FDA Advisors on Opioid Dosing Limits: We Dunno
Too little data to go on, members say
https://www.medpagetoday.com/publichealthpolicy/opioids/80451
If FDA panelists reached one consensus at the end of a two-day meeting this week, it was that there’s not enough information to know just what regulatory action — if any — the agency should take about higher-dose opioids for outpatients with constant or chronic pain.
“We need much better-quality data to help inform us,” summed up panelist Sean Mackey, MD, PhD, of the Stanford School of Medicine.
Questions about the needs of chronic pain patients and the role opioids play in their lives remain unanswered, members of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesia Drug Products Advisory Committee said. “To get at those uncertainties we need better, high-quality data in real-world patients,” Mackey stated. “This is an incredibly vulnerable patient population.”
The FDA held the public meeting Tuesday and Wednesday to discuss the risks and benefits of strong opioid doses — defined loosely as 90 morphine milligram equivalents per day or more — and whether the agency should consider action to reduce access to high-strength products. Just what that action might be was unclear: “We’re talking about the impact of any possible action you think we should or shouldn’t do,” an FDA official told the committee. “Nothing’s on or off the table.”
The meeting was announced in April, just weeks after the advocacy group Public Citizen called for a moratorium on new opioid drug approvals until a new regulatory framework, such as the one proposed in a 2017 National Academies of Science, Engineering, and Medicine report, is developed.
It also came on the heels of a Risk Evaluation and Mitigation Strategy (REMS) launched in September for immediate-release opioids, expanding the FDA’s REMS for extended-release and long-acting opioids for outpatients established in 2012.
Some groups have asked the FDA to withdraw the approval of higher dosage strength oral and transmucosal opioid analgesics due to safety concerns, said Judy Staffa, PhD, RPh, associate director for the Public Health Initiatives Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research (CDER), in introductory remarks.
“Higher dosage strength products may be more harmful in cases of accidental exposure and overdose, and may also be more sought out for misuse and abuse,” she noted. In recent years, federal, local, state, and payer efforts have evolved to encourage more judicious prescribing of opioid analgesics, she said: “It is in this complex and changing environment that we need to consider potential regulatory actions that would impact the availability of higher dosage strength products to vary degrees, depending on the action taken.”
But without more data, the value or harm of new FDA action is unclear, panelists said. “We don’t know what would happen with misuse and abuse and what would happen with public health,” acknowledged Moon Hee V. Choi, PharmD, of CDER’s Division of Advisory Committee and Consultancy Management. And many committee members voiced concerns that any action to limit high opioid doses could destabilize pain patients and lead to lower quality of life and suicidality.
“I see a lot of risks associated with that, for patients particularly,” said panelist Joseph O’Brien, president of the National Scoliosis Foundation in Stoughton, Massachusetts. “Probably the best example of that is the misuse and misunderstanding of the CDC guidelines.”
“We have now shifted the opioid epidemic to a patient-care crisis,” O’Brien stated. “There is now more feedback from patients and concern and alarm that they’re not getting what they need.”
Others at the meeting, including guest speaker Adriane Fugh-Berman, MD, of the Georgetown University PharmedOUT project, called for high-dose opioids to be removed from the market completely.
“I can’t think of another self-administered class of medications where doubling a dose has potentially lethal consequences,” Fugh-Berman told the advisory committee. “A handful of pills is a visual reminder that you’re taking a lot of medicine, and that’s a good thing.”
But taking a handful of opioids opens up greater risks for patients who aren’t sure how many they have taken in a day and poses hardships for those who have difficulties swallowing, some panelists argued. It also makes it difficult to spot whether others are diverting pills for their own use.
Clearer education about high-strength opioids and proper disposal is needed, most panelists urged. Using specialists to follow patients with high-dose prescriptions more closely also could minimize patient risks — and that doesn’t necessarily mean physicians, pointed out panelist William Becker, MD, of Yale School of Medicine. “Consider a model like a Coumadin clinic, where pharmacists do the requisite monitoring and make decisions on dose titrations,” he said. “This is the kind of distributed model that might work to help preserve access, yet ratchet up the amount of appropriate monitoring and specialization that will increase safety.”
To encourage further discussion, the FDA has established a docket for public comment about this issue, which remains open until June 30. To date, more than 1,000 comments have been registered.
The agency will not issue a final determination until input from the advisory committee process has been considered and all reviews have been finalized. That determination may be affected by issues not discussed at the advisory committee meeting.
If the FDA can’t/won’t make opiate dosing recommendations because there’s not enough information to know just what regulatory action — if any — the agency should take about higher-dose opioids for outpatients with constant or chronic pain.
One has to ask… what sort of data does the DEA and CDC have to come to rather specific limits on opiate dosing and/or what combination of meds have NO VALID MEDICAL USE ?
Could it be that the DEA is just coming up with OPINIONS to try to justify their activities ?
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