The Medicines and Healthcare products Regulatory Agency (MHRA) has warned that some of these pens are failing to deliver a dose of adrenaline due to blocked needles.
“Patient safety is our highest priority”
MHRA spokeswoman
It is thought that around two in every 1,000 pens have been affected.
The issue was first detected by pen makers, Bausch & Lomb UK, during routine testing of the syringe component of Emerade in June 2018.
At the time, the company found the problem to be a “rare event” affecting 1.5 in every 10,000 pens.
However, recent information suggests the occurrence of needle blockages in batches on the market is higher than first estimated.
According to MHRA, the potential for the pens to fail to deliver a dose of adrenaline when activated is now estimated to be 0.23%. This means it would affect 2.3 in every 1,000 pens.
However, the regulator – which ensures medical devices are safe on behalf of the Department of Health and Social Care – said that if patients followed existing advice to carry two in-date pens with them at all times, the risk would be substantially reduced.
Patients are already recommended to have two pens on them in case they do not improve after the first injection.
In wake of the news, MHRA said that health professionals should contact all patients, and their 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 autoinjectors with them at all times”.
The government agency said the manufacturer conducted extensive investigations and has now implemented corrective actions.
It added that it would not be recalling batches of Emerade and that devices manufactured with all the corrective processes were expected to be introduced into the market from mid-July 2019.
An MHRA spokeswoman said: “Emerade products have a good safety record.
“As with all medicines, the safety of Emerade is carefully monitored.
“Patients should carry the recommended two pens and use the second one if they are still unwell after 5-15 minutes.
“Patient safety is our highest priority and our role, as regulator, is to make sure the medicines you and your family take are safe and effective.”
MHRA added that any patients experiencing any problem with Emerade failing to activate should report this via the MHRA’s Yellow Card system and keep the pen for further examination.
The warning is only applicable to Emerade devices and not to any other marketed brands of adrenaline auto-injectors.
There are two alternative adrenaline pen devices available in the UK but MHRA said there were insufficient supplies available to support the removal of one whole brand, and that specific training was needed to use the alternatives.
https://www.nursingtimes.net/news/policies-and-guidance/medicines-regulator-issues-warning-over-faulty-allergy-pens/7029728.article