Two years after their release, the CDC’s opioid prescribing guidelines continue to plague pain management practices.
John, a former cable company salesman, successfully used OxyContin for years to treat the severe back pain caused by injuries he sustained during a mugging in 2011. Before he found a medication that worked for him, he recalled, “My wife was about to leave me, because I was a miserable bastard. When you’re in that much pain, you want to just go to sleep and not wake up.”
Last fall, John said, a physician’s assistant told him his dose, 60 mg, three times per day, was too high and would have to be dramatically reduced under a new rule setting a limit of 90 morphine milligram equivalents (MME) per day. “My whole life turned upside down in a matter of 30 days,” he said. “I’m back in bed now. I can’t really get up very much, and I’m right back where I started in 2011.”
Although John was told that exceeding 90 MME a day was “no longer legal,” pain practitioners largely recognize that the MME ceiling is officially just a suggestion based on the opioid prescribing guidelines published by the US Centers for Disease Control and Prevention (CDC) in 2016.1 Some clinicians, however, have interpreted the recommendation as a hard-and-fast rule, leaving patients like John to suffer needlessly from pain that had previously been under control.
More generally, many medical experts say the CDC guidelines play up the hazards of opioids while playing down their benefits. The overall message is that clinicians should be stingy with these medications, prescribing them only as a last resort and maintaining the lowest possible doses. Despite the CDC’s protestations to the contrary, the mission of preventing abuse and diversion seems to be interfering with the average pain practitioner’s duty to provide appropriate care, leading in extreme cases to suicides by patients who are unable to get the pain relief they need.
After the CDC guidelines were published, Dan Carr, MD, then the president of the American Academy of Pain Medicine (AAPM), worried about unintended consequences. “The CDC guideline makes disproportionately strong recommendations based upon a narrowly selected portion of the available clinical evidence,” he said in an AAPM statement at the time.2 “It is incumbent upon us all to monitor the deployment of the guideline to ensure that it does not inadvertently encourage under-treatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately.”
Two years later, Carr’s warning is proving prescient. “There are many pain clinics flooded with patients who have been treated previously by their primary care physician,” said AAPM President-Elect Jianguo Cheng, MD. These refugees include patients who “have been functional” and “responding well” to opioids for “many years,” he said.
Sidney Schnoll, MD, PhD, an addiction and pain treatment specialist who is vice president of pharmaceutical risk management services at the consulting firm Pinney Associates, has witnessed similar problems. “I get calls from patients whom I treated years ago, who were on stable doses of medication, doing very well, who have chronic pain conditions, and they can’t get medication to treat their pain,” he said. “They’re being taken off medication on which they had done very well for years.”
The CDC guidelines in themselves are not legally binding. Congress, however, has imposed the recommendations on the Department of Veterans Affairs (VA), and at least 18 states have enacted elements of them. In 2016 and 2017, according to a tally by the National Conference of State Legislatures,3 14 states imposed limits on the duration of initial prescriptions for acute pain, ranging from three days (Kentucky) to two weeks (Nevada), with seven days the most common. Arizona enacted a five-day limit in January. Four states (Arizona, Maine, Nevada, and Rhode Island) have imposed daily dose ceilings, while Maryland has limited opioid prescriptions to “the lowest effective dose” and a quantity “not greater than needed for the expected duration of pain.”3
In seven other states, the legislature authorized or directed another body to impose limits on opioid prescriptions. In addition to these statutory changes, the guidelines are shaping the policies and practices of regulators, insurers, and law enforcement agencies, leading to an industry-wide perception that departing from them is bad medical practice.
Stefan Kertesz, MD, MSc, an internist and professor of preventive medicine at the University of Alabama at Birmingham who specializes in pain and addiction, said physicians are facing “pressure from many directions.” He said the burdens include “scrutiny from state officials,” “barriers from insurance and pharmacy benefit plans,” “more restrictive guidelines from state licensing boards,” “stories of some physicians losing their livelihoods and being shut down,” and “super-intense rhetoric from thought leaders and journalists,” who tend to blame physicians for causing the “opioid epidemic” through careless prescribing. “Under that kind of pressure,” said Dr. Kertesz, “who wouldn’t change what they’re doing, even if it hurts a few patients?”
Too Much Left to Interpretation
The CDC has implied there is something special about the 90 MME cap, as well as 50 MME per day, the level at which the agency urges extra caution. But the authors of a 2015 study4 of opioid-related deaths in North Carolina reported that “dose-dependent opioid overdose risk among patients increased gradually and did not show evidence of a distinct risk threshold.” Critics have called the CDC’s cutoffs arbitrary, since patients vary widely in the way they metabolize and respond to opioids, especially if they have developed a tolerance after years of effective opioid management.
“There seems to be no clear clinical evidence that opioid risks increase with 50 MME per day or that doses should never exceed 90 MME per day in any patient,” according to Pergolizzi et al.5 “It seems unnecessary and counterproductive to decrease a patient’s dose of opioids just to achieve an arbitrary limit.”
CDC officials have said they do not want doctors to impose dose reductions on patients. “We do hear stories about people being involuntarily taken off opioids,” Deborah Dowell, MD, MPH, a co-author of the guidelines and senior medical advisor/chief medical officer at the CDC’s Division of Unintentional Injury Prevention, said at a prescription drug abuse summit in 2017.6 “We specifically advise against that in the guidelines.”