European Medicines Agency (EMA) Review of Adrenaline Auto-Injectors

On 25 June 2015, the European Medicines Agency (EMA) recommended several measures, including the introduction of more effective educational material, to ensure that patients and carers use adrenaline auto-injectors (AAIs) successfully.

Adrenaline auto-injectors are potentially life-saving treatments for anaphylaxis (severe allergic reactions) while the patient waits for emergency medical assistance.  In the UK the following brands are available –  Jext and EpiPen.

Emerade devices in all doses (150mcg, 300mcg and 500mcg) have been recalled and are not currently available. Read the latest statements on this in our Latest News section here.

The EMA carried out a review of adrenaline auto-injectors following concerns that currently available devices may deliver adrenaline under the skin instead of into a muscle, and this may delay response to treatment.

Having assessed all the available data, EMA’s Committee for Medicinal Products for Human Use (CHMP) acknowledged that giving the medicine by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis. However, the CHMP noted that several factors may affect whether adrenaline is actually delivered into a muscle; these include needle length, the thickness of fat under the skin, the way the auto-injector works (e.g. if it is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection.

The CHMP also concluded that further data should be generated to better understand how adrenaline penetrates body tissues when given with each of the different auto-injectors.  This means there will be further clinical trials to try to establish his.

The CHMP recommendation was sent to the European Commission which endorsed it and issued a legally binding decision that is valid throughout the EU.

The Anaphylaxis Campaign has followed this through with the MHRA, and we will continue to keep you updated on this review.

Key points for people prescribed AAIs

• Adrenaline auto-injectors are used to treat severe allergic reactions, while the patient awaits emergency medical assistance. They are designed so that they can be easily used by the patient themselves or a carer
• The review of adrenaline auto-injectors showed that patients could benefit from further training to use the auto-injector successfully.
• You will receive training from your doctor or nurse on how to use your adrenaline auto-injector. Training devices are available so that you can practise with it before you need the auto-injector in an emergency. A training video will be produced to show you in detail how to use the injector properly. Please be aware that we also produce training called AllergyWise which contains comprehensive information on the correct use of AAIs in an emergency – this is available for free for our members.  Find out more here.
• It is important that you use the auto-injector correctly so that the adrenaline is delivered into your muscle and works as quickly as possible.
• If you have been prescribed an adrenaline auto?injector because you are at risk of severe allergic reactions, you should ensure you are familiar with it and carry it with you at all times.
• It is likely that your doctor will recommend that you carry two injectors, in case a second dose is needed while you wait for emergency assistance. The Anaphylaxis Campaign actively campaigns that two devices are prescribed and carried at all times by patients.
• Your family members, carers or teachers should also be instructed in the correct use of your auto-injectors.
• If you have any question or concern, speak with your doctor or pharmacist. Or contact our helpline team – 01252 542029, email info@anaphylaxis.org.uk.