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Patient Safety Commissioner publishes sodium valproate redress recommendations

Today, the Patient Safety Commissioner published The Hughes Report recommending redress options for those who have been harmed by the anti-seizure medication sodium valproate. The report also made recommendations for research and recognised the key role of the Epilepsy Research Institute in calling for greater research investment. These recommendations have come as a result of research into sodium valproate, funded in part by the Institute, and the tireless campaigning of families affected.

What is The Hughes Report?

Following the 2020 First Do No Harm Review, which highlighted the avoidable harm caused by sodium valproate, Minister for Mental Health and Women’s Health Strategy, Maria Caulfield MP, asked the Patient Safety Commissioner to explore redress options. The Hughes Report, led by Dr Henrietta Hughes, outlines their recommended compensation options for the families harmed by sodium valproate. The Government will now consider these options and set out the next steps, including whether they want to progress with implementation. 

What were the key takeaways?

The main recommendations from the report were: 

  • Financial redress for those harmed by valproate through an Interim Scheme (a fixed initial sum with payments starting in 2025) followed by a Main Scheme (more bespoke financial support based on individual circumstances).
  • Non-financial redress should be provided to measurably improve access to public services for those harmed by valproate.
  • People affected should be signposted to services that can provide free emotional support
  • The government must ensure the launch of a redress scheme is accompanied by an awareness raising campaign to ensure that all potentially eligible patients are made aware of the scheme’s existence. The government must also make specific efforts to ensure patients from disadvantaged and marginalised groups are reached.
  • The report also made recommendations for those harmed by pelvic mesh.

The Hughes Report also sets out recommendations for future research to be undertaken in this area, recognising the key role of the Epilepsy Research Institute in calling for greater research investment. Recommendations included a call for dedicated research funds for valproate and other anti-seizure medications to help close knowledge gaps and enable those harmed to participate in studies.  In addition, the report  outlines the need for longitudinal research studies, a greater understanding of the impact of all anti-seizure medications, and the development of a digital Annual Risk Acknowledgement Form to enable monitoring of all anti-seizure medications.

Janet Williams & Emma Murphy, Independent Fetal Anti-Convulsant Trust (INFACT) patient campaign group said:

“The Hughes Report is a huge milestone. Dr Henrietta Hughes has spoken with families, as well as researchers like Dr Rebecca Bromley who have driven forward the work in this area and is supporting the call for compensation by families. It took us five years to get better warning labels on patient leaflets and sodium valproate packaging. To get to this point, where redress options are being considered has taken us another five years. It’s a tremendous turning point and this report cements all the work we have done to get to where we are.”

Rosemarie Pardington, Chief Executive of the Epilepsy Research Institute said:

“For people living with epilepsy, deciding to start a family can still cause great anxiety and stress as they try to balance and understand the risk in order to make an informed choice. The recommendations today go some way to acknowledging the impact sodium valproate has had on some families and in proposing forms of redress. Through research, we need to better understand the mechanisms by which anti-seizure medicines can cause harm, as well as develop new strategies and treatments that prevent, and/or significantly reduce that harm. At the Epilepsy Research Institute, we fully understand the importance of this research and supports the call for further investment to enable this to happen.”

Dr Rebecca Bromley, Reproduction & Hormones Theme Lead said:

“I am delighted to see the publication of the Hughes Report today. Building on the 2020 First Do No Harm Review, the report outlines the devastating situation 20,000 mothers with epilepsy around the UK found themselves in. The systems needed were not in place to detect the risks associated with sodium valproate quickly enough and that is why we are here today – to see the Hughes Report outlining the next steps for the government. Research conducted by UK researchers was central to detecting and delineating the risks associated with valproate, but there is much more to do to ensure that the treatment of epilepsy is optimised and future families are not harmed.”

Our knowledge of risks associated with sodium valproate has accumulated slowly over time and has been underpinned by the significant investment made by the Epilepsy Research InstituteWe now know valproate carries a 10% risk of major malformations and a 30-40% risk of developmental symptoms. The decline in prescribing the drug to expectant women occurred after decades of use, where countless babies were born with preventable causes of physical and learning disabilities. Change happened, but not soon enough. And lessons from this need to be learned.

You can read more about  the Hughes Report and the journey to recognising the risks associated with valproate in today’s Feature from Dr Rebecca Bromley. In the article, Dr Bromley shares more on what the report means for people affected by epilepsy and highlights the work the Institute is doing to radically advance research into the area through its Reproduction & Hormones research programme.

You can also watch Dr Rebecca’s Bromley response to the publication of The Hughes Report below.

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