The Medicines and Healthcare products Regulatory Agency (MHRA) have published new valproate safety and educational materials to support the implementation of new regulatory measures.
New safety and educational materials are now available on the MHRA website including updated guides for patients and healthcare professionals, a patient card and pharmacy poster.
These materials support new regulatory measures. From 31 January 2024:
- 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.
- 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.
Pharmacy teams should continue to dispense valproate. They should be prepared to discuss the new measures with their patients and share the new materials with them.
We have sent an email update to all pharmacy professionals to highlight the new materials.