Risk evaluation and mitigation strategies: Challenges and opportunities for health-system pharmacists

American Journal of Health-System Pharmacy

Volumn 67, Issue 18, 2010, Pages 1547-1554

  Stubbings, Joann ^a,b   Joshi, Rutu A ^b   Hoffman, James M ^c,d  

^a Research and Public Policy   (United States)

^b UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^c ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^d UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FOOD AND DRUG ADMINISTRATION; HEALTH SERVICE; HUMAN; NOTE; PATIENT SAFETY; PHARMACIST; PRIORITY JOURNAL; PROFESSIONAL PRACTICE; RISK ASSESSMENT; ARTICLE; DRUG LABELING; HOSPITAL PHARMACY; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD; RISK MANAGEMENT; UNITED STATES;

DRUG;

DRUG LABELING; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACISTS; PHARMACY SERVICE, HOSPITAL; PROFESSIONAL ROLE; RISK ASSESSMENT; RISK MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79952110483     PISSN: 10792082     EISSN: 15352900     Source Type: Journal    
DOI: 10.2146/ajhp090640     Document Type: Note

References (24)

1. Institute of Medicine. The future of drug safety: promoting and protecting the health of the public. www.iom.edu/Reports/2006/The-Future-of- Drug-Safety-Promoting-and-Protecting-the-Health-of-the-Public.aspx (accessed 2010 Mar 12).
2. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007; 356:2457-71. (Pubitemid 46919772)
3. Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med. 2005; 353:369-74. (Pubitemid 41132341)
4. Langer-Gould A, Atlas SW, Green AJ et al. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med. 2005; 353:375-81. (Pubitemid 41132342)
5. Sackner-Bernstein JD, Kowalski M, Fox M et al. Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials. JAMA. 2005; 293:1900-5. (Pubitemid 40548187)
6. Sackner-Bernstein JD, Skopicki HA, Aaronson KD. Risk of worsening renal function with nesiritide in patients with acutely decompensated heart failure. Circulation. 2005; 111:1487-91. (Pubitemid 40470642)
7. Topol EJ. Nesiritide - not verified. N Engl J Med. 2005; 353:113-6. (Pubitemid 41058341)
8. Van Assche G, Van Ranst M, Sciot R et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N Engl J Med. 2005; 353:362-8. (Pubitemid 41132340)
9. Food and Drug Administration. Guidance for industry: format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and REMS modifications. www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf (accessed 2010 Mar 12).
10. Thompson CA. MI risk prompts rofecoxib withdrawal. Am J Health-Syst Pharm. 2004; 61:2234-6, 2238.
11. Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110-cong-public- laws&docid=f:publ085.110.pdf (accessed 2010 Mar 12).
12. Leiderman DB. Risk management of drug products and the U.S. Food and Drug Administration: evolution and context. Drug Alcohol Depend. 2009, doi: 10.1016/j.drugalcdep.2009.02.007.
13. Food and Drug Administration. Guidance for industry: development and use of risk minimization action plans. www.fda.gov/downloads/RegulatoryInformation/ Guidances/UCM126830.pdf (accessed 2010 Jul 12).
14. Marre CA, Berry P. Designing a safety risk management strategy. Regul Focus. 2008 (Nov):21-5.
15. 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.
16. Food and Drug Administration. Approved risk evaluation and mitigation strategies. www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm (accessed 2010 Mar 12).
17. Wechsler J. FDA Amendments Act raises confidence and questions. Pharm Technol. 2007; 31(11):32,41.
18. Food and Drug Administration. Drug safety communication: erythropoiesis-stimulating agents (ESAs): Procrit, Epogen and Aranesp. www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm (accessed 2010 Mar 12).
19. Food and Drug Administration. Drug safety communication: new safety requirements for long-acting inhaled asthma medications called long-acting betaagonists (LABAs). www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm (accessed 2010 Mar 12).
20. Woodcock J. A difficult balance - pain management, drug safety, and the FDA. N Engl J Med. 2009; 361:2105-9.
21. Food and Drug Administration. Risk evaluation and mitigation strategies (REMs) for extended-release and long-acting opioid analgesics. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ AnestheticAndLifeSupportDrugsAdvisoryCommittee/ucm217510.pdf (accessed 2010 Jul 16).
22. American Association of Colleges of Pharmacy. Oath of a pharmacist. www.aacp.org/resources/academicpolicies/studentaffairspolicies/Documents/ OATHOFAPHARMACIST2008-09.pdf (accessed 2010 Mar 12).
23. Armitstead J, Loyd L, Pane F et al. Implications of the specialty drug marketplace for health-system pharmacy: a roundtable discussion. Am J Health-Syst Pharm. 2007; 64:2364-72.
24. American Society of Health-System Pharmacists. ASHP policy positions: pharmaceutical industry. Policy number 0714: restricted drug distribution. www.ashp.org/Import/PRACTICEANDPOLICY/PolicyPositionsGuidelinesBestPractices/ BrowsebyTopic/PharmaceuticalIndustry/PolicyPositions.aspx#0714 (accessed 2010 Mar 12).