A recent post noted that HM Assistant Coroner for West London intended to issue a Regulation 28 Prevention of Future Deaths Report to the MHRA raising concerns about the adrenaline auto-injectors used by Natasha Ednan-Laperouse – in particular whether the length of the needle and the dose administered were appropriate.
The Coroner raises four matters of concern, including two requiring a response from the MHRA with details of action taken or proposed (by 3/12/18):
- In the Emergency treatment of anaphylactic reactions Guidelines for healthcare providers the preferred needle length is 25 mm for adrenaline injectors to access muscle in most people. I heard during expert evidence that Epipen needle length was 16mm – suitable according to the UK Resuscitation Council for “pre-term or very small infants”. The use of needles which access only subcutaneous tissue and not muscle is in my view inherently unsafe. An alternative autoinjector, Emerade has a 24 mm needle.
- The dose of adrenaline in Epipen is 300mcg. The UK Resuscitation Council recommends a standard emergency dose of 500mcg. Emerade contains a dose including 500mcg. The combination of what my expert told me was an inadequate dose of adrenaline for anaphylaxis and an inadequate length needle raises serious safety concerns.