The European Medicines Agency (EMA) has recommended several measures, including the introduction of more effective educational material, to ensure patients and carers use adrenaline auto-injectors successfully.
Adrenaline auto-injectors are potentially life-saving treatments for anaphylaxis while the patient waits for emergency medical assistance. 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 (eg, if it is spring loaded or not)
- The angle at which the device is placed on the skin
- The force used to activate the device
- How well the user follows the instructions for injection.
The CHMP concluded that training of the user is of paramount importance. The companies that market adrenaline auto-injectors will therefore be asked to develop more effective educational material for patients, as well as for healthcare professionals, to ensure their optimal use. This will include a training device with which patients can practise; audio-visual material to show in detail how the device is to be used; and a checklist for prescribers to ensure that sufficient information is given to the patient before they use the auto-injector.
The product information of adrenaline auto-injectors will also be updated with further warnings and precautions, including a recommendation that patients should be prescribed two auto-injectors which they should carry at all times, and a recommendation for family members, carers or teachers to be trained on how to use the auto-injector.
The EMA committee 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.
The CHMP recommendation will now be sent to the European Commission for a legally binding decision that will be valid throughout the EU.