By Donald M. Pizzi
Originally published by our sister publication Pain Medicine News
Citing significant new research produced over the past six years and the knowledge gleaned from speaking with stakeholders as impetus, the CDC released the final draft of its updated and expanded replacement to the 2016 “CDC Guideline for Prescribing Opioids for Chronic Pain.”
The CDC said in a statement it has followed a rigorous scientific process, “using the best available evidence and expert consultation”—including an independent federal advisory committee, four peer reviewers and members of the public who were allowed to comment online upon the release of the draft.
“The CDC aims to work with physicians and patients to develop the best pain care possible. Today’s announcement is about improving the lives of people in pain,” said Christopher M. Jones, PharmD, DrPH, MPH, the acting director of the CDC’s National Center for Injury Prevention and Control, and a co-author of the guideline, in a CDC press briefing on the update. “The release of this guideline today is about advancing pain care. One in five people have chronic pain; it is one of the most common reasons people present to a provider."
A Better Understanding of Lived Experiences
“Patients with pain should receive compassionate, safe and effective pain care,” he said. “We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of helping people reduce their pain and improve their quality of life.”
According to Jones, the new guideline is moored on four major priorities: determining whether to initiate opioids for pain; selecting opioids and determining opioid dosages; deciding the duration of initial opioid prescriptions and conducting follow-up; and assessing risk and addressing potential harms of opioid use.
Jones said the focus of the 2016 guideline was primarily on primary care physician prescribing for chronic pain, defined as pain of a duration of three months or more. The 2022 version, he said, expands its scope in several major areas including acute (less than one month) and subacute (one to three months) pain; prescribing in specialties outside of primary care (e.g., surgery, dentistry and emergency medicine); at-risk populations, such as older adults and individuals with opioid use disorder; recommendations for nonpharmacologic pain treatment; and a differentiation between patients on existing opioid therapy and new, opioid-naive patients.
Certain forms of chronic pain are excluded from the guideline, including pain related to sickle cell disease, cancer-related pain, and pain in palliative and end-of-life care.
He said the guideline strongly addresses the dangers of opioid tapering, including the addition of practical tips on how to wean patients off opioids. “It explicitly advises against any abrupt discontinuation or drastic reductions (in opioid dose),” he said.
This version of the guideline addresses health inequities and disparities as they relate to pain care, said Jones, specifically mentioning in the press briefing the unequal pain treatment experienced by Black patients. “There is much work to be done on providing equitable pain care,” he said. “Time and time again, research has showed where you live and who you are affects your pain care.”
Like the June 2022 draft guidance that it closely adheres to, the final draft continues the agency’s stance that opioids are not a first-line therapy for chronic pain, or even acute pain in some cases.
The final version includes language recognizing that clinical judgment should be relied on more strongly and removes recommended limits on opioids. The consensus from pain clinicians was the limits were often misinterpreted as hard caps, leading to severe unintended consequences, including the undertreatment of pain that left some patients so distressed they contemplated death or died by suicide.
The CDC has maintained that the prescribing limits in the original guideline (MMWR Recomm Rep 2016;65[RR-1]:1-49) were never a mandate or hard restriction.
“The guideline is a clinical tool to improve communication between clinicians and patients and empower them to make informed decisions about safe and effective pain care,” Jones said. “The recommendations are voluntary and provide flexibility to clinicians and patients to support individualized, patient-centered care. They should not be used as an inflexible, one-size-fits-all policy or law or applied as a rigid standard of care or to replace clinical judgment about personalized treatment.”
“The science on pain care has advanced over the past six years,” said Debbie Dowell, MD, MPH, the chief clinical research officer for the CDC’s Division of Overdose Prevention, in a press statement, adding that through the update process the CDC has listened to the perspective of patients, caregivers and clinicians. “We’ve been able to improve and expand our recommendations by incorporating new data with a better understanding of people’s lived experiences and the challenges they face when managing pain and pain care.”
Jones agreed, stating, “Our hope is that this new guideline is fueled by new research, and the human stories we heard.”
In response to questions regarding whether the 2016 guideline was misapplied by legislative bodies in various states—leading to pain patients denied appropriate opioid-related pain care—Jones said, “I want to be very clear: If policies are put in place that are one size fits all, that is inconsistent with the scope of this guideline. Operationally, if people use it as justification [to restrict care] we will monitor that and see it as an educational opportunity.” The CDC plans to partner with clinical organizations to monitor negative effects of the guideline, he said.
Jones said it is not the aim of the guideline to focus on the illicit drugs that are fueling the ongoing opioid crisis, but added that work is happening across government today to curb illicit opioid use.
"Illicitly manufactured fentanyl, or IMF, analogs are a leading contributor to the opioid crisis," said Joseph V. Pergolizzi, Jr., MD. "Public health educational efforts need to address this."
‘Time Will Tell’
“I think it is important to remember that the goal of the guideline was to reduce the number of overdose deaths,” said Lynn R. Webster, MD, FACPM, FASAM. “The CDC believed this would be best accomplished by reducing the supply or amount prescribed. It hasn’t worked out that way.”
Rather, he said, while opioid prescribing has dropped precipitously over a decade, opioid overdoses have skyrocketed, largely from illicit, nonprescription opioids. “The CDC should now focus on the cause of most opioid-related overdose deaths, which is to address the social and economic factors that create the demand for so many Americans to escape the pain of living,” he said.
Webster, who was critical of the 2016 guideline when it was released, called the revised version an improvement. The important change, he said, is the removal of an artificial 90 morphine milligram equivalent (MME) dose threshold, which he said was all too often mistaken for a mandate.
But he worries that something similar could happen with the 50-MME threshold the CDC kept “to signify a dose to pause and reassess benefits versus risks,” largely because it is not contained in the text of an actual recommendation, but rather under things to consider during implementation. Moreover, the The Opioid Working Group (a Federal Advisory Committee created in 2019) has stated a threshold of at least 50 MME per day is still “arbitrary,” Webster said.
“I recently testified in the defense of a physician criminally charged for violation of the Controlled Substances Act,” said Webster, a senior fellow at the Center for U.S. Policy in Washington, D.C., in an email. “A major argument against the doctor was that he exceeded the 2016 CDC-recommended 90 MME [threshold]. I fear that just mentioning 50 MME in the guideline will now be used to criminalize prescribing by the government at even a lower dose than the 90 MME [threshold]. Time will tell.”