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.

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.