Notice2022-25264
CDC Clinical Practice Guideline for Prescribing Opioids for Pain-United States, 2022
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Published
November 21, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), announces the availability of the CDC Clinical Practice Guideline for Prescribing Opioids for Pain--United States, 2022 (2022 Clinical Practice Guideline). The 2022 Clinical Practice Guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016 (2016 Guideline) 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 (duration less than 1 month), subacute pain (duration of 1-3 months), or chronic pain (duration of more than 3 months). The recommendations in the 2022 Clinical Practice Guideline do not apply to pain management related to sickle cell disease, cancer-related pain treatment, palliative care, or end-of-life care. The 2022 Clinical Practice Guideline finalizes the draft clinical practice guideline issued on February 10, 2022.
Full Text
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<title>Federal Register, Volume 87 Issue 223 (Monday, November 21, 2022)</title>
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[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70823-70827]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25264]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2022-0024]
CDC Clinical Practice Guideline for Prescribing Opioids for
Pain--United States, 2022
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the Department of Health and Human Services (HHS), announces the
availability of the CDC Clinical Practice Guideline for Prescribing
Opioids for Pain--United States, 2022 (2022 Clinical Practice
Guideline). The 2022 Clinical Practice Guideline updates and expands
the CDC Guideline for Prescribing Opioids for Chronic Pain--United
States, 2016 (2016 Guideline) 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 (duration less than 1 month), subacute pain (duration of 1-3
months), or chronic pain (duration of more than 3 months). The
recommendations in the 2022 Clinical Practice Guideline do not apply to
pain management related to sickle cell disease, cancer-related pain
treatment, palliative care, or end-of-life care. The 2022 Clinical
Practice Guideline finalizes the draft clinical practice guideline
issued on February 10, 2022.
DATES: The 2022 Clinical Practice Guideline is available November 21,
2022.
FOR FURTHER INFORMATION CONTACT: Arlene I. Greenspan, National Center
for Injury Prevention and Control, Centers for Disease Control and
Prevention, 4770 Buford Highway NE, MS S106-9, Atlanta, GA 30341;
Telephone: 770-488-4696. Email: <a href="/cdn-cgi/l/email-protection#523d223b3d3b3621123136317c353d24"><span class="__cf_email__" data-cfemail="c3acb3aaacaaa7b083a0a7a0eda4acb5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
[[Page 70824]]
Background
In the 2016 Guideline, CDC communicated the intent to evaluate and
reassess evidence and recommendations for opioid prescribing for adult
patients as new evidence became available and to determine when new
evidence would prompt an update. To achieve these aims, CDC funded the
Evidence-based Practice Centers at the Agency for Healthcare Research
and Quality (AHRQ) to conduct systematic reviews of the scientific
evidence in the following five areas: (1) noninvasive (e.g., exercise,
physical therapy, psychological therapies), nonpharmacological
treatments for chronic pain; (2) nonopioid pharmacologic treatments for
chronic pain; (3) opioid treatments for chronic pain; (4) treatments
for acute pain; and (5) acute treatments for episodic migraine. Based
on the evidence described in these reviews, an update to the 2016
Guideline was warranted.
CDC developed the 2022 Clinical Practice Guideline recommendations
using the Grading of Recommendations, Assessment, Development, and
Evaluation (GRADE) framework, which specifies the systematic review of
scientific evidence and offers a transparent approach to grading
quality of evidence and strength of recommendations. Recommendations
were made based on systematic reviews of the available scientific
evidence while considering benefits and harms; patient, caregiver, and
clinician values and preferences for pain treatment; and resource
allocation (e.g., costs to patients or health systems, including
clinician time). CDC drafted recommendation statements in the 2022
Clinical Practice Guideline to assist clinicians in determining whether
or not to initiate opioids for pain, selecting opioids and determining
opioid dosages, deciding duration of initial opioid prescription and
conducting follow-up, and assessing risk and addressing potential harms
of opioid use.
The 2022 Clinical Practice Guideline includes recommendations for
primary care clinicians (including physicians, nurse practitioners, and
physician assistants) 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 2022 Clinical Practice Guideline is not a regulation or a law.
