PARLIAMENTARY WRITTEN QUESTION
Epilepsy: Pregnancy (23 February 2021)

To ask the Secretary of State for Health and Social Care, if he will take steps to immediately extend the Medicines and Healthcare products Regulatory Agency and NHS Digital's Medicines in Pregnancy Valproate Registry to include all anti-epileptic drugs.

Asked by:
Marsha De Cordova (Labour)

The Medicines and Healthcare products Regulatory Agency (MHRA) is working with NHS Digital to develop a registry to monitor the use of valproate and compliance with the current regulatory position, and to monitor any children born to women on valproate. A report detailing the findings from the first stage of the registry was published in January. Work is now ongoing to extend the registry to include to women in the devolved administrations. As recommended in the Independent Medicines and Medical Devices Safety Review (IMMDSR), it will be further developed to include all women prescribed an antiepileptic drug. This has been prioritised within the next phase of development.

The conclusions of the Commission on Human Medicines’ safety review of epilepsy medicines in pregnancy were communicated publicly to support decisions around the best treatment options for girls and women. These communications were via the MHRA’s Drug Safety Update bulletin, an accompanying public assessment report and a patient safety leaflet. A news release and social media accompanied the publication alongside email alerts that targeted relevant healthcare professionals, prescribing publications and professional organisations. The MHRA is also working with the National Institute for Health and Care Excellence, the Royal College of General Practitioners and the Association of British Neurologists to update relevant clinical guidance to reflect the findings of the review. The impact of this review and the uptake of communications will be monitored and consideration be given to the need for further communications to healthcare professionals.

The Department, through the National Institute for Health Research (NIHR) funds a range of research in maternal and neonatal health focussing on the safety of maternity and neonatal services, and the national maternity ambition to halve maternal deaths, stillbirths and neonatal deaths and brain injury by 2025. The NIHR has funded three studies on anti-epilepsy medication use during pregnancy. The NIHR welcomes funding applications for research into any aspect of human health, including safer medicines for pregnant women with epilepsy.

Answered by:
Ms Nadine Dorries (Conservative)
4 March 2021