WASHINGTON ― US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, said the agency wants to find ways to limit both the number of opioid prescriptions and the duration of those prescriptions and is asking healthcare providers to step up and support this effort.
“Some limits on duration of use are an inevitability,” said Dr Gottlieb, who spoke at a special session of the annual meeting of the National Academy of Medicine (NAM) here. He fleshed out more details on the agency’s stated intentions to address the opioid epidemic.
The pharmaceutical industry is supporting limits to duration of use, the supply chain has imposed restrictions, and about 20 states have put limits on first-time opioid prescriptions, noted Dr Gottlieb.
“In an optimal world, we would see the provider community decide to work with these bodies,” he said. But, he said, “We do see pushback from the provider community to a point about what this represents for intrusion and regulation of the practice of medicine.”
Controlled substances are different ― and demand some intrusion, said Dr Gottlieb. “This is the one place where there has been a very long-standing, explicit expression from Congress that Congress intended that there be more regulation of the practice of medicine,” he said.
Limited-Dose Packaging
The FDA’s authority to more strictly regulate opioid prescribing is currently somewhat limited, but the agency is going to do what it can to reduce the total exposure to opioids, said Dr Gottlieb.
At the NAM meeting, he hit on a previously expressed sentiment that the nation “is simply awash in immediate-release [IR] opioid products,” noting that IR formulations account for 90% of the 190 million opioid prescriptions written each year in the United States.
Reducing the number of prescriptions and the duration of those prescriptions means ensuring that the medications are for appropriate medical indications and that the duration of use “comports with the clinical circumstance,” he said.
“We know that’s not always happening,” said Dr Gottlieb.
He said he would like to see IR formulations packaged in 3-, 6-, or 8-day packs, or that they be packaged in some other configuration of limited duration.
Such short-duration packs could be used for acute situations, such as for the treatment of postsurgical pain. For a longer duration of use ― such as for pain from metastatic cancer ― a prescriber “might have to go through mandatory education,” he said.
Dr Gottlieb called on clinicians to help the FDA “build expert guidelines” that would spell out the appropriate duration of use for different clinical circumstances. Those guidelines could then be incorporated into drug labeling.
Massachusetts Governor Charlie Baker (R), a former CEO of Harvard Pilgrim Healthcare who is also on the President’s Commission on Combatting Drug Addiction and the Opioid Crisis, said at the NAM meeting that clinicians in his state were responding well to limits on initial prescriptions and to a beefed-up prescription drug monitoring program (PDMP).
About 97% of prescribers use the PDMP, up from about half before a new state law went into effect. In addition, he said, in 2017, “for the first time in 15 years, the number of prescriptions and the number of deaths went down.” Opioid-related deaths and prescriptions declined by 5% this year compared to 2016.
But, he noted, fentanyl is rapidly overtaking other opioids as a cause of overdose death, rising from 18% of such deaths in 2014 to 81% this year. “That is one brutal new wrinkle to this whole conversation,” said Baker.
Dr Gottlieb said that if the FDA and other regulators had accurately seen what was coming a decade ago, they likely would have moved more incrementally to stem the rising tide. But given the size of the opioid problem now, “the type of action we need to take to get ahead of this crisis is going to be far more dramatic,” he said.
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