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Health leaders still letting down valproate patients, warns safety commissioner

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Health leaders still letting down valproate patients, warns safety commissioner

Patients are still having to “pick up the pieces” due to inappropriate sodium valproate dispensing, England’s first Government-appointed patient safety commissioner (PSC) has said.

In her PSC report for 2022-23, Dr Henrietta Hughes said that despite much progress in tackling patient safety incidents, the concerns raised by patients and their families in the 2020 Independent Medicines and Medical Devices Safety review (IMMDS) are ongoing.

She wrote: “There are still, on average, three babies a month born after exposure to sodium valproate.

“This is a scandal bigger than thalidomide, with an estimated 20,000 children exposed to the drug with physical deformities and learning disabilities whose needs are not being met.”

Dr Hughes described how, on her second day in post, a patient sent her “a photo of sodium valproate dispensed in a plain white box with no warning labels”. This led to swift engagement with the GPhC and a letter being sent out to all registered pharmacists, as well as follow-ups with superintendent pharmacists. 

She added: “I have discovered, through my own clinical practice as a GP, that the electronic prescribing system does not align prescription size to packaging size, so boxes need to be split under current legislation.”

She also cited findings that women taking sodium valproate are not routinely having a yearly review with a specialist prescriber, and that contraception provision is “patchy” – with just 64 per cent of women using highly effective contraception in a recent NHS England audit. 

“This is not because of inaction, it is because health leaders don’t understand the health system including the funding arrangements, don’t own the problem and don’t always work effectively together, leaving patients to pick up the pieces.”

Dr Hughes welcomed the decision to focus on sodium valproate prescribing in the 2023 community pharmacy audit and said she awaits the results.

She went on to say that in her work she has encountered concerns “about a much wider range of problems,” including “devastating losses from suicide after taking isotretinoin… [and] patients who have had catastrophic side effects from medicines such as fluoroquinolones, topical steroid treatment, antidepressants, prescribed benzodiazepines, and painkillers”.

Sluggish progress with digital systems is creating “error-provoking environments,” she warned, with 237 million medication errors recorded each year in the NHS, adding: “The drivers for digital transformation are productivity and cost when the overwhelming driver should be benefits to patient safety.

“I want us to be able to look back in astonishment on the way that we operate now. Without listening and acting on patient voices, safety continues to be compromised and patients and families continue to suffer the consequences of harm.”

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