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CME/CE

Opioid REMS and Safe Use Practices: What Are the Implications Today?

  • Authors: Carl N. Kraus, MD; Charles Argoff, MD; Carol Havens, MD; Renee Manworren, PhD, APRN, PCNS-BC
  • CME/CE Released: 6/5/2012
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 6/5/2013
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Target Audience and Goal Statement

This activity is intended for neurologists, primary care providers, nurses, and pharmacists.

The goal of this activity is to educate physicians, nurses, and pharmacists about risk evaluation and mitigation strategies associated with long-acting and extended-release opioids.

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

  1. Summarize why risk evaluation and mitigation strategies (REMS) are necessary for opioid drugs
  2. Outline the potential components of a REMS program
  3. Describe strategies that clinicians can use to effectively implement safe use practices


Disclosures

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Authors

  • Carl N. Kraus, MD

    Vice President of Medical Affairs, Medscape, LLC, New York, New York

    Disclosures

    Disclosure: Carl N. Kraus, MD, has disclosed no relevant financial relationships.

    Dr Kraus does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

    Dr Kraus does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

  • Charles Argoff, MD

    Professor of Neurology, Albany Medical College; Director, Comprehensive Pain Center, Albany Medical Center, Albany, New York

    Disclosures

    Disclosure: Charles Argoff, MD, has disclosed the following relevant financial relationships:
    Served as an advisor or consultant for: Ameritox; Cephalon, Inc.; Covidien; Eli Lilly and Company; Forest Laboratories, Inc.; Grünenthal Group; Jazz Pharmaceuticals, Inc.; Nuvo Research Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Pfizer Inc, ProStrakan, Quest Diagnostics, Recro Pharma, Inc.
    Served as a speaker or a member of a speakers bureau for: Covidien; Eli Lilly and Company; Endo Pharmaceuticals; Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Millennium Pharmaceuticals, Inc.; NeurogesX, Inc.
    Received grants for clinical research from: Eli Lilly and Company; Endo Pharmaceuticals; Forest Laboratories, Inc.; NeurogesX, Inc.; Pfizer Inc.
    Owns stock, stock options, or bonds from: Pfizer Inc.

    Dr Argoff does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States

    Dr Argoff does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

  • Carol Havens, MD

    Director of Clinical Education, Kaiser Permanente Northern California Region; President, California Academy of Family Physicians, Sacramento, California

    Disclosures

    Disclosure: Carol Havens, MD, has disclosed no relevant financial relationships.

    Dr Havens does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

    Dr Havens does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

  • Renee Manworren, PhD, APRN, PCNS-BC

    Nurse Scientist, Division of Pain and Palliative Medicine, Connecticut Children's Medical Center; Assistant Professor of Pediatrics, University of Connecticut School of Medicine, Hartford, Connecticut

    Disclosures

    Disclosure: Renee Manworren, PhD, APRN, PCNS-BC, has disclosed no relevant financial relationships.

    Dr Manworren does intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

    Dr Manworren does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editors

  • Sarah Williams, PhD

    Scientific Director, Medscape, LLC

    Disclosures

    Disclosure: Sarah Williams, PhD, has disclosed no relevant financial relationships.

  • Neil Chesanow

    Senior Clinical Editor, Medscape, LLC

    Disclosures

    Disclosure: Neil Chesanow has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Nafeez Zawahir, MD

    CME Clinical Director, Medscape, LLC

    Disclosures

    Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

  • Laurie E. Scudder, DNP, NP

    Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC

    Disclosures

    Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.


Accreditation Statements

    For Physicians

  • Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    Medscape, LLC designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Medscape, LLC staff have disclosed that they have no relevant financial relationships.

    Contact This Provider

    For Nurses

  • Medscape, LLC is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

    Awarded 0.50 contact hour(s) of continuing nursing education for RNs and APNs; 0.50 contact hours are in the area of pharmacology.

    Accreditation of this program does not imply endorsement by either Medscape, LLC or ANCC.

    Contact This Provider

    For Pharmacists

  • Medscape, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Medscape, LLC designates this continuing education activity for 0.50 contact hour(s) (0.05 CEUs) (Universal Activity Number Number 0461-0000-12-066-H05-P).

    Contact this provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]


Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test.

Follow these steps to earn CME/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. We encourage you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.

*The credit that you receive is based on your user profile.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test.

Follow these steps to earn CME/CE credit*:

 

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. Medscape Education encourages you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.

*The credit that you receive is based on your user profile.

CME/CE

Opioid REMS and Safe Use Practices: What Are the Implications Today?

Authors: Carl N. Kraus, MD; Charles Argoff, MD; Carol Havens, MD; Renee Manworren, PhD, APRN, PCNS-BCFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME/CE Released: 6/5/2012

Valid for credit through: 6/5/2013

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The US Food and Drug Administration (FDA) has determined that a risk evaluation and mitigation strategy (REMS) is required for extended-release and long-acting opioid medications to ensure that their benefits outweigh their risks. Prescriber education and patient education are vital components of this REMS. The FDA's Blueprint for Prescriber Continuing Education Program illustrates the importance of educating healthcare professionals in the safe use of these medications and, in fact, is a ground-breaking step in the REMS arena. To clarify the clinical implications of the REMS for long-acting and extended-release opioids, a roundtable discussion was developed by Medscape in association with the Collaborative for REMS Education [CO*RE]. This discussion was taped on March 30, 2012, in New York City.

REMS
 
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