It is a set of voluntary recommendations intended to support clinicians
as they work in consultation with their patients to address pain. It is
intended to be flexible to support, not supplant, clinical judgment and
individualized, patient-centered decision-making. It is not intended to
be applied as inflexible standards of care across patient populations
by healthcare professionals, health systems, third-party payers,
organizations, or governmental jurisdictions. The 2022 Clinical
Practice Guideline is intended to achieve the following: improved
communication between clinicians and patients about the risks and
benefits of pain treatment, including opioid therapy for pain; improved
safety and effectiveness for pain treatment, resulting in improved
function and quality of life for patients experiencing pain; and
reduction in the risks associated with long-term opioid therapy,
including opioid use disorder, overdose, and death.
To help ensure the 2022 Clinical Practice Guideline's integrity,
credibility, and consideration of patient, caregiver, and clinician
values and preferences, CDC obtained input through individual
conversations with patients, caregivers, experts, clinicians, through
public comment opportunities, and a federally chartered advisory
committee, the Board of Scientific Counselors of the National Center
for Injury Prevention and Control (BSC/NCIPC). CDC also obtained
feedback from a panel of external peer reviewers who are experts in
topics related to opioid prescribing.
Summary of Public Comment and CDC Response
On February 10, 2022, CDC published a notice in the Federal
Register announcing the availability of the draft clinical practice
guideline (87 FR 7838). The notice gave the public an opportunity to
submit comments by April 10, 2022. CDC received approximately 5,500
unique comments (including one comment submitted with 28,322 additional
signatories) from the public, including patients with acute and chronic
pain, caregivers, and clinicians. Comments also included organizational
perspectives from medical associations, professional organizations,
academic institutions, state and local governments, and advocacy and
industry groups.
CDC carefully catalogued, reviewed, and qualitatively analyzed all
comments submitted by members of the public. All public comments were
carefully reviewed and considered when revising the draft clinical
practice guideline. Most comments submitted to the public docket for
the draft clinical practice guideline were submitted by individuals
living with pain and their caregivers, families, and friends.
CDC highly values insights gained from these public comments and
especially thanks those patients living with pain who shared their
personal experiences in this public forum.
Themes from the comments included: (1) concerns about the 2016
Guideline; (2) overall considerations for the 2022 Clinical Practice
Guideline; (3) considerations for Recommendation Statements in the 2022
Clinical Practice Guideline; and (4) suggestions for scientific
articles to include in supporting rationales to supplement information
from the systematic reviews about acute and chronic pain management.
(1) Concerns about the 2016 Guideline
Respondents shared their personal experiences with pain care,
including with misinterpretation and misapplication of the 2016
Guideline. In particular, they mentioned issues with misapplication
related to prescribed dosing limits and forced tapers.
CDC Response
<bullet> CDC added language to the 2022 Clinical Practice Guideline
emphasizing that it provides voluntary clinical practice
recommendations that are not intended to be inflexible standards of
care or implemented as absolute limits of policy or practice for
patients by clinicians, healthcare systems, or government entities.
<bullet> CDC added language throughout the document that further
emphasizes that both the benefits and the risks of continuing opioid
therapy should be considered by clinicians when providing pain care for
patients.
<bullet> CDC added discussion throughout the document pertaining to
changes related to dosage thresholds and appropriate application. For
example, the following was added to the Rationale:
Importantly, to discourage the misapplication of opioid pain
medication dosage thresholds as inflexible standards, revised
recommendation statement language emphasizes principles such as
avoiding increasing dosage above levels likely to yield diminishing
returns in benefits relative to risks to patients. More specific
considerations related to dosage have been moved to implementation
considerations that follow each recommendation statement, where more
nuance is offered to inform clinical decision-making and individualized
patient care.
[[Page 70825]]
(2) Overall Considerations for the 2022 Clinical Practice Guideline
Respondents focused on the importance of clinician judgment that
promotes flexible opioid prescribing practices focused on the
individual patient. They were appreciative of CDC's inclusion of
language emphasizing open communication between patients and clinicians
and updated language to discourage forced tapers. Regarding the latter,
respondents encouraged CDC to further emphasize and strengthen this
language.
