Officials at the Centers for Disease Control and Prevention (CDC) Tuesday released clinical guidelines for prescribing opioids to help combat the nation’s overdose epidemic, and physicians were swift to respond. Physicians are embracing the concepts for reducing harm but simultaneously are pointing out serious shortcomings that will need to be addressed.
What’s in the guidelines
The guidelines, which were published in JAMA and on the CDC website, are intended for primary care clinicians who treat adult patients for chronic pain in outpatient settings. Their main goals are to help physicians improve communication with their patients about the benefits and risks of using prescription opioids for chronic pain, provide safer and more effective care for chronic pain, and reduce opioid use disorder and overdose among their patients.
The guidelines are intended to be a “flexible tool” to support informed decision-making, improve physicians’ confidence about how to manage chronic pain, and promote safer and more effective options for pain management, CDC Director Tom Frieden, MD, said on a media call Tuesday.
The guidelines include 12 clinical recommendations, which are centered on three principles for improving patient care and safety:
- Nonopioid therapy—including physical therapy, exercise, nonopioid medications and cognitive behavioral therapy—is preferred for chronic pain management (excluding active cancer, palliative and end-of-life care).
- If opioids are prescribed, they should be at the lowest possible effective dosage to reduce the risks of opioid use disorder and overdose.
- If opioids are prescribed, physicians should exercise caution and monitor the patient closely. Steps include consulting their state’s prescription drug monitoring program and tapering opioids if the desired effect is not achieved.
Three of the recommendations cover how to determine when to initiate or continue opioids for chronic pain. Four recommendations help physicians make decisions about opioid selection, dosage, duration, follow up and discontinuation. And five recommendations deal with assessing risk and addressing harms.
Following release of the guidelines, Patrice A. Harris, MD, the AMA board chair-elect and chair of the AMA Task Force to Reduce Opioid Abuse, noted that the AMA was “largely supportive of the guidelines” and noted the AMA’s shared goal of reducing harm from opioid abuse and seeking solutions to end the public health epidemic.
But Dr. Harris highlighted several concerns that remained from the draft guidelines on which the AMA submitted comments. “We remain concerned about the evidence base informing some of the recommendations; conflicts with existing state laws and product labeling; and possible unintended consequences associated with implementation, which includes access and insurance coverage limitations for non-pharmacologic treatments, especially comprehensive care; and the potential effects of strict dosage and duration limits on patient care,” she said.
“We know this is a difficult issue and doesn’t have easy solutions,” Dr. Harris said. “If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable. If they produce unintended consequences, we will need to mitigate them. They are not the final word. More needs to be done, and we plan to continue working at the state and federal level to engage policy makers to take steps that will help end this epidemic.”
In conjunction with release of the guidelines, the JAMA Network published several perspectives from prominent physicians.
“The CDC guideline for prescribing opioids for chronic pain is an important and essential step forward,” Yngvild Olsen, MD, of the Institutes for Behavior Resources Inc., wrote in a JAMA editorial. “With support from physicians across the country, as well as from policymakers at all levels, implementation of the recommendations in this guideline has the potential to improve and save many, many lives.”
But Dr. Olsen underscored that “success depends on simultaneously addressing significant gaps in the health care system.” These include “enormous gaps in reimbursement, both for chronic pain and for addiction treatment” and “few available care models that give primary care practitioners the time, resources and support to care for patients with complex chronic pain at risk for or with addiction.”
Noting a lack of evidence for the benefit of long-term use of opioids, Mitchell Katz, MD, of the Los Angeles County Department of Health Services, wrote in an editorial in JAMA Internal Medicine that the guidelines “have done an admirable job of summarizing our ignorance and putting forth 12 sensible recommendations, none of which meets a rigorous standard of evidence but all of which, if implemented, would reduce harm and likely improve chronic pain control in the United States.” Dr. Katz was a member of the Opioid Guideline Workgroup that reviewed the recommendation categories and level of evidence for these guidelines.
William Renthal, MD, of the Department of Neurology at Brigham and Women’s Hospital of Harvard Medical School, also highlighted the lack of clinical evidence in an editorial in JAMA Neurology: “[T]here are few well-controlled clinical studies on opioid-prescribing methods for chronic pain. While the guidelines will be updated as new data become available, concerns may be raised that appropriate access to opioids could be negatively affected by federal guidelines based on admittedly weak data.”
But Dr. Renthal noted the prudent principles of the guidelines. “It is important to note that the CDC guidelines are in this respect, an iteration of well-accepted medical principles of drug prescribing: to use the lowest effective dose for the shortest possible duration,” he wrote.
An editorial in JAMA Pediatrics by Neil L. Schechter, MD, of Boston Children’s Hospital, and Gary A. Walco, PhD, of Seattle Children’s Hospital, highlights the exclusion of children from the guidelines. “The CDC guideline is now published, without regard for pediatric patients,” they wrote. They called for greater clarification that the guidelines should not be applied to those younger than 18 years of age and recommended the development of future guidelines specifically for addressing indications and safety concerns for pediatric patients.
Thomas Lee, MD, of Press Ganey, reflected on the overall opioids situation in his JAMA editorial: “The data will never be perfect. The measures will never be perfect. The guidelines will never be perfect. And neither will clinicians and their performance. But by acknowledging these imperfections and trying to get better with the tools available, physicians can more effectively reduce the suffering of patients.”