Process for Updating the Opioid Prescribing Guideline
Patients with pain deserve safe and effective pain management.
Pain, particularly chronic pain, can lead to impaired physical functioning, poor mental health, and a reduced quality of life. It contributes to substantial morbidity and mortality in the United States each year. Chronic pain is the leading cause of disability in the United States and the economic costs are staggering—$560 to $635 billion dollars annually.1
A key aim of pain management is the provision of individualized, patient-centered care that focuses on optimizing function and supporting activities of daily living. CDC provides guidance to clinicians, as well as tools and resources for patients and clinicians, to help advance comprehensive pain care. One key way we do promote patient-centered pain care is through the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. In this context, our ultimate goal is to help people set and achieve personal goals to reduce pain and improve function.
The 2016 CDC Guideline for Prescribing Opioids is being updated.
In the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain, CDC indicated the intent to re-evaluate the Guideline as new evidence became available and to determine when sufficient new evidence might prompt an update. CDC has stayed abreast of new research as it became available since 2016 and conducted formal reviews of new available evidence on noninvasive, nonpharmacological treatment and nonopioid pharmacological treatment of chronic pain. As a result of these reviews, CDC determined that an update of the Guideline, and an expansion to certain acute conditions, was warranted.
The update process uses multiple key sources of input.
The 2016 Guideline was developed using the best available scientific evidence and followed a rigorous scientific process. The update to the Guideline is following a similar process and includes several opportunities for community and partner engagement. CDC highly values public engagement and has ensured there are multiple opportunities to hear from and incorporate feedback from patients with pain, caregivers, clinicians, and partners.
Sources of input used to inform the update of the Guideline include:
- CDC funded the Agency for Healthcare Research & Quality’s (AHRQ)external icon to conduct systematic reviews of the scientific evidence published since the Guideline’s release in March 2016.
- Each of these reviews will continue to be updated into 2022 as new evidence becomes available.
- Noninvasive Nonpharmacological Treatment for Chronic Pain (An Update)external icon
- Nonopioid Pharmacologic Treatments for Chronic Painexternal icon
- Opioid Treatments for Chronic Painexternal icon
- Treatments for Acute Pain: A Systematic Reviewexternal icon
- Acute Treatments for Episodic Migraineexternal icon
- These engagements provided opportunities to learn more about pain management from the lived experiences, values, preferences, and perspectives of patients, caregivers, and clinicians. They provided a variety of perspectives and stories on the personal and professional experience of managing chronic and acute pain.
- Presentations on community engagement themes are posted on the BSC website:
- The major themes from the community engagement and the public comments will be posted in the Federal Register, along with the draft updated Guideline.
- The Opioid Working Group was established to provide independent, broad, external, transparent input on the diverse and complex issues involved in updating the Guideline. The primary purpose of the OWG was to review the draft updated Guideline (as prepared by CDC) and to deliver a report describing the OWG’s findings and observations about the draft to the BSC/NCIPC.
- The OWG had 23 members. OWG members included patients with pain, caregivers, and family members of patients with pain. The OWG also included clinicians and subject matter experts. The members represented a diversity of perspectives, backgrounds, experiences, sexes, races/ethnicities, and geographic regions.
- The OWG was established on December 4, 2019, and held 11 virtual meetings from October 2020 through June 2021. The workgroup reviewed the processes used for community engagement, the framework used to rate the quality of evidence, and the draft of the Guideline update.
- The OWG presented its report to the BSC/NCIPC at a public meeting on July 16, 2021. An opportunity for public comment was published in the Federal Register: Federal Register :: Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC)external icon
- The BSC/NCIPC reviewed the OWG’s report and provided recommendations to the Department of Health and Human Services (HHS), which oversees CDC.
- In addition to 18 members selected by the HHS Secretary, the BSC/NCIPC includes 13 nonvoting ex-officio members from related federal agencies. The BSC is an HHS committee and BSC recommendations are sent to HHS for its response.
- The OWG included representatives from the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Food and Drug Administration (FDA), and the Indian Health Service (IHS).
- Additional federal partners will be engaged throughout the Guideline update process. Federal partners will have the opportunity to review the full draft updated Guideline as part of the final review and approval process.
