Adrenaline auto-injectors – patient safety update

08 Aug 2019

Patient safety update for pharmacy teams facing availability issues on certain adrenaline auto-injectors devices

Following the recent Department of Health and Social Care (DHSC) Supply Disruption Alert for Emerade, the NPA Pharmacy Services Team has received a number of queries from NPA members regarding suitable alternatives and actions to take to support affected patients.

The supply disruption alert included a management plan to manage the shortages of the affected Emerade adrenaline auto injector (AAI) devices:

  • Emerade 300 micrograms Bausch & Lomb UK Ltd — limited supplies available with further supplies expected by the end of September 2019
  • Emerade 500 micrograms – Bausch & Lomb UK Ltd — out of stock with supplies expected on 28 August 2019

Alternative AAIs and stock availability as of 6/8/19:

  • Epipen® 0.3mg manufactured by Mylan
    Stock availability — In stock through a prescription validation service, as below

    • Send anonymized prescriptions to Alliance Healthcare, either by fax to 0330 332 8126 or email scriptvalidation@alliance-healthcare.co.uk
    • Include your Alliance Healthcare account number
    • A maximum of two devices per prescription can be ordered

 

  • Jext 300 micrograms manufactured by Alk Abello Ltd
    Stock availability — In stock with Alliance Healthcare, delivered weekly ony

Implications for patients

Neither of the alternatives, EpiPen or Jext, is available in a 500 microgram strength AAI. Therefore, according to the supply disruption alert: “The advice from national experts is, in the absence of Emerade 500 microgram, affected patients should be prescribed 300 microgram AAIs and advised to keep at least two pens with them at all times”.

Ref: https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102885

Patient counselling

The way each AAI is used is different and it is important for the prescribing medical professional to ensure that patients are trained on how to use their new device.

  • Further guidance for patients requesting general information on adrenaline and anaphylaxis can be found on the NHS conditions website

Legislation

Under Regulation 238 of The Human Medicines Regulations 2012, a person may parenterally administer a prescription only medicine specified in Schedule 19 where this is for the purpose of saving life in an emergency. Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis is listed under this Schedule.

Guidelines

The Resuscitation council (UK) FAQs on anaphylaxis treatment provides guidance regarding the type of adrenaline product to use to treat an anaphylactic reaction in a healthcare setting:

“Auto-injectors are primarily for self-use by patients who are at risk of an anaphylactic reaction. They should be prescribed on an individual basis by a specialist in allergy….”

“Ultimately it is a local decision whether a healthcare setting opts to use auto-injectors instead of adrenaline ampoules. If there is no other form of adrenaline available it would be appropriate for a healthcare professional to use an adrenaline auto-injector for the treatment of an anaphylactic reaction.”

Ref: https://www.resus.org.uk/faqs/faqs-anaphylaxis-treatment/

MHRA alert

A Class 4 CAS alert issued by the MHRA on 11 July 2019 identified a risk of certain units of Emerade pens in all strengths failing to deliver a dose of adrenaline from the syringe due to needle blockage.

Scotland

A Scottish drug alert has been issued on 01 August 2019 for the disruption of supply of Emerade 500mcg and 300mcg AAI.

NPA patient safety support

  • The NPA has published a Standard Operating Procedure (SOP) covering the administration of adrenaline from an ampoule, and an auto-injector device. This is intended to support pharmacy teams in administering adrenaline if required to do so, either as part of providing vaccination services, or to manage any other anaphylaxis situation.
  • The NPA patient safety section of our website contains a dedicated section on adrenaline which includes links to the various adrenaline alerts, the latest stock availability information for AAIs and the adrenaline SOP
  • The patient safety section of our website is freely accessible as part of the NPA’s Medication Safety Officer (MSO) role for independent pharmacies in England with fewer than 50 branches.

Contact us

For further advice and support from the Pharmacy Services team:

  • Call us on 01727 891800 between 9am and 6pm Monday – Friday, and 9am to 1pm on Saturdays
  • Email us anytime at pharmacyservices@npa.co.uk

Produced by the NPA Pharmacy Services team August 2019.