PREVENTING MEDICATION ERRORS

Committee on Identifying and Preventing Medication Errors

Board on Health Care Services

Philip Aspden, Julie A. Wolcott, J. Lyle Bootman, Linda R. Cronenwett, Editors

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, DC
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Preventing Medication Errors PREVENTING MEDICATION ERRORS Committee on Identifying and Preventing Medication Errors Board on Health Care Services Philip Aspden, Julie A. Wolcott, J. Lyle Bootman, Linda R. Cronenwett, Editors INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, DC www.nap.edu

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Preventing Medication Errors 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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. HHSM-500-2004-00020C between the National Academy of Sciences and Department of Health and Human Services (Centers for Medicare and Medicaid Services). 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. Library of Congress Cataloging-in-Publication Data Preventing medication errors / Committee on Identifying and Preventing Medication Errors, Board on Health Care Services ; Philip Aspden … [et al.], editors. p. ; cm. — (Quality chasm series) Includes bibliographical references and index. ISBN-13: 978-0-309-10147-9 (hardcover) ISBN-10: 0-309-10147-6 (hardcover) 1. Medication errors—Prevention. I. Aspden, Philip. II. Institute of Medicine (U.S.). Committee on Identifying and Preventing Medication Errors. III. Series. [DNLM: 1. Medication Errors—prevention & control—United States. 2. Safety Management—United States. QZ 42 P9435 2006] RM146.P744 2006 615'.6—dc22 2006029215 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. 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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Preventing Medication Errors “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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Preventing Medication Errors 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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Preventing Medication Errors COMMITTEE ON IDENTIFYING AND PREVENTING MEDICATION ERRORS J. LYLE BOOTMAN (Co-chair), Dean and Professor, University of Arizona College of Pharmacy; Founding and Executive Director, University of Arizona Center for Health Outcomes and PharmacoEconomic (HOPE) Research LINDA R. CRONENWETT (Co-chair), Professor and Dean, School of Nursing, University of North Carolina at Chapel Hill DAVID W. BATES, Chief, Division of General Medicine, Brigham and Women’s Hospital; Medical Director of Clinical and Quality Analysis, Partners Healthcare System; Professor of Medicine, Harvard Medical School ROBERT M. CALIFF, Associate Vice Chancellor for Clinical Research, Director of the Duke Clinical Research Institute, and Professor of Medicine, Division of Cardiology, Duke University Medical Center H. ERIC CANNON, Director of Pharmacy Services and Health and Wellness, IHC Health Plans, Intermountain Health Care REBECCA W. CHATER, Director of Clinical Services, Kerr Drugs, Inc./ KDI Clinical Services MICHAEL R. COHEN, President, Institute for Safe Medication Practices JAMES B. CONWAY, Senior Fellow, Institute for Healthcare Improvement; Senior Consultant, Dana-Farber Cancer Institute; Adjunct Lecturer on Health Care Management, Department of Health Policy and Management, Harvard School of Public Health R. SCOTT EVANS, Senior Medical Informaticist, Department of Medical Informatics, LDS Hospital and Intermountain Health Care; Professor, Department of Medical Informatics, and Adjunct Professor, Department of Medicine, University of Utah ELIZABETH A. FLYNN, Associate Research Professor, Department of Pharmacy Care Systems, Harrison School of Pharmacy, Auburn University JERRY H. GURWITZ, Chief, Division of Geriatric Medicine and Dr. John Meyers Professor of Primary Care Medicine, University of Massachusetts Medical School; and Executive Director, Meyers Primary Care Institute, University of Massachusetts Medical School, Fallon Foundation, and Fallon Community Health Plan CHARLES B. INLANDER, Former President, People’s Medical Society KEVIN B. JOHNSON, Associate Professor and Vice Chair, Department of Biomedical Informatics, and Associate Professor, Department of Pediatrics, Vanderbilt University Medical School

