Abstract:
PURPOSE:We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveillance system for monitoring the safety of medical products (drugs, biologics, and devices) in the USA. METHODS:A common data model was designed to address the priorities of the Mini-Sentinel Pilot and to leverage the experience and data of participating organizations and data partners. A review of existing common data models informed the process. Each participating organization designed a process to extract, transform, and load its source data, applying the common data model to create the Mini-Sentinel Distributed Database. Transformed data were characterized and evaluated using a series of programs developed centrally and executed locally by participating organizations. A secure communications portal was designed to facilitate queries of the Mini-Sentinel Distributed Database and transfer of confidential data, analytic tools were developed to facilitate rapid response to common questions, and distributed querying software was implemented to facilitate rapid querying of summary data. RESULTS:As of July 2011, information on 99,260,976 health plan members was included in the Mini-Sentinel Distributed Database. The database includes 316,009,067 person-years of observation time, with members contributing, on average, 27.0 months of observation time. All data partners have successfully executed distributed code and returned findings to the Mini-Sentinel Operations Center. CONCLUSION:This work demonstrates the feasibility of building a large, multiorganizational distributed data system in which organizations retain possession of their data that are used in an active surveillance system.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Curtis LH,Weiner MG,Boudreau DM,Cooper WO,Daniel GW,Nair VP,Raebel MA,Beaulieu NU,Rosofsky R,Woodworth TS,Brown JSdoi
10.1002/pds.2336subject
Has Abstractpub_date
2012-01-01 00:00:00pages
23-31eissn
1053-8569issn
1099-1557journal_volume
21 Suppl 1pub_type
杂志文章abstract::The current medical care environment has created expectations that exceed its capabilities, one effect of which has been an increasing awareness of lapses in the quality of healthcare, including medical errors. As more new therapies reach clinical application, the expectations on the part of the public are unlikely to...
journal_title:Pharmacoepidemiology and drug safety
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journal_title:Pharmacoepidemiology and drug safety
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journal_title:Pharmacoepidemiology and drug safety
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 撤回出版物
doi:
更新日期:2013-02-01 00:00:00
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pub_type: 杂志文章,评审
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更新日期:2016-01-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
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更新日期:2013-11-01 00:00:00
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doi:10.1002/pds.803
更新日期:2003-10-01 00:00:00
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pub_type: 杂志文章
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更新日期:2019-05-01 00:00:00
abstract:PURPOSE:An increasing consumption of opioids in the general population has been reported in several countries also among pregnant women. Limited information is available regarding the effect of prenatal exposure to analgesic opioids on long-term neurocognitive function in children. The primary aim of the study was to d...
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pub_type: 杂志文章
doi:10.1002/pds.4170
更新日期:2017-06-01 00:00:00
abstract:OBJECTIVES:The purpose of this study was to generate data regarding the drug utilization pattern in pediatric population of our tertiary care hospital so that we could generate an essential medicine list (EML). BACKGROUND:Drug therapy accounts for a major portion of expenditure toward health care. Reduction in health ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1832
更新日期:2010-04-01 00:00:00
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doi:10.1002/pds.1545
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:2019-06-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
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doi:10.1002/pds.1353
更新日期:2007-06-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
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更新日期:2013-03-01 00:00:00
abstract:PURPOSE:The aim of the present study was to determine whether community pharmacists recommend appropriate medications and give valid information to pregnant women. METHODS:A total of 163 community pharmacists randomly selected in the Midi-Pyrénées area were interviewed by means of an open questionnaire. Ten scenarios ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:2004-10-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:2017-05-01 00:00:00
abstract:PURPOSE:The purposes of the study are to compare safety specifications between Japan and the European Union (EU) and to identify the factors affecting categorization of important identified or potential risks. METHODS:Safety specifications were collected from orphan and nonorphan drugs approved in Japan between 2014 a...
journal_title:Pharmacoepidemiology and drug safety
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更新日期:2018-11-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4140
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND AND AIMS:Non-adherence is considered a major barrier to better outcomes of diabetes care. A relationship has been established between polypharmacy and patients' adherence. This study aims to investigate the occurrence of polypharmacy and non-adherence in general practice, their mutual relationship and the as...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,随机对照试验
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更新日期:2009-11-01 00:00:00
abstract:PURPOSE:To evaluate the impact of 2 policy changes on quetiapine dispensing in Australia: removal of prior authorisation for prescribing (policy 1: July 2007) and removal of repeat prescriptions for 25-mg quetiapine (policy 2: January 2014). METHODS:We performed an interrupted time series analysis using Pharmaceutical...
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pub_type: 杂志文章
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更新日期:2018-04-01 00:00:00
abstract:OBJECTIVE:To assess the extent, characteristics and determinants of benzodiazepine prescription in outpatient Primary Health Care. METHODS:A clinical audit of a stratified random sample of Primary Health Care Centres in the seven islands and 1.6 million inhabitants region of 'Canarias' in Spain was carried out. From t...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199905/06)8:3<207::AID-PDS
更新日期:1999-05-01 00:00:00