The Centers for Disease Control and Prevention (CDC) yesterday published the final version of its newly revised advice about prescribing opioids for pain, which aims to ameliorate the damage done by the guidelines it issued in 2016. The new guidelines, which are similar to the draft that the CDC published in February, emphasize individualized treatment and include warnings against "rigid standards," "rapid tapers," "abrupt opioid discontinuation," and "patient abandonment," which give you a sense of the disastrous impact that the 2016 version had on patient care.
The CDC blames that fiasco on "misapplication" of its advice by clinicians, pharmacists, insurers, regulators, and legislators. Because all those people misunderstood what the CDC was recommending, it says, patients across the country experienced "untreated and undertreated pain, serious withdrawal symptoms, worsening pain outcomes, psychological distress, overdose, and suicidal ideation and behavior."
When patients respond to CDC-inspired medical practices by killing themselves, it might be time to concede that the agency issued its advice without sufficiently considering the potential for unintended but foreseeable consequences. The CDC never quite admits that, and its new guidance has similarly malignant potential.
One of the chief complaints about the 2016 guidelines, which were aimed at clinicians who prescribe opioids for chronic pain, was their implication that daily doses above specified levels were inherently suspect. "When opioids are started, clinicians should prescribe the lowest effective dosage," the CDC said in the fifth of its 12 main recommendations. "Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day."
That recommendation was widely interpreted to mean that crossing those thresholds was reckless, if not prima facie evidence of malpractice. Clinicians, pharmacists, insurers, regulators, and legislators responded accordingly, imposing MME-based limits on prescriptions. Worse, many doctors were so anxious to avoid accusations of overprescribing that they imposed abrupt, precipitous reductions on patients who already exceeded the CDC's arbitrary cutoffs, even when they had been functioning well at those doses for years. Some physicians dropped pain patients or refused to prescribe opioids at all, even when it was medically appropriate. They surmised that it was best, for the sake of their licenses and livelihoods, to avoid that class of medication altogether.
These problems were severe and widespread enough to prompt warnings from the American Medical Association and the Food and Drug Administration. How did the CDC respond? The new guidelines, which are aimed at clinicians who prescribe opioids for acute pain (lasting less than a month) and subacute pain (lasting one to three months) as well as chronic pain (lasting more than three months), do not emphasize the 90 MME/day cutoff. But they still tell doctors to beware of doses exceeding 50 MME per day.
"Before increasing total opioid dosage to ≥50 MME/day, clinicians should pause, considering that dosage increases to >50 MME/day are unlikely to provide substantially improved pain control for most patients while overdose risk increases with dosage, and carefully reassess evidence of benefits and risks," the CDC says. "Additional dosage increases beyond 50 MME/day are progressively more likely to yield diminishing returns in benefits for pain and function relative to risks to patients. Clinicians should carefully evaluate a decision to increase dosage after an individualized assessment of benefits and risks and weighing factors such as diagnosis, incremental benefits for pain and function relative to risks with previous dosage increases, other treatments and effectiveness, and patient values and preferences."
The CDC's continued emphasis on a specific dose threshold belies its avowed commitment to "individualized assessment." It ignores wide variation in how patients metabolize and respond to pain medication as well as the fundamental dubiousness of converting different drugs into "morphine milligram equivalents."
Unlike the 2016 guidelines, the new version does not mention the 50 MME/day threshold in its 12 main recommendations, which are presented in bold type. The warnings about exceeding that specific level are instead relegated to the discussion following the fourth recommendation, which says: "When opioids are initiated for opioid-naïve patients with acute, subacute, or chronic pain, clinicians should prescribe the lowest effective dosage. If opioids are continued for subacute or chronic pain, clinicians should use caution when prescribing opioids at any dosage, should carefully evaluate individual benefits and risks when considering increasing dosage, and should avoid increasing dosage above levels likely to yield diminishing returns in benefits relative to risks to patients."
That does not seem like much of an improvement, unless you assume that clinicians won't read past the part in bold. Surely they will wonder which doses the CDC thinks are "likely to yield diminishing returns in benefits relative to risks to patients." They will find the answer a few paragraphs down.
