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URGENT (England): adrenaline auto-injectors 150mcg protocol to be implemented from 17 October 2018

18 Oct 2018

Following the recent DHSC Supply Disruption Alert on Epipen® and EpiPen® Junior adrenaline AAIs, the DHSC and NHS England has now issued an interim protocol and FAQs for dispensing all brands of AAIs 150mcg.

Following the recent Department of Health and Social Care (DHSC) Supply Disruption Alert on Epipen® and EpiPen® Junior adrenaline auto-injectors (AAIs), the DHSC and NHS England has now issued an interim protocol, along with FAQs, for dispensing all brands of AAIs 150mcg:

 

From today – Wednesday 17 October 2018 – pharmacies/dispensing doctors receiving any prescription (NHS and private) for 150mcg AAIs (all brands) must follow a 2-step validation process until further notice. See the interim protocol and FAQs documents for full details.

For partially fulfilled prescriptions, pharmacy contractors are required to endorse clearly the quantity supplied and submit it to NHS Business Services Authority with the end of month bundle prescription.

 

Where supply for an NHS prescription is determined to be delayed as per the flowchart, DHSC has confirmed to the NPA Pharmacy team that this will be  a ‘technical breach’ of the NHS Terms of Service, such prescriptions are as  ‘delayed supply’ rather an a refusal to supply. NHS England has adopted this interim protocol due to the unusual circumstance with the current AAI shortage to ensure patient safety is not compromised. Therefore, if a pharmacy delays an NHS prescription within the validation protocol, they will not be penalised for breaching the NHS Terms of Service.

 

The Medicines & Healthcare products Regulatory Agency (MHRA) has approved specified lot number of EpiPen® 300mcg, and specified lot number of Jext 150mcg and 300mcg, to be used past their expiry date during this critical period of shortage.

 

Patients can sign up to the Expiry Alert Service for both EpiPen® and Jext – this is free to use. Patients/parents/carers should regularly check the viewing window of their adrenaline device to make sure the liquid inside is clear and colourless.

 

Key steps to take for pharmacists and pharmacy team:

  1. Ensure that the pharmacists and members of the dispensing team in particular read and understand the full contents of the DHSC Supply Disruption Alert, letters and protocol and familiarise themselves with it fully
  2. Print off the flowchart and ensure that it is readily available in the dispensary
  3. Ensure that the whole pharmacy team is aware of this matter and refer all patients/parents/carers with queries about adrenaline to the pharmacist
  4. If a supply of adrenaline is not made after following the protocol:
    • The pharmacist must explain to the patient/parent/carer that the prescription will be dispensed at a later date when a supply is available
    • A letter is available for pharmacist/dispensing doctor to supply to the patient/parent/carer within the aforementioned DHSC Supply Disruption Alert
    • Explain that if the situation changes and they use one of their devices, they must return to the pharmacy for supply
    • The pharmacists/dispensing doctor practice should speak to/contact the prescriber if there is any uncertainty about the best course of action for the patient, and to assess any risks to the patient
  5. For AAIs not under the DHSC validation protocol, the wholesaler may have their own process which pharmacies are required to follow – these should be checked and a note made and kept for reference
  6. If in doubt or to check anything, call the NPA Pharmacy team on 01727 891800 — we are available to advise and support you Monday-Friday 9am-6pm and Saturday 9am-1pm

 

The NPA has dedicated a webpage for all adrenaline-related news; this includes the latest adrenaline auto-injector stock update.

For further information please contact the NPA Pharmacy Services team on 01727 891800 or email at pharmacyservices@npa.co.uk.