Many respondents expressed concern that mention of specific
morphine milligram equivalents in the 2022 Clinical Practice Guideline
would lead to hard limits on opioid prescriptions. Respondents also
were concerned that specific pain conditions were called out as
conditions to which the draft clinical practice guideline was not
applicable while others went unmentioned.
Respondents noted that the length of the draft clinical practice
guideline was a barrier to end users. However, respondents also noted
that several organizational features of the draft clinical practice
guideline were helpful, such as a call-out box that summarizes its
intended use, including conditions for which it is not applicable.
Respondents suggested that additional detail in these boxes would be
beneficial for those who may not read beyond this content. In addition,
professional organizations suggested the development of supplemental
one-pagers and supporting materials to further increase the utility of
the document.
Finally, some respondents providing comments on behalf on
individuals with non-pain related conditions that use opioids for
treatment (e.g., ostomy-related conditions and restless leg syndrome
[RLS]) proposed that the 2022 Clinical Practice Guideline title should
be adjusted to better reflect its content and intended use.
CDC Response
<bullet> CDC added language throughout the document to emphasize
that the 2022 Clinical Practice Guideline provides voluntary clinical
practice recommendations that are not intended to be inflexible
standards of care or implemented as absolute limits of policy or
practice for patients by clinicians, healthcare systems, or government
entities.
<bullet> CDC added discussion throughout the document pertaining to
changes related to dosage thresholds and appropriate application. For
example, the following was added to the Rationale:
Importantly, to discourage the misapplication of opioid pain
medication dosage thresholds as inflexible standards, revised
recommendation statement language emphasizes principles such as
avoiding increasing dosage above levels likely to yield diminishing
returns in benefits relative to risks to patients. More specific
considerations related to dosage have been moved to the Implementation
Considerations that follow each recommendation statement, where more
nuance is offered to inform clinical decision-making and individualized
patient care.
<bullet> CDC revised language in the scope and audience section to
further emphasize that all types of pain need effective treatment:
Although some principles in this clinical practice guideline might
be helpful in the management of pain related to sickle cell disease,
cancer-related pain treatment, palliative care, and end-of-life care,
some recommendations might not be relevant for pain management in these
contexts. Other guidelines more specifically address pain management in
these situations; therefore, this clinical practice guideline does not
apply to patients experiencing pain associated with these conditions or
types of care. This does not imply that any other types of pain are
more or less worthy of effective treatment, only that clinicians are
referred to existing clinical guidelines that more specifically address
unique considerations for management of pain related to sickle cell
disease, cancer-related pain treatment, palliative care, and end-of-
life care.
<bullet> CDC added call-out boxes to the document to highlight
critical information:
[cir] Box 1. Executive summary of the CDC Clinical Practice
Guideline for Prescribing Opioids for Pain-United States, 2022
[cir] Box 2. Intended use of CDC's Clinical Practice Guideline for
Prescribing Opioids for Pain-United States, 2022
[cir] Box 3. Recommendations for prescribing opioids for
outpatients with pain, excluding pain management for sickle cell
disease, cancer-related pain treatment, palliative care, and end-of-
life care; recommendation categories; and evidence types, CDC Clinical
Practice Guideline for Prescribing Opioids for Pain-United States, 2022
[cir] Box 4. Guiding principles for implementation of the CDC
Clinical Practice Guideline for Prescribing Opioids for Pain-United
States, 2022 recommendations
[cir] Box 5. Areas for additional research to build the evidence
base for optimal pain management
<bullet> CDC is developing translation and communication materials
to support accurate implementation of the 2022 Clinical Practice
Guideline. These resources will be short references and ``at-a-glance''
materials to support appropriate application and interpretation.
<bullet> CDC changed the name of the document from the CDC Clinical
Practice Guideline for Prescribing Opioids to the CDC Clinical Practice
Guideline for Prescribing Opioids for Pain to further emphasize its
focus on prescription opioids for the treatment of pain.
(3) Considerations for Recommendation Statements in the 2022 Clinical
Practice Guideline
Respondents noted that frequent follow-up appointments, office
visits, and drug screening requirements were barriers to care and
health equity. They also expressed concern about stigma related to
toxicology testing.
