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Volumn 23, Issue 6, 2014, Pages 619-627

A modular, prospective, semi-automated drug safety monitoring system for use in a distributed data environment

Author keywords

Active; Distributed database; Monitoring; Pharmacoepidemiology; Prospective; Surveillance

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; ATORVASTATIN; AZITHROMYCIN; CELECOXIB; CERIVASTATIN; CIPROFLOXACIN; LISINOPRIL; MACROLIDE; NONSTEROID ANTIINFLAMMATORY AGENT; PAROXETINE; ROFECOXIB; ROSUVASTATIN; TELITHROMYCIN; TRICYCLIC ANTIDEPRESSANT AGENT; PRESCRIPTION DRUG;

EID: 84901812175     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3616     Document Type: Article
Times cited : (23)

References (41)
  • 2
    • 6044267892 scopus 로고    scopus 로고
    • Failing the public health--rofecoxib, Merck, and the FDA
    • Topol EJ. Failing the public health--rofecoxib, Merck, and the FDA. N Engl J Med 2004; 351: 1707-1709.
    • (2004) N Engl J Med , vol.351 , pp. 1707-1709
    • Topol, E.J.1
  • 3
    • 33749339372 scopus 로고    scopus 로고
    • Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2
    • McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 2006; 296: 1633-1644.
    • (2006) JAMA , vol.296 , pp. 1633-1644
    • McGettigan, P.1    Henry, D.2
  • 4
    • 37349104178 scopus 로고    scopus 로고
    • Early detection of adverse drug events within population-based health networks: application of sequential testing methods
    • Brown JS, Kulldorff M, Chan KA, et al. Early detection of adverse drug events within population-based health networks: application of sequential testing methods. Pharmacoepidemiol Drug Saf 2007; 16: 1275-1284.
    • (2007) Pharmacoepidemiol Drug Saf , vol.16 , pp. 1275-1284
    • Brown, J.S.1    Kulldorff, M.2    Chan, K.A.3
  • 5
    • 84881502708 scopus 로고    scopus 로고
    • You can observe a lot (about medical products) by watching (those who use them)
    • Gagne JJ. You can observe a lot (about medical products) by watching (those who use them). Epidemiology 2013; 24: 700-702.
    • (2013) Epidemiology , vol.24 , pp. 700-702
    • Gagne, J.J.1
  • 6
    • 72449176909 scopus 로고    scopus 로고
    • Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor?
    • Trifiro G, Pariente A, Coloma PM, et al. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf 2009; 18: 1176-1184.
    • (2009) Pharmacoepidemiol Drug Saf , vol.18 , pp. 1176-1184
    • Trifiro, G.1    Pariente, A.2    Coloma, P.M.3
  • 7
    • 84862932391 scopus 로고    scopus 로고
    • The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction
    • Platt R, Carnahan RM, Brown JS, et al. The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf 2012; 21(Suppl 1): 1-8.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.SUPPL. 1 , pp. 1-8
    • Platt, R.1    Carnahan, R.M.2    Brown, J.S.3
  • 8
    • 78751688048 scopus 로고    scopus 로고
    • Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership
    • Stang PE, Ryan PB, Racoosin JA, et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 2010; 153: 600-606.
    • (2010) Ann Intern Med , vol.153 , pp. 600-606
    • Stang, P.E.1    Ryan, P.B.2    Racoosin, J.A.3
  • 9
    • 84877736063 scopus 로고    scopus 로고
    • Rapid assessment of cardiovascular risk among users of smoking cessation drugs within the US Food and Drug Administration's Mini-Sentinel program
    • Toh S, Baker MA, Brown JS, Kornegay C, Platt R, Mini-Sentinel I. Rapid assessment of cardiovascular risk among users of smoking cessation drugs within the US Food and Drug Administration's Mini-Sentinel program. JAMA Intern Med 2013; 173: 817-819.
