Epilepsy and Pregnancy: Sodium Valproate

There is no central record of the number of women who have ‘received’ the Pregnancy Prevention Programme, nor whether they have signed the Annual Risk Acknowledgement Form.

Responsibility for the implementation of the new regulatory measures relating to valproate was assigned to integrated care boards (ICBs) in November 2023, via a National Patient Safety alert, which is available at the following link:

https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-valproate-organisations-to-prepare-for-new-regulatory-measures-for-oversight-of-prescribing-to-new-patients-and-existing-female-patients-natpsa-slash-2023-slash-013-slash-mhra

ICBs across the country have taken action in response to this alert. The Cheshire and Mersey ICB is a particular exemplar. NHS England monitors primary care prescribing and the exposure to valproate during pregnancy using the Medicines in Pregnancy Registry, with further information available at the following link:

https://tabanalytics.data.england.nhs.uk/t/Public/views/MedsPreg/TitlePage?%3Aembed=y&%3Aiid=1&%3AisGuestRedirectFromVizportal=y

This shows a significant reduction in the number of pregnancies during which valproate may have been taken. In the last six-month reporting period, the data indicates that there were up to 11 pregnancies during which valproate may have been prescribed. This is across a population of approximately 15,000 women between the ages of 13 to 54 years old who are prescribed valproate each month.