond the labelled expiry date.
- If you are unsure whether your Jext® auto injector is affected, talk to your pharmacist.
- The Jext® auto injectors should continue to be stored as labelled on the pack.
- Towards the end of the extended use period (the end of the month listed in the right column of the table above), a new auto injector will still need to be obtained.
- You should continue to check periodically the viewing window in the label of your auto injector to ensure that the liquid inside is clear and colourless. Do not use the autoinjector if the liquid is discoloured.
- You should consult your doctor or pharmacist if you have any concerns regarding this announcement. ALK cannot give specific treatment advice to patients.
If you require additional information or have any questions, please contact ALK Customer Services: 0118 903 7940.
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® website: www.epipen.co.uk
A Jext® trainer can be ordered on the Jext website: www.jext.co.uk
I have a different question, can you help?
In recent weeks we have received a dramatic increase in inquiries to our Helpline with lots of our members and the wider allergic community expressing concern on a range of topics. Our helpline and information team have answered some of the most frequently asked questions that we have recently received. Please click here to view these.
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.
After the dramatic increase in inquiries to our Helpline with lots of our members and the wider allergic community expressing concern on a range of topics our Helpline Team have answered some of our frequently asked questions which you can view here.
Alternatively if you have any other questions or concerns please contact our Helpline and Information team at [email protected] or call 01252 542 029 for support between Monday-Friday, 9am-5pm.