Due to known significant risk of serious harm the MHRA has stipulated new regulatory measures for oral valproate medicines:

• Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
• at their next annual specialist review, women and girls of childbearing potential receiving valproate should have their treatment reviewed using the revised Annual Risk Acknowledgement Form. At this review, if the patient has never been reviewed by two specialists either at initiation or annual review, a second specialist signature will be needed if the patient is to continue on valproate. Women do not need to be recalled for an additional review. Once a patient has received a treatment review by two specialists, subsequent annual reviews only require one specialist.

MHRA Drug Safety Update - Valproate reproductive risks

https://www.gov.uk/guidance/valproate-reproductive-risks#materials-and-resources

Due to known significant risk of serious harm the MHRA has stipulated new regulatory measures for oral valproate medicines:

• Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
• at their next annual specialist review, women and girls of childbearing potential receiving valproate should have their treatment reviewed using the revised Annual Risk Acknowledgement Form. At this review, if the patient has never been reviewed by two specialists either at initiation or annual review, a second specialist signature will be needed if the patient is to continue on valproate. Women do not need to be recalled for an additional review. Once a patient has received a treatment review by two specialists, subsequent annual reviews only require one specialist.

MHRA Drug Safety Update - Valproate reproductive risks

 https://www.gov.uk/guidance/valproate-reproductive-risks#materials-and-resources