CDC Response
<bullet> CDC added language to address health equity and additional
considerations and context related to health equity, such as language
about using virtual follow-up visits for patients for whom virtual
visits are part of standard care (e.g., in remote areas where distance
or other context makes follow-up visits challenging) or for patients
for whom in-person follow-up visits are challenging (e.g., frail
patients) under Recommendation 7's implementation considerations and
supporting text.
<bullet> The second sentence of Recommendation 7 has been changed
from ``Clinicians should evaluate benefits and risks of continued
therapy with patients every 3 months or more frequently'' to
``Clinicians should regularly reevaluate benefits and risks of
continued opioid therapy with patients.'' Of note, the more specific
``3-month'' time frame is still discussed in the Implementation
Considerations and Supporting Rationale, where more nuanced
considerations for flexibility are discussed.
<bullet> CDC augmented language in the implementation
considerations for Recommendation 10 to state:
Toxicology testing should not be used in a punitive manner but
should be used in the context of other clinical information to inform
and improve patient care. Clinicians should not
[[Page 70826]]
dismiss patients from care on the basis of a toxicology test result.
Dismissal could have adverse consequences for patient safety,
potentially including the patient obtaining opioids or other drugs from
alternative sources and the clinician missing opportunities to
facilitate treatment for substance use disorder.
(4) Suggestions for Scientific Articles About Acute and Chronic Pain
Management
Some respondents submitted scientific articles about acute and
chronic pain management for CDC to consider citing as additional
informative references in the supporting rationales. CDC carefully
reviewed each submitted comment and made edits or added additional
citations to the draft clinical practice guideline where appropriate.
Some examples of recommended sources and revisions are below.
<bullet> To demonstrate the undertreatment of sickle cell disease
due to stigma and racism, the organization Sick Cells recommended that
CDC cite this reference: Phillips S, Chen Y, Masese R, Noisette L,
Jordan K, et al. (2022) Perspectives of individuals with sickle cell
disease on barriers to care. PLOS ONE 17(3): e0265342. <a href="https://doi.org/10.1371/journal.pone.026534">https://doi.org/10.1371/journal.pone.026534</a>.
<bullet> The Michigan Opioid Prescribing Engagement Network
suggested that CDC cite its OPEN Prescribing Recommendations as an
additional reference for Recommendation 1. This reference was already
included in the document: Michigan Opioid Prescribing Engagement
Network. Prescribing recommendations. Ann Arbor, MI: Michigan Opioid
Prescribing Engagement Network. <a href="https://michigan-open.org/prescribing-recommendations">https://michigan-open.org/prescribing-recommendations</a>.
<bullet> The American Geriatric Society noted that a reference to
its 2009 American Geriatric Society Recommendations for Chronic Pain
Medications in Older Adults (AGS Guideline) was not current and
recommended CDC cite different sources for its discussion of the use of
acetaminophen for the treatment of pain among adults aged 18 and over.
<bullet> The National Pain Advocacy Center stated that several
studies finding adverse outcomes after opioid stoppage, dose reduction,
or dose variation were not cited or were cited inaccurately.
<bullet> The American Academy of Addiction Psychiatry recommended
the inclusion of the Alcohol Use Disorders Identification Consumption
Test (AUDIT-C), as done by the Veterans Health Administration, instead
of the full Alcohol Use Disorders Identification Test (AUDIT).
<bullet> The American College of Obstetrics and Gynecology (ACOG)
recommended that other critical concepts regarding family planning and
contraceptive counseling from additional resources be included in the
document. ACOG also recommended an additional reference with safety
data regarding buprenorphine/naloxone combination use in pregnancy:
Link HM, Jones H, Miller L, Kaltenbach K, Seligman N. Buprenorphine-
naloxone use in pregnancy: a systematic review and metaanalysis. Am J
Obstet Gynecol MFM. 2020 Aug;2(3):100179. doi: 10.1016/
j.ajogmf.2020.100179. Epub 2020 Jul 3. PMID: 33345863.
CDC Response
<bullet> CDC included Phillips et. al. in the references section.
<bullet> CDC added a citation to the Open Prescribing
Recommendations again in reference to Recommendation 1.
<bullet> CDC deleted reference to the 2009 American Geriatric
Society Guideline throughout the document.
<bullet> CDC added the references from the National Pain Advocacy
Center. Several recommended references were already included in the
draft clinical practice guideline.
