This article has been brought to you by Slough Borough Council's Health and Safety Adviser, Vicki Swift, for the attention of all Headteachers and bursars.
As you may have seen in the news there is currently a shortage of certain types of epi pens. Official guidance has been released relating to action that should be taken by parents.
However, as schools staff may be required to dispense an Epi Pen or Epi Pen Junior it is important that they understand the temporary position when using the different types of Epi Pen.
The main focus of this alert relates to certain lots of 0.3mg EpiPens. For further information, please refer to webpage: http://www.epipen.co.uk/. Please ensure that this information is issued to all relevant staff.
Extended Use Beyond Labelled Expiry Date for Select Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors
To address supply constraints of EpiPen 0.3mg, Mylan UK have obtained acceptance from the MHRA to extend the use beyond labelled expiry date for specific lot (batch) numbers of EpiPen 0.3mg auto-injectors, beyond the labelled expiry date by four months. The affected lot numbers are listed in the table below. This announcement is based on a careful review of product stability data.
The affected lots, which have labelled expiry dates between July 2018 and November 2018 are listed in the table below.
|
Lot |
Labelled Expiry Date (end of the month) |
Extended Use by Date (end of the month) |
|
6FA794J |
07.2018 |
11.2018 |
|
6FA795Y |
07.2018 |
11.2018 |
|
7FA112F |
09.2018 |
01.2019 |
|
7FA106B |
09.2018 |
01.2019 |
|
7FA283B |
10.2018 |
02.2019 |
|
7FA251D |
10.2018 |
02.2019 |
|
7FA250B |
10.2018 |
02.2019 |
|
7FA265C |
11.2018 |
03.2019 |
|
7FA265B |
11.2018 |
03.2019 |
Important: the extended use only applies to the lots of EpiPen 0.3mg auto-injectors listed above.
The extension of use beyond the labelled expiry date does not apply to EpiPen 0.15mg auto-injectors or any lot numbers not specified. Patients must continue to adhere to the manufacturer’s expiry date labelled on any EpiPen not covered by the lot numbers above.
Further information
- To make sure patients can access their medicines during this shortage, the period that the nine specific lots of EpiPen 0.3mg (listed above) can be used has been extended by a further four months beyond the labelled expiry date on the pack.
- You can find the lot number on the end-flap of the box and on the EpiPen itself. If you’re unsure whether your EpiPen is affected, please talk to your pharmacist.
- This extension of use beyond the labelled expiry date is based on stability data showing these batches of EpiPen 0.3mg auto-injectors will work just as well for this period. This has been reviewed by the UK medicines regulator, MHRA. EpiPen auto-injectors should continue to be stored as labelled on the pack.
- At the end of the extended use beyond the labelled expiry date period (the end of the month listed in the right column above), you will still need to obtain a new auto-injector by the usual means.
EpiPen Jr 0.15mg Adrenaline Auto-Injector
EpiPen Jr 0.15mg Adrenaline Auto-Injectors continue to be temporarily unavailable. During this period of temporary unavailability, the manufacturers encourage patients to speak to their healthcare provider about alternate adrenaline auto-injectors.
EpiPen 0.3mg Adrenaline Auto-Injector
Pfizer recently made available to Mylan a limited volume of single and twin-pack EpiPen 0.3mg Auto-Injectors that will expire in February 2019.
Contact Information
If you require additional information or have any questions, please contact Mylan Customer Services: +44(0) 1707 853 100.