Valproate is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.
In 2018 the MHRA implemented regulations that any use of valproate in patients of childbearing potential has to be within the terms of the Pregnancy Prevention Programme (Prevent).
This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.
In 2020, two patient safety incidents associated with the failure to implement Prevent were reported in Aneurin Bevan University Health Board (ABUHB).
To support a prudent approach to the implementation of Prevent, a risk assessment of all patients in ABUHB was to be undertaken to establish if there is a valid exemption in place or if the patient is already using a highly effective form of contraception.
A total of 265 patients were audited with the assessment form. 65% of the patients were prescribed valproate by neurology, 98 referrals were made to neurology to complete an ARAF50 referrals were made to mental health to complete an ARAF. Around 50% of the females of child bearing age are permanently exempted from having an ARAF, e.g., had hysterectomy, learning disabilities.
