Quality standard
Quality statement 1: Valproate
Quality statement 1: Valproate
Quality statement
Women and girls 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% to 40% of babies) and congenital malformations (approximately 10% of babies).
Valproate must not be used in pregnancy. It must not be used in girls and women of childbearing potential (including young girls who are likely to need treatment into their childbearing years) unless other options are unsuitable and a pregnancy prevention programme in place, in line with the MHRA safety advice on valproate. This is because of the risk of malformations and developmental abnormalities in the baby.
The MHRA has published temporary advice on the valproate pregnancy prevention programme during the COVID-19 pandemic.
Quality measures
The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.
Structure
Evidence of practice arrangements and written clinical protocols to ensure that women and girls of childbearing potential are not prescribed valproate to treat a mental health problem.
Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example clinical protocols.
Process
Proportion of women and girls 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 and girls who are of childbearing potential.
Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.
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: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.
What the quality statement means for different audiences
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 and girls 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 and girls of childbearing potential to treat a mental health problem.
Commissioners of primary care and specialist and general mental health services specify within contracts that providers should not prescribe valproate to women and girls of childbearing potential to treat a mental health problem.
Women and girls who may become pregnant or who are pregnant should not be prescribed a medication called valproate to treat a mental health problem because it can harm unborn babies.
Source guidance
Antenatal and postnatal mental health. NICE guideline CG192 (2014, updated 2020), recommendations 1.2.3 and 1.4.27
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.
Valproate must not be used in pregnancy. It must not be used in girls and women of childbearing potential (including young girls who are likely to need treatment into their childbearing years) unless other options are unsuitable and a pregnancy prevention programme in place, in line with the MHRA safety advice on valproate. This is because of the risk of malformations and developmental abnormalities in the baby.
The MHRA has published temporary advice on the valproate pregnancy prevention programme during the COVID-19 pandemic.
Women and girls of childbearing potential
Childbearing potential should be determined for women and girls 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. It also includes younger girls who are likely to need treatment into their childbearing years. [Adapted from NICE's guideline on antenatal and postnatal mental health]
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.