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.
Supplying valproate safely to women and girls
Pharmacy professionals have a key role in supplying valproate safely. Valproate must not be used in any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place.
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
When patients are visiting pharmacies for pregnancy tests or emergency hormonal contraception remember to ask them about any medications they are taking so you can provide further advice if their medicines are teratogenic.
You must make sure that the patient label is not placed over the warning labels or warning sticker on the box. Women taking valproate have shared with us examples of where this has happened.
Epilim boxes now have a perforated warning card which you can flip up or remove to reveal a space for the patient label. Make sure you keep the warning card with the box and give both to the patient.
Image 1: A box of Epilim medicine with the safety warning attached
Image 2: A box of Epilim medicine with the safety warning removed to show space for the patient label
Find out more about what you need to do in our Focus on supplying medicines safely: sodium valproate
Watch our film where we speak to two women whose children were affected by exposure to sodium valproate during their pregnancies, to find out why it’s so important to make sure that women are made aware of the risks when dispensing sodium valproate.
Read a blog from Duncan Rudkin, our Chief Executive, where he uses a revalidation reflective account to reflect on his own role in raising awareness about dispensing valproate safely
Valproate case study
This in-depth case study explores patient Millie’s interactions with the different healthcare professionals she meets. It explores how to approach difficult conversations and highlights the important role all healthcare professionals have in prescribing and dispensing valproate safely.
How pharmacies can support women and girls taking valproate
Our inspectors check the pharmacy team are following the requirements of the Pregnancy Prevention Programme during inspections.
Medicines in Pregnancy Registry
NHS Digital and the Medicines and Healthcare products Regulatory Agency (MHRA) have developed a valproate registry. Work is underway to extend the valproate registry to include Scotland and Wales. Data collected in England between April 2018 and September 2020 shows:
- 47,532 females (ages 0-54) were prescribed one or more prescriptions for valproate in one or more months within the reporting period
- 180 females were prescribed valproate while pregnant
- 238 females stopped receiving prescriptions of valproate prior to their pregnancy