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Hypersensitivity and allergy

All unexpired Emerade autoinjectors recalled after pens fail to activate

The Medicines and Healthcare products Regulatory Agency has advised prescribers to issue alternative brands of adrenaline pens until the Emerade autoinjectors have been fixed.

Emerade adrenaline autoinjector

Source: Bausch & Lomb

Due to shortages of alternative brands, the Medicines and Healthcare products Regulatory Agency has stated that patients should continue to use their Emerade autoinjectors until they expire

The manufacturer of Emerade Adrenaline Autoinjectors have recalled unexpired batches of all strengths of the injector, after reports that they were failing to activate.

Bausch & Lomb recalled all unexpired batches of 150, 300 and 500 microgram Emerade autoinjectors after finding an error in one component believed to cause some pens to fail to activate and deliver adrenaline.

In an alert published on 28 November 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) instructed prescribers to issue adrenaline pens of another brand until the error has been corrected, with all Emerade devices expected to be unavailable for the foreseeable future.

However, the MHRA added that due to the UK currently having “insufficient supplies of alternative brands to replace all of the Emerade pens held by patients”, patients should continue to use their Emerade pens until they expire, but be informed of the risk.

After expiry, patients should be prescribed a different brand — EpiPen or Jext — which would “avoid a serious shortage of adrenaline pens for the wider patient community” as the risk of not having a pen is “much higher than having a pen that may not activate,” the MHRA said.

In another alert issued on 29 November 2019, the MHRA gave an action plan for prescribers which said clinicians should also consider prescribing “a vial of adrenaline to be drawn up by the patient for self-administration” on rare occasions.

Concerns about the availability of adrenaline pens follows the EpiPen shortage in 2018, when manufacturing problems at Pfizer’s factories resulted in shortages of its autoinjectors, leading pharmacists to restrict sales to patients.

Despite the government announcing in November 2018 that the supply of adrenaline autoinjectors had returned to normal, EpiPen rationing was introduced again in June 2019.

A spokesperson for the charity Anaphylaxis Campaign said it recognised “this is a very difficult time for patients who carry Emerade devices”.

The charity reminded healthcare professionals to train individuals in how to use their adrenaline autoinjectors, to reinforce advice to patients to not expose adrenaline autoinjectors to temperatures above 25oC, and to remind patients to always carry two devices.

Commenting on the recall, a spokesperson for the Royal Pharmaceutical Society said: “Pharmacists work incredibly hard to ensure that patients get the medicines they need. If a particular medicine isn’t in stock, pharmacists will contact other pharmacies in the area to see if they have any stock or wholesalers to confirm when stock will be available.”

“If there isn’t a ready alternative, they may suggest that the patient go back to their GP, who could prescribe a similar device.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20207413

Readers' comments (1)

  • "...leading pharmacists to restrict sales to patients."

    I think that this statement needs restructuring. I believe community pharmacists tried to fulfil their obligations to dispensing product that was in short supply or discuss alternatives with prescribers.

    Unsuitable or offensive? Report this comment

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