Author: Nikki Kean
Nearly three years later, the agency finally seems to be listening, with two publications in April that take a hard look at the guideline and how it is being applied in clinical practice.
Clarification has been needed for a long time, said Tanya Uritsky, PharmD, a clinical pharmacy specialist in pain medication stewardship at the Hospital of the University of Pennsylvania, in Philadelphia. “The psychological risks of abrupt tapering and discontinuation of opioids cannot be overlooked—we have heard troubling stories of addiction and suicide that result from the physical and emotional distress [of abrupt tapering]. These cases are very real.”
In an April 1, 2019, report published in Pain Medicine, a multidisciplinary expert panel convened by the CDC identified the following challenges that have arisen in the wake of the guideline: improper application of dosage ceilings and prescription duration guidance, failure to appreciate the importance of patient involvement in decisions to taper or discontinue opioids, barriers to diagnosis and treatment of opioid use disorder, and impeded access to recommended comprehensive, multimodal pain care (Pain Med 2019;20:724-735). The report also addressed problems that arose after regulators and policymakers may have applied the CDC guideline recommendations “without flexibility and, sometimes, without full awareness of what the guideline contains.”
The authors stressed that efforts to implement prescribing recommendations to reduce opioid-related harms are laudable. However, “inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages [have resulted] in sudden opioid discontinuation or dismissal of patients” from physician practices, wrote the authors, Deborah Dowell, MD, MPH, and Tamara Haegerich, PhD, of the CDC, and Roger Chou, MD, of Oregon Health & Science University, in Portland.
Many of these misapplications have been reported for populations outside the scope of the guidelines, they wrote, including patients with cancer, surgical patients and patients with acute sickle cell disease.
The CDC guideline was developed on the basis of the best available evidence at the time, with input from a multidisciplinary group of experts, the authors noted. However, “in situations [where] evidence is limited, it is particularly important not to extend implementation beyond the guideline’s statements and intent.” This includes cases in which patients have been on higher dose opioids for many years.
MME Limits Misunderstood
For example, the guideline states that “clinicians should … avoid increasing dosage” to 90 or more morphine milligram equivalents per day or to “carefully justify” such a decision. That did not mean that prescribers should cut dosages, or discontinue opioids, that were already above that threshold, the authors said, “yet it has been used to justify stopping opioid prescriptions or coverage.”
The authors also stressed that the CDC guideline “does not apply to dosing for medication-assisted treatment for opioid use disorder,” adding, “we know little about the benefits and harms of reducing high dosages of opioids in patients who are physically dependent on them.”
The authors added that the issue of tapering may have become muddied due to misinterpretation of the guideline. “Patients who are able to safely taper their opioid use are likely to have a lower risk of overdose, and evidence is accumulating that they might experience reduced pain,” they stated.
However, other patients may find tapering a challenge and “could face risks related to withdrawal symptoms, increased pain, or unrecognized opioid use disorder.”
In such cases, abrupt tapering may lead patients to seek other sources of opioids or have adverse psychological and physical outcomes, they noted.
The bottom line is that clinicians should be allowed to individualize treatment based on the patient’s history, and policies should allow such flexibility, according to the authors. “Effective implementation of the guidelines requires recognition that there are no shortcuts to safer opioid prescribing, or to appropriate and safe reduction or discontinuation of opioid use,” they said.
The safest course is to start “fewer patients on opioid treatment,” and not escalate patients “to high dosages in the first place,” the authors noted. To achieve that goal, the authors encouraged clinicians to maximize nonopioid treatment, and review the risks and benefits of opioid therapy with patients. For those already on opioids, “closely monitor patients on higher dose opioids for overdose risk, and offer and arrange medication-assisted treatment when opioid use disorder is identified,” they concluded.
Allowing for Interpretation
The difference between “policy” and “guideline” is frequently misunderstood—as is the case here, Dr. Uritsky noted. “Guidelines allow for clinical interpretation, [while] policy has legal ramifications,” she said. “If the CDC guidelines were not from a government agency, but rather from a medical society, the fear of litigation that is driving a lot of the abrupt discontinuation and tapering would not have come so strongly into play.”
Most medical guidelines have the backing of major medical societies versus a selected group of “experts,” Dr. Uritsky explained. “This allows for medical community support, acceptance and safe implementation.”
What is missing from all of this guidance is the “how-to,” she added. “There is a lot of suggesting what is ‘best,’ based on limited evidence, but how does one taper safely and effectively or talk to patients about discontinuation or alternatives? What are other safe and effective pain treatment options?”
At the core of the opioid crisis are mental health problems, noted Dr. Uritsky, as well as a core lack of human connection and communication. “What I see in response is a lot of blanket rules and statements that are missing that individual touch. We are in need of sub-guidelines and best practices that outline the details of the approach and provide more real guidance to apply to clinical practice,” she stressed.
Don’t Punish Clinicians
The goal, Dr. Uritsky noted, should be to “establish best practices that encourage clinical judgment and teach proper documentation,” but to do so in a way “that does not punish clinicians when they go outside of the guidelines while using good clinical judgment.”
Physicians also have expressed their concern. “[Patients have] suffered … because of the crackdown on opioids,” said Barbara McAneny, MD, during the 2018 American Medical Association (AMA) Interim Meeting. “The pendulum swung too far when pain was designated a vital sign, and now we are in danger of it swinging back so far that patients are being harmed,” said Dr. McAneny, the 2018-2019 president of the AMA. “We need to use our expertise in patient care to change the dialogue to appropriate pain control.”