Linkage between the Danish National Health Service Prescription Database, the Danish Fetal Medicine Database, and other Danish registries as a tool for the study of drug safety in pregnancy

Abstract

A linked population-based database is being created in Denmark for research on drug safety during pregnancy. It combines information from the Danish National Health Service Prescription Database (with information on all prescriptions reimbursed in Denmark since 2004), the Danish Fetal Medicine Database, the Danish National Registry of Patients, and the Medical Birth Registry. The new linked database will provide validated information on malformations diagnosed both prenatally and postnatally. The cohort from 2008 to 2014 will comprise 589,000 pregnancies with information on 424,000 pregnancies resulting in live-born children, ∼420,000 pregnancies undergoing prenatal ultrasound scans, 65,000 miscarriages, and 92,000 terminations. It will be updated yearly with information on ∼80,000 pregnancies. The cohort will enable identification of drug exposures associated with severe malformations, not only based on malformations diagnosed after birth but also including those having led to termination of pregnancy or miscarriage. Such combined data will provide a unique source of information for research on the safety of medications used during pregnancy.

Keywords:

• malformations
• teratology
• therapeutic drug monitoring
• epidemiological methods
• registries

Acknowledgments

The study was supported by the Program for Clinical Research Infrastructure established by the Lundbeck Foundation and the Novo Nordisk Foundation. We thank all sonographers and specialists in fetal medicine for contributing data to the Danish Fetal Medicine Database, in particular, the Danish Fetal Medicine Research Group (Karin Sundberg, Department of Obstetrics, Center of Fetal Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen; Anne-Cathrine Shalmi, Department of Gynecology and Obstetrics, Hilleroed Hospital, Hilleroed; Hanne Søndergaard Jensen, Department of Gynecology and Obstetrics, Herning Hospital, Herning; Laura Vase, Department of Gynecology and Obstetrics, Viborg Hospital, Viborg; Inger Stornes, Department of Gynecology and Obstetrics, Randers Hospital, Randers; Annette Hessellund, Department of Gynecology and Obstetrics, Naestved Hospital, Naestved; Lene Brendstrup, Department of Gynecology and Obstetrics, Soenderborg Hospital, Soenderborg; Eske Bendsen, Department of Gynecology and Obstetrics, Esbjerg Hospital, Esbjerg; Lene Sperling, Department of Gynaecology and Obstetrics, Odense University Hospital, Odense; Christina Kamper, Department of Gynaecology and Obstetrics, Horsens Hospital, Horsens; Helle Zingenberg, Department of Gynaecology and Obstetrics, Herlev Hospital, Herlev; Finn S Jørgensen, Fetal Medicine Unit, Department of Gynaecology and Obstetrics, Copenhagen University Hospital Hvidovre, Copenhagen; Lone Krebs, Department of Gynaecology and Obstetrics, Holbaek Hospital, Holbaek; Lillian Skibsted, Department of Gynaecology and Obstetrics, Roskilde Hospital, Roskilde; Annette Wind Olesen, Department of Gynaecology and Obstetrics, Kolding Hospital, Kolding; Anne Sørensen, Department of Gynaecology and Obstetrics, Aalborg University Hospital, Aalborg; and Birgitte Størup, Department of Gynaecology and Obstetrics, Hjoerring Hospital, Hjoerring).

Disclosure

The authors report no conflicts of interest in this work.