Speaker Michael R. Clark, MD, MPH, MBA Vice Chair, Clinical Affairs Director, Chronic Pain Treatment Programs Department of Psychiatry & Behavioral Sciences Johns Hopkins Medicine Baltimore, MD Series
Chair Charles E. Argoff, MD Professor of Neurology Albany Medical College Director, Comprehensive Pain Program Albany Medical Center Albany, NY
AMA PRA Category 1 Credit Medium
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Opioid prescriptions have increased dramatically in the last decade, and opioid abuse and misuse has become a major public health concern. In 2012 the FDA approved a classwide risk management program, known as a Risk Evaluation and Mitigation Strategy (REMS), for all extended-release or long-acting (ER/LA) opioid analgesics. As part of this program, continuing education is being made available to prescribing clinicians to enhance their management of patients with chronic pain.
This REMS-compliant training module (Module 5 of 6) discusses managing common adverse events and respiratory depression, pharmacodynamics and pharmacokinetics of opioid analgesics, opioid metabolism, drug-drug interactions, and drug information for opioid-tolerant patients. The remainder of the FDA Blueprint will be addressed in the subsequent module.
. Target Audience
This educational activity is designed to meet the needs of all health care professionals who prescribe ER/LA opioid analgesics, including physicians, nurses, NPs, PAs, pharmacists, dentists, and pain specialists.
Upon completion of this educational activity, the participant should be able to:
State the most serious and the most common adverse effects of ER/LA opioid therapies.
Describe the different drug-drug interactions and underlying pharmacokinetic and pharmacodynamic mechanisms of the various ER/LA opioid analgesics.
List the specific ER/LA opioid products, including specific dosage unit strengths and doses for some products, for which tolerance to sedating and respiratory-depressant effects is critical for safe use.
Explain how improper use of tablet and capsule ER/LA opioid analgesics could lead to rapid release of the opioid leading to overdose and death.
Describe instances that could make the use of transdermal ER/LA opioid products unsafe, such as factors that can increase absorption of the opioid leading to fatal overdose.
Michael R. Clark, MD, MPH, MBA, discloses the following relationships with commercial interests:
Advisory Board: Ameritox
Charles Argoff, MD, discloses the following relationships with commercial interests:
Advisory Board: Teva, Daiichi Sankyo, Pfizer, Nektar, Purdue, Depomed, Xenoport
Consultant: Teva, Daiichi Sankyo, Pfizer, Nektar, Purdue, Depomed, Xenoport
Grant Recipient: Endo Pharmaceuticals, Forest Labs, Lilly
Speakers Bureau: Janssen, Allergan, Depomed, Xenoport
Rick Ricer, MD, Physician Reviewer, University of Cincinnati, has no conflicts of interest to disclose.
Susan P. Tyler, MEd, CCMEP, FACEHP, University of Cincinnati, has no conflicts of interest to disclose.
Gena Dolson, MS, MCM Education Senior Medical Writer, has no conflicts of interest to disclose.
Kathleen Hines, MCM Education Editorial Director, has no conflicts of interest to disclose.
The University of Cincinnati requires all faculty to disclose any planned discussion of an investigational and/or off-label use of a pharmaceutical product or device within their presentation. Participants should note that the use of products outside FDA-approved labeling should be considered experimental and are advised to consult current prescribing information for approved indications.
In this educational activity, the faculty reports his presentation will not contain reference to investigational and/or off-label uses.
This activity has been planned and implemented in accordance with the Essentials Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the University of Cincinnati and MCM Education. The University of Cincinnati is accredited by the ACCME to provide continuing medical education for physicians.
The University of Cincinnati designates this Enduring Material Activity for a maximum of 0.75 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Release date: April 14, 2014
Last review date: April 14, 2014
Expiration date: April 15, 2015 Commercial Support Statements
This educational activity is supported by an independent educational grant from the ER/LA Opioid Analgesic REMS Program Companies. Please see
http://ce.er-la-opioidrems.com/IwgCEUI/rems/pdf/List_of_RPC_Companies.pdf 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. Instructions
* Link to and Log into program on QuantiaMD.com
* Complete the pre-activity assessment.
* Review the educational activity
* Complete the post-activity assessment and score a minimum of 75% (you are allowed two retakes).
* Complete the evaluation
* View, print, or save a CME certificate verifying your
credit/participation in this activity Computer Requirements: Minimum System Requirements: Pentium III, 600 MHz or Equivalent Processor 512 MB of RAM Windows XP, Vista, or 7 Mac OS X 800x600 Monitor Resolution 16-bit Color 16 bit Sound Card with Speakers
There is no charge for CME credit.
The opinions or views expressed in this CME activity are those of the presenters and do not necessarily reflect the opinions or recommendations of the University of Cincinnati, MCM Education, or the commercial supporter(s). Participants should critically appraise the information presented and are encouraged to consult appropriate resources for information surrounding any product, device, or procedure mentioned.