Databases
EUROmediCAT has mainly focused on studies of risk of congenital anomaly, and studies of drug utilisation in pregnancy. However, the EUROmediCAT network now also researches other pregnancy outcomes, and uses a variety of methodological approaches to study medication safety in pregnancy.
The EUROmediCAT Central Database
Population-based congenital anomaly registries contributing their data to the EUROmediCAT Central Database are members of EUROCAT (European Surveillance of Congenital Anomalies). Only EUROCAT member registries which collect medication exposure information participate in EUROmediCAT - currently 19 registries from 14 countries. A description of each member registry is available at http://www.euromedicat.eu/content/Partners-Registry-Descriptions-February-2017.pdf.
Cases of congenital anomaly include livebirths, stillbirths and fetal deaths from 20 weeks gestation, and terminations of pregnancy for fetal anomaly (of any gestational age). The inclusion of terminations of pregnancy is a vital component of valid population-based congenital anomaly data. Member registries transmit a standard dataset that includes anonymised individual records containing information on the mother and baby, diagnosis, first trimester medication exposures, maternal illness and family history, as described in EUROCAT Guide 1.4. Medication exposure is coded to the WHO Anatomical Therapeutic Chemical (ATC) classification. Medication exposure is usually obtained from medical records created during pregnancy, but some registries use additional sources such as maternal interview, or prescription records, as described in the Member Registry Descriptions.
Registries use common software to transmit data to the central database.
Data are available from 1995, and are transmitted yearly (e.g. all data from 2017 births would be transmitted by October 2019). By the end of 2021, the EUROmediCAT Central Database covered a population of 13.2 million births from 1995-2019, and contained data on 35,931 congenital anomaly cases with one or more medication exposures in the first trimester of pregnancy (excluding vitamins and minerals). Annual surveillance now covers approximately 750,000 births per year throughout Europe.
Total Prevalence rates, Prevalence rates and Livebirth Prevalence rates of all EUROCAT congenital anomaly subgroups in EUROmediCAT registries are available at the EUROCAT website and a summary table can be viewed here.
The EUROmediCAT Central Database is held at Ulster University.
The EUROmediCAT Central Database can be used for signal evaluation and signal detection studies, using a case-control design with malformed controls. No data on non-malformed babies is held centrally, Examples of published studies using this database relating to antiepileptics, SSRIs and antiasthmatics can be found at www.EUROmediCAT.eu/publicationsandpresentations.
The EUROmediCAT Distributed Database
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. Click here to see all of the partners able to provide linked data. 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 FP7 EUROmediCAT Research Programme piloted and validated data linkage. This is described in WP3: Prescription Data Linkage
Funded studies can now access more recent data, and data from more participating registries which have developed this capacity.
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).
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. Click here to see more details. 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
Five countries are currently able to conduct collaborative drug utilisation studies following a common protocol (UK, Netherlands, 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.
This approach was sucessfully used in Workpackage 6 of teh FP EUROmediCAT Programme, for antiepileptic, antidiabetic, antidepressant and antiasthmatic medications (www.EUROmediCAT.eu/publicationsandpresentations).