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Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France

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...

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Autores principales: Fauvelle, Khristina, Bigna, Jean Joel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9607717/
https://www.ncbi.nlm.nih.gov/pubmed/36287388
http://dx.doi.org/10.1007/s40264-022-01234-8
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author Fauvelle, Khristina
Bigna, Jean Joel
author_facet Fauvelle, Khristina
Bigna, Jean Joel
author_sort Fauvelle, Khristina
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40264-022-01234-8.
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spelling pubmed-96077172022-10-28 Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France Fauvelle, Khristina Bigna, Jean Joel Drug Saf Original Research Article 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40264-022-01234-8. Springer International Publishing 2022-10-26 2023 /pmc/articles/PMC9607717/ /pubmed/36287388 http://dx.doi.org/10.1007/s40264-022-01234-8 Text en © The Author(s) 2022, corrected publication 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Fauvelle, Khristina
Bigna, Jean Joel
Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
title Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
title_full Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
title_fullStr Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
title_full_unstemmed Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
title_short Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
title_sort compliance with prescribing and dispensing conditions for valproate and related substances in girls and women of childbearing potential: a survey of community pharmacists in france
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9607717/
https://www.ncbi.nlm.nih.gov/pubmed/36287388
http://dx.doi.org/10.1007/s40264-022-01234-8
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