Opioid Analgesics: Risk Evaluation and Mitigation Strategy (REMS) and the New FDA Blueprint
- CME / AMA PRA Category 1 Credit™
- MOC / ABIM MOC Part 2 Credit
- MOC / ABAI MOC Points
Physicians across many specialties manage acute and chronic pain in their patients on a daily basis. However, gaps in pain care for many physicians exist due to time limitations and lack of training in pain management.
With the many issues related to pharmacologic therapies for pain (i.e. misuse and noncompliance, addiction, adverse effects, tolerance, and polypharmacy), physicians are duly concerned. It is challenging for physicians to stay current with emerging evidence on abuse-deterrent formulations of opioid medications. Clinicians may feel uncomfortable communicating with patients about the issue of misuse and may not be prepared to make use of the prescription-drug-monitoring programs available to assist in identifying opioid misuse.
Presenting clinicians with a thorough review of the FDA’s “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain” will allow them to provide evidence-based pain management to their patients on a daily basis. The activity will also provide tools to help clinicians mitigate issues associated with opioid therapies, i.e. misuse and addiction, and take steps to avert the opioid addiction crisis.
The Need for Comprehensive Pain Education
Definitions and Mechanisms of Pain
Assessing Patients in Pain
Components of an Effective Treatment Plan
General Principles of Pharmacologic Analgesic Therapy
Managing Patients on Opioids Analgesics
Addiction Medicine Primer
This activity is intended for those involved with direct patient care, including clinicians registered with the DEA who are eligible to prescribe all opioid analgesics. In addition, because of the broad scope of the revised FDA Blueprint, the intended audience may include members of the healthcare team without authorization to prescribe.
At the conclusion of this activity, participants should be able to:
- Define components of an effective treatment plan, such as treatment goals, patient engagement, and collaboration within the healthcare team
- Assess the risks and benefits of non-pharmacologic therapies prior to initiating long-term pharmacologic therapy
- Identify patients who are candidates for treatment with nonopioid pharmacologic analgesics
- Evaluate criteria for initiating opioid analgesic
- Identify risk factors for addiction to opioid analgesics
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of University of North Texas Health Science Center (UNTHSC) and Rockpointe. UNTHSC is accredited by the ACCME to provide continuing medical education for physicians.
University of North Texas Health Science Center designates this enduring material for a maximum of 3.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Associate Professor, Department of Psychiatry
Director of Pain and Chemical Dependency Research
Center for Studies of Addiction
Perelman School of Medicine, University of Pennsylvania
Dr. Cheatle specializes in the evaluation and treatment of chronic pain disorders from a biopsychosocial perspective and has been involved in extensive research, including an NIH-funded 5-year longitudinal study of the development of addiction in patients initiating prescription opioid therapy for chronic pain and as Principal Investigator for an NIH/NIDA-grant assessing phenotypic and genotypic markers of prescription opioid abuse. His main focus of research is pain management and addiction in vulnerable populations (HIV/AIDS, psychiatric patients) and pain and suicidal ideation and behavior.
Pain Management and Wellness Center
Englewood Hospital and Medical Center
Clinical Associate Professor, Anesthesiology
Rutgers New Jersey Medical School
Board Certified Pain Management, Anesthesiology, Palliative Care and Addiction Medicine
Dr. Gudin has dedicated his career to promoting education in pain management. He attends and has presented at the American Pain Society, American Academy of Pain Management, American Academy of Physical Medicine and Rehabilitation, as well as many other national venues. Dr. Gudin serves as a consultant to state medical boards on challenging cases, as well as to industry on novel analgesic products and risk management associated with opioids.
Adjunct Assistant Clinical Professor
University of California
San Diego, CA
Dr. McCarberg is a member of the American Academy of Family Physicians, American Academy of Pain Medicine, American Pain Society, and International Association for the Study of Pain. Several of his awards and leadership positions include: national guideline committees for post-operative pain, fibromyalgia, and osteoarthritis; the Elizabeth Narcessian Award for Outstanding Educational Achievement in the Field of Pain from the American Pain Society; Presidential Commendation from the American Academy of Pain Medicine; Award of Honor for Excellence in Geriatric Medicine from the National Institute of Medicine; Mayday Pain and Society Fellowship; Award of Excellence from the Southern California Pain Initiative; Highest Rated Physician, Member Appraisal of Physician Services, from Kaiser Permanente; and Ambassador of the Year from the National Pain Foundation.
