Valproate: new regulatory measures for oversight of prescribing to new and existing patients

9 February 2024 (Updated 2 July 2025)

Sodium valproate, valproic acid and valproate semisodium (valproate) are drugs that can be used to treat epilepsy and bipolar disorder. They are also sometimes used for other conditions.

In November 2023, a National Patient Safety Alert was issued, and an NHS programme of support was launched to make the use of valproate as safe as possible. The programme’s aim was to eliminate the harm valproate can cause to a baby exposed to the drug in pregnancy, whilst providing the best possible personalised care for patients with conditions treated with valproate. 

In September 2024, guidance was issued for male patients following a study which has indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children. 

Information for patients

It is very important that patients do not stop taking valproate without advice from a healthcare professional. Patients should discuss concerns about the risks of valproate, with their doctor, pharmacist or another healthcare professional.

Men and Women are required to always use contraception when taking valproate. Contraception should also be taken for 3 months after stopping valproate. 

Information for clinicians and staff

The Medicines and Healthcare Products Regulatory Agency (MHRA) patient safety alert states that:

  • Valproate should only be considered as a treatment option for both women and men if all other treatment options have proved ineffective or are not tolerated. 
  • If Valproate is being considered, both women and men should be counselled by an appropriate health care professional to inform them of the risks. 
  • To initiate prescribing of valproate in all patients under the age of 55, two specialists are required to independently consider and document that there is no other effective treatment option.
  • Women already taking valproate need two specialists to independently agree that sodium valproate is the most effective treatment for their epilepsy. This procedure is not currently required for men already taking valproate.
  • Men and Women are required to always use contraception when taking valproate. Contraception should also be taken for 3 months after stopping valproate. 

Cheshire and Merseyside response 

In response to the alert and subsequent national guidance and resources, a Cheshire and Merseyside Valproate Programme was established to provide a co-ordinated approach across primary and secondary care. The programme consisted of neurologists, psychiatrists, paediatricians, GPs, pharmacists and data and digital support who have collaborated to develop a Cheshire and Merseyside Valproate dashboard and Prescribing Guidance document and resources.

Resources

The prescribing guidance document has been approved by the Cheshire and Merseyside Area Prescribing Group and Medicines Optimisation and Pharmacy Group.

The document consists of:

  • Links to national guidance
  • Contraception information
  • Recommended Snomed codes to use in electronic health records
  • Roles and responsibilities for primary and secondary care
  • Secondary care template letter
  • Visual guides
  • Easy read Patient information leaflet

The Cheshire and Merseyside Valproate dashboard uses primary care data to identify patients on Valproate. The dashboard can be filtered by PCN, GP practice, age, patient number, medication type, most recent medication data, flag for recent medication, QOF register, ARAF referral and ARAF completion. 

Access to the dashboard can be requested by providing your name, role, organisation and reason for access to: cipha.support@cheshireandmerseyside.nhs.uk.