Updates to Adrenaline Auto-Injectors

EpiPen trainer, Jext trainer, Emerade Trainer

Emerade – Bausch & Lomb

  • Ireland

The HPRA (Health Products Regulatory Authority) in Ireland announced that PharmaSwiss was recalling all lots (batches) of Emerade 150mcg pre-filled pens, Emerade 300mcg pre-filled pens and Emerade 500mcg pre-filled pens.

Anyone who possesses an Emerade pen for their own use or for someone in their care is urged to ensure that their pens are brought back to their pharmacy and immediately replaced with an alternative product. The HPRA states that no other brand of adrenaline pens is impacted by this recall.

See the full recall notice here: https://www.hpra.ie/homepage/medicines/news-events/item?t=/patient-level-recall-of-all-batches-of-emerade-adrenaline-auto-injector-pens&id=48720c26-9782-6eee-9b55-ff00008c97d0

  • United Kingdom

A fault which causes needle blockage in some Emerade pens was first detected in June 2018. At the time, the fault was thought to affect 1.5 in every 10,000 pens and was therefore considered a rare event. More recent information shows that the rate of needle blockage is higher than this. An alert was released in July of this year to show the fault may effect 2.3 in every 1,000 pens.

This notification of potential for needle blockage applies to Emerade devices of all strengths. It does not apply to the other marketed brands of adrenaline auto-injectors.

At this time, the MHRA is not recalling batches of Emerade. In the UK there are two alternative adrenaline auto-injector devices available. However, the different brands of adrenaline auto-injectors are not used in exactly the same way and therefore specific training and advice is required for each of the devices. Furthermore, there are insufficient supplies available of alternative brands to support the removal of one brand.

The manufacturer conducted extensive investigations and has implemented corrective actions. Emerade manufactured with all the corrective processes was expected to be introduced into the market from mid-July 2019.

See the full drug alert notice here: https://www.emerade-bausch.co.uk/Content/emerade-drug-alert.pdf

Supply Updates

Emerade 500mcg (Adrenaline Tartrate)

A limited supply of Emerade 500mcg (Adrenaline Tartrate) will be available in wholesalers from 23rd of September and we are working with our supply chain to ensure that this is optimized to be available to patients with a valid Emerade 500mcg prescription. The next shipment will be available in October.

Emerade 300mcg (Adrenaline Tartrate)

We are currently experiencing some delays in the next supply of Emerade 300mcg (Adrenaline tartrate) which will not be available until 11th of October in wholesalers.

Emerade 150mcg (Adrenaline Tartrate)

There is a limited supply of Emerade 150mcg (primarily a paediatric dose) which should be available in pharmacy and wholesalers and a further shipment due into the market to be available in wholesalers on 4th of October.

Source: https://www.anaphylaxis.org.uk/2019/09/24/latest-update-on-adrenaline-auto-injector-supply-in-the-uk-september-2019/

Jext – ALK

United Kingdom

Supply of Jext® (adrenaline as tartrate) 150 mcg and 300 mcg Adrenaline Auto-Injector

You may be aware of the recent supply issues affecting some brands of adrenaline auto-injectors, which have resulted in increased demands on alternative brands of auto-injectors including Jext.  The overall market supply of adrenaline auto-injectors is being monitored by the Department of Health and Social Care.

ALK is working hard to help address the situation and has significantly increased production of its Jext® 150 mcg and 300 mcg adrenaline auto-injectors at its European manufacturing facility. However, due to the time needed for manufacture and the magnitude of the current deficit, it is not possible for ALK to completely meet the shortfall in supply in the short term.

ALK is working closely with its UK distribution partner Alliance Healthcare to ensure equitable distribution of supplies but it is likely that Jext® 150 mcg and Jext® 300 mcg will not be available at all times.

 

Extended Use Beyond Labelled Expiry Date for Selected Lots of Jext® 150 mcg and 300 mcg Adrenaline Auto-Injectors

To support and maintain an overall adequate supply, ALK has obtained acceptance from the UK medicines regulator, MHRA, to extend the use of specific lot (batch) numbers of Jext® 150 mcg and Jext® 300 mcg auto-injectors, beyond the labelled expiry date by four months. The affected lot numbers are listed in the table below.

 

Read more here: https://www.allergylifestyle.com/wp-content/uploads/2019/10/Annex-7-Patient-Association-Website-Extended-Use-2019.pdf

EpiPen – Mylan

United Kingdom

Extended use for specific lot numbers of EpiPen® 0.3mg Adrenaline Auto‐injectors.

This letter is sent in agreement with the UK medicines regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), to inform you of the following:

Summary

Mylan UK have obtained acceptance from the MHRA to extend the use of specific lot numbers of EpiPen® 0.3mg auto‐injectors, by 4 months beyond the labelled expiry date.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Find more information here: https://www.bsaci.org/announcements/epipen-0-3mg-extended-use-beyond-labelled-expiry-date-for-specific-lots

 

Disclaimer: The information provided is for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis or treatment. Allergy Lifestyle Limited (t/a) Allergy Lifestyle) uses reasonable endeavours to check the accuracy of information provided however no warranty is given that they are error-free.

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