To ask the Secretary of State for Health and Social Care, what assessment (a) his Department and (b) the Medicines and Healthcare products Regulatory Agency have made on the adequate needle length for an adrenalin autoinjector to deliver a dose.
16 October 2018
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for licensing of medicines and undertook a review in 2014 into adrenaline auto-injectors, which included consideration of adrenaline auto-injector needle length to treat anaphylaxis. This concern was subsequently taken forward by the MHRA as part of a wider European safety review which reported in 2015. One conclusion from the European review was that studies in human volunteers were required for each brand of adrenaline auto-injector in order to evaluate the rate and extent of adrenaline uptake into the bloodstream. Brands available in the United Kingdom are Epipen, Jext and Emerade. A full evaluation will be undertaken when results from all currently marketed products are available, anticipated to be by end 2019.
An additional legal requirement following the European safety review was that the exposed needle length for the respective devices should be included in the product information to inform the healthcare professional and patient. This has been implemented for all adrenaline auto-injector products sold throughout Europe.
Other recommendations from the European review included improved training and educational materials for patients, carers and healthcare professionals and further improvements to the product information. This has been implemented for all adrenaline auto-injector products sold in the UK.