EMA Takes Steps to Improve Adrenaline Auto-Injector Use

Miriam E. Tucker

Disclosures

July 01, 2015

The European Medicines Agency (EMA) has recommended several measures to better ensure appropriate patient and carer use of adrenaline auto-injectors for severe allergic reactions.

The move is prompted by concern that the devices are often being used incorrectly. In particular, some users have been delivering the injections subcutaneously rather than intramuscularly, according to an EMA statement.

After a data review, the EMA's Committee for Medicinal Products for Human Use has confirmed that intramuscular injection is the preferred route of administration in the treatment of anaphylaxis.

The committee also called for improved educational materials for both users and healthcare professionals, demonstrating how to use the injectors. These include a training device for patients to practice, audiovisual material demonstrating correct technique, and a prescriber checklist to ensure the patient has received sufficient information.

The product label for adrenaline auto-injectors will also be updated with further warnings and precautions, including a recommendation that patients be prescribed two auto-injectors and be advised to carry them at all times, and that family members, teachers, and other carers should also be trained how to give the injections.

The recommendation to prescribe two auto-injectors is based on the uncertainty about the adequacy of drug delivery from the auto-injectors, which can vary by needle length, skin-to-muscle depth, whether or not the device is spring-loaded, the angle of placement on the skin, and the force used to activate the device.

The product manufacturers will be asked to carry out a pharmacokinetic/pharmacodynamic study to better elucidate how adrenaline penetrates body tissues when given through an auto-injector.

The opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all European Union Member States.

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