Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, for what reasons epilepsy is allocated only one achievement point in the General Medical Services Statement of Financial Entitlements (Amendment) Directions 2019; and what steps he is taking to ensure that GP's put women who are prescribed Valproate and able to have children on a pregnancy prevention programme.
Answered by Neil O'Brien
Epilepsy is allocated one achievement point within the Quality and Outcomes Framework (QOF) in the General Medical Services Statement of Financial Entitlements (Amendment) (No.2) Directions 2022. QOF clinical indicators are subject to approval by the National Institute for Health and Care Excellence (NICE) and are underpinned by NICE clinical guidelines and are subject to consultation with the General Practitioners Committee of the British Medical Association.
Sodium valproate must not be used in any woman or girl able to have children unless she has a Pregnancy Prevention Programme in place. This is laid out in guidance issued by the Medicines and Healthcare products Regulatory Agency, last updated in February 2021, which can be found at the following link:
https://www.gov.uk/guidance/valproate-use-by-women-and-girls.
The programme is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant. It includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, which must take place at least annually.
A Valproate Registry has been set up which, in line with a recommendation of the Cumberlege review, has been extended to other antiepileptic drugs taken during pregnancy. It includes all women in England who are taking National Health Service (NHS) prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. The registry improves our ability to monitor implementation and compliance with the Pregnancy Prevention Programme.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if his Department will review the Quality Outcomes Framework to incorporate updates to the Valproate Pregnancy Prevention Program announced by the Medicines and Healthcare Products Regulatory Agency,
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Quality and Outcomes Framework (QOF) clinical indicators are subject to approval by the National Institute for Health and Care Excellence (NICE) and are underpinned by NICE clinical guidelines. Any changes to the QOF are subject to consultation with the General Practitioners Committee of the British Medical Association.
Asked by: Alan Brown (Scottish National Party - Kilmarnock and Loudoun)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of establishing a compensation scheme for people who have been harmed by sodium valproate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Last year, we worked with NHS Resolution to launch a claims gateway on its website to provide further support to patients who may wish to bring a clinical negligence claim in relation to harm from sodium valproate. We are also taking a range of action to improve the future safety of medicines and medical devices, setting high standards for industry to market and manufacture products, with the aim of reducing harm in the future.
Ministers recently discussed this issue with Henrietta Hughes, the new Patient Safety Commissioner, and the Department will ensure her views feed into our work moving forward.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will set targets for the (a) reduction and (b) end of the use of sodium valproate other than in exceptional circumstances.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
While sodium valproate is authorised for the treatment of epilepsy and bipolar disorder, other medicines are available to treat these conditions. Currently, sodium valproate should not be used in pregnancy unless another suitable treatment is unavailable. It should not be used in women of childbearing potential unless the conditions of the Valproate Pregnancy Prevention Programme are fulfilled.
On 12 December, the Medicines and Healthcare products Regulatory Agency highlighted concerns regarding ongoing exposure to valproate in pregnancy and made recommendations for new safety measures to be put in place. Concerns on the use of sodium valproate are associated with reproduction and may not be applicable to all patients. In due course, the new safety measures will require all patients under 55 years old receiving sodium valproate to be reviewed and for two specialists to independently consider and document that there are no other effective or tolerated treatments. No specific targets have been determined, as it is unclear what proportion of patients require sodium valproate when other medicines are not effective or tolerated.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to replace sodium valproate therapy.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
While sodium valproate is authorised for the treatment of epilepsy and bipolar disorder, other medicines are available to treat these conditions. Currently, sodium valproate should not be used in pregnancy unless another suitable treatment is unavailable. It should not be used in women of childbearing potential unless the conditions of the Valproate Pregnancy Prevention Programme are fulfilled.
On 12 December, the Medicines and Healthcare products Regulatory Agency highlighted concerns regarding ongoing exposure to valproate in pregnancy and made recommendations for new safety measures to be put in place. Concerns on the use of sodium valproate are associated with reproduction and may not be applicable to all patients. In due course, the new safety measures will require all patients under 55 years old receiving sodium valproate to be reviewed and for two specialists to independently consider and document that there are no other effective or tolerated treatments. No specific targets have been determined, as it is unclear what proportion of patients require sodium valproate when other medicines are not effective or tolerated.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the accuracy of the data available on patients who have been prescribed sodium valproate,; and if he will make an assessment of the potential benefits of a register of patients who have been prescribed medicines with a known and significant risk.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Medicines and Pregnancy Registry uses National Health Service dispensing data from community pharmacies in England and NHS maternity services to identify female patients who have received anti-epileptic medication, including sodium valproate and those who have received a prescription in a month that they were pregnant. While this dispensing data accurately reflects the medicines received, it relates to patients in England and may not include patients prescribed sodium valproate in hospitals or private healthcare or those who do not present to NHS maternity services.
All medicines may potentially cause side effects and some of these side effects could be classified as significant risks when used as prescribed, in specific patient populations or in certain circumstances such as during pregnancy. While registries can be helpful when investigating or monitoring specific aspects of prescribed medicines, the integration of records within existing healthcare systems may be more effective at monitoring patient outcomes.
Asked by: Charlotte Nichols (Labour - Warrington North)
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 to ensure that all babies of women taking Valproate during pregnancy receive a thorough examination at birth by a geneticist for diagnosis of Fetal Valproate Spectrum Disorder.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
There is no simple test to diagnose fetal valproate syndrome. Where a patient has taken valproate during pregnancy and has concerns regarding their child’s health, advice should be sought from their general practitioner. The child may be referred to a specialist for an assessment. In December 2020, the ‘Guidance Document on Valproate Use in Women and Girls of Childbearing Years’ was published, which provides recommendations for healthcare professionals where there are concerns for children born to mothers who have taken valproate during pregnancy.
Asked by: Feryal Clark (Labour - Enfield North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will provide an update on plans for financial redress for those harmed by (a) mesh implants, (b) Primodos and (c) Sodium Valproate.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Government’s response to the Independent Medicines and Medical Devices Safety Review did not accept the recommendation to establish separate redress schemes. We have worked with NHS Resolution to launch online claims gateways to support patients who may wish to bring a clinical negligence claim in relation to pelvic mesh and sodium valproate. We are improving the safety of medicines and medical devices through high standards for industry to market and manufacture products with the aim of reducing harm in future.
Asked by: Charlotte Nichols (Labour - Warrington North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make it his policy to offer compensation to people effected by Valproate in pregnancy.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Government’s response to the Independent Medicines and Medical Devices Safety Review did not accept the recommendation to establish a separate redress scheme for those harmed by sodium valproate. We have worked with NHS Resolution to launch an online gateway to provide further support to patients who may wish to bring a clinical negligence claim in relation to sodium valproate. We are also improving the safety of medicines and medical devices through setting high standards for industry to market and manufacture products to reduce harm in the future.
Asked by: Feryal Clark (Labour - Enfield North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, in reference to the Medicines and Pregnancy Registry: Antiepileptic use in females aged 0 to 54 in England, whether his Department has reported the total number of people affected by Valproate in pregnancy to the Office of National Statistics.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Department has not reported the total number of people affected by sodium valproate in pregnancy to the Office of National Statistics. The Medicines and Pregnancy Registry contains data on every woman in England receiving National Health Service-prescribed sodium valproate and all other antiepileptics taken during pregnancy and whether the individual is pregnant and accessing NHS care for that pregnancy. The Registry publishes data twice a year.