    • (2013) JAMA Intern Med , vol.173 , pp. 817-819
    • Toh, S.1    Baker, M.A.2    Brown, J.S.3    Kornegay, C.4    Platt, R.5    Mini-Sentinel, I.6
  • 10
    • 84901816630 scopus 로고    scopus 로고
    • OMOP Web RL [Accessed on February 22, 2014] at
    • Observational Medical Outcomes Partnership: OMOP Web RL. 2013. [Accessed on February 22, 2014] at http://omop.fnih.org/.
    • (2013) Observational Medical Outcomes Partnership
  • 11
    • 84862626391 scopus 로고    scopus 로고
    • Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system
    • Gagne JJ, Glynn RJ, Rassen JA, et al. Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system. Clin pharmacol Therapeut 2012; 92: 80-86.
    • (2012) Clin pharmacol Therapeut , vol.92 , pp. 80-86
    • Gagne, J.J.1    Glynn, R.J.2    Rassen, J.A.3
  • 12
    • 84857042212 scopus 로고    scopus 로고
    • Active safety monitoring of new medical products using electronic healthcare data: selecting alerting rules
    • Gagne JJ, Rassen JA, Walker AM, Glynn RJ, Schneeweiss S. Active safety monitoring of new medical products using electronic healthcare data: selecting alerting rules. Epidemiology 2012; 23: 238-246.
    • (2012) Epidemiology , vol.23 , pp. 238-246
    • Gagne, J.J.1    Rassen, J.A.2    Walker, A.M.3    Glynn, R.J.4    Schneeweiss, S.5
  • 13
    • 81355139590 scopus 로고    scopus 로고
    • Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development
    • Schneeweiss S, Gagne JJ, Glynn RJ, Ruhl M, Rassen JA. Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development. Clin Pharmacol Ther 2011; 90: 777-790.
    • (2011) Clin Pharmacol Ther , vol.90 , pp. 777-790
    • Schneeweiss, S.1    Gagne, J.J.2    Glynn, R.J.3    Ruhl, M.4    Rassen, J.A.5
  • 14
    • 84859852184 scopus 로고    scopus 로고
    • Early steps in the development of a claims-based targeted healthcare safety monitoring system and application to three empirical examples
    • Wahl PM, Gagne JJ, Wasser TE, et al. Early steps in the development of a claims-based targeted healthcare safety monitoring system and application to three empirical examples. Drug Saf 2012; 35: 407-416.
    • (2012) Drug Saf , vol.35 , pp. 407-416
    • Wahl, P.M.1    Gagne, J.J.2    Wasser, T.E.3
  • 15
    • 77956625112 scopus 로고    scopus 로고
    • A basic study design for expedited safety signal evaluation based on electronic healthcare data
    • Schneeweiss S. A basic study design for expedited safety signal evaluation based on electronic healthcare data. Pharmacoepidemiol Drug Saf 2010; 19: 858-868.
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , pp. 858-868
    • Schneeweiss, S.1
  • 16
    • 84856050291 scopus 로고    scopus 로고
    • Design considerations in an active medical product safety monitoring system
    • Gagne JJ, Fireman B, Ryan PB, et al. Design considerations in an active medical product safety monitoring system. Pharmacoepidemiol Drug Saf 2012; 21(Suppl 1): 32-40.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.SUPPL. 1 , pp. 32-40
    • Gagne, J.J.1    Fireman, B.2    Ryan, P.B.3
  • 17
    • 84901793064 scopus 로고    scopus 로고
    • Taxonomy for monitoring methods within a medical product safety surveillance system
    • report of the Mini-Sentinel Taxonomy Project Work Group. Available at[9 September 2013].
    • Taxonomy for monitoring methods within a medical product safety surveillance system: report of the Mini-Sentinel Taxonomy Project Work Group. 2010. Available at http://www.mini-sentinel.org/work_products/Statistical_Methods/Mini-Sentinel_FinalTaxonomyReport.pdf [9 September 2013].
