메뉴 건너뛰기




Volumn 43, Issue 5, 2009, Pages 603-616

Constant vigilance: The role of pharmaceutical companies in medicine safety

Author keywords

Benefit risk balance; FDAAA; Medicine safety; Pharmacovigilance signals; Risk management

Indexed keywords

DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; PATIENT SAFETY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; UNITED STATES;

EID: 70350168895     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150904300509     Document Type: Review
Times cited : (1)

References (30)
  • 1
    • 70350188378 scopus 로고    scopus 로고
    • Pfizer Drug Safety Stakeholder Research. November March Available upon request from correspondence author
    • Pfizer Drug Safety Stakeholder Research. November 2006. Adverse Events Reporting Survey Pfizer/Ipsos, March 2008. [Available upon request from correspondence author.]
    • (2006) Adverse Events Reporting Survey Pfizer/Ipsos
  • 2
    • 70350190031 scopus 로고    scopus 로고
    • Available at
    • Harris Interactive. Available at: http://www.harrisinteractive.com/news/ allnewsbydate.asp?NewsID=1206.
  • 3
    • 32544448934 scopus 로고    scopus 로고
    • Council for International Organisations of Medical Sciences. Report of CIOMS Working Groups III and V, Geneva, See also
    • Council for International Organisations of Medical Sciences. Guidelines for Preparing Core Clinical-Safety Information on Drugs, Report of CIOMS Working Groups III and V, Geneva, 1998. See also: http://www.who-umc.org/DynPage. aspx7id=22684.
    • (1998) Guidelines for Preparing Core Clinical-Safety Information on Drugs
  • 4
    • 33947232511 scopus 로고    scopus 로고
    • Available at
    • Pharmaceutical Industry Profile 2006, p. 4. Available at: http://www.phrma.org/files/2006%20Industry%20Profile.pdf.
    • Pharmaceutical Industry Profile 2006 , pp. 4
  • 6
    • 53849084855 scopus 로고    scopus 로고
    • Good practices for handling adverse events detected through patient registries
    • Dreyer NA, Sheth N, Trontell A, Gliklich RE. Good practices for handling adverse events detected through patient registries. Drug Inf J. 2007;42:421-428.
    • (2007) Drug Inf J , vol.42 , pp. 421-428
    • Dreyer, N.A.1    Sheth, N.2    Trontell, A.3    Gliklich, R.E.4
  • 7
    • 70350200925 scopus 로고    scopus 로고
    • Available at: See
    • Sutent Risk Management Plan. Available at: http://www.emea.europa.eu/ humandocs/PDFs/EPAR/sutent/068706en6.pdf. See pp. 41-42.
    • Sutent Risk Management Plan , pp. 41-42
  • 9
    • 70350185469 scopus 로고    scopus 로고
    • Available at
    • EMEA. Tracleer, section 2.7.2. Available at: http://www.emea.europa.eu/ humandocs/PDFs/EPAR/tracleer/EMEA-H-401-II-29-AR.pdf.
    • Tracleer, Section 2.7.2
  • 10
    • 85077295724 scopus 로고    scopus 로고
    • Bosentan enters market with risk management program
    • March 15, Available at
    • Thompson CA. Bosentan enters market with risk management program. Am J Health Syst Pharm. March 15, 2002. Available at: http://www.ashp.org/import/ News/HealthSystemPharmacyNews/newsarticle.aspx?id=901.
    • (2002) Am J Health Syst Pharm
    • Thompson, C.A.1
  • 11
    • 70350190030 scopus 로고    scopus 로고
    • For FDA guidance to industry on the development and use of RiskMAPs, see: Note that FDA has indicated it plans to revise this guidance in light of the passage of FDAAA. For discussion of RiskMAPS, including evaluating their effectiveness, see Jones and Bartlett
    • For FDA guidance to industry on the development and use of RiskMAPs, see: http://www.fda.gov/cder/guidance/6358fnl.htm#-Toc67721195. Note that FDA has indicated it plans to revise this guidance in light of the passage of FDAAA. For discussion of RiskMAPS, including evaluating their effectiveness, see Cobert B. Manual of Drug Safety and Pharmacovigilance. Jones and Bartlett, 2007: 71-74.
    • (2007) Manual of Drug Safety and Pharmacovigilance , pp. 71-74
    • Cobert, B.1
  • 12
    • 70350182278 scopus 로고    scopus 로고
    • FDA Questions and Answers. Notice on drugs and biological products deemed to have risk evaluation and mitigation strategies
    • Available at
    • FDA Questions and Answers. Notice on drugs and biological products deemed to have risk evaluation and mitigation strategies. Federal Register. Available at: http://www.fda.gov/RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ FoodandDrugAdministrationAmendmentsActof2007.
    • Federal Register
  • 13
    • 70350208853 scopus 로고    scopus 로고
    • REMS. Available at
    • Food and Drug Administration. REMS. Available at: http://www.fda.gov/ cber/genadmin/rems.htm.
  • 14
    • 70350210545 scopus 로고    scopus 로고
    • Manufacturers face new risk-management requirements
    • Wechsler J. Manufacturers face new risk-management requirements. Pharm Tech. 2009; 33:26-32.
    • (2009) Pharm Tech , vol.33 , pp. 26-32
    • Wechsler, J.1
  • 15
    • 70350199680 scopus 로고    scopus 로고
