National compliance with UK wide guidelines for usage of valproate in women of childbearing potential. (May 2022)

• Record Type: Journal Article
• Authors: Eriksson, SH; Tittensor, P; Sisodiya, SM
• Is Part Of: Seizure. Volume 98(2022)
• Page Start: 8
• Page End: 12
• Publication Date: 2022-05
• Subjects: Valproate -- Pregnancy -- Epilepsy -- Teratogenicity -- Guidelines; Epilepsy -- Periodicals; Epilepsy -- Periodicals; Seizures -- Periodicals; Épilepsie -- Périodiques; Electronic journals; Electronic journals; 616.853
• DOI: 10.1016/j.seizure.2022.03.020
• Languages: English
• ISSNs: 1059-1311

Abstract

Highlights: For most women, there was documentation in the notes that they had been informed about the risks associated with taking valproate during pregnancy (93.1%) and the need to be on highly effective contraception or that this was not deemed appropriate (92.2%). A signed annual risk acknowledgement form (ARAF) was available in the notes for 81.2% of the women but only 66% of these were completed in the last year. Although many women seemed to have received appropriate information, there were still a proportion for whom that was not the case, highlighting the need for further work from clinicians and regulators to facilitate identification of women taking valproate and implementation of a digital ARAF. For clinicians the audit highlights a need to carefully counsel women about the teratogenic risks of continuing to take valproate versus the risk of deteriorating seizure control if the drug is withdrawn and create a partnership of trust with the patient in order to arrive at the best clinical decision for that individual. Abstract: Valproate (VPA) is an effective treatment for epilepsy and also used in bipolar disorder. However, VPA is associated with a significant risk of birth defects and developmental disorders if used during pregnancy. This has led to the introduction of measures to reduce the use of valproate in women of childbearing potential such as the 'Prevent' pregnancy prevention program (PPP) and the completion of an annual risk acknowledgement form (ARAF). The aim of the current audit was to assess compliance with the guidance. An audit tool was made available to neurologists registered with the Association of British Neurologists (ABN) and to epilepsy nurse specialists via the Epilepsy Nurses Association (ESNA) in the UK. Data were collected between November 2020 and March 2021. The main indication for valproate was generalised epilepsy (55.8%), followed by focal (22.5%). For most, there was documentation that the woman had been informed about the risks associated with taking valproate during pregnancy (93.1%) and the need to be on highly effective contraception or that this was not deemed appropriate (92.2%). A signed ARAF was available in the notes for 81.2% although only 66% were <12 months old. Although information had been made available for most women, there were still individuals where this was not documented. Further work is needed to facilitate identification of women taking valproate and implementation of a digital ARAF. For clinicians, the audit highlights a need to carefully counsel women about the teratogenic risks of continuing to take valproate versus the risk of deteriorating seizure control if the drug is withdrawn. This is particularly true of women with focal epilepsy, where there may be safer, equally effective, alternative anti-seizure medication (ASM). The aim should be to create a partnership of trust between the patient and clinician in order to arrive at the best clinical decision for that individual.