Valproate and the Pregnancy Prevention Programme: exceptional circumstances

In March 2018 the European Medicines Agency endorsed new measures to avoid in utero valproate exposure. Subsequently, updated valproate regulations published by the Medicines and Healthcare products Regulatory Agency (MHRA)1 contraindicate the use of valproate medicines in girls or women of childbearing age unless they participate in the Pregnancy Prevention Programme. Participants must be fully informed of the risks of valproate use in pregnancy, sign a Risk Acknowledgement Form each year, have an annual specialist review, and adhere to a highly effective (pregnancy rate of <1%) but invasive contraception. Valproate is widely prescribed in general practice for a range of indications including epilepsy, bipolar affective disorder, and migraine. This article will argue that there are exceptional circumstances, and personal and practical implications, that have not been adequately considered in the MHRA regulations on valproate prescribing.