From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother-child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population

Adjusted trajectory of medication exposure taking into account the periodicity of dispensations and the number of dispensed packs and comparative analysis on EFEMERIS database

We presented an adjustment method for the calculation of medication exposure trajectories based on the number of dispensed packs and the type of dispensations (occasional or regular). A comparative study based on the EFEMERIS data was carried out using three different scenarios of trajectory calculation depending on whether or not the number of packs and the periodicity of medication dispensations were taken into account. The impact of the scenario was highlighted using global indicators on the number of Define-Daily Dose on all women exposed; the study of changes in individual trajectories from one scenario to another was carried out; we also compared the results of a clustering into four groups. If 65% of the trajectories remained unchanged, we could observe on the rest significant changes in number of DDD and/or on individual exposure profile. We observed 4% of trajectories that were attributed to a different cluster, and the clustering was of better quality with the adjustment method. Depending on the study context, an impact on cluster distribution could be observed for some maternal characteristics and neonatal outcomes. This was the case for a higher occurrence of neonatal pathology for neonates from mothers belonging to the cluster with high doses of psychotropics, thus reinforcing the conclusions of previous studies of a link between high exposure to psychotropic medications and presence of pathology for the newborn.</div