Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, when he plans to implement in full the recommendations of European Medicines Agency's review into sodium valproate.

The Medicines and Healthcare products Regulatory Agency (MHRA) initiated and led the European Medicines Agency’s (EMA) review of the risk of developmental disorders associated with valproate, which completed in November 2014. MHRA has fully implemented the recommendations of the review to update the Summary of Product Characteristics and Package Leaflet with strengthened warnings and to provide educational materials in the form of booklets aimed at ensuring prescribers and patients have the information they need to make an informed choice. The outcome of the EMA review was communicated in a letter to healthcare professionals accompanied by a guide for healthcare professionals and a booklet for patients in January 2015 through the Central Alerting System (a web based cascade system for issuing alerts to the National Health Service) and the MHRA’s Drug Safety Update bulletin.

MHRA has, in addition, worked with professional bodies, voluntary organisations and patient groups to expand on the educational materials agreed by the EMA review and has developed a valproate toolkit which 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 the Central Alerting System and 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 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, 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.