UK Shortage of EpiPens Continues, with EpiPen Jr Unavailable

Theresa Bebbington

September 25, 2018

Editor's Note: 30th September 2018 - Allergy UK and the MHRA issued a statement saying specified EpiPens could be used up to 4 months beyond their expiry date while supply problems persist.

An on-going supply shortage of EpiPens has put a strain on all three brands of adrenaline auto-injectors (AAIs) available in the UK – and now EpiPen Jr 0.15 mg is temporarily unavailable.

One brand is the EpiPen, which comes in two versions: 0.3 mg is suitable for children and adults weighing more than 25 kg, and EpiPen Jr 0.15 mg is for children weighing between 7.5 kg and 25 kg. 

Mylan Pharmaceutical Company, which owns the rights to the EpiPen but subcontracts the manufacturing to the US-based Meridian Medical Technologies, a subsidiary of Pfizer, released a statement in 2017 to warn about "the limited availability" of the EpiPen 0.3mg stock "in coming weeks". 

By 9th May 2018, both the EpiPen 0.3 mg and EpiPen Jr 01.5 mg were in short supply in the UK, and it was added to the drug shortages list in the US. A Pfizer representative reported that supply problems of certain third-party components, along with process changes and inspections, have limited the company’s ability to manufacture enough AAIs to meet demand.
 

Latest Update on EpiPens

In an update released by Mylan on 18th September 2018, the company stated that Meridian Medical Technologies "continues to experience interruptions" in the production of the two EpiPens and continues to "maintain a stock management process for the[ir] distribution". They are only available by prescription and limited to a maximum of two AAIs per prescription. 

New in this update, Mylan has also reported that "there is currently temporary unavailability" of the EpiPen Jr 01.5 mg and say it "is likely to be in place for the coming few weeks until the next shipment arrives". In addition, a limited volume of EpiPen 0.3 mg is now available, but it will expire in February 2019 – normally, EpiPens have a 20-month period from the date of manufacturer to its expiry date. Mylan reports that this particular supply will not be subject to their current prescription validation process. The update also says:

"Pfizer is working hard to increase production and anticipates supply will stabilise in the fourth quarter of 2018; however, it is important to note that currently supply from Pfizer continues to vary and, as such, may not always be available for pharmacies to order."

A spokesperson for the Department of Health and Social Care said: "We are working with the manufacturers of EpiPen to resolve the supply situation as quickly as possible. Limited supplies are available and are being closely managed to ensure that patients can continue to access supplies.

"We have been in regular contact with suppliers of alternative adrenaline auto injector devices to ask them to speed up future deliveries and bring additional stocks to the UK where possible."
 

Alternative AAIs

Two other manufacturers supply AAIs and, with the shortage of EpiPens, demand for their products have increased. Emerade, distributed by Bausch + Lomb, is available in three doses – 150, 300 and 500 mcg. Bausch + Lomb have had an increased demand for their 150 mcg AAI in particular and stated on 14 September 2018 that their next supply will be available to pharmacies on 1 October 2018. They are working with their manufacturer to increase production but say they "will not be able to supply the total demand that is normally delivered by other companies".

ALK manufactures Jext, which is prescribed in two doses: 300 mcg for children and adults weighing more than 30 kg and 150 mcg for children weighing between 15 and 30 kg. They stated on 17 September 2018 that their supplies have been under increasing demands over the last few months "due to the inability of our competitor to secure consistent supply of product across the whole of the EU. As a result we have increased production at our European manufacturing site to try and reduce the risk to patient safety." Although both their 150 mcg and 300 mcg pens are currently in stock in the UK, they say "this situation remains fluid and is affected significantly by availability of other devices". They anticipate that there may be times when Jext will be out of stock. ALK have a delivery scheduled for the week of 24 September and plan to have an increased level of stock available for the remainder of the year.

In the latest statement released on 14th September 2108 by the charity AllergyUK, the organisation says they are working with the Department of Health and suppliers to bring regular updates. They're advising patients who carry AAIs to ensure they allow plenty of time to replace devices before they reach their expiry dates. Assistance may be needed with instructions for use of alternative devices if these are offered.

The Medicines & Healthcare products Regulatory Agency (MHRA) updated its advice on AAIs in August 2018, recommending that patients check the expiry date on AAIs and asking for a new prescription before the old ones expire, saying out-of-date injectors may not work.

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