Healthcare databases in Europe for studying medicine use and safety during pregnancy

被引:47
作者
Charlton, Rachel A. [1 ]
Neville, Amanda J. [2 ]
Jordan, Sue [3 ]
Pierini, Anna [4 ]
Damase-Michel, Christine [5 ]
Klungsoyr, Kari [6 ,7 ]
Andersen, Anne-Marie Nybo [8 ]
Hansen, Anne Vinkel [9 ]
Gini, Rosa [10 ]
Bos, Jens H. J. [11 ]
Puccini, Aurora [12 ]
Hurault-Delarue, Caroline [5 ]
Brooks, Caroline J. [13 ]
de Jong-van den Berg, Lolkje T. W. [11 ]
de Vries, Corinne S. [1 ]
机构
[1] Univ Bath, Dept Pharm & Pharmacol, Bath BA2 7AY, Avon, England
[2] Azienda Osped Univ Ferrara, IMER Emilia Romagna Registry Birth Defects, Ferrara, Italy
[3] Swansea Univ, Dept Nursing, Coll Human & Hlth Sci, Swansea, W Glam, Wales
[4] Natl Res Council IFC CNR, Inst Clin Physiol, Pisa, Italy
[5] Univ Toulouse 3, Fac Med, INSERM UMR1027, F-31062 Toulouse, France
[6] Norwegian Inst Publ Hlth, Med Birth Registry Norway, Oslo, Norway
[7] Univ Bergen, Dept Global Publ Hlth & Primary Care, Bergen, Norway
[8] Univ Copenhagen, Dept Publ Hlth, Sect Social Med, Copenhagen, Denmark
[9] Hosp Lillebaelt, Kolding, Denmark
[10] Agenzia Reg Sanita Toscana, Florence, Italy
[11] Univ Groningen, Dept Pharm, Pharmacoepidemiol & Pharmacoecon Unit, Groningen, Netherlands
[12] Emilia Romagna Region Hlth Author, Drug Policy Serv, Bologna, Italy
[13] Swansea Univ, Inst Life Sci, Coll Med, Swansea, W Glam, Wales
关键词
electronic medical records; automated data; pregnancy; teratogens; pharmacoepidemiology; PRESCRIPTION DRUG-USE; NEURAL-TUBE DEFECTS; PHARMACY DATA; RISK; MALFORMATIONS; NETHERLANDS; PREVENTION; EFEMERIS; REGISTER; INCREASE;
D O I
10.1002/pds.3613
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
PurposeThe aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy. MethodsA sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed. ResultsEight databases were included, and the total population covered was 25 million. All databases recorded live births, seven captured stillbirths and five had full data available on spontaneous pregnancy losses and induced terminations. In six databases, data were usually available to determine the date of the woman's last menstrual period, whereas in the remainder, algorithms were needed to establish a best estimate for at least some pregnancies. In seven databases, it was possible to use data recorded in the databases to identify pregnancies where the offspring had a congenital anomaly. Information on confounding variables was more commonly available in databases capturing data recorded by primary-care practitioners. All databases captured maternal co-prescribing and a measure of socioeconomic status. ConclusionThis study suggests that within Europe, electronic healthcare databases may be valuable sources of data for evaluating medicine use and safety during pregnancy. The suitability of a particular database, however, will depend on the research question, the type of medicine to be evaluated, the prevalence of its use and any adverse outcomes of interest. (c) 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
引用
收藏
页码:586 / 594
页数:9
相关论文
共 31 条
[1]   Prescription drug use in pregnancy [J].
Andrade, Susan E. ;
Gurwitz, Jerry H. ;
Davis, Robert L. ;
Chan, K. Arnold ;
Finkelstein, Jonathan A. ;
Fortman, Kris ;
McPhillips, Heather ;
Raebel, Marsha A. ;
Roblin, Douglas ;
Smith, David H. ;
Yood, Marianne Ulcickas ;
Morse, Abraham N. ;
Platt, Richard .
AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, 2004, 191 (02) :398-407
[2]   Increase in use of selective serotonin reuptake inhibitors in pregnancy during the last decade, a population-based cohort study from the Netherlands [J].
Bakker, Marian K. ;
Kolling, Pieternel ;
Berg, Paul B. van den ;
de Walle, Hermien E. K. ;
van den Berg, Lolkje T. W. de Jong .
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2008, 65 (04) :600-606
[3]   Drug prescription patterns before, during and after pregnancy for chronic, occasional and pregnancy-related drugs in the Netherlands [J].
Bakker, MK ;
Jentink, J ;
Vroom, F ;
Van den Berg, PB ;
de Walle, HEK ;
de Jong-Van Den Berg, LTW .
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 2006, 113 (05) :559-568
[4]   Paper 1: The EUROCAT Network-Organization and Processes [J].
Boyd, Patricia A. ;
Haeusler, Martin ;
Barisic, Ingeborg ;
Loane, Maria ;
Garne, Ester ;
Dolk, Helen .
BIRTH DEFECTS RESEARCH PART A-CLINICAL AND MOLECULAR TERATOLOGY, 2011, 91 :S2-S15
[5]   Data resources for investigating drug exposure during pregnancy and associated outcomes - The General Practice Research Database (GPRD) as an alternative to pregnancy registries [J].
Charlton, Rachel A. ;
Cunnington, Marianne C. ;
de Vries, Corinne S. ;
Weil, John G. .
DRUG SAFETY, 2008, 31 (01) :39-51
[6]   Comparing the General Practice Research Database and the UK Epilepsy and Pregnancy Register as Tools for Postmarketing Teratogen Surveillance Anticonvulsants and the Risk of Major Congenital Malformations [J].
Charlton, Rachel A. ;
Weil, John G. ;
Cunnington, Marianne C. ;
Ray, Sayantani ;
de Vries, Corinne S. .
DRUG SAFETY, 2011, 34 (02) :157-171
[7]   Electronic healthcare databases for active drug safety surveillance: is there enough leverage? [J].
Coloma, Preciosa M. ;
Trifiro, Gianluca ;
Schuemie, Martijn J. ;
Gini, Rosa ;
Herings, Ron ;
Hippisley-Cox, Julia ;
Mazzaglia, Giampiero ;
Picelli, Gino ;
Corrao, Giovanni ;
Pedersen, Lars ;
Lei, Johan ;
Sturkenboom, Miriam .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2012, 21 (06) :611-621
[8]   Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project [J].
Coloma, Preciosa M. ;
Schuemie, Martijn J. ;
Trifiro, Gianluca ;
Gini, Rosa ;
Herings, Ron ;
Hippisley-Cox, Julia ;
Mazzaglia, Giampiero ;
Giaquinto, Carlo ;
Corrao, Giovanni ;
Pedersen, Lars ;
van der Lei, Johan ;
Sturkenboom, Miriam .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2011, 20 (01) :1-11
[9]   PREVENTION OF THE 1ST OCCURRENCE OF NEURAL-TUBE DEFECTS BY PERICONCEPTIONAL VITAMIN SUPPLEMENTATION [J].
CZEIZEL, AE ;
DUDAS, I .
NEW ENGLAND JOURNAL OF MEDICINE, 1992, 327 (26) :1832-1835
[10]   Prescription drug use during pregnancy in developed countries: a systematic review [J].
Daw, Jamie R. ;
Hanley, Gillian E. ;
Greyson, Devon L. ;
Morgan, Steven G. .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2011, 20 (09) :895-902