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Volumn 35, Issue 2, 2012, Pages 91-104

Risk evaluation and mitigation strategies (REMS): Educating the prescriber

Author keywords

Benefit risk assessment; Opioid analgesics; Risk management; Romiplostim

Indexed keywords

4 AMINOPYRIDINE; ALVIMOPAN; ARFORMOTEROL; BOTULINUM TOXIN A; BRILLINTA; BUPRENORPHINE; CARBAMAZEPINE; DEXTROPROPOXYPHENE; DEXTROPROPOXYPHENE NAPSILATE; EXTRANEAL; FENTANYL; FENTANYL CITRATE; FINGOLIMOD; FLUTICASONE PROPIONATE PLUS SALMETEROL; FORMOTEROL FUMARATE; FORMOTEROL FUMARATE PLUS MOMETASONE FUROATE; GLIMEPIRIDE PLUS PIOGLITAZONE; GLIMEPIRIDE PLUS ROSIGLITAZONE; HYDROMORPHONE; INDACATEROL; LEVOFLOXACIN; METFORMIN PLUS PIOGLITAZONE; METFORMIN PLUS ROSIGLITAZONE; MORPHINE SULFATE PLUS NALTREXONE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PARATHYROID HORMONE[1-34]; PIOGLITAZONE; PRASUGREL; RECOMBINANT ERYTHROPOIETIN; ROSIGLITAZONE; TESTOSTERONE; TIAGABINE; TOCILIZUMAB; UNCLASSIFIED DRUG; UNINDEXED DRUG; VANDETANIB; VARENICLINE;

EID: 84855823712     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11597840-000000000-00000     Document Type: Article
Times cited : (17)

