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.
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
(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.
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).