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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.
Contents
- The National Academies of SCIENCES • ENGINEERING • MEDICINE
- COMMITTEE ON PAIN MANAGEMENT AND REGULATORY STRATEGIES TO ADDRESS PRESCRIPTION OPIOID ABUSE
- Reviewers
- Preface
- Acknowledgments
- Acronyms and Abbreviations
- Summary
- 1. Introduction
- PART I. PAIN MANAGEMENT AND RESEARCH
- PART II. ADDRESSING THE OPIOID EPIDEMIC
- 4. Trends in Opioid Use, Harms, and Treatment
- TRENDS IN PRESCRIPTION OPIOID USE AND MISUSE
- HEROIN USE AND ITS RELATION TO PRESCRIPTION OPIOID USE
- ILLICIT OPIOID MARKETS
- THE CURRENT STATE OF SURVEILLANCE SYSTEMS
- RECENT DEVELOPMENTS IN PHARMACEUTICAL TREATMENT OF OPIOID USE DISORDER
- TRENDS IN TREATMENT OF OPIOID OVERDOSE WITH NALOXONE
- SUMMARY AND RECOMMENDATIONS
- REFERENCES
- 5. Evidence on Strategies for Addressing the Opioid Epidemic
- 6. Opioid Approval and Monitoring by the U.S. Food and Drug Administration
- OVERVIEW OF THE FDA'S REGULATORY PROCESS FOR PRESCRIPTION DRUGS AND ITS APPLICATION TO OPIOIDS
- PUBLIC HEALTH DIMENSIONS OF FDA DRUG REGULATION
- KEY ELEMENTS OF AN INTEGRATED DECISION-MAKING FRAMEWORK FOR OPIOID REGULATION
- IMPLEMENTATION OF AN INTEGRATED FRAMEWORK FOR OPIOID REGULATION
- SUMMARY AND RECOMMENDATIONS
- REFERENCES
- 4. Trends in Opioid Use, Harms, and Treatment
- APPENDIXES
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.
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