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: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the publication of the Commission on Human Medicines' report, Epilepsy Medicines in Pregnancy on 7 January 2021, what plans he has to ensure greater awareness among health professionals of the risk of physical and neurodevelopmental harm associated with the use of many anti-epileptic drugs taken in pregnancy.
Answered by Nadine Dorries
The conclusions of the Commission on Human Medicines’ safety review were communicated publicly to support decisions around the best treatment options for girls and women. These communications were issued via the Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update bulletin, an accompanying public assessment report and a patient safety leaflet. A news release and social media accompanied the publication alongside email alerts that targeted relevant healthcare professionals, prescribing publications and professional organisations. The MHRA is working with the National Institute for Health and Care Excellence, the Royal College of General Practitioners and the Association of British Neurologists to update relevant clinical guidance to reflect the findings of the review. The impact of this review and the uptake of January communications will be monitored and consideration will be given to the need for further communication with healthcare professionals.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Commission on Human Medicines report, Epilepsy Medicines in Pregnancy, published on 7 January 2021, what plans he has to ensure greater awareness among health professionals of the risk of physical and neurodevelopmental harm associated with the use of many anti-epileptic drugs taken in pregnancy.
Answered by Nadine Dorries
The Registry is being built around routinely collected data of all women in England who are taking National Health Service-prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. Work is now ongoing to extend the Registry to include women in the devolved administrations. In the next phase of development, the Registry will be extended to include all girls and women prescribed an antiepileptic drug.
The conclusions of the Commission on Human Medicines’ safety review of the risk of physical and neurodevelopmental harm in children of mothers who took epilepsy medicines in pregnancy were communicated publicly to support decisions around the best treatment options for girls and women. These communications were via the Medicines and Healthcare products Regulatory Agency’s (MHRA) Drug Safety Update bulletin, an accompanying public assessment report and a patient safety leaflet. A news release and social media accompanied the publication alongside email alerts that targeted relevant healthcare professionals, prescribing publications and professional organisations. The MHRA is also working with the National Institute for Health and Care Excellence, the Royal College of General Practitioners and the Association of British Neurologists to update relevant clinical guidance to reflect the findings of the review. The impact of this review and the uptake of communications will be monitored.
Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans he has for extending the MHRA and NHS Digital Medicines in Pregnancy Valproate Registry to include all anti-epileptic drugs.
Answered by Nadine Dorries
The Registry is being built around routinely collected data of all women in England who are taking National Health Service-prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. Work is now ongoing to extend the Registry to include women in the devolved administrations. In the next phase of development, the Registry will be extended to include all girls and women prescribed an antiepileptic drug.
The conclusions of the Commission on Human Medicines’ safety review of the risk of physical and neurodevelopmental harm in children of mothers who took epilepsy medicines in pregnancy were communicated publicly to support decisions around the best treatment options for girls and women. These communications were via the Medicines and Healthcare products Regulatory Agency’s (MHRA) Drug Safety Update bulletin, an accompanying public assessment report and a patient safety leaflet. A news release and social media accompanied the publication alongside email alerts that targeted relevant healthcare professionals, prescribing publications and professional organisations. The MHRA is also working with the National Institute for Health and Care Excellence, the Royal College of General Practitioners and the Association of British Neurologists to update relevant clinical guidance to reflect the findings of the review. The impact of this review and the uptake of communications will be monitored.
Asked by: Marsha De Cordova (Labour - Battersea)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans the Government has to increase funding for (a) safer medicines research and (b) ensuring safer medicines for pregnant women with epilepsy in order to limit existing risks around physical and neurodevelopmental harm.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency (MHRA) is working with NHS Digital to develop a registry to monitor the use of valproate and compliance with the current regulatory position, and to monitor any children born to women on valproate. A report detailing the findings from the first stage of the registry was published in January. Work is now ongoing to extend the registry to include to women in the devolved administrations. As recommended in the Independent Medicines and Medical Devices Safety Review (IMMDSR), it will be further developed to include all women prescribed an antiepileptic drug. This has been prioritised within the next phase of development.
The conclusions of the Commission on Human Medicines’ safety review of epilepsy medicines in pregnancy were communicated publicly to support decisions around the best treatment options for girls and women. These communications were via the MHRA’s Drug Safety Update bulletin, an accompanying public assessment report and a patient safety leaflet. A news release and social media accompanied the publication alongside email alerts that targeted relevant healthcare professionals, prescribing publications and professional organisations. The MHRA is also working with the National Institute for Health and Care Excellence, the Royal College of General Practitioners and the Association of British Neurologists to update relevant clinical guidance to reflect the findings of the review. The impact of this review and the uptake of communications will be monitored and consideration be given to the need for further communications to healthcare professionals.
The Department, through the National Institute for Health Research (NIHR) funds a range of research in maternal and neonatal health focussing on the safety of maternity and neonatal services, and the national maternity ambition to halve maternal deaths, stillbirths and neonatal deaths and brain injury by 2025. The NIHR has funded three studies on anti-epilepsy medication use during pregnancy. The NIHR welcomes funding applications for research into any aspect of human health, including safer medicines for pregnant women with epilepsy.
Asked by: Marsha De Cordova (Labour - Battersea)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the publication of the Commission on Human Medicines' report, Epilepsy Medicines in Pregnancy on 7 January 2021, what plans he has in place for an awareness raising campaign to inform healthcare professionals and the general public of the risks associated with the use of anti-epileptic drugs taken in pregnancy.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency (MHRA) is working with NHS Digital to develop a registry to monitor the use of valproate and compliance with the current regulatory position, and to monitor any children born to women on valproate. A report detailing the findings from the first stage of the registry was published in January. Work is now ongoing to extend the registry to include to women in the devolved administrations. As recommended in the Independent Medicines and Medical Devices Safety Review (IMMDSR), it will be further developed to include all women prescribed an antiepileptic drug. This has been prioritised within the next phase of development.
The conclusions of the Commission on Human Medicines’ safety review of epilepsy medicines in pregnancy were communicated publicly to support decisions around the best treatment options for girls and women. These communications were via the MHRA’s Drug Safety Update bulletin, an accompanying public assessment report and a patient safety leaflet. A news release and social media accompanied the publication alongside email alerts that targeted relevant healthcare professionals, prescribing publications and professional organisations. The MHRA is also working with the National Institute for Health and Care Excellence, the Royal College of General Practitioners and the Association of British Neurologists to update relevant clinical guidance to reflect the findings of the review. The impact of this review and the uptake of communications will be monitored and consideration be given to the need for further communications to healthcare professionals.
The Department, through the National Institute for Health Research (NIHR) funds a range of research in maternal and neonatal health focussing on the safety of maternity and neonatal services, and the national maternity ambition to halve maternal deaths, stillbirths and neonatal deaths and brain injury by 2025. The NIHR has funded three studies on anti-epilepsy medication use during pregnancy. The NIHR welcomes funding applications for research into any aspect of human health, including safer medicines for pregnant women with epilepsy.
Asked by: Marsha De Cordova (Labour - Battersea)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will take steps to immediately extend the Medicines and Healthcare products Regulatory Agency and NHS Digital's Medicines in Pregnancy Valproate Registry to include all anti-epileptic drugs.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency (MHRA) is working with NHS Digital to develop a registry to monitor the use of valproate and compliance with the current regulatory position, and to monitor any children born to women on valproate. A report detailing the findings from the first stage of the registry was published in January. Work is now ongoing to extend the registry to include to women in the devolved administrations. As recommended in the Independent Medicines and Medical Devices Safety Review (IMMDSR), it will be further developed to include all women prescribed an antiepileptic drug. This has been prioritised within the next phase of development.
The conclusions of the Commission on Human Medicines’ safety review of epilepsy medicines in pregnancy were communicated publicly to support decisions around the best treatment options for girls and women. These communications were via the MHRA’s Drug Safety Update bulletin, an accompanying public assessment report and a patient safety leaflet. A news release and social media accompanied the publication alongside email alerts that targeted relevant healthcare professionals, prescribing publications and professional organisations. The MHRA is also working with the National Institute for Health and Care Excellence, the Royal College of General Practitioners and the Association of British Neurologists to update relevant clinical guidance to reflect the findings of the review. The impact of this review and the uptake of communications will be monitored and consideration be given to the need for further communications to healthcare professionals.
The Department, through the National Institute for Health Research (NIHR) funds a range of research in maternal and neonatal health focussing on the safety of maternity and neonatal services, and the national maternity ambition to halve maternal deaths, stillbirths and neonatal deaths and brain injury by 2025. The NIHR has funded three studies on anti-epilepsy medication use during pregnancy. The NIHR welcomes funding applications for research into any aspect of human health, including safer medicines for pregnant women with epilepsy.
Asked by: Valerie Vaz (Labour - Walsall South)
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 healthcare professionals are aware of the findings of the safety review of epilepsy medicines in pregnancy, published by the Medicines and Healthcare Products Regulatory Agency on 7 January 2021.
Answered by Nadine Dorries
The conclusions of the Commission on Human Medicines’ safety review were communicated to healthcare professional via the Medicines and Healthcare products Regulatory Agency’s (MHRA) Drug Safety Update bulletin and an accompanying public assessment report. A news release and social media accompanied the publication alongside email alerts that targeted relevant healthcare professionals, prescribing publications and professional organisations. The MHRA is also working with the National Institute for Health and Care Excellence, the Royal College of General Practitioners and the Association of British Neurologists to update relevant clinical guidance to reflect the findings of the review. The impact of this review and the uptake of communications will be monitored and consideration be given to the need for further communications to healthcare professionals.
Asked by: Liz Twist (Labour - Blaydon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent estimate he has made of the GP-to-patient ratio for female patients aged 15 to 45 with epilepsy in Blaydon constituency.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
Data on the general practitioner (GP) to patient ratio for female patients between the ages of 15 to 45 years old with epilepsy is not available at national or regional levels.
Asked by: Liz Twist (Labour - Blaydon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what (a) funding and (b) training his Department plans to provide to GPs on supporting women diagnosed with epilepsy and carrying out the Pregnancy Prevention Program.
Answered by Nadine Dorries
It is a Care Quality Commission regulatory requirement for general practitioners to follow the Medicines and Healthcare products Regulatory Agency’s (MHRA) guidance on valproate prescribing. The MHRA advises that ‘Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place’.
In 2019/20 NHS England implemented a quality improvement module worth approximately £44 million nationally to encourage practices to improve their prescribing safety. This aimed to improve engagement with women of childbearing age being prescribed sodium valproate and pregnancy prevention for these patients.
The standard of medical training is the responsibility of the General Medical Council (GMC), which is an independent statutory body.?The GMC has the general function of promoting high standards of education and co-ordinating all stages of education to ensure that medical students and newly qualified doctors are equipped with the knowledge, skills and attitudes essential for professional practice.