Adrenaline auto-injectors: reminder for prescribers to support safe and effective use
Emerade 300 and 500 microgram adrenaline auto-injectors have been re-supplied to the market following the implementation of corrective actions – patients and their caregivers should be provided with training and advice specific to their prescribed adrenaline auto-injector. Follow the advice in the Summary of Product Characteristics for dosing considerations and continue to reiterate to patients the importance of carrying 2 in-date adrenaline auto-injectors with them at all times.
Post-publication note - July 2023
The information in this article has been superseded by the June 2023 Drug Safety Update. MHRA guidance and Summary of Product Characteristics and Patient Information Leaflets should be used for the most up to date advice. In June 2023, we launched a new toolkit of resources health and social care professionals to support the safe and effective use of adrenaline auto-injectors. The resources are freely available for download from the MHRA’s guidance page on adrenaline auto-injectors (AAIs).
Advice for healthcare professionals:
- Emerade 300 microgram and 500 microgram adrenaline auto-injectors have been re-supplied to the market following the implementation of corrective actions to resolve the issue that caused some devices to fail to activate and deliver adrenaline
- for each adrenaline auto-injector, follow advice in the Summary of Product Characteristics to prescribe appropriate doses for individual patients (see section on dosing considerations)
- remind patients to follow existing advice to carry 2 in-date adrenaline auto-injectors with them at all times and to replace them before they expire
- provide patients and their caregivers with training and advice specific to their prescribed adrenaline auto-injector; encourage them to order a trainer device from the manufacturer to ensure they are familiar with using their auto-injector
- suspected adverse drug reactions or defective medicines should be reported to the Yellow Card scheme
Advice for healthcare professionals to provide to patients:
- the 300 and 500 microgram strengths of Emerade are being made available again, following corrections made to the auto-injector device
- the Epipen and Jext brands of adrenaline auto-injector in a strength of 300 microgram continue to be suitable alternatives to the Emerade 500 microgram adrenaline auto-injector; this has been confirmed by measurement of adrenaline blood levels following administration
- it is vital to carry 2 in-date adrenaline auto-injectors with you at all times and replace them before they expire
- make sure you and your caregivers know when and how to use your adrenaline auto-injector before you need to use it in an emergency; practice with a training device so you are familiar with how your particular auto-injector works
- always read the Patient Information Leaflet that accompanies your medicines and ask your doctor, nurse, or pharmacist if you have any questions
- you should use your adrenaline auto-injector as soon as you suspect a severe allergic reaction (anaphylaxis), especially any signs affecting your airway (swelling of your tongue or a feeling of constriction in your throat), breathing (wheezing, difficulty in breathing), or your circulation (feeling faint, dizzy, cold clammy skin)
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At first signs of anaphylaxis:
- Use an adrenaline auto-injector immediately; do not delay
- Call 999, ask for an ambulance, and say ana-phyl-ax-is (even if symptoms appear to be improving after using an auto-injector)
- Lie down and raise your legs
- Use a second auto-injector if your symptoms haven’t improved after 5 minutes
- Lying down is important to keep blood flowing to your organs; you can sit up if you are struggling to breathe, but keep your legs elevated as far as possible and lie back down again as soon as you can
Adrenaline auto-injectors in the UK
Adrenaline auto-injectors are authorised for the emergency treatment of severe acute allergic reactions (anaphylaxis) triggered by allergens in foods, medicines, insect stings or bites, and other allergens, as well as for exercise-induced or idiopathic anaphylaxis. Adrenaline auto-injectors available in the UK are:
In addition to advice in the Summary of Product Characteristics and Patient Information Leaflet, each brand of adrenaline auto-injector has educational materials available for healthcare professionals and patients. People with allergies and their carers can also use manufacturers’ websites to order trainer devices and to sign up for expiry alert services.
Emerade activation issue
In 2020, Emerade adrenaline auto-injectors were recalled from patients and pharmacies due to an error in one component that caused some auto-injectors to fail to activate and deliver adrenaline.
The MHRA has reviewed the Marketing Authorisation Holder‘s results from its investigation into activation failures and the subsequent implementation of corrective actions. The MHRA has confirmed that 300 microgram and 500 microgram strengths of the Emerade auto-injectors can be re-introduced in the UK. In October 2021, a letter was sent to healthcare professionals to inform them of the reintroduction. The Emerade 150 microgram auto-injector will not be returning to market at this time, further details will be provided at a later date.
Report of Adrenaline Auto-injector Expert Working Group
In October 2019, the Commission on Human Medicines (CHM) endorsed the formation of an Adrenaline Auto-injector Expert Working Group (EWG) to examine a range of cross-cutting areas to support the effective and safe use of adrenaline auto-injectors for the emergency treatment of anaphylaxis. Members of the EWG included representatives from patient groups, allergy charities, the NHS, as well as allergy and immunology medical specialists.
On 11 November 2021, the Group’s conclusions and recommendations were made available in a Public Assessment Report: Recommendations to support the effective and safe use of adrenaline auto-injectors. A letter has also been sent to stakeholder organisations so that these recommendations can be implemented.
Dosing considerations for adrenaline auto-injectors
Each brand of adrenaline auto-injector is available in more than one strength (corresponding to the dose delivered by the device). Broadly, the lower strength is suitable for younger children and the higher strengths suitable for older children and adults. Advice in Section 4.2 of the Summary of Product Characteristics should be followed for recommendations on dose, which are guided principally on age of the patient and their bodyweight.
Only one brand of adrenaline auto-injector (Emerade) is available in a 500 microgram strength, with the other 2 brands being available in a maximum strength of 300 microgram. The labelled strength of adrenaline auto-injectors reflects the dose of adrenaline dispensed by the device in a single injection. However, the amount of adrenaline reaching the bloodstream in a particular time window can differ according to patient-specific and device-specific factors.
In 2015, a safety review mandated that manufacturers carry out pharmacokinetic/pharmacodynamic studies for adrenaline auto-injectors. Findings from these studies were added to section 5.2 of the Summary of Product Characteristics. These studies found that in healthy people, adrenaline auto-injectors of the same strength but with shorter needles and potentially higher propulsive force (EpiPen and Jext 300 micrograms) delivered more of the adrenaline dose to the bloodstream in the first 30 minutes than did the Emerade 300 microgram auto-injector. As such, the Epipen or Jext brands of 300 microgram adrenaline auto-injector are both suitable alternatives to the Emerade 500 microgram adrenaline auto-injector.
Further information for prescribers and patients on adrenaline blood level data is included in the report linked above and in the Summary of Product Characteristics for each medicine.
Report suspected adverse drug reactions
Please report suspected adverse drug reactions (ADRs) or suspected defective medicines to the MHRA through the Yellow Card scheme. For adrenaline auto-injectors details of the strength and batch number should also be included to assist monitoring.
Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:
- the Yellow Card website
- the Yellow Card app; download from the Apple App Store or Google Play Store
- some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)
When reporting please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates, and product brand name. Any suspected non-activated or otherwise defective pens should be retained for investigation and the Marketing Authorisation Holder contacted for advice.
Report suspected side effects to medicines, vaccines, medical device and test kit incidents used in coronavirus (COVID-19) testing and treatment using the dedicated Coronavirus Yellow Card reporting site or the Yellow Card app. See the MHRA website for the latest information on medicines and vaccines for COVID-19.
Article citation: Drug Safety Update volume 15, issue 4: November 2021: 2.