The revised and expanded pain treatment guidelines that the Centers for Disease Control and Prevention (CDC) published today mention “patient abandonment” eight times. They also include two occurrences of this admonition, in bold and italics: “Clinicians should not abandon patients.“
That gives you a sense of the disastrous impact that the original version of the CDC’s advice, published in 2016, had on medical care. Something clearly has gone terribly wrong when clinicians have to be reminded that they are not supposed to abandon patients. At the same time, the CDC’s acknowledgment of the problem signals its willingness to address the needless suffering caused by the 2016 guidelines, which resulted in undertreatment, reckless “tapering” of pain medication, denial of care, and procrustean policies that prioritize reductions in opioid prescribing over the interests of patients.
The original guidelines, which were aimed at primary care physicians and focused on “prescribing opioids for chronic pain,” included grave warnings about the dangers of exceeding 90 morphine milligram equivalents (MMEs) a day. Many physicians, pharmacists, insurers, regulators, and legislators read that threshold as a hard cap, meaning that it should never be exceeded and that chronic pain patients who were already above it should be forced to comply with this arbitrary limit.
Although the 2016 guidelines focused on chronic pain, they also touched on acute pain, because “long-term opioid use often begins with treatment of acute pain.” For acute pain, the CDC said, a prescription for “three days or less will often be sufficient,” while “more than seven days will rarely be needed.” As a result, the CDC notes in the new guidelines, “more than half of all states have passed legislation that limits initial opioid prescriptions for acute pain to a seven day supply or less,” while “many insurers, pharmacy benefit managers, and pharmacies also have enacted similar policies.”
Ostensibly, the guidelines were purely advisory. But in practice, many patients found to their dismay, they were mandatory.
“Some policies that were purportedly drawn from the 2016 CDC Guideline have, in fact, been notably inconsistent with the 2016 CDC Guideline and have gone well beyond its clinical recommendations,” the CDC says in the new guidelines, which are still in draft form pending public comment. “Such misapplication includes extension of the 2016 CDC Guideline to patient populations not covered in the 2016 CDC Guideline (e.g., cancer and palliative care), opioid tapers and abrupt discontinuation without collaboration with patients, rigid application of opioid dosage thresholds, application of the Guideline’s recommendations for opioid use for pain to medications for opioid use disorder treatment…duration limits by insurers and by pharmacies, and patient dismissal and abandonment.”
What did all this “misapplication” mean in practice? The CDC notes that the Food and Drug Administration (FDA) “has advised that risks of rapid tapering or sudden discontinuation of opioids in physically dependent patients include acute withdrawal symptoms, exacerbation of pain, serious psychological distress, and thoughts of suicide.”
The CDC is referring to the “safety announcement” that the FDA issued three years ago in response to complaints from patients and pain specialists. Notably, that FDA warning mentioned not just “thoughts of suicide” but completion of the act. When patients respond to CDC-inspired medical practices by killing themselves, it might be time to admit that the agency issued its advice without sufficiently considering the potential for unintended but foreseeable consequences.
The CDC never quite admits that in the new guidelines. But it has made several notable changes aimed at discouraging “misapplication” of its advice.
“This voluntary clinical practice guideline provides recommendations and does not require mandatory compliance,” the CDC says in its Federal Register announcement. “The clinical practice guideline is intended to be flexible so as to support, not supplant, clinical judgment and individualized, patient-centered decision-making.”
The revised guidelines, which include 12 main recommendations, address acute as well as chronic pain and offer advice for “clinicians” generally. They explicitly do not apply to “sickle cell disease-related pain management, cancer pain treatment, palliative care, and end-of-life care.” The new advice retains a bias against opioid treatment but, unlike the 2016 version, does not imply that daily doses of more than 90 MME for chronic pain are inherently suspect. The CDC emphasizes the importance of collaborating with patients, tailoring treatment, and weighing risks against benefits. It says that calculus includes not only the pros and cons of opioid treatment but also the dangers of abrupt dose reductions.
