Appendix E
Summary

Preventing Medication Errors: Quality Chasm Series Institute of Medicine



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The Future of Drug Safety: Promoting and Protecting the Health of the Public Appendix E Summary Preventing Medication Errors: Quality Chasm Series Institute of Medicine

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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public “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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public issues before such strategies are implemented and aggressively solving technological problems during the implementation process. Regulatory issues must also be addressed for electronic transmission of prescriptions to be practical. Effective Use of Well-Designed Technologies To deliver safe drug care, health care organizations should make effective use of well-designed technologies, which will vary by setting. Although the evidence for this assertion is strongest in the inpatient setting (AHRQ, 2005), the use of technology will undoubtedly lead to major improvements in all settings. In acute care, technologies should target prescribing by including computerized provider order entry with clinical decision support. Administration is also a particularly vulnerable stage in the medication-use process, and several technologies are likely to be especially important in this stage. These include electronic medication administration records, which can improve documentation of what medications have been given and when, as well as machine-readable identification, such as bar coding, and smart IV infusion pumps. All these technologies should be linked electronically. In nursing homes, computerized prescribing with decision support will likely be important, although there has been little research on its efficacy (Gurwitz et al., 2005). Moreover, implementation of computerized prescribing in this setting will be challenging since most nursing homes have very limited resources. Some evidence suggests that computerized prescribing will be important in the outpatient setting as well (Gandhi et al., 2003), although it may not yield significant safety benefits without added decision support. Equally important are likely to be approaches that improve communication between patients and providers. Communication of Patient-Specific Medication-Related Information The delivery of care often involves moving the locus of care among sites and providers. These “handoffs” are fraught with errors. One strategy for reducing errors during these care transitions is to reconcile medication orders between transition points, especially between care settings such as hospital and outpatient, but also between points within organizations, such as the intensive care unit and a general care unit. This reconciliation involves comparing what a patient is taking in one setting with what is being provided in another to avoid errors of transcription and omission, duplication of therapy, and drug–drug and drug–disease interactions. This process typically reveals many discrepancies (Pronovost et al., 2003).

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The Future of Drug Safety: Promoting and Protecting the Health of the Public Reconciliation is facilitated when medication data are transmitted electronically among providers, with confirmation by the patient. Three important steps are required. First, a complete and accurate medication list must be compiled. Second, the data must be structured into components such as the medication name, dose, route, frequency, duration, start date, and so on. Third, these data must be formatted in a way that allows disparate computer systems to understand both their structure and content. The power of interoperable health care data was demonstrated after the devastation of Hurricane Katrina. Pharmacy chains were able to make patients’ medication lists available quickly to care providers, and states with immunizations registries were able to retrieve immunization records, enabling the enrollment of children in new schools. Monitoring for Errors All health care provider groups should seek to be high-reliability organizations preoccupied with the possibility of failure (Reason, 2000). They should implement active internal monitoring programs so that progress toward improved medication safety can be accurately demonstrated. Voluntary internal reporting systems have recognized limitations for evaluating the true frequency of medication errors and ADEs (Flynn et al., 2002). Error detection methods that complement such systems should be used in all care settings. These include computerized detection of ADEs, observation of medication passes in hospitals to assess administration errors, and audits of filled prescriptions in community pharmacies to monitor dispensing errors. Many external programs exist to which patients and providers can report a medication error or hazardous situation (IOM, 2004). Voluntary practitioner reporting to an external program will continue to be important, as it is often the only way practitioners can effect change outside their organizations. Errors need to be reported and analyzed if improvements in care are to be achieved. Adopting a Safety Culture Patient safety can best be achieved through the adoption of a culture of safety—an organizational commitment to continually seeking to improve safety. To achieve a safety culture, senior management of health care organizations must devote sufficient attention to safety, as well as make sufficient resources available for quality improvement and safety teams (IOM, 2004). Senior management must also authorize the investment of resources in technologies that have been demonstrated to be effective but are not yet widely implemented in most organizations, such as computerized provider order entry systems and electronic health records. It has become increas-

