Five years ago, the US Food and Drug Administration (FDA) ordered manufacturers of extended-release and long-acting (ER/LA) opioids to offer clinicians training on how to prescribe the drugs for pain to prevent patients from getting addicted or overdosing.
Now the FDA is proposing an expansion of that educational mandate for opioid makers — to teach physicians how to manage pain with yoga, cognitive therapy, acupuncture, chiropractic, and other nonpharmacologic methods.
“Nobody has overdosed from too much mindfulness,” said Corey Waller, MD, who chairs the legislative advocacy committee of the American Society of Addiction Medicine (ASAM), in an interview with Medscape Medical News.
The idea of instructing clinicians about safer alternatives to opioid analgesics wins applause from pain-management and addiction experts, but whether it will blunt the opioid abuse epidemic is another matter. Insurers typically don’t cover the likes of yoga or acupuncture for pain, and patients may reject what they consider esoteric therapies in favor of a fast-acting pill. In addition, most clinicians haven’t volunteered to take opioid prescribing courses since the FDA required their creation, which raises the question of whether they should be mandatory.
Right now, the only mandate is for manufacturers of ER/LA opioids to make prescriber training available. That requirement is part of a Risk Evaluation and Mitigation Strategy (REMS) for these drugs that the FDA approved in July 2012 in response to the burgeoning number of opioid overdoses. Drug companies don’t offer the training themselves; they just pay for it. The REMS curriculum is based on a blueprint developed by the FDA and taught by accredited continuing medical education providers (which include Medscape).
Opioid Hammers and Unicorns
The current FDA blueprint confines itself largely to prescribing ER/LA opioids, with only a few passing references to immediate-release opioids and nonopioid analgesics. A proposed revision released on May 10 amounts to a curriculum on pain management, with sections on assessing patients in pain, creating a pain-treatment plan, and using nonopioid analgesics and adjuvant medications such as antiepileptic drugs and antidepressants.
Another section states that nonpharmacologic therapies can play an important role in managing pain, especially when it’s musculoskeletal or chronic. They include psychological approaches such as cognitive behavioral therapy, physical therapy, surgery, and complementary treatments such as acupuncture and chiropractic. Clinicians “should be knowledgeable” about when they might be helpful.
The proposal for a more eclectic blueprint makes sense to Bob Twillman, PhD, executive director of the Academy of Integrative Pain Management, formerly known as the American Academy of Pain Management. “We say pain is a biopsychosocial experience,” Dr Twillman told Medscape Medical News.
The tight focus on opioids in the first version reminded him of the adage, “If your only tool is a hammer, then every problem looks like a nail.”
“They felt the hammer of opioids was the only thing they had,” said Dr Twillman.
Will the average physician buy into yoga or chiropractic as a solution for his or her patient’s pain? “If we’re successful in showing them good enough evidence that it’s just as effective [as medication], they will,” answered Dr Twillman.
The alternative therapies that enjoy the most scientific evidence are yoga and mindfulness, noted ASAM’s Dr Waller. Such approaches “need to move out of alternative medicine and into normal…treatments.”
Dr Waller said that alternative pain therapies will catch on more with physicians than with patients, many of whom are likely to dismiss them as “voodoo” and too slow-working to boot. “American culture doesn’t allow for delayed gratification,” he said.
Both Dr Waller and Dr Twillman lament the widespread lack of third-party reimbursement of nonpharmacologic treatment of pain, which many patients can’t afford on their own dime. “We have to go beyond education and get into advocacy to get these things covered,” said Dr Twillman. Right now, telling people to treat their pain without drugs is like telling them to “pet a unicorn.”
“The Voluntary Approach Is Not Enough”
The FDA is seeking public comment on its revisions to the opioid education blueprint and the wider discussion of pain management. The deadline to submit comments is July 10. Instructions on how to submit them appear on the website of the Federal Register.
If the revised blueprint is eventually adopted, its impact will depend in part on how many physicians volunteer to take an opioid prescribing class. So far, the numbers have been disappointing. In 2012, the FDA set a goal of educating 160,000 opioid prescribers by March 2016 through REMS. The actual headcount in 2016 came to 66,000, according to an FDA spokesperson, who noted that other continuing-education classes compete for clinicians’ attention.
In the past, the FDA has favored legislation that would require clinicians to receive opioid prescribing education as a condition of registration with the Drug Enforcement Administration. Such legislation has never been enacted, and the revised blueprint for opioid education does not broach the subject of mandating clinicians to get the training.
However, the voluntary-versus-mandatory issue received its due at a 2-day public workshop the FDA convened earlier this week in Silver Spring, MD, to explore the future of opioid prescriber training. Participants, who included health system administrators, federal and state health agency officials, consumer advocates, and representatives of various professional societies, were divided roughly half and half on the question, according to Dr Twillman and Dr Waller, who also attended.
However, most of the representatives from professional societies argued for keeping prescriber education voluntary. Dr Twillman and his society fell on that side of the debate. He told Medscape Medical News that the hassles of mandated coursework might motivate some clinicians to stop prescribing opioids, which has already started to happen in the wake of new and stricter guidelines from the Centers for Disease Control and Prevention. “In some cases, patients have been abandoned,” he said.
ASAM, represented by Dr Waller, was one of the few societies that said clinicians should be required to take a REMS class on opioids. “The voluntary approach is not enough,” he told Medscape Medical News. “We’ve seen how that’s gone.”
“A voluntary effort takes a longer time, and 50,000 people dying each year from overdoses is not okay.”
One thing Dr Twillman and Dr Waller agree on is that the FDA’s revised blueprint for opioid education will make the learning experience much longer. The average course now runs about 3 hours, according to Dr Twillman. Dr Waller said the version he teaches lasts about 2 hours. Both physicians estimate that the blueprint will require at least twice as much time.
It would be too much information to absorb in one sitting, said Dr Twillman. “It’s going to have to be presented in chunks.”
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