ADVERSE DRUG EVENT REPORTING

THE ROLES OF CONSUMERS AND HEALTH-CARE PROFESSIONALS

WORKSHOP SUMMARY

Jeffrey M. Drazen, Jennifer Rainey, Heather Begg, and Adrienne Stith Butler, Rapporteurs

Forum on Drug Discovery, Development, and Translation

Board on Health Sciences Policy

INSTITUTE OF MEDICINE OF THE NATIONAL PRESS

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu



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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary ADVERSE DRUG EVENT REPORTING THE ROLES OF CONSUMERS AND HEALTH-CARE PROFESSIONALS WORKSHOP SUMMARY Jeffrey M. Drazen, Jennifer Rainey, Heather Begg, and Adrienne Stith Butler, Rapporteurs Forum on Drug Discovery, Development, and Translation Board on Health Sciences Policy INSTITUTE OF MEDICINE OF THE NATIONAL PRESS THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This project was supported by contracts between the National Academy of Sciences and the Department of Health and Human Services (Contract Nos. 223-01-2460, HHSP233200600500P, HHSPP23320042509X1, and N01-OD-4-2139), the Department of Veterans Affairs (Contract No. V101(93)P-2136), Abbott Laboratories, American Diabetes Association, American Society for Microbiology, Amgen, Inc., Association of American Medical Colleges, AstraZeneca Pharmaceuticals, Blue Cross Blue Shield Association, Burroughs Wellcome Fund, Doris Duke Charitable Foundation, Eli Lilly and Company, Entelos, Inc., GlaxoSmithKline, Johnson & Johnson, March of Dimes Birth Defects Foundation, Merck & Company, Pfizer Inc., Schering-Plough Research Institute, and UnitedHealth Group. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13 978-0-309-10276-6 International Standard Book Number-10 0-309-10276-6 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2007 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Suggested citation: Institute of Medicine (IOM). 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals, Workshop Summary. Washington, DC: The National Academies Press. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Advising the Nation. Improving Health.

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION Gail H. Cassell (Co-Chair), Eli Lilly and Company (1/1/2005–12/31/2008) Edward W. Holmes (Co-Chair), National University of Singapore (1/1/2005–12/31/2008) Naomi Aronson, Blue Cross Blue Shield Association (1/9/2007–12/31/2008) Nina Bhardwaj, New York University School of Medicine (1/1/2005–9/7/2006) Leslie Z. Benet, University of California, San Francisco (1/1/2005–12/31/2008) Catherine Bonuccelli, AstraZeneca Pharmaceuticals (1/9/2007–12/31/2008) Linda Brady, National Institute of Mental Health (1/9/2007–12/31/2008) Robert M. Califf, Duke University Medical Center (1/1/2005–12/31/2008) Scott Campbell, American Diabetes Association (1/1/2005–12/31/2008) C. Thomas Caskey, University of Texas–Houston Health Science Center (1/1/2005–12/31/2008) Francis D. Chesley, Jr., Agency for Healthcare Research and Quality (1/9/2007–12/31/2008) Mark Clanton, National Cancer Institute (1/1/2005–12/31/2006) Peter Corr, Pfizer Inc. (Retired) (1/9/2007–12/31/2007) Jeffrey M. Drazen, New England Journal of Medicine (1/1/2005–12/31/2008) William E. Evans, St. Jude Children’s Research Hospital (1/1/2005–12/31/2006) Joseph M. Feczko, Pfizer Inc. (1/9/2007–12/31/2008) Wayne Fenton (Deceased), National Institute of Mental Health (1/1/2005–9/3/2006) Garret A. FitzGerald, University of Pennsylvania School of Medicine (1/1/2005–12/31/2008) Elaine K. Gallin, The Doris Duke Charitable Foundation (1/1/2005–12/31/2008) Steven K. Galson, Food and Drug Administration (1/9/2007–12/31/2008) Alan M. Garber, Stanford University (1/1/2005–12/31/2007) Mikhail Gishizky, Entelos, Inc. (1/1/2005–12/31/2008)

