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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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PAIN MANAGEMENT AND
THE OPIOID EPIDEMIC

BALANCING SOCIETAL AND INDIVIDUAL
BENEFITS AND RISKS OF PRESCRIPTION
OPIOID USE

Committee on Pain Management and Regulatory Strategies to
Address Prescription Opioid Abuse

Richard J. Bonnie, Morgan A. Ford, and Jonathan K. Phillips, Editors

Board on Health Sciences Policy

Health and Medicine Division

A Consensus Study Report of

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www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
×

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This activity was supported by Grant No. HHSF223201610015C from 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: 978-0-309-45954-9
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Pain management and the opioid epidemic: Balancing societal and individual benefits and risks of prescription opioid use. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24781.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
×

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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.

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Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
×

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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.

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For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
×

COMMITTEE ON PAIN MANAGEMENT AND REGULATORY STRATEGIES TO ADDRESS PRESCRIPTION OPIOID ABUSE

RICHARD J. BONNIE (Chair), Harrison Foundation Professor of Medicine and Law; Director, Institute of Law, Psychiatry and Public Policy, University of Virginia School of Law, Charlottesville

HORTENSIA DE LOS ANGELES AMARO, Associate Vice Provost for Community Research Initiatives; Dean’s Professor of Social Work and Preventive Medicine, School of Social Work, University of Southern California, Los Angeles

LINDA BURNES BOLTON, System Chief Nurse Executive; Vice President, Nursing; Chief Nursing Officer, Cedars-Sinai Medical Center, Los Angeles, California

JONATHAN P. CAULKINS, H. Guyford Stever Professor of Operations Research and Public Policy, Heinz School of Public Policy and Management, Carnegie Mellon University, Pittsburgh, Pennsylvania

DAVID CLARK, Professor of Anesthesia, Perioperative Pain Medicine and Pain, Stanford University; Director, Veterans Affairs Pain Clinic, Palo Alto, California

ELI ELIAV, Professor and Director, Eastman Institute for Oral Health; Vice Dean for Oral Health, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, New York

GARRET FITZGERALD, McNeil Professor in Translational Medicine and Therapeutics, Perelman School of Medicine, University of Pennsylvania, Philadelphia

TRACI C. GREEN, Deputy Director, Injury Prevention Center, Boston Medical Center, Boston University School of Medicine, Massachusetts; Associate Professor of Emergency Medicine and Epidemiology, The Warren Alpert School of Medicine, Brown University, Providence, Rhode Island

MIGUEL HERNÁN, Kolokotrones Professor of Biostatistics and Epidemiology, Harvard T.H. Chan School of Public Health; Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology, Boston, Massachusetts

LEE D. HOFFER, Associate Professor, Department of Anthropology, Case Western Reserve University, Cleveland, Ohio

PAUL E. JARRIS, Senior Vice President of Maternal and Child Health Program Impact; Deputy Medical Director, March of Dimes Foundation, Washington, DC

KAROL KALTENBACH, Emeritus Professor of Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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AARON S. KESSELHEIM, Associate Professor of Medicine, Harvard Medical School; Director, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women’s Hospital, Boston, Massachusetts

ANNE MARIE McKENZIE-BROWN, Associate Professor of Anesthesiology; Director, Division of Pain Management, Emory University School of Medicine, Atlanta, Georgia

JOSE MORON-CONCEPCION, Associate Professor of Anesthesiology, School of Medicine, Washington University, St. Louis, Missouri

A. DAVID PALTIEL, Professor, Department of Health Policy and Management, School of Public Health, School of Management, Yale University, New Haven, Connecticut

VALERIE REYNA, Professor of Human Development; Director, Human Neuroscience Institute, Cornell University, Ithaca, New York

MARK SCHUMACHER, Chief, Division of Pain Medicine; Professor of Anesthesiology, School of Medicine, University of California, San Francisco

