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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN: DEVELOPING THE EVIDENCE Committee on Evidence-Based Clinical Practice Guidelines for Prescribing Opioids for Acute Pain Board on Health Care Services Health and Medicine Division A Consensus Study Report of PREPUBLICATION COPY—Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by a contract between the National Academy of Sciences and the U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/25555 Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2019 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2019. Framing opioid prescribing guidelines for acute pain: Developing the evidence. Washington, DC: The National Academies Press. https://doi.org/10.17226/25555. PREPUBLICATION COPY—Uncorrected Proofs

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. PREPUBLICATION COPY—Uncorrected Proofs

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. PREPUBLICATION COPY—Uncorrected Proofs

COMMITTEE ON EVIDENCE-BASED CLINICAL PRACTICE GUIDELINES FOR PRESCRIBING OPIOIDS FOR ACUTE PAIN BERNARD LO (Chair), President and Chief Executive Officer, The Greenwall Foundation; Professor of Medicine Emeritus, Director, Program in Medical Ethics, Emeritus, University of California, San Francisco MARK C. BICKET, Director of Pain Fellowship Program, Director of Quality and Safety, Assistant Professor, Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine (resigned from committee August 2019) NICHOLAS W. CARRIS, Assistant Professor, Department of Pharmacotherapeutics and Clinical Research, USF Health Taneja College of Pharmacy, Assistant Professor, Department of Family Medicine, USF Health Morsani College of Medicine, University of South Florida ROGER CHOU, Professor, Medicine, Oregon Health & Science University School of Medicine; Director, Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University M. KIT DELGADO, Assistant Professor, Emergency Medicine and Epidemiology, University of Pennsylvania Perelman School of Medicine CHRISTINE D. GRECO, Clinical Director, Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children’s Hospital; Assistant Professor, Anesthesia, Harvard Medical School HILLARY V. KUNINS, Executive Deputy Commissioner, New York City Department of Health and Mental Hygiene MARJORIE C. MEYER, Associate Professor, Maternal Fetal Medicine, Division Director, Maternal Fetal Medicine, Medical Director, Birthing Center, University of Vermont Medical Center RICHARD PAYNE, Esther Colliflower Professor of Medicine and Divinity Emeritus, Duke Divinity School and Duke University Medical Center; John B. Francis Chair in Bioethics, Center for Practical Bioethics (resigned from committee December 2018) ROSEMARY C. POLOMANO, Associate Dean for Practice, Professor, Pain Practice, University of Pennsylvania School of Nursing; Professor, Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine; Adjunct Professor, Uniformed Services University of the Health Sciences Graduate School of Nursing CARDINALE B. SMITH, Associate Professor of Medicine, Division of Hematology/Medical Oncology and Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai; Director, Quality for Cancer Services, Mount Sinai Health System ERIC C. SUN, Assistant Professor, Department of Anesthesiology, Pain and Perioperative Medicine, Stanford University (resigned from committee September 2019) JENNIFER F. WALJEE, Associate Professor of Surgery, Department of Surgery, University of Michigan School of Medicine; Co-Director, Michigan Opioid Prescribing Engagement Network STEVEN J. WEISMAN, Medical Director, Pain Management, Children’s Wisconsin; Professor, Anesthesiology and Pediatrics, Medical College of Wisconsin CHARLES G. WIDMER, Head, Division of Facial Pain, Department of Orthodontics, Associate Professor, Department of Orthodontics, University of Florida College of Dentistry PREPUBLICATION COPY—Uncorrected Proofs v

Study Staff ROBERTA WEDGE, Study Director CYNDI TRANG, Research Associate RUTH COOPER, Senior Program Assistant MICAH WINOGRAD, Senior Finance Business Partner SHARYL J. NASS, Director, Board on Health Care Services PREPUBLICATION COPY—Uncorrected Proofs vi

Reviewers This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, 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 thank the following individuals for their review of this report: Rita Agarwal, Stanford University Huda Akil, University of Michigan Soraya Azari, University of California, San Francisco Brian T. Bateman, Brigham and Women's Hospital Alfred O. Berg, University of Washington School of Medicine James C. Eisenach, Wake Forest School of Medicine Daniel M. Fox, Milbank Memorial Fund Haytham Kaafarani, Massachusetts General Hospital Nancy E. Lane, University of California, Davis Zachary F. Meisel, University of Pennsylvania Robert Wallace, University of Iowa Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by Kenneth W. Kizer, Atlas Research and Linda C. Degutis, Henry M. Jackson Foundation. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. PREPUBLICATION COPY—Uncorrected Proofs vii

In Memoriam This Consensus Study Report is dedicated to Dr. Richard Payne, an international expert in palliative care and pain management, a valued member of the committee, and an irreplaceable friend and colleague. PREPUBLICATION COPY—Uncorrected Proofs ix