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Stephen Groft, National Institutes of Health (1/1/2005–12/31/2008) Carole A. Heilman, National Institute of Allergy and Infectious Diseases (1/1/2005–3/13/2006) Dale Hu, Centers for Disease Control and Prevention (1/1/2005–12/31/2005) Michael Katz, March of Dimes Birth Defects Foundation (1/1/2005–12/31/2008) William F. Keane, Merck & Co., Inc. (1/1/2005–12/31/2008) Chaitan Khosla, Stanford University (1/1/2005–12/31/2006) Antonia Kolokathis, Pfizer Inc. (1/1/2005–12/31/2005) Allan M. Korn, Blue Cross and Blue Shield Association (1/1/2005–12/31/2008) David Korn, Association of American Medical Colleges (1/1/2005–12/31/2006) Ronald L. Krall, GlaxoSmithKline (1/9/2007–12/31/2008) Jeffrey M. Leiden, Clarus Ventures (1/1/2005–12/31/2007) John M. Leonard, Abbott Laboratories (1/9/2007–12/31/2008) Nancy Loving, National Coalition for Women with Heart Disease (1/1/2005–6/7/2006) John R. Marler, National Institute of Neurological Disorders and Stroke (1/1/2005–12/31/2008) Musa Mayer, AdvancedBC.org (1/1/2005–12/31/2007) Garry A. Neil, Johnson & Johnson (1/1/2005–12/31/2008) Joshua J. Ofman, Amgen, Inc. (1/1/2005–12/31/2008) Susanne Pattee, Cystic Fibrosis Foundation (1/1/2005–12/31/2007) Cecil B. Pickett, Schering-Plough Research Institute (1/1/2005–12/31/2006) Joanne L. Rhoads, National Institute of Allergy and Infectious Diseases (1/9/2007–12/31/2008) Brian Schuster, U.S. Department of Veterans Affairs (1/1/2005–12/31/2006) B. A. Schwetz, U.S. Department of Health and Human Services (1/1/2005–12/31/2008) Janet Shoemaker, American Society for Microbiology (1/1/2005–12/31/2008) Lana Skirboll, National Institutes of Health (1/9/2007–12/31/2008) Nancy S. Sung, Burroughs Wellcome Fund (1/1/2005–12/31/2008)

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary James R. Swartz, Stanford University (1/1/2005–12/31/2005) Reed V. Tuckson, UnitedHealth Group (1/1/2005–12/31/2008) Sean Tunis, Centers for Medicare and Medicaid Services (1/1/2005–12/31/2006) Janet Woodcock, Food and Drug Administration (1/1/2005–12/31/2008) IOM Staff Robert B. Giffin, Director (July 2006 to present) Alexander K. Ommaya, Director (January 2005–July 2006) Adrienne Stith Butler, Senior Program Officer (December 2006 to present) Sally Robinson, Program Officer (December 2006 to present) Heather Begg, Program Associate (January 2005–July 2006) Jennifer Rainey, Research Assistant (January 2005–July 2006) Andrea Knutsen, Senior Program Assistant (October 2005 to present)

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Shawn C. Becker, Patient Safety Initiatives, U.S. Pharmacopeia Center for the Advancement of Patient Safety Marc L. Berger, Outcomes Research & Management, Merck & Co., Inc. Scott E. Campbell, Research Programs, American Diabetes Association Edward Holmes, School of Medicine, University of California, San Diego

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Mel Worth, Scholar-in-Residence, Institute of Medicine. Appointed by the National Research Council and Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Contents     Summary   1 1   Introduction   7 2   Current Adverse Event Reporting Systems   12      Monitoring Adverse Drug Events,   12      MedWatch,   14      Reporting Adverse Events to Institutional Review Boards,   15      Reporting Adverse Events to the Centers for Medicare and Medicaid Services,   16      New Approaches for Improving Reporting Systems,   17 3   Active Surveillance Systems   18      Types of Surveillance,   19      Surveillance Technology,   19      The Veterans Affairs Health-Care Database System,   24      Data Quality,   25 4   Consumer Involvement in Reporting Adverse Events   26      Consumer Involvement in the Current MedWatch System,   27      Outreach Programs and Tools,   29      Postmarketing Surveillance and Direct-to-Consumer Advertising,   30      Role of Advocacy Groups,   31      Potential Solutions and Next Steps,   33

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary 5   Drug-Drug Interactions   34      Drug Interaction Databases,   35      Communicating Drug Interaction Information,   38 6   Drug Labels   40      New Label Requirements,   41      Communication of Risk to Consumers and Physicians,   43      Drug Labeling and Drug-Drug Interactions,   44      Tools for Improvement,   45     References   48     Appendixes     A   Workshop Agenda   53 B   Speaker Biographies   58