MHRA issues clarification on use of spare pens in schools

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued clarification on when schools’ spare adrenaline auto-injectors can be used.

As of 2017, schools and local authority maintained nurseries can purchase spare adrenaline auto-injectors, used to treat anaphylaxis, as a back-up in the case of an emergency. Previously, guidance for schools stated that these spare auto-injectors could only be administered to children already prescribed adrenaline and with the written permission of their parents.

In a letter from MHRA in response to queries on this issue, it clarified that the legal exemption under Regulation 238 of the Human Medicines Regulations 2012 permits a school’s spare adrenaline auto-injector(s) to be used for any pupil or other person not known by the school to be at risk of anaphylaxis in an emergency. Written permission is not required. However, the MHRA highlighted that this was for exceptional circumstances only where the reaction could not have been foreseen.

In normal circumstances, a child at risk of anaphylaxis and prescribed adrenaline would be known to school staff, always have their own medication in school, along with a written Allergy Action Plan that includes parental consent for the use of the spare adrenaline auto-injectors. However, this clarification of the law could potentially save a life in the event of a child experiencing anaphylaxis for the first time due to an unrecognised allergy.

Simon Williams, Chief Executive of Anaphylaxis UK, said:

“It is great to have clarification from the MHRA on this topic as there has been some confusion about who can be given a school’s spare adrenaline auto-injectors. Schools can now confidently use their spare auto-injectors to save the life of anyone having anaphylaxis without fear of reproach.”

For more information on obtaining spare adrenaline auto-injectors and to download a template letter, visit our Safer Schools page.