Medication During Pregnancy

Introduction

Medication use during pregnancy is common.

The safety of many medications for use in pregnancy has not been established at the moment that the medication is licensed because animal studies are seriously limited in their ability to predict human terato genesis and pregnant women are excluded from pre-marketing clinical trials in humans.
In addition, teratogenic effects in humans cannot be predicted reliably from the class of a drug or from what is known about its pharmacology and toxicology.
Many medications are subject to contraindications or special warning be cause they have not been sufficiently studied during pregnancy to know the possible risks.
For women with chronic diseases where medication use is essential to their health and to the health of their fetus, uncertainty about medication safety particularly needs to be addressed.

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:

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.

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

The University of Groningen 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.

Relevant EUROCAT Reports

Will be available soon

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