[cir] Hallvik SE, El Ibrahimi S, Johnston K, et al. Patient
outcomes after opioid dose reduction among patients with chronic opioid
therapy. Pain. 2022;163(1):83-90.
[cir] Binswanger IA, Glanz JM, Faul M, et al. The Association
between Opioid Discontinuation and Heroin Use: A Nested Case-Control
Study. Drug and Alcohol Dependence. 2020;217:108248.
[cir] Perez HR, Buonora M, Cunningham CO, Heo M, Starrels JL.
Opioid Taper Is Associated with Subsequent Termination of Care: a
Retrospective Cohort Study. J Gen Intern Med. 2020;35(1):36-42.
<bullet> CDC modified its inclusion from full AUDIT to AUDIT-C in
the Supporting Rationale for Recommendation 7.
<bullet> CDC added additional family planning and contraceptive
planning concepts and the following sources:
[cir] ACOG Committee Opinion No. 762. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2019;133:e78-89.
[cir] Patient-Centered Contraceptive Counseling. Committee
Statement No. 1. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2022;139:349-53.
[cir] Interpregnancy care. Obstetric Care Consensus No. 8. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2019;133:e51-72.
<bullet> CDC added Link. et al.
For more information about CDC's response to peer reviewers' and
public comments, please see the Supporting & Related Materials tab of
this docket.
For more information about the 2022 Clinical Practice Guideline or
the process of updating it, please visit <a href="https://www.cdc.gov/opioids/guideline-update/index.html">https://www.cdc.gov/opioids/guideline-update/index.html</a>.
Supporting and Related Material in the Docket
The docket contains the following supporting and related materials:
(1) the 2022 Clinical Practice Guideline; (2) the GRADE tables; (3)
CDC's response to peer review of the draft clinical practice guideline;
(4) CDC's response to public comments on the draft clinical practice
guideline; (5) the draft clinical practice guideline released for
public comment on February 10, 2022; (6) the Opioid Workgroup (OWG)
Report, prepared at the request of the BSC/NCIPC and which the BSC/
NCIPC unanimously voted to have CDC adopt, and CDC's response to
observations outlined in the OWG Report; and (7) an Overview of
Community Engagement and Public Comment Opportunities, which describes
key themes that emerged about participant values and preferences
regarding pain management, as well as CDC's response to input obtained
from these efforts.
The GRADE tables include clinical evidence review ratings of the
evidence for the key clinical questions. The OWG Report describes the
workgroup's findings and observations about an initial draft clinical
practice guideline presented to the BSC/NCIPC at a public meeting on
July 16, 2021. The OWG, comprising three BSC/NCIPC members in
accordance with federal advisory committee policy, as well as patients
with pain, caregivers, and family members of patients with pain, and
clinicians and subject matter experts with a variety of relevant pain
management expertise, was designed to provide independent, broad,
external, and transparent input to the BSC/NCIPC on the diverse and
complex issues addressed in the draft clinical practice guideline. OWG
meetings were coordinated by an NCIPC subject matter expert who served
as the Designated Federal Official. CDC's response to the OWG Report
reflects and describes how CDC incorporated OWG observations and
comments in the revised draft clinical practice guideline.
The Overview of Community Engagement and Public Comment
Opportunities document provides a summary of efforts implemented
throughout the clinical practice
[[Page 70827]]
guideline update process to better understand the lived experiences and
perspectives of community members and to ensure additional input from
patients, caregivers, clinicians, and the public. This document also
summarizes CDC's response to the themes and findings that emerged
throughout the community engagement and public comment opportunities
and describes how CDC carefully considered and incorporated diverse
perspectives and input from multiple sources into the draft clinical
practice guideline that was posted for public comment.
Availability of the 2022 Clinical Practice Guideline
The CDC Clinical Practice Guideline for Prescribing Opioids for
Pain--United States, 2022 can be found in the Supporting & Related
Materials tab of this docket on the Federal eRulemaking Portal:
identified by Docket No. CDC-2022-0024 and at <a href="https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm?s_cid=rr7103a1_w">https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm?s_cid=rr7103a1_w</a>.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-25264 Filed 11-18-22; 8:45 am]
BILLING CODE 4163-18-P
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