draft update cdc guidlines for prescribing
- 1. National Center for Injury Prevention and Control Draft Updated CDC Guideline for Prescribing Opioids: Background, Overview, and Progress Deborah Dowell, MD, MPH CAPT, USPHS Chief Clinical Research Officer Division of Overdose Prevention BSC/NCIPC Meeting July 16, 2021
- 2. Updating the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain: background
- 3. SLIDE SUB-HEADLINE PLACEHOLDER Slide body copy and paragraph text placeholder. Guidelines like the opioid prescribing guideline help ensure patients receive safe, effective pain treatment, including opioids when the benefits outweigh the risks. Guidelines like the opioid prescribing guideline help ensure patients receive safe, effective pain treatment, including opioids when the benefits outweigh the risks.
- 4. Pain is one of the most common reasons adults seek medical care. Acute pain (duration <1 month) is a physiologic response to noxious stimuli that can become pathologic, is normally sudden in onset, time limited, and often caused by injury, trauma, or medical treatments such as surgery. Chronic pain (duration of ≥3 months) can be the result of an underlying medical disease or condition, injury, medical treatment, inflammation, or an unknown cause. Chronic pain is often interlinked with acute pain.
- 5. Chronic pain is the leading cause of disability in the U.S. It is estimated that ~1 in 5 U.S. adults had chronic pain in 2019. ~1 in 14 adults experienced high- impact chronic pain, defined as having pain most days or every day in the past three months that limited life or work activities. Zelaya, C. E., Dahlhamer, J. M., Lucas, J. W., & Connor, E. M. (2020). Chronic Pain and High-impact Chronic Pain Among U.S. Adults, 2019. NCHS Data Brief(390), 1-8.
- 6. Pain is a complex phenomenon. Pain is influenced by many factors, including biological, psychological, and social factors. There are substantial differences in pain treatment effectiveness. Prevention, assessment, and treatment of pain is a persistent challenge for clinicians and health systems.
- 7. Need for opioid prescribing guideline in 2016 • Need for clear recommendations incorporating recent evidence • Existing guidelines were several years old and did not reflect newer evidence
- 8. The guideline was released March 15, 2016 in the Morbidity and Mortality Weekly Report and in the Journal of the American Medical Association.
- 9. 2016 CDC Guideline: purpose, use, and primary audience • Recommendations for prescribing opioid pain medications: • for patients 18 and older • in outpatient, primary care settings • in treating chronic pain • Not intended for use in cancer treatment, palliative care, or end-of-life care • Primary audience: primary care clinicians • family practice, internal medicine • physicians, nurse practitioners, physician assistants
- 10. Organization of 2016 CDC Guideline recommendations 12 recommendations were grouped into three conceptual areas: • Determining when to initiate or continue opioids for chronic pain • Opioid selection, dosage, duration, follow-up, and discontinuation • Assessing risk and addressing harms of opioid use
- 11. 2016 CDC Guideline – 12 recommendations Determining when to initiate or continue opioids for chronic pain 1. Opioids not first-line or routine therapy for chronic pain 2. Set goals for pain and function when starting 3. Discuss expected benefits and risks with patients Opioid selection, dosage, duration, follow-up and discontinuation 4. Start with short-acting opioids 5. Prescribe lowest effective dose; reassess benefits and risks when increasing dose, especially to >50 MME; avoid or justify escalating dosages to >90 MME 6. Prescribe no more than needed for acute pain; 3 days often sufficient; >7 days rarely needed 7. If benefits of continuing opioids do not outweigh harms, optimize other therapies and work with patients to taper Assessing risk and addressing harms of opioid use 8. Assess risks; consider offering naloxone 9. Check PDMP for other prescriptions, high total dosages 10.Check urine for other controlled substances 11.Avoid concurrent benzodiazepines and opioids whenever possible 12.Arrange medication-assisted treatment for opioid use disorder
- 12. 2016 CDC Guideline implementation Translation and communication Clinician training/education Health systems Insurers/payers 3 4 2 1
- 13. Overall and high-risk opioid prescribing decreased at accelerated rates following 2016 CDC Guideline release From Bohnert ASB, Guy GP Jr, Losby JL. Opioid Prescribing in the United States Before and After the Centers for Disease Control and Prevention's 2016 Opioid Guideline. Ann Intern Med. 2018 Sep 18;169(6):367-375 Pre-Guideline (1/2012) Monthly decline prior to Guideline release (1/2012-2/2016) Monthly decline following Guideline release (4/2016-12/2017) Opioid prescribing rate/100K population 6577 -23.48 (CI, -26.18 to -20.78) -56.74 (CI, -65.96 to -47.53) Patients with overlapping opioid + benzodiazepine Rx (%) 21.04% -0.02% (CI, -0.04% to -0.01%) -0.08% (CI, -0.08% to -0.07%) High-dosage opioid Rx (≥90 MME/day)/100k population 683 -3.56 (95% CI, -3.79 to -3.32) -8.00 (CI, -8.69 to -7.31)
- 14. Some policies and practices attributed to the 2016 Guideline were misapplications of its recommendations Examples of misapplications of recommendations: • To impose hard limits or “cutting off” opioids • To populations outside of the 2016 Guideline’s scope (e.g., to patients with cancer pain or post-surgical pain) • To patients receiving or starting medications for opioid use disorder The 2016 Guideline does not support abrupt tapering or sudden discontinuation of opioids.
