Patients in the UK have been experiencing difficulties acquiring EpiPens since April 2018, after manufacturing issues caused a series of supply problems. Nearly two years later some pharmacies are still experiencing difficulties getting hold of them, despite supposedly sufficient EpiPen supplies in the country.

In an October 2019 survey of 100 community pharmacies in England, carried out by Channel 5 News and reported in The Pharmaceutical Journal, 31 pharmacies reported that they were unable to order auto-adrenaline injectors (AAIs) because they were out of stock, and a further 22 were unsure if they could supply them.

EpiPen supply issues since April 2018

EpiPen manufacturer Mylan first acknowledged issues with its supply of 0.3mg EpiPens in May 2018, and in September that year confirmed that the supply chain issues were also impacting EpiPen Junior 0.15mg. Following this, pharmacies were allocated EpiPen products on a prescription-only basis, and could only order two pens per prescription.

By November 2018, NHS England announced that sufficient stock levels of adrenaline auto-injectors (AAIs) were available once more, but the prescription validation process has periodically remained in place ever since. Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer subsidiary that manufactures EpiPen, is still experiencing supply constraints.

Mylan says: “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. Additionally, timely supply updates can be found on our website.

“We continue to work closely with Meridian Medical Technologies to stay informed of anticipated shipments and future supply, with the aim to achieve a steady state of supply. We expedite shipments upon receipt, however at this time we cannot commit to a specific time when the supply constraint will be fully resolved.”

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Cautious optimism for UK patients

Ben Beckles, who carries an EpiPen, is now able to access the medication he needs. However, he spent a year of the shortage struggling to get hold of it. During this time he was instructed to carry his out-of-date EpiPens.

Beckles says: “It’s been a bit of a pain having to traipse from pharmacy to pharmacy in the hope one of these places might have one. However, my allergies have got better with age, I’m very sensible with what I can and can’t eat and I’ve been fortunate having only ever had to use my Epipen once when I was in infant school.

“For those without an Epipen and with more severe allergies the psychological impact must’ve been way worse.”

The ongoing validation process means that pharmacies cannot keep any EpiPen products in general stock, but must order them in for every individual prescription. An anonymised copy of the script must be sent to Alliance Pharmaceutical, EpiPen’s sole UK distributor, after which two pens per script can be sent to the ordering store.

This means patients often need to pay their pharmacy multiple visits to get hold of the life-saving medication they need. The inconvenience is understandably distressing for people with severe allergies who rely on the pens for their safety and wellbeing.

Ensuring equitable distribution

A Department of Health and Social Care spokesperson says the validation process remains in place to ensure equitable distribution of supplies to all patients in the UK who require an EpiPen. It prevents any pharmacies from ordering in more pens than they need, which could potentially leave other suppliers without.

Britain’s LloydsPharmacy chain said that it hadn’t experienced any issues since the introduction of the prescription validation process.

Leading British pharmacy Boots UK expressed similar sentiment, saying: “Although not all stock is freely available, patients with a script can access prescriptions from their pharmacy via the Script Validation service for many lines, with a 36-hour turnaround. Our supplier, AHDL, has confirmed that there’s currently no backlog on this service.”

However, the fact remains that just three months ago, 53 out of 100 pharmacies found themselves unable to order the devices or unsure if it would be possible to do so. Pharmacies appear to be on stronger footing than they were in late 2019, but for now it appears that issues with the nation’s supply of EpiPens will unfortunately persist.