Learning Objectives
After completing this module you will be able to:
- Understand the teratogenic risks of valproate
- Apply the MHRA Pregnancy Prevention Programme requirements
- Counsel female patients on effective contraception
- Know the documentation and annual review requirements
The Risk
Sodium valproate and valproate-containing medicines carry significant risk when used in pregnancy. Studies show:
- Approximately 10% risk of major congenital malformations (neural tube defects, cardiac abnormalities)
- 30-40% risk of developmental disorders (autism, lower IQ, educational difficulties)
MHRA Requirements — Pregnancy Prevention Programme
All female patients of childbearing potential prescribed valproate must:
- Be enrolled in the Pregnancy Prevention Programme (PPP)
- Attend annual review with their specialist
- Use highly effective contraception
- Acknowledge understanding of risks by signing the Patient Card annually
Prescribing Restrictions
Valproate must NOT be started in women of childbearing potential unless:
- Alternative treatments have been tried and found ineffective
- A Risk Acknowledgement Form is signed by both clinician and patient
- Effective contraception is confirmed
Dispensing
Community pharmacies must check for the Patient Card at each dispensing. The yellow Patient Card and Risk Acknowledgement Form are mandatory.