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

ABSTRACT:

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

SUBMITTER: Toussi M 

PROVIDER: S-EPMC7894134 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature