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 and Bloxwich)
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 and Consett)
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
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 and Consett)
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.
Asked by: Caroline Nokes (Conservative - Romsey and Southampton North)
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 identify all women of childbearing age in receipt of prescriptions for sodium valproate.
Answered by Nadine Dorries
In April 2018, the valproate Pregnancy Prevention Programme (PPP) was implemented and the four Chief Medical Officers in the United Kingdom asked general practitioners to identify all relevant women and girls on valproate in their practice, check they are on effective contraception as appropriate, and refer them for specialist review annually. Specialist prescribers were asked to review treatment of women and girls on valproate and ensure that an annual risk acknowledgement form is signed by the patient and prescriber. Key stakeholders are working together to drive forward compliance with the PPP, better embed the PPP into routine clinical care and ensure women with epilepsy and bipolar disorder receive the healthcare they require.
The Medicines and Healthcare products Regulatory Agency is also working on developing a registry, the main aims of which would be to identify girls and women of childbearing potential prescribed valproate, monitor compliance with the current regulatory requirements, and to identify and monitor outcomes in any children born to women on valproate.
Asked by: Fiona Bruce (Conservative - Congleton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the GP-to-patient ratio for female patients with epilepsy aged people 15 and 45 years in the Congleton constituency.
Answered by Jo Churchill
Data on the general practitioner 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: Jonathan Reynolds (Labour (Co-op) - Stalybridge and Hyde)
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 between 15 and 45 with epilepsy in Stalybridge and Hyde constituency.
Answered by Jo Churchill
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: Christian Wakeford (Labour - Bury South)
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 between the ages of 15 and 45 years old with epilepsy in Bury South constituency.
Answered by Jo Churchill
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: Emma Hardy (Labour - Kingston upon Hull West and Haltemprice)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the GP to patient ratio for female patients between the ages of 15 to 45 years old with epilepsy in the Kingston upon Hull West and Hessle constituency.
Answered by Jo Churchill
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.