The EUROmediCAT Distributed Database
Click here to see a description of the partner databases where congenital anomaly registers can be linked to healthcare databases.
Some EUROmediCAT Registries are able to link congenital anomaly registries to electronic prescription databases or healthcare databases containing prescription data. This enhances the medication data available in terms of ascertainment of potential exposure, and detail of type of medication, timing and dose. The data are held in each country, not centrally, for data protection reasons. However, they are analysed using a common protocol, and the results combined centrally. For studies using data on cases of congenital anomaly only, a common software is available, developed under FP7 EUROmediCAT.
The EUROmediCAT Distributed Database can be used in addition to, or in place of, the EUROmediCAT Central Database. It can be used for signal detection or signal evaluation studies using a case-malformed control approach. In some coutnries, it is possible to obtain data also on non-malformed babies (see Population Linked Cohorts section below).
It has been used in subsequent studies, see publications.
Disease Cohorts
Seven countries are able to participate in multi-country studies which establish a cohort of pregnant women with a specific disease, where this cohort is linked to the congenital anomaly registry. Medication exposure and other data relevant to the disease of interest are recorded to allow confounding by indication to be addressed. This provides data on the congenital anomaly rate in the exposed and unexposed population. This approach was successfully piloted for a study of insulin analogs in women with diabetes in Workpackage 4 of the FP7 EUROmediCAT Programme, in which a retrospective cohort of more than 1,600 women with diabetes was constructed. This study design is suitable where the exposure is relatively rare, where women with the disease in qestion are treated in specialist centres, and where details information related to the disease is required.
Population Linked Cohort
Eight countries (Norway, Denmark, Wales, Italy - two regions, Spain - one region, Sweden, Finland, France -one region) are currently able to link congenital anomaly registry data on all pregnancies in their population, including medication exposure. This means data is available on all pregnancy outcomes, not just babies with congenital anomalies. Data are held in each country, not centrally, but results are combined. This approach was successfully employed in the FP7 EUROmediCAT Programme to study antiasthmatic and SSRI exposures and currently within the IMI ConcePTION project. (www.EUROmediCAT.eu/publicationsandpresentations).
Electronic Healthcare Databases for studies of Drug Utilisation in Pregnancy
Six countries are currently able to conduct collaborative drug utilisation studies following a common protocol (UK, Netherlands, Spain, Italy, France and Denmark). These studies examine the proportion of pregnant women receiving/redeeming prescriptions for selected medications before pregnancy, during pregnancy (by trimester) and after pregnancy.