Pain Management and the Opioid Epidemic Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use (2017) / Chapter Skim
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to convene an ad hoc committee to • update the state of the science on pain research, care, and education since publication of the 2011 Institute of Medicine (IOM) report Relieving Pain in America: A Blueprint for Transforming Preven tion, Care, Education, and Research, including the evolving role of opioids in pain management; • characterize the epidemiology of the opioid epidemic and the evi dence on strategies for addressing it; • identify actions the FDA and other organizations can take to respond to the epidemic, with a particular focus on the FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring; and • identify research questions that need to be addressed to assist the FDA in implementing this framework.2 1 This summary does not include references.
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The FDA commissioned this study specifically to inform this reassessment. The committee interpreted its charge as focusing primarily on prescribed opioids, although its analysis of the epidemiology of the opioid epidemic and strategies for addressing it took into account the diversion of prescription opioids into illicit markets and the impact of use of prescription opioids on use of illicit opioids, such as heroin.
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As a result, harms associated with use of prescription opioids affect not only patients with pain themselves but also their families, their communities, and society at large. The complexity of pain is matched by the complexity of achieving appropriate use of opioids in the context of the often suboptimal clinical management of pain within the fragmented U.S.
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While each such alternative has its own indications and risks, there are some circumstances in which nonopioid analgesics (e.g., nonsteroidal anti-inflammatory drugs) are likely to be as effective as opioids, or more so, for reducing pain associated with the conditions for which they are indicated, and when used appropriately, these analgesics carry a lower risk of adverse outcomes relative to opioids.
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in the United States, the National Institutes of Health, the Substance Abuse and Mental Health Services Administration, the U.S. Department of Veterans Affairs, industry, and other relevant research sponsors should consider greater investment in research on pain and OUD, including but not limited to research aimed at • improving understanding of the neurobiology of pain; • developing the evidence on promising pain treatment modalities and supporting the discovery of innovative treatments, including nonaddictive analgesics and nonpharmacologic approaches at the level of the individual patient; and • improving understanding of the intersection between pain and OUD, including the relationships among use and misuse of opioids, pain, emotional distress, and the brain reward pathway; vulner ability to and assessment of risk for OUD; and how to properly manage pain in individuals with and at risk for OUD.
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Tracking the toll of expected nonmedical use of specific products on the health of people who inject drugs is of public health importance. Another critical feature of the opioid crisis is that the prescription and illicit opioid epidemics are intertwined; indeed, a majority of heroin users report that their opioid misuse or OUD began with prescription opioids.
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The National Institute on Drug Abuse and the U.S. Centers for Disease Control and Prevention should invest in data col lection and research relating to population-level opioid use patterns and consequences, especially nonmedical use of prescription opioids and use of illicit opioids, such as heroin and illicitly manufactured fentanyl.
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Specific means for meeting this need may extend beyond the protocolized setting of traditional clinical trials to encompass use of data from less traditional sources, such as online forums. The agency should consider reports of family members or other third parties affected by the drug, as well as data on outcomes in subpopulations that are at high risk of OUD or that exhibit mental health comorbidities common in patients with pain.
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Steps to this end should include use of risk evaluation and mitigation strategies that have been demonstrated to improve prescribing practices, close active surveillance of the use and misuse of approved opioids, periodic formal reevaluation of opioid approval decisions, and aggressive regulation of advertising and promotion to curtail their harmful public health effects. Evidence on the effectiveness of the current REMS for opioids is limited.
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Drug Enforcement Administration should apply the same public health con siderations outlined in Recommendation 6-1 for approval decisions to scheduling and rescheduling decisions, and study empirically the outcomes of scheduling determinations at the patient and population health levels. STRATEGIES FOR ADDRESSING THE OPIOID EPIDEMIC A constellation of policies, interventions, and tools related to lawful access to opioids and clinical decision making are available for use in reducing or containing opioid-related harms while meeting the needs of patients with pain.
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It also is important to keep in mind that restrictions on lawful access to prescription opioids can have other untoward effects: any policy designed to shrink the incidence of future OUD (and other harms) due to use of prescribed opioids by curtailing legal access to these medications will inevitably drive some people who already have OUD into the illegal market.
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Drug Enforcement Administra tion to develop an evidence-based national approach to pain education encompassing pharmacologic and nonpharmacologic treatments and educational materials on opioid prescribing. Insurance-based policies have substantial potential to reduce the use of specific prescription drugs, although their impact on health outcomes remains uncertain.
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of an education program designed to raise awareness among patients with pain and the general public about the risks and benefits of prescription opioids and to promote safe and effective pain management. Medication-assisted treatment is the standard of care for OUD, even for special populations such as pregnant and postpartum women.
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The provision of naloxone to overdose victims by laypersons or health professionals in the prehospital setting is the standard of care, and communitybased programs and other first responder agencies have adopted this protocol for treating opioid overdose. Mechanisms for increasing naloxone prescribing and dispensing, equipping first responders, and possibly enabling direct patient access (e.g., over-the-counter status)
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Access to evidence-based treatment for OUD and efforts to prevent overdose deaths and other harms should therefore be increased substantially and immediately as a public health priority. Action by the nation's political and public health leadership also is warranted to reduce the occurrence of new cases of prescription opioid-induced OUD through the implementation of scientifically grounded policies and clinical practices to promote responsible opioid prescribing and through advocacy for research aimed at identifying and developing nonaddictive alternatives to opioids for treatment of pain.
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