Are You Ready for REMS (Risk Evaluation Mitigation Strategies)?
Practical Recommendations for Managed Care - An Overview for Pain Management

• Release date: August 5, 2011
• Expiration date: February 28, 2013
• Estimated time to complete activity: 75 minutes
• Compatible with (IE 6 and up, Firefox, Safari)

Target Audience

• Medical directors, pharmacy directors, clinical pharmacists, quality directors, as well as network physicians affiliated with various managed care organizations.
• Other managed care health professionals including case managers, policy administrators, utilization managers, IT professionals, etc.

Purpose Statement

The Food and Drug Administration Amendments Act of 2007 (FDAAA) authorizes the Food and Drug Administration (FDA) to require pharmaceutical manufacturers to submit a Risk Evaluation and Mitigation Strategy (REMS) if safety data suggest that a REMS is necessary to ensure that the benefits of the drug outweigh the potential risks. The FDA may require a REMS prior to product approval or post-approval for products that did not initially require a REMS. A REMS may include such strategies for managing risks associated with potentially harmful drugs as medication guides, communication plans for health care professionals, and elements to assure safe use (ETASU). The purpose of this activity is to improve the overall knowledge of, competency with, and performance for the administration of a REMS in a managed care setting. Current and evolving pain management REMS appropriate for a managed care setting will be utilized as a best practice model for a successful approach to meeting REMS requirements.

Educational Objectives
After completing this knowledge-based activity, the participant should be better able to:

• Describe the policy and process implications of the FDA Amendments Act of 2007 (FDAAA) for implementation within a managed care setting
• Discuss the components and purpose of a Risk Evaluation and Mitigation Strategy (REMS) relevant to a managed care setting
• Define the roles of specific managed care professionals (pharmacists, physicians, administrators) related to the implementation of a REMS
• Using examples, outline activities that are essential for managed care professionals to effectively implement and manage a REMS related to pain management

Distinguished Faculty

John M. Cruickshank, DO, MBA, CPE Chief Medical Officer Lovelace Health Plan Click here for biography

Jeffrey D. Dunn, PharmD, MBA Formulary and Contract Manager Select Health, Inc. Click here for biography

Continuing Education

Statement of Credit-Participants who successfully complete this activity (including scoring at least 70% on the post-test and completing and submitting the evaluation) will be issued a statement of credit. This statement of credit will be made available immediately.

	Physicians. The Meniscus Educational Institute is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Meniscus Educational Institute designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

	Pharmacists. This educational activity is sponsored by the Meniscus Educational Institute. The Meniscus Educational Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. The ACPE Universal Activity Number assigned to this program, for 1.25 contact hours (0.125 CEUs), is 0429-9999-11-005-H05-P.

Financial Disclosures

All individuals in positions to control the content of this program (eg, planners, faculty, content reviewers) are expected to disclose all financial relationships with commercial interests that may have a direct bearing on the subject matter of this continuing education activity. Participants have the responsibility to assess the impact (if any) of the disclosed information on the educational value of the activity. All faculty have been offered a modest honorarium from the accredited provider for their participation in this activity.

John M. Cruickshank, DO, MBA, CPE, Faculty, has nothing to disclose.
Jeffrey D. Dunn, PharmD, MBA, Faculty, serves as a consultant or advisor for ORxPharma and Johnson and Johnson.
Karen Abbas RN, MS, AOCN, Project Director, has nothing to disclose.
Carol Balmer, PharmD, BCOP, Education Committee Reviewer, has nothing to disclose.
Glenn J. Bingle, MD, PhD, FACP, Medical Education Committee Reviewer, has nothing to disclose.
Steve Casebeer, MBA, Planner, has nothing to disclose.
Philip DenBleyker, PharmD, Pilot Reviewer, has nothing to disclose and has declined honorarium for this activity.
Robert A. Dowd, PharmD, Pilot Reviewer, has nothing to disclose.
Anne Eder, MD, PhD, Pilot Reviewer, has nothing to disclose.
Jessica Huang, PharmD, Pilot Reviewer, has nothing to disclose.

Disclaimer

This activity has been designed to provide continuing education that is focused on specific objectives. In selecting educational activities clinicians should pay special attention to the relevance of those objectives and the application to their particular needs. The intent of all Meniscus Educational Institute educational opportunities is to provide learning that will improve patient care. Clinicians are encouraged to reflect on this activity and its applicability to their own patient population.

The opinions expressed in this activity are those of the faculty and reviewers and do not represent an endorsement by MEI or the companies providing educational grant support of any specific therapeutics or approaches to diagnosis or patient management.

Product Disclosure

This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the US Food and Drug Administration. For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the prescribing information for each product.

There is no fee for participating in this activity.