Valproate Safety Implementation Group
The clinically-led Valproate Safety Implementation Group (VSIG) has been established to coordinate a programme of work to reduce the use of valproate in people who can get pregnant by 50% by 2023, and to help prevent unplanned pregnancies in this group of patients.
The VSIG is supporting the implementation of the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review, published in July 2020, and brings together the relevant public bodies along with expert clinicians.
Three patient and public voice (PPV) representatives have also been recruited and appointed by NHS England and NHS Improvement to be members of the VSIG.
NHS England and NHS Improvement are working with the PPV representatives to engage patient groups and the public, including voluntary, charitable and community organisations, on the work being undertaken for the safer use of valproate in women of childbearing potential.
The risks of valproate during pregnancy
Sodium valproate is a drug that can be used to treat epilepsy and bipolar disorder. It is also sometimes used to prevent migraine headaches.
While very effective and safe for many patients, there are substantial 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.
VSIG programme aims
To help prevent this harm, the VSIG has committed to exploring three key areas:
- stopping initiation and deprescribing valproate where safer alternatives are available and making dispensing safer
- ensuring patients in this group who do take valproate have access to highly effective contraception, sexual and reproductive health advice
- ensuring shared decision making is in place wherever valproate is prescribed to people who can get pregnant.
The VSIG is leading on several initiatives to inform patients and to support healthcare providers and staff around the safe prescribing and management of valproate.
- 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.
- Developing better data sources to identify people who can get pregnant who take valproate.
- 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.
- The creation of a shared care protocol for valproate medicines for patients of child-bearing potential to improve patient safety and links between care settings.
- Ensuring valproate is dispensed safely, with original packing, clear warnings and in line with Medicines and Healthcare Products Regulatory Agency (MHRA) requirements.
- 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.
If you are a clinician or patient representative and have any queries about the VSIG, please email firstname.lastname@example.org.
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.