A National Academy of Sciences, Engineering, and Medicine (NASEM) panel is calling on regulators to overhaul opioid policies and give more weight to societal risks and benefits when approving or recalling opioid drugs, noting that some of these policies meant to curb the opioid epidemic may actually be driving illicit drug use.
The NASEM panel is also recommending mandatory education on opioid use disorders and pain treatment for prescribers, pharmacists, and others in healthcare, along with removing barriers to evidence-based treatment for opioid use disorders (OUDs).
The committee urged the US Food and Drug Administration (FDA) to review every opioid on the market using a proposed new risk-benefit framework and to promptly remove those that do not meet appropriateness criteria.
The recommendations in the NASEM report, "Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use," echo those announced by the FDA in February 2016 as part of an overhaul of how it regulates opioids.
In a statement, FDA Commissioner Scott Gottlieb, MD, said he "was encouraged to see that many of NASEM's recommendations for the FDA are in areas where we've already made new commitments."
The 18-member NASEM committee outlined the facts and trends of what it sees as a deepening opioid crisis — but also said data are severely lacking on the characterization of the epidemic and on the intertwining of pain and OUD.
A Leading Cause of Death
Overdoses are the leading cause of unintentional death in the United States, noted committee chair, Richard J. Bonnie, Harrison Foundation Professor of Medicine and Law and director of the Institute of Law, Psychiatry, and Public Policy at the University of Virginia, Charlottesville, in a briefing.
"The numbers are extraordinary, and unfortunately, it's still getting worse," said Dr Bonnie. He said the response to the epidemic will require a coordinated and sustained effort — with an emphasis on continued attention.
"We have a habit in our country of taking notice and then moving on rapidly to something else," he said. But, he said, "It took two decades for this epidemic to reach its current proportions, and it will take some significant period of time for it to unwind."
Efforts to get physicians to write fewer opioid prescriptions have worked, but more needs to be done to educate and train clinicians, pharmacists, and other health professionals about the biology of pain, pain management, and OUD treatment, the panel notes.
That education has largely been provided — after medical school and residency — through continuing medical education sponsored by the opioid manufacturers.
The FDA now requires opioid makers to offer CME to clinicians, pharmacists, and others involved with the therapies. Participation by health professionals is voluntary, but the agency is weighing making participation mandatory.
The NASEM panel said health professional education about pain basics and opioids should be voluntary — and that it should not be offered by drug makers. "It would be optimal if any additional educational programs that we envision would be independent from manufacturers," said NASEM committee member Aaron Kesselheim, MD, associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics and Law at Brigham & Women's Hospital, Boston, Massachusetts.
Treatment education, however, should be required, and provided by health professional schools, professional societies, and state licensing boards. That training should include but not be limited to physicians, nurses, pharmacists, dentists, physician assistants, psychologists, and social workers.
Physicians and pharmacists also should be educated and trained to recognize and counsel patients at risk for OUD and/or overdose. The NASEM panel said those providers also should be encouraged to offer the overdose reversal agent naloxone when an opioid is prescribed to those at risk or when a patient seeks treatment for overdose or other opioid-related issues.
The panel was also "struck by the relative lack of attention to educating the general public about the risks and benefits of prescription opioids" and urged widespread, targeted education to raise awareness.
Policies Boost Illicit Opioid Use
Recent data from the Centers for Disease Control and Prevention indicate that opioid prescribing has declined in some areas of the country but remains high elsewhere. And many people who otherwise would have been using prescription opioids have moved on to heroin, in part because of heroin's lower cost, but also because of regulatory efforts — such as increasing the availability of abuse-deterrent opioids — said the NASEM panel.
"Given the lack of evidence supporting the use of opioids for chronic noncancer pain, and the intertwined nature of prescription and illicit opioid use, reliance on abuse-deterrent formulations may undermine a successful public health response to the opioid epidemic," said committee member Traci Green, PhD, associate professor of emergency medicine at Boston University. Until studies clarify whether the ostensible public good of abuse-deterrent formulations outweighs the harm — driving people to illicit highs — "the committee advises caution," said Dr Green.
The FDA, however, is doubling down on abuse-deterrent opioids. Dr Gottlieb said the agency "strongly supports a transition from the current market dominated by conventional opioids to one in which the majority of opioids having meaningful abuse-deterrent properties."
The panel noted that any policy designed to curb legal access to opioids would inevitably drive some to the illegal market. The response should be increased treatment, said the report. Some two million Americans have an OUD, but medication-assisted treatment — the gold standard — is frequently not offered, understood, or reimbursed, said the committee.
It recommended that states — with assistance from the federal government — provide universal access to evidence-based treatment for OUD in a variety of settings, especially in areas with high rates of OUD. The US Department of Health and Human Services and state health financing agencies should also remove barriers to coverage of FDA-approved medications for OUD, the panel said.
The committee urged improved access to low-cost naloxone and immunity for prescribers, dispensers, and laypeople for possessing or administering the therapy. Making syringes freely available for sale or distribution is also recommended to help reduce harms from injection drug use, said the panel.
New Regulatory Framework
The panel had multiple recommendations for how the FDA could improve its review before approval and monitoring of opioids after approval.
Preapproval trials could enroll people who live in areas with high rates of misuse and overdose, as well as others who are at highest risk for OUD, said Dr Kesselheim. Approval criteria should weigh the individual characteristics of that particular opioid, the risks and benefits to patients and to public health, the diversion potential, predicted effects on use of other opioids or illicit drugs, and potential for off-label use, he said.
At 1, 4, and 7 years after approval, the FDA should formally re-evaluate an opioid to ensure postmarketing data are collected and submitted to the agency. The FDA should also actively monitor opioids after approval, rather than wait for passive reports, said Dr Kesselheim.
Dr Gottlieb said the agency had already taken steps to re-review opioids, which led to the removal in June of the abuse-deterrent extended-release formulation of oxymorphone (Opana ER, Endo Pharmaceuticals).
The recall was "based on concern that the product's risks associated with its deliberate misuse outweigh its intended benefits when it was used as directed and lead to dangerous unintended consequences," said Dr Gottlieb.
The report was sponsored by the US Food and Drug Administration.
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Cite this: US Opioid Policies Need Major Overhaul, Experts Say - Medscape - Jul 14, 2017.
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