Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use

Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use


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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.

Product Details

ISBN-13: 9780309459549
Publisher: National Academies Press
Publication date: 10/28/2017
Pages: 482
Sales rank: 1,265,870
Product dimensions: 6.00(w) x 10.00(h) x 1.10(d)

Table of Contents

Acronyms and Abbreviations xxi

Summary 1

1 Introduction 17

Study Charge 18

Study Approach 20

Definitions and Terminology 22

Study Context 24

Study Scope and Emphasis and Report Organization 39

References 42

Part I Pain Management and Research

2 Pain Management and The Intersection of Pain and Opioid Use Disorder 49

The Scope of the Problem of Pain 49

Opioid Analgesics 53

Nonopioid Pharmacologic Treatments 70

Interventional Pain Therapies 82

Nonpharmacologic Treatments 84

Differences in Pain Experiences and Treatment Effectiveness Among Subpopulations 91

The Intersection Between Pain and Opioid Use Disorder 95

References 96

3 Progress and Future Directions in Research on Pain and Opioid Use Disorder 119

Basic Pain Research 120

The Neurobiology of the Reward Pathway and the Intersection of Pain and Opioid Use Disorder 131

Preclinical and Translational Research 135

Clinical Research 142

Intersection of Pain and Opioid Use Disorder 152

Support for Research 162

Summary and Recommendation 162

References 163

Part II Addressing The Opioid Epidemic

4 Trends in Opioid Use, Harms, and Treatment 187

Trends in Prescription Opioid Use and Misuse 188

Heroin Use and Its Relation to Prescription Opioid Use 206

Illicit Opioid Markets 217

The Current State of Surveillance Systems 227

Recent Developments in Pharmaceutical Treatment of Opioid Use Disorder 230

Trends in Treatment of Opioid Overdose with Naloxone 244

Summary and Recommendations 248

References 249

5 Evidence on Strategies For Addressing The Opioid Epidemic 267

Nature of the Evidence 268

The Need for a Systems Approach 271

Strategies for Restricting Supply 279

Strategies for Influencing Prescribing Practices 293

Strategies for Reducing Demand 316

Strategies for Reducing Harm 326

Summary and Recommendations 340

References 343

6 Opioid Approval and Monitoring by The U.S. Food and Drug Administration 359

Overview of the FDA's Regulatory Process for Prescription Drugs and Its Application to Opioids 361

Public Health Dimensions of FDA Drug Regulation 380

Key Elements of an Integrated Decision-Making Framework for Opioid Regulation 388

Implementation of an Integrated Framework for Opioid Regulation 391

Summary and Recommendations 409

References 414


A Data Sources and Methods 425

B Biographical Sketches of Committee Members and Consultants 435

C Existing Data Sources on Opioid Use, Misuse, Overdose, and Other Harms 447

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