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

9 February 2024 (Updated 24 October 2024)

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 NHS programme of support was launched to make the use of valproate as safe as possible. The programme’s aim is 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.

A National Patient Safety Alert was issued on the 28th of November 2023 mandating healthcare organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients.

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 either women under the age of 55 or men, two specialists are required to independently consider and document that there is no other effective treatment option.
  • Women already taking valproate, will need two specialists to independently agree that sodium valproate remains 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

ICBs need to ensure that there is a co-ordinated approach across primary and secondary care to implement these measures and that all actions outlined within the alert have been implemented. Please click here to access the actions within the alert.

Approach

A Steering Group has been developed to co-ordinate a Cheshire and Merseyside response. Representation includes:

  • Neurology
  • Psychiatry
  • Paediatrics
  • Primary care
  • Pharmacy
  • Business Intelligence and CIPHA / Data into Action Group
  • Operational support

The monthly Steering Group is led by Professor Marson, Professor of Neurology at the Walton Centre. Task and Finish groups have also been established to support the data, digital, and prescribing workstreams.