    • July 8, Available at
    • ClinPage. FDAAA update at DIA. July 8, 2008. Available at: http://www.clinpage.com/article/fdaaa-update-at-dia/.
    • (2008) FDAAA Update at DIA
  • 16
    • 84996224355 scopus 로고    scopus 로고
    • The clock moves backwards on FDA's drug review timelines: The impact of FDAAA, REMS and the lack of agency resources
    • Church RF. The clock moves backwards on FDA's drug review timelines: the impact of FDAAA, REMS and the lack of agency resources. Update. 2009; March/April: 10-13.
    • (2009) Update , vol.MARCH-APRIL , pp. 10-13
    • Church, R.F.1
  • 17
    • 70350198089 scopus 로고    scopus 로고
    • ICH website. Available at
    • ICH website. Available at: http://www.ich.org/cache/compo/276-254-1.html.
  • 18
  • 20
    • 60749099873 scopus 로고    scopus 로고
    • Defining "signal" and its subtypes in pharmacovigilance based on a systematic review of previous definitions
    • Hauben M, Aronson JK. Defining "signal" and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf. 2009;32(2):99-110.
    • (2009) Drug Saf , vol.32 , Issue.2 , pp. 99-110
    • Hauben, M.1    Aronson, J.K.2
  • 21
    • 34250212715 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
    • Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356:2457-2471. (Pubitemid 46919772)
    • (2007) New England Journal of Medicine , vol.356 , Issue.24 , pp. 2457-2471
    • Nissen, S.E.1    Wolski, K.2
  • 22
    • 35848930559 scopus 로고    scopus 로고
    • Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death
    • Diamond GA, Kaul S. Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Ann Intern Med. 2007;147:578-581. (Pubitemid 351664507)
    • (2007) Annals of Internal Medicine , vol.147 , Issue.8 , pp. 578-581
    • Diamond, G.A.1    Bax, L.2    Kaul, S.3
  • 23
    • 70350183823 scopus 로고    scopus 로고
    • For a general description of pharmacoepidemiology, see
    • For a general description of pharmacoepidemiology, see: http://www.pharmacoepi.org/about/index.cfm.
  • 24
    • 0342561627 scopus 로고    scopus 로고
    • Association between non-steroidal anti-inflammatory drugs and upper gastrointestinal tract bleeding/perforation: An overview of epidemiologic studies published in the 1990s
    • For example, see
    • For example, see: Hernández-Díaz S, García Rodríguez LA. Association between non-steroidal anti-inflammatory drugs and upper gastrointestinal tract bleeding/perforation: an overview of epidemiologic studies published in the 1990s. Arch Intern Med. 2000;160:2093-2099.
    • (2000) Arch Intern Med , vol.160 , pp. 2093-2099
    • Hernández-Díaz, S.1    García Rodríguez, L.A.2
  • 25
    • 0036789104 scopus 로고    scopus 로고
    • Stratifying the risk of NSAID-related upper gastrointestinal clinical events: Results of a double-blind outcomes study in patients with rheumatoid arthritis
    • Laine L, Bombardier C, Hawkey CJ, et al. Stratifying the risk of NSAID-related upper gastrointestinal clinical events: results of a double-blind outcomes study in patients with rheumatoid arthritis. Gastroenterology. 2002;4:1006-1012.
    • (2002) Gastroenterology , vol.4 , pp. 1006-1012
    • Laine, L.1    Bombardier, C.2    Hawkey, C.J.3
  • 26
    • 34247193634 scopus 로고    scopus 로고
    • Application of the bradford hill criteria to assess the causality of cisapride-induced arrhythmia: A model for assessing causal association in pharmacovigilance
    • Perrio M, Voss S, Shakir SA. Application of the Bradford Hill criteria to assess the causality of cisapride-induced arrhythmia: a model for assessing causal association in pharmacovigilance. Drug Saf. 2007;(30):333-346. (Pubitemid 46624532)
    • (2007) Drug Safety , vol.30 , Issue.4 , pp. 333-346
    • Perrio, M.1    Voss, S.2    Shakir, S.A.W.3
  • 28
    • 34547663626 scopus 로고    scopus 로고
    • The effect of cytochrome P450 metabolism on drug response, interactions, and adverse effects
    • Lynch T, Price A. The effect of cytochrome P450 metabolism on drug response, interactions, and adverse effects. Am Fam Physician. 2007;76(3):391-396. (Pubitemid 47219454)
    • (2007) American Family Physician , vol.76 , Issue.3 , pp. 391-396
    • Lynch, T.1    Price, A.2
  • 29
    • 0034034158 scopus 로고    scopus 로고
    • Genetic polymorphism of thiopurine methyltransferase and its clinical relevance for childhood acute lymphoblastic leukemia
    • McLeod HL, Krynetski EY, Relling MV, Evans WE. Genetic polymorphism of thiopurine methyltransferase and its clinical relevance for childhood acute lymphoblastic leukemia. Leukemia. 2000;14:567-572.
    • (2000) Leukemia , vol.14 , pp. 567-572
    • McLeod, H.L.1    Krynetski, E.Y.2    Relling, M.V.3    Evans, W.E.4
  • 30
    • 70350199679 scopus 로고    scopus 로고
    • FDAAA. Available at
    • FDAAA. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi? dbname=110-cong-public-laws&docid=f:publ085.110.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.