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FDA's Risk Evaluation and Mitigation Strategies Program: What Pharmacists Need to Know
This activity is for pharmacists and is sponsored by Postgraduate Healthcare Education, LLC (PHE).
There has been no commercial support for this activity.
Casey Covrett, PharmD, BCPS
Postgraduate Healthcare Education, LLC
[at the time this article was prepared]
Casey Covrett, PharmD, BCPS hereby states that he has no relevant affiliation or financial relationship or relationship to products or devices with a commercial interest related to the content of this activity to disclose.
The following reviewer, Karen Blumenschein, Pharm D, MS Addiction Studies, hereby states that she does not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
Susanne Batesko, RN, BSN, Robin Carrino, L. Michael Posey, BSPharm, MA, and Jeannette Wick, RPh, MBA, FASCP, as well as the planners, managers, and other individuals, not previously disclosed, who are in a position to control the content of Postgraduate Healthcare Education (PHE) continuing education (CE) activities hereby state that they have no relevant conflicts of interest and no financial relationships or relationships to products or devices during the past 12 months to disclose in relation to this activity. We are committed to providing participants with a quality learning experience and to improve clinical outcomes without promoting the financial interests of a proprietary business.
Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Credits: 2.0 hours (0.20 ceu)
Published: June 1, 2016
Expires: June 30, 2018
Type of Activity: Knowledge
Fee Information: $6.97
Estimated time to complete activity: 120 minutes
This accredited activity has been designed for pharmacists.
HOW TO EARN CREDIT
During the period June 1, 2016 through June 30, 2018 participants must 1) read the learning objectives and faculty disclosures; 2) study the educational activity; and 3) complete the post-test and the evaluation form. To answer the questions, click on your selected choice for each answer then proceed to the next question. Once completed, click on Grade Exam at the bottom of the page. Your post-test will automatically be graded. If you successfully complete the post-test (score of 70% or higher), your statement of participation will be made available immediately. Click on the View Statement of Participation link and print the statement for your records. If you receive a score lower than 70%, you will receive a message notifying you that you did not pass the post-test. You will have 2 opportunities to pass the post-test. To receive Credit, you must provide your date of birth and NABP number. All Credit information will be uploaded into CPE monitor within 30 days.
The goal of this activity is to update pharmacists regarding the progression of risk evaluation and mitigation strategies (REMS).
Upon completion of this activity, participants should be better able to:
- Explain the evolution from risk minimization action plans (RiskMAPs) to REMS.
- Identify key elements that may be included in REMS.
- Describe the effect that a REMS has on the health care distribution system.
- Summarize the existing challenges surrounding REMS.
REQUIRED COMPUTER HARDWARE/SOFTWARE
Please ensure the computer system you plan to use meets the following minimum requirements:
- Operating System: Windows 98 or higher & Macintosh 2.2 or higher
- Internet Browser (Mac &/ Windows): Internet Explorer 6.0 or higher, Google Chrome, Safari 5.0.6 or higher, Firefox 3.0.3 or higher & Opera 5 or higher
- Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible
- Monitor Screen Resolution: 320 x 480 or higher
- Media Viewing Requirements: Adobe Reader, Microsoft PowerPoint, Flash Player & HTML5
Disclosure of Unlabeled Use and Disclaimer
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of Postgraduate Healthcare Education, LLC. 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 patients' conditions, and possible contraindications on dangers in use, (review of any applicable manufacturer's product information) and comparison with recommendations of other authorities.
The author, sponsor, and publisher of this continuing education activity have made all reasonable efforts to ensure that all information contained herein is accurate in accordance with the latest available scientific knowledge at the time of acceptance for publication. However, because information regarding drugs (their administration, dosages, contraindications, adverse reactions, interactions, special warnings, precautions, etc.) is subject to constant change, the reader is advised to check the manufacturer's package insert for information concerning recommended dosages and potential problems and cautions prior to dispensing or administering the drug. Special precautions should be taken when a drug is new, or highly toxic, or is unfamiliar to the dispenser or administrant. This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the U.S. Food and Drug Administration (FDA). Neither the publisher nor sponsor promotes the use of any agent outside of approved labeling. Statements made in this monograph have not been evaluated by the FDA. Nutritional products discussed are not intended for the diagnosis, treatment, cure, or prevention of any disease.