    • (2010)
  • 18
    • 84901746468 scopus 로고    scopus 로고
    • Taxonomy for monitoring methods within a medical product safety surveillance system
    • year two report of the Mini-Sentinel Taxonomy Project Workgroup. Available at[9 September 2013].
    • Taxonomy for monitoring methods within a medical product safety surveillance system: year two report of the Mini-Sentinel Taxonomy Project Workgroup. 2012. Available at http://www.mini-sentinel.org/work_products/Statistical_Methods/Mini-Sentinel_Methods_Taxonomy-Year-2-Report.pdf [9 September 2013].
    • (2012)
  • 19
    • 84862626391 scopus 로고    scopus 로고
    • Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system
    • Gagne JJ, Glynn RJ, Rassen JA, et al. Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system. Clin Pharmacol Ther 2012; 92: 80-86.
    • (2012) Clin Pharmacol Ther , vol.92 , pp. 80-86
    • Gagne, J.J.1    Glynn, R.J.2    Rassen, J.A.3
  • 20
    • 77956638740 scopus 로고    scopus 로고
    • Multivariate-adjusted pharmacoepidemiologic analyses of confidential information pooled from multiple health care utilization databases
    • Rassen JA, Avorn J, Schneeweiss S. Multivariate-adjusted pharmacoepidemiologic analyses of confidential information pooled from multiple health care utilization databases. Pharmacoepidemiol Drug Saf 2010; 19: 848-857.
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , pp. 848-857
    • Rassen, J.A.1    Avorn, J.2    Schneeweiss, S.3
  • 21
    • 79958845225 scopus 로고    scopus 로고
    • Covariate selection in high-dimensional propensity score analyses of treatment effects in small samples
    • Rassen JA, Glynn RJ, Brookhart MA, Schneeweiss S. Covariate selection in high-dimensional propensity score analyses of treatment effects in small samples. Am J Epidemiol 2011; 173: 1404-1413.
    • (2011) Am J Epidemiol , vol.173 , pp. 1404-1413
    • Rassen, J.A.1    Glynn, R.J.2    Brookhart, M.A.3    Schneeweiss, S.4
  • 22
    • 77953625909 scopus 로고    scopus 로고
    • Privacy-maintaining propensity score-based pooling of multiple databases applied to a study of biologics
    • Rassen JA, Solomon DH, Curtis JR, Herrinton L, Schneeweiss S. Privacy-maintaining propensity score-based pooling of multiple databases applied to a study of biologics. Med Care 2010; 48: S83-S89.
    • (2010) Med Care , vol.48
    • Rassen, J.A.1    Solomon, D.H.2    Curtis, J.R.3    Herrinton, L.4    Schneeweiss, S.5
  • 23
    • 67651042983 scopus 로고    scopus 로고
    • High-dimensional propensity score adjustment in studies of treatment effects using health care claims data
    • Schneeweiss S, Rassen JA, Glynn RJ, Avorn J, Mogun H, Brookhart MA. High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology 2009; 20: 512-522.
    • (2009) Epidemiology , vol.20 , pp. 512-522
    • Schneeweiss, S.1    Rassen, J.A.2    Glynn, R.J.3    Avorn, J.4    Mogun, H.5    Brookhart, M.A.6
  • 24
    • 84862907574 scopus 로고    scopus 로고
    • Design considerations, architecture, and use of the Mini-Sentinel distributed data system
    • Curtis LH, Weiner MG, Boudreau DM, et al. Design considerations, architecture, and use of the Mini-Sentinel distributed data system. Pharmacoepidemiol Drug Saf 2012; 21(Suppl 1): 23-31.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.SUPPL. 1 , pp. 23-31
    • Curtis, L.H.1    Weiner, M.G.2    Boudreau, D.M.3
  • 25
    • 84901814731 scopus 로고    scopus 로고
    • Modular Program 3: frequency of select events during exposure to a drug/procedure group of interest. Available at
    • Modular Program 3: frequency of select events during exposure to a drug/procedure group of interest. 2013. Available at http://www.mini-sentinel.org/work_products/Data_Activities/Mini-Sentinel-Modular_Program_3-Documentation.pdf'
    • (2013)
  • 26
    • 79956217851 scopus 로고    scopus 로고
    • A combined comorbidity score predicted mortality in elderly patients better than existing scores
    • Gagne JJ, Glynn RJ, Avorn J, Levin R, Schneeweiss S. A combined comorbidity score predicted mortality in elderly patients better than existing scores. J Clin Epidemiol 2011; 64: 749-759.
