Quality statement 1: Valproate

Quality statement

Women of childbearing potential are not prescribed valproate to treat a mental health problem.

Rationale

Valproate is commonly used to treat epilepsy and some mental health problems. However, it can harm unborn babies when taken during pregnancy. Babies exposed to valproate in the womb are at a high risk of serious developmental disorders (approximately 30–40% of babies) and congenital malformations (approximately 10% of babies). In January 2015, the Medicines and Healthcare products Regulatory Agency issued a Drug safety update on Medicines related to valproate: risk of abnormal pregnancy outcomes. It included a strengthened warning stating that valproate should not be prescribed to female children, female adolescents or women of childbearing potential unless other treatments are ineffective or not tolerated. Valproate should therefore only be prescribed to treat mental health problems in women of childbearing potential in exceptional circumstances. If valproate is prescribed the woman must be informed of and understand the:

  • risks associated with valproate during pregnancy

  • need to use effective contraception

  • need for regular review of treatment

  • need to rapidly consult if she is planning a pregnancy or becomes pregnant.

Quality measures

Structure

Evidence of practice arrangements and written clinical protocols to ensure that women of childbearing potential are not prescribed valproate to treat a mental health problem.

Data source : Local data collection.

Process

Proportion of women of childbearing potential prescribed valproate to treat a mental health problem.

Numerator – the number in the denominator prescribed valproate to treat a mental health problem.

Denominator – the number of women who are of childbearing potential.

Data source: Local data collection.

Outcome

Children with serious developmental disorders or congenital malformations born to mothers who took valproate in pregnancy for treatment of a mental health problem.

Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (primary care, community health services, general mental health services and specialist secondary care mental health services) have practice arrangements and written clinical protocols in place to ensure that women of childbearing potential are not prescribed valproate to treat a mental health problem.

Healthcare professionals (GPs and mental health professionals) do not prescribe valproate to women of childbearing potential to treat a mental health problem.

Commissioners of primary care and specialist and general mental health services (NHS England regional teams and clinical commissioning groups) specify within contracts that providers should not prescribe valproate to women of childbearing potential to treat a mental health problem.

What the quality statement means for service users and carers

Women who may become pregnant or who are pregnant should not be prescribed a medication called valproate to treat a mental health problem as it can harm unborn babies.

Source guidance

Definitions of terms used in this quality statement

Valproate

At the time of publication 3 formulations of valproate were available in the UK: sodium valproate and valproic acid (licensed for the treatment of epilepsy) and semi‑sodium valproate (licensed for the treatment of acute mania and continuation treatment in people whose mania responds to treatment). Both semi‑sodium and sodium valproate are metabolised to valproic acid (also known as valproate), which is the pharmacologically active component.

Women of childbearing potential

Childbearing potential should be determined for women on an individual basis. It should not be determined solely by age because childbearing potential can be dependent on factors other than age. It includes girls and young women under 18 and pregnant women.

[Adapted from Antenatal and postnatal mental health (NICE guideline CG192)]

Equality and diversity considerations

When information is provided, there must be equal access to information for all women, including those with additional needs, such as physical or learning disabilities, and those who do not speak or read English. Women receiving information should have access to an interpreter or independent advocate if needed.