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EpiPen Shortage

Mylan UK have obtained acceptance from the Medicines & Healthcare Products Regulatory Agency (MHRA) to extend the use of specific lot numbers of EpiPen® 0.3mg auto‐injectors, beyond the labelled expiry date by four months, for specific auto-injectors, which have labelled expiry dates between July 2018 and November 2018.

FAO: ALL RWSS H&S SLA SCHOOLS

 

Hi everyone

As many of you have already recognised and reported, there has been a significant interruption in the production of EpiPen® 0.3mg auto-injectors, consequently resulting in intermittent supply constraints in the UK and a resultant shortage for schools and parents wishing to obtain replacement EpiPens. 

Mylan UK have obtained acceptance from the Medicines & Healthcare Products Regulatory Agency (MHRA) to extend the use of specific lot numbers of EpiPen® 0.3mg autoinjectors, beyond the labelled expiry date by four months, for specific auto-injectors, which have labelled expiry dates between July 2018 and November 2018.

The manufacturer anticipates that supply of EpiPen 0.3mg will stabilise in the fourth quarter (October to December) of 2018.  The supply status will be continuously reviewed by the manufacturer and the Department of Health & Social Care. 

To ensure patients can access their medicines during this shortage, the period that nine specific lots of EpiPen 0.3mg (listed below) can be used, has been extended by 4 months beyond the labelled expiry date on the pack. 

 

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:

1.    The extended use only applies to the lots of EpiPen® 0.3mg auto-injectors listed above.  Patients can continue to use the EpiPen® 0.3mg auto-injectors of these specified lots safely until the extended use by date as stated above. 

2.    This extended use does not apply to EpiPen 0.15mg auto‐injectors or any lot number of EpiPen® 0.3mg auto-injectors not specified in the list above. Patients must continue to adhere to the labelled expiry date on any EpiPen not covered by the lot numbers above. 

This extended use of 4 months beyond the labelled expiry date for the specific lots is based on supportive stability data for EpiPen® 0.3mg auto-injectors and has been reviewed by the MHRA.  The EpiPen® 0.3mg auto-injectors of these specific lots will continue to work safely and as intended within the allowed extended use by date.  The EpiPen® auto-injectors should continue to be stored as labelled on the pack. 

At the end of the extended use period (the end of the month listed in the right column in the list above), a new auto-injector will still need to be obtained. 

The information provided in this statement on the specific lot numbers listed above supersedes any other communication that patients may receive from the EpiPen® expiry alert service. This information has been issued by Allergy UK and can be read, in full, at the following link:

https://www.allergyuk.org/about/latest-news/762-extended-use-of-epipen-03mg-adrenaline-autoinjector

Please ensure that this important information is shared, at the earliest opportunity, with affected parents, colleagues and other schools. 

Please feel free to forward this email directly to all affected parents and other schools as you wish.

I hope this is helpful.

Kind regards

Ray

 

Ray West CMIOSH FIIRSM RSP MIIAI DipAI MIFPO CertEd QTLS OSHCR

Chartered Health & Safety Consultant/Trainer

RW Safety Solutions

PO Box 937, Portsmouth, Hampshire, PO1 9LP

07843 262855