    • (2011) J Clin Epidemiol , vol.64 , pp. 749-759
    • Gagne, J.J.1    Glynn, R.J.2    Avorn, J.3    Levin, R.4    Schneeweiss, S.5
  • 27
    • 0035500992 scopus 로고    scopus 로고
    • Performance of comorbidity scores to control for confounding in epidemiologic studies using claims data
    • Schneeweiss S, Seeger JD, Maclure M, Wang PS, Avorn J, Glynn RJ. Performance of comorbidity scores to control for confounding in epidemiologic studies using claims data. Am J Epidemiol 2001; 154: 854-864.
    • (2001) Am J Epidemiol , vol.154 , pp. 854-864
    • Schneeweiss, S.1    Seeger, J.D.2    Maclure, M.3    Wang, P.S.4    Avorn, J.5    Glynn, R.J.6
  • 28
    • 84856034091 scopus 로고    scopus 로고
    • Using high-dimensional propensity scores to automate confounding control in a distributed medical product safety surveillance system
    • Rassen JA, Schneeweiss S. Using high-dimensional propensity scores to automate confounding control in a distributed medical product safety surveillance system. Pharmacoepidemiol Drug Saf 2012; 21(Suppl 1): 41-49.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.SUPPL. 1 , pp. 41-49
    • Rassen, J.A.1    Schneeweiss, S.2
  • 30
    • 84876243495 scopus 로고    scopus 로고
    • Evaluating strategies for data sharing and analyses in distributed data settings
    • Available at[9 September 2013].
    • Evaluating strategies for data sharing and analyses in distributed data settings. 2012. Available at http://www.mini-sentinel.org/work_products/Statistical_Methods/Mini-Sentinel_Methods_Evaluating-Strategies-for-Data-Sharing-and-Analyses.pdf [9 September 2013].
    • (2012)
  • 32
    • 78751631255 scopus 로고    scopus 로고
    • A maximized sequential probability ratio test for drug and vaccin safety surveillance
    • Kulldorff M, Davis RL, Kolczak M, Lewis E, Lieu T, Platt R. A maximized sequential probability ratio test for drug and vaccin safety surveillance. Seq Anal 2011; 3: 58-78.
    • (2011) Seq Anal , vol.3 , pp. 58-78
    • Kulldorff, M.1    Davis, R.L.2    Kolczak, M.3    Lewis, E.4    Lieu, T.5    Platt, R.6
  • 33
    • 84884290134 scopus 로고    scopus 로고
    • Treatment dynamics of newly marketed drugs and implications for comparative effectiveness research
    • Gagne JJ, Bykov K, Willke RJ, Kahler KH, Subedi P, Schneeweiss S. Treatment dynamics of newly marketed drugs and implications for comparative effectiveness research. Value Health 2013; 16: 1054-1062.