- 15. CDC responses to misapplication of the 2016 Guideline beyond its intended scope CDC February 28, 2019 - Letter to ASCO*, ASH*, and NCCN*: • The Guideline provides recommendations for prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. • Guidelines addressing pain control in sickle cell disease should be used to guide decisions. • Clinical decision-making should be based on: • an understanding of the patient’s clinical situation, functioning, and life context • careful consideration of the benefits and risks of all treatment options, including opioid therapy *American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH), National Comprehensive Cancer Network® (NCCN)
- 16. The New England Journal of Medicine “there are no shortcuts to safer opioid prescribing… or to appropriate and safe reduction or discontinuation of opioid use” DOI: 10.1056/NEJMp1904190 No Shortcuts to Safer Opioid Prescribing Deborah Dowell, M.D., M.P.H., Tamara Haegerich, Ph.D., and Roger Chou, M.D.
- 17. Pocket Guide: Tapering Opioids for Chronic Pain
- 18. HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics
- 19. In the 2016 CDC Guideline, CDC indicated the intent to evaluate the Guideline as new evidence became available and to determine when sufficient new evidence would prompt an update. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016;65(RR-1):1-49. CDC outlined the potential for a future update in the 2016 Guideline.
- 20. New evidence has emerged since release of the 2016 Guideline. • Benefits and harms of opioids for acute and chronic pain • Comparisons with nonopioid pain treatments • Opioid tapering and discontinuation New evidence has emerged since release of the 2016 Guideline.
- 21. Requests for CDC to provide recommendations on opioid prescribing for acute pain from: Professional specialty societies U.S. policymakers Media
- 22. Updated Guideline development Prior to drafting the updated Guideline, CDC obtained input from patients, caregivers, clinicians, and the public.
- 23. Community engagement summary Patients, caregivers, and clinicians provided input on their lived experiences and perspectives related to pain and pain management options. Key themes expressed included: • Need for patients and clinicians to make shared decisions • The impact of misapplication of the 2016 CDC Guideline • Inconsistent access to effective pain management solutions • Achieving reduced opioid use through diverse approaches
- 24. CDC funded the Agency for Healthcare Research and Quality (AHRQ) to conduct five systematic reviews Chronic Pain Noninvasive Nonpharmacological Treatment for Chronic Pain (An Update) Nonopioid Pharmacologic Treatments for Chronic Pain Opioid Treatments for Chronic Pain Completed April 2020—with updates into 2022 Acute Pain Treatments for Acute Pain Systematic Review Treatments for Acute Episodic Migraine Completed December 2020— with updates into 2022
- 25. Several noninvasive, nonpharmacologic treatments are associated with sustained improvements in pain and/or function. Across several common acute pain conditions: • NSAIDs associated with similar or greater improvements in pain and function than opioids • Evidence of diminished pain reduction over time with opioids Evidence on long-term effectiveness of opioids remains very limited. Evidence summaries 1
- 26. Serious adverse events associated with medications included • Cardiovascular, gastrointestinal, or renal effects with NSAIDs • Opioid use disorder and overdose with opioids Many noninvasive, nonpharmacologic treatments are not associated with serious harms. Evidence summaries 2
- 27. Tapering or discontinuing opioids in patients who have taken them long-term can be associated with significant harms, particularly if: • Opioids are tapered rapidly • Patients do not receive effective support Evidence summaries 3
- 29. Information presented today is based on the DRAFT updated Guideline. The updated Guideline is still in development. Release is anticipated in late 2022. Information presented today is based on the DRAFT updated Guideline. The updated Guideline is still in development. Release is anticipated in late 2022.
- 30. The purpose of the Guideline is to support clinicians and patients to work together to create and maintain safe, consistent, and effective personal treatment plans. The purpose of the Guideline is to support clinicians and patients to work together to create and maintain safe, consistent, and effective personal treatment plans.
