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Medication Introduction

 

 

Introduction

The general goal is to develop a European reproductive pharmacovigilance system

The potential for this pharmacovigilance system has been proved by recent studies concerning antiepileptic drugs. In 2007, EUROCAT created a EUROCAT Antiepileptic Study Database including data from 19 registries, 1995-2005. This dataset was used to conduct a case-control study evaluating the risk of orofacial clefts in relation to lamotrigine exposure.  (Dolk, 2008). Studies related to Valproic Acid (VPA) (Jentink, 2010) and Carbamazepine  (Jentink 2010) and specific birth defects were recently published. Further funding from Glaxo Smith Kline has been obtained to continue the Lamotrigine Study to 2013.

Objectives

 

The main objective for the EUROCAT Joint Action, WP9, is to develop the conditions for a European monitoring system for safety of medication use in pregnancy, whereby signal detection and implementation can be performed, mainly using case-malformed control study designs. This involves updating and analyzing existing data, enabling more registries to provide medication exposure data and improving medication data quality.

 

The following 19 registries contribute data on medication use to the central database:


Belgium, Antwerp

Belgium, Hainaut-Namur
Croatia, Zagreb

Denmark, Odense

France, Paris

France, Strasbourg

Germany, Mainz

Germany, Saxony-Anhalt

Ireland, Cork & Kerry

Italy, Tuscany

Italy, EmiliaRomagna

Malta

Netherlands, North

Norway

Poland

Poland, Wielkopolska

Spain, Basque Country

Switzerland, Vaud

UK, Wales


Data Quality

The EUROCAT central database has been modified to allow ATC drug codes for cases born from 1995 (or the first year medication exposure information was routinely recorded by the registry).

A EUROCAT data quality indicator (DQI) was introduced in 2012 to assess if registries record medication exposure in the first trimester of pregnancy using ATC coding . Further data quality indicators will be developed to improve data collection on medication exposure within the EUROCAT database.

 

University of Groningen is a partner in the PROTECT consortium funded by the IMI led by EMA. As partner to this project, the University of Groningenwill seek to make it relevant to EUROCAT's work on improving information about drug exposure during pregnancy.


Relation to other networks

 

EUROCAT Central Registry at the University of Ulster with the University of Groningen were involved in the European Network of Centres for Pharmacoepidemiology (ENCCeP) of the European Medicines Agency (EMA),  an important forum for pharmacovigilance, to develop a code of conduct for scientific independence and transparency, particularly for industry funded pharmacovigilance studies.  EUROCAT seeks to maintain the highest standards of scientific independence and transparency, in accordance with the ENCePP Code of Conduct.  The ENCePP Code of Conduct - http://www.encepp.eu/documents/encepp_studies/ENCePP%20Code%20of%20Conduct_20100507.pdf

 

The University of Groningenen and the UMCG are members of the Special Interest Group on Medication in Pregnancy from the ISPE. EUROCAT has organised a joint symposium on ‘Biases to consider when studying the risk of medication use in pregnancy’ with ENTIS at the annual meeting of the ISPE, in 2012 in Barcelona.