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
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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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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.
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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
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
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, The 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.
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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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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
|AAAPT||ACTTION−APS−AAPM Pain Taxonomy|
|AAN||American Academy of Neurology|
|AAOMS||American Association of Oral and Maxillofacial Surgeons|
|AAOS||American Academy of Orthopaedic Surgeons|
|AAPD||American Academy of Pediatric Dentistry|
|AAPM||American Academy of Pain Medicine|
|ACOEM||American College of Occupational and Environmental Medicine|
|ACOG||American College of Obstetricians and Gynecologists|
|ACP||American College of Physicians|
|ACTTION||Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks|
|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|
|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|
|EHC||Effective Health Care program|
|EHR||electronic health record|
|FDA||U.S. Food and Drug Administration|
|GRADE||Grading of Recommendations Assessment, Development and Evaluation|
|IOM||Institute of Medicine|
|MHA||Massachusetts Health & 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|
|PDMP||prescription drug monitoring program|
|PICOTS||patient, problem, or population; intervention; comparison, control, or comparator; outcome; time; and setting|
|RCT||randomized controlled trial|
|SCD||sickle cell disease|
|THA||total hip arthroplasty|
|TKA||total knee arthroplasty|
|USPSTF||U.S. Preventive Services Task Force|
|VA||U.S. Department of Veterans Affairs|
|WHO||World Health Organization|