메뉴 건너뛰기




Volumn 22, Issue 9, 2013, Pages 727-734

Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs

Author keywords

[No Author keywords available]

Indexed keywords

ARIPIPRAZOLE; ATORVASTATIN; BEVACIZUMAB; CLOPIDOGREL; DULOXETINE; ENOXAPARIN; ESCITALOPRAM; ESOMEPRAZOLE; ETANERCEPT; FLUTICASONE; INFLIXIMAB; MONTELUKAST; OLANZAPINE; OXYCODONE; PIOGLITAZONE; PRESCRIPTION DRUG; QUETIAPINE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; ROSUVASTATIN; SALMETEROL; VENLAFAXINE;

EID: 84882350639     PISSN: 20445415     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmjqs-2012-001704     Document Type: Article
Times cited : (29)

References (38)
  • 2
    • 36749023278 scopus 로고    scopus 로고
    • Introduction to the new prescription drug labeling by the food and drug administration
    • Lal R, Kremzner M. Introduction to the new prescription drug labeling by the Food and Drug Administration. Am J Health Syst Pharm 2007;64:2488-94.
    • (2007) Am J Health Syst Pharm , vol.64 , pp. 2488-94
    • Lal, R.1    Kremzner, M.2
  • 3
    • 74849133022 scopus 로고    scopus 로고
    • Antidepressants and suicide risk: How did specific information in FDA safety warnings affect treatment patterns?
    • Busch SH, Frank RG, Leslie DL, et al. Antidepressants and suicide risk: how did specific information in FDA safety warnings affect treatment patterns? Psychiatr Serv 2010;61:11-16.
    • (2010) Psychiatr Serv , vol.61 , pp. 11-16
    • Busch, S.H.1    Frank, R.G.2    Leslie, D.L.3
  • 4
    • 77954203365 scopus 로고    scopus 로고
    • Influence of physicians' management and communication ability on patients' persistence with antihypertensive medication
    • Tamblyn R, Abrahamowicz M, Dauphinee D, et al. Influence of physicians' management and communication ability on patients' persistence with antihypertensive medication. Arch Intern Med 2010;170:1064-72.
    • (2010) Arch Intern Med , vol.170 , pp. 1064-72
    • Tamblyn, R.1    Abrahamowicz, M.2    Dauphinee, D.3
  • 5
    • 34249722276 scopus 로고    scopus 로고
    • Helping patients with type 2 diabetes mellitus make treatment decisions: Statin choice randomized trial
    • Weymiller AJ, Montori VM, Jones LA, et al. Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Intern Med 2007;167:1076-82.
    • (2007) Arch Intern Med , vol.167 , pp. 1076-82
    • Weymiller, A.J.1    Montori, V.M.2    Jones, L.A.3
  • 6
    • 0034853557 scopus 로고    scopus 로고
    • Understanding risk and lessons for clinical risk communication about treatment preferences
    • Edwards A, Elwyn G. Understanding risk and lessons for clinical risk communication about treatment preferences. Qual Health Care 2001;10(Suppl 1):i9-13.
    • (2001) Qual Health Care , vol.10 , Issue.SUPPL. 1
    • Edwards, A.1    Elwyn, G.2
  • 7
    • 0038630872 scopus 로고    scopus 로고
    • Pharmacist involvement in a multidisciplinary inpatient medication education program
    • Calabrese AT, Cholka K, Lenhart SE, et al. Pharmacist involvement in a multidisciplinary inpatient medication education program. Am J Health Syst Pharm 2003;60:1012-18.
    • (2003) Am J Health Syst Pharm , vol.60 , pp. 1012-18
    • Calabrese, A.T.1    Cholka, K.2    Lenhart, S.E.3
  • 8
    • 33750574360 scopus 로고    scopus 로고
    • Safety and risk communication to patients
    • Thürmann PA. Safety and risk communication to patients. Expert Opin Drug Saf 2006;5:747-50.
    • (2006) Expert Opin Drug Saf , vol.5 , pp. 747-50
    • Thürmann, P.A.1
  • 9
    • 33744961171 scopus 로고    scopus 로고
    • Highlights and a hidden hazard-The FDA's new labeling regulations
    • Avorn J, Shrank W. Highlights and a hidden hazard-the FDA's new labeling regulations. N Engl J Med 2006;354: 2409-11.
    • (2006) N Engl J Med , vol.354 , pp. 2409-11
    • Avorn, J.1    Shrank, W.2
  • 10
    • 84882406208 scopus 로고    scopus 로고
    • Adequate drug warnings in the face of uncertain causality: The learned intermediary doctrine and the need for clarity
    • Imbroscio M, Bell G. Adequate drug warnings in the face of uncertain causality: the learned intermediary doctrine and the need for clarity. West Virginia Law Rev 2005;107:847-65.
    • (2005) West Virginia Law Rev , vol.107 , pp. 847-65
    • Imbroscio, M.1    Bell, G.2
  • 11
    • 71049184878 scopus 로고    scopus 로고
    • Lost in transmission-FDA drug information that never reaches clinicians
    • Schwartz LM, Woloshin S. Lost in transmission-FDA drug information that never reaches clinicians. N Engl J Med 2009;361:1717-20.
    • (2009) N Engl J Med , vol.361 , pp. 1717-20
    • Schwartz, L.M.1    Woloshin, S.2
  • 12
    • 33646057979 scopus 로고    scopus 로고
    • Surrogate markers, emboldened and boxed warnings, and an expanding culture of misinformation: Evidence-based clinical science should guide FDA decision making about product labeling
    • Shulman LP, Bateman LH, Creinin MD, et al. Surrogate markers, emboldened and boxed warnings, and an expanding culture of misinformation: evidence-based clinical science should guide FDA decision making about product labeling. Contraception 2006;73:440-2.
    • (2006) Contraception , vol.73 , pp. 440-2
    • Shulman, L.P.1    Bateman, L.H.2    Creinin, M.D.3
  • 13
    • 0023574975 scopus 로고
    • Effect of government and commercial warnings on reducing prescription misuse: The case of propoxyphene
    • Soumerai SB, Avorn J, Gortmaker S, et al. Effect of government and commercial warnings on reducing prescription misuse: the case of propoxyphene. Am J Public Health 1987;77:1518-23.
    • (1987) Am J Public Health , vol.77 , pp. 1518-23
    • Soumerai, S.B.1    Avorn, J.2    Gortmaker, S.3
  • 14
    • 79957577277 scopus 로고    scopus 로고
    • A quantitative analysis of adverse events and 'overwarning' in drug labeling
    • Duke J, Friedlin J, Ryan P. A quantitative analysis of adverse events and 'overwarning' in drug labeling. Arch Intern Med 2011;171:944-6.
    • (2011) Arch Intern Med , vol.171 , pp. 944-6
    • Duke, J.1    Friedlin, J.2    Ryan, P.3
  • 17
    • 19444376788 scopus 로고    scopus 로고
    • The safety of rofecoxib
    • Burnier M. The safety of rofecoxib. Expert Opin Drug Saf 2005;4:491-9.
    • (2005) Expert Opin Drug Saf , vol.4 , pp. 491-9
    • Burnier, M.1
  • 18
    • 84874511186 scopus 로고    scopus 로고
    • Consistency in the safety labeling of bioequivalent medications
    • Duke J, Friedlin J, Li X. Consistency in the safety labeling of bioequivalent medications. Pharmacoepidemiol Drug Saf 2013;22:294-301.
    • (2013) Pharmacoepidemiol Drug Saf , vol.22 , pp. 294-301
    • Duke, J.1    Friedlin, J.2    Li, X.3
  • 19
    • 84882441987 scopus 로고    scopus 로고
    • (accessed 16 Apr)
    • Daily Med: about Daily Med. http://dailymed.nlm.nih.gov/dailymed/about. cfm (accessed 16 Apr 2013).
    • (2013) Daily Med: About Daily Med
  • 20
    • 84882392630 scopus 로고    scopus 로고
    • Government of Canada HC. (accessed 17 Apr)
    • Government of Canada HC. Drug Product Database Online Query. http://webprod5.hc-sc.gc.ca/dpd-bdpp (accessed 17 Apr 2013).
    • (2013) Drug Product Database Online Query
  • 22
    • 84882356544 scopus 로고    scopus 로고
    • Australian Government Department of Health and Ageing. (accessed 17 Apr)
    • Australian Government Department of Health and Ageing. Information about prescription medicines in Australia. https://www.ebs.tga.gov.au (accessed 17 Apr 2013).
    • (2013) Information about Prescription Medicines in Australia
  • 24
    • 84882357300 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research. (accessed 16 Apr)
    • Center for Drug Evaluation and Research. Drugs@FDA data files. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm (accessed 16 Apr 2013).
    • (2013) Drugs@FDA Data Files
  • 25
    • 84964936658 scopus 로고    scopus 로고
    • ADESSA: A real-time decision support service for delivery of semantically coded adverse drug event data
    • Duke JD, Friedlin J. ADESSA: a real-time decision support service for delivery of semantically coded adverse drug event data. AMIA Annu Symp Proc 2010;2010:177-81.
    • (2010) AMIA Annu Symp Proc , vol.2010 , pp. 177-81
    • Duke, J.D.1    Friedlin, J.2
  • 26
    • 84882361438 scopus 로고    scopus 로고
    • First Data Bank. (accessed 16 Apr)
    • First Data Bank. FDB Med Knowledge. http://www.fdbhealth.com/fdb- medknowledge-clinical-modules/ (accessed 16 Apr 2013).
    • (2013) FDB Med Knowledge
  • 27
    • 79961135005 scopus 로고    scopus 로고
