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13 JUNE 2018 UPDATE:

NOTE: Statement updated to include additional ordering instructions for pharmacists

Availability of EpiPen® 0.3mg Adrenaline Auto-Injector

Overview

Due to manufacturing delays from our contract manufacturer, Meridian Medical Technologies, a Pfizer company, there are intermittent supply constraints on EpiPen® 0.3mg Adrenaline Auto-Injector in the UK.

Latest Supply Status

Distribution of EpiPen® 0.3mg Adrenaline Auto-Injector is being carefully monitored, in coordination with our UK distribution partner, Alliance Healthcare, to help manage product availability on an ongoing basis until a steady supply resumes. In late April, we initiated a stock management process for EpiPen® 0.3mg Adrenaline Auto-Injector in which pharmacies are allocated product on a prescription-only basis and can place orders for up to a maximum of two EpiPen® 0.3mg Auto-Injectors per prescription. This process is still in place.

To further support the continuity of supply and immediate market demand, we have secured a limited volume of EpiPen® 0.3mg Adrenaline Auto-Injectors with an expiry date of October 2018. This supply is not subject to the current prescription validation process, as outlined above, and will be offered to pharmacists to order and have in stock. The product meets all required quality standards.

With patient access as our priority, we will continue to proactively and diligently update pharmacies, healthcare professionals and patient advocacy groups across the country regarding any changes in stock availability. 

There are currently sufficient supplies of EpiPen Jr® 0.15mg Adrenaline Auto-Injectors in the UK.

Ongoing Supply Management

Mylan is working closely with Pfizer to manage supply carefully to avoid long-term supply shortages. Pfizer anticipates that production rates will increase over the coming months; however, at this time, cannot commit to a specific time for when the supply constraint will be fully resolved. We are confident in the safety and efficacy of the EpiPen® products being produced at Pfizer’s site and are working closely with them to alleviate the situation and achieve a steady state of supply as expeditiously as possible.

Information for Patients

Mylan is unable to make any specific treatment recommendation to individual patients. Patients should speak to their healthcare provider for appropriate actions to be taken.

Information for Prescribers

Please note, when validating the expiry date of an adrenaline auto-injector, the product expires on the last day of the month indicated. For example, if it expires in October, it remains valid (not expired) until Oct 31.

Instructions for Pharmacists

Pharmacies that are presented with a prescription for EpiPen® 0.3mg Adrenaline Auto-Injectors are able to place an order for up to a maximum of two EpiPen® 0.3mg Adrenaline Auto-Injectors per prescription.

Please send anonymized prescriptions for EpiPen® 0.3mg Adrenaline Auto-Injectors to Alliance Healthcare’s prescription validation service, either by Fax (0203 044 8996) or email (EOHotline@remove-this.alliance-healthcare.co.uk). Please include your Alliance Healthcare account number when placing your order.

The prescription validation service is not required for orders of EpiPen® 0.3mg Adrenaline Auto-Injectors with an expiry date of October 2018 and orders can be placed through your usual channels. Stock can be ordered via the usual ordering methods but please make sure you specifically reference the pip code: pip 8133308 EPIPEN 300MCG (EXP 10/2018).

Contact Information

If you require additional information or have any questions, please contact +44(0) 1707 853 100.

 

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EPI-2018-0165 Date of preparation: May 2018