Coroner: Medicines regulator must ‘take action’ after anti-nausea P-med death

A coroner has written to the medicines regulator and NHS England (NHSE) following the death of a 35-year-old woman after taking the anti-nausea drug cyclizine, which she had purchased from a community pharmacy.

Legal case in court
Ms Roberts' family said that they “had been able to obtain cyclizine in a pharmacy” without being questioned

Earlier this month, (December 8) coroner Joanne Kearsley found that 35-year-old Charlene Roberts died from cyclizine toxicity, anorexia, aspiration pneumonia and factitious disorder at Fairfield General Hospital on January 12, 2023.

The senior coroner for the coroner area of Manchester North wrote to the Medicines and Healthcare Products Regulatory Agency (MHRA) and NHSE to warn them about “cyclizine abuse”, urging them to “take action” on the issue.

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In a prevention of future deaths report, she noted the anti-sickness medication as a “matter of concern”, highlighting that it is “not a controlled drug”.

Before her death, Ms Roberts had managed to purchase a pharmacy-only (P) form of cyclizine from a local pharmacy, Ms Kearsley added.

The coroner said that there was a “lack of understanding” about preventing patients from abusing the drug and advised that pharmacists should always question patients on why oral cyclizine is required when it is requested.

Purchased medicine from local pharmacy

In her report, Ms Kearsley described Ms Roberts as “an extremely complex patient who could be difficult to engage”.

She said that Ms Roberts has been prescribed cyclizine “around 2014”. Ms Roberts’ prescription went “unquestioned for over five years” until she was diagnosed with “cyclizine abuse…linked to past trauma” in 2019, Ms Kearsley’s report said.

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She said that in 2022 medical staff thought Ms Roberts “was at a significant risk of death due to her eating disorder and her cyclizine abuse”. 

However, she was rejected from “nearly 20” inpatient eating disorder services, “predominantly” due to her dual diagnosis of substance abuse and an eating disorder, the report noted.

The report said that on January 10, 2023 Ms Roberts was admitted as an inpatient at Fairfield General hospital “with a suspected infection”. Two days later, her “condition deteriorated and she went into cardiac arrest”, it said.

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The report described staff discovering after Ms Roberts’ death that she had left the ward the day before and “taken an Uber taxi to a local pharmacist where she had purchased cyclizine”.

“Her cause of death following examination was found to be due to cyclizine toxicity,” the report concluded.

Patients should be questioned before obtaining drug

Ms Kearsley said that the court “heard evidence that intravenous cyclizine is available by prescription only but oral cyclizine can be purchased over the counter at a pharmacy”.

Addressing the MHRA in her report, she stressed that “a pharmacist should seek information as to why it is required and should be present” before selling the drug. 

She said that Ms Robert’s family told the court that after her death that “they had been able to obtain cyclizine in a pharmacy directly from a pharmacy assistant” without being questioned.

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Addressing NHSE, Ms Kearsley wrote that there was a “lack of clarity and understanding and professionals” over whether the controlled drugs local intelligence network could be used for medicines – such as over-the-counter cyclizine – that are not controlled drugs.

Ms Kearsley told the MHRA and NHSE that “action should be taken to prevent future death”.

She said that the bodies were “under a duty to respond to” the report by February 2 2024. 

The response “must contain details of action taken or proposed to be taken” or “explain why no action is proposed”, she added. 

The MHRA and NHSE declined to comment.

Responding to the report, Royal Pharmaceutical Society (RPS) president Claire Anderson told C+D that the membership organisation was “saddened to hear” of Ms Roberts’ death.

“While the coroner’s report was not addressed to the RPS, we are now considering a response alongside the other recipients,” she added.

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Kate Bowie

Read more by Kate Bowie

Kate Bowie joined C+D as a digital reporter in August 2023 after graduating from a master’s in journalism at City, University of London. She began covering the primary care beat at the end of 2022, when she carried out several health investigations focused on staffing issues, NHS funding and health inequalities.

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