By Ed Coghlan.

The Oregon Health Authority proposal to force taper opioid medications to zero in Medicaid patients has helped accelerate the “opioid debate” among pain professionals.

“The debate has turned into an argument of opioid yes or opioid no,” said Beth Darnall, Ph.D. Clinical Professor in the Stanford University’s Department of Anesthesiology, Perioperative and Pain Medicine, and by courtesy, Psychiatry and Behavioral Sciences. “It’s not a black and white issue, in fact the solution is in the grey.”

Dr. Darnall testified at the Oregon Health Evidence Review Commission recently and strongly cautioned against the forced taper to zero opioid dose proposal.

“A forced taper may destabilize an individual both medically and psychologically,” she told them. “Our primary concern is the well-being of patients. In our study of voluntary patient-centered opioid tapering, we apply patient-centered considerations and very close monitoring so we can collect the data on how to implement safe and compassionate opioid reduction in patients who desire this pathway, and ensure good management of their pain. Right now, data are lacking.”

Dr. Darnall has authored three books that address opioid reduction and is principal investigator for the EMPOWER study, a multi-site, 4-state pragmatic clinical trial that is investigating how to best help physicians and patients successfully reduce long term opioid use in chronic pain using patient-centered methods. The EMPOWER study was designed for patients who seek to reduce their opioid dose. The project is funded by the Patient Centered Outcomes Research Institute (PCORI) and involves over 1,400 patients taking long term opioids; the goal is to help patients reduce opioid dose without increasing pain.

“There’s a segment of patients who want to reduce opioids and never had a pathway to do it in a supportive, outpatient setting,” she said. “The goal is not zero opioids unless the patient chooses that goal,” she emphasized. Rather, the EMPOWER study seeks to help patients achieve their lowest comfortable dose over the study period. The team’s pilot data suggest this will be at least a 50 percent reduction in opioid dose—on average—without increased pain. However, the team recognizes that not everyone will achieve this threshold. The team will also conduct an observational study of patients who choose to remain on their stable opioid dose (they are not part of the patient-centered opioid tapering study) and will characterize patients who do well on long-term opioid therapy.

The tapering study, she emphasized, is designed ensure that patients who wish to reduce their opioid doses are protected and can taper safely and effectively. The priority is patient safety not opioid reduction.

“Patients work with their healthcare clinician to slowly reduce their opioid dose over the one year time frame. If they wish to go slower or pause the taper, they have that control over the process. We track their symptoms weekly and address their needs. We believe that patients are best helped when we work with them and attend to their individual needs rather than pushing against them.” The EMPOWER study includes patients with chronic pain in the design and conduct of the study.

Regarding forced tapering in community-based outpatients, she said, “evidence is lacking to show that it reduces patient risks without increasing their pain or psychological distress. There is information that indicates forced opioid reduction can be harmful to some patients.”

I shared with her a recent conversation with one of our readers (and a long-time friend) who is working to reduce his opioid intake after ten years of using them—and that he’s very worried about what’s going to happen to his ability to deal with his pain.

“There are multiple issues at play,” Dr. Darnall said. “Even once a person such as your friend decides they want to reduce their opioid dose, how their opioid taper is implemented matters greatly. Clinician training is needed, systems for close monitoring and follow-up care should be in place, and fundamentally we need to recognize that opioid tapering is not right for every patient taking opioids. While guidelines may have their place, when misapplied as a mandate, or when rigid mandates exist, vulnerable patients may suffer.” Finally, ensuring access to supportive therapies may help patients achieve their desired goals, and this is a focus of the EMPOWER study. Two-thirds of EMPOWER patients will receive one of two chronic self-management classes. The team will determine if the classes help patients have better outcomes, and which treatment is best for whom.

Dr. Darnall said that patient-centeredness is perhaps the most important factor to consider in the opioid debate. “People are living with complex medical conditions and have varied treatment needs. We cannot apply rigid mandates that do not account for individual differences and expect good outcomes. Even if a segment of the population would benefit from rigid mandates, we must carefully consider the needs of patients who may be harmed by them. “These are likely to be the patients with the least voice or means.” she said.

Here is a link to Dr. Darnall’s testimony in Oregon.

Empower.stanford.edu

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