Class 2 Medicines Recall: Emerade 150 micrograms solution for injection in pre-filled syringe, PL 33616/0013 (EL(20)A/14)
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 microgram auto-injectors (also referred to as pens) from patients due to an error in one component of the auto-injector believed to cause some pens to fail to activate and deliver adrenaline.
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 |
Brief description of the problem
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 microgram auto-injectors (also referred to as pens) from patients due to an error in one component of the auto-injector believed to cause some pens to fail to activate and deliver adrenaline.
Results from manufacturer testing of Emerade auto-injectors recalled from patients in Europe indicate that approximately 13% of pens need higher than normal force to activate, implying a higher risk of activation failure than was previously understood. This applies to all strengths of Emerade.
For Emerade 150 micrograms auto-injectors, the MHRA, in conjunction with the Department of Health & Social Care (DHSC) has established that there are sufficient supplies of alternative auto-injectors to allow for a recall to patient level.
General Practitioners (GPs) should send the attached to all patients and carers, as appropriate, who have been prescribed Emerade 150 micrograms auto-injectors.
GPs should also send the attached to all patients and carers for information.
Actions for healthcare professionals
All healthcare professionals in primary, secondary or specialist healthcare services who prescribe, supply or administer adrenaline auto-injectors, or who advise patients and their carers, should ensure that they:
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identify patients who have been supplied with Emerade 150 micrograms auto-injectors and ensure they are reviewed to determine whether their adrenaline auto-injector prescription is still appropriate and in line with existing guidance;
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immediately inform patients and carers to request a new prescription to replace each Emerade 150 microgram auto-injector with one new adrenaline pen in an alternative brand. Healthcare professionals should be aware that the licensed dosing recommendations for each brand of pen are not identical. They are available in the Summary of Product Characteristics (SmPC) and should be followed (see page 3 of );
- inform patients to return Emerade 150 microgram auto-injectors to the pharmacy, only when they have two alternative adrenaline auto-injectors in their possession;
- pharmacists and pharmacies who receive Emerade 150 microgram auto-injectors from patients should quarantine the pens and return to them to their supplier using the supplier’s approved process.
- inform patients:
- that they should always carry 2 in-date auto-injectors with them at all times in case they need to administer a second dose of adrenaline before the arrival of the emergency services;
- that they need to receive training, so they are confident in being able to use any new devices (see further information on page 3 of );
- of the signs of anaphylaxis and the actions they should immediately take (see Management of Anaphylaxis on page 4 of ).
- are aware that this recall also applies to Emerade 150 microgram auto-injectors that are in emergency anaphylaxis kits held by healthcare professionals, such as dental surgery kits etc.
- adrenaline ampoules, as opposed to auto-injectors, should be stocked when renewing the adrenaline in anaphylaxis kits (ensuring dosing charts, needles and syringes are included). See further information on page 3 of .
- are aware that this recall also applies to Emerade 150 microgram auto-injectors that are currently held by schools. See further information on the use of pens in school, page 4 of ;
Prescribers should issue no more than two adrenaline auto-injectors per patient (of any brand or strength) unless:
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schools require separate pens to be kept on the school premises (e.g. in a medical room) in which case prescribers may need to consider issuing more than two but no more than four pens per child (of any brand or strength). See further information on the use of pens in school, page 4 of ;
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for the rare scenario where patients might need more than two adrenaline pens prescribed (for example, a prior severe reaction resistant to treatment with adrenaline), where the prescriber may issue additional pens.
General Practitioners (GPs) should send the attached to all patients and carers, as appropriate, who have been prescribed Emerade 150 micrograms auto-injectors.
Patients and carers should be told of the important differences between brands of adrenaline pen in how they are used.
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healthcare professionals – doctors, nurses and pharmacists – should ensure they provide training to patients and carers in correct use of the new pen. Instructions for use can be found in the SmPC (prescriber’s information) and in the Patient Information Leaflets (PILs) that are supplied with the different pens and on the respective manufacturers’ websites where training videos are available. Training pens that do not contain adrenaline can also be obtained free of charge from the manufacturers. Healthcare professionals and patients are strongly recommended to obtain these to assist with training. The trainer pens can be used repeatedly, allowing patients to practise regularly with them so they are prepared for use in an emergency.
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the following links provide training materials for the different devices:
EpiPen
Jext
Emerade
Emergency use adrenaline auto-injectors in the healthcare setting
Adrenaline pens that are currently held by healthcare professionals, i.e. in emergency anaphylaxis kits, dental kits etc. are subject to the recall. More information on clinical alternatives can be found in the download document.
Guidance on the use of adrenaline auto-injectors in schools
For more information on the use of adrenaline auto-injectors in schools, see Auto Injectors in Schools - More information can be found in .
Information on Emerade 300 microgram and Emerade 500 microgram auto-injectors
Emerade 300 microgram and Emerade 500 microgram auto-injectors are not being recalled at present as there are insufficient supplies of alternatives to provide replacements. For all patients currently in possession of higher strengths of Emerade auto-injectors (i.e. 300 or 500 microgram auto-injectors), the advice from MHRA and DHSC remains that the risk to the patient of being left without a pen, and therefore having no adrenaline to administer, is greater than allowing them to keep pens that may not activate, especially if two pens are carried. Although the risk of activation failure is now estimated to be higher than was previously reported, most Emerade pens will still activate as intended. Therefore, patients should be advised to retain their unexpired Emerade pens, to avoid being left without access to any adrenaline pens.
Additional information is available for patients prescribed an Emerade 300 microgram auto-injector and Emerade 500 microgram auto-injector in the download section below.
Management of anaphylaxis
All patients should be made aware of the signs and symptoms of anaphylaxis and that at the first onset of any signs or symptoms of anaphylaxis, they or a carer/bystander should:
- administer an adrenaline auto-injector device without delay, even if there is doubt whether it is anaphylaxis;
- call an ambulance (999) immediately after giving the injection and say this is an emergency case of anaphylaxis;
- administer a second auto-injector 5 to 15 minutes after the initial dose, if no improvement is seen or if the patient deteriorates after an initial improvement;
- use a second adrenaline auto-injector immediately if an Emerade pen fails to activate despite pressing firmly against the thigh, see for pictorial guidance;
- make further attempts to activate a failed Emerade pen while waiting for the ambulance if the patient is not improving, even if one pen has worked, as this may suggest a need for a second or more doses. The purpose of adrenaline pens is to start treatment for anaphylaxis that is continued by the emergency services.
Letters for patients and carers
Patients with Emerade 150 microgram auto-injectors should be provided with the supplementary letter and information (see )
Patients with Emerade 300 microgram or Emerade 500 microgram auto-injectors should be provided with the supplementary letter and information (see )
Contacts for further information
For stock enquiries please contact Bausch & Lomb Customer Services, Tel: 020 8781 2991
Email: Pharma_CS@bausch.com - please note, only in-date pens that are returned by patients, will be refunded, (i.e. expiry date of March 2020 onwards).
For medical information enquiries please contact the Pharmacovigilance and Medical Information Officer, Tel: 0208 781 5523, Email: Pharmacovigilance.UK@bausch.com
Further information on Emerade including use of the mobile app can be found online.
Download the document