Executive Summary – THE ROYAL COLLEGES Guidance

Valproate (Epilim, Depakote, Convulex, Episenta, Epival, Kentlim, Orlept, Syonell, Valpal) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy. Strengthened regulations governing its use have recently been put in place.The pregnancy prevention programme, PPP, is a key element of the new regulations.

Valproate is licensed for use only in the treatment of epilepsy and bipolar disorder. For some women with these conditions, it may be the only drug that controls their condition. In any woman, abrupt cessation of valproate is dangerous and should not be undertaken.

For most women of child-bearing potential with bipolar disorder there are other drugs that have been shown to be at least as effective. The implementation of the new regulations is central to reducing the significant harms associated with valproate use. In daily practice, challenging situations may arise when valproate use is being considered, reviewed or discontinued. Clinicians are required to act in the best interests of each individual patient.

This document is intended to provide practical information and guidance, and sources of further support, for clinicians involved with valproate: it gathers data, where available, on best practice and summarises consensus opinion from seventeen national bodies across the UK.

The areas covered for girls are: epilepsy; bipolar disorder; competence to consent to treatment, confidentiality in young women and transition from paediatric to adulthood care. In women of childbearing potential, we discuss: contraception for the PPP across the age range and its risks, discontinuation or exchanging of valproate, women remaining on valproate without a PPP, intellectual disability, failure to carry out annual specialist review, prescribing responsibility, special situations such as status epilepticus, women detained in prison or under the Mental Health Act.

In addition, we consider: valproate dispensing; women not at risk of pregnancy; healthcare when pregnancy does occur on valproate; competencies across specialties and roles; adoption and surrogacy; peri-menopausal women and babies born following in utero valproate exposure.

The licensed indications for valproate are serious, sometimes life-threatening, conditions.

Valproate may be an effective therapy, but the significant risks associated with its use require clinicians to observe the regulations. However, the circumstances of each individual patient are unique and require bespoke management. This guidance cannot cover every scenario and will require updating as regulations, circumstances and knowledge evolve, and clinicians should pay attention to new information as it is made available.