Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 55-06/18)
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
MDR Number
MDR 55-06/18
Company name
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited)
Product description
| Product | PL Number |
| 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 |
Brief description of the problem
Bausch & Lomb UK limited has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
This issue was first detected in June 2018 during routine stability testing of the syringe component of Emerade, with potential to affect 1.5 in every ten thousand pens, and therefore considered a rare event. However, recent information indicates that the potential occurrence of needle blockage in batches on the market is higher than first estimated and we are therefore bringing it to the attention of patients.
The potential for units on the market to have a blockage of the needle which could lead to Emerade failing to deliver a dose when activated is now estimated to be 0.23 %, which would affect 2.3 in every thousand pens. (This estimate is based on simulated laboratory conditions without the auto-injector component which may lower the potential rate of failure to deliver.)
However, if the patient follows the existing advice to carry two in-date pens with them at all times, the risk of not being able to deliver a dose of adrenaline before the emergency services arrive is substantially reduced (from 0.23% to 0.000529%).
It should be emphasised that two pens are already recommended to be carried at all times in case the patient does not improve after the first injection which may occur for a number of reasons.
This notification of potential for needle blockage applies to Emerade devices of all strengths. It does not apply to the other marketed brands of adrenaline auto-injectors.
The Medicines and Healthcare products Regulatory Agency (MHRA) is not recalling batches of Emerade.
In the UK there are two alternative adrenaline auto-injector devices available. However, the different brands of adrenaline auto-injectors are not used in exactly the same way and therefore specific training and advice is required for each of the devices.
Furthermore, there are insufficient supplies available of alternative brands to support the removal of one brand.
The manufacturer conducted extensive investigations and has implemented corrective actions. Emerade manufactured with all the corrective processes is expected to be introduced into the market from mid-July 2019.
Action for healthcare professionals and patients
Healthcare 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.
This advice is provided in the approved patient information leaflet for Emerade, which should be provided to the patient or caregiver at dispensing.
Patients experiencing any problem with Emerade failing to activate should report this via the MHRA’s Yellow Card Scheme and keep the pen for further examination.
Additional advice to patients
Additional advice to reiterate to patients is to:
- Check expiry date and replace the pen before it expires
- Use the autoinjector at first signs of anaphylaxis
- Call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna -fill-axis’)
- Lie flat if possible with your legs up to keep your blood flowing
- Use second pen if still unwell after 5-15 minutes
There is also a fact sheet with advice on the use of adrenaline auto-injectors which patients or carers are encouraged to read.
The risk of device mishandling or device failure exists with all adrenaline auto-injectors and is something that patients and carers should be aware of.
The chance of a successful outcome is increased if there is prompt administration of adrenaline at the first signs of anaphylaxis.
Even with an apparently successful response to adrenaline auto-injector administration, patients may relapse some hours later which underlines the importance that the emergency services should always be called.
Contact details for further information
For stock enquiries please contact Bausch & Lomb Customer Services:
Tel: 0208 781 2991 Email: Pharma_CS@bausch.com
For medical information enquiries please contact Lizanne Kombrink, Pharmacovigilance and Medical Information Officer:
Tel: 0208 781 5523 Email: Pharmacovigilance.UK@bausch.com
Additional information
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
MHRA calculation for reduced risk by carrying two pens instead of one
If one pen is carried, the risk of not having a pen that is working and therefore being unable to administer adrenaline is 0.23% (2.3 in 1,000 or a probability 0.0023). The risk of one pen being faulty is independent of the risk that another pen is faulty as the potential defect is not linked to a particular batch. Therefore, to calculate the risk of not having a pen that is working if two pens are carried, i.e. both pens are faulty, one needs to multiply together the probabilities of each pen being faulty. When these probabilities are multiplied (0.0023 x 0.0023) the result is 0.00000529 which when converted back to a percentage is 0.000529%, a chance of 5.29 per million. Therefore the risk is substantially reduced by carrying two pens.
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