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The below Parliamentary question was asked by Baroness Masham of Ilton on 2014-06-11.

To ask Her Majesty’s Government how the Department of Health plans to cover the cost of the number of children requiring specialised healthcare due to the effects of fetal valproate syndrome.

Earl Howe

The health and care needs of children with fetal valproate syndrome will be met by a range of services and in the majority of cases the local clinical commissioning group (CCG) will decide on the level of provision of services, taking into account the needs of the population it serves. The CCG’s decisions are underpinned by clinical insight and knowledge of local healthcare needs.

The below Parliamentary question was asked by Baroness Masham of Ilton on 2014-06-11.

To ask Her Majesty’s Government whether there are any plans to implement a system to ensure that female patients prescribed valproate or any other anti-convulsant medication are given information relating to potential problems in pregnancy.

Earl Howe

All doctors, during undergraduate and postgraduate training, are made aware of all of the current evidence when prescribing in pregnancy. This is especially so when prescribing drugs that are potentially teratogenic such as anticonvulsants.

The core curriculum for trainee obstetricians which is overseen by the Royal College of Gynaecologists contains a detailed module on epilepsy in pregnancy including sodium valproate which all trainees are required to complete.

The Royal College of Physicians has a similar core learning module on drugs in pregnancy for physicians in training. It is recommended that women with epilepsy attend for pre pregnancy counselling so that management of their epilepsy in any future pregnancy can be discussed as well as any risks and benefits of medication they are taking.

NHS England expects all clinicians prescribing these drugs to follow the National Institute for Health and Care Excellence (NICE) guidance. This is a very powerful tool to improve commissioning. The NICE guidance issued in January 2012 recommends that epilepsy nurse specialists should be an integral part of the network of care of children, young people and adults with epilepsy (para 1.8.3). One of their roles is to educate, inform and support the patient and their family with specific training about the management of epilepsy.

The below Parliamentary question was asked by Baroness Masham of Ilton on 2014-06-11.

To ask Her Majesty’s Government what information is currently given to female patients concerning the potential problems of taking valproate in pregnancy; and how that information reflects the guidelines established by the National Institute for Health and Care Excellence on those issues.

Earl Howe

The Patient Information Leaflet (PIL) that accompanies the medicine is intended to supplement the information provided by the prescriber. The PIL for Epilim (a brand of valproate for the treatment of epilepsy) states that women who are pregnant or of childbearing age should not take valproate unless explicitly advised by their doctor and provides information on birth defects, impaired development and other problems which may occur in babies born to mothers who take valproate during pregnancy. The PILs for other brands of valproate used in the treatment of epilepsy and to control mania in bipolar disorder contain similar warnings. The warnings in the information for healthcare professionals, the Summary of Product Characteristics (SPC) and the PIL are currently the subject of a Europe–wide review which was prompted by new data on the risk of developmental disorders in children born to mothers who took valproate during pregnancy.

The National Institute for Health and Care Excellence (NICE) clinical guideline on epilepsy made the following recommendation as a key priority for implementation: "Women and girls with epilepsy and their partners, as appropriate, must be given accurate information and counselling about contraception, conception, pregnancy, caring for children, breastfeeding and menopause." NICE’s clinical guideline on bipolar disorder recommends that valproate should not routinely be prescribed to pregnant women with bipolar disorder.

The below Parliamentary question was asked by Baroness Masham of Ilton on 2014-06-11.

To ask Her Majesty’s Government what practical steps are being taken to ensure that the experiences and interests of children with fetal valproate syndrome and their families are represented as an integral part of patient involvement at every level of the reformed National Health Service.

Earl Howe

NHS England has developed a delivery model which sets out a systematic approach to the way that it works. Each aspect of its work is underpinned by a commitment to increase patient experience, engagement and participation. This is reflected in their business plan 2014-15 to 2016-17.

In September 2013, it launched a package of measures designed to ensure that the voices of patients, their carers and the public are at the centre of healthcare services.

‘Transforming Participation in Health and Care – The NHS belongs to us all’ has been developed by NHS England with a wide range of stakeholders and partners. Its purpose is to support commissioners to improve individual and public participation and to better understand and respond to the needs of the communities they serve.

It supports two legal duties requiring clinical commissioning groups (CCGs) and commissioners in NHS England to enable:

– patients and carers to participate in planning, managing and making decisions about their care and treatment, through the services they commission; and

– the effective participation of the public in the commissioning process itself, so that services provided reflect the needs of local people.

The guidance highlights a range of ways in which National Health Service commissioners can fulfil their statutory responsibilities and seize the opportunity to deliver personalised and responsive care to all. It includes a wide range of tools, resources and case studies that commissioners will find useful when developing their own responses.

The guidance is a starting point and NHS England will be working with partners to develop further resources to support commissioners to develop their approaches to both individual and public participation.

The reforms to the health and social care system set out in the Health and Social Care Act have also emphasised the need for integration. Central to these reforms is the establishment of statutory health and wellbeing boards to encourage local authorities to take a more strategic approach to providing integrated health and local government services. The boards are intended to bring together bodies from the NHS, public and local government, including Healthwatch as the patient’s voice, jointly to plan how best to meet local health and care needs, and to commission services accordingly.

The below Parliamentary question was asked by Baroness Masham of Ilton on 2014-06-11.

To ask Her Majesty’s Government what plans are being made to improve the collection of information about children and adults affected by anti-convulsant drugs during pregnancy.

Earl Howe

The Department and The Medicines and Healthcare Products Regulatory Agency have met representatives of Independent Fetal Anti Convuslant Trust (In-FACT) to discuss issues relating the prescribing of anti-epileptic drugs to women of child bearing age. We are considering what action might be taken. This includes looking at our current data collection systems to see how information on the incidence of fetal anti convulsant syndrome can be improved.