Medicines Healthcare Products Regulatory Agency
Advice for healthcare professionals:
Emerade activation failure
- some Emerade pens have failed to activate, which could lead to an injection of adrenaline not being administered in cases of anaphylaxis (see Class 4 Medicines Defect Information 3 October 2019 for details)
- contact patients (and their caregivers if necessary) in possession of Emerade adrenaline auto-injectors to advise them:
- when an Emerade pen is used, it should be pressed very firmly against the thigh
- if administration does not result in activation (see pictures of an activated vs in-activated pen in letter for patients), a second pen should be immediately used
- if there is no improvement in a patients condition and a further dose of adrenaline is needed, additional attempts should be made to administer a pen that has failed to activate, while awaiting the arrival of the emergency services
- any suspected defective adrenaline auto-injectors should be retained for investigation (see below for advice on reporting defects and contacting the marketing authorisation holder)
EpiPen and Jext extended use beyond labelled expiry date
- to support adequate supply of adrenaline auto-injectors in the UK, an extension by 4 months of the use-by dates has been approved for:
- if patients are in possession of a device with an extended use-by date, advise them or their caregivers that it will continue to work safely within this extended period, but that a new auto-injector will need to be obtained at the end of the period stated
- advise patients to continue to check periodically the viewing window in the label of their device to ensure the liquid inside is clear and colourless; it should not be used if the liquid is discoloured
All adrenaline auto-injectors
- patients should continue to follow existing advice to carry 2 in-date pens with them at all times
- different brands of adrenaline auto-injector are not used in exactly the same way so specific training and advice for patients and carers is required before using each of the devices (see below)
- 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 device label itself) and encourage them to sign up for the Expiry Alert Service of their specific adrenaline auto-injector on the manufacturers website
Emerade: activation issue
Emerade adrenaline auto-injectors are one of 3 brands available for emergency treatment of anaphylaxis. MHRA has notified Bausch and Lomb UK of reports that Emerade pens have failed to activate. An activation failure means that the needle is not released from the device and therefore the injection is not administered. Bausch and Lomb UK is conducting extensive investigations. It has been confirmed that some Emerade pens did not activate when normal force was applied, however the rate of occurrence could not be accurately estimated at the time the drug alert was issued.
MHRA advice, endorsed by the UK Commission on Human Medicines, is that in the interests of patient safety it is important to allow patients to keep their Emerade pens, so they still have access to adrenaline. Most Emerade pens in circulation will activate and deliver adrenaline as expected. However, it is important for patients to be aware of the possibility of activation failure so they can take measures to ensure they always have 2 pens with them and to be aware how to check that a pen has activated successfully. A letter for healthcare professionals to provide to patients is provided in the Drug Alert, issued 3 October 2019.
Emerade: update on previous alert on needle blockage
On 11 July 2019, a Class 4 Medicines Defect Information alert was issued related to a risk of needle blockage associated with Emerade 150, 300 and 500 microgram medicines. This issue is not related to the activation issue described above and is expected to be resolved in batches of Emerade released from July 2019, however, in the meantime affected devices will remain on the market and in patients possession. There is a very small risk of inadvertent injection of small particles from the blocked needle into the bloodstream, or of a minor localised inflammatory response from injection of particles into muscle or subcutaneous tissue.
Reporting non-activated devices
It is important to report all suspected adverse reactions or product quality defects to the Yellow Card Scheme. For adrenaline auto-injectors details of the strength and batch number should also be included to assist monitoring.
Any suspected non-activated or otherwise defective pens should be retained for investigation and the marketing authorisation holder contacted for advice (see alert for contact details).
Other available adrenaline auto-injectors in the UK
In the UK there are 3 adrenaline auto-injector devices on the market, Emerade, manufactured by Pharmaswiss ?eska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited); EpiPen, manufactured by Mylan; and Jext, manufactured by ALK-Abello. These different brands of adrenaline auto-injector are not used in exactly the same way and specific training and advice for patients and carers should be provided as appropriate. Training devices can be ordered via the websites of each brand.
There is also an MHRA fact sheet with advice on the use of adrenaline auto-injectors, which patients or carers are encouraged to read. This advice is relevant to all 3 adrenaline auto-injectors available on the UK market.
Extended use beyond labelled expiry date
Adrenaline auto-injectors are in short supply around the world, not only in the UK. The overall market supply of adrenaline auto-injectors is being monitored by the Department of Health and Social Care.To ensure patients have access to adrenaline, MHRA has given permission for the manufacturers of EpiPen and Jext to extend the use-by dates of certain batches of medicines for 4 months after the listed expiry date. Letters with this information (for EpiPen and Jext) have been sent to allergists and allergy clinics, and information has been issued to patients registered for such alerts including via the Expiry Reminder Service. Further information may also be found on the UK websites of EpiPen and Jext.
Not all batches are included in this extension. Patients must continue to adhere to the labelled expiry date on any auto-injector not covered by the lot numbers noted in the letter or on the websites.
Patients should be advised to seek a new adrenaline auto-injector before the end of the month stated in the extension (for example, if a pen lists expiry of December 2019, and the use-by date has been extended to April 2020, they can use the pen up to 30 April 2020).
Advise patients to continue to check periodically the view