The all-out effort to reduce opioid use nationwide is a balancing act that requires collaboration across federal agencies, educational and professional organizations, insurance companies, and health care practitioners, according to Nora Volkow, M.D., director of the National Institute on Drug Abuse (NIDA).
Commenting on a report on pain management and the opioid epidemic released July 13 by the National Academies of Sciences, Engineering, and Medicine, Volkow told Psychiatric News, “On the one hand, there is the need to change the culture of opioid prescribing—already the focus of various initiatives by government and professional medical associations. On the other hand, we must ensure that patients who need these medications for severe pain conditions can still get them.”
The 380-page report—which describes the state of the science on pain research, care, and education and offers recommendations for future steps to stem the opioid epidemic—was written by a committee of 18 experts convened by the National Academies at the request of the Food and Drug Administration (FDA).
To improve awareness of the risks and benefits of opioids, the National Academies committee recommended enhanced education for both health professionals and the public. The report outlines several strategies, including requiring that all health care professionals receive basic training in the treatment of opioid use disorders and training for prescribers and pharmacists so that they know how to recognize and counsel patients at risk for opioid use disorder or overdose.
Drug overdose, driven primarily by opioids, is now the leading cause of unintentional injury deaths in the United States, and trends indicate that premature deaths associated with the use of opioids are likely to climb, according to the report.
As of 2015, at least 2 million people in the United States were estimated to have an opioid use disorder involving prescription opioids and almost 600,000 have an opioid use disorder involving heroin. While the annual number of deaths from prescription opioids remained relatively stable between 2011 and 2015, overdose deaths from illicit opioids—including heroin and synthetic opioids such as fentanyl—nearly tripled during this period. Part of this was due to a growing number of people whose use began with prescription opioids.
“The report focuses on many factors that contribute to this epidemic such as inadequate coverage by insurance companies of comprehensive multimodal pain management, inadequate access to treatments of substance use disorder, and lack of access to naloxone and safe injection equipment,” psychiatrist Patrice A. Harris, M.D., immediate past chair of the American Medical Association’s Board of Trustees and chair of AMA’s Task Force to Reduce Opioid Use, told Psychiatric News.
To begin to stem the epidemic, the report cautions that efforts to reduce access to opioids should be coupled with investments in treatment. The committee recommended that states—with assistance from relevant federal agencies, particularly the Substance Abuse and Mental Health Services Administration (SAMHSA)—provide universal access to evidence-based treatment for opioid use disorder in a variety of settings, including hospitals, criminal justice settings, and substance use–treatment programs.
The committee also recommended that states implement laws and policies that improve access to the medication naloxone, which blocks or reverses the effects of opioids, as well as safe injection equipment to reduce transmission of infectious diseases. For example, offering prescribers immunity from civil liability or criminal prosecution for prescribing, dispensing, or distributing naloxone, and laypersons immunity for possessing or administering it could help reduce the harms of opioid use and death, the group noted.
The report suggests that the FDA also take actions to change how it approaches prescription opioid products and approval decisions.
“The FDA traditionally has taken a product-specific approach to drug approval decisions... While this approach works well in most cases, the committee believes it is necessary to view regulatory oversight of opioid medications differently from that of other drugs because these medications can have a number of consequences not only at the individual level but also at the household and societal levels," the report stated.
“The broad reach of the epidemic has blurred the formerly distinct social boundary between prescribed opioids and illegally manufactured ones, such as heroin,” said committee chair Richard J. Bonnie, professor of medicine and law, and director of the Institute of Law, Psychiatry, and Public Policy at the University of Virginia, Charlottesville, in a press release. “We want to convey a clear message about the magnitude of the challenge. This epidemic took nearly two decades to develop, and it will take years to unravel.”
The committee recommended several additional strategies:
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The FDA should complete a review of the safety and effectiveness of all approved opioids.
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Public and private payers should develop reimbursement models that support evidence-based and cost-effective comprehensive pain management, including both drug and non-drug treatments for pain.
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The Department of Health and Human Services, in concert with state organizations, should conduct or sponsor research on how data from prescription drug monitoring programs can be better leveraged to track opioid prescribing and dispensing information.
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The National Institutes of Health, SAMHSA, the U.S. Department of Veterans Affairs, and industry should invest in research that examines the nature of pain and opioid use disorder, as well as develop new non-addictive treatments for pain. ■
The report “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use” can be accessed
here.