FDA seeks to tailor length of opioid prescriptions to patient conditions


The Food and Drug Administration is developing new opioid prescribing guidelines that would tailor the duration of the prescriptions to specific patient conditions.

Speaking at a provider roundtable with Rep. Greg Walden, R-Hood River, on Tuesday in Bend, FDA Commissioner Dr. Scott Gottlieb said the agency was working with provider groups and the National Academy of Medicine to determine what amount of prescription pain medication would be appropriate after various surgeries and procedures, instead of relying on the current one-size-fits-all approach.

Prescribing guidelines from the Centers for Disease Control and Prevention, for example, say that three days or less of opioids are often sufficient and that more than seven days will rarely be needed, but do not differentiate based on condition.

“From my perspective, one of the concerns about the five-day, seven-day sort of limit is the 14 days becomes seven days, but the two days becomes seven days,” Gottlieb said. “So you’re going to be bringing some prescriptions down to a more appropriate duration, but you’re also going to be bringing prescriptions that are shorter to a longer duration.”

The commissioner said the guidelines will focus initially on acute care conditions where overprescribing has been rampant. Agency data suggests that patients often need opioids for only one or two days after laparoscopic gallbladder or hernia surgeries, but may need pain killers for a week or more after a heart bypass or orthopedic procedures.

Gottlieb is also leading a joint effort with cancer groups to develop better guidelines for opioid use to treat cancer pain, but the agency will not be looking at new guidelines for chronic pain conditions at this time.

Gottlieb spoke just two days before an Oregon committee plans to begin reviewing a proposal that would limit Medicaid coverage for five broad chronic pain conditions to 90 days of opioid pain relievers and would force patients who have been taking opioids for longer to be tapered off those medications within a year. Oregon implemented a similar strategy for low back pain two years ago.

While Gottlieb said the agency wasn’t focused on what states were doing with respect to opioid limits, he spoke about the need to balance efforts to address overprescribing and give doctors the flexibility to prescribe opioids for those who need them.

“There are certain patients for whom chronic use is appropriate,” Gottlieb said. “We need to recognize that and allow for that.”

Rick Treleaven, director of Redmond-based BestCare Treatment Services, expressed concerns that after years of promoting opioid use, the pendulum was swinging too far the other way at both the federal and the state level.

“We’re getting so tight again with the pain medication, that it’s inhumane,” he said at the roundtable. “We’ve got to find that middle ground.”

The wide-ranging discussion with local Central Oregon health officials, held at the Oregon State University, Cascades campus, touched on a number of opioid-related topics.

• Walden touted the 57 separate opioid measures passed by the House Energy and Commerce committee he chairs and rolled into H.R. 6, passed by the House in June. Senate leaders are now working on their own version of the opioid bill, which will then have to be reconciled with the House version.

“Hopefully, in September, we hope to get it on the president’s desk,” Walden said. “I don’t anticipate major changes.”

• Included in the House bill was a measure to allow providers treating patients with addiction to coordinate care with those patients’ other medical providers. Doctors have complained that a privacy measure last updated in 1987 was preventing better integration of their care.

• Gottlieb reiterated the agency’s commitment to developing new abuse-deterrent formulations of pain medications. Some attempts by drug makers to produce abuse-deterrent drugs have run into hurdles, causing the manufacturers to withdraw from the approval process. But Gottlieb said there were new technologies and novel approaches that had merit.

“I think they can be potentially very effective,” he said.

• The FDA issued new rules on Monday that would allow drug makers to get approval for addiction treatments without having to prove they could get patients with addictions completely off of opioids.

“That was a high threshold to hit,” Gottlieb said. “If you could have a treatment, for example, that cuts down the risk of overdose or cuts down on craving, that might be an important adjunct to an overall approach to care.”

• Gottlieb said that while the U.S. has made progress in reducing overprescribing of opioids, the progress has been more than offset by the increase in illicit opioids, such as fentanyl, flowing into the country.

“The amount of illicit drugs is dramatically more than the reduction that we’ve seen,” he said. “It’s being backfilled with fentanyl.”

• The agency has received new authority and funding to ramp up efforts to intercept illicit substances and unapproved drugs coming into the U.S. by mail. Gottlieb said more than 800 million packages were mailed to the U.S. last year, and this year, the number could exceed 1 trillion. That provides a gap through which illicit substances such as fentanyl can be shipped into the U.S. “What we’re trying to do,” he said, “is plug those gaps.”

• Crook County Health Director Muriel Delavergne-Brown raised concerns about the rising cost of and difficulty of obtaining Narcan, the drug used to reverse opioid overdoses. The county health department supplies the Prineville Police Department and the Crook County sheriff’s deputies with the medication but is facing challenges in acquiring sufficient supply.

• Several providers at the roundtable raised concerns over the continued prescribing of opiods and benzodiazepines, a combination that has been shown to dramatically increase the risk of overdose.

“It’s kind of the shadow epidemic to the opioid epidemic,” said Kim Swanson, chair of the Central Oregon Pain Standards task force. “And it’s not been hit as hard with education or guidelines.”

—Reporter: 541-633-2162, mhawryluk@bendbulletin.com

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