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.
The Medicines and Healthcare products Regulatory Agency (MHRA) have now published materials to support the implementation of these new measures, along with a Drug Safety Update.
New safety and education materials
These materials are all available on the MHRA website and include:
- Pharmacy poster - Provides important actions for pharmacists dispensing valproate to female patients.
- Patient card - Provides key information for female patients receiving valproate on contraception and pregnancy prevention.
- Warning stickers - To be added to packaging of medicine in exceptional circumstances where the original pack cannot be dispensed.
- Patient guide - Provides those taking valproate (or their parent, caregiver, or responsible person) with information on the risks of valproate in pregnancy and the risks to male patients and what they need to do.
- Healthcare Professional Guide - Provides updated information for healthcare professionals on the risks of valproate in pregnancy and the risks for male patients, the new conditions for valproate prescribing and key points for patient discussions.
The resources also include an Annual Risk Acknowledgement Form for female patients starting valproate and at annual review and Risk Acknowledgement Form for male patients starting valproate.