He has served on the Board of Directors of the American Pain Society and recently on the Professional Education and Training Sub-committee of the NIH’s Interagency Pain Research Coordinating Committee, which has proposed the US Department of Health and Human Service’s National Pain Strategy. He has given more than 250 presentations on pain management issues and is the author or co-author of 115 articles, book chapters, and books. He is board-certified by the American Board of Pain Medicine and the American Board of Family Practice and certified in geriatrics and hospice and palliative care. Dr. McCarberg received his medical doctorate from Northwestern University Medical School in Chicago, IL. He completed a medical internship and a residency in family practice at Highland Hospital in Rochester, NY.
ABIM MOC DESIGNATION STATEMENT
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 3.0 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.
To receive CME credit and/or MOC points, you MUST pass the post-test and complete the evaluation. For ABIM MOC points, your information will be shared with the ABIM through UNTHSC’s ACCME Program and Activity Reporting System (PARS). Please allow 6-8 weeks for your MOC points to appear on your ABIM records.
ABP PART 2 MOC DESIGNATION STATEMENT
Successful completion of this CME activity, which includes participation in the activity and individual assessment of and feedback to the learner, enables the learner to earn up to 3.0 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit learner completion information to ACCME for the purpose of granting ABP MOC credit.
To receive CME credit and/or MOC points, you MUST pass the post-test and complete the evaluation. For ABP MOC points, your information will be shared with the ABP through UNTHSC’s ACCME Program and Activity Reporting System (PARS). Please allow 6-8 weeks for your MOC points to appear on your ABP records.
ABAI MOC DESIGNATION STATEMENT
MOC Approval Statement
Through the American Board of Medical Specialties (“ABMS”) ongoing commitment to increase access to practice relevant Continuing Certification Activities through the ABMS Continuing Certification Directory, “Opioid Analgesics: Risk Evaluation and Mitigation Strategy (REMS) and the New FDA Blueprint” has met the requirements as a MOC Part II Self-Assessment or MOC Part II CME Activity (apply toward general CME requirement) for the following ABMS Member Boards:
MOC Part II Self-Assessment Activity
Physical Medicine and Rehabilitation
MOC Part II CME Activity
Allergy and Immunology
Medical Genetics and Genomics
Physical Medicine and Rehabilitation
Psychiatry and Neurology
DISCLOSURE/CONFLICT OF INTEREST STATEMENT
Program Faculty Disclosures
Martin D. Cheatle, PhD: Nothing to disclose
Jeffrey Gudin, MD: Consultant: AcelRx, BioDelivery Sciences International, KemPharm, Mallinckrodt, Nektar, Pernix, Quest Diagnostics; Speaker’s Bureau: AstraZeneca; Consultant/Speaker’s Bureau: Averitas, Daiichi Sankyo, Salix, Scilex
Bill McCarberg, MD: Consultant/Independent Contractor: Collegium, Daiichi Sankyo, Ferring, GlaxoSmithKline, Pfizer, Scilex; Speaker’s Bureau: Adapt, Ferring; Stock/Shareholder: Biospecifics Technologies, Collegium, Johnson and Johnson, Sellas Life Sciences
Non-faculty Content Contributors Disclosures
Terry Ann Glauser, MD, MPH; Chad Williamson, MS, MBA, CMPP; Blair St. Amand; Lisa Nash, DO, MS-HPEd, FAAFP; Ashley Marostica, MSN, RN, CCM: Nothing to disclose.
INSTRUCTIONS FOR PARTICIPANTS AND OBTAINING CME CREDIT/MOC POINTS
This activity is jointly provided by University of North Texas Health Science Center and Rockpointe.
This activity is supported by an independent educational grant from the Opioid Analgesic REMS Program Companies. For a listing of REMS Program Companies, please see: https://ce.opioidanalgesicrems.com/RpcCEUI/rems/pdf/resources/List_of_RPC_Companies.pdf. This activity is intended to be fully compliant with the Opioid Analgesic REMS education requirements issued by the US Food and Drug Administration.
Optimizing Care for Hereditary Angioedema: Strategies for Personalizing Treatment Selection and Effective Patient Communication
Credits 1.00 (60 min)