36654 - Pregnancy: Sodium Valproate (Answered)

Cat Smith
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.

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.