The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance:A descriptive study
Autor: | Meijer, Willemijn M., Cornel, Martina C., Dolk, Helen, de Walle, Hermien E.K., Armstrong, Nicola C., de Jong-van den Berg, Lolkje T.W., Abramsky, Lenore, Addor, Marie Claude, Baena, Neus, Bakker, Marian, Barisic, Ingeborg, Bianca, Sebastiano, Boyd, Patricia, De Vigan, Catherine, Draper, Elizabeth, Garne, Ester, Gatt, Miriam, Gener, Blanca, Haeusler, Martin, Irgens, Lorentz, Jordan, Hilary, Loane, Maria, O'Mahony, M. T., Martínez-Frías, Maria Luisa, Berjemo, Eva, Mc Donnel, Bob, Nelen, Vera, Neville, Amanda, Clabrese, Olga, Rivieri, Francesca, Pierini, Anna, Bianchi, Fabrizio, Riaño Galán, Isolina, Ritvanen, Annukka, Robert-Gnansia, Elisabeth, Stoll, Claude, Soares, Maria, Tenconi, Romano, Wellesley, Diana, Wiesel, Awi |
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Přispěvatelé: | Human genetics, Groningen University Institute for Drug Exploration (GUIDE), Science in Healthy Ageing & healthcaRE (SHARE), Reproductive Origins of Adult Health and Disease (ROAHD) |
Jazyk: | angličtina |
Rok vydání: | 2006 |
Předmět: |
Drug
Pediatrics medicine.medical_specialty drug exposure LACTATION Databases Factual Drug-Related Side Effects and Adverse Reactions Epidemiology media_common.quotation_subject International Cooperation Population Postmarketing surveillance Pharmacy post-marketing surveillance medicine media_common.cataloged_instance Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) MALFORMATIONS Registries EXPOSURE European union education media_common Safety surveillance education.field_of_study business.industry congenital anomalies Infant Newborn Abnormalities Drug-Induced WOMEN Pharmacoepidemiology medicine.disease Europe PREGNANCY Pharmaceutical Preparations REGISTRATION CLASSIFICATION-SYSTEM Medical emergency Descriptive research business |
Zdroj: | Meijer, W M, Cornel, M C, Dolk, H, de Walle, H E K, Armstrong, N C, de Jong-van den Berg, L T W, Abramsky, L, Addor, M C, Baena, N, Bakker, M, Barisic, I, Bianca, S, Boyd, P, De Vigan, C, Draper, E, Garne, E, Gatt, M, Gener, B, Haeusler, M, Irgens, L, Jordan, H, Loane, M, O'Mahony, M T, Martínez-Frías, M L, Berjemo, E, Mc Donnel, B, Nelen, V, Neville, A, Clabrese, O, Rivieri, F, Pierini, A, Bianchi, F, Riaño Galán, I, Ritvanen, A, Robert-Gnansia, E, Stoll, C, Soares, M, Tenconi, R, Wellesley, D & Wiesel, A 2006, ' The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance : A descriptive study ', Pharmacoepidemiology and Drug Safety, vol. 15, no. 9, pp. 675-682 . https://doi.org/10.1002/pds.1265 Pharmacoepidemiology and Drug Safety, 15(9), 675-682. John Wiley and Sons Ltd Pharmacoepidemiology and Drug Safety, 15(9), 675-682. Wiley |
ISSN: | 1053-8569 |
Popis: | Background European Surveillance of Congenital Anomalies (EUROCAT) is a network of population-based congenital anomaly registries in Europe surveying more than I 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. Copyright (c) 2006 John Wiley & Sons, Ltd. |
Databáze: | OpenAIRE |
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