References (24)
  • 1
    • 77952075690 scopus 로고    scopus 로고
    • US Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research US Department of Health and Human Services September [online] [Accessed 2011 May 10]
    • US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, US Department of Health and Human Services. Guidance for industry: format and content of proposed Risk Evaluation and Mitigation Strategies (REMS), REMS assessments, and proposed REMS modifications: draft guidance. September 2009 [online]. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/ Guidances/UCM184128.pdf [Accessed 2011 May 10]
    • (2009) Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS) REMS Assessments and Proposed REMS Modifications: Draft Guidance
  • 2
    • 77950267684 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US Food and Drug Administration Last updated Aug 2009 [online] [Accessed 2011 May 10]
    • US Department of Health and Human Services, US Food and Drug Administration. Adverse Event Reporting System (AERS). Last updated Aug 2009 [online]. Available from URL: http://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm [Accessed 2011 May 10]
    • Adverse Event Reporting System (AERS)
  • 3
    • 84872446614 scopus 로고    scopus 로고
    • US Department ofHealth andHuman Services,US Food and Drug Administration Last updated April 2011 [online] [Accessed 2011 May 10]
    • US Department ofHealth andHuman Services,US Food and Drug Administration. Potential signals of serious risks/new safety information identified fromthe Adverse EventReporting System (AERS). Last updated April 2011 [online]. Available from URL: http://www.fda.gov/Drugs/GuidanceCom plianceRegulatoryInformation/Surveillance/AdverseDrug Effects/UCM082196 [Accessed 2011 May 10]
    • Potential Signals of Serious Risks/new Safety Information Identified Fromthe Adverse EventReporting System (AERS)
  • 4
    • 69849083249 scopus 로고    scopus 로고
    • Public perceptions of the pharmaceutical industry and drug safety: Implications for the pharmacovigilance professional and the culture of safety
    • Olsen AK, Whalen MD. Public perceptions of the pharmaceutical industry and drug safety: implications for the pharmacovigilance professional and the culture of safety. Drug Saf 2009; 32: 805-10
    • (2009) Drug Saf , vol.32 , pp. 805-810
    • Olsen, A.K.1    Whalen, M.D.2
  • 5
    • 73949098596 scopus 로고    scopus 로고
    • Risk management of drug products and the U.S. Food and Drug Administration: Evolution and context
    • Leiderman DB. Risk management of drug products and the U.S. Food and Drug Administration: evolution and context. Drug Alcohol Depend 2009; 105: S9-13
    • (2009) Drug Alcohol Depend , vol.105
    • Leiderman, D.B.1
  • 6
    • 62249223945 scopus 로고    scopus 로고
    • Anticipating REMS
    • Anticipating REMS. Nat Rev Drug Discov 2008; 7: 963
    • (2008) Nat Rev Drug Discov , vol.7 , pp. 963
  • 7
    • 34548771009 scopus 로고    scopus 로고
    • European Agency for the Evaluation of Medicinal Products, Committee for Medicinal Products for Human Use November [online] [Accessed 2011 Nov 15]
    • European Agency for the Evaluation of Medicinal Products, Committee for Medicinal Products for Human Use. Guideline on risk management systems for medicinal products for human use. November 2005 [online]. Available from URL: http://www.pharmacoepi.org/riskmgmt/emea100505.pdf [Accessed 2011 Nov 15]
    • (2005) Guideline on Risk Management Systems for Medicinal Products for Human Use
  • 8
    • 79953076105 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research Last updated May 2011 [online] [Accessed 2011 Nov 15]
    • US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Approved Risk Evaluation and Mitigation Strategies (REMS). Last updated May 2011 [online]. Available from URL: http://www.fda.gov/ Drugs/DrugSafety/PostmarketDrug SafetyInformationforPatientsandProviders/ ucm111350.htm [Accessed 2011 Nov 15]
    • Approved Risk Evaluation and Mitigation Strategies (REMS)
  • 9
    • 84871193373 scopus 로고    scopus 로고
    • US Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research US Department of Health and Human Services February 2011 [online] [Accessed 2011 May 10]
    • US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, US Department of Health and Human Services. Guidance for industry: medication guides-distribution requirements and inclusion in Risk Evaluation and Mitigation Strategies (REMS): draft guidance. February 2011 [online]. Available from URL: http://www.fda.gov/down loads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244570.pdf [Accessed 2011 May 10]
    • Guidance for Industry: Medication Guides-distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS): Draft Guidance
  • 10
    • 84855857136 scopus 로고    scopus 로고
    • Raritan (NJ): Ortho McNeil-Janssen Pharmaceutical Inc [online] [Accessed 2011 May 10]
