NHS England has developed a validation protocol to maintain supplies of EpiPen adrenaline auto injectors (AAI) during the current shortage.
Due to supply levels reaching critical levels, there is a need to implement controls on the supply of 150microgram AAI.
Children weighing 25kg or less with the greatest short term need are to be considered the priority, and should have at least one in-date 150microgram AAI. This can only be achieved by restricting issue of new devices until further notice.
All prescriptions (private and NHS) must be validated with the wholesaler prior to supply to a named patient using the validation protocol
Patients must be informed and made aware of the patient letter issued previously. It should be explained that in this critical shortage period it is sufficient that patients with multiple AAIs can hold just one in-date (at least one month left before expiry) AAI provided the expired device (considered a back-up) is not discoloured and contains no precipitate. If only one device is supplied against a prescription for two devices then the patient should be advised to obtain a new prescription for the second device when supply eases or they use a device.
It is important to note that when validating the expiry date of 150microgram AAI, the product expires on the last day of the month indicated eg, a device with an expiry date of ’October 2018 does not expire until the END of October 2018.
Practices can also advise patients that Mylan UK have received authorisation to extend the use of specific batch numbers of EpiPen 300mcg auto‐injectors, beyond the labelled expiry date by four months.
Specific batches of Jext 150/300mcg AAIs also now have a four month post-expiry authorisation.
The extended use only applies to the lots listed above. Patients must continue to adhere to the labelled expiry date on any device not listed above.
If a supply is made check if the patient/ carer/ parent has used the issued brand of AAI before. If not, see links below for training information:
To view the latest updates and clinical guidance, please visit Specialist Pharmacy Services website.
As of October 19, 2018:
- EpiPen Junior 150mcg is out of stock with no further supplies expected until the end of October
- Jext 150mcg and Emerade 150mcg are expected to be in stock w/c 15 October; patients with already expired devices are the priority. Further deliveries all of three auto-injectors are expected during November, but there may be ongoing constraints until the end of this year.
- EpiPen 300mcg are currently available, but constraints are anticipated to continue for the coming month.
- Supplies of Jext 300mcg, Emerade 300mcg and 500mcg are currently available.