Women must also be aware of the need to take contraception while on valproate. A risk acknowledgement form must be completed and signed during a review, which must take place at least once a year.
On 24 April 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) changed the licence for valproate medicines in the UK. Valproate must no longer be prescribed to women or girls who are able to become pregnant unless they are on the Pregnancy Prevention Programme (PPP).
Between October 2019 and January 2020, Epilepsy Action worked with Epilepsy Society and Young Epilepsy to conduct another survey of women who have taken or who are taking valproate, since the introduction of the PPP.
At Young Epilepsy, we are committed to ensuring that women and girls with epilepsy receive safe, informed care. This survey, conducted with Epilepsy Action and Epilepsy Society, explored how well the Pregnancy Prevention Programme (PPP) is being implemented for those taking valproate—a medication known to cause serious risks during pregnancy.
Key Findings
Awareness of Risks
- 11% of women were unaware that valproate can cause birth defects.
- 18% didn’t know it can lead to learning and developmental problems in children.
- Only 47% had heard of the PPP, despite its importance.
Pregnancy Prevention Programme (PPP)
- 11% had received none of the PPP materials from healthcare professionals.
- 10 women were prescribed valproate for the first time but not signed up to the PPP.
- 79 women continued taking valproate without being enrolled in the PPP.
Information Materials
- Only 46% received the Prevent card; 42% received the booklet.
- 75% received the patient information leaflet.
- Most women who received materials understood them well.
Annual Risk Acknowledgement Form
- 47% had not been asked to sign the form, which is required annually.
- Among those who received no PPP materials, 77% had not signed the form.
Healthcare Professional Engagement
- Only 55% had discussed valproate with a healthcare professional since August 2018.
- Many reported no discussion with their GP (25%), neurologist (21%), or epilepsy nurse (16%).
Pharmacy Support
- 49% had no discussion with their pharmacist about valproate risks.
- 51% never received the Patient Card with their prescription.
Regional Insights
- Northern Ireland showed the lowest awareness and engagement.
- Wales performed best in terms of awareness and form completion.
- East Midlands had a disproportionately high number of women receiving no information.
Conclusion
Despite improvements, many women are still unaware of the risks of taking valproate during pregnancy. Healthcare professionals and pharmacists must do more to ensure women are informed, supported, and enrolled in the PPP. We urge better communication, consistent distribution of materials, and sensitivity to individual circumstances.
