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

Willemijn M. Meijer, Martina C. Cornel, Helen Dolk, Hermien E.K. de Walle, Nicola C. Armstrong, Lolkje T.W. de Jong-van den Berg*, Lenore Abramsky, Marie Claude Addor, Neus Baena, Marian Bakker, Ingeborg Barisic, Sebastiano Bianca, Patricia Boyd, Catherine De Vigan, Elizabeth Draper, Ester Garne, Miriam Gatt, Blanca Gener, Martin Haeusler, Lorentz IrgensHilary Jordan, Maria Loane, M. T. O'Mahony, Maria Luisa Martínez-Frías, Eva Berjemo, Bob Mc Donnel, Vera Nelen, Amanda Neville, Olga Clabrese, Francesca Rivieri, Anna Pierini, Fabrizio Bianchi, Isolina Riaño Galán, Annukka Ritvanen, Elisabeth Robert-Gnansia, Claude Stoll, Maria Soares, Romano Tenconi, Diana Wellesley, Awi Wiesel

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
Pages (from-to)675-682
Number of pages8
JournalPharmacoepidemiology and Drug Safety
Volume15
Issue number9
DOIs
Publication statusPublished - 1 Sep 2006

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