    • R Development Core Team. Vienna, Austria: R Foundation for Statistical Computing
    • R Development Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing, 2011.
    • (2011) R: A Language and Environment for Statistical Computing
  • 28
    • 38449092323 scopus 로고    scopus 로고
    • Consumer medication information in the United States, Europe, and Australia: A comparative evaluation
    • Raynor DK, Svarstad B, Knapp P, et al. Consumer medication information in the United States, Europe, and Australia: a comparative evaluation. J Am Pharm Assoc 2007; 47:717-24.
    • (2007) J Am Pharm Assoc , vol.47 , pp. 717-24
    • Raynor, D.K.1    Svarstad, B.2    Knapp, P.3
  • 29
    • 80051749010 scopus 로고    scopus 로고
    • Bringing greater transparency to 'black box' warnings
    • Buckley NA, Rossi S. Bringing greater transparency to 'black box' warnings. Clin Toxicol 2011;49:448-51.
    • (2011) Clin Toxicol , vol.49 , pp. 448-51
    • Buckley, N.A.1    Rossi, S.2
  • 30
    • 84882364726 scopus 로고    scopus 로고
    • HealthCanada. 29 May. (accessed 16 Apr 2013)
    • HealthCanada. Transparency-release of product monographs directly to requesters. 29 May 2006. http://www.hc-sc.gc.ca/dhp-mps/alt-formats/hpfb-dgpsa/ pdf/prodpharma/pm-notice-mp-avis-trans-eng.pdf (accessed 16 Apr 2013).
    • (2006) Transparency-release of Product Monographs Directly to Requesters
  • 31
    • 70549113620 scopus 로고    scopus 로고
    • U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: Results of a national survey
    • Chen DT, Wynia MK, Moloney RM, et al. U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey. Pharmacoepidemiol Drug Saf 2009;18:1094-100.
    • (2009) Pharmacoepidemiol Drug Saf , vol.18 , pp. 1094-100
    • Chen, D.T.1    Wynia, M.K.2    Moloney, R.M.3
  • 32
    • 33947496346 scopus 로고    scopus 로고
    • The effect of antidepressant warnings on prescribing trends in Ontario, Canada
    • Kurdyak PA, Juurlink DN, Mamdani MM. The effect of antidepressant warnings on prescribing trends in Ontario, Canada. Am J Public Health 2007;97:750-4.
    • (2007) Am J Public Health , vol.97 , pp. 750-4
    • Kurdyak, P.A.1    Juurlink, D.N.2    Mamdani, M.M.3
  • 33
    • 33845671149 scopus 로고    scopus 로고
    • For Merck, the Vioxx paper trail won't go away
    • 21 August
    • Berenson A. For Merck, the Vioxx paper trail won't go away. NY Times 21 August 2005; A1.
    • (2005) NY Times
    • Berenson, A.1
  • 34
    • 84861682205 scopus 로고    scopus 로고
    • Drug, patient, and physician characteristics associated with off-label prescribing in primary care
    • Eguale T, Buckeridge DL, Winslade NE, et al. Drug, patient, and physician characteristics associated with off-label prescribing in primary care. Arch Intern Med 2012;172:781-8.
    • (2012) Arch Intern Med , vol.172 , pp. 781-8
    • Eguale, T.1    Buckeridge, D.L.2    Winslade, N.E.3
  • 35
    • 32644436054 scopus 로고    scopus 로고
    • Adherence to black box warnings for prescription medications in outpatients
    • Lasser KE, Seger DL, Yu DT, et al. Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med 2006;166:338-44.
    • (2006) Arch Intern Med , vol.166 , pp. 338-44
    • Lasser, K.E.1    Seger, D.L.2    Yu, D.T.3
  • 36
    • 66749091667 scopus 로고    scopus 로고
    • Pediatric antidepressant use after the black-box warning
    • Busch SH, Barry CL. Pediatric antidepressant use after the black-box warning. Health Aff 2009;28:724-33.
    • (2009) Health Aff , vol.28 , pp. 724-33
    • Busch, S.H.1    Barry, C.L.2
  • 37
    • 0035720060 scopus 로고    scopus 로고
    • ICH Harmonised Tripartite Guideline: Guideline for good clinical practice
    • International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use
    • International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised Tripartite Guideline: guideline for good clinical practice. J Postgrad Med 2001;47:199-203.
    • (2001) J Postgrad Med , vol.47 , pp. 199-203
  • 38
    • 15744395046 scopus 로고    scopus 로고
    • Communicating with patients about harms and risks
    • Herxheimer A. Communicating with patients about harms and risks. PLoS Med 2005;2:e42.
    • (2005) PLoS Med , vol.2
    • Herxheimer, A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.