Dear Colleagues
As you know the Cumberlege report was published in July 2020. One of the topics of the report was valproate and the teratogenic risk in women of childbearing potential.
The ABN has been engaging with various regulatory bodies, including the MHRA and its valproate stakeholders group, to improve safety surrounding the prescription of valproate in women of childbearing potential. Despite all the publicity and messages to healthcare professionals, there are several reports from patient organisations highlighting poor practice, for example patients still not informed or aware of the risks. A recent survey by three epilepsy charities (Epilepsy Action, Epilepsy Society and Young Epilepsy) found that nearly 20% of women taking valproate were still not aware of the teratogenic risks and that only 41% had signed up to the Pregnancy Prevention Programme. Surveys of specialist clinicians (Angus-Leppan et al 2020 doi:10.1111/ANE.13231) report that around 43% of clinicians estimate that all, and 31% that most, women under their care had completed the annual risk acknowledgement form. There have been further updates of the MHRA information material and annual risk acknowledgment form since this survey.
The aim of the current evaluation is to ask all neurologists to audit their services to obtain reliable data on current practice among British neurologists, so that we can provide robust and meaningful data to MHRA and other organisations about our own practice. This can be done on an individual or departmental level.
To facilitate this, we have developed a simple audit tool:
Part A: Click here for sample of audit form that neurologists/department can use for each individual patient when reviewing all cases under their care.
Part B: Click here to submit aggregated (not individual patient) data to the ABN Valproate Working Group after the local audit.
We will then collate findings from across the country to complement the patient surveys with data from clinicians, informing discussions and demonstrating our engagement with this important process.
Please do not hesitate to contact us should you have any questions or comments regarding the audit.
Sofia Eriksson and Sanjay Sisodiya for the ABN Valproate Working Group
