This webpage is for the communication of Valproate related changes as per the recent MHRA regulations.
What is changing?
Requirements for initiating patients on Valproate medicines is changing. The process to initiate and annual risk assessment form processes have changed.
Who does this affects?
This affects all clinicians that use or come into contact with Valproate containing medicines. As the process changes, and stricter rules are in place to ensure patients are on the correct medicine, the assurance that these governance processes are being adhered to are pertinent. Patients will also be affected, and may have more questions about their valproate containing medicines.
When are the changes taking place?
These changes take from January 2024.
How will things work in the future?
This will affect the process of the way new patients are started on Valproate containing medicines under the age of 55 years old. The requirements for the annual risk assessment forms have changed and assurance around these practices are required by the MHRA.
What should we do?
Clinicians’ initiating or reviewing patients on Valproate containing medicines must review and follow the guidance below, to ensure compliance with the MHRA regulatory changes.
Valproate clinical and digital task and finish groups have been set up locally, regionally, and nationally to support this work. If you would like to get involved or would like any further information, please contact: MSO
The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semi-sodium (valproate). This follows a comprehensive review of safety data, advice from the Commission on Human Medicines and an expert group, and liaison with clinicians and organisations. Due to the known significant risk of serious harm to a baby after exposure to valproate in pregnancy, these measures aim to ensure valproate is only used if other treatments are ineffective or not tolerated, and that any use of valproate in women of childbearing potential who cannot be treated with other medicines is in accordance with the Pregnancy Prevention Programme (PPP). Given these and other risks of valproate, these measures also aim to reduce initiation of valproate to only in patients for whom no other therapeutic options are suitable.
The regulatory change in January 2024, for oral valproate medicines, means that:
A. Valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
B. At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes.
List of roles that could fulfil the second signatory:
Page 66: Valproate-report-review-and-expert-advice.pdf (publishing.service.gov.uk)
QPAs on Valproate: Medicines Safety :: YourSpace Mersey Care
Medication safety page: Medicines Safety :: YourSpace Mersey Care