Adrenaline 150 microgram auto-injectors supply: Urgent actions required by pharmacy teams

Adrenaline 150 microgram auto-injectors supply: Urgent actions required by pharmacy teams

October 16, 2018

Please note there has been an update to the protocol which can be found here.

Further to previous announcements about the availability of EpiPen and EpiPen Junior, the Department of Health and Social Care (DHSC) and NHS England have asked all community pharmacies to implement additional validation processes from tomorrow (Wednesday 17th October).

Steps for pharmacies to take

1. Read the new protocol from DHSC, noting in particular:

  • The flow chart of questions to ask patients to ascertain those who are in most need of supply;
  • The extension to the usability of some batches of Jext 150 and 300, previously advised of 300 EpiPen expiry extension; and
  • The guidance that all expired pens with precipitate or discoloured should be discarded. This can be checked by viewing the contents of the glass cartridge.

2. Read the FAQs prepared by DHSC

3. Implement the protocol with immediate effect (i.e. from 17th October)

This has been put in place following critical supply issues to ensure that the limited stock of adrenaline 150 microgram auto-injectors that will become available this week reaches those most in need.

DHSC has stated: “We have now reached a critical supply issue and need to implement controls on the supply of 150 microgram adrenaline auto-injectors. Children weighing 25kg or less with the greatest short term need must have access to these first, ensuring that every patient has at least one in date 150 microgram adrenaline auto-injector. This can only be achieved by restricting issue of new devices until further notice.”

Pharmacy contractors and their teams are asked to read the below protocol and Q&As and to implement this new verification procedure with immediate effect on Wednesday 17th October.

Read the Epipen 150 microgram validation protocol

Read the Q&As for pharmacies and dispensing practices

As the documents set out, community pharmacies are being asked to play a role in prioritising the limited stock now available by asking all patients who present with prescriptions (both NHS and private) for  adrenaline 150 microgram auto-injectors some brief validation questions to check whether they are most in need of a supply. A flowchart outlining the questions to be asked is included in the Protocol.

The Dispenser Validation Protocol

DHSC is advising that all patients need to have access to a minimum of two adrenaline 150 microgram auto-injectors, but that it is sufficient if just one of these is in-date (in this context meaning at least one month left before expiry) provided the patient also carries an expired device as back-up which is not discoloured and contains no precipitate.

Note: DHSC is now advising that expired auto-injectors should not be used if they contain a precipitate or are discoloured. This can be checked by viewing the contents of the glass cartridge in the auto-injector through the viewing window.

The dispenser validation protocol should allow pharmacies to deduce whether a prescription should be fulfilled, partially fulfilled, or supply should be delayed. The process applies to EpiPen Junior 150 microgram, Jext 150 microgram and Emerade 150 microgram adrenaline auto-injectors. The dispenser validation process does not apply to 300 microgram or 500 microgram strengths of adrenaline auto-injectors.

Ordering and Dispensing Auto-Injectors

Where patients meet the criteria and are eligible to receive supplies, pharmacies will then need to order the product from wholesalers who will carry out an additional prescription validation step.

Wholesalers have been asked to put in place measures to control the distribution of the limited available stock and will ask pharmacies to verify their order requests, perhaps by faxing or sending an image of the prescription with all the patient details obscured or by providing a unique prescription identifier number.

Where pharmacies only partially fulfil a prescription, patients will need to be advised to return to their prescriber for another one when they no longer have two devices or supply issues ease; an ‘owing’ should not be issued for the remaining auto-injectors. The prescription should be endorsed with the quantity supplied and submitted as part of the end of month submission process. Pharmacies unable to obtain any stock of adrenaline auto-injectors due to restrictions arising from existing wholesaler distribution arrangements should signpost patients to another pharmacy.

Where a patient is prescribed a different brand to what they have previously received, pharmacies will need to ensure that patients, parents and carers know how to use the auto-injector being supplied.

Pharmacy teams can use the patient letter shared on October 15th to help explain the situation to patients.

Further Recommendations and Information

DHSC have said that it is only through strict adherence to the protocol questions and criteria that stock will be able to reach patients who have a priority need.

In addition to the validation processes, there have been some changes to the recommendations around use of the various auto-injectors in addition to the changes announced previously. Pharmacy teams should note:

  • During the period of reduced supply, the cut-off for switching from 150 microgram to 300 microgram dosage for all devices is now 25kg. This change will result in off-label use of Jext 150 microgram and Emerade 150 microgram;
  •  The extension to the usability of some lots of Jext 150 microgram and 300 microgram, and the previously advised Epipen 300 microgram expiry extension; and
  • The guidance that all expired auto-injectors with precipitate or discoloured should be discarded.

Pharmacies with existing wholesaler orders for adrenaline 150 micgrogram auto-injectors placed prior to Wednesday October 17th will need to complete the new validation processes to ensure stock is ordered for those patients most in need. We expect wholesalers to contact you regarding this, but you may wish to raise this with them directly also.

As a reminder of the current distribution arrangements:

Emerade is available via AAH and Phoenix

Epipen is available via Alliance Healthcare

Jext is available via Alliance Healthcare

 

For further information see our dedicated adrenaline resource page

 



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