Risk evaluation and mitigation strategies: Impact on patients, health care providers, and health systems

American Journal of Health-System Pharmacy

Volumn 66, Issue SUPPL. 7, 2009, Pages

  Shane, Rita ^a,b  

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Food and drug administration (U.S.); Patient information; Pharmacists; Postmarketing surveillance; Regulations; Risk management; Toxicity

Indexed keywords

ABARELIX; ALOSETRON; AMBRISENTAN; BOSENTAN; CLOZAPINE; DOFETILIDE; ECULIZUMAB; FENTANYL; HYDROMORPHONE; ISOTRETINOIN; LENALIDOMIDE; METHADONE; MIFEPRISTONE; MORPHINE; NATALIZUMAB; OPIATE; OXYBATE SODIUM; OXYCODONE; OXYMORPHONE; SMALLPOX VACCINE; THALIDOMIDE;

CONFERENCE PAPER; DRUG APPROVAL; DRUG LABELING; DRUG MARKETING; DRUG MONITORING; DRUG PACKAGING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HEALTH INSURANCE; PATIENT CARE; PHARMACIST; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK EVALUATION AND MITIGATION STRATEGY; RISK MANAGEMENT;

EID: 74049088154     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp090461     Document Type: Conference Paper

References (34)

1. Institute of Medicine. The future of drug safety: promoting and protecting the health of the public. September 22, 2006. http://www.iom.edu/ CMS/3793/26341/37329.aspx (accessed 2009 Jun 18).
2. Agency for Healthcare Research and Quality and U.S. Food and Drug Administration. Implementation of risk minimization action plans (RiskMAPs) to support quality use of pharmaceuticals: opportunities and challenges; public workshop. http://www.fda.gov/OHRMS/ DOCKETS/98fr/07-2574.pdf (accessed 2009 Jun 11).
3. 110th U.S. Congress. Food and Drug Administration Amendments Act of 2007. http://frwebgate.access.gpo.gov/ cgi-bin/getdoc.cgi?dbname=110-cong- public-laws&docid=f:publ085.110 (accessed 2009 Jun 11).
4. McEvoy GK, ed. Clozapine. In: AHFS Drug Information 2009. Bethesda, MD: American Society of Health-System Pharmacists; 2009:2464-77.
5. U.S. Food and Drug Administration. Guidance for industry: development and use of risk minimization action plans. March 2005. http://www.fda.gov/ohrms/ dockets/ac/05/briefing/2005-4136b1-03- Risk%20Minimization%20Action%20 Plans.pdf (accessed 2009 Jun 11).
6. Thalidomid package insert. Summit, NJ: Celgene Corporation; 2007 Feb.
7. Accutane package insert. Nutley, NJ: Roche Laboratories Inc; 2008 Nov.
8. Tikosyn package insert. New York, NY: Pfizer Labs; 2004 Mar.
9. McEvoy GK, ed. Natalizumab. In: AHFS Drug Information 2009. Bethesda, MD: American Society of Health-System Pharmacists; 2009:3704-9.
10. Tysabri package insert. South San Francisco, CA: Elan Pharmaceuticals Inc; 2008 Oct.
11. U.S. Food and Drug Administration. The Sentinel Initiative: a national strategy for monitoring medical product safety. http://www.fda.gov/Safety/FDAs SentinelInitiative/ucm089474.htm (accessed 2009 Jun 11).
12. Formulary Productions. Drugs with black box warnings - comprehensive list. http://www.formularyproductions. com/master/showpage.php?dir= blackbox&whichpage=9 (accessed 2009 Jun 11).
13. U.S. Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) under review for CellCept and Myfortic. http://www.fda.gov/ Drugs/ DrugSafety/PostmarketDrugSafety InformationforPatientsandProviders/ ucml48735.htm (accessed 2009 Jun 11).
14. U.S. Food and Drug Administration. Antiepileptic drugs, http://www.fda.gov/ Safety/MedWatch/Safetylnformation/ SafetyAlertsforHumanMedicalProducts/ ucm074939.htm (accessed 2009 Jun 11).
15. U.S. Food and Drug Administration. Testosterone gel products (AndroGel 1% and Testim 1%). http://www.fda.gov/ Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ ucml49346.htm (accessed 2009 Jun 11).
16. U.S. Food and Drug Administration. Tarceva (erlotinib) May 2009. http:// www.fda.gov/Safety/MedWatch/Safety Information/SafetyAlertsforHuman MedicalProducts/ucm150596.htm (accessed 2009 Jun 11).
