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, what steps his Department is taking through the Medicines and Healthcare Products Regulatory Agency to ensure that all women of child-bearing age who are prescribed Valproate have received the new guidance on the use of that treatment.
Answered by Baroness Blackwood of North Oxford
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. When it was authorised, valproate was known to have risks in pregnancy. The statutory Patient Information Leaflet which accompanies the medicine provides up-to-date detailed information on the risks of valproate in pregnancy. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals and a checklist for prescribers; a reminder card to be provided by pharmacists to patients when the product is dispensed; a guide for women; and clear package labelling carrying a prominent warning about use in pregnancy. It was widely disseminated to relevant healthcare professionals from February 2016 including through a Central Alerting System (a web based cascade system for issuing alerts to the National Health Service), the MHRA’s Drug Safety Update bulletin and in hard copy from the marketing authorisation holders. Electronic copies of the toolkit are hosted on several websites, including the Electronic Medicines Compendium.
In addition the MHRA has worked, and continues to work with, a coalition of stakeholders including Royal Colleges, professional bodies, patient groups, relevant charities and health system organisations, including clinical commissioning groups, to increase awareness of the toolkit among general practitioners, pharmacists and patients, through a variety of communication channels.
In order to monitor the effectiveness of the valproate toolkit, the MHRA continues to work with all stakeholders to gather feedback that demonstrates the toolkit materials are being used. This includes working with voluntary organisations and patient groups to produce online patient surveys to measure awareness of the risks among patients. Furthermore, the MHRA is conducting a study using the Clinical Practice Research Datalink to track changes in prescribing of valproate to women and girls following the communications to healthcare professionals and patients on the risks of valproate in pregnancy. The marketing authorisation holder is conducting Europe-wide studies to measure the changes in patterns of prescribing and the awareness of healthcare professionals of the risks. The available data will be brought together in a regularly updated dashboard that will be used to track the impact of the communications on patient and professional awareness over time.
All doctors are expected to comply with good practice set out in General Medical Council (GMC) guidance. The GMC prescribing guidance states that doctors should reach agreement with the patient on the treatment proposed, explaining the likely benefits, risks and burdens, including serious and common side effects. Doctors should report any adverse reactions to medicines through the Yellow Card Scheme.
Asked by: Norman Lamb (Liberal Democrat - North Norfolk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, pursuant to the Answer of 30 November 2016 to Question 54957, if he will introduce a national compensation fund for people affected by the teratogenic effects of sodium valproate.
Answered by Baroness Blackwood of North Oxford
The current priority of the Medicines and Healthcare products Regulatory Agency (MHRA) is to work to ensure that women taking valproate are fully aware of the risks in pregnancy. Once this is achieved we will look back and see what lessons have been or could be usefully learnt by examining events. There is no current proposal to establish a compensation fund.
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Since it was authorised, valproate was known to have risks in pregnancy. Because of ongoing concerns about women’s awareness of the risks, the MHRA has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls. The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy.
In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies, patient groups and relevant charities to increase awareness of the toolkit among general practitioners, pharmacists and patients.
Asked by: Norman Lamb (Liberal Democrat - North Norfolk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what the implications are for his policies of the decision by the French parliament to establish a national compensation fund for people affected by the teratogenic effects of sodium valproate.
Answered by Baroness Blackwood of North Oxford
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Since it was authorised, valproate was known to have risks in pregnancy. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls. The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy.
In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies, patient groups and relevant charities to increase awareness of the toolkit among general practitioners, pharmacists and patients. The MHRA’s current priority is working to ensure that women taking valproate are fully aware of the risks in pregnancy. Once this is achieved we will look back and see what lessons have been or could be usefully learnt by examining events.
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, what steps he is taking to monitor the effectiveness of the Medicines and Healthcare Products Regulatory Agency toolkit on the risks of valproate medicines in female patients in ensuring that female patients are better informed about the risks of taking valproate medicines during pregnancy.
Answered by George Freeman
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Since it was authorised, valproate was known to have risks in pregnancy. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. It was widely disseminated on 8 February 2016 through a Central Alerting System (a web based cascade system for issuing alerts to the National Health Service) and the MHRA’s Drug Safety Update bulletin. Electronic copies of the toolkit are hosted on several websites including the Electronic Medicines Compendium. Letters and hard copies of the toolkit were sent by the marketing authorisation holder directly to general practitioners (GPs), pharmacists and relevant specialists. This included 400,000 patient cards, 81,000 patient guides and 22,000 healthcare professional booklets.
In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies including the Royal Pharmaceutical Society, patient groups and relevant charities to increase awareness of the toolkit among GPs, pharmacists and patients.This work will include exploring how clinical commissioning groups can help ensure the toolkit materials are being used.
