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.
Availability of EpiPen®
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 27th September 2018:
Extended use for certain lot numbers of EpiPen® 0.3mg adrenaline auto?injector
This letter is sent in agreement with the Medicines and Healthcare Products Regulatory Agency (MHRA) to inform you of the following:
Mylan UK have obtained acceptance from the MHRA to extend the use of specific lot numbers of EpiPen® 0.3mg auto?injectors, beyond the labelled expiry date by four months. The affected lot numbers, 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 above. Patients can continue to use the EpiPen® 0.3mg auto-injectors of these specified lots safely until the extended use by date as stated above.
This extended use does not apply to EpiPen 0.15mg auto?injectors or any lot number of EpiPen® 0.3mg autoinjectors not specified. Patients must continue to adhere to the labelled expiry date on any EpiPen not covered by the lot numbers above.
Further information on the extended use of the listed lots of EpiPen 0.3mg autoinjectors
There has been interruption in the production of EpiPen® 0.3mg autoinjectors, consequently resulting in intermittent supply constraints in the UK.
The manufacturer anticipates that supply of EpiPen® 0.3mg will stabilise in the fourth quarter (October to December) of 2018. The supply status will be continuously reviewed by the manufacturer and the Department of Health and Social Care.
To make sure patients can access their medicines during this shortage, the period that nine specific lots of EpiPen® 0.3mg (listed above) can be used has been extended by 4 months beyond the labelled expiry date on the pack.
This extended use of 4 months beyond the labelled expiry date for the specific lots is based on supportive stability data for EpiPen® 0.3mg autoinjectors and has been reviewed by the MHRA. The EpiPen® 0.3mg autoinjectors of these specific lots will continue to work safely and as intended within the allowed extended use by date. The EpiPen® autoinjectors should continue to be stored as labelled on the pack.
At the end of the extended use period (the end of the month listed in the right column above), a new autoinjector will still need to be obtained.
Further information on recommendations to professional bodies and patient support groups
- Tell patients and caregivers about the extended use by date of the specified lots of EpiPen® 0.3mg autoinjectors as listed above. This does not apply to other lots of EpiPen® 0.3mg autoinjectors and does not apply to any of EpiPen® 0.15mg autoinjectors.
- Show patients and caregivers where to find the lot numbers on their device (on the end-flap of the box and if necessary, on the EpiPen® itself) and encourage them to sign up for the Expiry Alert Service.
- Reassure patients and caregivers that their device will continue to work safely over the extended use period.
- Remind patients and caregivers that they should still obtain a new device at the end of the extended use period.
Please continue to report any adverse events. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
The information provided in this statement on the specific lot numbers listed above supersedes any other communication that patients may receive from the EpiPen® expiry alert service.
If you require additional information or have any questions, please contact Mylan Customer Services: +44(0) 1707 853 100.
Availability of Jext®
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 26th September 2018:
As you may be aware, there has been ongoing supply constraints with EpiPen® Adrenaline Auto-Injector in the UK. As the EpiPen® device is the most commonly prescribed device in the UK, this has put considerable strain on our ability to maintain stocks of Jext® adrenaline auto-injector with demand far exceeding our normal expectations and forecasting. As a result we have significantly increased production at our European manufacturing site to try and reduce the risk to poses to patient safety.
Currently in the UK we have stock of both our 150mcg and 300mcg pens but this situation remains fluid and is affected significantly by availability of other devices. We have had weekly deliveries throughout the last few months and there are further planned deliveries in the coming weeks and throughout the remainder of the year. However, due to shelf life limitations and production lead times it is not possible to hold sufficient reserve stock to make up the overwhelming shortfall with the current situation or to obtain further stocks at short notice. Unfortunately, this means that it is probable that Jext® will be out of stock in some areas intermittently.
Our next delivery will arrive in the UK early next week, followed by an increased level of stock for the rest of the year. We are working closely with the Department of Health, NHS England and the Irish authorities alongside our wholesaler Alliance Healthcare Ltd to ensure equitable distribution of our stock and are working hard to increase ongoing supplies to the UK.
ALK would urge patients to be mindful of the expiry date of their pens; check the clarity of the adrenaline through the window in the side of the pen and order new pens in a timely and appropriate manner through their local pharmacy. In this way we can all help ensure patient safety while we manage these global supply issues.
If you require any additional information, please contact ALK-Abelló customer services on 0118 903 7940 or [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.