“Payers and health systems should not use this clinical practice guideline to set rigid standards related to dose or duration of opioid therapy” and “should ensure that policies based on cautionary dosage thresholds do not result in rapid tapers or abrupt discontinuation of opioids,” the CDC says. “For patients already receiving higher opioid dosages, clinicians should carefully weigh benefits and risks and exercise care when reducing or continuing opioid dosage. If risks outweigh benefits 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 clinical circumstances of the patient, to 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 abruptly or rapidly reduce opioid dosages.”
Although these warnings are welcome (if overdue), it is not completely clear what “work[ing] closely with patients” means. “While some experts felt there should be more consideration of obtaining informed consent prior to tapering opioids,” the CDC says, “others believed that informed discussion is more appropriate than informed consent when considering tapering opioids given clinicians’ overriding responsibility to avoid providing treatment that harms patients.”
The CDC’s new recommendations do not include a warning about prescribing more than 90 MME per day for chronic pain. But the CDC does urge caution about raising doses for patients with “subacute or chronic pain” above 50 MME per day. “Many patients do not experience benefit in pain or function from increasing opioid dosages to ≥50 MME/day but are exposed to progressive increases in risk as dosage increases,” it says. “Therefore, before increasing total opioid dosage to ≥50 MME/day, clinicians should pause and carefully reassess evidence of individual benefits and risks. If a decision is made to increase dosage, clinicians should use caution and increase dosage by the smallest practical amount.”
The CDC adds this underlined caveat: “The recommendations related to opioid dosages are not intended to be used as an inflexible, rigid standard of care; rather, they are intended to be guideposts to help inform clinician-patient decision making. Further, these recommendations apply specifically to starting opioids or to increasing opioid dosages, and a different set of benefits and risks applies to reducing opioid dosages.”
The CDC acknowledges the concern that advice tied to specific doses might lead to suboptimal care and misguided policies, as happened with its earlier emphasis on the 90 MME/day threshold. Its solution is to omit any reference to the 50 MME/day threshold from its highlighted recommendation, relegating that discussion to the “implementation considerations.” Lynn Webster, a former president of the American Academy of Pain Medicine, notes that the CDC does not acknowledge the weak scientific basis for MME thresholds, which do not take into account wide variation in how patients metabolize and respond to pain medication.
The CDC clearly prefers that doctors treat pain with something other than opioids whenever that is feasible. But it acknowledges that nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen also carry risks and may not provide adequate relief. And while its discussion of nonpharmaceutical treatments may strike pain specialists as excessively optimistic, it does not insist that patients try every other conceivable option before opioids.
“Opioids should not be considered first-line or routine therapy for subacute or chronic pain,” the CDC says. “This does not mean that patients should be required to sequentially ‘fail’ nonpharmacologic and nonopioid pharmacologic therapy or be required to use any specific therapy before proceeding to opioid therapy.”
The CDC has eliminated the blanket suggestion that opioid prescriptions for acute pain generally should not last longer than a week. Instead, it says “a few days
or less are often sufficient,” but “durations should be individualized based on the clinical circumstances of the specific patient.” The CDC recommends starting with the lowest effective dose, avoiding long-acting formulations, instructing patients to take pain pills as needed rather than on a fixed schedule, and eschewing the practice of prescribing more pills than a patient might need “just in case” his pain lasts longer than expected.
While those recommendations may seem commonsensical, they entail tradeoffs. The CDC says prescriptions should be limited to “the expected duration of pain severe enough to require opioids.” But it acknowledges that the “expected duration” is not necessarily the same as the actual duration. A patient taking hydrocodone after an injury or surgery, for example, may find that he is still in pain after his pills run out. The CDC is so keen to avoid the risk that unused pills will be diverted to nonmedical use that it is willing to let such patients suffer until they manage to get another prescription.
“To minimize unintended impact on patients with an unexpectedly prolonged duration of severe acute pain,” the CDC says, “clinicians, practices, and health systems should have mechanisms in place to provide timely re-evaluation for the subset of patients who experience severe acute pain that continues longer than the expected duration to confirm or revise the initial diagnosis and to adjust management accordingly. In particular, clinicians, practices, and health systems should ensure all patients can access and afford additional evaluation and treatment, as needed, to minimize disparities across patients based on access to and affordability of care and refills.”
