EMERADE® AAIs: Update on Failure to activate
The MHRA (Medicine & Healthcare products Regulatory Agency) has sent out an Alert to healthcare professionals regarding Emerade® adrenaline auto injectors failing to activate. The extent of the problem is not yet clear and we know how worrying this will be for those patients who have been prescribed this brand of AAI for themselves or for their children.
In this situation Allergy UK wants to provide some reassurance and practical advice to help those patients who carry in date Emerade® AAIs. This is based on MHRA’s own guidelines but we want to also reassure patients that Allergy UK is closely monitoring this situation and, most importantly, to reaffirm that our Helpline team on 01322 619898 is also here to help with support and guidance.
The MHRA is advising
- Remember that on the basis of the current information available most Emerade® pens will activate normally
- Carry two in date pens at all times. The MHRA considers that the risk of not having a pen at all is much higher that having a pen that may not activate
- Be sure that you know how to use your pen
- If needed, use your pen exactly as instructed by the manufacturer
- Follow current recommended storage instructions for Emerade® Make sure these are the latest instructions
- Use your second pen immediately if the first pen does not activate
- Check expiry dates
- Press the pen harder against the injection site if it fails to activate immediately
- Use the second pen if the first fails to activate
- Expose your pens to temperatures above 25 degrees centigrade, for example by leaving it close to a radiator or heater.
- If you are planning to travel to a hot climate talk to your doctor in good time about prescribing a different brand. This advice is included in current storage instructions
- Delay - administer an adrenaline pen if you suspect anaphylaxis and immediately dial 999 for an ambulance
The MHRA is advising that when your Emerade® pen has expired you should be prescribed a different brand - Epipen® or Jext®. Remember that other brands work in a different way and you will need guidance on how to use a different brand from your health professional, the brand’s website or the instruction leaflet. Be sure to learn how to use your AAI from the patient information leaflets:
The Yellow Card Reporting process
The MHRA runs a Yellow Card Scheme through which suspected defects and adverse events can be reported. This is important as it allows continuous monitoring of medical devices such as AAIs.
If you suspect activation issues with your Emerade® device, it is important to report these to the MHRA as soon as possible using the Yellow Card reporting tool. Please provide as much information as possible when reporting your concerns.
The above advice is based on the information we have so far and we will be providing updates as soon as we can. In the meantime we will do all we can to monitor this situation on behalf of our community. Remember that on the basis of current information available most Emerade® pens will activate normally.
Click here to read the full GOV.UK alert