Food allergy deaths have been on the increase for decades with Allergy UK reporting an astounding 615% increase in the rate of hospital admissions for anaphylaxis within the UK between 1992 and 2012.
More recent NICE guidance published in March 2016 also confirms that anaphylaxis incidents within the UK are ever increasing. It is therefore alarming to learn that 6 years later we are experiencing a national shortage of EpiPens, the most popular adrenaline auto-injector (AAI) device on the market in Britain.
In light of the national shortage, allergy sufferers have been advised to retain their out-of-date EpiPen devices for use in an emergency situation - providing the liquid inside is not cloudy or discoloured.
Alternative devices are available, but is this good enough? Stocks of alternative adrenaline devices have also been reported as ‘variable’.
The fact that patients are now being encouraged to retain out-of-date EpiPens is alarming and the fact that the current Medicines and Healthcare products Regulatory Authority (MHRA) issued advice in August 2018 confirming that ‘out-of-date injectors may not work’.
It therefore appears that medical organisations could be failing to adequately protect allergy sufferers from the life threatening risks associated with anaphylaxis.
These shortcomings are especially potent in a country where 1 in 3 of the UK population is reported to suffer from allergies.
Nevertheless, the EpiPen (and other AAI devices) remains widely perceived as a magic life saving device. However, we have heard over the past couple of weeks that this is not true.
The inquest into the tragic death of Natasha Ednan-Laperouse has revealed that even those EpiPens which are in circulation may be inadequate to meet the basic needs of allergy sufferers.
Natasha Ednan-Laperouse, like many allergy sufferers, had two EpiPens with a 16mm length needle containing 300 micrograms of adrenaline.
Conversely, if a patient were to attend hospital for anaphylaxis, a dosage of 500 micrograms would be administered.
Furthermore, questions have now been raised of the effectiveness of 16mm length needles. Certainly prior to Natasha’s death, concerns were raised that current AAI devices may deliver adrenaline under the skin rather than into the muscle which may delay responses to the adrenaline.
In his prevention of death report published yesterday, the Coroner in Natasha's inquest wrote to the Chief Executive of manufaturer of the Epipen, Pfizer, stating:
"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."
Pfizer are now under a legal duty to respond to this report within 56 days, namely by 3rd December 2018. Their response must contain details of action taken or proposed to be taken, setting out the timetable for action or explain why no action is proposed.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) carried out a review of adrenaline auto-injectors on 25 June 2015 and acknowledged that administering adrenaline by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis.
It concluded that several factors may affect whether adrenaline is effectively delivered into a muscle including but not limited to the length of a needle and the thickness of fat lying under the skin.
It was considered that further data was required to understand how adrenaline penetrates body tissues.
During Natasha’s Inquest, Consultant Allergy expert, Dr Croom explained to the Court that the UK Resuscitation Council's guidance have confirmed that 16mm auto-injector needles are effective for use in pre-term or very small infants however, the ideal length of a needle on an AAI for older patients is 25mm.
The longer needle ensures full access to the muscle so that the adrenalin is effectively administered.
This poses the question, why, when the Resuscitation Council’s guidance is that 25mm needles are the most effective to treat episodes of anaphylaxis, are EpiPens with needles of 16mm in length continually manufactured and prescribed to allergy sufferers of all ages?
Additionally, there appears to be insufficient training throughout the NHS and amongst patients themselves about anaphylaxis generally. The European Medicines Agency’s (EMA’s) CHMP department have recommended that companies marketing AAI’s should develop more effective educational material for patients and healthcare professionals to ensure the optimal use of AAI devices.
They have suggested that patients should have access to a training device to practise administering adrenaline, audio-visual material to show how to use the device and prescribers should be given a checklist to ensure that patients are provided with sufficient information before purchasing auto-injector devices.
It seems these recommendations have yet to be implemented. Coroner, Dr Sean Cummings, has confirmed after hearing evidence surrounding the circumstances of Natasha Ednan-Laperouse’s tragic death that he will be providing a report to the MHRA and to the manufacturers of the EpiPen in relation to the inadequate length of the needle and to the dosage of adrenaline within the device.
We hope that Dr Sean Cummings reports will encourage the manufactures of EpiPen (King, a subsidiary of Pfizer) to reconsider the design of the EpiPen in conjunction with the UK Resuscitation Council's guidance.
We also hope that the MHRA will take wider action to ensure that all AAI devices afford allergy sufferers sufficient protection.