Valproate Integrated Quality Improvement

A national programme of support for integrated care boards was launched in November 2023 to make use of valproate as safe as possible, striving to eliminate the harm it causes to babies in the womb, while providing the best possible personalised care for patients and preventing deaths from epilepsy and/or bipolar disorders.

Valproate Integrated Quality Improvement (VIQI) is supporting the implementation of the recommendations of the Independent medicines and medical devices safety (IMMDS) review, published in July 2020, and recommendations from the Patient safety commissioner, published in 2023.

The risks of valproate in pregnancy

Sodium valproate is a medicine that can be used to treat epilepsy and bipolar disorder. It is also sometimes used for other conditions.

It is very important that you do not stop taking valproate without advice from a healthcare professional. If you are concerned about the risks of valproate, talk to your doctor, pharmacist or another healthcare professional.

While effective and safe for many people who have epilepsy and/or bipolar disorder, there are high risks if valproate is taken while pregnant. It can harm the baby in two ways:

• birth defects when the baby is born
• problems with development and learning, including being late in learning to walk and talk, lower intelligence than other children of the same age, and memory problems as the child grows up.

There is also some concern that babies who are born to men who take valproate in the three months before conception may also have problems with development and learning. This concern is being investigated by the Medicines and Healthcare Products Regulatory Agency (MHRA).

Valproate Integrated Quality Improvement programme aims

To help prevent this harm, the VIQI has committed to exploring these areas:

• ensuring shared decision making is in place wherever valproate is prescribed
• ensuring patients who take valproate have access to highly effective contraception, sexual health advice and support with family planning
• reducing the prescribing of valproate for mental health conditions if there are effective alternatives
• making sure everyone gets the same level of care and protection.

Supporting activity

VIQI follows on from the work of a former NHS England led programme around the safety of valproate.

The work of that programme included:

• sending a letter to all women and girls aged 12 and over who have a current prescription for valproate.
• developing a set of prescribing indicators to monitor the use of valproate medicines among people who can get pregnant. The Valproate Safety Dashboard makes monitoring valproate use straight forward for patients, the public and health professionals.
• publishing the Medicines in Pregnancy Registry to monitor the number of people who give birth and have taken valproate, in a month in which they were pregnant.
• co-producing accessible information materials and risk communications with patients. Shared decision tools have been published for people with bipolar disorder or epilepsy to help them understand the potential risks and benefits of valproate and support them to decide whether to start, or continue taking it.
• ensuring valproate is dispensed safely, with original packing, clear warnings and in line with Medicines and Healthcare Products Regulatory Agency (MHRA) requirements.

Other resources

• Valproate use by women and girls – MHRA webpage on the risks of taking valproate medicines during pregnancy. This page includes patient leaflets, details of patient support networks and clinical resources.
• information on sodium valproate on the nhs.uk website.

Further information

If you are a clinician or patient representative and have any queries about the VIQI, please email patientsafety.enquiries@nhs.net.

Please note we are not able to review any individual cases; if you are currently taking valproate and have any questions or concerns, please speak to your GP.