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Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe

PURPOSE: The purpose of this study was to evaluate the effectiveness of the risk minimisation measures (RMMs) implemented in Europe in 2014 for valproate‐containing products to mitigate their risk during pregnancy and to characterise valproate prescribing patterns in women of childbearing potential...

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Autores principales: Toussi, Massoud, Shlaen, Margarita, Coste, Florence, de Voogd, Hanka, Dimos, Vasilis, Kaplan, Sigal
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7894134/
https://www.ncbi.nlm.nih.gov/pubmed/33108674
http://dx.doi.org/10.1002/pds.5166
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author Toussi, Massoud
Shlaen, Margarita
Coste, Florence
de Voogd, Hanka
Dimos, Vasilis
Kaplan, Sigal
author_facet Toussi, Massoud
Shlaen, Margarita
Coste, Florence
de Voogd, Hanka
Dimos, Vasilis
Kaplan, Sigal
author_sort Toussi, Massoud
collection PubMed
description PURPOSE: The purpose of this study was to evaluate the effectiveness of the risk minimisation measures (RMMs) implemented in Europe in 2014 for valproate‐containing products to mitigate their risk during pregnancy and to characterise valproate prescribing patterns in women of childbearing potential (WCBP) before and after implementation of RMMs. METHODS: A multinational cohort study based on existing data sources using a pre‐/post‐ design was performed in five European countries (France, Germany, Spain, Sweden, UK) in an outpatient setting. Effectiveness of RMMs was assessed by comparing the proportion of valproate initiations as second (or subsequent) line therapy before and after implementation of RMMs (primary outcome) with an increase in this proportion indicating success of RMMs. Overall use of valproate and incidence of pregnancies in WCBP were also examined. RESULTS: The proportion of valproate initiations as second line therapy increased after implementation of RMMs in incident female users in Sweden (from 81.1%, 95% CI 79.9%‐82.3% to 84.5%, 95% CI 83.5%‐85.5%) and the UK (from 66.4%, 95% CI 64.5%‐68.3% to 72.4%, 95% CI 70.0%‐74.9%), it remained the same in Germany and Spain and decreased in France from 48.7% (95% CI 45.6%‐51.9%) to 40.6% (95% CI 37.6%‐43.7%). In Sweden and the UK, the incidence of pregnancies exposed to valproate decreased in the post‐implementation period: 8.0 vs 9.5 and 10.9 vs 16.9 per 1000 person‐years, respectively. CONCLUSION: The results on primary outcome of this study suggest limited effectiveness of the RMMs. Additional RMMs were implemented in 2018.
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spelling pubmed-78941342021-03-02 Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe Toussi, Massoud Shlaen, Margarita Coste, Florence de Voogd, Hanka Dimos, Vasilis Kaplan, Sigal Pharmacoepidemiol Drug Saf Original Articles PURPOSE: The purpose of this study was to evaluate the effectiveness of the risk minimisation measures (RMMs) implemented in Europe in 2014 for valproate‐containing products to mitigate their risk during pregnancy and to characterise valproate prescribing patterns in women of childbearing potential (WCBP) before and after implementation of RMMs. METHODS: A multinational cohort study based on existing data sources using a pre‐/post‐ design was performed in five European countries (France, Germany, Spain, Sweden, UK) in an outpatient setting. Effectiveness of RMMs was assessed by comparing the proportion of valproate initiations as second (or subsequent) line therapy before and after implementation of RMMs (primary outcome) with an increase in this proportion indicating success of RMMs. Overall use of valproate and incidence of pregnancies in WCBP were also examined. RESULTS: The proportion of valproate initiations as second line therapy increased after implementation of RMMs in incident female users in Sweden (from 81.1%, 95% CI 79.9%‐82.3% to 84.5%, 95% CI 83.5%‐85.5%) and the UK (from 66.4%, 95% CI 64.5%‐68.3% to 72.4%, 95% CI 70.0%‐74.9%), it remained the same in Germany and Spain and decreased in France from 48.7% (95% CI 45.6%‐51.9%) to 40.6% (95% CI 37.6%‐43.7%). In Sweden and the UK, the incidence of pregnancies exposed to valproate decreased in the post‐implementation period: 8.0 vs 9.5 and 10.9 vs 16.9 per 1000 person‐years, respectively. CONCLUSION: The results on primary outcome of this study suggest limited effectiveness of the RMMs. Additional RMMs were implemented in 2018. John Wiley & Sons, Inc. 2020-11-23 2021-03 /pmc/articles/PMC7894134/ /pubmed/33108674 http://dx.doi.org/10.1002/pds.5166 Text en © 2020 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Toussi, Massoud
Shlaen, Margarita
Coste, Florence
de Voogd, Hanka
Dimos, Vasilis
Kaplan, Sigal
Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe
title Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe
title_full Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe
title_fullStr Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe
title_full_unstemmed Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe
title_short Effectiveness of risk minimisation measures for valproate: A drug utilisation study in Europe
title_sort effectiveness of risk minimisation measures for valproate: a drug utilisation study in europe
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7894134/
https://www.ncbi.nlm.nih.gov/pubmed/33108674
http://dx.doi.org/10.1002/pds.5166
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