The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study.

Details

Serval ID
serval:BIB_49DDBB1FA87C
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study.
Journal
Pharmacoepidemiology and Drug Safety
Author(s)
Meijer W.M., Cornel M.C., Dolk H., de Walle H.E., Armstrong N.C., de Jong-van den Berg L.T.
Working group(s)
EUROCAT Working Group
ISSN
1053-8569
Publication state
Published
Issued date
2006
Peer-reviewed
Oui
Volume
15
Number
9
Pages
675-682
Language
english
Notes
(Addor M.C. included in the EUROCAT Working Group)
Abstract
BACKGROUND: European Surveillance of Congenital Anomalies (EUROCAT) is a network of population-based congenital anomaly registries in Europe surveying more than 1 million births per year, or 25% of the births in the European Union. This paper describes the potential of the EUROCAT collaboration for pharmacoepidemiology and drug safety surveillance. METHODS: The 34 full members and 6 associate members of the EUROCAT network were sent a questionnaire about their data sources on drug exposure and on drug coding. Available data on drug exposure during the first trimester available in the central EUROCAT database for the years 1996-2000 was summarised for 15 out of 25 responding full members. RESULTS: Of the 40 registries, 29 returned questionnaires (25 full and 4 associate members). Four of these registries do not collect data on maternal drug use. Of the full members, 15 registries use the EUROCAT drug code, 4 use the international ATC drug code, 3 registries use another coding system and 7 use a combination of these coding systems. Obstetric records are the most frequently used sources of drug information for the registries, followed by interviews with the mother. Only one registry uses pharmacy data. Percentages of cases with drug exposure (excluding vitamins/minerals) varied from 4.4% to 26.0% among different registries. The categories of drugs recorded varied widely between registries. CONCLUSIONS: Practices vary widely between registries regarding recording drug exposure information. EUROCAT has the potential to be an effective collaborative framework to contribute to post-marketing drug surveillance in relation to teratogenic effects, but work is needed to implement ATC drug coding more widely, and to diversify the sources of information used to determine drug exposure in each registry.
Keywords
Abnormalities, Drug-Induced, Adverse Drug Reaction Reporting Systems, Databases, Factual, Europe, Humans, Infant, Newborn, International Cooperation, Pharmaceutical Preparations, Registries
Pubmed
Web of science
Create date
02/04/2009 8:27
Last modification date
20/08/2019 13:57
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