- 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 teratogenesis 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 because 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.
- We need postmarketing pharmacovigilance to verify the safety of medications used in pregnancy, or to alert us to any early signs of risks
The general goal is to develop a European reproductive pharmacovigilance system
- to provide early warning regarding risk of congenital anomalies related to medication,
- to test signals generated by pregnancy registers and other sources,
- to monitor whether known teratogens have been successfully avoided during pregnancy
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.
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:
Ireland, Cork & Kerry
Spain, Basque Country
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.