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Preventing Medication Errors WILSON D. PACE, Professor of Family Medicine and Green-Edelman Chair for Practice-based Research, University of Colorado; Director, American Academy of Family Physicians National Research Network KATHLEEN R. STEVENS, Professor and Director, Academic Center for Evidence-Based Practice, University of Texas Health Science Center, San Antonio EDWARD WESTRICK, Vice President of Medical Management, University of Massachusetts Memorial Health Care ALBERT W. WU, Professor of Health Policy and Management and Internal Medicine, The Johns Hopkins University Health Care Services Board CLYDE J. BEHNEY, Acting Director (June 2005 to December 2005 and from May 2006) JOHN C. RING, Director (from December 2005 to May 2006) JANET M. CORRIGAN, Director (September 2004 to May 2005) ANTHONY BURTON, Administrative Assistant Study Staff PHILIP ASPDEN, Study Director JULIE A. WOLCOTT, Program Officer (to April 2006) ANDREA M. SCHULTZ, Research Associate (from June 2006) RYAN L. PALUGOD, Research Assistant (from December 2005) TASHARA BASTIEN, Senior Program Assistant (to January 2006) WILLIAM B. MCLEOD, Senior Librarian GARY J. WALKER, Senior Financial Officer (from December 2005) TERESA REDD, Financial Advisor (to December 2005) ELIZABETH E. LAFALCE, Intern (April to May, 2005)

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Preventing Medication Errors 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 NRC’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: LOWELL ANDERSON, Watauga Corporation MARGE BOWMAN, University of Pennsylvania Health System PATRICIA FLATLEY BRENNAN, School of Nursing and College of Engineering, University of Wisconsin-Madison DAVID COUSINS, National Patient Safety Organization, London DON E. DETMER, American Medical Informatics Association and The University of Virginia WILLIAM EVANS, St. Jude Children’s Research Hospital, Memphis ANN HENDRICH, Ascension Health, St. Louis, MO CRAIG HOESLEY, University Hospital, University of Alabama at Birmingham WILLIAM J. KOOPMAN, Department of Medicine, University of Alabama at Birmingham GERALD D. LAUBACH, Pfizer Inc., Past President

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Preventing Medication Errors LUCIAN LEAPE, Department of Health Policy and Management, Harvard School of Public Health ART LEVIN, Center for Medical Consumers, New York, NY G. STEVE REBAGLIATI, Department of Emergency Medicine, Oregon Health and Sciences University HUGH TILSON, School of Public Health, University of North Carolina 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 Paul F. Griner, University of Rochester, Professor Emeritus and Charles E. Phelps, University of Rochester. Appointed by the National Research Council and Institute of Medicine, they were 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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Preventing Medication Errors Preface In 2000, the Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System raised awareness about medical errors and accelerated existing efforts to prevent such errors. The present report makes clear that with regard to medication errors, we still have a long way to go. The current medication-use process, which encompasses prescribing, dispensing, administering, and monitoring, is characterized by many serious problems and issues that threaten both the safety and positive outcomes of the process. Each of the steps in the process needs improvement and further study. At the beginning of the medication-use process, prescribers often lack sufficient knowledge about how the drugs they are prescribing will work in specific patient populations. If the balance of medication risks and benefits is not known (as is common, for example, with children and the elderly), it is impossible to say whether medication use is safe. Improving medication use and reducing errors, therefore, requires improving the quality of information generated by the pharmaceutical industry and other researchers regarding drug products and their use in clinical practice. We also need to better understand how to communicate such information to clinicians and patients via packaging, leaflets, and health information technology systems. Lastly, we need to understand how better to prevent medication errors in all care settings and in transitions between care settings. In this report, the IOM Committee on Identifying and Preventing Medication Errors proposes a research agenda for industry and government that can help meet these critical needs. Despite the lack of data regarding many interventions that might improve the quality and safety of medication use, the committee offers recom-

