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Suggested Citation:"Appendix A: Data Sources and Methods." 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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Appendix A

Data Sources and Methods

DESCRIPTION OF THE STUDY COMMITTEE

The study committee consisted of 18 members with expertise in pain management, basic pain research, epidemiology, medical anthropology, substance use disorder, nursing, law, drug development, public health, health policy and policy modeling, and decision science. Two consultants with expertise in health care and food and drug law were appointed to contribute to the regulatory components of the report. See Appendix B for biographical sketches of the committee members. The committee convened for six 2-day meetings in July 2016, September 2016, November 2016, December 2016, January 2017, and March 2017.

LITERATURE REVIEW

Several strategies were used to identify literature relevant to the committee’s charge. First, a search of bibliographic databases, including MEDLINE, Scopus, and Web of Science, was conducted to obtain articles from peer-reviewed journals. In addition, the Cochrane Database of Systematic Reviews was queried, as were relevant federal, state, and local agencies and organizations for guidelines or other grey literature. The LexisNexis database was also reviewed for relevant legal and policy literature. The searches focused on pain management, education, and research, as well as opioids, epidemiology, law, and policy. The keywords used included best practices, pain management, evidence-based treatment, epidemiology, insurance/reimbursement (health coverage, health insurance, Medicaid, Medicare, payer reimbursement), non-pharmaceutical pain management

Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×

(acupuncture, cognitive behavioral therapy, self-care, non-pharmacologic pain management, self-management, psychological pain management), pharmacologic pain management (pain relievers, pain medicine, pharmacological treatment, medical pain management), pain conditions (acute pain, analgesia, arthritis, back pain, burn pain, cancer, chronic pain, chronic diseases, end of life, fibromyalgia, hyperalgesia, joint pain, knee pain, mental health disorders, neck pain, neuropathic pain, osteoarthritis, palliative care, post-traumatic stress, shoulder pain), age (young adult, adult, geriatric, nursing home residents, pregnant women, neonatal, neonatal abstinence syndrome, neonatal opioid withdrawal syndrome, nursing mothers), law enforcement (policing, drug enforcement, prescription drug monitoring), public health, vulnerable populations, opioids, heroin, fentanyl, abuse/misuse, abuse-deterrent, addiction/dependence, illicit drugs, medication assisted treatment, naloxone, opioid diversion, overdose/death, prescribing practices, routes of administration, safe use/storage/disposal, synthetic opioids). In addition, committee members, meeting participants, and others from the public submitted articles and reports on these topics.

PUBLIC WORKSHOPS

The committee hosted a brief public session at its first meeting as well as two public workshops to obtain information on specific aspects of the study charge. These were held in conjunction with the committee’s July, September, and November meetings. The committee determined the topics and speakers for the public workshops. The committee also held open forums at each public workshop at which members of the public were encouraged to provide testimony on any topics related to the study charge. The committee found these workshops to be highly informative for its deliberations. Agendas for the three meetings are presented in Boxes A-1 through A-3.

The brief public session at the committee’s first meeting in July (see Box A-1) was attended by representatives from the U.S. Food and Drug Administration (FDA), the study sponsor, to review and discuss the charge to the committee. The first workshop, held in September, focused on the portion of the committee’s task related to updating the state of the science of pain medicine and related education and research (see Box A-2). The workshop presentations and discussions are summarized in a Proceedings of a Workshop—in Brief titled Pain Management and Prescription Opioid-Related Harms: Exploring the State of the Evidence, which was released to the public on November 4, 2016.

The second workshop, held in November, focused on regulatory strategies that can be implemented by the FDA, as well as actions that can be taken by others, to address the opioid epidemic while taking into account the needs of pain patients (see Box A-3).

Suggested Citation:"Appendix A: Data Sources and Methods." 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:"Appendix A: Data Sources and Methods." 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:"Appendix A: Data Sources and Methods." 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:"Appendix A: Data Sources and Methods." 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:"Appendix A: Data Sources and Methods." 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:"Appendix A: Data Sources and Methods." 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:"Appendix A: Data Sources and Methods." 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:"Appendix A: Data Sources and Methods." 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:"Appendix A: Data Sources and Methods." 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.
×
Page 425
Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×
Page 426
Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×
Page 427
Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×
Page 428
Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×
Page 429
Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×
Page 430
Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×
Page 431
Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×
Page 432
Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×
Page 433
Suggested Citation:"Appendix A: Data Sources and Methods." 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.
×
Page 434
Next: Appendix B: Biographical Sketches of Committee Members and Consultants »
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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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