CDC Revises Opioid Prescription Guidelines

The CDC is revising their controversial 2016 opioid prescribing guidelines. A draft version was released earlier this month, and public comments are being accepted through April 11, 2022.

Revised Guideline for Prescribing Opioids

The revised clinical practice guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic Pain— United States, 2016, and provides evidence-based recommendations for clinicians who provide pain care, including those prescribing opioids, for outpatients age 18 years and older with acute pain, subacute pain, or chronic pain, not including sickle cell disease related pain management, cancer pain treatment, palliative care, and end-of life care.

The clinical practice guideline includes recommendations for primary care clinicians as well as for outpatient clinicians in other specialties, including those managing dental and postsurgical pain in outpatient settings and emergency clinicians providing pain management for patients being discharged from emergency departments. The recommendations cover four categories, including:

Determining Whether or Not to Initiate Opioids for Pain
Opioid Selection and Dosage
Opioid Duration and Follow-Up
Assessing Risk and Addressing Harms of Opioid Use

An Individualized Approach

As with the earlier version, the revised guideline is voluntary, does not require mandatory compliance, and is intended to be flexible so as to support, not supplant, clinical judgment and individualized, patient-centered decision-making. The goal is to use opioids “only if benefits are anticipated to outweigh risks to the patient.”

Despite the “voluntary” nature of the earlier guideline, however, stakeholders throughout the industry interpreted them more rigidly, leaving patients with chronic pain with fewer treatment options, payers denying coverage of long-term opioid prescriptions, and even some physicians being investigated for improper prescribing, according to Stefan Kertesz, MD, a professor and opioid policy researcher at the Marnix E. Heersink School of Medicine at the University of Alabama at Birmingham and the Birmingham Veterans Affairs Medical Center.

The original guideline “resulted in many patients with long-term pain losing medications that actually helped them, and losing their doctor. Similarly, many doctors refused to see patients who had ongoing prescription opioid needs,” Kertesz says. “The main shift in the new draft guideline is that it more strongly urges an individualized approach to opioid prescribing.”

Christopher Jones, PharmD, acting director for the CDC’s National Center for Injury Prevention and Control, also believes the 2016 guideline left the CDC with the responsibility to “mitigate some of the missteps that have occurred.”

“Since 2016, we’ve learned that there is great variation in the practice of pain care and the experiences of patients living with pain,” Jones says. “It’s important that opioids be used thoughtfully, recognizing that they have a place in pain care, while at the same time using the guidelines in a flexible way, not as a rigid standard of care.”

Use versus Abuse

The revised guidelines follow the news from last November that annual drug overdoses exceeded 100,000 for the first time in the U.S. for a 12-month period that ended in April 2021. Those deaths represent a 28.5 percent increase from just one year earlier. Overdoses from opioids alone account for 75,673 of those deaths, up from 56,064 the year before.

Interestingly, most fatalities don’t appear to be caused by abuse of opioids by patients with long-term prescriptions for chronic pain. Instead, the CDC attributed the rapid acceleration in overdose death rates largely to the lethal effects of synthetic opioids and illegal fentanyl.

In fact, opioid prescribing in the United States has declined in recent years. According to the CDC, opioid prescriptions peaked in 2012, with more than 225 million prescriptions dispensed at a rate of 81.3 prescriptions for every 100 people. By 2020, however, only 142 million prescriptions were dispensed at a rate of 43.3 prescriptions for every 100 people.

Doctors must strike a careful balance between the need to provide relief for pain sufferers and the potential for addiction and abuse, says Sean Mackey, MD, PhD, chief of the division of pain medicine at the Stanford University School of Medicine in California.

“Our goals with these therapies are to reduce pain and improve function and quality of life,” Dr. Mackey says.

Revision Process

An Opioid Workgroup (OWG) was established in 2019 by the Board of Scientific Counselors of the National Center for Injury Prevention and Control (BSC/NCIPC) at the CDC’s request to review the updated draft Guideline for opioid prescribing. The OWG’s observations and comments are integrated throughout the current draft. The CDC also gave the opportunity for patients living with pain and their families, friends, and caregivers to offer their perspective to help inform the update of the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.

The current open comment period will provide a final opportunity for stakeholders to voice concerns and offer suggestions.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” says Jones. “ We want to hear many voices from the public, including people living with pain and the health care providers who help their patients manage pain. The ultimate goal of this clinical practice guideline is to help people set and achieve their personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal.”

Submitting Comments

Written comments must be received on or before April 11, 2022. You can submit comments, identified by Docket No. CDC-2022-0024, by either of the following methods:

Federal eRulemaking Portal: https://www.regulations.gov/commenton/CDC-2022-0024-0001. Follow the instructions for submitting comments.
Mail: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S106-9, Atlanta, GA 30341, Attn: Docket No. CDC-2022-0024.

All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to http://regulations.gov, including any personal information provided. CDC does not accept comments by email.