In the alert letter, the regulatory agency announced that a rate of 0.23% of the syringe pens (2.3 pens in every 1,000) produced by Bausch & Lomb fail to deliver the dose of adrenaline due to blockage of the needle.
According to the UK Medicines and Healthcare products Regulatory Agency (MHRA), this estimate is based on “simulated laboratory conditions without the auto-injector component, which may lower the potential rate of failure to deliver.”
The alert refers to Emerade solution for injection in pre-filled syringes of 150μg, 300μg and 500μg and does not apply to any other marketed brands.
The MHRA noted that it is not recalling any batches of the product due to insufficient supplies available of alternative brands to support the removal. In the UK, there are two alternative brands available; however, the alternatives are not used in exactly the same way and require specific training.
According to the regulatory agency, Bausch & Lomb conducted ‘extensive investigations’ and has implemented corrective actions, with batches of the product manufactured with the corrective processes expected to reach the market from ‘mid-July 2019’.
The issue on Emerade was first detected in June 2018, with the potential of failure then estimated to have been 0.15% and therefore considered a rare event. However, recent detections saw that the potential occurrence of needle blockage in batches on the market is now higher than first estimated.
The MHRA suggests that the patients should follow the existing advice to carry two in-date pens with them at all times, in which case the potential of delivery failure is reduced to 0.000529%.
Patients and healthcare providers are recommended to carry two pens nevertheless, in case the signs of anaphylaxis do not improve after the first injection, and the intake of a second dose is required.