Preface If readers look in their medicine cabinets, it is likely many will find prescription opioids left over from a previous acute pain episode. The treating clinician likely wanted to err on the side of providing adequate pain relief. But from an individual and a public health perspective, these leftover opioid pills may lead to long-term use, opioid use disorder, and unintentional overdoses among patients and others, if taken by people for whom the pills were not prescribed. The committee believes that the need both to alleviate severe acute pain and to reduce public health harms make this report important for a broad audience, including clinicians and other health care providers, patients, and the public. How might this report be useful? Evidence on opioid use, patient outcomes, and adverse effects for patients and the public health is being published continuously. This report offers a framework for evaluating that evidence to support a clinical practice guideline, recommends acute pain indications where better practice guidelines might affect public health, and points out evidence gaps that need to be filled with future research. Both acute pain and opioid use disorder and overdose can cause distress to patients and their communities; emotions on these topics run high. This report points the way to how rigorous evidence and guidelines based on that evidence can reduce inappropriate opioid prescribing for acute pain and thereby help prevent further distress. On behalf of the committee, I would like to express our sincere gratitude to the many individuals and groups who provided valuable information and insights to assist the committee with its deliberations. In particular, we would like to thank the representatives of the U.S. Food and Drug Administration: Scott Gottlieb, Judy Staffa, and Douglas Throckmorton. The following individuals also participated in the committee’s workshops: Richard Barth, Jr., Dartmouth- Hitchcock Medical Center; Brian Bateman, Brigham & Women’s Hospital; Leslie Bisson, University at Buffalo; Kevin Bozic, The University of Texas at Austin Dell Medical School; Steven Brown, University of Arizona College of Medicine; Benjamin Friedman, Albert Einstein College of Medicine; David Goldfarb, New York University School of Medicine; Elizabeth Habermann, Mayo Clinic; Elliot Hersh, University of Pennsylvania School of Dental Medicine; Debra Houry, Centers for Disease Control and Prevention (CDC); Ula Hwang, Mount Sinai Icahn School of Medicine; David Jevsevar, Dartmouth Geisel School of Medicine; Clifford Ko, University of California, Los Angeles (UCLA), School of Medicine; Elliot Krane, Stanford University; Lisa Leffert, Massachusetts General Hospital; Christina Mikosz, CDC; Paul Moore, University of Pittsburgh School of Dental Medicine; Douglas Owens, U.S. Preventive Services Task Force and Stanford University; Darshak Sanghavi, OptumLabs; Holger Schünemann, GRADE and McMaster University; Paul Shekelle, UCLA School of Medicine; Wally Smith, Virginia Commonwealth University; and Joanna Starrels, Albert Einstein College of Medicine. We would also like to thank the following individuals for conducting data analyses for the committee: Jill Ashman, Carol DeFrances, Pinyao Rui, Susan Schappert, and Brian Ward from CDC, and Brian Bateman from Brigham and Women’s Hospital. We also appreciate the materials sent by other interested parties, including several medical specialty societies. As chair, I also want to thank my colleagues on the committee for their hard work, willingness to reconsider their views in the light of evidence and other perspectives, and their collegiality. I also want to acknowledge the contributions of Mark Bicket, M.D., and Eric Sun, PREPUBLICATION COPY—Uncorrected Proofs xi

M.D., Ph.D., who stepped off the committee when they started full-time positions with the federal government. I also want to remember Richard Payne, M.D., who died shortly after resigning from the committee, for his career-long dedication to relieving the suffering of patients living with pain and his commitment to reducing health disparities. Finally, the committee’s report would not have been possible without the expertise, dedication, and hard work of the National Academies’ staff: Roberta Wedge, Cyndi Trang, Ruth Cooper, Daniel Bearss, and Rebecca Morgan. The committee gratefully thanks them. Bernard Lo, Chair Committee on Evidence-Based Clinical Practice Guidelines for Prescribing Opioids for Acute Pain PREPUBLICATION COPY—Uncorrected Proofs xii

Contents ACRONYMS AND ABBREVIATIONS xix SUMMARY S-1 1 INTRODUCTION 1-1 Opioid Prescribing Patterns, 1-2 Opioid-Related Morbidity and Mortality, 1-3 Standardizing Opioid Prescribing Practices, 1-4 Committee’s Charge, 1-5 Committee’s Approach, 1-5 Organization of the Report, 1-8 References, 1-8 2 MANAGING ACUTE PAIN 2-1 Definitions, 2-2 Presentation and Treatment of Acute Pain, 2-5 Access to Appropriate Acute Pain Management, 2-13 References, 2-16 3 DEVELOPMENT AND USE OF CLINICAL PRACTICE GUIDELINES 3-1 Principles of Clinical Practice Guideline Development, 3-2 Methodologies for Developing Clinical Practice Guidelines, 3-4 Examples of Opioid Prescribing Guidelines for Acute Pain, 3-7 References, 3-13 4 FRAMEWORK FOR CLINICAL PRACTICE GUIDELINES 4-1 The Clinical Practice Guideline Development Process, 4-3 Establishing a Guideline Development Group, 4-3 Determining the Scope of the Guideline, 4-4 Analytic Framework, 4-5 Literature Search and Retrieval, 4-11 Evidence Evaluation Framework, 4-12 From Evidence to Recommendations, 4-17 Implementation, 4-18 References, 4-21 5 IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 5-1 Methods for Identifying Priority Surgical and Medical Indications for Clinical Practice Guideline Development, 5-2 Surgical Indications Overview, 5-4 Medical Indications Overview, 5-24 Emergency Department Considerations, 5-35 Conclusions, 5-36 PREPUBLICATION COPY—Uncorrected Proofs xiii

