There is growing consensus that for some patients, higher doses of a gold standard medication used to treat opioid addiction could also be higher than lower doses for maintaining patient health and treatment, particularly for those using fentanyl.
But whether someone has access to higher doses of buprenorphine — which curbs opioid cravings and withdrawal — will depend on where they live.
In most states, Medicaid — the biggest payer for substance use disorder treatment within the U.S. — limits the doses it pays to arbitrary limits, typically not more than 24 milligrams.
In some states, comparable to Tennessee, this value is as little as 16 milligrams. When “underdosing,” patients may experience symptoms which will make them return to the medications they are attempting to stop, risking an overdose and even death.
Providers say higher doses, sometimes as much as 32 milligrams, are vital given a drug supply dominated by highly potent fentanyl.
“It's probably the biggest challenge we face in our community because so many patients require higher doses to achieve the desired outcome that the drug is intended to achieve,” said Ryan Alexander, an addiction medicine physician and medical director of substance programming on the McNabb Center in Knoxville, Tennessee.
TennCare, Tennessee's Medicaid program, only pays for doses larger than 16 milligrams under certain circumstances.
“If you have a limit of 16 milligrams and the cravings are not controlled, you have poor control of the disease,” Alexander said. “This poses a risk of relapse and overdose.”
Restrictions on buprenorphine prescribing have received more attention as providers anticipate the increasing use of fentanyl and other synthetic opioids, which accounted for 70% of drug overdose deaths in 2022.
Several recent studies have shown that dosage limits may stand in the best way of higher care.
A study The study, published last month in JAMA Network Open, found that adults with opioid use disorder who received doses of buprenorphine greater than 24 milligrams had a lower risk of emergency room visits or behavioral health-related inpatient visits. It is consistent with other recent studies that reach similar conclusions.
Still, there appears to be a misconception that “less is more,” said Melissa Weimer, medical director of the Yale Addiction Medicine Consult Service, which treats hospitalized patients with substance use disorders.
“Less is not more. For these individuals, you need an adequate dose, and if they don't have an adequate dose, they are actually not protected from an opioid overdose and are more likely to undergo what you might call unsuccessful treatment with buprenorphine . “said Weimer. “I think that’s the change that’s happened with fentanyl, is that there can’t be a one-size-fits-all treatment.”
Medicaid programs often cite Food and Drug Administration labeling that states the dose needs to be as much as 24 milligrams and “doses greater than 24 mg have not been shown to provide clinical benefit.”
But doctors say the labeling doesn't keep pace with scientific understanding of the rapidly evolving opioid epidemic.
“If the drugs people are using are no longer prescription opioids or heroin, but illicit fentanyl with much higher potency, it seems reasonable that you need something stronger to deal with it,” Bobby Mukkamala said , President-elect of the American Medical Association Chair of the AMA's Substance Use and Pain Care Task Force.
Earlier this 12 months, the AMA House of Delegates, the legislative and policy-making body of the American Medical Association, passed a resolution supporting the power of physicians to prescribe buprenorphine doses above the FDA-approved label if approved by their prescriber Doctor advisable.
It was also urgent Federal agencies, manufacturers, medical organizations, and health plans must review dosage evidence and revise labels and guidelines accordingly.
Some states, comparable to Washington and the District of Columbia, recently increased their limits to 32 milligrams.
The FDA didn’t reply to a request for comment on next steps.
“These higher doses can improve outcomes for patients. It literally keeps people alive if you have the right dose. The obstacle to this is unscientific, bureaucratic regulations from insurance companies,” said Mukkamala.
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