ADVERSE DRUG EVENT REPORTING
THE ROLES OF CONSUMERS AND HEALTH-CARE PROFESSIONALS
Jeffrey M. Drazen, Jennifer Rainey, Heather Begg, and Adrienne Stith Butler, Rapporteurs
THE NATIONAL ACADEMIES PRESS
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
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Copyright 2007 by the National Academy of Sciences. All rights reserved.
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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.
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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.
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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)
Blue Cross Blue Shield Association (1/9/2007–12/31/2008)
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)
AstraZeneca Pharmaceuticals (1/9/2007–12/31/2008)
National Institute of Mental Health (1/9/2007–12/31/2008)
Robert M. Califf,
Duke University Medical Center (1/1/2005–12/31/2008)
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)
National Cancer Institute (1/1/2005–12/31/2006)
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)
Entelos, Inc. (1/1/2005–12/31/2008)
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)
Centers for Disease Control and Prevention (1/1/2005–12/31/2005)
March of Dimes Birth Defects Foundation (1/1/2005–12/31/2008)
William F. Keane,
Merck & Co., Inc. (1/1/2005–12/31/2008)
Stanford University (1/1/2005–12/31/2006)
Pfizer Inc. (1/1/2005–12/31/2005)
Allan M. Korn,
Blue Cross and Blue Shield Association (1/1/2005–12/31/2008)
Association of American Medical Colleges (1/1/2005–12/31/2006)
Ronald L. Krall,
Jeffrey M. Leiden,
Clarus Ventures (1/1/2005–12/31/2007)
John M. Leonard,
Abbott Laboratories (1/9/2007–12/31/2008)
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)
Garry A. Neil,
Johnson & Johnson (1/1/2005–12/31/2008)
Joshua J. Ofman,
Amgen, Inc. (1/1/2005–12/31/2008)
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)
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)
American Society for Microbiology (1/1/2005–12/31/2008)
National Institutes of Health (1/9/2007–12/31/2008)
Nancy S. Sung,
Burroughs Wellcome Fund (1/1/2005–12/31/2008)
James R. Swartz,
Stanford University (1/1/2005–12/31/2005)
Reed V. Tuckson,
UnitedHealth Group (1/1/2005–12/31/2008)
Centers for Medicare and Medicaid Services (1/1/2005–12/31/2006)
Food and Drug Administration (1/1/2005–12/31/2008)
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)
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
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.