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

WM Meijer, MC Cornel, Helen Dolk, HEK de Walle, NC Armstrong, LTW de Jong-van den Berg, [Unknown] EUROCAT Working Group

Research output: Contribution to journalArticle

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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.
LanguageEnglish
Pages675-682
JournalPharmacoepidemiology and Drug Safety
Volume15
Issue number9
Early online date7 Jun 2006
DOIs
Publication statusE-pub ahead of print - 7 Jun 2006

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Registries
Safety
Pharmaceutical Preparations
Pharmacoepidemiology
Parturition
Information Storage and Retrieval
European Union
First Pregnancy Trimester
Marketing
Vitamins
Obstetrics
Minerals
Mothers
Databases
Interviews

Cite this

Meijer, WM., Cornel, MC., Dolk, H., de Walle, HEK., Armstrong, NC., de Jong-van den Berg, LTW., & EUROCAT Working Group, U. (2006). The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study. Pharmacoepidemiology and Drug Safety, 15(9), 675-682. https://doi.org/10.1002/pds.1265
Meijer, WM ; Cornel, MC ; Dolk, Helen ; de Walle, HEK ; Armstrong, NC ; de Jong-van den Berg, LTW ; EUROCAT Working Group, [Unknown]. / The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study. In: Pharmacoepidemiology and Drug Safety. 2006 ; Vol. 15, No. 9. pp. 675-682.
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title = "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.",
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Meijer, WM, Cornel, MC, Dolk, H, de Walle, HEK, Armstrong, NC, de Jong-van den Berg, LTW & EUROCAT Working Group, U 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

The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study. / Meijer, WM; Cornel, MC; Dolk, Helen; de Walle, HEK; Armstrong, NC; de Jong-van den Berg, LTW; EUROCAT Working Group, [Unknown].

In: Pharmacoepidemiology and Drug Safety, Vol. 15, No. 9, 07.06.2006, p. 675-682.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study

AU - Meijer, WM

AU - Cornel, MC

AU - Dolk, Helen

AU - de Walle, HEK

AU - Armstrong, NC

AU - de Jong-van den Berg, LTW

AU - EUROCAT Working Group, [Unknown]

PY - 2006/6/7

Y1 - 2006/6/7

N2 - 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.

AB - 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.

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DO - 10.1002/pds.1265

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VL - 15

SP - 675

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JO - Pharmacoepidemiology and Drug Safety

T2 - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

SN - 1053-8569

IS - 9

ER -