Sodium Valproate

(asked on 29th August 2025) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 23 July 2025 to Question 68387 on Epilepsy and Pregnancy: Sodium Valproate, what steps his Department is taking to ensure (a) consistent and (b) effective implementation of the Pregnancy Prevention Programme by Integrated Care Boards.


Answered by
Karin Smyth Portrait
Karin Smyth
Minister of State (Department of Health and Social Care)
This question was answered on 11th September 2025

NHS England has worked collaboratively with the Medicines and Healthcare products Regulatory Agency (MHRA) on the safer use of valproate containing medicines and there have been several steps to ensure that integrated care boards (ICBs) lead the implementation of the regulations set out by the MHRA. The agency issued a National Patient Safety Alert on valproate in November 2023, 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

The Medicines and Pregnancy Register monitors prescribing of valproate and highlights the number of pregnancies potentially exposed to valproate. This data demonstrates a reduction in prescribing valproate to women and girls as well as a reduction in the number of possible exposed pregnancies since the Pregnancy Prevention Programme (PPP) was introduced in 2018. Analysis shows the implementation of the PPP by ICBs is consistent across the country. The register is available at the following link:

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

Other information available to patients, clinical practitioners and prescribers includes: information from the MHRA; Decision Support Tools and Patient Information leaflets issued by NHS England; and the Valproate Integrated Quality Improvement Programme offered by NHS England. These are available at the following links:

https://www.gov.uk/guidance/valproate-reproductive-risks

https://www.england.nhs.uk/personalisedcare/shared-decision-making/decision-support-tools/

https://www.southeastclinicalnetworks.nhs.uk/our-networks/valproate/

https://www.england.nhs.uk/patient-safety/sodium-valproate/

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