Valproate is a treatment for epilepsy and bipolar disorder. Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders. As such, it is vital that women and girls are dispensed valproate safely.
The GPhC is reminding all pharmacy professionals of what they must do to ensure women and girls receive the right information about valproate and the risk of birth defects.
When inspecting pharmacies, GPhC inspectors are looking to see whether the standards are being met, and they will systematically check compliance with the MHRA’s Pregnancy Prevention Programme for valproate during inspections of registered pharmacies.
For women and girls, when they are dispensed valproate, they should expect:
- to be provided with a Patient Card every time valproate is dispensed
- for valproate to be dispensed with a copy of the patient information leaflet, and if repackaged, with a warning on the container supplied
- to be reminded of the risks in pregnancy and the need for highly effective contraception, and a reminder of the need for annual specialist review
- to be asked if they have received the Patient Guide
Duncan Rudkin Chief Executive at the General Pharmaceutical Council said:
“There are significant risks of birth defects for children born to women and girls who take valproate during pregnancy. As such it is essential that valproate is dispensed correctly, and this means pharmacy professionals need to familiarise themselves with the guidance from the MHRA and the importance of the Valproate Pregnancy Prevention Plan (PPP).
“The MHRA’s guidance states that: Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.
“As the regulator patient safety is our highest priority. When inspecting pharmacies, our inspectors are looking to see whether our standards are being met, and will systematically check compliance with the pregnancy prevention programme for valproate during inspections of registered pharmacies.”
The Medicines and Healthcare Regulatory Agency has guidance and supporting materials on valproate use by women and girls on the .GOV.uk website.
Information about raising concerns about a pharmacy professional or pharmacy is available on our website.