17. 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. http:// www.fda.gov/OHRMS/DOCKETS/98fr/ E8-6201.pdf (accessed 2009 Jun 11).
18. U.S. Food and Drug Administration. Approvedriskevaluationandmitigationstrategies (REMS).http://www.fda.gov/Drugs/ DrugSafety/PostmarketDrugSafety InformationforPatientsandProviders/ ucml11350.htm (accessed 2009 July 5).
19. U.S. Food and Drug Administration. Sec. 505-1. [21 USC §355-1] Risk evaluation and mitigation strategies, http:// www.fda.gov/RegulatoryInformation/ Legislation/FederalFoodDrugand CosmeticActFDCAct/FDCActChapterV DrugsandDevices/ucm 109090.htm (accessed 2009 Jun 11).
20. U.S. Food and Drug Administration. Medication guides for prescription drug products. http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfCFR/ CFRSearch. cfm?CFRPart=208&showFR=1 (accessed 2009 Jun 18).
21. U.S. Food and Drug Administration. Potential signals of serious risks/new safety information identified from the Adverse Event Reporting System (AERS). http://www.fda.gov/Drugs/Guidance ComplianceRegulatorylnformation/ Surveillance/AdverseDrugEffects/ UCM082196 (accessed 2009 Jun 11).
22. U.S. Food and Drug Administration. FDA requires boxed warning for all botulinum toxin products. April 30, 2009. http:// www.fda.gov/NewsEvents/ Newsroom/ PressAnnouncements/ucm149574.htm (accessed 2009 Jun 11).
23. U.S. Food and Drug Administration. FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs: agency warns against chronic use of these products to treat gastrointestinal disorders. February 26, 2009. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ ucml49533.htm (accessed 2009 Jun 11).
24. U.S. Food and Drug Administration. Questions and answers on medication guides for erythropoiesis-stimulating agents (ESAs). http://www.fda.gov/ Drugs/DrugSafety/PostmarketDrug SafetyInformationforPatientsand Providers/ucm109380.htm (accessed 2009 Jun 19).
25. U.S. Food and Drug Administration. FDA statement on the voluntary withdrawal of Raptiva from the U.S. market. April 8, 2009. http://www.fda.gov/ NewsEvents/Newsroom/Press Announcements/ucm149561.htm (accessed 2009 Jun 11).
26. U.S. Food and Drug Administration. Questions and answers on the Federal Register notice on drugs and biological products deemed to have risk evaluation and mitigation strategies, http:// www.fda.gov/RegulatoryInformation/ Legislation/FederalFoodDrugand CosmeticActFDCAct/Significant AmendmentstotheFDCAct/Foodand DrugAdministrationAmendments Actof2007/ucm095439. htm (accessed 2009 Jun 11).
27. Nplate package insert. Thousand Oaks, CA: Amgen Inc; 2008 Aug.
28. Perreault S, Burzynski J. Romiplostim: a novel thrombopoiesis-stimulating agent. Am J Health-Syst Pharm. 2009; 66:817-24.
29. Ordering Nplate. Answering your questions about the Nplate (romiplostim) NEXUS program. http.//www.nplate nexus.com/ordering.html (accessed 2009 Jun 18).
30. U.S. Food and Drug Administration. Risk evaluation and mitigation strategies for certain opioid drugs; notice of public hearing. April 20, 2009. http://www.fda. gov/OHRMS/DOCKETS/98fr/E9-8992. pdf (accessed 2009 Jun 11).
31. U.S. Food and Drug Administration. Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; final monograph. April 29, 2009. http://edocket.access.gpo.gov/2009/ pdf/ E9-9684.pdf (accessed 2009 Jun 11).
32. American Society of Health-System Pharmacists. ASHP statement on criteria for an intermediate category of drug products. Am J Health-Syst Pharm. 2009; 66:502-5.
33. Aker JL. Consumer comprehension & outcomes research: risk communication advisory committee. May 1, 2009. http:// www.fda.gov/ohrms/ dockets/ac/09/ slides/2009-4421s2-02.pdf (accessed 2009 Jun 11).
34. Anon. House passes user fee and drug safety legislation. July 12, 2007. http://www.ashp.org/import/news/News Capsules/article.aspx?id=86 (accessed 2009 Jun 11).