STANDARDIZING MEDICATION LABELS

Confusing Patients Less

Workshop Summary

Lyla M. Hernandez, 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



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Lyla M. Hernandez, Rapporteur Roundtable on Health Literacy Board on Population Health and Public Health Practice

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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 Gov- erning Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engi- neering, 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 project was supported by contracts between the National Academy of Sci- ences and the UnitedHealth Group (unnumbered award); Academy for Edu- cational Development (unnumbered award); Kaiser Permanente (unnumbered award); American Academy of Family Physicians (unnumbered award); Affinity Health Plan (unnumbered award); Merck & Co., Inc. (unnumbered award); Pfizer Institute (unnumbered award); Department of Health and Human Services (N01- OD-4-2139, TO#148); and Glaxo Smith Kline (G050002912). Any opinions, find- ings, 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. This summary is based on the proceedings of a workshop that was sponsored by the Roundtable on Health Literacy. It is prepared in the form of a workshop summary by and in the name of the rapporteur as an individually authored document. International Standard Book Number-13: 978-0-309-11529-2 International Standard Book Number-10: 0-309-11529-9 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 2008 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). 2008. Standardizing medica- tion labels: Confusing patients less, workshop summary. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health.

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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 govern- ment 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 mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing 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 pro- viding 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

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MEMbERS OF THE PLANNINg gROuP FOR THE WORkSHOP ON CHANgINg PRESCRIPTION MEDICATION uSE CONTAINER INSTRuCTIONS TO IMPROvE HEALTH LITERACy AND MEDICATION SAFETy CAROLyN COCOTAS, R.T., M.P.A., Director, Affinity Health Plan JEAN kRAuSE, Executive Vice President and CEO, American College of Physicians Foundation RuTH PARkER, M.D., Associate Professor of Medicine, Emory University School of Medicine ANDy STERgACHIS, Ph.D., R.Ph., Professor of Epidemiology, University of Washington DONNA SWEET, M.D., Director of Internal Medicine Education, Via Christi Regional Medical Center–St. Francis CAROL TEuTSCH, M.D., Director of Medical Services, Merck & Co. SAbRA WOOLLEy, Ph.D., Program Director, Health Communication and Informatics Branch, National Cancer Institute 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. 

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MEMbERS OF THE ROuNDTAbLE ON HEALTH LITERACy gEORgE ISHAM, M.D., M.S. (Chair), Medical Director and Chief Health Officer, HealthPartners bARbARA ALLEN, M.P.A., Senior Project Officer, Office of Health Information Systems, Centers for Medicare and Medicaid Services SHARON E. bARRETT, M.S., Health Literacy Specialist, Language, Culture, and Literacy Projects, Association of Clinicians for the Underserved CAROLyN COCOTAS, R.T., M.P.A., Director, Affinity Health Plan MICHAEL L. DAvIS, M.b.A., Vice President, General Mills bARbARA A. DEbuONO, M.D., M.P.H., Senior Medical Director/ Group Leader, Pfizer, Inc. DEbbIE FRITZ, Ph.D., Director, GlaxoSmithKline LINDA HARRIS, Ph.D., Acting Team Leader, Health Communication and eHealth Team, U.S. Department of Health and Human Services bETSy L. HuMPHREyS, M.L.S., Deputy Director, National Library of Medicine, National Institutes of Health LINDA JOHNSTON-LLOyD, M.Ed., Senior Advisor, Health Resources and Services Administration, Center for Quality JEAN kRAuSE, Executive Vice President and CEO, American College of Physicians Foundation LEE kRAvITZ, Editor-in-Chief and Senior Vice President, Parade Magazine DENNIS MILNE, M.b.A., Vice President, Patient Education, American Heart Association PHyLLIS NARAgON, M.A., Director, American Academy of Family Physicians Foundation DENNIS S. O’LEARy, M.D., President, Joint Commission on Accreditation of Healthcare Organizations RuTH PARkER, M.D., Associate Professor of Medicine, Emory University School of Medicine yOLANDA PARTIDA, M.S.W., D.P.A., Director, National Program Office, University of California, San Francisco, Fresno Center for Medical Education & Research kyu bAk LOuIS RHEE, M.D., M.P.P., Chief Medical Officer, Baltimore Medical System WILLIAM SMITH, Ed.D., Academy for Educational Development CAROL TEuTSCH, M.D., Director, Medical Services, Merck & Co. WINSTON F. WONg, M.D., M.S., Clinical Director, Community Benefit, Kaiser Permanente SAbRA WOOLLEy, Ph.D., Program Director, Health Communication and Informatics Branch, National Cancer Institute i

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ANTRONETTE yANCEy, M.D., M.P.H., Associate Professor of Health Services and Director, Doctorate in Public Health Program, University of California, School of Public Health, Los Angeles Staff ROSE MARIE MARTINEZ, Sc.D., Director, Board on Population Health and Public Health Practice LyLA M. HERNANDEZ, M.P.H., Senior Program Officer HOPE R. HARE, M.F.A., Administrative Assistant TIA CARTER, Senior Project Assistant 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. ii

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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 pub- lished 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: Diane D. Cousins, R.Ph., United States Pharmacopeia Standards Division, Department of Healthcare Quality & Information Susan Cummins, M.D., Food and Drug Administration, Center for Drug Evaluation and Research, U.S. Department of Health and Human Services Hugh Tilson, M.D., Ph.D., Public Health Leadership Program, University of North Carolina School of Public Health Winston F. Wong, M.D., M.S., Disparities Improvement and Quality Initiatives, Kaiser Permanente, National Program Office Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse a final draft of the report before its release. The review of this report was overseen ix

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x RevieweRs by Harold J. Fallon, M.D., School of Medicine, University of Alabama at Birmingham. 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 author and the institution.

