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

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

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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: 978-0-309-49687-2
International Standard Book Number-10: 0-309-49687-X
Digital Object Identifier: https://doi.org/10.17226/25555

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Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2020. Framing opioid prescribing guidelines for acute pain: Developing the evidence. Washington, DC: The National Academies Press. https://doi.org/10.17226/25555.

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, and 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

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

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:

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.

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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.

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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 and 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, Icahn School of Medicine at Mount Sinai; David Jevsevar, Geisel School of Medicine at Dartmouth; 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, 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

Contents

ACRONYMS AND ABBREVIATIONS

SUMMARY

1 INTRODUCTION

Opioid Prescribing Patterns

Opioid-Related Morbidity and Mortality

Standardizing Opioid Prescribing Practices

Committee’s Charge

Committee’s Approach

Organization of the Report

References

2 MANAGING ACUTE PAIN

Definitions

Presentation and Treatment of Acute Pain

Access to Appropriate Acute Pain Management

References

3 DEVELOPMENT AND USE OF CLINICAL PRACTICE GUIDELINES

Principles of Clinical Practice Guideline Development

Methodologies for Developing Clinical Practice Guidelines

Examples of Opioid Prescribing Guidelines for Acute Pain

References

4 FRAMEWORK FOR DEVELOPING CLINICAL PRACTICE GUIDELINES

The Clinical Practice Guideline Development Process

Establishing a Guideline Development Group

Determining the Scope of the Guideline

Analytic Framework

Literature Search and Retrieval

Evidence Evaluation Framework

From Evidence to Recommendations

Implementation

References

5 IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES

Methods for Identifying Priority Surgical and Medical Indications for Clinical Practice Guideline Development

Surgical Indications Overview

Medical Indications Overview

Emergency Department Considerations

Conclusions

References

6 EVALUATING CLINICAL PRACTICE GUIDELINES FOR PRESCRIBING OPIOIDS FOR ACUTE PAIN

Applying the Analytic Framework to Selected Surgical Indications

Applying the Analytic Framework to Selected Medical Indications

References

7 THE PATH FORWARD

Addressing the Committee’s Tasks

A Framework for Evidence-Based Clinical Practice Guidelines

Developing Clinical Practice Guidelines for Opioids

Developing the Evidence Base

Prioritizing Indications

A Research Agenda for Opioid Prescribing for Acute Pain

References

APPENDIXES

A COMMITTEE BIOGRAPHICAL SKETCHES

B LITERATURE SEARCH STRATEGIES

C PUBLIC SESSION AGENDAS

Acronyms and Abbreviations