    • (2013) Value Health , vol.16 , pp. 1054-1062
    • Gagne, J.J.1    Bykov, K.2    Willke, R.J.3    Kahler, K.H.4    Subedi, P.5    Schneeweiss, S.6
  • 34
    • 84862230912 scopus 로고    scopus 로고
    • An event-based approach for comparing the performance of methods for prospective medical product monitoring
    • Gagne JJ, Walker AM, Glynn RJ, Rassen JA, Schneeweiss S. An event-based approach for comparing the performance of methods for prospective medical product monitoring. Pharmacoepidemiol Drug Saf 2012; 21: 631-639.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , pp. 631-639
    • Gagne, J.J.1    Walker, A.M.2    Glynn, R.J.3    Rassen, J.A.4    Schneeweiss, S.5
  • 35
    • 33646470853 scopus 로고    scopus 로고
    • Cardiovascular outcomes in new users of coxibs and nonsteroidal antiinflammatory drugs: high-risk subgroups and time course of risk
    • Solomon DH, Avorn J, Sturmer T, Glynn RJ, Mogun H, Schneeweiss S. Cardiovascular outcomes in new users of coxibs and nonsteroidal antiinflammatory drugs: high-risk subgroups and time course of risk. Arthritis Rheum 2006; 54: 1378-1389.
    • (2006) Arthritis Rheum , vol.54 , pp. 1378-1389
    • Solomon, D.H.1    Avorn, J.2    Sturmer, T.3    Glynn, R.J.4    Mogun, H.5    Schneeweiss, S.6
  • 36
    • 2442493150 scopus 로고    scopus 로고
    • Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults
    • Solomon DH, Schneeweiss S, Glynn RJ, et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 2004; 109: 2068-2073.
    • (2004) Circulation , vol.109 , pp. 2068-2073
    • Solomon, D.H.1    Schneeweiss, S.2    Glynn, R.J.3
  • 37
    • 84869102347 scopus 로고    scopus 로고
    • Comparative risk for angioedema associated with the use of drugs that target the renin-angiotensin-aldosterone system
    • Toh S, Reichman ME, Houstoun M, et al. Comparative risk for angioedema associated with the use of drugs that target the renin-angiotensin-aldosterone system. Arch Intern Med 2012; 172: 1582-1589.
    • (2012) Arch Intern Med , vol.172 , pp. 1582-1589
    • Toh, S.1    Reichman, M.E.2    Houstoun, M.3
  • 38
    • 33749429683 scopus 로고    scopus 로고
    • Achilles tendon rupture and its association with fluoroquinolone antibiotics and other potential risk factors in a managed care population
    • Seeger JD, West WA, Fife D, Noel GJ, Johnson LN, Walker AM. Achilles tendon rupture and its association with fluoroquinolone antibiotics and other potential risk factors in a managed care population. Pharmacoepidemiol Drug Saf 2006; 15: 784-792.
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , pp. 784-792
    • Seeger, J.D.1    West, W.A.2    Fife, D.3    Noel, G.J.4    Johnson, L.N.5    Walker, A.M.6
  • 39
    • 9644252909 scopus 로고    scopus 로고
    • Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs
    • Graham DJ, Staffa JA, Shatin D, et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA 2004; 292: 2585-2590.
    • (2004) JAMA , vol.292 , pp. 2585-2590
    • Graham, D.J.1    Staffa, J.A.2    Shatin, D.3
  • 40
    • 13444263619 scopus 로고    scopus 로고
    • Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study
    • Graham DJ, Campen D, Hui R, et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005; 365: 475-481.
    • (2005) Lancet , vol.365 , pp. 475-481
    • Graham, D.J.1    Campen, D.2    Hui, R.3
  • 41
    • 84860599298 scopus 로고    scopus 로고
    • Role of disease risk scores in comparative effectiveness research with emerging therapies
    • Glynn RJ, Gagne JJ, Schneeweiss S. Role of disease risk scores in comparative effectiveness research with emerging therapies. Pharmacoepidemiol Drug Saf 2012; 21(Suppl 2): 138-147.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.SUPPL. 2 , pp. 138-147
    • Glynn, R.J.1    Gagne, J.J.2    Schneeweiss, S.3


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