GovWire

National Patient Safety Alert Reference Number

NatPSA/2023/004/MHRA

PL Number

PL 33616/0015

PL 33616/0014

MDR Number

MDR 020-05/23

Company Name

Pharmaswiss ?eska republika s.r.o. and distributor Bausch & Lomb UK Limited

Product description

Emerade 500 micrograms solution for injection in pre-filled syringe, PL 33616/0015

SNOMED Code 23420111000001107

Emerade 300 micrograms solution for injection in pre-filled syringe, PL 33616/0014

SNOMED Code 23415811000001102

Active Pharmaceutical Ingredients: adrenaline (as tartrate)

Explanation of identified safety issue

Pharmaswiss ?eska republika s.r.o. and distributor Bausch & Lomb UK Limited is recalling all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens) from patients. This is due to an issue identified during an ISO 11608 Design Assessment study where some auto-injectors failed to deliver the product or activated prematurely.

Specifically, the 1-metre free-fall (vertical orientation) pre-conditioning resulted in damage to internal components of the auto-injector, leading either to failure to deliver the product or premature activation. This damage was not visibly apparent following the pre-conditioning but was evident only on subsequent functional testing. It is unclear what impact this has on auto-injectors in clinical use, however as a precautionary measure and owing to the inability to identify this issue before the auto-injectors are used, the auto-injectors are being recalled.

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 at patient level. Pharmaswiss ?eska republika s.r.o. and distributor Bausch & Lomb UK Limited has confirmed that future production of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors is on hold. Therefore, no further supplies will be available, and patients will need to be switched to an appropriate alternative.

Healthcare professionals should inform patients, or carers of patients, who carry Emerade 300 or 500 microgram auto-injector pens to obtain a prescription for and be supplied with an alternative brand. They should then be informed to return their Emerade 300 or 500 microgram pens to their local pharmacy.

At the point of prescribing and dispensing, it is vital that patients and carers receive training to ensure they are completely familiar with how their new device works. This is because each brand of adrenaline auto-injector works differently. Patients should continue to carry two devices at all times in case they need to administer a second dose of adrenaline before the arrival of the emergency services (see links to training material below).

Alternative brands of adrenaline auto-injectors (EpiPen and Jext) are available in a maximum strength of 300 micrograms. There is evidence to suggest that a single EpiPen (300 micrograms) or Jext (300 micrograms) pen will be a suitable replacement for a single Emerade 500 micrograms pen. This is based on recently available results from two studies (including one by the manufacturer of Emerade) which compared blood levels of adrenaline following injection of Emerade 500 micrograms pens with those following EpiPen 300 micrograms or Jext 300 micrograms pens. Patients must continue to always carry two adrenaline pens at all times. Prescribers are to follow dosage guidance in individual Summary of Product Characteristics (SmPC).

Further information is available in the recent Public Assessment Report: Recommendations to support the effective and safe use of adrenaline auto-injectors. This report provides a combined summary of the conclusions and recommendations of the Commission on Human Medicines Adrenaline Auto-injector Expert Working Group to support the effective and safe use of Adrenaline Auto-injectors.

Actions required

Actions required to complete by 12 May 2023:

The action to recall should be coordinated by the Chief Pharmacist/Superintendent Pharmacist/Responsible Pharmacist, Dispensing GPs and GP practices in the first instance. The below actions should be initiated by General Practitioners (GPs) and Pharmacy Teams immediately.

1. Stop supplying the impacted products immediately. Quarantine all remaining stock and return it to your supplier/MAH using your suppliers approved process.
2. Identify patients who have been supplied with Emerade 500 micrograms and Emerade 300 micrograms auto-injectors and ensure that they are reviewed by their prescriber to determine whether their adrenaline auto-injector prescription is still appropriate and in line with existing guidance.
3. immediately inform patients and carers to request a new prescription to replace each Emerade 500 micrograms and Emerade 300 micrograms auto-injector with an adrenaline pen in an alternative brand. Epipen 300 or Jext 300 are appropriate alternatives to Emerade 500 micrograms. Dosing recommendations are available in the Summary of Product Characteristics (SmPC) and should be followed (see links below).
4. Inform patients to return Emerade 500 micrograms and Emerade 300 micrograms auto-injectors to any pharmacy after they have obtained a total of two equivalent strength adrenaline pens in an alternative brand.

General Practitioners (GPs) and Pharmacy Teams should send the linked letter Advice for patients who have been prescribed Emerade auto-injectors, to all patients and carers who have been prescribed Emerade auto-injectors. See reference information in the Download documents section.

Further advice for all healthcare professionals

Inform patients:

• that they should carry two in-date adrenaline 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 take immediately (see Management of Anaphylaxis in the alert for further advice)

Be aware that this recall also applies to Emerade 500 micrograms and Emerade 300 micrograms auto-injectors that are in emergency anaphylaxis kits held by healthcare professionals, such as dental surgery kits etc.

Stock adrenaline ampoules, as opposed to auto-injectors, when renewing the adrenaline in anaphylaxis kits (ensuring dosing charts, needles and syringes are included). See further information below

Be aware that this recall also applies to Emerade 500 micrograms and Emerade 300 micrograms auto-injectors that are currently held by schools. See further information below.

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 schools below
• patients rarely 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

Different brands of adrenaline pens work differently. Patients and carers should be told of these important differences.

Healthcare professionals doctors, nurses and pharmacists should, where possible, ensure that they provide training to patients and carers in the correct use of the new pen. Instructions for use can be found in the SmPC (prescribers 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 practice regularly with them so they are prepared for use in an emergency.

The following links provide training materials for the different devices:

EpiPen

• EpiPen devices
• EpiPen 0.15mg
• EpiPen 0.3mg

Jext

• Jext devices
• Jext 150 Training Vi
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