Pain Management and the Opioid Epidemic Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use (2017) / Chapter Skim
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1 Introduction
1 Introduction
Pages 17-46
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From page 17... ...
As of 2015, 2 million Americans aged 12 years or older had an OUD involving prescription opioids, and about 600,000 had an OUD involving heroin, an illicit opioid (HHS, 2016a)
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In 2014, the FDA approved an ADF version of Zohydro to replace the original version. In the wake of these decisions and in light of concerns about the growing opioid problem, the FDA launched an Opioids Action Plan in early 2016.
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Based on its review of the evidence, the committee was to identify regulatory actions the FDA can take to address the opioid epidemic, with a focus on the agency's development of a formal method (a regulatory framework) for incorporating the broader public health impacts of opioids into its future opioid approval decisions.
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as to the state of the science regarding prescription opioid abuse and misuse, including prevention, management, and intervention, and to provide an update from the 2011 Institute of Medicine (IOM) report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, which includes a further character ization of the evolving role that opioid analgesics play in pain management. The report additionally will make recommendations on the options available to the FDA to address the prescription opioid overdose epidemic, from both the individual and public health perspectives, and to otherwise further advance the field.
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Areas of particular focus include – FDA actions to be taken as a part of development, review and ap proval, and safe use of pain medicines, such as: - Development of a formal method to incorporate the broader public health impact of opioid abuse in future FDA approval decisions regarding opioids - development of nonopioid pain medicines to treat severe pain The - development of abuse-deterrent opioids The - incorporation of prevention strategies into safe opioid pre The scribing, including modification of the standard opioid indication statements - development of medicines for medication assisted treatment The for patients with opioid use disorder - development of medicines to treat opioid overdose The - education of prescribers and patients about safe use of pain The medications - education of prescribers and patients about appropriate medi The cation storage and disposal – Actions by prescribers, professional societies, and government agen cies (local, state, and federal)
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. The second workshop focused on the regulatory aspects of the committee's charge, including how the FDA might incorporate public health considerations into its regulatory framework for evaluation of prescription drugs.
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) ; and when referring to statutes, such as the Controlled Substances Act, that use this term.
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With few effective alternatives, moreover, many medical professionals used morphine to treat chronic pain conditions. This and the nonmedical use of opioids were major drivers of an opioid addiction epidemic that took place in the latter 19th century (Courtwright, 2015)
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. In 1996, the American Academy of Pain Medicine and American Pain Society issued a joint consensus statement titled The Use of Opioids for the Treatment of Chronic Pain, describing potential benefits of using opioids for management of chronic (including noncancer)
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prosecuted many physicians for illegal distribution of OxyContin (Hoffman, 2016) .7 Nonetheless, sales of prescription opioids continued to increase (Pan, 2016)
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for all approved and marketed ER/LA and some of the most common IR opioid analgesics grew from 148 million in 2005 to 206 million by 2011. Opioid dispensing during this period was driven primarily by IR opioids (which work quickly and often are prescribed for short-term, intermittent, or "breakthrough" pain)
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. While the number of overdose deaths from prescription opioids remained relatively stable between 2011 and 2015, overdose deaths from illicit opioids (e.g., heroin and synthetic opioids such as fentanyl)
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. CDC's 2016 Guideline for Prescribing Opioids for Chronic Pain explicitly declares that nonpharmacologic and nonopioid therapies are preferred for treating chronic pain (Dowell et al., 2016)
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, harm reduction strategies implemented to reduce opioid overdose included making the opioid overdose reversal drug naloxone available outside of pharmacies without a prescription and opening supervised injection facilities (SIFs) (British Columbia was the first region in North America to open a SIF, in 2003)
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. The United States' response to the opioid epidemic also has taken on an increasingly public health focus.
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. To its congressional sponsors, the CSA represented a key step in the direction of a national public health approach to drug abuse and addiction.
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And the Synthetic Drug Abuse Prevention Act of 2012 not only mandated restrictive scheduling for various synthetic drugs but also streamlined the scheduling process so that newly approved drugs could enter the market more quickly. Among the many important issues that have surfaced during the opioid crisis are whether the public health goals of the CSA envisioned by its architects have been achieved, and whether regulatory activities carried out by the FDA and the DEA under the FDCA and the CSA have been suitably coordinated and harmonized.
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The National Pain Strategy highlights difficulties surrounding the use of opioids in pain management. Its recommendations include augmenting the use of population-level data to inform national policy on opioid use, including regulatory actions undertaken by the FDA and the DEA.
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framework, and its recommendations are based on a systematic review of the scientific evidence, as well as consideration of benefits and harms, values and preferences, and resource allocation. The guideline was specifically developed for primary care clinicians, including physicians, nurse practitioners, and physician assistants, prescribing opioids to patients with chronic pain (>3 months' duration)
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Practitioners seeking DEA registration for prescribing controlled substances would have been required to receive training on responsible opioid prescribing practices. Opioid REMS would have been required to include effective educational materials, and efforts would have been made to enhance education in health professional schools as well as continuing education through state and federal agencies.
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Are they convertible to a common metric? The task is made somewhat easier if one recognizes that the point of contention regarding the use of opioids in serving the "needs of pain patients" focuses almost entirely on treatment of chronic noncancer pain.
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. When viewed from the perspective of an individual physician and an individual patient seeking treatment for chronic pain, regulations restricting access to opioids may be objectionable because they are perceived as unduly constraining the options available to physicians seeking to alleviate the suffering of each patient under their care.
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STUDY SCOPE AND EMPHASIS AND REPORT ORGANIZATION Study Scope and Emphasis The breadth of the committee's charge posed several challenges. First, the charge envisioned two fairly distinct tasks -- an update of the science of pain research, care, and education since the IOM's 2011 report, including the evolving role of opioids in pain management, and a "new" report summarizing the "state of the science" on the use and misuse of prescription opioids and on approaches for addressing the problem.
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However, the FDA knows it cannot address the opioid problem on its own, and its charge to the committee clearly invited a broader view of the report's intended audience. The committee chose to take this broader view because it was convinced that successful efforts to prevent, ameliorate, and minimize the public health harms associated with use and misuse of prescription opioids will require coordinated action at all levels of government and by a diverse array of stakeholder organizations.
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It is also clear, however, that overprescribing was not the sole cause of the problem. While increased opioid prescribing for chronic pain has been a vector of the opioid epidemic, researchers agree that such structural factors as lack of economic opportunity, poor working conditions, and eroded social capital in depressed communities, accompanied by hopelessness and despair, are root causes of the misuse of opioids and other substances and SUD (Carpenter et al., 2016; Compton et al., 2014; Nagelhout et al., 2017)
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From page 42... ...
2015. The effectiveness and risks of long-term opioid therapy for chronic pain: A systematic review for a National Institutes of Health Pathways to Prevention Workshop.
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2016. The opioid epidemic and the long term opioid therapy for chronic noncancer pain revisited: A transatlantic perspective.
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2011. Epidemic: Responding to America's prescription drug abuse crisis.
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2017. Overview of the prescription opioid epidemic and the FDA activities to address it.
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Presentation to the Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse, Washington, DC. November 4.
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