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The Future of Drug Safety: Promoting and Protecting the Health of the Public ingly clear that the introduction of any of these technologies requires close attention to business processes and ongoing maintenance. As noted above, studies have shown that these tools can have unintended and adverse consequences, and that avoiding these consequences requires addressing both business and cultural issues. Recommendation 3: All health care organizations should immediately make complete patient-information and decision-support tools available to clinicians and patients. Health care systems should capture information on medication safety and use this information to improve the safety of their care delivery systems. Health care organizations should implement the appropriate systems to enable providers to: Have access to comprehensive reference information concerning medications and related health data. Communicate patient-specific medication-related information in an interoperable format. Assess the safety of medication use through active monitoring and use these monitoring data to inform the implementation of prevention strategies. Write prescriptions electronically by 2010. Also by 2010, all pharmacies should be able to receive prescriptions electronically. By 2008, all prescribers should have plans in place to implement electronic prescribing. Subject prescriptions to evidence-based, current clinical decision support. Have the appropriate competencies for each step of the medication-use process. Make effective use of well-designed technologies, which will vary by setting. ENORMOUS KNOWLEDGE DEFICITS MUST BE ADDRESSED Current methods for generating and communicating information about medications are inadequate and contribute to a growing rate of medication errors. Likewise, error incidence rates, costs to the health system, and prevention strategies are not well understood. As a result, there are enormous gaps in the knowledge required to implement a safe medication-use system.

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The Future of Drug Safety: Promoting and Protecting the Health of the Public Risk/Benefit Information for Prescription Drugs Being able to determine whether a medication error has been made depends on knowing the correct dose of the drug for that patient at that time and whether the indication for that drug is correct in comparison with alternative approaches to treatment. Over the past several decades, however, drug evaluations have not been sufficiently comprehensive. As a result, the balance of risk and benefit for a drug frequently is not known for a given population. Such gaps in therapeutic knowledge often result in devastating effects on clinical practice and patient health, as exemplified by adverse events involving hormone replacement therapy, cyclooxygenase-2 (COX-2) inhibitors, and nonsteroidal anti-inflammatory drugs that resulted in increased morbidity and mortality. These issues are magnified in specific patient populations. For example, the majority of prescriptions written for children are off label—not based on empirical demonstration of safety and efficacy. Among those over age 80, the fastest-growing segment of the population, almost nothing is known about the balance of risks and benefits. Patients with renal dysfunction are another large and growing group for whom more comprehensive studies are needed. And patients with multiple comorbidities are typically excluded from premarketing clinical trials, yet many of the major problems with drug toxicity have occurred in those taking multiple medications because of multiple diseases. Thus the numbers and types of patients for whom clinical outcomes are measured must be greatly increased to elucidate the proper dosing of drugs in individuals and within subgroups. Of critical concern is the need for transparency through the publication of clinical studies in a national repository to advance medication safety, error prevention, and public knowledge. Such a repository should include postmarket studies. The goal of such studies is to generate new data about a drug’s effects in the population; often, however, these studies place insufficient emphasis on safety information. There is a need for comprehensive redesign and expansion of the mechanisms for undertaking clinical studies to improve understanding of the risks and benefits of drug therapies, prevent errors and ADEs, and meet the health needs of the population. Communication of Drug Information How information about a drug is communicated to providers and consumers can directly affect the frequency of medication errors and ADEs (see Box S-6). Drug information is communicated through labeling and packaging, marketing practices, and advertisements. Poorly designed materials and inadequate representation of the risks and benefits to providers and consumers have led to many errors, including inappropriate prescribing;

