71 women in Jersey have been prescribed an epilepsy medication that has been linked to birth defects and development issues in newborns when taken during pregnancy, it has emerged – though no harm associated with the drug has been formally recorded in Jersey within the last five years.
Sodium valproate is a drug used to treat epilepsy and bipolar disorder, but it has also been linked to miscarriages and birth defects.
In 2016, the UK’s Medicines and Healthcare Products Regulatory Agency said babies exposed to sodium valproate in the womb had a high risk of serious developmental disorders.
About 20,000 children in the UK are estimated to have life-changing injuries caused by the drug.
The Hughes report, published on 7 February 2024, called on the UK government to set up a redress scheme to award £100,000 to people harmed by valproate.
In Jersey, an audit last year identified 263 patients across paediatric, adult and child metal health, neurology, learning disability, and primary care departments who had been prescribed the drug.
Of these patients, 71 (27%) are female.
The figures were this week revealed by the Health Minister in response to a written question from Deputy Hilary Jeune.
Deputy Tom Binet confirmed that no reports have been submitted to the Health Department’s harm reporting system for sodium valproate in the past five years.
The Minister explained that, following a national patient safety alert regarding sodium valproate on 28 November 2023, Medical Director Simon West was “promptly designated” to lead the response in Jersey.
The safety alert asked healthcare organisations across the UK to prepare for new regulatory measures for prescribing valproate to new patients and existing female patients.
The target date for developing an “action and improvement plan” set for 31 January 2024 was “successfully met” in Jersey, the Health Minister said.
Deputy Binet explained that a clinical working group was established to develop a new valproate policy, and create a flow chart to simplify decision-making for clinicians.
The flow chart was updated following further advice issued in February this year, which amended the valproate advice for older males due to a perceived lower risk.
“All primary care pharmacies, GPs, hospital doctors, and the hospital pharmacy were informed of the requirement to have an annual risk assessment form signed for females of reproductive potential and for males at initiation,” said Deputy Binet.
The Health Minister also confirmed that “most” hospital electronic prescribing systems have been updated to remind clinicians of the risks associated with sodium valproate, and the necessity of annual reviews.
He added: “Over the past five years, no prescribing errors regarding sodium valproate have been reported in the Hospital.”
Deputy Binet explained that sodium valproate packaging has included warning labels regarding pregnancy for over a decade, and confirmed that the Hospital dispensary will only supply drugs in their original packs to ensure all relevant safety information is shared with patients.
Under Health Department policy, two specialists must independently agree that sodium valproate is the best option for a patient before initiating treatment in Jersey.
“The patient must be provided with information regarding the risks and sign a consent form acknowledging these risks,” explained Deputy Binet.
He added that patients prescribed valproate medicines are monitored via blood tests, and have the opportunity to discuss side effects at specialist appointments.
“Patients are counselled at initiation regarding side effects, and they will be receiving patient information leaflets at every dispensing,” the Minister said.
Every six months, the electronic prescribing system prompts doctors to check a patient’s bloods and weight, and to remind them about the importance of using “highly effective contraception” whilst taking valproate.