메뉴 건너뛰기




Volumn 49, Issue 6, 2009, Pages 729-743

White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system

Author keywords

Food and Drug Administration; Health care administration; Health care providers; Patient accountability; Patient education; Pharmacists; Provider education; Quality of care; REMS; Risk evaluation and mitigation strategies; Risk management; Workflow

Indexed keywords

ARTICLE; DRUG TOXICITY; HEALTH CARE DELIVERY; HUMAN; INFORMED CONSENT; METHODOLOGY; PATIENT EDUCATION; REGISTER; RISK ASSESSMENT; RISK MANAGEMENT;

EID: 75349103708     PISSN: 15443191     EISSN: 15443450     Source Type: Journal    
DOI: 10.1331/JAPhA.2009.09541     Document Type: Article
Times cited : (20)

References (18)
  • 1
    • 85031054508 scopus 로고    scopus 로고
    • Accessed at September 18
    • U.S. Food and Drug Administration. A guide to drug safety terms at FDA. Accessed at www.fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm107976.pdf, September 18, 2009.
    • (2009) A Guide to Drug Safety Terms at FDA
  • 2
    • 0035515739 scopus 로고    scopus 로고
    • The risk revolution: An examination of the regulatory environment
    • Morris LA. The risk revolution: an examination of the regulatory environment. J Am Pharm Assoc. 2001;41(suppl 1):S5-10.
    • (2001) J Am Pharm Assoc , vol.41 , Issue.SUPPL. 1
    • Morris, L.A.1
  • 4
    • 80855162444 scopus 로고    scopus 로고
    • Accessed at August 3
    • U.S. Food and Drug Administration. Questions and answers about Lotronex (11/29/2000). Accessed at www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsand-Providers/ucm110887.htm, August 3, 2009.
    • (2009) Questions and Answers about Lotronex (11/29/2000)
  • 5
    • 73949098596 scopus 로고    scopus 로고
    • Risk management of drug products and the U.S. Food and Drug Administration: Evolution and context
    • March 21, Epub ahead of print
    • Leiderman DB. Risk management of drug products and the U.S. Food and Drug Administration: evolution and context. Drug Alcohol Depend. March 21, 2009 [Epub ahead of print].
    • (2009) Drug Alcohol Depend
    • Leiderman, D.B.1
  • 6
    • 0024468426 scopus 로고
    • Development of the Clozaril Patient Management System
    • Bastani B, Alphs LD, Meltzer HY. Development of the Clozaril Patient Management System. Psychopharmacology. 1989;99(suppl):S122-5.
    • (1989) Psychopharmacology , vol.99 , Issue.SUPPL.
    • Bastani, B.1    Alphs, L.D.2    Meltzer, H.Y.3
  • 8
    • 85031049946 scopus 로고    scopus 로고
    • Accessed at August 14
    • U.S. Food and Drug Administration. A synopsis of the elements of the S.T.E.P.S. program. Accessed at www.fda.gov/OHRMS/DOCKETS/AC/04/briefing/4017B1- 06b%20Overview%20STEPS%20Section%20C%20Tab%207.pdf, August 14, 2009.
    • (2009) A Synopsis of the Elements of the S.T.E.P.S. Program
  • 9
    • 33845346759 scopus 로고    scopus 로고
    • What is the best approach to reducing birth defects associated with isotretinoin?
    • Abroms L, Maibach E, Lyon-Daniel K, Feldman SR. What is the best approach to reducing birth defects associated with isotretinoin? PLoS Med. 2006;3:e483.
    • (2006) PLoS Med , vol.3
    • Abroms, L.1    Maibach, E.2    Lyon-Daniel, K.3    Feldman, S.R.4
  • 10
    • 85031065311 scopus 로고    scopus 로고
    • Accessed at July 6
    • U.S. Food and Drug Administration. Briefing document for iPLEDGE year one update. Accessed at www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4311b1-02- ipledge.pdf, July 6, 2009.
    • (2009) Briefing Document for IPLEDGE Year One Update
  • 14
    • 65549113312 scopus 로고    scopus 로고
    • Identification of drug and biological products deemed to have risk evaluation and mitigation strategies for purposes of the Food and Drug Administration Amendments Act of 2007
    • U.S. Food and Drug Administration
    • U.S. Food and Drug Administration. Identification of drug and biological products deemed to have risk evaluation and mitigation strategies for purposes of the Food and Drug Administration Amendments Act of 2007. Fed Regist. 2008;73:16313-4.
    • (2008) Fed Regist , vol.73 , pp. 16313-16314
  • 15
    • 70349215992 scopus 로고    scopus 로고
    • Risk evaluation and mitigation strategies for certain opioid drugs; notice of public meeting
    • U.S. Food and Drug Administration
    • U.S. Food and Drug Administration. Risk evaluation and mitigation strategies for certain opioid drugs; notice of public meeting. Fed Regist. 2009;74:17967-70.
    • (2009) Fed Regist , vol.74 , pp. 17967-17970
  • 16
    • 53049100172 scopus 로고    scopus 로고
    • Drug-risk communication to pharmacists: Assessing the impact of risk-minimization strategies on the practice of pharmacy
    • Lee LY, Kortepeter CM, Willy ME, Nourjah P. Drug-risk communication to pharmacists: assessing the impact of risk-minimization strategies on the practice of pharmacy. J Am Pharm Assoc. 2008;48:494-500.
    • (2008) J Am Pharm Assoc , vol.48 , pp. 494-500
    • Lee, L.Y.1    Kortepeter, C.M.2    Willy, M.E.3    Nourjah, P.4
  • 17
    • 84891480996 scopus 로고    scopus 로고
    • Accessed at August 31
    • U.S. Food and Drug Administration. Minutes of the Risk Communication Advisory Committee, FDA. Accessed at www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM152593.pdf, August 31, 2009.
    • (2009) Minutes of the Risk Communication Advisory Committee, FDA
  • 18
    • 84891417229 scopus 로고    scopus 로고
    • Providing effective information to consumers about prescription drug risks and benefits; public workshop
    • U.S. Food and Drug Administration
    • U.S. Food and Drug Administration. Providing effective information to consumers about prescription drug risks and benefits; public workshop. Fed Regist. 2009;74:33265-7.
    • (2009) Fed Regist , vol.74 , pp. 33265-33267


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.