- 31. Updated Guideline development This guideline is intended to: • Improve communication between clinicians and patients about benefits and risks of opioid therapy for pain • Improve the safety and effectiveness of pain treatment • Reduce risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death
- 32. This guideline provides guidance only and does not replace clinical judgment and individualized decision-making. • The Guideline is a tool to enhance the patient-provider relationship, informing the decision-making process and treatment planning. • Recommendations for clinicians are intended to improve pain management and patient safety. The Guideline is not a law, set of regulations or requirements.
- 33. Primary care clinicians physicians, nurse practitioners, and physician assistants Outpatient clinicians in other specialties those managing dental and postsurgical pain and emergency clinicians providing pain management for patients being discharged from emergency departments Recommendations for clinicians who are prescribing opioids for outpatients: • Aged ≥18 years • Acute (duration <1 month) or subacute (duration of 1-3 months) pain • Chronic (duration of ≥3 months) pain • Outside of sickle cell disease-related pain management, cancer pain treatment, palliative care, and end-of-life care Updated Guideline audience
- 34. Based on input from patients, caregivers, clinicians, and the public as well as on new evidence, the updated guideline draft includes: • Expanded guidance on acute and subacute pain • Updated information on benefits and risks of nonpharmacologic, nonopioid pharmacologic, and opioid therapies for chronic pain • Expanded guidance on opioid tapering and on pain management for patients already receiving opioids long-term Updated Guideline scope
- 35. The updated draft recommendations address: 1) Determining whether or not to initiate opioids for pain 2) Opioid selection and dosage 3) Opioid duration and follow-up 4) Assessing risk and addressing harms of opioid use Updated Guideline focus areas
- 36. CDC developed the updated draft recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. Recommendations are made on the basis of a systematic review of the scientific evidence while considering: • Benefits and harms • Values and preferences • Resource allocation (e.g., costs to patients or health systems, including clinician time) Updated Guideline development
- 37. Category A: Most patients should receive the recommended course of action Category B: Individual decision making required; advantages and disadvantages of a clinical action are more balanced GRADE recommendation categories
- 38. Type 1: Randomized controlled trials (RCTs); overwhelming observational studies Type 2: RCTs (limitations); strong observational Type 3: RCTs (notable limitations); observational Type 4: RCTs (major limitations); observational (notable limitations) clinical experience GRADE evidence types
- 39. Each draft recommendation is followed by a draft rationale for the recommendation, with considerations for implementation noted.
- 40. Anticipated that the draft updated Guideline will be posted in the Federal Register for a 60-day public comment period by the end of 2021. Upcoming public comment opportunity
- 41. Anyone who would like to receive information related to the ongoing work of the NCIPC, specific to drug overdose prevention (including the ongoing response to the opioid overdose epidemic) as well as other drug overdose updates (e.g., pertaining to resources and tools), may sign up at www.cdc.gov/emailupdates and select topics of interest. Subscription Topics: Injury, Violence, and Safety Subtopic: Drug Overdose News
- 42. Our ultimate goal is to help people set and achieve personal goals for pain and function. Our ultimate goal is to help people set and achieve personal goals for pain and function.
- 43. When rigorously developed and judiciously implemented, clinical practice guidelines can optimize clinical decision-making by: • Reducing inappropriate practice variation • Enhancing the translation of research into practice • Increasing patient safety • Improving healthcare quality and outcomes Conclusion
- 44. Draft updated Guideline authors Deborah Dowell, MD Kathleen Ragan, MSPH Christopher M. Jones, PharmD, DrPH Grant T. Baldwin, PhD Roger Chou, MD BSC/NCIPC Opioid Workgroup Chinazo O. Cunningham, MD, MS (Chair) Anne L. Burns, RPh Beth Darnall, PhD Frank Floyd, MD, FACP Christine Goertz, DC, PhD Elizabeth Habermann, PhD, MPH Joseph Hsu, MD Marjorie Meyer, MD Paul Moore, DMD, PhD, MPH Aimee Moulin, MD, MAS Kate Nicholson, JD Tae Woo Park, MD, MSc Jeanmarie Perrone, MD Travis Reider, PhD, MA Roberto Salinas, MD, CAQ, (G, HPM) Doreleena Sammons-Hackett, SM, CPM Wally R. Smith, MD Jennifer Waljee, MD, MPH, MS Mark Wallace, MD Wilson Compton, MD, MPE (Ex-Officio) Neeraj Gandotra, MD (Ex-Officio) Mallika Mundkur, MD, MPH (Ex-Officio) Stephen Rudd, MD, FAAFP, CPPS (Ex-Officio) Melanie R. Ross, MPH, MCHES (Designated Federal Official) Thank you to all the patients, caregivers, clinicians, and other individuals who shared their input and experiences during the community engagement opportunities. Acknowledgements
- 45. Thank you! The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.