Michelle Victor and Jennifer Ellis from the consumer law and product safety team discuss the recent reports of defects in Emerade adrenaline pen devices. Jennifer suffers from severe allergies and herself uses Emerade adrenaline pens.
Last year I reported on the national shortage of auto-injectors available to allergy sufferers generally. The health care system failed to meet the demands of those with allergies who were left without access to life-saving auto-injectors. People were instead advised to retain out-of-date auto-injector devices for use in emergency situations despite the fact that advice published by the Medicines and Healthcare products Regulatory Authority (MHRA) in August 2018 confirmed that such out-of-date injectors ‘may not work’.
There was then an array of speculation during the inquest into the tragic death of 15-year-old Natasha Ednan-Laperouse as to the effectiveness of auto-injectors with 16mm length needles. Guidance issued by the Resuscitation Council (based on recommendations from the Department of Health) suggested that ‘a 25mm needle is best and is suitable for all ages’. With a needle length of 24mm, the Emerade auto-injector was naturally favored by many allergy sufferers (including myself). Whilst Pfizer and the Resuscitation Council (UK) both confirmed that the Resuscitation Council (UK)’s guidance specifically applied to injections administered in controlled conditions of healthcare settings, I nevertheless felt somewhat safer being in possession of the Emerade device with the longer needle - up until today that is!
Earlier today Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) reported a defect of needle blockage in the Emerade devices. The defect may lead to a failure in the device delivering a dose of adrenaline. The MHRA have confirmed that ‘all Emerade pens currently on the market’ are potentially defective. The devices subject to the drug alert are:-
- Emerade 150 micrograms solution for injection in pre-filled syringe PL 33616/0013
- Emerade 300 micrograms solution for injection in pre-filled syringe PL 33616/0014
- Emerade 500 micrograms solution for injection in pre-filled syringe PL 33616/0015
I am currently in possession of two Emerade Auto-injectors (500 micrograms PL 33616/0015). I received both of my Emerade auto-injectors in October last year during the national shortage of auto-injectors. I can’t help but wonder whether the reported defect is therefore attributable to the national shortage of auto-injectors and whether the need to meet increased demand for auto-injectors culminated in a rushed production process.
The alert states that Healthcare Professionals should contact all patients, and carers, who have been supplied with an Emerade device to inform them of the potential defect and reinforce the advice to always carry two in-date adrenaline auto-injectors with them at all times. I have yet to be informed of this defect by any of my healthcare professionals.
It was initially considered that the defect potentially affected 1.5 in every ten thousand pens and was therefore a rarity. Such statistics are now being called into question and incidents of needle blockage may be higher than first estimated. It is now believed that the needle blockage may affect 2.3 in every thousand pens. The manufacturer emphasises that the recommended advice is to always carry two in-date pens at all times thus minimising the risk of having one of the defective devices. On this basis the MHRA is not recalling the current Emerade pens in circulation. This seems grossly irresponsible of the regulator.
I have carried these devices by my side consistently for the past 9 months in the event of an emergency. I am in no way comforted by the notion that the risk of needle blockage is low and further reduced by me carrying two of these potentially defective devices. Given the reliance on this device as a life saving device, and given the lack of alternative treatments to anaphylaxis which can be fatal, this is not a risk I wish to be subjected to no matter how small. These devices need to be reliable! Is the Government therefore doing enough to combat the national shortage of auto-injectors and to protect allergy sufferers from such defective devices or could more be done?