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 - Minister of State (Department for Work and Pensions)
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 - 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: 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 - 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: 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, 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 - 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: 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, for what reasons no points have been allocated to ongoing management for epilepsy medication in the General Medical Services contract Quality and Outcomes Framework.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
Changes to the Quality and Outcomes Framework (QOF)- including allocation of points- are agreed as part of wider amendments to the General Medical Services (GMS) Contract. These changes are negotiated by NHS England and the British Medical Association’s (BMA) General Practitioners Committee England. Guidance on the 2019/20 GMS Contract concerning the QOF was published by the BMA and NHS England in April 2019. This guidance includes an epilepsy indicator which states that ‘the contractor establishes and maintains a register of patients aged 18 or over receiving drug treatment for epilepsy’. QOF points are generally weighted to the estimated workload associated with an indicator. Registers generally incur a lower workload than other indicators and therefore tend to attract a lower points value than other types of indicators.
Care of patients with long term conditions in general practice is described in the essential services element of the contract and funded through the global sum payment. Patients should expect to receive high quality care irrespective of whether or not their condition is included in the QOF. The QOF indicators will continued to be reviewed going forward.
It is a Care Quality Commission regulatory requirement for general practitioners (GPs) 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’.
NHS England are also taking broader action to support implementation of the MHRA pregnancy prevention guidelines. In April 2019, they introduced a new Quality Improvement module on prescribing safety into the QOF. As part of this module they expect practices to audit three measures, one of which is that girls and women of childbearing potential currently being prescribed valproate have had an annual specialist medication review and are taking this in compliance with the pregnancy prevention programme as documented by a specialist in the annual risk acknowledgement form. It is the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate medicines to make sure women are aware of the risks and are on the pregnancy prevention programme.
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, for what reasons epilepsy is allocated one point in the General Medical Services Statement of Financial Entitlements (Amendment) Directions 2019; and what steps GPs take to ensure that women of child bearing age who are prescribed Valporate are enrolled in a pregnancy prevention programme.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
Changes to the Quality and Outcomes Framework (QOF)- including allocation of points- are agreed as part of wider amendments to the General Medical Services (GMS) Contract. These changes are negotiated by NHS England and the British Medical Association’s (BMA) General Practitioners Committee England. Guidance on the 2019/20 GMS Contract concerning the QOF was published by the BMA and NHS England in April 2019. This guidance includes an epilepsy indicator which states that ‘the contractor establishes and maintains a register of patients aged 18 or over receiving drug treatment for epilepsy’. QOF points are generally weighted to the estimated workload associated with an indicator. Registers generally incur a lower workload than other indicators and therefore tend to attract a lower points value than other types of indicators.
Care of patients with long term conditions in general practice is described in the essential services element of the contract and funded through the global sum payment. Patients should expect to receive high quality care irrespective of whether or not their condition is included in the QOF. The QOF indicators will continued to be reviewed going forward.
It is a Care Quality Commission regulatory requirement for general practitioners (GPs) 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’.
NHS England are also taking broader action to support implementation of the MHRA pregnancy prevention guidelines. In April 2019, they introduced a new Quality Improvement module on prescribing safety into the QOF. As part of this module they expect practices to audit three measures, one of which is that girls and women of childbearing potential currently being prescribed valproate have had an annual specialist medication review and are taking this in compliance with the pregnancy prevention programme as documented by a specialist in the annual risk acknowledgement form. It is the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate medicines to make sure women are aware of the risks and are on the pregnancy prevention programme.
Asked by: Tom Brake (Liberal Democrat - Carshalton and Wallington)
Question to the Home Office:
To ask the Secretary of State for the Home Department, whether children suffering from epilepsy and associated illnesses will be able to apply for emergency use of medical cannabis after receiving the consent of a doctor.
Answered by Nick Hurd
We recognise that people suffering from chronic pain and debilitating illnesses will look to alleviate their symptoms. Recent cases have shown that we need to look more closely at the use of cannabis based medicine in healthcare in the UK. That is why the Home Secretary announced on 19 June that there would be a two-part review into the use of cannabis for medicinal purposes.
In lieu of the outcomes of this review, a time limited expert panel of clinicians has been set up and will establish a process to assess applications for special licences to prescribe cannabis based medicinal products and, where appropriate, recommend applications to the Home Secretary and the Department of Health in Northern Ireland.
Clinicians will be at the heart the process. Any proposal on a course of treatment will be clinically led with evidence based recommendations provided by clinicians. As such the Expert Panel will only consider applications from GMC registered practitioners who are listed on the GMC’s Specialist Register. The panel will not accept applications directly from members of the public or from general practitioners.
The expert panel will assess applications for special licences to prescribe cannabis based medicinal products and provide recommendations to the Home Secretary and the Health Secretary for Northern Ireland within 2 to 4 weeks of the submission of a correct and complete application. The Minister will then decide whether a licence should be granted. Provision for cases to be processed more quickly is possible, by convening of a virtual panel comprising a minimum of four members.
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, how (a) his Department and (b) the Medicines and Healthcare Products Regulatory Agency will be alerted when all concerned women have been warned of the dangers of prescribed 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. 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: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, whether GPs are required to (a) record and (b) report each instance when they have warned a female patient of the dangers of prescribed 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. 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.