Abstract
INTRODUCTION: Prenatal exposure to valproate and related substances is associated with a risk of malformations and/or neurodevelopmental disorders. In France, prescription and dispensing conditions of oral valproate forms are subject to risk minimization measures for girls and women of childbearing potential with the aim to limit pregnancy under this treatment. These risk minimization measures were issued in 2015 and were strengthened in 2018. OBJECTIVE: We aimed to evaluate compliance with prescription and dispensing conditions of valproate for oral administration: an annual prescription from a specialist and a signed risk acknowledgment form. METHODS: Two prospective observational surveys were carried out between 2018 and 2020 on a representative sample of French community pharmacies. Data were collected from female patients aged 2-49 years presenting to one of the participating pharmacies with a valproate prescription. RESULTS: In total, 1067 and 824 valproate prescriptions were analyzed in 2018 and 2020, respectively, the majority of which were for girls and women of childbearing potential (≥ 92%). The prescription and dispensing conditions for valproate were met in 42% of cases (95% confidence interval 39-45) in 2018 and in 47% of cases (95% confidence interval 43-50) in 2020. Compliance levels were higher for prescriptions from neurologists (≥ 60%) than from other prescribers (≤ 45%). CONCLUSIONS: In France, the implementation of specific risk minimization measures for girls and women of childbearing potential with respect to oral valproate forms and related substances requires a stronger involvement of stakeholders. Increased awareness and compliance among healthcare professionals regarding risk minimization measures could limit prenatal exposure to valproate.