REMS Update 2017: Risk Evaluation and Mitigation Strategy


This educational supplement has been created to educate healthcare professionals on the safe and proper use of Extended-Release (ER) and Long-Acting (LA) opioids for chronic pain management. Opioids are the cornerstone of modern pain management. They are highly complex molecules which require knowledge and integration of basic science, clinical, pharmacological, psychosocial, abuse, diversion, and public health aspects of opioids. This Opioid Risk Evaluation and Mitigation Strategy (REMS) supplement is a valuable tool that can be utilized daily by everyone in your practice. Continuing Medical Education (CME/CE) credits are available for studying this supplement and completing the online test. The supplement and test can be completed in a little more than three hours, but it will have a lifetime benefit!

Program Overview

The videos will evaluate clinical guidelines for the use of opioids, including the FDA Opioid REMS requirements, and their impact on the management of chronic pain. This program will also evaluate recommended opioid risk-reduction strategies HCPs can use to detect opioid misuse in a timely manner. Finally, the activity will identify communication strategies HCPs can use to improve their relationships with their patients to ensure optimal patient outcomes and reduce the risk of opioid misuse and abuse.

Target Audience

The target audience includes all clinicians registered with the DEA, eligible to prescribe schedule 2 or 3 drugs that have written at least one ER/LA opioid prescription in the past year, including primary care (family practice and internal medicine); anesthesiology (including pain management); oncology; neurology; orthopedics; PM&R and palliative care physicians, physician assistants and nurse practitioners. Pharmacists would also benefit from this education.

Learning Objectives

Upon completion of this activity, participants will be able to:

  1. Build on the core principles and objectives of REMS 2013
  2.  Update statistics on drug use and abuse
  3.  Highlight recent guidelines and commentary
  4.  Discuss use of Naloxone
  5. Understand improved methods of dealing with adverse reactions including opioid induced constipation
  6. Discuss the introduction of 5 new drugs


Bernard Abrams, MD
Clinical Professor of Neurology
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri
Daniel Doleys, MD, PhD
Clinical Psychologist
Clinical Director
The Doleys Clinic
Birmingham, Alabama

Bill McCarberg, MD
Adjunct Assistant Clinical Professor
University of California, San Diego School of Medicine
San Diego, California
Neighborhood Healthcare
Escondido, California

Disclosure Statements

It is the policy of the Elsevier Office of Continuing Medical Education that all faculty, instructors, and planners disclose real or apparent conflicts of interest relating to the topics of this educational activity.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:

Name of Faculty or PresenterRelationship Identified With:
Bernard Abrams, MDNo financial relationships to disclose.
Daniel Doleys, MDNo financial relationships to disclose.
Bill McCarberg, MD

Consultant/Advisor: AstraZeneca, Collegium Pharmaceutical Inc., Daiichi Sankyo Company, Limited, Depomed, Inc., Pfizer Inc, Takeda Pharmaceuticals U.S.A., Inc.

Stockholder: BioSpecifics Technologies Corp, Collegium Pharmaceutical Inc., Galena Biopharma, Johnson & Johnson Services, Inc., Nektar

Non-faculty: Gordon Ringler; Sandy Breslow; Alison Kemp; Leah Johnson; Maunak V. Rana, MD; and Karen Overstreet, EdD, RPh; hereby state that neither they nor their spouse/life partner have any financial relationships to products or devices with any commercials interest related to the content of this activity of any amount during the past 12 months.

Financial Support

This activity is supported by an independent educational grant from the ER/LA Opioid Analgesic REMS Program Companies. Please see for a listing of the member companies. This activity is intended to be fully compliant with the ER/LA Opioid Analgesic REMS education requirements issued by the US Food & Drug Administration.

Provider Information

Co-provided by the Elsevier Office of Continuing Medical Education and Dannemiller.

CME Credit (Physicians)

The Elsevier Office of Continuing Medical Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The Elsevier Office of Continuing Medical Education designates this enduring activity 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.

AANP Credit (Nurse Practitioners)

Dannemiller is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 090419. This program is accredited for 3.0 contact hour(s) which includes 3.0 hours of pharmacology.

CME Inquiries/Special Needs

For all CME inquiries or special needs, please contact

Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Elsevier Office of Continuing Medical Education, Dannemiller, Inc., and ER/LA Opioid Analgesic REMS Program Companies do not recommend the use of any agent outside of the labeled indications.

Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Method of Participation

In order to claim credit, participants must complete the following:

  1. Read the learning objectives, accreditation information and faculty disclosures at the beginning of this activity.
  2. Complete the Pre-Activity Questions
  3. Read or Review the activity content.
  4. Complete the Post-Activity Test Questions and Evaluation.
  5. Physicians and Nurses who receive a grade of 70% or better on the Post-Activity Test Questions and who complete the Evaluation will receive a CME/CE Certificate.
  6. All other participants who receive a grade of 70% or better on the Post-Activity Test Questions and who complete the Evaluation will receive a Certificate of Participation.
Course summary
Available credit: 
  • 3.00 AANP
  • 3.00 AMA PRA Category 1 Credit(s)™
  • 3.00 Non-physician
Course opens: 
Course expires: 

Available Credit

  • 3.00 AANP
  • 3.00 AMA PRA Category 1 Credit(s)™
  • 3.00 Non-physician
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