Study Staff

MORGAN A. FORD, Study Director

JONATHAN K. PHILLIPS, Associate Program Officer

ANNE CLAIBORNE, Senior Program Officer

CLARE STROUD, Senior Program Officer (until May 2017)

PAMELA REESE, Senior Program Assistant (until July 2016)

THELMA L. COX, Senior Program Assistant (August 2016–March 2017)

DANIEL FLYNN, Senior Program Assistant (from December 2016)

HILARY BRAGG, Program Coordinator, Board on Health Sciences Policy

CHRISTIE BELL, Financial Officer

ANDREW M. POPE, Director, Board on Health Sciences Policy

Consultants

RONA BRIERE, Consultant Editor

ERIN HAMMERS FORSTAG, Freelance Science Writer

MARGARET FOSTER RILEY, University of Virginia

PATRICIA J. ZETTLER, Georgia State University

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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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:

GEORGES C. BENJAMIN, American Public Health Association

PHILLIP O. COFFIN, San Francisco Department of Public Health

SANDRA COMER, Columbia University

PENNEY COWAN, American Chronic Pain Association

RAYMOND J. DINGLEDINE, Emory University School of Medicine

BARUCH FISCHHOFF, Carnegie Mellon University

PETER BARTON HUTT, Covington & Burling, LLP

SANDRA H. JOHNSON, St. Louis University School of Law

DAVID JULIUS, University of California, San Francisco

ERIN E. KREBS, Minneapolis Veterans Affairs Health Care System

RICHARD LARSON, Massachusetts Institute of Technology

RICHARD C. MOHS, Global Alzheimer’s Platform Foundation

DANIEL RAYMOND, Harm Reduction Coalition

PETER REUTER, University of Maryland

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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JOSHUA M. SHARFSTEIN, Johns Hopkins Bloomberg School of Public Health

PATRICK TIGHE, University of Florida College of Medicine

SARAH WAKEMAN, Massachusetts General Hospital

ALEC WALKER, Harvard T.H. Chan School of Public Health

CLIFFORD WOOLF, Harvard Medical School

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 KRISTINE M. GEBBIE, Flinders University, and SARA ROSENBAUM, The George Washington University. 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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Preface

Nature and human ingenuity have spawned a class of opioid drugs that alleviate pain and, not coincidentally, induce feelings of well-being. Unfortunately, overprescribing and misuse of these drugs pose serious risks to individuals who consume them and the population at large. Industrial and postindustrial societies have been grappling with the challenge of balancing these benefits and risks for more than 150 years. Alarmingly, rates of opioid use disorder (OUD) and opioid overdose deaths have reached unprecedented levels over the past two decades, and have risen much faster in the United States than in most other countries.

U.S. Department of Health and Human Services data suggest that at least 2 million Americans have an OUD involving prescribed opioids and nearly 600,000 have an OUD involving heroin, with about 90 Americans dying every day from overdoses that involve an opioid. Recognizing the magnitude of the problem, the U.S. Food and Drug Administration (FDA) asked the National Academies of Sciences, Engineering, and Medicine (the National Academies) to characterize the epidemic and to recommend actions that the FDA and other public and private organizations should take to address it, balancing society’s interest in reducing opioid-related harms with the needs of individuals suffering from pain. It was my privilege to chair a committee of talented experts chosen by the National Academies to carry out this important charge.

Few communities have been left untouched by the recent surge of opioid-related deaths. Perhaps at no time in modern history has there been broader public understanding of the nature and consequences of substance use disorder, including OUD. Indeed, the broad reach of the epidemic has

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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blurred the formerly distinct social boundary between use of prescribed opioids and use of heroin and other illegally manufactured ones. These unfortunate developments may have finally reframed the “cops versus docs” debate that has characterized U.S. drug policy since World War II.

