Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study.

ABSTRACT:

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. Inci

SUBMITTER: Abtahi S 

PROVIDER: S-EPMC10252161 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature