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Painful Consequences of Federal Prescription Guidelines
By Nita Ghei
Late in 2016, I went to what I expected to be a routine follow-up appointment with my neurologist for my intractable chronic migraine disease. Instead, I found that the neurologist I had been seeing for 15 years had abruptly left the practice and a new policy prohibiting any opioid prescriptions had been instituted, with no discussion of individualized care plans. I was no longer able to receive the only medication that, at the time, could help me through the most painful episodes of my disease.
As I struggled to cope with undertreated pain and declining health, I found I was far from unique. From 2017 onward, a growing chorus of chronic pain patients shared reports about the abrupt discontinuation of opioid therapy, being dismissed as patients and, most tragically, an increase in suicides. There are about 50 million chronic pain patients in the U.S., of whom 20 million have high-impact pain; it is estimated that some half of these patients need opioids to maintain function and quality of life. Yet federal policymakers, focused on averting the “opioid crisis,” are denying these medications to the people who truly need them.
The CDC Guideline and Its Effects
Though opioid prescriptions have been declining since 2012, pain patients have seen an extraordinary acceleration of restrictions in their treatment plans and access to care, particularly in the past five years. Various factors might be cited to explain this trend, including state regulations, insurance requirements or the risk aversion of prescribing physicians. Whatever the justification, one document issued by the Centers for Disease Control and Prevention in March 2016 has been frequently cited: the “CDC Guideline for Prescribing Opioids for Chronic Pain.”
The CDC document was meant to be a prescribing guide for primary care physicians, in an effort to prevent “overprescribing” according to the conventional narrative of the opioid crisis. The Guideline was supposed to help prevent primary care physicians from writing too-generous opioid prescriptions and contributing to the substance use disorder crisis.
What actually unfolded was completely different—and entirely foreseeable.
In what probably became its most notorious metric, the CDC Guideline said clinicians “should avoid increasing dosage to =90 MME/day or carefully justify a decision to titrate dosage to =90 MME/day,” where MME stands for morphine milligram equivalents, a way to compare the potencies of opioid doses. Following that statement, 90 MME became the magic number. It gave lawmakers and law enforcement personnel a number to use. It gave increasingly risk-averse physicians a concrete goal as they sought to avoid legal scrutiny.
As the Drug Enforcement Administration stepped up raids based on the metrics suggested in the Guideline, the numbers of pain-management physicians shrank, particularly in rural areas. All too often, hundreds of medically fragile patients were left without care or health records overnight, as law enforcement swept up all documents in an ever-expanding search for “overprescribers.” Chronic pain patients saw access to opioid therapy rapidly shrink. Worse, they found that primary care was also harder to find: almost 80% of primary care physicians surveyed were reluctant to take them on as patients.
The physicians who still provided pain management and opioid prescriptions tried to protect themselves. For their patients—Americans with disabilities or with incurable or progressive diseases—this meant jumping through an increasing number of humiliating and demeaning hoops to secure the medication that was necessary for maintaining quality of life. The CDC Guideline suggested drug testing every two to four months. Many practices began to require monthly tests, which are often not covered by insurance. This expense alone can push care out of reach for many chronic pain patients.
Each new requirement increases the burden on chronic pain patients and might make it impossible for seriously sick people to get pain relief or even medical care. Many physicians require patients to sign “pain contracts” that can contain a variety of terms, including random pill counts, travel limitations, a promise to refuse opioid prescriptions from another physician even in a surgical emergency, and so forth. Often, these conditions are harsher than those imposed on a parolee.
It did not matter that the Guideline was not an official regulation and therefore had no force of law. Nor did it matter that the Guideline was never intended for specialist practices like the neurology practice I went to, or that doses higher than 90 MME were not banned but merely flagged for extra thought. Repeated statements by the CDC about misapplication of the Guideline have been ignored.
In an increasingly uncertain environment, with an inchoate threat of criminal prosecution and asset forfeiture looming, many medical practices, including my neurologist’s, decided that the safest number of opioid prescriptions was zero. From a risk-management perspective, it may have been. In terms of patient outcomes, however, it was not.
A Flawed Narrative
The Guideline was based on the factional narrative around the so-called opioid crisis and “deaths of despair.” This narrative is one of doctors overprescribing narcotics, of widespread distribution of large prescriptions of opioids for minor aches, and of addiction following even a short-term use of prescribed pain relievers as directed. Sometimes this narrative includes an additional flourish: its proponents claim that there is no evidence that opioids help with chronic pain, and that there are “more effective” treatments available.
This narrative is plausible. It is superficially convincing. It offers a simple solution: restrict access to prescription opioids, and the crisis will be resolved! Unfortunately, it is also almost entirely wrong.
Nonmedical opioid users are mostly distinct from medical users, and medical users very rarely end up with substance use disorder. In a study of fatal overdoses in Massachusetts, only about 1% of those who died had a valid prescription. Additionally, for millions of chronic pain patients, there are no other treatments available that are as effective. Typically, we have tried everything else.
Nonetheless, this tidy narrative, focused entirely on the damage from addiction, drives policy. It conflates all opioids and all users, ignoring the enormous benefit opioids have provided to millions of sick and disabled Americans. The entire policy conversation on the opioid crisis is rife with conflation on multiple levels that muddies the analysis: medical and nonmedical users, prescription and street drugs.
This conflation allows for an easy and visible policy fix: impose constraints on prescribing opioids. And we end up with policies that focus on restricting access to prescription opioids for both people and pets. In fact, however, illicit fentanyl analogs are the leading cause of overdose deaths, and 85% of overdose deaths in 2019 were linked to street drugs. Opioid prescription numbers peaked in 2012 and have fallen sharply ever since, but overdose deaths have continued to grow. There is little reason to believe that diversion of prescription opioids is taking place at the patient level; chronic pain patients, anecdotally, are undertreated. To the extent that there is diversion, it seems to happen before the medication gets to the patient.
Street drugs, especially illicit fentanyl analogs, are driving the overdose crisis. The CDC Guideline, and its entirely foreseeable misapplication by policymakers and medical providers, focuses on the wrong target. In doing so, the Guideline actively harms a vulnerable population: Americans with disabilities and with painful, incurable, progressive diseases. And it fails to help address the ostensible problem of overdose deaths.
The CDC’s goal should be harm reduction; instead, its Guideline has made things worse for millions of Americans living with chronic pain. Rather than persisting with its present course of expanding the Guideline to include pediatric and acute pain, the CDC should rescind the Guideline, which would make all pain patients better off. It is worth remembering that the Food and Drug Administration, which is responsible for regulating opioids, saw no need for such guidelines. The CDC would do better to emulate the FDA’s example and leave medical decision-making to patients and their physicians.