Adrenaline auto-injectors (AAIs): new guidance and resources for safe use

We inform healthcare professionals that the Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidance includes an easy step-by-step guide on what to do in an emergency and provides updated advice on body positioning.

From:
Medicines and Healthcare products Regulatory Agency
Published
27 June 2023
Therapeutic area:
Respiratory disease and allergy

Resources for the safe use of adrenaline auto-injectors (AAIs)

On 19 June 2023, the MHRA, with the support of allergy awareness advocates, has launched a safety campaign to raise awareness of anaphylaxis and provide advice on the use of adrenaline auto-injectors (AAIs). The launch coincides with the World Allergy Week, an annual initiative led by the World Allergy Organization.

A toolkit of resources is now available for health and social care professionals to support the safe and effective use of AAIs.

The resources are freely available for download from the MHRA’s guidance page on Adrenaline Auto-Injectors (AAIs) and include:

Video about the correct use of your AAI

Welsh version of video about the correct use of your AAI

Advice for healthcare professionals:

  • use the materials to inform patients and caregivers what do if they suspect anaphylaxis and how to use adrenaline auto-injectors (AAIs)
  • prescribers should prescribe 2 AAIs to make sure patients always have a backup
  • talk to your colleagues about the safe use of AAIs and the signs of anaphylaxis using the mnemonic A, B, C for Airway, Breathing and Circulation
  • report any suspected defective AAIs to the Yellow Card scheme. Keep defective AAIs for investigation. Your report improves the safety of medicines and medical device

Advice for healthcare professionals to provide to patients and carers:

  • adrenaline auto-injectors (AAIs) should be used without delay if anaphylaxis is suspected, even if in doubt about the severity of the event
  • signs may include swelling in the throat or tongue, wheezing or breathing difficulty, dizziness, tiredness and confusion
  • immediately dial 999 to summon emergency medical help after administering adrenaline; say anaphylaxis (“ana-fill-axis”)
  • if you are not already lying down, lie down flat and raise your legs (if you’re pregnant, lie on your left side); this will assist blood flow to the heart and vital organs
  • stay lying down even if you feel better
  • if you struggle to breathe, you can gently sit up - don’t change position suddenly; you should then lie down again as soon as you can
  • do not stand up even if someone encourages you to
  • use your second AAI if you haven’t improved after 5 minutes
  • you should always carry 2 AAIs at all times; check the expiry dates and speak to your GP or seek advice from a pharmacist if you need a replacement
  • report any suspected defective AAIs to the Yellow Card scheme. Keep defective AAIs for investigation. Your report improves the safety of medicines and medical devices

About adrenaline auto-injectors (AAIs)

Adrenaline auto-injectors (AAIs) (product names Epipen or Jext) deliver adrenaline by means of an auto-injector device for the emergency treatment of anaphylaxis, a life-threatening severe allergic reaction.

In October 2019 the Commission on Human Medicines (CHM) endorsed the formation of an Adrenaline Auto-injector Expert Working Group (AAI EWG) to examine a range of issues to support the effective and safe use of AAIs for the emergency treatment of anaphylaxis.

One of the agreed actions for the group was to develop a communication campaign so that patients, healthcare professionals and the wider public can be better equipped to understand the importance of AAIs as potentially life-saving healthcare products.

View the full Public Assessment Report: Recommendations to support the effective and safe use of adrenaline auto-injectors.

AAIs are intended for self-administration by the patient or for administration by the patient’s carer. AAIs should always be carried by the patient considered to be at risk of anaphylaxis. An AAI should be administered early, at the first signs of anaphylaxis, in line with clear evidence that this improves patient outcome. This requires the patient and carer to be confident in recognising the early signs of anaphylaxis and in distinguishing a severe, life-threatening allergic reaction from one that is less severe and does not require adrenaline. Making this distinction can be challenging, given the wide range of signs and symptoms of anaphylaxis. If there is doubt about the severity of an episode, adrenaline should be administered without delay as the risks of delay outweigh the potential risks from unnecessary administration of adrenaline.

Report adverse drug reactions on a Yellow Card

Please continue to report any suspected adverse drug reactions to the Yellow Card scheme.

Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:

When reporting suspected adverse drug reactions, please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, and treatment dates. When reporting for a biological medicine or vaccine, please ensure that you provide the brand name (or product licence number and manufacturer), and the specific batch number.

We made a small change in August 2023 to clarify that new AAIs can be obtained from a GP.

Article citation: Drug Safety Update volume 16, issue 11: June 2023: 3. 

Updates to this page

Published 27 June 2023
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