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
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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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.
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International Standard Book Number-10 0-309-10276-6
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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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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)
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)
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)
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
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.