NPSA Alert - Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients

SPS commentary:

Feedback on the alert will be collected at ICB level in England, and responses are not being collected from NHS Trusts.  A new or existing group is required to co-ordinate the implementation of the new regulatory measures, and is tasked with updating all local guidance and protocols relating to the prescribing of valproate to reflect the new regulatory position.  Commissioning work is also to be undertaken if necessary to understand the needs of the local population.

The regulatory change in January 2024, for oral valproate medicines, means that:
A. Valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.

B. At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes.

A Public Assessment Report and other online resource collections have been produced to outline the measures and the detail of the safety review.