作者
Shahab Abtahi, Romin Pajouheshnia, Carlos E Durán, Judit Riera-Arnau, Magdalena Gamba, Ema Alsina, Vjola Hoxhaj, Morten Andersen, Claudia Bartolini, Sarah Brøgger Kristiansen, Jeremy Brown, Christine Erikstrup Hallgreen, Patricia Garcia-Poza, Helga Gardarsdottir, Rosa Gini, Anna Girardi, Emily Holthuis, Consuelo Huerta, Luisa Ibánez, Giorgio Limoncella, Mar Martín-Pérez, Olga Paoletti, Giuseppe Roberto, Patrick Souverein, Karin MA Swart, Kevin Wing, Miriam Sturkenboom, Olaf Klungel
发表日期
2023/7
期刊
Drug Safety
卷号
46
期号
7
页码范围
689-702
出版商
Springer International Publishing
简介
Introduction
Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018.
Objectives
To investigate the effectiveness of the 2018 EU RMMs on valproate utilisation in five European countries/regions.
Methods
A multi-database, times series study of females of childbearing potential (12–55 years) was conducted using electronic medical records from five countries/regions (01.01.2010–31.12.2020): Denmark, Tuscany (Italy), Spain, the Netherlands, and the UK. Clinical and demographic information from each database was transformed to the ConcePTION Common Data Model, quality checks were conducted and a distributed analysis was performed using common scripts. Incident and prevalent use of valproate, proportion of discontinuers and switchers to alternative medicine, frequency of …
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