References, 5-37 6 EVALUATING CLINICAL PRACTICE GUIDELINES FOR PRESCRIBING OPIOIDS FOR ACUTE PAIN 6-1 Applying the Analytical Framework to Select Surgical Indications, 6-2 Applying the Analytical Framework to Select Medical Indications, 6-16 References, 6-32 7 THE PATH FORWARD 7-1 Addressing the Committee’s Tasks, 7-2 A Framework for Evidence-Based Clinical Practice Guidelines, 7-2 Developing Clinical Practice Guidelines for Opioids, 7-5 Developing the Evidence Base, 7-11 Prioritizing Indications, 7-13 A Research Agenda for Opioid Prescribing for Acute Pain, 7-15 References, 7-16 APPENDIXES A COMMITTEE BIOGRAPHICAL SKETCHES A-1 B LITERATURE SEARCH STRATEGIES B-1 C PUBLIC SESSION AGENDAS C-1 PREPUBLICATION COPY—Uncorrected Proofs xiv

Acronyms and Abbreviations AAAPT ACTTION−APS−AAPM Pain Taxonomy AAOMS American Association for Oral and Maxillofacial Surgeons AAOS American Academy of Orthopaedic Surgeons AAPD American Academy of Pediatric Dentistry AAPM American Academy of Pain Medicine ACCTION Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks ACOEM American College of Occupational and Environmental Medicine ACOG American College of Obstetrics and Gynecology ACP American College of Physicians ADA American Dental Association AGREE Appraisal of Guidelines, Research and Evaluation AHIP America’s Health Insurance Plans AHRQ Agency for Healthcare Research and Quality AHS American Headache Society APS American Pain Society ASIPP American Society of Interventional Pain Physicians AUA American Urological Association CDC Centers for Disease Control and Prevention CI confidence interval CMSS Council of Medical Specialty Societies CORE Center for Opioid Research and Education CPG clinical practice guideline DoD U.S. Department of Defense DSM-5 Diagnostic and Statistical Manual for Mental Disorders, 5th Edition EAU European Association of Urology ED emergency department EHC Effective Health Care EHR electronic health record FDA U.S. Food and Drug Administration GRADE Grading of Recommendations Assessment, Development and Evaluation PREPUBLICATION COPY—Uncorrected Proofs xv

IOM Institute of Medicine MHA Massachusetts Hospital Association MME morphine milligram equivalent NAMCS National Ambulatory Medical Care Survey NHAMCS National Hospital Ambulatory Medical Care Survey NHLBI National Heart, Lung, and Blood Institute NSAID nonsteroidal anti-inflammatory drug OME oral morphine equivalent OPEN Opioid Prescribing Engagement Network OR odds ratio PDMP prescription drug monitoring program PICOTS patient, problem, or population; intervention; comparison, control, or comparator; outcome; time; and setting QI quality improvement RCT randomized controlled trial SCD sickle cell disease SMB state medical board THA total hip arthroplasty TKA total knee arthroplasty USPSTF U.S. Preventive Services Task Force VA U.S. Department of Veterans Affairs VOC vaso-occlusive crisis WHO World Health Organization PREPUBLICATION COPY—Uncorrected Proofs xvi

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The opioid overdose epidemic combined with the need to reduce the burden of acute pain poses a public health challenge. To address how evidence-based clinical practice guidelines for prescribing opioids for acute pain might help meet this challenge, Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence develops a framework to evaluate existing clinical practice guidelines for prescribing opioids for acute pain indications, recommends indications for which new evidence-based guidelines should be developed, and recommends a future research agenda to inform and enable specialty organizations to develop and disseminate evidence-based clinical practice guidelines for prescribing opioids to treat acute pain indications.

The recommendations of this study will assist professional societies, health care organizations, and local, state, and national agencies to develop clinical practice guidelines for opioid prescribing for acute pain. Such a framework could inform the development of opioid prescribing guidelines and ensure systematic and standardized methods for evaluating evidence, translating knowledge, and formulating recommendations for practice.

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