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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 standardizing medication labels that this report summarizes. Sponsors from the Department of Health and Human Services are the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, the Office of Disease Prevention and Health Promotion, and the National Cancer Institute. Non-federal sponsorship is provided by the Academy for Education Development, Affinity Health Plan, the American Academy of Family Physicians Foun- dation, GlaxoSmithKline, Kaiser Permanente, Merck and Co., Inc., and Pfizer, Inc. The Roundtable is especially grateful to UnitedHealth Group, which provided funds specifically for this workshop. The American College of Physicians Foundation commissioned a thoughtful white paper, Improv- ing Prescription Drug Container Labeling in the United States: A Health Literacy and Medication Safety Initiative, which provided an important base of information for workshop participants. The Roundtable wishes to express its gratitude to the four expert speakers whose presentations provided the background for the issues on medication labeling: Dan Budnitz, Terry C. Davis, Michael Wolf, and Alastair Wood. Additional thanks go to Alastair Wood, who developed and presented a proposal for standardization of medication labels that energized discussion. Reactions to these presentations were provided by the following distinguished individuals: Cindy Brach, William Bullman, xi

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xii ACknowledgMents Vanessa Cajina, William Dolan, Merrill J. Egorin, William Ellis, Alan Goldhammer, Susan Johnson, Mary Ann F. Kirkpatrick, Gerald McEvoy, Nancy Ostrove, Virginia Torrise, Darren Townzen, Linda Weiss, Roger Williams, Albert Wu, and Mara Youdelman. The Roundtable wishes to thank the planning committee members for their hard work in putting together an excellent workshop agenda. Members of the planning committee are Carolyn Cocotas, Jean Krause, Rose Marie Martinez, Ruth Parker, Andy Stergachis, Donna Sweet, Carol Teutsch, and Sabra Woolley. Thanks also go to George Isham for moderat- ing the entire workshop.

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Contents 1 INTRODUCTION 1 The Workshop Agenda, 2 2 PRESENTATIONS 3 Drug Safety in Ambulatory Care, 3 dan Budnitz, M.d., M.P.H. The Role of Health Literacy in Patient Care, 5 terry C. dais, Ph.d. The American College of Physicians Foundation White Paper on Drug Labeling: Findings, 8 Michael wolf, Ph.d., M.P.H. Simplification of Drug Dosing Times: Can We Confuse Patients Less?, 13 Alastair J. J. wood, M.d., F.A.C.P. 3 FEDERAL AGENCY REACTION TO PRESCRIPTION USE INSTRUCTION STANDARDIZATION 19 Cindy Brach, M.P.P., 19 Nancy Ostrove, Ph.D., 21 Virginia Torrise, Pharm.D., 22 Discussion, 23 4 REACTION FROM THE PHARMACY FIELD TO PRESCRIPTION USE INSTRUCTION STANDARDIZATION 25 Alan Goldhammer, Ph.D., 25 xiii

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xi Contents Darren K. Townzen, R.Ph., M.B.A., 26 Gerald McEvoy, Pharm.D., 27 William Ellis, R.Ph., M.S., 29 Discussion, 30 5 OTHER STAKEHOLDER REACTION TO PRESCRIPTION USE INSTRUCTION STANDARDIZATION: PHYSICIANS AND PATIENTS 31 William Dolan, M.D., 31 Albert Wu, M.D., M.P.H., 32 William Bullman, M.A.M., 33 Linda Weiss, Ph.D., 34 Mara Youdelman, J.D., L.L.M., 36 Discussion, 38 6 OTHER STAKEHOLDER REACTION TO PRESCRIPTION USE INSTRUCTION STANDARDIZATION: EDUCATORS OF PHARMACISTS AND PHYSICIANS 39 Mary Ann F. Kirkpatrick, Ph.D., 39 Merrill Egorin, M.D., 41 Discussion, 42 7 WHAT WOULD IT TAKE TO MOVE TOWARD PRESCRIPTION USE INSTRUCTION STANDARDIZATION? 43 Roger Williams, M.D., 43 Darren K. Townzen, R.Ph., M.B.A., 45 Susan Johnson, Pharm.D., Ph.D., 45 Vanessa Cajina, M.P.A., 46 Discussion, 47 8 CLOSING REMARKS 49 Ruth Parker, M.D., 49 REFERENCES 51 APPENDIXES A WORKSHOP AGENDA 53 B BIOSKETCHES OF THE WORKSHOP SPEAKERS 57 C ACP WHITE PAPER 69

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x Contents TABLES 2-1 Patient Misunderstanding of Medication Instructions, 15 2-2 Schedule for Taking Medications TID, QID, and BID, 16 2-3 Simplified Medication Schedule for TID, QID, and BID, 16 C-1 Primary Findings, 73 C-2 Physician-Written Prescriptions and Pharmacy Interpretations, 82 C-3 Description of Standards for an Enhanced Rx Container Label, 91 FIGURES 2-1 Phase–factor matrix for identifying plausible intervention, 4 2-2 Auxiliary warning labels, 6 2-3 Readability does not equal clarity, 7 2-4 Transcription of Rx to label imperfect and variable, 14 2-5 Standard dosing times on prescriptions, 17 C-1 Components of drug labeling, 75 C-2 Sources of patient medication information, 78

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