Opioid Analgesics: Risk Evaluation and Mitigation Strategy (REMS)

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Release Date: June 28, 2019
Expiration Date: June 28, 2020

AGENDA
Need for Comprehensive Pain Education
Definitions and Mechanisms of Pain
Assessing Patients in Pain
General Principles of Nonpharmacologic Approaches
General Principles of Pharmacologic Analgesic Therapy
Neurobiology of Addiction
Take-home Points

PROGRAM OVERVIEW
Pain continues to be a significant public-health problem in the US, causing significant reductions in patients’ quality of life. Despite the pain-relieving properties of opioid medications, patients with acute and chronic pain are often undertreated due to a variety of physician- and patient-related concerns and barriers, including the potential for misuse and abuse.

The Food and Drug Administration (FDA) developed the Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits outweigh the risks with opioid treatments. The FDA Blueprint was recently updated to include more information on pain management, including components of an effective treatment plan, nonpharmacologic and pharmacologic treatments for pain (nonopioid and opioid analgesics), and a primer on addiction medicine. The updated blueprint applies not only to prescribers, but to all healthcare providers involved in the management of patients with acute and chronic pain.

Opioid Analgesics: Risk Evaluation and Mitigation Strategy (REMS) incorporates the updated FDA blueprint into practical education designed to help clinicians improve the quality of care and reduce the pain of their patients.

TARGET AUDIENCE
This activity is intended for the multidisciplinary healthcare team, (PCPs, nurses, behavioral health providers, psychiatrists, and pharmacists) who need to obtain a balance between optimal pain reduction and minimization of adverse events (e.g. abuse, addiction, side effects, and risk of workplace accidents).

EDUCATIONAL OBJECTIVES
At the conclusion of this activity, participants should be able to demonstrate the ability to:

Identify risk factors and vulnerabilities associated with addiction to opioid analgesics and provide patient/caregiver counselling when necessary
Discuss the components of an effective treatment plan, including patient interactions, treatment goals, and collaboration within the healthcare team
Analyze the specific benefits and risks to initiating non-medication therapies before utilizing long-term medications
Recognize patients who are candidates for treatment with nonopioid pharmacologic analgesics
Explain the decision to initiate long-term opioid analgesics, including ER/LA opioids, with consideration to providing in-home naloxone
Determine when referral to a pain specialist is appropriate for a patient with chronic pain

FACULTY
Charles E. Argoff, MD
Professor of Neurology
Albany Medical College
Director, Comprehensive Pain Center
Director, Pain Management Fellowship
Albany Medical Center
Albany, NY

Charles E. Argoff, MD is Professor of Neurology at Albany Medical College and Director of the Pain Management Fellowship at Albany Medical Center. Dr. Argoff is a member of the American Academy of Neurology, the International Association for the Study of Pain, the American Academy of Pain Medicine, and the American Pain Society. He also serves as the Co-Editor of the Neuropathic Pain Section for Pain Medicine.

Christopher Gharibo, MD 
Associate Professor of Anesthesiology and Orthopedics
Medical Director of Pain Medicine
NYU Langone Health
New York, NY

Christopher Gharibo, MD is an Associate Professor in the Departments of Anesthesiology and Pain Medicine, as well as Orthopedics, at the NYU School of Medicine. He also serves as the Medical Director of Pain Medicine at NYU Langone Hospitals Center.

Dr. Gharibo obtained his medical doctorate from Rutgers Medical School in 1992 and completed his anesthesiology residency at NYU Medical Center. He served his pain medicine fellowship at Thomas Jefferson University Hospital in Philadelphia. He is a Diplomate of the American Board of Anesthesiology and holds subspecialty certification in pain medicine.

He has acute pain experience with system-wide use of interventional techniques in combination with non-opioids and opioids as part of multimodal acute pain management pathways. His areas of clinical expertise include low back and neck pain of musculoskeletal and spinal origin, cancer pain, and neuropathic pain syndromes, such as painful peripheral neuropathies and reflex sympathetic dystrophy.

Timothy J. Atkinson, PharmD, BCPS, CPE
Clinical Pharmacy Specialist, Pain Management
Director, PGY2 Pain Management and Palliative Care Residency
Owner, Vanguard Pain Management Consulting LLC
Nashville, TN

Timothy J. Atkinson, PharmD, BCPS, CPE is a Clinical Pharmacy Pain Specialist and federal employee in a regional referral pain clinic near Nashville, TN. Dr. Atkinson specializes in complex and high-risk pain medication management through direct patient care and electronic consult services.

He is a Residency Director for a PGY-2 Pain and Palliative Care Pharmacy Residency program and strong advocate for expansion of clinical pharmacists with expertise in collaborative drug therapy management (CDTM) specific to pain management. Dr. Atkinson is the owner of Vanguard Pain Management Consulting, where he advises clients in managed care and the pharmaceutical industry. Among these activities, he serves as a clinical product advisor for Axial Healthcare, where he develops evidence-based methods for monitoring opioid use for managed care. His research interests include opioid equivalencies, serum level monitoring, and pain management in specialty disease states and the elderly.

Aaron Williams, MA
Senior Director of Training and TA for Substance Use
National Council for Behavioral Health
Washington, DC

Aaron Williams, MA is an advisor on all substance use initiatives at the National Council. He collaborates with other addictions specialists on publications, presentations, and technical assistance. He brings more than 16 years of experience in substance abuse treatment services, program evaluation, and substance use and mental health services integration. Mr. Williams has a strong background in workforce development and the use of evidence-based practices in clinical settings.