It has become clear (and is well-documented in this Consensus Study Report) that the opioid epidemic will not be controlled without deploying multiple policy tools. Increasing access to treatment for individuals with OUD is imperative, together with a substantial program of research to develop new nonaddictive treatments for pain. The committee urges the FDA to reshape and monitor the legal market for opioids and to facilitate use of safe and effective agents for treating persons with OUD and reducing overdose deaths. In addition, the professional societies, insurers, health care organizations, pharmaceutical manufacturers, and state and federal agencies collectively responsible for shaping prescribing practices should attend to the multiple weaknesses in the nation’s health system that led to this epidemic. Meanwhile, law enforcement agencies will continue to be responsible for curtailing trafficking in illegally manufactured opioids, most recently the low-priced, high-potency fentanyl manufactured in clandestine labs domestically and also streaming into the country from abroad. Although criminal drug law enforcement was beyond the scope of this report, the need for improved tools for tracking the dynamic interaction between the legal and illegal markets is one of its core themes.

The Controlled Substances Act, which provides one of the two prongs of federal statutory regulation of opioids (the other being the Food, Drug, and Cosmetic Act), was enacted by Congress in 1970, as part of an omnibus drug policy bill that also established the National Commission on Marijuana and Drug Abuse, for which I had the honor of serving as Associate Director. The Commission’s second report, issued in 1973, championed strong roles for federal public health agencies, and for federally funded scientific research, in a coordinated national policy for substance use disorder prevention and treatment. Perhaps the tragic effects of the opioid epidemic will reinvigorate federal leadership and provide the impetus for comprehensive and sustained national action.

Richard J. Bonnie, Chair

Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Acknowledgments

The National Academies of Sciences, Engineering, and Medicine’s (the National Academies’) Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse and its supporting staff thank the representatives of the study sponsor, the U.S. Food and Drug Administration, including Robert Califf, Sharon Hertz, Joshua Lloyd, and Douglas Throckmorton, who gladly provided the committee with background information, responded to questions, and participated in the committee’s open sessions and workshops. We also thank the many other individuals who shared their expertise and information during the committee’s workshops (see Appendix A for the names of the speakers). Their contributions informed the committee’s deliberations and enhanced the quality of this Consensus Study Report. The study staff, including board director Andrew Pope, study director Morgan Ford, associate program officer Jonathan Phillips, and administrative assistant Thelma Cox, were central in shepherding the report through all its stages. The committee would also like to thank senior program officers Anne Claiborne and Clare Stroud for the guidance they provided throughout the study, as well as science writer Erin Hammers, who helped to draft portions of the report. Special thanks are also due to Rona Briere and Alisa Decatur for their editorial support. We also appreciate the many staff at the National Academies who contributed to the production and review of the report, including Daniel Bearss, Clyde Behney, Christie Bell, Chelsea Frakes, Ellen Kimmel, Janice Mehler, Bettina Ritter, Lauren Shern, and Taryn Young. The committee and staff also extend their gratitude to Greta Gorman, Nicole Joy, Sarah Kelley, An Nguyen-Gia, and Jennifer Walsh for their assistance with report communications and release activities.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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6-1 Approval of Zohydro Extended-Release

6-2 Overarching Recommendation for Development of an Integrated Framework for Regulation of Opioids

6-3 Recommendations for the Clinical Development Stage

6-4 Recommendation for the Approval Stage

6-5 Recommendation for the Post-Approval Monitoring Stage

6-6 Recommendations for Other Regulatory Decisions

A-1 Meeting 1 Open Session Agenda

A-2 Pain Management and Prescription Opioid-Related Harms: Exploring the State of the Evidence

A-3 Regulatory Strategies to Address Prescription Opioid-Related Harms

FIGURES

S-1 Number of overdose deaths from prescription and illicit opioids, United States, 1999–2015

1-1 Nationally estimated number of prescriptions dispensed for extended-release/long-acting (ER/LA) and selected immediate-release (IR) opioid analgesics (oral solids and transdermal products) from U.S. outpatient retail pharmacies, 2005–2015

