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Drug Saf. 2015 Nov;38(11):1083-93. doi: 10.1007/s40264-015-0321-9.

Improving Information on Maternal Medication Use by Linking Prescription Data to Congenital Anomaly Registers: A EUROmediCAT Study.

Author information

1
Department of Genetics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. l.de.jonge@umcg.nl.
2
Paediatric Department, Hospital Lillebaelt, Kolding, Denmark.
3
Agenzia regionale di sanità della Toscana, Florence, Italy.
4
College of Human and Health Sciences, Swansea University, Swansea, UK.
5
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
6
Medical Birth Registry of Norway, Norwegian Institute of Public Health, Oslo, Norway.
7
Institute of Nursing and Health Research, Ulster University, Newtownabbey, County Antrim, Northern Ireland, UK.
8
Registro IMER-IMER Registry (Emila Romagna Registry of Birth Defects), Center for Clinical and Epidemiological Research, University of Ferrara, Ferrara, Italy.
9
Tuscany Registry of Congenital Defects (RTDC), Fondazione Toscana "Gabriele Monasterio", Pisa, Italy.
10
Institute of Clinical Physiology, National Research Council (IFC-CNR), Pisa, Italy.
11
Drug Policy Service, Emilia Romagna Regional Health Authority, Bologna, Italy.
12
SAIL Databank, Swansea University, Swansea, UK.
13
Public Health Wales, Singleton Hospital, Swansea, UK.
14
Section of Social Medicine, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
15
Department of Genetics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
16
Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

Abstract

INTRODUCTION:

Research on associations between medication use during pregnancy and congenital anomalies is significative for assessing the safe use of a medicine in pregnancy. Congenital anomaly (CA) registries do not have optimal information on medicine exposure, in contrast to prescription databases. Linkage of prescription databases to the CA registries is a potentially effective method of obtaining accurate information on medicine use in pregnancies and the risk of congenital anomalies.

METHODS:

We linked data from primary care and prescription databases to five European Surveillance of Congenital Anomalies (EUROCAT) CA registries. The linkage was evaluated by looking at linkage rate, characteristics of linked and non-linked cases, first trimester exposure rates for six groups of medicines according to the prescription data and information on medication use registered in the CA databases, and agreement of exposure.

RESULTS:

Of the 52,619 cases registered in the CA databases, 26,552 could be linked. The linkage rate varied between registries over time and by type of birth. The first trimester exposure rates and the agreements between the databases varied for the different medicine groups. Information on anti-epileptic drugs and insulins and analogue medicine use recorded by CA registries was of good quality. For selective serotonin reuptake inhibitors, anti-asthmatics, antibacterials for systemic use, and gonadotropins and other ovulation stimulants, the recorded information was less complete.

CONCLUSION:

Linkage of primary care or prescription databases to CA registries improved the quality of information on maternal use of medicines in pregnancy, especially for medicine groups that are less fully registered in CA registries.

PMID:
26153398
PMCID:
PMC4608981
DOI:
10.1007/s40264-015-0321-9
[Indexed for MEDLINE]
Free PMC Article

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