Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-08/19)
MDR Number
MDR 57-08/19
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
The MHRA has notified Bausch and Lomb UK Limited of reports that Emerade pens have failed to activate. This is not related to the risk of needle blockage reported in the previous drug alert. The risk of needle blockage is expected to be resolved in all new stock manufactured since July 2019.
The activation failures have not been traced to particular batches. Bausch and Lomb UK Limited are conducting a thorough investigation to identify the reason.
Following discussions with alternative adrenaline auto-injector suppliers there are currently sufficient supplies available to meet historic demand. However, there are insufficient surplus devices to replace all the Emerade pens that would need to be recalled.
Therefore, at present, the MHRA is advising that Emerade devices should not be recalled. On the basis of all the information available, most pens will activate as normal.
Patients are advised to continue to follow existing advice to carry two in-date pens with them at all times.
When an Emerade pen is used, it should be pressed very firmly against the thigh. If this does not result in activation, the patient should immediately use their second pen. Information is provided to patients on page 5 of Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-08/19).
If the patient is not improving, suggesting a further dose of adrenaline is needed, additional attempts should be made to administer a pen that has failed to activate, while awaiting the arrival of the emergency services.
Activation Issue – Further Information
An activation failure means that the needle is not released from the device and therefore the injection is not administered. Bausch and Lomb UK Limited are conducting extensive investigations. It has been confirmed that some Emerade pens did not activate when normal force was applied, however the rate of occurrence cannot be accurately estimated at present.
Supply
Following discussions with alternative adrenaline auto-injector suppliers there are currently sufficient supplies available to meet historic demand. However, there are insufficient surplus devices to replace all the Emerade pens that would need to be recalled. Therefore, at present, the MHRA is advising that Emerade devices should not be recalled.
The MHRA advice, endorsed by the UK Commission on Human Medicines, is that in the interests of patient safety it is important to allow patients to keep their Emerade pens at present so they still have access to adrenaline instead of risking many patients being left without any adrenaline pens. It is emphasised that the majority of Emerade pens in circulation will activate and deliver adrenaline as expected. However, it is important for patients to be aware of the possibility of activation failure so they can take measures to ensure they always have two pens with them and to be aware how to check that a pen has activated successfully.
In the UK there are two alternative adrenaline auto-injector devices on the market, EpiPen, manufactured by Mylan and Jext, manufactured by ALK-Abello. These different brands of adrenaline auto-injector are not used in exactly the same way so specific training and advice for patients and carers is required before using each of the devices.
The MHRA is fully aware of the issues and is being kept informed by Bausch and Lomb UK Limited of their ongoing investigations.
It is important to report all suspected adverse reactions or product quality defects via the Yellow Card Reporting tool, https://yellowcard.mhra.gov.uk/ More information can be found on page 6 of Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-08/19).
Needle Blockage – Further Information
The previous notification related to a risk of needle blockage, that comes with a very small risk of inadvertent injection of small particles released from the blockage into the bloodstream. There would be a risk of a minor inflammatory response to a once only injection of particles into muscle or subcutaneous tissue.
This risk is expected to be resolved in all new stock manufactured since July 2019 that will now start to be released to the market. It will take some time before the new stock can replace all the existing stock in circulation.
The activation failures are not specific to any particular batches of product and are not related to the potential needle blockage.
Information for Patients:
The MHRA has provided additional information below (see pages 4 and 5 on Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-08/19)) for patients and carers who have Emerade pens. Information is provided on the activation failures and advice on how to handle an emergency event should a pen fail to activate and how to tell whether this has occurred by inspection of the pen.
Action for healthcare professionals
Healthcare Professionals are urged to share this information will patients and carers who have been prescribed an Emerade pen, to 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 and carers with Emerade pens
Use the autoinjector at first signs of anaphylaxis. As a precaution you should press the pen very firmly against the thigh.
If this does not result in activation, you should immediately use your second pen. See Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-08/19) to illustrate what a non-activated pen looks like
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. However, if you are having difficulty breathing, you may need to sit up to make breathing easier
Use second pen if still unwell after 5-15 minutes
If a further dose of adrenaline is needed before the emergency services arrive, additional attempts should be made to administer a pen that has failed to activate. This is because reports received suggest that a pen may activate after further attempts.
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.