That seems like a lot of wishful thinking. Even with “mechanisms” in place, patients will suffer from unrelieved pain while they are jumping through these hoops. There is an unacknowledged value judgment here that says the war on drugs takes precedence over patient welfare.
Likewise with the CDC’s position that “opioids are not first-line therapy” for patients recovering from dental surgery. The aim here is to prevent unnecessary prescriptions that might contribute to opioid “misuse.” But pursuing that goal means that many dental patients who find that Tylenol and Advil are inadequate will just have to suck it up.
The CDC’s bias against opioids does not seem to be justified by the addiction risk it emphasizes. In 2015, according to the National Survey on Drug Use and Health, nearly 100 million Americans used prescription opioids, including nonmedical users as well as bona fide patients. Judging from their responses to survey questions, about 2 million of them, slightly more than 2 percent, qualified for a diagnosis of “substance use disorder”—a catchall category that subsumes what used to be known as “substance abuse” and the more severe “substance dependence”—at some point during the previous year. By comparison, data from the same survey indicate that 9 percent of past-year drinkers had an alcohol use disorder in 2015.
Nor are fatal overdoses as common as the CDC implies. A 2015 study of opioid-related deaths in North Carolina, reported in Pain Medicine, found 478 fatalities among 2.2 million residents who were prescribed opioids in 2010, an annual rate of 0.022 percent. Webster notes that the CDC dubiously blames opioid prescribing for increases in drug-related deaths between 1999 and 2010 without acknowledging that the upward trend in fatalities accelerated after the government succeeded in reducing the use of opioid pain medication. As opioid prescriptions fell, opioid-related deaths, primarily involving heroin and illicit fentanyl, rose to record levels.
Even when the CDC concedes that opioids are necessary, that message may be lost amid all its warnings about the dangers of these drugs. The CDC says “there is an important role for opioid therapy for acute pain related to severe traumatic injuries (including crush injuries and burns), invasive surgeries typically associated with moderate to severe postoperative pain, and other severe acute pain when NSAIDs and other therapies are contraindicated or likely to be ineffective.” Yet The New York Times reports that the guidelines “advise against prescribing opioids, except for traumatic injuries, such as burns and auto accidents.” If Times health law reporter Jan Hoffman got that impression, clinicians might as well, leading to further “misapplication” of the CDC’s advice.
Overall, however, the proposed guidelines represent a substantial improvement on the advice the CDC gave in 2016. “The framing is better,” says Kate Nicholson, president of the National Pain Advocacy Center. She notes “much more emphasis on the importance of treating pain, individualization, patient-centered care, disparities in care, and [the point] that the guideline should not be used as the basis for policy or a substitute for clinical judgment.” She adds that “the two provisions that wreaked the most havoc—the day and dosage thresholds—have been removed from the actual recommendations.”
Nicholson also has concerns. The remaining references to MME thresholds are not adequately justified, she says, and “could still be lifted by policy makers.” She also suggests that expanding the guidelines to cover shorter-term pain “opens a can of worms and may confuse more than clarify.” While “a lot has improved,” she says, “a lot still needs to be addressed.”
Bob Twillman, former executive director of the Academy of Integrative Pain Management, also welcomed many of the CDC’s changes. “The wording of the recommendations themselves is much improved over the 2016 version,” he told the Pain News Network. “In particular, the elimination of specific dosage numbers is welcomed because those were very easy for policymakers and payers to latch onto in setting policies.”
While “it’s good that they are removing those,” Twillman said, “I fear that it’s a bit like closing the barn door after the horse has escaped. 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.”
Webster is less impressed by the CDC’s changes. “The good thing,” he says, is that “the explicit dose limits were removed and the days of opioid supply for acute pain are not specific.” But “although they say that the guideline should not be an inflexible standard of care imposed on specific populations,” he notes, “they do not expressly state that law enforcement and policy makers should not use them to set a standard of care or to prosecute providers.”
Webster questions why the CDC felt a need to advise doctors about pain treatment in the first place. That function “should be left to professional organizations,” he says. “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.”