Over the years, Mr. Williams has managed several projects related to the adoption of medications in addiction treatment in health centers. These projects include Project ECHO style Learning Collaboratives in which federally funded community health centers from across the county participate in virtual learning community sessions focused on increasing health centers’ use of buprenorphine for the treatment of opioid dependence and developing pain management protocols.

PHYSICIAN 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 USF Health and Rockpointe. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

CME CREDIT DESIGNATION
USF Health designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

For information about the CME accreditation of this program, please email: cpdsupport@health.usf.edu.

ABIM MOC DESIGNATION STATEMENT

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 2.25 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.

For ABIM MOC points, your information will be shared with the ABIM through USF Health's ACCME Program and Activity Reporting System (PARS). Please allow 6-8 weeks for your MOC points to appear on your ABIM records.

MIPS CREDIT DESIGNATION
Completion of this accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA_PSPA_28) for the Merit-based Incentive Payment Program (MIPS).

AAFP DESIGNATION STATEMENT
This Enduring Material activity, Opioid Analgesics: Risk Evaluation and Mitigation Strategy (REMS), has been reviewed and is acceptable for up to 2.25 Prescribed credit(s) by the American Academy of Family Physicians. AAFP certification begins 06/28/2019. Term of approval is for one year from this date. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

PHARMACIST ACCREDITATION STATEMENT
The Potomac Center for Medical Education is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

PHARMACIST CREDIT DESIGNATION
The Potomac Center for Medical Education designates this educational activity for a maximum of 2.25 hours (0.225 CEUs) of continuing education credit (UAN number 0418-9999-19-002-H05-P).

This is a knowledge-based activity.

DISCLAIMER
The information provided at this CME/CE activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

EOE/ADA
USF is an Equal Opportunity/ Affirmative Action/ Equal Access Institution.

NON-ENDORSEMENT
USF Health does not endorse any product, material, or service mentioned in association with this activity.

POTENTIAL CONFLICTS OF INTEREST
USF Health endorses the standards of the ACCME that require everyone in a position to control the content of an accredited educational activity to disclose all financial relationships with commercial interests that are related to the content of the educational activity. All accredited activities must be balanced, independent of commercial bias, and promote improvements or quality in healthcare. All recommendations involving clinical medicine must be based on evidence accepted within the medical profession.

A conflict of interest is created when individuals in a position to control the content of an accredited educational activity have a relevant financial relationship with a commercial interest which therefore may bias his/her opinion and teaching. This may include receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, stocks, or other financial benefits.

USF Health will identify, review, and resolve all conflicts of interest that speakers, authors, or planners disclose prior to an educational activity being delivered to learners. Disclosure of a relationship is not intended to suggest or condone bias in any presentation, but is made to provide participants with information that might be of potential importance to their evaluation of a presentation.

Faculty Disclosures

The faculty reported the following relevant financial relationships that they or their spouse/partner have with commercial interests:

Charles E. Argoff, MD: Speakers’ Bureau: Allergan, Amgen, Assertio Therapeutics, Daiichi Sankyo, Lilly, Novartis, TerSera Therapeutics, Teva; Advisory Board: BioDelivery Sciences, Collegium, Flowonix, Kaleo, Lilly, Novartis, Pfizer, Regeneron, Scilex, Shionogi, Teva, US WorldMeds, Vertex; Grants/Research Support: Allergan, Grünenthal, Jazz Pharma; Royalty: Elsevier; Stock/Shareholder: Assertio Therapeutics, Pfizer

Timothy J. Atkinson, PharmD, BCPS, CPE: Advisory Board: Daiichi Sankyo, Purdue Pharma; Consultant: Axial Healthcare

Christopher Gharibo, MD: Advisory Board: AstraZeneca, Daiichi Sankyo, Kaleo, Noven, Pernix Therapeutics; Speakers’ Bureau: AstraZeneca, Daiichi Sankyo, Kaleo, Noven, Pernix Therapeutics

Aaron Williams, MA: Nothing to disclose

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:

Rebecca Jimenez-Sanders, MD: Speaker’s Bureau: Amgen, Teva

Kathy Merlo; Blair St. Amand; Martin Myers, MD; Ashley Marostica RN, MSN, CCM; Brian Jack, MD; USF Health CPD staff: 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/CE/MIPS CREDIT/MOC POINTS
There is no fee for this activity. To receive credit, participants must take the pre-test, view this CME activity in its entirety, and then complete the post-test, with a score of 75% or better, and evaluation. The estimated time for completion of this activity is 2 hours and 15 minutes. For MOC, participants must also complete the online post-test and receive a passing score. For MIPS, participants must also complete follow up surveys at 30 and 90 days post-activity in order to receive credit. To receive their certificates, participants must demonstrate mastery of the presented material via the post-test. Participants are allowed to take the post-test multiple times.

INSTRUCTIONS FOR OBTAINING MOC Points
Physicians seeking ABIM MOC Points will be required to provide:

ABIM six-digit ID number
First and last name
Date of birth (mm/dd)

In collaboration with

This activity is supported by an independent educational grant from the Opioid Analgesic REMS Program Companies. Please see https://ce.opioidanalgesicrems.com/RpcCEUI/rems/pdf/resources/List_of_RPC_Companies.pdf for a listing of REMS Program Companies. This activity is intended to be fully compliant with the Opioid Analgesic REMS education requirements issued by the US Food and Drug Administration.