87 FR 223 pgs. 70823-70827 - CDC Clinical Practice Guideline for Prescribing Opioids for Pain—United States, 2022
Type: NOTICEVolume: 87Number: 223Pages: 70823 - 70827
Pages: 70823, 70824, 70825, 70826, 70827Docket number: [Docket No. CDC-2022-0024]
FR document: [FR Doc. 2022-25264 Filed 11-18-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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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.
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: opioids@cdc.gov.
[top] SUPPLEMENTARY INFORMATION:
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
• 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.
• 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.
• 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:
[top] 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.
(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
• 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.
• 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.
• 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.
• CDC added call-out boxes to the document to highlight critical information:
? Box 1. Executive summary of the CDC Clinical Practice Guideline for Prescribing Opioids for Pain-United States, 2022
? Box 2. Intended use of CDC's Clinical Practice Guideline for Prescribing Opioids for Pain-United States, 2022
? 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
? Box 4. Guiding principles for implementation of the CDC Clinical Practice Guideline for Prescribing Opioids for Pain-United States, 2022 recommendations
? Box 5. Areas for additional research to build the evidence base for optimal pain management
• 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.
• 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
• 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.
• 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.
• CDC augmented language in the implementation considerations for Recommendation 10 to state:
[top] 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
(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.
• 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. https://doi.org/10.1371/journal.pone.026534.
• 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. https://michigan-open.org/prescribing-recommendations.
• 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.
• 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.
• 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).
• 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
• CDC included Phillips et. al. in the references section.
• CDC added a citation to the Open Prescribing Recommendations again in reference to Recommendation 1.
• CDC deleted reference to the 2009 American Geriatric Society Guideline throughout the document.
• CDC added the references from the National Pain Advocacy Center. Several recommended references were already included in the draft clinical practice guideline.
? 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.
? 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.
? 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.
• CDC modified its inclusion from full AUDIT to AUDIT-C in the Supporting Rationale for Recommendation 7.
• CDC added additional family planning and contraceptive planning concepts and the following sources:
? ACOG Committee Opinion No. 762. American College of Obstetricians and Gynecologists. Obstet Gynecol 2019;133:e78-89.
? Patient-Centered Contraceptive Counseling. Committee Statement No. 1. American College of Obstetricians and Gynecologists. Obstet Gynecol 2022;139:349-53.
? Interpregnancy care. Obstetric Care Consensus No. 8. American College of Obstetricians and Gynecologists. Obstet Gynecol 2019;133:e51-72.
• 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 https://www.cdc.gov/opioids/guideline-update/index.html.
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.
[top] The Overview of Community Engagement and Public Comment Opportunities document provides a summary of efforts implemented throughout the clinical practice
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 https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm?s_cid=rr7103a1_w.
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