On Feb. 10, the Centers for Disease Control and Prevention (CDC) published its draft CDC Practice Guideline for Prescribing Opioids. It represents a welcome, long overdue, and desperately needed change in direction from its disastrous 2016 Guideline for Prescribing Opioids for Chronic Pain.
Unfortunately, the CDC is making a serious mistake by calling its 2022 guideline an “update” of its 2016 guideline because an update does not convey to the many individuals and entities that misapplied the earlier guideline to stop relying on it and to alter their current policies and practices. To make this point clear, the CDC should rescind its 2016 guideline and issue the 2022 guideline as a new approach to prescribing opioids.
The many problems with the 2016 guideline have been identified by chronic pain patients and their advocates, leading experts on pain management, and professional organizations, including the American Medical Association (AMA). We need not repeat the criticisms in detail, but three of the CDC’s recommendations have been especially problematic.
First, it unequivocally stated that “[n]onpharmacologic therapy and nonopioid therapy are preferred for chronic pain.” This rigid position has been criticized, especially as applied to patients who have been on long-term opioid therapy. Second, it recommended a maximum of 90 morphine milligram equivalents (MME) per day, an inflexible cap that has been shown to be inadequate for long-term patients with episodes of severe pain. Third, it recommended the gradual tapering of opioids with the consent of patients, but the recommendation has been unilaterally and recklessly implemented by some physicians, with tragic results.
An even greater problem with the 2016 guideline is that it has been widely misapplied by entities and individuals who believe that aggressively curtailing the number and strength of opioid prescriptions will reduce opioid addiction and overdose. This baseless and simplistic approach to the complex societal problem of substance abuse has been a catastrophic failure. Between 2012 and 2020, the number of opioid prescriptions declined dramatically from 255 million to 142 million a year, but the number of overdose deaths soared from 41,000 to 100,000. An estimated 30 percent of overdose fatalities are suicides.
The 2016 guideline was intended for use by primary care clinicians in outpatient settings, but it has been applied more widely, including by pain management physicians and in inpatient settings. The guideline was not intended for cancer patients or end-of-life care, but it has been applied to both groups of individuals, causing needless misery to these most vulnerable individuals.
The 2016 guideline “has achieved its greatest impact by convincing health care provider organizations that violations of the guideline by their member physicians may increase organizational liability exposure.” Many physicians, concerned about licensing, credentialing, civil and criminal liability, or the stigma of being labeled a “pill mill” doctor, have stopped prescribing opioids for new patients or even long-term patients who have a long record of responsible use of opioid analgesics. Desperate chronic pain patients who have been abandoned by their physicians often have turned to heroin or illicit fentanyl with catastrophic results, and an increasing number of chronic pain patients unable to control their unremitting pain have taken their own lives.
Although the CDC did not intend these dreadful outcomes, it has known of these results since at least 2019. The CDC must take ownership of its role in this aspect of the opioid/pain management crisis and do more than simply release an “update” of the 2016 guideline. The 2016 guideline has been adopted by state legislatures in 36 states to criminalize prescriptions in excess of 90 MME even when clinically appropriate, used by large retail pharmacy chains in refusing to fill or refill valid opioid prescriptions, followed by health insurance companies to discontinue coverage for opioids, relied on by physicians who require patients with debilitating medical conditions to take antidepressants before opioids, and misunderstood by members of the public who mischaracterize individuals with serious health conditions and extreme pain as drug-seeking addicts.
The CDC is in the best position to develop and implement a comprehensive strategy to undo the widespread harms caused by the 2016 guideline. It should rescind the 2016 guideline; complete the drafting and release of a flexible, humane and patient-centered 2022 guideline; and embark on a multi-faceted informational and educational campaign. The latter should be coordinated with stakeholders and groups interested in or affected by the 2016 guideline. The CDC should take an active part in the rollout of its new 2022 guideline, including by producing online materials and public service messaging in various media, and providing outreach and technical support to legislators, public health officials and organizations of physicians and chronic pain patients.
As the AMA has stated, “It is clear that the CDC guideline has harmed many patients.” The CDC has the obligation and opportunity to take aggressive measures to put the treatment of chronic pain patients back on the proper course.
Mark A. Rothstein is the Herbert F. Boehl Chair of Law and Medicine and Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine. Julia Irzyk is an advocate for individuals with disabilities and coauthor of “Disabilities and the Law, 4th Edition” (Thomson Reuters 2021).