Summary
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.
Content
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:
- 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
- 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.
- 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 during COVID-19. 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 so that they know the signs of anaphylaxis and the actions they should immediately take and 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.
- 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)
- are aware that this recall also applies to Emerade 500 microgram auto-injectors that are currently held by schools.
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).
- 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 letter “Advice for patients who have been prescribed an Emerade 500 microgram auto-injector” on page 6 of the alert, to all patients and carers, as appropriate, who have been prescribed Emerade 500 micrograms auto-injectors.
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