What is EUROmediCAT?
EUROmediCAT is a European research consortium dedicated to improving medication safety in pregnancy. Its aim is to build a European system for the evaluation of safety of medication use in pregnancy in relation to the risk of congenital anomalies. The EUROmediCAT consortium started work on 1 March 2011 with financial support provided by the European Union under the 7th Framework Program (grant agreement HEALTH-F5-2011-260598). This initial funding was for 4 years duration. It was established as a daughter project to EUROCAT (European Surveillance of Congenital Anomalies. Information about achievements of EUROmediCAT 2011-2015 can be found under FP7 EUROmediCAT. Since then, EUROmediCAT has diversified its funding sources, as can be seen under EUROmediSAFE and Current Research Projects and is working to establish sustainable infrastructure funding.
Rationale
Teratogenicity - risk of congenital anomaly - is of major importance in decisions about drug safety in pregnancy. When drugs are licensed for marketing, information with respect to reproductive toxicity is only available from pre-marketing animal studies which are seriously limited in their ability to predict human teratogenesis. Moreover, pregnant women are excluded from pre-marketing clinical trials in humans, so the safety of many drugs in pregnancy has not been established at the moment that a drug is licensed. Post-marketing surveillance of teratogenic effects in humans is essential. Many drugs are subject to contraindications or special warning because they have not been sufficiently studied during pregnancy to know the possible risks. Pregnant women with chronic diseases such as diabetes, epilepsy, asthma and depression need treatment during pregnancy, and safety information about the drug classes relating to these chronic diseases is a particular priority. Furthermore, as many pregnancies in Europe are unplanned, some drugs may be taken unintentionally during organogenesis before the pregnancy has been recognised, and safety issues related to such use need evaluation.
To address these issues, it is important to build a systematic post-marketing surveillance system to evaluate safety of drugs in pregnancy so better information can be provided to health care professionals and patients. Congenital anomaly registries, which have their early origins in the wake of the Thalidomide disaster with the aim of detecting a possible new teratogen at the earliest stage possible, are a crucial part of such a post-marketing surveillance system. This project is built on an existing network of congenital anomaly registries, the European Surveillance of Congenital Anomalies (EUROCAT) network. Innovative approaches are being tested to link congenital anomaly registries to exposed pregnancy cohorts, and to healthcare databases.
Providing better information on teratogenicity is one part of improving medication safety in pregnancy. Clinicians and women alter their decisions regarding medication choice in pregnancy as a result of safety information available, and it is important to monitor the resulting trends in the prevalence of medication use in pregnancy, using healthcare databases. For drugs which are known teratogens with such a high risk that pregnancy must be avoided, pregnancy prevention programs (PPPs) have been developed. The efficacy of existing PPPs needs to be evaluated together with the reasons for success or failure. The use of the internet by pregnant women in Europe is growing, and can provide both access to teratogenic drugs, and to safety information about drugs. The growing role of the internet needs evaluation to develop appropriate medication safety measures.
The central aim of EUROMEDICAT is to build a European system for reproductive safety evaluation, which enables us to identify systematically and comprehensively the possible adverse effects in pregnancy of a drug in humans at the earliest stage post marketing, and enables us to monitor and evaluate safety measures undertaken in Europe.