Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps are being taken to ensure cumulative drug toxicity and polypharmacy risks are actively monitored in people prescribed sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
There are established systems within the National Health Service to ensure that cumulative drug toxicity and polypharmacy risks are actively monitored in people prescribed sodium valproate. In practice, this involves establishing arrangements for assessing, reviewing, and monitoring the ongoing need for treatments, and, given that sodium valproate is almost invariably initiated in secondary care, clear shared-care arrangements between secondary and primary care clinicians, supported by the involvement of pharmacists, to minimise the risks associated with cumulative drug toxicity and polypharmacy.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether NHS England plans to commission specialist multidisciplinary services for people affected by sodium valproate exposure, including care coordination, to help reduce emergency admissions and diagnostic times.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has been made of the adequacy of the diagnostic time taken and levels of misdiagnosis among individuals harmed by sodium valproate, and its impact on long-term outcomes.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has been made of whether NHS care pathways are adequate for individuals harmed by sodium valproate that require lifelong, multidisciplinary care.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what guidance exists for Integrated Care Boards on supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking with the Minister for the Cabinet Office to help tackle the harm caused by sodium valproate to (a) women with epilepsy and (b) their families.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Everyone who has been harmed from sodium valproate has our deepest sympathies.
Action has been taken to minimise the risk associated with valproate to women with epilepsy, and their families. This includes the valproate Pregnancy Prevention Programme, which ensures that women and girls taking valproate understand the potential risks should they become pregnant, are using effective contraception, and are regularly monitored. Further measures introduced in 2024 mean valproate must not be started in new patients, either male or female, younger than 55 years old, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
The Government is also carefully considering the Patient Safety Commissioner’s recommendations made in The Hughes Report, which includes proposed approaches to redress for those harmed by sodium valproate. This work requires coordinated input from several departments, and we will provide a further update in due course.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what learning has been implemented following the coroner’s finding that harm from sodium valproate exposure contributed to the death of Jake Aldcroft.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Everyone who has been harmed from sodium valproate has our deepest sympathies.
Action has been taken to minimise the risk of foetal harm associated with valproate, and to ensure that healthcare professionals are also able to support any babies and families that are affected. The valproate Pregnancy Prevention Programme ensures that women and girls taking valproate understand the potential risks should they become pregnant, are using effective contraception, and are regularly monitored. It is supported by educational materials for healthcare professionals and patients.
The programme was updated in January 2024 to reflect updated Medicines and Healthcare Products Regulatory Agency advice that valproate must not be started in new patients, either male or female, younger than 55 years old, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the Government plans to mandate structured medication reviews for patients receiving long-term sodium valproate, particularly as part of antiepileptic polytherapy.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
There are no current plans to mandate Structured Medication Reviews (SMRs) specifically for patients receiving long-term sodium valproate. NHS England has, however, provided substantial funding to expand the number of clinical pharmacists working in primary care networks, with a key part of their role being to undertake SMRs for groups of patients who are most likely to benefit. Whilst treatment with sodium valproate does not, in itself, guarantee an SMR, an SMR might be triggered if a patient meets certain criteria, for example, if they are considered to have complex and problematic polypharmacy or if they are in a care home.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the Government has made an assessment of the potential merits of piloting a no-fault compensation model for individuals harmed by sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has not yet undertaken an assessment of the potential merits of piloting a no-fault compensation model for individuals harmed by sodium valproate.
This is a complex, cross-Government policy area involving multiple organisations. As set out in the Hughes Report, the Government is carefully considering the Patient Safety Commissioner’s recommendations, including the proposed approaches to redress for those harmed by sodium valproate. This work requires coordinated input from several departments, and we will provide a further update in due course.
I met with the Patient Safety Commissioner in December 2025, to discuss progress following the Hughes Report and made clear that the Department’s expectation of continued, proactive engagement with the Patient Safety Commissioner and key stakeholders.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many Yellow Card reports relating to harm from sodium valproate, including prenatal exposure, have been received since 2000; and what regulatory action followed.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) publishes data received via the Yellow Card scheme in the form of interactive Drug Analysis Profiles (iDAPs). These interactive profiles display a complete listing of all suspected adverse drug reactions (ADRs) that have been reported to the MHRA via the Yellow Card scheme for particular drug substances. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies. You will be able to find information here for several different data points such as the number of ADR reports by year, age and sex, as well as information of the types of reactions included in the reports for valproic acid. Guidance concerning the interpretation of the information included is provided at the bottom of each iDAP page. It is particularly important to note that reports are not confirmed side effects to a medication and that incidence cannot be derived since a number of factors influence the reporting of ADRs.
Warnings about possible risks associated with the use of valproate during pregnancy are included in the product information. These have been updated as new data has emerged. The Pregnancy Prevention Programme was introduced in 2018, due to concerns that pregnancies exposed to valproate continued to be reported. A further review by the Commission of Human Medicines on the reproductive risks of valproate resulted in additional regulatory action being implemented in January 2024 to help ensure women receive the information on reproductive risks and are only prescribed valproate if two specialists consider and document that there is no other effective or tolerated treatment. Communications about these updates were distributed to healthcare professionals in the United Kingdom via the MHRA’s bulletin Drug Safety Update.