NHS Digital is working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to develop comprehensive national Medicines in Pregnancy Registries which can give a better understanding of the use, benefits, and risks of medicines taken in pregnancy. This report is an analysis of existing administrative patient data as a proof of concept, to establish the use and value of these data sets in supporting robust and sustainable medicine registries. The data produced are designed to support the MHRA in monitoring the level of success of the valproate pregnancy prevention plan and to enable the wider health and care system to further understand outcomes for women prescribed valproate during pregnancy and their children and consequently to improve patient care.

Valproate is a licenced treatment for epilepsy and bipolar disorder. It is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy. Since its introduction in the UK in 1974, the product information for doctors has included a warning about the possible risk of birth defects. As the nature and magnitude of risks to the unborn child have been increasingly understood, the warnings have been strengthened. Valproate must not be used in any woman or girl able to have children unless she is supported by a Pregnancy Prevention Programme (PPP). This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

To monitor the implementation of and adherence to the PPP, understand changes in the use of valproate and the impact of these changes on women and their children, and to facilitate further research into outcomes following the use of valproate in pregnancy, MHRA and NHS Digital initiated development of a valproate registry.