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The Future of Drug Safety: Promoting and Protecting the Health of the Public BOX S-6 Drug Naming, Labeling, and Packaging Problems Brand names and generic names that look or sound alike Different formulations of the same brand or generic drug Multiple abbreviations to represent the same concept Confusing word derivatives, abbreviations, and symbols Unclear dose concentration/strength designations Cluttered labeling—small fonts, poor typefaces, no background contrast, overemphasis on company logos Inadequate prominence of warnings and reminders Lack of standardized terminology confusion among products, affecting dispensing and administration; and compromised ability to monitor the effects of drugs adequately. In particular, drug names that look or sound alike increase the risk of medication errors. Abbreviations, acronyms, certain dose designations, and other symbols used for labeling also have caused errors. Even the layout and presentation of drug information on the drug container or package label can be visually confusing, particularly if it is designed for marketing rather than clinical purposes. Unit-of-use packaging—containers that provide enough medication for a particular period, such as blister packs containing 30 individually wrapped doses—is not widely employed in the United States but is used extensively elsewhere. This form of packaging brings important safety and usage benefits. The committee believes the expanded implementation of unit-of-use packaging in this country warrants further investigation. Another issue related to medication safety is the common practice of providers offering free samples of prescription drugs to patients to start them on their medications quickly, to adjust prescribed doses before the full prescription is filled, and to offset medication costs for indigent and underinsured patients. However, there has been growing unease about the way free samples are distributed. In particular, concern exists about the resulting lack of documentation of medication use and the bypassing of standard prescribing and dispensing services, which incorporate drug-interaction checking and pharmacy counseling services. There is a need for resarch on the impact of differing sample distribution methods on medication safety. Recommendation 4: Enhancing the safety and quality of the medication-use process and reducing errors requires improved methods for labeling drug products and communicating medication information to providers and consumers. For such improve-

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The Future of Drug Safety: Promoting and Protecting the Health of the Public ments to occur, materials should be designed according to designated standards to meet the needs of the end user. Industry, AHRQ, the FDA, and others as appropriate (e.g., U.S. Pharmacopeia, Institute for Safe Medication Practices) should work together to undertake the following actions to address labeling, packaging, and the distribution of free samples: The FDA should develop two guidance documents for industry: one for drug naming and another for labeling and packaging. The FDA and industry should collaborate to develop (1) a common drug nomenclature that standardizes abbreviations, acronyms, and terms to the extent possible, and (2) methods of applying failure modes and effects analysis to labeling and packaging. Additional study of optimum designs for all drug labeling and information sheets to reflect human and cognitive factors should be undertaken. Methods for testing and measuring the effects of these materials on providers and consumers should also be established, including methods for field testing of the materials. The FDA, the NLM, and industry should work with consumer and patient safety organizations to improve the nomenclature used in consumer materials. The FDA, the pharmaceutical industry, and other stakeholders should collaborate to develop a strategy for expanding unit-of-use packaging for consumers to new therapeutic areas. Studies should be undertaken to evaluate different unit-of-use packaging and design approaches that will best support various consumer groups in their medication self-management. AHRQ should fund studies to evaluate the impact of free samples on overall patient safety, provider prescribing practices, and consumer behavior (e.g., adherence to the medication regimen), as well as alternative methods of distribution that can improve safety, quality, and effectiveness. Health Information Technology Realization of the full benefits of many health information technologies (such as decision-support systems, smart IV pumps, bar code administration systems, and pharmacy database systems) is hampered by the lack of common data standards for system integration and well-designed interfaces for end users. Problems with data standards for drug information are threefold. First, there is no complete, standardized set of terms, concepts, and codes to represent drug information. Second, there is no standardized method for

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The Future of Drug Safety: Promoting and Protecting the Health of the Public presenting safety alerts according to severity and/or clinical importance. Instead, providers are sometimes inundated with too many alerts, which can result in “alert fatigue.” Third, many systems lack intelligent mechanisms for relating patient-specific data to allowable overrides, such as those associated with a particular patient and drug allergy alert or duplicate therapy request. The ability of clinicians to use health information technologies successfully depends on how well the technologies have been designed at the level of human-machine interaction (i.e., the user interface). Displaying information in a cluttered, illogical, or confusing manner leads to decreased user performance and satisfaction. Moreover, a poorly designed user interface can contribute to medication errors. Addressing user interface issues requires greater attention to the cognitive and social factors influencing clinicians in their daily workflow and interaction with technologies (van Bemmel and Musen, 1997). Recommendation 5: Industry and government should collaborate to establish standards affecting drug-related health information technologies. Specifically: The NLM should take the lead in developing a common drug nomenclature for use in all clinical information technology systems, based on standards for the national health information infrastructure. AHRQ should take the lead in organizing mechanisms for safety alerts according to severity, frequency, and clinical importance to improve clinical value and acceptance. AHRQ should take the lead in developing intelligent prompting mechanisms specific to a patient’s unique characteristics and needs; provider prescribing, ordering, and error patterns; and evidence-based best-practice guidelines. AHRQ should take the lead in developing user interface designs based on the principles of cognitive and human factors and the context of the clinical environment. AHRQ should support additional research to determine specifications for alert mechanisms and intelligent prompting, as well as optimum designs for user interfaces. Research on Medication Errors: Incidence Rates, Costs, and Prevention Strategies In reviewing the research literature, the committee concluded that large gaps exist in our understanding of medication error incidence rates, costs,