1-2 Number of overdose deaths from prescription and illicit opioids, United States, 1999–2015

4-1 Benzodiazepine prescribing patterns and deaths from drug overdose among U.S. veterans receiving opioid analgesics: Case-cohort study. Overdose deaths rise sharply when opioid dose is 50 mg or greater and benzodiazepine is also used

4-2 Public health impact of heroin use

4-3 Age-adjusted heroin overdose death rates per 100,000 population from 2014 (light blue) to 2015 (dark blue), by census region of residence

4-4 Age-adjusted rates of death related to prescription opioids and heroin drug poisoning in the United States, 2000–2014

4-5 Percentage of heroin initiates among persons aged 12–49, by prior and past-year dependence on/abuse of nonmedical pain relievers (NMPRs), 2002–2011

4-6 Estimated number of chronic heroin users, 2000–2010 (in millions)

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
×
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Acronyms and Abbreviations

ACA

Patient Protection and Affordable Care Act

ADAM

Arrestee Drug Abuse Monitoring

ADF

abuse-deterrent formulation

ADP

adenosine diphosphate

ANDA

Abbreviated New Drug Application

APAP

N-Acetyl-p-Aminophenol (acetaminophen)

ARRIVE

Animals in Research: Reporting In Vivo Experiments

ASAM

American Society of Addiction Medicine

ASIC

acid-sensing ion channel

ATP

adenosine triphosphate

BH4

tetrahydrobiopterin

BMT

buprenorphine maintenance therapy

CASP6

caspase-6

CB

cannabinoid receptor

CBT

cognitive behavioral therapy

CDC

U.S. Centers for Disease Control and Prevention

CDSS

clinical decision support system

CEWG

Community Epidemiology Working Group

CGMP

Current Good Manufacturing Practice

CHARM

Children and Recovering Mothers

CI

confidence interval

CNCP

chronic noncancer pain

CNS

central nervous system

Page xxii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
×

CoEPE

Center of Excellence in Pain Education

COMM

Current Opioid Misuse Measure

COX

cyclooxygenase

CRPS

complex regional pain syndrome

CSA

Controlled Substances Act

CSF1

colony-stimulating factor 1

DA

dopamine

DAMP

damage-associated molecular pattern

DATA

Drug Addiction Treatment Act of 2000

DAWN

Drug Abuse Warning Network

DDD

defined daily dose

DEA

U.S. Drug Enforcement Administration

DIRE

Diagnosis, Intractability, Risk, Efficacy tool

DoD

U.S. Department of Defense

DOJ

U.S. Department of Justice

DOPR

delta opioid receptor

DSM

Diagnostic and Statistical Manual of Mental Disorders

DTC

direct-to-consumer

DUR

drug utilization review

ECHO

Extension for Community Healthcare Outcomes

EEG

electroencephalogram

EMR

electronic medical record

EP3

E prostanoid receptor 3

EpFA

epoxy fatty acid

ER/LA

extended-release/long-acting

ERK

extracellular signal-regulated kinase

ETASU

elements to assure safe use

FAAH

fatty acid amide hydrolase

FAERS

FDA’s Adverse Event Reporting System

FDA

U.S. Food and Drug Administration

FDASIA

FDA Safety and Innovation Act of 2012

FDCA

Food, Drug, and Cosmetic Act

FQHC

federally qualified health center

GI

gastrointestinal

GPR

G protein-coupled receptor

GRADE

Grading of Recommendations, Assessment, Development, and Evaluation

GTP

guanosine triphosphate

Page xxiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
×

HCV

hepatitis C virus

HHS

U.S. Department of Health and Human Services

HIV

human immunodeficiency virus

HMGB1

high mobility group box 1 protein

ICD

International Classification of Diseases

IL-6

interleukin-6

IMMPACT

Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials

IND

Investigational New Drug

IOM

Institute of Medicine

IPRCC

Interagency Pain Research Coordinating Committee

IR

immediate-release

KOPR

kappa opioid receptor

MAT

medication-assisted treatment

MCH

maternity care home

MED