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Preventing Medication Errors mendations for change that should be implemented and evaluated. People who use medications to meet their health care needs have a huge stake in that effort. The most powerful strategy for improving safety may be motivating providers and organizations to support the full engagement of patients and surrogates in improving the safety of medication use. In addition, providers and leaders of health care organizations must create the climate and infrastructure necessary to continuously learn about and improve the safety of all steps in the medication-use process. This report provides guidance on the types of error prevention strategies that should be implemented in each care setting. It also presents the committee’s recommendations for the pharmaceutical industry, government, and regulatory, certification, and accreditation bodies, each of which has a role to play in improving the quality and safety of medication use. This report represents the culmination of the dedicated efforts of three groups of people. We would like to thank our fellow committee members who have worked long and diligently on this challenging study, the many experts who provided formal testimony to the committee and informal advice throughout the study, and the staff of the Health Care Services Board who managed the study and coordinated the writing of the final report. J. Lyle Bootman, Ph.D., Sc.D. Linda R. Cronenwett, Ph.D., M.A., R.N. Cochairs July 2006

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Preventing Medication Errors Acknowledgments The Committee on Identifying and Preventing Medication Errors wishes to acknowledge the many people whose contributions and support made this report possible. The committee benefited from presentations made by a number of experts over the past 2 years. The following individuals shared their research, experience, and perspectives with the committee: Tom Abrams, Food and Drug Administration; Bruce Bagley, American Academy of Family Physicians; Robert Ball, Food and Drug Administration; Jim Battles, Agency for Healthcare Research and Quality; Karen Bell, Centers for Medicare and Medicaid Services; Douglas Bierer, Consumer Healthcare Products Association; David Bowen, Office of Senator Edward Kennedy; Bill Braithwaite, eHealth Initiative; Dan Budnitz, Centers for Disease Control and Prevention; Betsy Chrischilles, University of Iowa; John Clarke, ECRI; David Classen, First Consulting Group; Ilene Corina, Patients United Limiting Substandards and Errors in Healthcare; Diane Cousins, U.S. Pharmacopeial Convention; Loriann De Martini, California Department of Health Services; Noel Eldridge, Veterans Health Administration; Frank Federico, Institute for Healthcare Improvement; Susan Frampton, Planetree; David Gustafson, University of Wisconsin; Ed Hammond, Duke University; Mark Hayes, Office of Senator Chuck Grassley; Carol Holquist, Food and Drug Administration; David Hunt, Centers for Medicare and Medicaid Services; Gordon Hunt, Sutter Health; John Jenkins, Food and Drug Administration; Mike Kafrissen, Johnson & Johnson; Ken Kizer, National Quality Forum; Richard Moore, Massachusetts State Senator; Bill Munier, Agency for Healthcare Research and Quality; Dianne Murphy, Food and Drug Administration; Steve Northrop, Office of Senator Chuck Grassley; Jerry

