AAI update from the Medicine Supply Team at the DHSC

20-Nov-2019

Update released 19th November 2019



Adrenaline Auto-Injectors (AAIs) 

  •          Recent supply issues affecting some brands of AAIs has impacted on all manufacturers, however, there are currently sufficient supplies overall to meet normal patient demand.  

Emerade (Bausch & Lomb UK Ltd) 

  •          Emerade 150 microgram and 500 microgram devices are currently available. 
  •          Emerade 300 microgram devices are expected to be available late November 2019.  
  •          On 3 October 2019, the MHRA issued a drug alert for all strengths of Emerade devices following reports from the manufacturer, Bausch & Lomb UK Limited, of Emerade devices that have failed  to activate. In this situation, the needle of the pen is not released from the autoinjector when used, and a dose of adrenaline cannot be delivered.  
  •          This issue makes it particularly important that users carry two pens at all times. Please see the link below for further information: 

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-emerade-150-300-and-500-microgram-solution-for-injection-in-pre-filled-syringe-mdr-57-08-19  

Jext (ALK-Abello Ltd) 

  •          Jext 150 microgram devices are currently available.  
  •          UK licensed Jext 300 microgram is currently unavailable; supplies of an unlicensed Jext 300 microgram device are being supplied through Alliance Healthcare via the PIP code: 801-   6941 (see company letter attached). 
  •          A medicine supply notification has been shared with the NHS (attached) which provides further information. 
  •          Specific batches of UK licensed Jext 150 micrograms and 300 micrograms have received MHRA approval for extended use by four months beyond the labelled expiry date. 
  •          Clinicians should check with patients requesting new Jext 150 micrograms and 300 micrograms to establish if they currently hold one of the batches that can be used beyond the listed expiry. If one of the listed batches is held, further supplies should be delayed until the extended expiry date, counselling the patient on the extended expiry. 
  •          Please see the link for further information: https://jext.co.uk/ 

 

EpiPen/EpiPen Junior (Mylan) 

  •          Supplies of both EpiPen and EpiPen Junior are currently available via a prescription validation process. 
  •          Community Pharmacies can place orders for up to a maximum of two EpiPen's per prescription. Trusts place orders via Mylan’s customer service team. 
  •          Specific batches of EpiPen 300 micrograms have received MHRA approval for extended use by four months beyond the labelled expiry date. 
  •          Clinicians should check with patients requesting new EpiPen 300 micrograms to establish if they currently hold one of the batches that can be used beyond the listed expiry. If one of the listed batches is held, further supplies should be delayed until the extended expiry date, counselling the patient on the extended expiry. 
  •          Please see the link for further information: http://www.epipen.co.uk/ 

 

Adrenaline 1:1000 ampoules for anaphylaxis kits  

  •          Adrenaline 1:1000 ampoules are currently available in sufficient quantities to meet normal demand.  
  •          Some healthcare professionals may be holding an AAI in preference to adrenaline ampoules, to treat anaphylactic reactions; this should not be necessary.  
  •          All healthcare professionals providing services where anaphylaxis treatment may be required, including but not exclusive to flu vaccination services, should have the competency to draw up and administer intramuscular adrenaline from ampoules with a normal syringe and needle.  
  •          During the current shortage, please use ampoules and not auto-injectors to replenish anaphylaxis kits. Remember to include the relevant dosing charts, syringes and needles. 
  •          The Green Book and Resuscitation Council guidance provides additional advice to healthcare professionals on the use of adrenaline in response to anaphylaxis. Pharmacists providing vaccination services may also wish to refer to PSNC FAQs. There is an expectation that healthcare professionals should use adrenaline ampoules in preference to Emerade or other AAIs. 

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