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

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.

journal_name

Pharmacoepidemiol Drug Saf

journal_title

Pharmacoepidemiology and drug safety

authors

Meijer WM,Cornel MC,Dolk H,de Walle HE,Armstrong NC,de Jong-van den Berg LT,EUROCAT Working Group.

doi

10.1002/pds.1265

subject

Has Abstract

pub_date

2006-09-01 00:00:00

pages

675-82

issue

eissn

1053-8569

issn

1099-1557

journal_volume

pub_type

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