Introduction

• The MHRA advises that valproate (Epilim, Depakote) carries high risks of birth defects (11%) and neurodevelopmental disorders (30-40%) if taken during pregnancy, and potential male fertility/reproductive risks
• It must not be used in women/girls of childbearing potential (defined as females under 55 years of age) unless a Pregnancy Prevention Programme (PPP) is in place
• This is a practical guide for primary care to support adherence to the MHRA guidance for female patients of childbearing age prescribed valproate/valproic acid. Responsibility for completing the annual risk assessment form (ARAF) lies with the specialist, however, primary care prescribers must ensure the requirements below are recorded in patient notes before issuing a prescription for valproate under a shared care agreement (SCA)
• See SCA for full description of responsibilities

Sexual Health in Coventry And Warwickshire | Sexual Health Hub

Acknowledgements: Adapted with permission from: Shropshire, Telford and Wrekin Integrated Care System. Valproate Annual Risk Assessment Form (ARAF) and Pregnancy Prevention Programme (PPP) guidance for GP practices (Female patients only) Available at:

https://www.shropshireandtelfordformulary.nhs.uk/docs/files/Valproate%20ARAF%20and%20PPP%20guidance%20for%20GP%20practices%20V1_1.pdf?UNLID=767276562025910153813

References:

• Guidance. Valproate -reproductive risks – GOV.UK 

• Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, andSyonell▼): updated safety and educational materials to support patient discussion on reproductive risks – GOV.UK (https: /www.gov.uk/drug-safety-update/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-updated-safety-and-educational-materials-to-support-patient-discussion-on-reproductive-risks )

• Annual Risk Assessment Form Document (medicines.org.uk)(https://www.medicines.org.uk/emc/rmm/104331/Document )

• MHRA – GUIDE FOR HEALTHCARE PROFESSIONALS (GOV.UK) https://www.medicines.org.uk/emc/rmm/104333/Document#gref