"The recommendations related to opioid dosages are not intended to be used as an inflexible, rigid standard of care," the CDC says. "Rather, they are intended to be guideposts to help inform clinician-patient decision-making."
Is this presentation less likely than the 2016 version to encourage the "rigid application of opioid dosage thresholds" that the CDC officially eschews? Probably not, especially given six years of adaptation to the agency's original advice.
"I fear that it's a bit like closing the barn door after the horse has escaped," Bob Twillman, former executive director of the Academy of Integrative Pain Management, told me after the draft version of the guidelines was published. "There is a lot of work that needs to be done to modify or eliminate policies that were tied to the specific numbers in the 2016 guideline, and I'd like to see CDC play a role in that work."
Even while retaining the warnings about crossing the 50 MME/day line, the CDC tries to limit the harm that advice might cause. "Payers, health systems, and state medical boards," it says, "should ensure that policies based on cautionary dosage thresholds do not result in rapid tapers or abrupt discontinuation of opioids."
When patients are already receiving opioids, the CDC adds, "clinicians should carefully weigh benefits and risks and exercise care when changing opioid dosage. If benefits outweigh risks of continued opioid therapy, clinicians should work closely with patients to optimize nonopioid therapies while continuing opioid therapy. If benefits do not outweigh risks of continued opioid therapy, clinicians should optimize other therapies and work closely with patients to gradually taper to lower dosages or, if warranted based on the individual circumstances of the patient, appropriately taper and discontinue opioids. Unless there are indications of a life-threatening issue such as warning signs of impending overdose (e.g., confusion, sedation, or slurred speech), opioid therapy should not be discontinued abruptly, and clinicians should not rapidly reduce opioid dosages from higher dosages."
While these warnings are welcome (if overdue), it is not clear what "work[ing] closely with patients" means. "Although some experts indicated there should be more consideration of obtaining informed consent before tapering opioids," the CDC says, "others believed that informed discussion is more appropriate than informed consent when considering tapering opioids because of clinicians' overriding responsibility to avoid providing treatment that harms patients. Some experts were concerned that overemphasizing risks of tapering could increase harm from continued high-dosage opioid use."
In other words, the CDC is not saying that doses should be reduced only with the patient's consent. In the CDC's view, "informed discussion," possibly followed by a unilateral decision to which the patient objects, might be good enough.
Although the 2016 guidelines ostensibly were limited to chronic pain treatment, they included a recommendation regarding opioid prescriptions for acute pain. "Three days or less will often be sufficient," the CDC said. "More than seven days will rarely be needed." Like the warnings about exceeding specified daily doses, that advice predictably resulted in arbitrary limits on prescriptions, including statutory restrictions.
The new guidelines do not include a specific recommendation regarding the length of prescriptions for acute pain. "When opioids are needed for acute pain," the bolded recommendation says, "clinicians should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids." The discussion below that recommendation cites research suggesting that "in most cases, clinicians considered an initial opioid prescription of 4–7 days' duration sufficient." But the CDC also notes that "longer durations of opioid therapy are more likely to be needed when the mechanism of injury is expected to result in prolonged severe pain (e.g., severe traumatic injuries)."
This new advice is less likely to be read as supporting arbitrary limits on the length of prescriptions. But as with the MME thresholds, the damage already has been done, and reversing it will not be easy. Since 2016, according to a tally by the National Conference of State Legislatures, at least 20 states have imposed restrictions on initial prescriptions for acute pain, typically ranging from three to seven days.
All of these problems could have been avoided, of course, if the CDC had not presumed to advise doctors on how to treat pain in the first place. That function "should be left to professional organizations," says Lynn Webster, a former president of the American Academy of Pain Medicine. "Several experts in the field predicted the outcome of the 2016 CDC guidelines before they were issued.…The debacle with the 2016 CDC guidelines [illustrates] the reason the CDC should not be imposing their views on how pain medicine should be practiced."