Adrenaline – urgent patient safety update and reminder on ordering process for EpiPen®, and stock availability

10 Oct 2019

Following the ongoing disruptions in production of Emerade, EpiPen® and Jext adrenaline auto-injectors (AAI), the NPA Pharmacy Services Team has continued to receive a number of queries regarding suitable alternatives and actions to take to support affected patients.

To support community pharmacies, we have created a dedicated ‘adrenaline stock availability table which is updated regularly to reflect the latest stock availability of AAIs and adrenaline solution for injection ampoules. This open-access resource can be accessed by all community pharmacies.

EpiPen®

The prescription validation process for EpiPen® 0.3mg remains in effect and has now been extended to include EpiPen® Jr 0.15mg. Pharmacies can supply patients with a maximum of two AAIs per prescription; this will continue until steady supply is re-established.

Prescription validation process

Community pharmacy teams are reminded to take the above timeframe into consideration when placing orders and advising patients ordering repeat prescriptions.

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that patients carry two adrenaline auto-injectors at all times.
  • Patients should also be reassured that there are other adrenaline auto-injectors available which are not subject to the prescription validation process, and with their agreement, pharmacists can speak with their GP and arrange for a new prescription for two devices of an alternative adrenaline auto-injector to be prescribed.

 Extended use beyond labelled expiry date

In order to ensure patients have access to their AAI during the ongoing supply shortage, the MHRA has permitted the use of specific lot numbers of EpiPen® auto-injector 0.3mg for four months beyond the labelled expiry date. The MHRA has reviewed the stability data for the selected lot numbers and agreed that extension of use beyond the expiry date will temporarily improve patient access to the use of EpiPen® auto injector 0.3mg. Additional guidance for pharmacy teams including information to support patients can be found on the NPA website.

Supply to schools

  • Send the valid written requisition to Alliance Healthcare using the contact details above
  • Supply is limited to a maximum of two EpiPen® 0.15mg and 0.3mg AAIs per prescription

 Supply for use in GP practice

  • GP practices can email a request for EpiPen® 0.15mg and 0.3mg AAI to the Mylan customer service team at services@mylan.co.uk; this will be forwarded on to the relevant department to be processed
    • Ideally requests should be limited to a quantity of two AAIs per order

NHS Flu vaccination advanced service 2019/20 (England only)
NHS England & Improvement (NHSE-I) encourages pharmacy contractors to consider using adrenaline solution for injection ampoules instead of AAIs. Pharmacists should be competent to draw up and administer adrenaline from ampoules with a normal syringe and needle. This will conserve supplies of AAIs for patients, carers, teachers, etc. who cannot be expected to inject adrenaline using this route of administration.

Administering SOP

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.

FAQ’s

 Can I use the adrenaline auto-injector to treat anaphylaxis under the England NHS Flu Vaccination Service?

Healthcare professionals, including pharmacists providing vaccination services, should not routinely be holding stock of AAIs to treat anaphylactic reactions instead of adrenaline ampoules as part of a proper anaphylaxis pack. An AAI is intended for self-administration and should only be used to treat an anaphylactic reaction when no other adrenaline preparation is available. Pharmacists providing the NHS Flu vaccination service (England) should have immediate access to adrenaline 1 in 1000 injection and access to a telephone.

 Where can I obtain the syringe and needles required for the anaphylaxis pack?

The Green Book states an anaphylaxis pack must always be available where vaccination services are being provided.  An anaphylaxis pack normally consists of two ampoules of adrenaline 1:1000, four 23G needles, four graduated 1ml syringes and Laerdal or equivalent masks suitable for children and adults. The following syringes and compatible needles are available to order from Medisave and Bunzl healthcare, if unobtainable from regular wholesalers

 

BD Luer-Lok 1ml syringe BD Microlance single use needles

o   size 23G, 25mm – blue

o   size 25G, 25mm – orange

Terumo 1ml syringe Terumo AGANI needle

o   size 23G, 1″ (25mm) – blue

o   size 25G, 1″ (25mm) – orange

 

 NPA patient safety support

 

For further information please contact the NPA Pharmacy Services team:

 

Produced by the NPA Pharmacy Services team, 10 October 2019.