Patient safety tsar to ‘eliminate’ dispensing of sodium valproate in white boxes

Henrietta Hughes, patient safety commissioner for England, has pledged to work with partners across healthcare to “eliminate” dispensing of sodium valproate in unlabelled white boxes without warnings about pregnancy.

In the commissioner’s report on her first 100 days in post, published on 2 February 2023, Hughes said “political upheaval” has prevented progress on this issue.

A consultation by the Department of Health and Social Care (DHSC) on ensuring sodium valproate is always supplied in original packaging closed in December 2021, but the DHSC is yet to announce the outcome.

Supplying sodium valproate in its original packaging would help to ensure all patients receive a patient information leaflet as part of the Pregnancy Prevention Programme, helping to address concerns that some women remain unaware of the significant risks posed to their unborn baby should they fall pregnant while taking sodium valproate.

In January 2023, an analysis of data from the Medicines and Pregnancy Registry carried out by The Pharmaceutical Journal showed that there is still a long way to go for NHS England to reach its target to reduce the use of valproate in female patients who can get pregnant by 50% by 2023.

In women who take valproate while pregnant, around 10% of babies will have a birth defect, such as spina bifida or a cleft lip and palate, and about 30–40% children may have developmental disorders, such as poor speech or lower intelligence.

In the report, Hughes also highlighted the 2019 community pharmacy audit, which showed that pharmacists were not referring or signposting a “sizeable minority” of women taking valproate, who appeared not to have appropriate contraception, back to the prescriber and said she would work with health leaders to ensure that all relevant patients are on a Pregnancy Prevention Plan and given the necessary information.

During her time in post, Hughes reported she had also had extensive conversations about the medicines and medical devices highlighted in the Independent Medicines and Medical Devices Safety Review ‘First Do No Harm’ report, published in 2020, which includes sodium valproate.

The commissioner’s report outlines a range of issues, including “devastating losses” from suicide after taking the acne treatment isotretinoin, “catastrophic side effects” from medicines such as fluroquinolones and antidepressants, and concerns about the Yellow Card reporting system, the COVID-19 vaccine damage redress scheme and the regulation of electroconvulsive therapy.

Hughes also promised to campaign to improve the use of Yellow Card reporting to address ongoing concerns about whether the voluntary system is working.

“I have discovered that we need a seismic shift in the way that patients’ and families’ voices are heard,” said Hughes in a press release accompanying the report.

“This requires changes in legislation, regulation, policy, commissioning, education, professionalism, attitudes, behaviours and culture.

“In essence, everything we do as a healthcare system because everything we do is about patients.”

Hughes said that “this is the moment” to set a new course with shared decision-making and patient partnership “as our destination”.

“I want us to be able to look back in astonishment on the way that we operate now,” she said.

“Without listening and acting on patient voices, safety continues to be compromised and patients and families continue to suffer the consequences of harm.”

Thorrun Govind, chair of the Royal Pharmaceutical Society’s English Pharmacy Board, said: ‘’We welcome the report which rightly highlights the importance of shared decision-making, the critical importance of the patient voice and the vital role of pharmacists to support patient safety.”