morphine equivalent dose

MME

morphine milligram equivalents

MOMS

Maternal Opioid Medical Supports

MOPR

mu (µ) opioid receptor

MPGES

microsomal prostaglandin E synthase

NAc

nucleus accumben

NAS

neonatal abstinence syndrome

NAVIPPRO

National Addictions Vigilance Intervention and Prevention Program

NDA

New Drug Application

NDEWS

National Drug Early Warning System

NeuPSIG

Neuropathic Pain Special Interest Group

NFLIS

National Forensic Laboratory Information System

NGF

nerve growth factor

NIDA

National Institute on Drug Abuse

NIH

National Institutes of Health

NMDA

N-Methyl-d-aspartate

NMPR

nonmedical pain relief

NNT

number needed to treat

NorBNI

norbinaltorphimine

NSAID

nonsteroidal anti-inflammatory drug

NSDUH

National Survey on Drug Use and Health

OIH

opioid-induced hyperalgesia

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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ONDCP

Office of National Drug Control Policy

OPRM1

opioid receptor mu1

OR

opioid receptor

ORT

Opioid Risk Tool

OTA

opioid treatment agreement

OTC

over-the-counter

OUD

opioid use disorder

PAMP

pathogen-associated molecular pattern

PDMP

prescription drug monitoring program

PG

prostaglandin

PGE

prostaglandin E

PHN

postherpetic neuralgia

POATS

Prescription Opioid Addiction Treatment Study

POMAQ

Prescription Opioid Misuse and Abuse Questionnaire

PPA

patient–provider agreement

PPRECISE

Preclinical Pain Research Consortium for Investigating Safety and Efficacy

PRR

pattern recognition receptor

PVB

paravertebral block

PWID

people who inject drugs

QALY

quality-adjusted life year

QL

quantity limit

RA

rheumatoid arthritis

RADARS

Researched Abuse, Diversion, and Addiction-Related Surveillance

RAGE

receptor for advanced glycation end products

RCT

randomized controlled trial

REMS

Risk Evaluation and Mitigation Strategy

RF

radiofrequency

RICO

Racketeer Influenced and Corrupt Organizations Act

RMTg

rostromedial tegmental nucleus

SA

short-acting

SAFE

Safety, Appropriateness, Fiscal Neutrality, and Effectiveness

SAMHSA

Substance Abuse and Mental Health Services Administration

SCOPE

Safe and Competent Opioid Prescribing Education

SCS

spinal cord stimulation

sEH

soluble epoxide hydrolase

SIF

safe injection facility

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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SIH

supervised injectable heroin

SIS

Spine Intervention Society

SMB

state medical board

SNP

single-nucleotide polymorphism

SNRI

serotonin–norepinephrine reuptake inhibitor

SOAPP

Screener and Opioid Assessment for Patients with Pain

SSRI

selective serotonin re-uptake inhibitor

SUD

substance use disorder

TCA

tricyclic antidepressant

TEDS

Treatment Episodes Data Set

THC

tetrahydrocannabinol

TIRF

transmuscosal immediate-release fentanyl

TLR

toll-like receptor

TNF

tumor necrosis factor

TPP

thrombotic thrombocytopenic purpura

TRPA1

transient receptor potential cation channel, member A1

TRPV

transient receptor potential cation channel, subfamily V

TTX

tetrodotoxin

VA

U.S. Department of Veterans Affairs

VGSC

voltage-gated sodium channel

VHA

Veterans Health Administration

VTA

ventral tegmental area

WHO

World Health Organization

Page xxvi Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Page xxii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Page xxiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Page xxiv Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Page xxvi Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies Press. doi: 10.17226/24781.
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Next: Summary »
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Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

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