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Preventing Medication Errors Osheroff, Micromedex; Emily Patterson, Ohio State University; John Reiling, Synergy Health and St. Joseph’s Hospital; Lisa Robin, Federation of State Medical Boards; William Rollow, Centers for Medicare and Medicaid Services; Jeffrey Rothschild, Brigham and Women’s Hospital Partners Healthcare; Lee Rucker, American Association of Retired Persons; Luke Sato, Harvard Risk Management Foundation; Stephen Schondelmeyer, University of Minnesota; David Schulke, American Health Quality Association; Paul Schyve, Joint Commission on Accreditation of Healthcare Organizations; Paul Seligman, Food and Drug Administration; Vickie Sheets, National Council of State Boards of Nursing; Pat Sodomka, Medical College of Georgia; Scott Stanley, University Health System Consortium; Jonathan Teich, Health Vision; Anne Trontell, Food and Drug Administration; Tim Vanderveen, Alaris & Cardinal Health; and Ed Weisbart, Express Scripts. The following individuals were important sources of information, generously giving their time and knowledge to further the committee’s efforts: Michele Boisse, American Society for Clinical Pharmacology and Therapeutics; Anne Burns, American Pharmacists Association; Francis Dobscha, Advance Med; Melody Eble, Johnson & Johnson; Atheer Kaddis, Blue Cross and Blue Shield of Michigan; Lucinda Maine, American Association of Colleges of Pharmacy; Gary Merica, York Hospital; Joseph Morris, Health Care Improvement Foundation; Richard Park, IVD Technology magazine; Ken Reid, Washington Information Source Co.; Ed Staffa, National Association of Chain Drug Stores; Kasey Thompson, American Society of Health-system Pharmacists; Marissa Schlaifer, Academy of Managed Care Pharmacy; Junelle Speller, American Academy of Pediatrics; Sharon Wilson, Center for Nursing Practice; and Charles Young, Massachusetts Board of Registration in Pharmacy. The committee commissioned eight papers that provided important background information for the report, and would like to thank all the authors for their dedicated work and helpful insights: Harvey J. Murff, Vanderbilt University; Ginette A. Pepper, University of Utah College of Nursing; Grace M. Kuo, Baylor College of Medicine; Marlene R. Miller, Karen A. Robinson, Lisa H. Lubomski, Michael L. Rinke, and Peter J Pronovost, The Johns Hopkins University; Benjamin C. Grasso, The Institute for Self-Directed Care; Albert I. Wertheimer and Thomas M. Santella, Temple University; Eta Berner, University of Alabama at Birmingham with assistance from Lorri Zipperer, Zipperer Project Management; Richard Maisiak, consultant; and Brent Petty, The Johns Hopkins University. The committee also benefited from the work of other committees and staff of the Institute of Medicine that conducted studies relevant to this report, particularly the Committee on Quality of Health Care in America and the Committee on Identifying Priority Areas for Quality Improvement. The Committee on Quality of Health Care in America produced the 2000

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Preventing Medication Errors report To Err Is Human: Building a Safer Health System and the 2001 report Crossing the Quality Chasm: A New Health System for the 21st Century. The committee on Identifying Priority Areas for Quality Improvement produced the 2003 report Priority Areas for National Action: Transforming Health Care Quality. Finally, funding for this project was provided by the Centers for Medicare and Medicaid Services. The committee extends special thanks for that support.

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Preventing Medication Errors Contents SUMMARY   1 1   INTRODUCTION   25 PART I: UNDERSTANDING THE CAUSES AND COSTS OF MEDICATION ERRORS   43 2   OVERVIEW OF THE DRUG DEVELOPMENT, REGULATION, DISTRIBUTION, AND USE SYSTEM   50 3   MEDICATION ERRORS: INCIDENCE AND COST   105 PART II: MOVING TOWARD A PATIENT-CENTERED, INTEGRATED MEDICATION-USE SYSTEM   143 4   ACTION AGENDA TO SUPPORT CONSUMER–PROVIDER PARTNERSHIP   151 5   ACTION AGENDA FOR HEALTH CARE ORGANIZATIONS   221 6   ACTION AGENDA FOR THE PHARMACEUTICAL, MEDICAL DEVICE, AND HEALTH INFORMATION TECHNOLOGY INDUSTRIES   266 7   APPLIED RESEARCH AGENDA FOR SAFE MEDICATION USE   310 8   ACTION AGENDAS FOR OVERSIGHT, REGULATION, AND PAYMENT   328

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Preventing Medication Errors APPENDIXES     A BIOGRAPHICAL SKETCHES OF COMMITTEE MEMBERS   349 B GLOSSARY OF TERMS AND ACRONYMS   359 C MEDICATION ERRORS: INCIDENCE RATES   367 D MEDICATION ERRORS: PREVENTION STRATEGIES   409 INDEX   447