Asked by: Rosie Duffield (Labour - Canterbury)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what additional steps have been taken to ensure that medical professionals are equipped to provide awareness of the risk of physical and neurodevelopmental harm to a baby associated with the use of many anti-epileptic drugs taken in pregnancy, specifically when providing such information via digital consultations and telemedicine.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that information is available electronically to support discussions between medical professionals and women and girls on the risk of physical and neurodevelopmental harm to babies born to mothers who take epilepsy medicines during pregnancy. Healthcare professionals have been reminded of their responsibility to inform women and girls of the risks of valproate specifically through letters from the United Kingdom’s Chief Medical Officers and Chief Pharmaceutical Officers and by articles in the MHRA’s electronic bulletin Drug Safety Update.
On 6 May 2020 the MHRA published guidance for specialists to support adherence to the pregnancy prevention requirements for women of childbearing potential taking valproate during the pandemic, particularly patients who are shielding due to other health conditions. This included guidance on annual review of patients using digital consultations.
Asked by: Rosie Duffield (Labour - Canterbury)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans his Department has to (a) collect and (b) disseminate data on individual women who have been prescribed anti-epileptic drugs to enable investigation into the reasons for the teratogenicity of valproate and other epilepsy medication.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency and NHS Digital have been working to build 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. The Registry is being built around routinely collected data on 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. The Registry will also be extended to include all girls and women prescribed an antiepileptic drug. This has been prioritised within the next phase of development. Once available, this data will be accessible to support additional research.
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: 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 his Department has to invest in epilepsy medicines research to ensure safer drugs for pregnant women with epilepsy.
Answered by Edward Argar - Minister of State (Ministry of Justice)
The National Institute for Health Research has funded three studies on anti-epilepsy medication use during pregnancy.
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 clinicians are discussing with women and girls the risks of taking sodium valproate and other anti-epileptic drugs (AEDs) during pregnancy.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that documents forming the basis of the valproate Pregnancy Prevention Programme are available electronically and distributed regularly as hard copies to prescribers and pharmacists to support discussions of the risks of taking sodium valproate during pregnancy with women and girls who require this medicine. Healthcare professionals have been reminded of their responsibility to inform women and girls taking valproate of the risks, through letters from the United Kingdom’s Chief Medical Officers and Chief Pharmaceutical Officers and by articles in the MHRA’s electronic bulletin Drug Safety Update. The conclusions of a safety review by the Commission of Human Medicines of the risks of other epilepsy medicines in pregnancy have recently been published to aid discussions about the most suitable treatment options.
The MHRA is working with the wider healthcare network to explore additional ways of improving the reach of regulatory communications through platforms in the healthcare and patient setting. The MHRA is working to establish a registry to monitor the use of valproate in women and girls and clinician and patient compliance with the current regulatory position.
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, with reference to the Commission on Human Medicines' review of the use of epilepsy medicines in pregnancy, published on 7 January 2021, whether the provisions of the Pregnancy Prevention Programme will be extended to include any other anti-epileptic drugs identified in posing a risk.
Answered by Nadine Dorries
The Commission on Human Medicines’ review concluded that lamotrigine and levetiracetam are safer to use during pregnancy than other epilepsy medicines and that some of the other reviewed antiepileptic drugs may also be associated with harms to the child. Where the data support evidence of harm, neither the magnitude nor the nature of the risks observed with the reviewed epilepsy medicines are as severe as that associated with the use of valproate during pregnancy. A Pregnancy Prevention Programme therefore has not been recommended for any of the other reviewed epilepsy medicines at this time.
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, whether his Department plans to (a) reinstate the Quality Outcomes Framework for Epilepsy indicator relating to contraception, conception and pregnancy and (b) give women who are taking anti-epileptic drugs access to pre-conceptional counselling through the Pregnancy Prevention Programme.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The Quality Outcomes Framework (QoF) indicator which focused upon contraception, conception and pregnancy advice was retired in 2014 due to limitations with measurement.
In July 2018, NHS England and Improvement (NHSE/I) published the ‘Report of the Review of the Quality and Outcomes Framework in England.’ This identified a number of principles for the reform of QoF which NHS E/I are continuing to implement, including a focus upon quality improvement activities in areas where metric development is challenging, and upon an increased personalisation of care. The report is available via the link below:
NHS E/I continue to keep the QoF epilepsy domain under review, and are exploring the potential for new indicators to be developed and implemented.
Every pregnant woman taking the anti-epilepsy drug valproate must be enrolled in the statutory Pregnancy Prevention Programme, and every healthcare professional involved in the prescribing and dispensing of valproate (so for example GPs and pharmacists) must ensure women are aware of the serious risks to pregnancy valproate presents.
Following advice from the Commission on Human Medicines, the available data relating to safety of use of non-valproate epileptic medicines during pregnancy is currently being evaluated. As part of this review, the product information for prescribers and patients will be evaluated to ensure that it is clear and up to date, including the need for preconception counselling, as appropriate. The communications from this review will be made publicly available in order to support informed decision making about the most appropriate choice of antiepileptic treatment in the individual case.