Program Description & Educational Objectives
In this activity, experts discuss the expanding role of government in regulating the evaluation and monitoring of safety of pharmaceutical drugs, starting with the background on the development of the Risk Evaluation and Mitigation Strategies (REMS). Furthermore, they highlight the components of and current requirements associated with these programs, the implications of REMS for different groups of healthcare professionals (ie, physicians, nurses, pharmacists), and strategies for implementation of REMS associated with rheumatoid arthritis therapies in the rheumatology practice.
Upon completion of this activity, participants will be able to:
- Discuss the rationale for REMS and understand the benefits and components of these programs
- Demonstrate improved understanding of current REMS programs for biologic therapies used in rheumatoid arthritis (RA)
- Establish effective models of coordinated implementation of REMS based on understanding of healthcare providers’ roles in delivery of care to patients with RA
Target Audience
This activity has been designed to meet the educational needs of rheumatologists, nurses, pharmacists, and other healthcare professionals involved in managing patients with rheumatoid arthritis.
Requirements for Successful Completion
In order to receive credit, participants must view the activity and complete the post-test and evaluation form. There are no pre-requisites and there is no fee to participate in this activity or to receive CME/CNE/CPE credit. Statements of Credit are awarded upon successful completion of the post-test and evaluation form.
Media: Internet
Release and Expiration Dates: August 04, 2010 - August 03, 2011
Time to Complete: 60 minutes
Faculty & Disclosure / Conflict of Interest Policy
All faculty AND staff involved in the planning or presentation of continuing education activities sponsored/provided by Purdue University College of Pharmacy are required to disclose to the audience any real or apparent commercial financial affiliations related to the content of the presentation or enduring material. Full disclosure of all commercial relationships must be made in writing to the audience prior to the activity.
Course Director and Interviewee
Allan Gibofsky, MD
Professor, Department of Medicine
Attending Physician
The New York Hospital–Cornell University Medical College
New York, New York
Allan Gibofsky, MD,
has a financial interest/relationship or affiliation in the form of:
Consultant for Abbott Laboratories; Amgen Inc.; Bristol-Myers Squibb Company; NicOx; Pfizer Inc; Roche Laboratories Inc.; and UCB Pharma, Inc.
Speakers Bureau participant with Abbott Laboratories; Amgen Inc.; Bristol-Myers Squibb Company; NicOx; Pfizer Inc; Roche Laboratories Inc.; and UCB Pharma, Inc.
Shareholder in Abbott Laboratories; Amgen Inc.; Bristol-Myers Squibb Company; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; and Pfizer Inc.
Interviewees
Arthur G. Lipman, PharmD, FASHP
University Professor, Department of Pharmacotherapy, College of Pharmacy
Adjunct Professor of Anesthesiology, School of Medicine
Director of Clinical Pharmacology, Pain Management Center
University of Utah Health Sciences Center
Salt Lake City, Utah
Arthur G. Lipman, PharmD, FASHP,
currently has no financial interests/relationships or affiliations in relation to this activity.
Max Hamburger, MD
President, New York State Rheumatology Society
Managing Partner, Rheumatology Associates of Long Island
President, American Society of Clinical Rheumatologists
Assistant Professor of Clinical Medicine
SUNY Stony Brook
Stony Brook, New York
Max Hamburger, MD,
has a financial interest/relationship or affiliation in the form of:
Consultant for Abbott Laboratories; Bristol-Myers Squibb Company; Genentech, Inc.; Novartis Pharmaceuticals Corporation; sanofi-aventis; and UCB Pharma, Inc.
Grant/Research Support from Abbott Laboratories; Amgen Inc.; Bristol-Myers Squibb Company; Genentech, Inc.; Human Genome Sciences, Inc.; Merck & Co., Inc.; Pfizer Inc; UCB Pharma, Inc.; and URL Pharma.
Honoraria from Abbott Laboratories; Bristol-Myers Squibb Company; Genentech, Inc.; Novartis Pharmaceuticals Corporation; sanofi-aventis; and UCB Pharma, Inc.
Kori Dewing, ARNP
Advanced Registered Nurse Practitioner
Virginia Mason Medical Center, Rheumatology
Clinical Instructor
University of Washington School of Nursing
Department of Biobehavioral Nursing and Health Systems
Seattle, Washington
Kori Dewing, ARNP,
has a financial interest/relationship or affiliation in the form of:
Honoraria from Institute for Continuing Healthcare Education, Inc. and InterQuest Medical and Scientific Communications.
Content Director
Kadrin Wilfong, MD
PVI, PeerView Institute for Medical Education, Inc.
Kadrin Wilfong, MD,
currently has no financial interests/relationships or affiliations in relation to this activity.
All additional planning committee members, PVI, PeerView Institute for Medical Education, Inc. staff, and Purdue University College of Pharmacy staff have no relationships to disclose.
Sponsorship, Credit & Support
Physicians
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. Purdue University College of Pharmacy, an equal access/equal opportunity institution, is accredited by the ACCME to provide continuing medical education for physicians.
Purdue University College of Pharmacy designates this educational activity for a maximum of 1 AMA PRA Category 1 CreditTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Nurses
Purdue University Continuing Nursing Education (CNEP-09, 06/01/2011) is an approved provider of continuing nursing education by the Indiana State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.
This activity has been approved for 1 contact hour(s).
Pharmacists
Purdue University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This is a knowledge-based, continuing education activity of Purdue University, an equal access/equal opportunity institution. Universal Activity Number (UAN): 0018-9999-10-136-H01-P, 1 contact hours (0.1 CEUs).
Release Date: August 04, 2010 Expiration Date: August 03, 2011
This CME/CNE/CPE activity is jointly sponsored by Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education.
This activity is supported by an educational grant from Genentech, Inc.
Disclosure of Unlabeled Use
The faculty of this educational activity may include discussions of products or devices that are not currently labeled for use by the FDA. Faculty members have been advised to disclose to the audience any reference to an unlabeled or investigational use.
No endorsement of unapproved products or uses is made or implied by coverage of these products or uses in our reports. No responsibility is taken for errors or omissions in reports.
Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings.