    • Levaquin (levofloxacin) Risk Evaluation and Mitigation Strategy (REMS). Raritan (NJ): Ortho McNeil-Janssen Pharmaceutical, Inc., 2008 [online]. Available from URL: http://www.fda.gov/downloads/Drugs/DrugSafety/Postmarket DrugSafetyInformationforPatientsandProviders/UCM150613. pdf [Accessed 2011 May 10]
    • (2008) Levaquin (Levofloxacin) Risk Evaluation and Mitigation Strategy (REMS)
  • 11
    • 0037792114 scopus 로고    scopus 로고
    • Fluoroquinolone-associated tendinopathy: A critical review of the literature
    • DOI 10.1086/375078
    • Khaliq Y, Zhanel GG. Fluoroquinolone-associated tendinopathy: a critical review of the literature. Clin Infect Dis 2003; 36: 1404-10 (Pubitemid 36702874)
    • (2003) Clinical Infectious Diseases , vol.36 , Issue.11 , pp. 1404-1410
    • Khaliq, Y.1    Zhanel, G.G.2
  • 13
    • 84855845791 scopus 로고    scopus 로고
    • Kenilworth (NJ): Schering-Plough [online] [Accessed 2011 May 10]
    • Cipro (ciprofloxacin) [medication guide]. Kenilworth (NJ): Schering-Plough, 2009 [online]. Available from URL: http://www.accessdata.fda. gov/drugsatfda-docs/label/2009/01953 7s69,19847s43,19857s50,20780s27CiproMedG. pdf [Accessed 2011 May 10]
    • (2009) Cipro (Ciprofloxacin) [Medication Guide]
  • 14
    • 84855823571 scopus 로고    scopus 로고
    • Kenilworth (NJ): Schering-Plough [online] [Accessed 2011 May 10]
    • Avelox (moxifloxacin hydrochloride) [medication guide]. Kenilworth (NJ): Schering-Plough, 2008 [online]. Available from URL: http://www.avelox.com/html/ pdf/avelox-med guide.pdf [Accessed 2011 May 10]
    • (2008) Avelox (Moxifloxacin Hydrochloride) [Medication Guide]
  • 15
    • 84855836217 scopus 로고    scopus 로고
    • Cary (NC): Cornerstone Therapeutics Inc [online] [Accessed 2011 May 10]
    • Factive (gemifloxacin) [medication guide]. Cary (NC): Cornerstone Therapeutics Inc., 2011 [online]. Available from URL: http://www.fda.gov/ downloads/Drugs/DrugSafety/UCM152723.pdf [Accessed 2011 May 10]
    • (2011) Factive (Gemifloxacin) [Medication Guide]
  • 16
    • 84855857133 scopus 로고    scopus 로고
    • Whitehouse Station (NJ): Merck & Co., Inc. [online] [Accessed 2011 May 10]
    • Noroxin (norfloxacin) [medication guide]. Whitehouse Station (NJ): Merck & Co., Inc., 2011 [online]. Available from URL: http://www.merck.com/ product/usa/pi-circulars/n/noroxin/noroxin-ppi.pdf [Accessed 2011 May 10]
    • (2011) Noroxin (Norfloxacin) [Medication Guide]
  • 17
    • 84855857137 scopus 로고    scopus 로고
    • Questions and answers on guidance for industry: Medication guides
    • US Food and Drug Administration [online] [Accessed 2011 Aug 30]
    • US Food and Drug Administration. Questions and answers on guidance for industry: medication guides. Distribution requirements and inclusion in Risk Evaluation and Mitigation Strategies (REMS) 2011 [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/ucm248459. htm [Accessed 2011 Aug 30]
    • (2011) Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)
  • 18
    • 69949092807 scopus 로고    scopus 로고
    • Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura
    • (Williston Park)
    • Jamali F, Lemery S, Ayalew K, et al. Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura. Oncology (Williston Park) 2009; 23: 704-9
    • (2009) Oncology , vol.23 , pp. 704-709
    • Jamali, F.1    Lemery, S.2    Ayalew, K.3
  • 19
    • 84855836216 scopus 로고    scopus 로고
    • Thousand Oaks (CA): Amgen Inc [online] [Accessed 2011 May 10]
    • Nplate Risk Evaluation and Mitigation Strategy. Thousand Oaks (CA): Amgen Inc., 2008 [online]. Available from URL: http://www.fda.gov/downloads/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm129516.pdf [Accessed 2011 May 10]
    • (2008) Nplate Risk Evaluation and Mitigation Strategy
  • 20
    • 68349114773 scopus 로고    scopus 로고
    • Opioid risk management: Understanding FDA mandated risk evaluation and mitigation strategies (REMS)
    • Sloan PA. Opioid risk management: understanding FDA mandated risk evaluation and mitigation strategies (REMS). J OpioidManag 2009; 5: 131-3
    • (2009) J OpioidManag , vol.5 , pp. 131-133
    • Sloan, P.A.1
  • 21
    • 73949129017 scopus 로고    scopus 로고
    • Risk management and postmarketing surveillance of CNS drugs
    • Henningfield JE, Schuster CR. Risk management and postmarketing surveillance of CNS drugs. Drug Alcohol Depend. 2009; 105 Suppl. 1: S56-64
    • (2009) Drug Alcohol Depend. , vol.105 , Issue.SUPPL. 1
    • Henningfield, J.E.1    Schuster, C.R.2
  • 23
    • 78650107749 scopus 로고    scopus 로고
    • US Food and Drug Administration [online] [Accessed 2011 Aug 30]
    • US Food and Drug Administration. Opioid drugs and Risk Evaluation and Mitigation Strategies (REMS) 2011 [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm [Accessed 2011 Aug 30]
    • (2011) Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.