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PAPERBACK list:$21.00 Web:$18.90 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles Preventing Medication Errors: Quality Chasm Series The Future of Drug Safety: Promoting and Protecting the Health of the Public Other Related Titles Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary (2007) Board on Health Sciences Policy (HSP) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 53   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. A Workshop Agenda Forum on Drug Discovery, Development, and Translation The Role of Consumers and Health-Care Professionals in Adverse Drug Event Reporting—Key Challenges and Opportunities November 3–4, 2005 Phoenix Park Hotel 520 North Capitol Street, NW Washington, DC 20001 Thursday, November 3, 2005 8:30 am Opening Remarks   Jeffrey M. Drazen, MD New England Journal of Medicine RARE EVENTS AND NEW DRUGS Topic 1: Recognition and reporting of adverse drug events by physicians including incentives and disincentives (e.g., rhabdomyolysis with statins; Churg-Strauss syndrome with anti-leukotrienes; liver failure with anti-diabetic drugs; opportunistic infections with immune modulators). 8:40 am Daniel E. Troy, JD Sidley Austin Brown & Wood LLP   Anne E. Trontell, MD, MPH U.S. Food and Drug Administration   Richard Platt, MD, MS Harvard Medical School Page 53 Front Matter (R1-R12) Summary (1-6) 1 Introduction (7-11) 2 Current Adverse Event Reporting Systems (12-17) 3 Active Surveillance Systems (18-25) 4 Consumer Involvement in Reporting Adverse Events (26-33) 5 Drug-Drug Interactions (34-39) 6 Drug Labels (40-47) References (48-52) A Workshop Agenda (53-57) B Speaker Biographies (58-70)

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OCR for page 53
Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary A Workshop Agenda Forum on Drug Discovery, Development, and Translation The Role of Consumers and Health-Care Professionals in Adverse Drug Event Reporting—Key Challenges and Opportunities November 3–4, 2005 Phoenix Park Hotel 520 North Capitol Street, NW Washington, DC 20001 Thursday, November 3, 2005 8:30 am Opening Remarks   Jeffrey M. Drazen, MD New England Journal of Medicine RARE EVENTS AND NEW DRUGS Topic 1: Recognition and reporting of adverse drug events by physicians including incentives and disincentives (e.g., rhabdomyolysis with statins; Churg-Strauss syndrome with anti-leukotrienes; liver failure with anti-diabetic drugs; opportunistic infections with immune modulators). 8:40 am Daniel E. Troy, JD Sidley Austin Brown & Wood LLP   Anne E. Trontell, MD, MPH U.S. Food and Drug Administration   Richard Platt, MD, MS Harvard Medical School

OCR for page 54
Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary   Saira A. Jan, PharmD, MS Horizon Blue Cross Blue Shield of New Jersey Rutgers Ernest Mario School of Pharmacy 9:30 am Discussion 10:45 am Break Topic 2: Once rare event reports have been received, how to identify possible signal and distinguish it from noise. 11:00 am Anne E. Trontell, MD, MPH U.S. Food and Drug Administration   David Hunt, MD, FACS CMS Quality Improvement Group 11:20 am Discussion 12:15 pm Lunch COMMON EVENTS AND THE MODULATION OF THEIR FREQUENCY BY DRUGS Topic 1: It is possible that drugs can modify the frequency of occurrence of a relatively common event. How can these events be detected? 1:00 pm K. Arnold Chan, MD, ScD Harvard School of Public Health   Francesca Cunningham, PharmD U.S. Department of Veterans Affairs   Hershel Jick, MD Boston University Medical Center   Micky Tripathi, PhD, MPP Massachusetts eHealth Collaborative 1:50 pm Discussion

OCR for page 55
Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Topic 2: Once a possible association is detected, how are cause and effect confirmed? Are randomized controlled trials needed or is epidemiology adequate? What is the role of regulators? How does one tease out single drug effects from drug-drug interactions? 2:20 pm Ronald Krall, MD GlaxoSmithKline   Nancy C. Santanello, MD, MS Merck Research Laboratories   Robert Powell, PharmD U.S. Food and Drug Administration   Raymond L. Woosley, MD, PhD The Critical Path Institute   Alastair J. J. Wood, MD Vanderbilt Medical School 3:10 pm Discussion 3:40 pm Break THE ROLE OF PATIENTS AND CONSUMERS IN THE ADVERSE EVENT REPORTING SYSTEM Topic 1: How should consumers be involved in reporting adverse events? What training and organizational support are needed? How should patient advocacy groups be engaged? 3:55 pm Marvin M. Lipman, MD, FACP Consumers Union   Michael Katz, MBA International Myeloma Foundation   Karen R. Cox, RN, PhD University of Missouri Health Care   Alison Rein, MS National Consumers League

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary 4:40 pm Discussion 5:00 pm Next Steps for the IOM Drug Forum 5:30 pm Adjourn Friday, November 4, 2005 8:30 am Opening Remarks   Jeffrey M. Drazen, MD New England Journal of Medicine DRUGS AND ADVERSE HEALTH EVENTS Topic 1: Is there a comprehensive database of known drug-drug interactions? How is its quality assured? How are the data used? How do we capture events when there are likely multiple sources of drugs? 8:40 am Jacob Abarca, PharmD, MS University of Arizona, College of Pharmacy   J. Russell Teagarden, RPh, MA Medco Health Solutions, Inc.   Scott Weingarten, MD, MPH Zynx Health   Sidney Kahn, MD, PhD Pharmacovigilance and Risk Management, Inc.   9:30 am Discussion Topic 2: Assuming that a database of adverse drug reactions exists (either rare events or common events that occur alone or as a result of drug-drug interactions), should this information be on a uniform drug label that separates adverse drug events and interactions by severity? How do we encourage physicians to use the information? 10:00 am A. Leander Fontaine, MD Pharmiceutics LLC

OCR for page 57
Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary   Rachel E. Behrman, MD, MPH U.S. Food and Drug Administration   Ed Staffa, RPh National Association of Chain Drug Stores   Cary Sennett, MD, PhD American Board of Internal Medicine 10:40 am Discussion 11:00 am Break Topic 3: Are there electronic systems that can be used to prompt health care providers to look for adverse drug related events and warn against potential drug-drug interactions? How are these systems deployed? 11:15 am Peter Kilbridge, MD Duke University Health System   Stuart Levine, PharmD Institute for Safe Medication Practices 11:40 am Discussion 12:00 pm Next Steps for the IOM Drug Forum 12:30 pm Adjourn

Representative terms from entire chapter:

drug event