Following the inquest concerning the death of Natasha Ednan-Laperouse, HM Assistant Coroner for West London will be issuing three Prevention of Future Deaths Reports under paragraph 7, Schedule 5, of the 2009 Act and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013, including a report:
- To the Medicines and Healthcare products Regulatory Agency (MHRA) and to the manufacturers of the Epipen in relation to the apparently inadequate length of the needle and the dosage of adrenaline within the device
See also the MHRA 2014 publication – Adrenaline Auto-injectors: A Review of Clinical and Quality Considerations which included the following advice:
- In view of information that indicates that AAIs will not deliver an intramuscular injection in all patients the needle length for all AAIs should be reviewed by the manufacturers and increased, if necessary, to ensure that an intramuscular injection is delivered to a greater proportion of patients. This is of particular importance in patients with a high BMI or those with increased skin to muscle distance.
- Also noted: studies […] showed that the skin to muscle depth is greater than the length of the needle in many people, particularly women due to a different distribution of fat from men.
- In the absence of evidence that the devices can deliver adrenaline intramuscularly to all patients, that the SmPC for all AAIs should be amended to state that “Successful intramuscular (IM) administration is dependent on the skin to muscle distance (SMTD) and in certain cases the administration may be subcutaneous. Care should be taken to ensure IM administration as far as possible”.
- MAHs should be encouraged to develop a 500 μg strength AAI.