Abstract

Valproate (VPA) is a known teratogen associated with greater risk of major congenital malformations and other neurodevelopmental sequelae than all other licensed antiepileptic medicines. To reduce the potential for VPA-related teratogenicity, the European Medicines Agency issued recommendations in 2018. Over two-thirds of women/girls with intellectual disability (ID) may have treatment-resistant epilepsy that could benefit from VPA treatment. This investigation compared VPA prescribing practice for women/girls with ID between European countries, specifically evaluating the practice in the UK with that in other countries. An expert working group with representation from key stake-holding organizations developed a survey for dissemination to relevant professionals across Europe. Seventy one responses were received (27 UK, 44 Europe). Clinicians in the UK were more likely to report that they are working to mandatory regulations compared with European respondents (P=.015). European respondents were less likely to be aware of user-independent contraception options (P=.06). In The UK, VPA regulations were more likely to be applied to women with ID than in Europe (P=.024). There is heterogeneity in the application of VPA regulations across Europe for women/girls with ID. In both the UK and Europe, the regulations lack suitable adjustments for specific ID-related factors.

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