So far, the MHRA has worked with voluntary organisations and patient groups to produce online patient surveys to measure awareness of the risks among patients. Furthermore, MHRA is conducting a study using the Clinical Practice Research Datalink to track changes in prescribing of valproate to women and girls following the communications to healthcare professionals and patients on the risks of valproate in pregnancy. The marketing authorisation holder is conducting Europe-wide studies to measure the changes in patterns of prescribing and awareness of the healthcare professionals of the risks. The available data will be brought together in a regularly updated dashboard that will be used to track the impact of the communications on patient and professional awareness over time.
The Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. For many people this will involve an early intervention programme from health visitors and midwives, to help a child develop, as well as provide support to the family. This might include: speech and language therapy – to help with any problems communicating or feeding; physiotherapy – to help with any muscle weakness or movement difficulties, and individual home teaching programmes.
Where a child has a special educational need the local authority must make support available to ensure the child had access to the same educational opportunities as a child without such a need. The Children and Families Act 2014 introduced a new statutory framework for local authorities and to work together to secure services for children and young people – up to the age of 25 – who have special educational needs or disability, across education, health and social care.
The MHRA’s current priority is to work to ensure that women taking valproate are fully aware of the risks in pregnancy. Once this is achieved we will look into the history of the episode and see what lessons have been or could be usefully learnt by examining events.
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, what steps he is taking to ensure that (a) clinical commissioning groups and (b) pharmacists are made aware of the Medicines and Healthcare products Regulatory Agency toolkit on the risks of valproate medicines in female patients.
Answered by George Freeman
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Since it was authorised, valproate was known to have risks in pregnancy. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. It was widely disseminated on 8 February 2016 through a Central Alerting System (a web based cascade system for issuing alerts to the National Health Service) and the MHRA’s Drug Safety Update bulletin. Electronic copies of the toolkit are hosted on several websites including the Electronic Medicines Compendium. Letters and hard copies of the toolkit were sent by the marketing authorisation holder directly to general practitioners (GPs), pharmacists and relevant specialists. This included 400,000 patient cards, 81,000 patient guides and 22,000 healthcare professional booklets.
In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies including the Royal Pharmaceutical Society, patient groups and relevant charities to increase awareness of the toolkit among GPs, pharmacists and patients.This work will include exploring how clinical commissioning groups can help ensure the toolkit materials are being used.
So far, the MHRA has worked with voluntary organisations and patient groups to produce online patient surveys to measure awareness of the risks among patients. Furthermore, MHRA is conducting a study using the Clinical Practice Research Datalink to track changes in prescribing of valproate to women and girls following the communications to healthcare professionals and patients on the risks of valproate in pregnancy. The marketing authorisation holder is conducting Europe-wide studies to measure the changes in patterns of prescribing and awareness of the healthcare professionals of the risks. The available data will be brought together in a regularly updated dashboard that will be used to track the impact of the communications on patient and professional awareness over time.
The Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. For many people this will involve an early intervention programme from health visitors and midwives, to help a child develop, as well as provide support to the family. This might include: speech and language therapy – to help with any problems communicating or feeding; physiotherapy – to help with any muscle weakness or movement difficulties, and individual home teaching programmes.
Where a child has a special educational need the local authority must make support available to ensure the child had access to the same educational opportunities as a child without such a need. The Children and Families Act 2014 introduced a new statutory framework for local authorities and to work together to secure services for children and young people – up to the age of 25 – who have special educational needs or disability, across education, health and social care.
The MHRA’s current priority is to work to ensure that women taking valproate are fully aware of the risks in pregnancy. Once this is achieved we will look into the history of the episode and see what lessons have been or could be usefully learnt by examining events.
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, if he will conduct an investigation into historical cases of birth defects caused by sodium valproate and the support now required by the families affected.
Answered by George Freeman
Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Since it was authorised, valproate was known to have risks in pregnancy. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.
The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. It was widely disseminated on 8 February 2016 through a Central Alerting System (a web based cascade system for issuing alerts to the National Health Service) and the MHRA’s Drug Safety Update bulletin. Electronic copies of the toolkit are hosted on several websites including the Electronic Medicines Compendium. Letters and hard copies of the toolkit were sent by the marketing authorisation holder directly to general practitioners (GPs), pharmacists and relevant specialists. This included 400,000 patient cards, 81,000 patient guides and 22,000 healthcare professional booklets.
In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies including the Royal Pharmaceutical Society, patient groups and relevant charities to increase awareness of the toolkit among GPs, pharmacists and patients.This work will include exploring how clinical commissioning groups can help ensure the toolkit materials are being used.
So far, the MHRA has worked with voluntary organisations and patient groups to produce online patient surveys to measure awareness of the risks among patients. Furthermore, MHRA is conducting a study using the Clinical Practice Research Datalink to track changes in prescribing of valproate to women and girls following the communications to healthcare professionals and patients on the risks of valproate in pregnancy. The marketing authorisation holder is conducting Europe-wide studies to measure the changes in patterns of prescribing and awareness of the healthcare professionals of the risks. The available data will be brought together in a regularly updated dashboard that will be used to track the impact of the communications on patient and professional awareness over time.
The Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. For many people this will involve an early intervention programme from health visitors and midwives, to help a child develop, as well as provide support to the family. This might include: speech and language therapy – to help with any problems communicating or feeding; physiotherapy – to help with any muscle weakness or movement difficulties, and individual home teaching programmes.
Where a child has a special educational need the local authority must make support available to ensure the child had access to the same educational opportunities as a child without such a need. The Children and Families Act 2014 introduced a new statutory framework for local authorities and to work together to secure services for children and young people – up to the age of 25 – who have special educational needs or disability, across education, health and social care.
The MHRA’s current priority is to work to ensure that women taking valproate are fully aware of the risks in pregnancy. Once this is achieved we will look into the history of the episode and see what lessons have been or could be usefully learnt by examining events.
Asked by: Steve McCabe (Labour - Birmingham, Selly Oak)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, pursuant to the Answer of 13 April 2016 to Question 32720, what recent assessment he has made of the effect of the removal of quality and outcomes framework indicators EP002 and EP003 on the number of avoidable epilepsy deaths.
Answered by Alistair Burt
As part of the 2013/14 negotiations with the British Medical Association’s General Practitioners Committee on changes to the General Practice (GP) contract, NHS England agreed to seek to simplify the Quality and Outcomes Framework (QOF). The aim was to remove unnecessarily prescriptive requirements for clinical practice and to give GPs greater flexibility in adapting clinical care to reflect the needs of individual patients.
The retirement of the epilepsy QOF indicators does not mean that patients will cease to receive advice on medication. It is normal clinical practice for GPs to counsel and/or refer patients for pre-conception advice. We would expect GPs to continue to record on their clinical systems where they have provided advice to patients and we intend to continue to collect this information from GP clinical systems so that it can be reported in the interests of transparency.
Asked by: Barry Sheerman (Labour (Co-op) - Huddersfield)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps his Department is taking to measure and improve the rate of premature mortality of people with autism who have no co-occurring learning disability.
Answered by Alistair Burt
The National Health Service is taking action to reduce premature death by increasing annual health checks for people with learning disabilities, including for those who also have autism. The NHS is working to reduce variation and improve care for physical health conditions that disproportionately impact on people with learning disabilities who also may have autism, including epilepsy and cancer. NHS England has commissioned the world's first Learning Disability Mortality Review Programme to support local areas to review deaths of people with learning disabilities and to use the information to improve service provision. This review programme for people with learning disabilities includes those who also have autism.
Think Autism set out a clear, cross Government programme of action, developed alongside people with autism, their families and carers to improve their lives and reduce premature mortality through better access to healthcare by making adjustments to services. This includes supporting the Royal College of General Practitioners Autism Initiative to improve understanding of autism amongst general practitioners (GPs).
Asked by: Barry Sheerman (Labour (Co-op) - Huddersfield)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will expand the scope of the Learning Disability Mortality Review to include people with autism and a learning disability.
Answered by Alistair Burt
The National Health Service is taking action to reduce premature death by increasing annual health checks for people with learning disabilities, including for those who also have autism. The NHS is working to reduce variation and improve care for physical health conditions that disproportionately impact on people with learning disabilities who also may have autism, including epilepsy and cancer. NHS England has commissioned the world's first Learning Disability Mortality Review Programme to support local areas to review deaths of people with learning disabilities and to use the information to improve service provision. This review programme for people with learning disabilities includes those who also have autism.
Think Autism set out a clear, cross Government programme of action, developed alongside people with autism, their families and carers to improve their lives and reduce premature mortality through better access to healthcare by making adjustments to services. This includes supporting the Royal College of General Practitioners Autism Initiative to improve understanding of autism amongst general practitioners (GPs).
Asked by: Luciana Berger (Liberal Democrat - Liverpool, Wavertree)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps his Department is taking to reduce premature death among people (a) with autism and a learning disability and (b) with autism and no learning disability.
Answered by Alistair Burt
Information is not collected centrally on how many clinical commissioning groups collect prevalence and standardised mortality data on autistic people as part of their joint strategic needs assessments.
The National Health Service is taking action to reduce premature death among people with autism and a learning disability, and with autism by increasing annual health checks for people with learning disabilities, including for those who also have autism. The NHS is working to reduce variation and improve care for physical health conditions that disproportionately impact on people with learning disabilities who also may have autism, including epilepsy and cancer. NHS England has commissioned the world's first Learning Disability Mortality Review Programme to support local areas to review deaths of people with learning disabilities and to use the information to improve service provision. This review programme for people with learning disabilities includes those who also have autism.
Think Autism set out a clear, cross Government programme of action, developed alongside people with autism, their families and carers to improve their lives and reduce premature mortality through better access to healthcare by making adjustments to services. This includes supporting the Royal College of General Practitioners (RCGPs) Autism Initiative to improve understanding of autism amongst GPs.