Class 2 Medicines Recall: Emerade 500 micrograms solution for injection in pre-filled syringe, PL 33616/0015 (EL(20)A/23
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 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 057-08/19
Company name
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited)
Product description
| Product | PL Number |
|---|---|
| Emerade 500 micrograms solution for injection in pre-filled syringe | PL 33616/0015 |
Brief description of the problem
This is a recall for Emerade 500 microgram pens only. This is a different alert to that issued on 04 March 2020 for Emerade 150 microgram auto-injectors and on 07 April 2020 for Emerade 300 microgram auto-injectors
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. Previous estimations of activation failure were obtained from tests on pens that had been stored in the manufacturing facility. Whereas, the recent results were obtained on pens carried by patients, suggesting an environmental contribution to the risk. Investigations are ongoing to understand this.
For Emerade 500 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 a recall to patient level.
The recall of Emerade 500 microgram auto-injectors from patients follows a previous recall of Emerade 150 microgram auto-injectors and Emerade 300 microgram auto-injectors from patients. More information on the previous alert can be found on the following links:
General Practitioners (GPs) should send the attached letter on page 6 of the attached alert, to all patients and carers, as appropriate, who have been prescribed Emerade 500 micrograms auto-injectors.
Alternative brands of adrenaline auto-injector (EpiPen and Jext) are available in a maximum strength of 300 micrograms. There is evidence to suggest that a single EpiPen (300 microgram) or Jext (300 microgram) pen will be a suitable replacement for a single Emerade 500 microgram pen. This is based on recently available results from a study which compared blood levels of adrenaline following injection of Emerade 500 microgram pens with those following EpiPen 300 microgram or Jext 300 microgram pens. You must continue to always carry two adrenaline pens with you at all times. Prescribers are to follow dosage guidance in individual Summary of Product Characteristics (SmPC).
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 500 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 500 microgram auto-injector with one new 300 microgram 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 links below);
- inform patients to return Emerade 500 microgram auto-injectors to the pharmacy, when they have obtained a total of two adrenaline 300 microgram auto-injectors in a different brand;
- Although pens should be returned to a pharmacy once a replacement is obtained, this should not require someone who is self-isolating to leave their home (see COVID-19 advice below)
- Pharmacies that receive Emerade 500 microgram auto-injectors from patients should quarantine the pens and return them to the supplier using the supplier’s approved process.
- Inform patients:
- that they should always carry two 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 in the attached document);
- of the signs of anaphylaxis and the actions they should immediately take (see Management of Anaphylaxis in the alert for further advice).
- are aware that this recall also applies to Emerade 500 microgram auto-injectors that are in emergency anaphylaxis kits held by healthcare professionals, such as dental surgery kits etc.
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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 in the attached document
- are aware that this recall also applies to Emerade 500 microgram auto-injectors that are currently held by schools. See further information on the use of pens in school, in the document;
Prescribers should issue no more than two adrenaline auto-injectors per patient (of any brand or strength) unless:
- 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 below
- 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 letter “Advice for patients who have been prescribed an Emerade 500 microgram auto-injector” on page 6 of the attached alert, to all patients and carers, as appropriate, who have been prescribed Emerade 500 micrograms auto-injectors.
Information in relation to Coronavirus (COVID-19):
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When a prescription is needed for replacement pens, where possible, telephone appointments should be considered, based on the current UK Government guidelines for social distancing in relation to Coronavirus (COVID-19). Patients should be informed to follow the advice of their local GP practice/hospital and only attend where they are instructed to do so. See further information on COVID-19.
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Healthcare professionals involved in the dispensing process may wish to consider how to ensure that vulnerable patients and those practising self-isolation, social distancing and shielding can still obtain their replacement auto-injectors, considering the use of delivery services where appropriate. Although pens should be returned to a pharmacy once a replacement is obtained, this should not require someone who is self-isolating or shielding to leave their home.
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At the present time, patients and carers may be unable to visit a healthcare professional to receive training in use of the new device. They must take particular care therefore to ensure that they read the instructions on how to use the pen in the leaflet contained in the box. Patients and carers should also consult training information for their new pen on the manufacturer’s website This includes training videos. All the manufacturers also provide trainer pens on request (mock pens that do not contain a needle or adrenaline) for patients and carers to practise with. Patients are strongly urged to obtain these.
Patients and carers should be told of the important differences between brands of adrenaline pen in how they are used.
- Healthcare professionals – doctors, nurses and pharmacists – should, where possible, 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.
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 .
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:
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administer an adrenaline auto-injector device without delay, even if there is doubt whether it is anaphylaxis;
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call an ambulance (999) immediately after giving the injection and say this is an emergency case of anaphylaxis;
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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;
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use a second adrenaline auto-injector immediately if an Emerade pen fails to activate despite pressing firmly against the thigh, see .
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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 500 microgram auto-injectors should be provided with the supplementary letter and information
Contacts for further information
For stock enquiries please contact Bausch & Lomb Customer Services
Tel: 020 8781 2991
Email: Pharma_CS@bausch.com
For medical information enquiries please contact the Pharmacovigilance and Medical Information Officer, Tel: 0208 781 5523, Email: Pharmacovigilance.UK@bausch.com
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional Teams are asked to forward this alert to Community Pharmacy, Dental and Optometry contractors and to any GP Practices within their regions that are not yet registered with the Central Alerting System (CAS).
Download documents