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The Future of Drug Safety: Promoting and Protecting the Health of the Public and prevention strategies. The committee believes the nation should invest about $100 million annually in the research proposed below. The primary focus of research on medication errors in the next decade should be prevention strategies, recognizing that to plan an error prevention study, it is essential to be able to measure the baseline rate of errors. Evidence on the efficacy of prevention strategies for improving medication safety is badly needed in a number of settings, including care transitions, ambulatory care (particularly home care, self-care, and medication use in schools), pediatric care, psychiatric care, and the use of OTC and complementary and alternative medications. For hospitals, key areas are further investigation of some prevention strategies (particularly bar coding and smart IV pumps) and how to integrate electronic health records with computerized provider order entry, clinical decision support, bar coding, and smart IV pumps. Overall, most data on medication error incidence rates come from the inpatient setting, but the magnitude of the problem is likely to be greater outside the hospital. Areas of priority for research on medication error and ADE incidence rates are care transitions, specialty ambulatory clinics, psychiatric care, the administering of medications in schools, and the use of OTC and complementary and alternative medications. Much more research is needed as well on the patient’s role in the prevention of errors, specifically, what systems provide the most cost-effective support for safe and effective medication self-management or for surrogate participation in medication use when a patient is unable to self-manage. Most studies of the costs of medication errors relate to hospitals, and some report data more than 10 years old (Bates et al., 1997). A better understanding of the costs and consequences of medication errors in all care settings is needed to help inform decisions about investing in medication error prevention strategies. Recommendation 6: AHRQ should take the lead, working with other government agencies such as CMS, the FDA, and the NLM, in coordinating a broad research agenda on the safe and appropriate use of medications across all care settings, and Congress should allocate the funds necessary to carry out this agenda. This agenda should encompass research methodologies, incidence rates by type and severity, costs of medication errors, reporting systems, and in particular, further testing of error prevention strategies. OVERSIGHT, REGULATION, AND PAYMENT Improving medication safety will require key changes in oversight, regulation, and payment. Accordingly, the following recommendation is addressed to the stakeholders that shape the environment in which care is

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The Future of Drug Safety: Promoting and Protecting the Health of the Public delivered, including legislators, regulators, accreditors, payers, and patient safety organizations.3 Recommendation 7: Oversight and regulatory organizations and payers should use legislation, regulation, accreditation, and payment mechanisms and the media to motivate the adoption of practices and technologies that can reduce medication errors, as well as to ensure that professionals have the competencies required to deliver medications safely. Payers and purchasers should continue to motivate improvement in the medication-use process through explicit financial incentives. CMS should evaluate a variety of strategies for delivering medication therapy management. Regulators, accreditors, and legislators should set minimum functionality standards for error prevention technologies. States should enact legislation consistent with and complementary to the Medicare Modernization Act’s electronic prescribing provisions and remove existing barriers to such prescribing. All state boards of pharmacy should undertake quality improvement initiatives related to community pharmacy practice. Medication error reporting should be promoted more aggressively by all stakeholders (with a single national taxonomy used for data storage and analysis). Accreditation bodies responsible for the oversight of professional education should require more training in improving medication management practices and clinical pharmacology. MOVING FORWARD The American people expect safe medication care. In this report, the committee proposes an ambitious agenda for making the use of medications safer. This agenda requires that all stakeholders—patients, care providers, payers, industry, and government, working together—commit to preventing medication errors. Given that a large proportion of injurious drug events are preventable, this proposed agenda should deliver early and measurable benefits. 3 Patient safety organizations are regulated through the Patient Safety and Quality Improvement Act of 2005 (P.L. 109-41). Broadly, they are organizations separate from health care providers that collect, manage, and analyze patient safety data, and advocate safety improvements on the basis of analysis of the patient safety data they receive.

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