- Opportunities for verbal and written input from the public have been available at four BSC/NCIPC meetings. Opportunities for public comment were published in the Federal Register.
- July 16, 2021: Federal Register :: Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC)external icon
- February 16, 2021: Federal Register :: Board of Scientific Counselors, National Center for Injury Prevention and Control; Correctionexternal icon
- August 20, 2020: Federal Register :: Board of Scientific Counselors, National Center for Injury Prevention and Controlexternal icon
- July 22, 2020: Federal Register :: Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC); Amended Notice of Meetingexternal icon
- CDC anticipates that the draft updated Guideline will be posted in the Federal Register for a 60-day public comment period by early 2022. This comment period will provide another critical opportunity for diverse input from the public.
- Peer review is planned to occur at the same time as the public comment period for the draft updated Guideline.
- The peer review panel will be selected by NCIPC Associate Directors for Science and senior leadership.
- Peer reviewers will be selected based on their expertise relevant to opioid prescribing, clinical and research practice, and related factors, while ensuring balance in scientific and technical perspectives, avoiding conflicts of interest, and ensuring independence from CDC and the process of developing the updated Guideline.
CDC carefully considers all input when revising the draft updated Guideline. Release of a final updated Guideline is anticipated in late 2022, along with a suite of translation and communication resources to facilitate effective implementation.
The following graphic provides an estimated timeline for the opportunities for engagement outlined above; if the timeline needs to be adjusted, changes will be reflected here.
See the PDF versionpdf icon.
Please continue to check this page for ongoing updates.
CDC anticipates that the draft updated Guideline will be posted in the Federal Register for a 60-day public comment period by early 2022. This comment period will provide another critical opportunity for diverse input from the public.
To receive email updates about this topic, enter your email address:
- Board of Scientific Counselors of the National Center for Injury Prevention and Control (BSC/NCIPC)
The Board of Scientific Counselors of the National Center for Injury Prevention and Control (BSC/NCIPC) is one of the federal advisory committees of the Centers for Disease Control and Prevention. The BSC/NCIPC advises the HHS Secretary; the CDC Director; and the NCIPC Director regarding surveillance; basic epidemiologic research; intervention research; and implementation, dissemination, and evaluation of promising and evidence-based strategies for the prevention of injury and violence. The BSC/NCIPC makes recommendations regarding policies, strategies, objectives, projects, and priorities and reviews progress toward injury and violence prevention.
- Federal Advisory Committee
Federal advisory committees are a key component of CDC’s overall strategy to achieve external stakeholder and public engagement in its efforts and commitment to improve people’s health. They provide advice or recommendations to the President of the United States or the agency on issues or policies within the scope of an agency’s responsibilities.
- Federal Register Notice (FRN)
The Federal Register external iconis the official journal of the United States Government. It provides legal notice of administrative rules and notices and Presidential documents in a comprehensive, uniform manner. A Federal Register Notice (FRN) is a specific post to the Federal Register. The Federal Register helps citizens and communities understand regulatory processes and participate in government decision-making processes. The website includes notices, proposed rules, and rules for comment across various federal agencies and topic areas. Here are resources to help navigate the website and commentary process:
Federal Register – Reader Aids – Using FederalRegister.Govexternal icon
Federal Register – Reader Aids – Videos & Tutorialsexternal icon
- Public Comment
For this effort, public comment opportunities include (a) the FRNs posted for community engagement on the experiences of patients, caregivers, and clinicians with the management of chronic and acute pain, (b) the multiple BSC/NCIPC meetings, and (c) the posting of the updated draft Guideline in the Federal Register.
- Department of Health and Human Services (HHS)
The mission of the U.S. Department of Health and Human Services (HHS)external icon is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.
- Board of Scientific Counselors of the National Center for Injury Prevention and Control (BSC/NCIPC)
- NCIPC Board of Scientific Counselors
- 2019 Opioid Workgroup
- CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 | MMWR
- Opioid Prescribing Guideline Resources
- Drug Overdose
- Grading of Recommendations Assessment, Development and Evaluation (GRADE)external icon
- Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011.