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Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
×

THE SAFE USE INITIATIVE AND HEALTH LITERACY

WORKSHOP SUMMARY

Cori Vancheri, Rapporteur

Roundtable on Health Literacy

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
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THE NATIONAL ACADEMIES PRESS
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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, the Agency for Healthcare Research and Quality, GlaxoSmithKline, Johnson & Johnson, and the Missouri Health Foundation (09-0290-HL-09).

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: 978-0-309-15931-9

International Standard Book Number-10: 0-309-15931-8

Additional copies of this report are available from

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For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2010 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.

Suggested citation: IOM (Institute of Medicine). 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
×

“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.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
×

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. Charles M. Vest 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. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
×

PLANNING COMMITTEE FOR THE WORKSHOP ON SAFE USE OF MEDICATIONS AND HEALTH LITERACY*

BENARD P. DREYER, Professor of Pediatrics,

New York University School of Medicine, and

Chair,

American Academy of Pediatrics Health Literacy Program Advisory Committee

DEBORAH FRITZ, Director,

Policy and Quality Standards, Public Policy and Standards, GlaxoSmithKline

RUTH PARKER, Professor of Medicine,

Emory University School of Medicine

*

IOM planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteur and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
×

ROUNDTABLE ON HEALTH LITERACY*

GEORGE ISHAM (Chair), Medical Director and Chief Health Officer,

HealthPartners

SHARON E. BARRETT, Health Literacy Staff Consultant,

Association of Clinicians for the Underserved

CINDY BRACH, Senior Health Policy Researcher,

Center for Delivery, Organization, and Markets, Agency for Healthcare Research and Quality

CAROLYN COCOTAS, Senior Vice President,

Quality and Corporate Compliance, F.E.G.S. Health and Human Services System

ARTHUR CULBERT, President and CEO,

Health Literacy Missouri

MICHAEL L. DAVIS, Senior Vice President,

Human Resources, General Mills, Inc.

BENARD P. DREYER, Professor of Pediatrics,

New York University School of Medicine, and

Chair,

American Academy of Pediatrics Health Literacy Program Advisory Committee

DEBORAH FRITZ, Director,

Policy and Quality Standards, Public Policy and Standards, GlaxoSmithKline

MELODY GOLLER, Health Education Manager,

Scientific Activities Division, American Academy of Family Physicians Foundation

MARTHA GRAGG, Vice President of Program,

Missouri Foundation for Health

LINDA HARRIS, Team Leader,

Health Communication and eHealth Team, Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services

BETSY L. HUMPHREYS, Deputy Director,

National Library of Medicine, National Institutes of Health

TERRIS KING, Deputy Director,

Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services

JEAN KRAUSE, Executive Vice President and CEO,

American College of Physicians Foundation

MARGARET LOVELAND,

Global Medical Affairs, Merck & Co., Inc.

RUTH PARKER, Professor of Medicine,

Emory University School of Medicine

YOLANDA PARTIDA, Director,

National Program Office, Hablamos Juntos, University of California, San Francisco, Fresno Center for Medical Education & Research

CLARENCE PEARSON, Consultant

*

IOM forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteur and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
×

SCOTT C. RATZAN, Vice President,

Global Health, Johnson & Johnson

WILL ROSS, Associate Dean for Diversity, Associate Professor of Medicine,

Washington University School of Medicine

WILLIAM SMITH, Senior Scientist and Director,

Academy for Educational Development

AMY WILSON-STRONKS, Project Director,

Division of Standards and Survey Methods, and

Principal Investigator,

Hospitals, Language, and Culture Study, The Joint Commission

WINSTON F. WONG, Medical Director,

Community Benefit, Disparities Improvement and Quality Initiatives, Kaiser Permanente

Study Staff

LYLA M. HERNANDEZ, Senior Program Officer

TREVONNE WALFORD, Program Assistant (August 2009-May 2010)

SUZANNE LANDI, Senior Program Assistant (May 2010-Present)

ROSE MARIE MARTINEZ, Director,

Board on Population Health and Public Health Practice

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Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
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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 process. We wish to thank the following individuals for their review of this report:

Deborah Fritz, GlaxoSmithKline

Cheryl Parks, University of Connecticut

Lee Sanders, University of Miami

Carol Teutsch, Consultant, University of California, Los Angeles

Although the reviewers listed above have provided many constructive comments and suggestions, they did not endorse the final draft of this report before its release. The review of this report was overseen by Harold Fallon, School of Medicine, University of Alabama. Appointed by the 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 rapporteur and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
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Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
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Acknowledgments

Without the support of the sponsors of the Institute of Medicine Roundtable on Health Literacy, it would not have been possible to plan and conduct the workshop on health literacy and the Safe Use Initiative which this report summarizes. Sponsorship for the Roundtable comes from the Agency for Healthcare Research and Quality, GlaxoSmithKline, Johnson & Johnson, and the Missouri Foundation for Health.

The Roundtable wishes to express its appreciation to Joshua Sharfstein of the Food and Drug Administration (FDA) who provided an overview of the FDA Safe Use Initiative and encouraged exploration of the collaborations that could be formed to increase the safety of patient drug use. The Roundtable is also grateful to H. Shonna Yin and Michael Wolf for their illuminating presentations about health literacy and the safe use of over-the-counter products. Discussion was stimulated by the expert presentations of Daniel Budnitz, William Ray Bullman, Edwin Kuffner, and Joanne Schwartzberg on initiatives to advance patient-centered drug safety. Thanks also go to Sandra DeBussey, Jill Griffiths, Mimi Johnson, Gerald McEvoy, and Susan Pisano for their presentations and insights into identifying activities around which to build partnerships for patient-centered drug safety.

The Roundtable would also like to thank the members of the workshop planning committee for their efforts in developing an excellent workshop agenda. Members of the planning committee were Benard Dryer, Deborah Fritz, and Ruth Parker.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
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Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
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Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
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Tables, Figures, and Boxes

TABLES

3-1

 

Inconsistencies Between Label and Dosage Delivery Device,

 

13

5-1

 

Understanding Label Information,

 

33

5-2

 

Voicing Understanding vs. Taking Correct Action,

 

34

5-3

 

Types of Patient Information Leaflets,

 

35

5-4

 

Lower Health Literacy Members Are in Need of Education and Information,

 

39

5-5

 

Discrepancy in Scores Between Highly Literate and Lower Literate Members Continues to Exist on Elements Related to the Actual Insurance Experience,

 

40

FIGURES

4-1

 

Advertise drug events treated in emergency departments by patient age, United States, 2004-2005,

 

26

4-2

 

Unintentional overdoses cause most emergency visits in children less than 5 years old,

 

26

4-3

 

Underlying causes of emergency visits for child overdoses, 2004-2005,

 

27

4-4

 

Variable awareness of analgesis/antipyretic ingredients in OTC and Rx products,

 

28

Suggested Citation:"Front Matter." Institute of Medicine. 2010. The Safe Use Initiative and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12975.
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BOXES

3-1

 

Health Literacy Tasks in OTC Drug Use,

 

14

4-1

 

Recommendations of the U.S. Pharmacopeia Health Literacy and Prescription Container Labeling Advisory Panel,

 

20

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Every year at least 1.5 million people suffer adverse effects from medication. These problems occur because people misunderstand labels, are unaware of drug interactions, or otherwise use medication improperly. The Food and Drug Administration's Safe Use Initiative seeks to identify preventable medication risks and develop solutions to them. The IOM held a workshop to discuss the FDA's Safe Use Initiative and other efforts to improve drug labeling and safety.

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