Opioid Analgesics: Risk Evaluation and Mitigation Strategy (REMS) and the New FDA Blueprint
Format: Webcourse
Credit(s): 3.00 (3 hrs)
Release Date: Aug 30, 2019
Expiration Date: Aug 30, 2020
Credit Type(s):
- CME / AMA PRA Category 1 Credit™
- MOC / ABIM MOC Part 2 Credit
- MOC / ABAI MOC Points
PROGRAM OVERVIEW
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.
AGENDA
Introduction
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
TARGET AUDIENCE
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.
EDUCATIONAL OBJECTIVES
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
ACCREDITATION
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.
CREDIT DESIGNATION
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.
FACULTY
Martin D. Cheatle, PhD
Associate Professor, Department of Psychiatry
Director of Pain and Chemical Dependency Research
Center for Studies of Addiction
Perelman School of Medicine, University of Pennsylvania
Philadelphia, PA
Associate Professor, Department of Psychiatry
Director of Pain and Chemical Dependency Research
Center for Studies of Addiction
Perelman School of Medicine, University of Pennsylvania
Philadelphia, PA
Martin D. Cheatle, PhD earned his PhD in psychology at Princeton University. He completed his clinical internship at the University of Pennsylvania School of Medicine and founded the Orthopedic Pain Center at Penn. He is the Director of Behavioral Medicine at the Penn Pain Medicine Center and Director of the Pain and Chemical Dependency Research at the Center for Studies of Addiction. He is also an Associate Professor of Psychiatry at the Perelman School of Medicine.
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.
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.
Jeff Gudin, MD
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
Newark, NJ
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
Newark, NJ
Jeff Gudin, MD completed his residency in anesthesiology at the Yale University School of Medicine and his fellowship at the Yale Center for Pain Management. While in New Haven, Dr. Gudin also trained in addiction medicine and directed a substance abuse treatment center. For the last 19 years, he has been the Director of the Pain Management and Wellness Center at Englewood Hospital and Medical Center. He is a Clinical Associate Professor of Anesthesiology at the Rutgers New Jersey Medical School. He remains active in teaching and research, and has lectured internationally on a variety of topics in pain management, 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.
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.
Bill McCarberg, MD
Adjunct Assistant Clinical Professor
University of California
San Diego, CA
Adjunct Assistant Clinical Professor
University of California
San Diego, CA
Bill McCarberg, MD is Founder of the Chronic Pain Management Program for Kaiser Permanente (retired) in San Diego, CA. He is currently working with Neighborhood Healthcare in Escondido California (Federally Qualified Health Center) and Elizabeth Hospice. He is Past President of the American Academy of Pain Medicine and President of the Western Pain Society. His is also Adjunct Assistant Clinical Professor at the University of California at San Diego School of Medicine.
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.
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
Diplomates of the American Board of Allergy and Immunology (ABAI) must attest to obtaining 25 hours of Allergy/Immunology-specific CME credits from accredited organizations every year in order to fulfill the lifelong learning component of MOC. Participation in this activity will support board certified allergists and immunologists in contributing towards this MOC requirement set forth by the ABAI.
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
Anesthesiology
Family Medicine
Internal Medicine
Medical Genetics and Genomics
Nuclear Medicine
Pediatrics
Physical Medicine and Rehabilitation
Preventive Medicine
Psychiatry and Neurology
Radiology
Thoracic Surgery
Urology
DISCLOSURE/CONFLICT OF INTEREST STATEMENT
In accordance with the appropriate accrediting bodies, all planners, teachers, and authors with control over activity content are required to disclose to the provider any relevant financial relationships (those held by the planner or significant other, currently or within the last 12 months) with commercial interests. Accredited providers are required to provide this information and disclosures will be provided at the activity.
DISCLAIMER
All information contained within this activity is intended for educational purposes only. Physicians and other healthcare professionals are encouraged to consult other sources and confirm the information contained in this site. No single reference or service can take the place of medical training, education and experience. This website does not define a standard of care, nor is it intended to dictate an exclusive course of management. This information should not substitute for a visit or consultation with a healthcare provider.
Program Faculty Disclosures
The program faculty reported the following relevant financial relationships that they or their spouse/partner have with commercial interests:
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
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
Non-faculty content contributors and/or reviewers reported the following relevant financial relationships that they or their spouse/partner have with commercial interests:
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.
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.
FDA DISCLOSURE
The contents of some CME/CE activities may contain discussions of non-approved or off-label uses of some agents mentioned. Please consult the prescribing information for full disclosure of approved uses.
SYSTEM REQUIREMENTS
In order to view this presentation, your computer must have audio capabilities (working speakers or headphones) and must have an internet browser capable of playing an HTML5 video.
INSTRUCTIONS FOR PARTICIPANTS AND OBTAINING CME CREDIT/MOC POINTS
There is no fee for this activity. To receive credit, participants must participate in the entire adaptive learning activity and complete the evaluation. The estimated time for completion of this activity is 3 hours. To receive their certificates, participants must demonstrate mastery of the presented material.
PROVIDER
This activity is jointly provided by University of North Texas Health Science Center and Rockpointe.
SUPPORTER
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.
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