An inventory of European data sources to support pharmacoepidemiologic research on neurodevelopmental outcomes in children following medication exposure in pregnancy: A contribution from the ConcePTION project

Joanne Given, Rebecca Bromley, Florence Coste, Sandra Lopez-Leon, Maria Loane

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Studies on medication safety in pregnancy are increasingly focusing on child neurodevelopmental outcomes. Establishing neurodevelopmental safety is complex due to the range of neurodevelopmental outcomes and the length of follow-up needed for accurate assessment. The aim of this study was to provide an inventory of European data sources for use in pharmacoepidemiologic studies investigating
neurodevelopment following maternal medication exposure.
The EUROmediSAFE inventory of data sources in Europe for evaluating perinatal and long-term childhood risks associated with in-utero exposure to medication was updated by contacting colleagues across 31 European countries, literature review and internet searches. Included data sources must record at least one neurodevelopmental outcome and maternal medication use in pregnancy must be available, either in the data source itself or through linkage with another data source. Information on the
domain of neurodevelopment, measure/scale used and the approach to measurement
were recorded for each data source.
Ninety data sources were identified across 14 countries. The majority (63.3%) were created for health surveillance and research with the remaining serving administrative purposes (21.1 % healthcare databases,15.6% other administrative databases). Five domains of neurodevelopment were identified - infant development (36 data
sources,13 countries), child behaviour (27 data sources, 10 countries), cognition (29 data sources, 12 countries), educational achievement (20 data sources, 7 countries), and diagnostic codes for neurodevelopmental disorders (42 data sources, 11 countries). Thirty-nine data sources, in 12 countries, had information on more than one domain of neurodevelopment.
This inventory is invaluable to future studies planning to investigate the neurodevelopmental impact of medication exposures during pregnancy. Caution must be used when combining varied approaches to neurodevelopment outcome measurement, the age of children in the data source, and the sensitivity and specificity of the outcome measure selected should be borne in mind.
Original languageEnglish
Article numbere0275979
Pages (from-to)1-23
Number of pages23
JournalPLoS ONE
Issue number10
Publication statusPublished (in print/issue) - 14 Oct 2022

Bibliographical note

Funding Information:
The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821520 (authors JG, ML, FC and RB). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The research leading to these Results was conducted as part of the ConcePTION consortium. This paper only reflects the personal views of the stated authors. The authors would like to acknowledge their colleagues in EUROCAT, EUROmediCAT and Euro-Peristat for providing information on data sources available in their countries. Professor Helen Dolk for helping to shape the paper and Matthew Bluett Duncan for assistance with the data collation.

Publisher Copyright:
© 2022 Given et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


  • Neurodevelopment
  • Pharmacoepidemiology
  • Database
  • Pharmacology
  • Inventory
  • Teratogenesis
  • Drug safety
  • Pregnancy
  • Humans
  • Information Storage and Retrieval
  • Infant
  • Cognition
  • Maternal Exposure
  • Female
  • Child Development
  • Neurodevelopmental Disorders
  • Child
  • Neurodevelopmental Disorders/chemically induced
  • Maternal Exposure/adverse effects


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