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OVERVIEW

The use of immunotherapies has grown tremendously over the past several years. These treatments incorporate novel mechanisms of action, response patterns, and safety profiles, distinguishing them from cytotoxic agents and even targeted therapies. Several immune-based treatments are now approved for treating patients with non-small–cell lung cancer (NSCLC). Through immune checkpoint inhibition, these novel treatments block cell-signaling pathways that malignant cells use to overcome the body's normal cancer-fighting response. This represents an important new approach to NSCLC therapy, yet it also poses significant challenges. The anticancer response with these agents requires activation and mobilization of immune cells, which may take longer to reduce tumor burden than the more familiar chemotherapy regimens. Infiltration of immune cells into the tumor may even create the mistaken impression that the cancer is worsening even though this is an expected effect of immune cell activation. Immune checkpoint inhibitors are also associated with their own characteristic adverse effects, which require careful monitoring and appropriate management. This module will provide pharmacists with the most up-to-date information on efficacy and safety of imumne-based NSCLC therapies, monitoring patients for immune-related toxicities, the unique strategies to manage adverse events, and the role of baseline testing of checkpoint inhibitor molecule expression in treatment selection, to optimize patient outcomes.

GOAL

The goal of this activity is to provide pharmacists with a thorough understanding of this emerging class of immunotherapy agents for treating patients with NSCLC. Readers will be presented with the most up-to-date information on the novel mechanisms of action and time course of the therapeutic response with these agents, as well as appropriate strategies for monitoring immune-related adverse events and their unique management approaches.

TARGET AUDIENCE

This enduring case activity is designed for oncology, health-system, managed care, and specialty pharmacists. No prerequisites required.

LEARNING OBJECTIVES

The University of Tennessee College of Pharmacy takes responsibility for the content, quality, and scientific integrity of this CPE activity. At the conclusion of this activity, the participant should be able to:

• Evaluate the efficacy and safety of immunotherapy as part of NSCLC treatment paradigms.
• Recognize unique disease response patterns and adverse event profile associated with immunotherapy treatment.
• Implement pharmacy-driven management strategies to optimize treatment plans for NSCL.

CREDIT DESIGNATION STATEMENT

The University of Tennessee College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Successful completion of this knowledge-based program will provide a statement for 1.0 contact hours of credit (0.10 CEU) and will be available at the completion of the activity. Successfully completing the activity and receiving credit includes: 1) attending the session; 2) watching, listening to, and participating in the educational activity; 3) completing the self-assessment instrument  with a score of at least 70%. CE credit will be submitted to the NABP CE Monitor. UAN:  0064-0000-16-214-H01-P. CE credit will be submitted to the NABP CPE Monitor within 30 days.  It is recommended that you check your NABP CPE Monitor e-profile database 30 days after the completion of any CE activity to ensure that your credits are posted.

NABP e-PROFILE ID NUMBER

Your CE credits will also be submitted electronically to NABP. Pharmacists or pharmacy technicians with questions regarding their NABP e-Profile or CPE Monitor should refer to the FAQ section on the NABP website: http://www.nabp.net/programs/cpe-monitor/cpe-monitor-service. To receive credit for your participation in this activity, all pharmacists must include their NABP e-Profile ID number, along with their date and month of birth. If incorrect information is provided, this will result in "rejected" status from the CPE Monitor. It is the responsibility of the participant to notify The University of Tennessee (within the 60 day submission timeframe) of their corrected information. Otherwise, the completed CE will not be accepted by the CPE Monitor.

Please allow up to 30 days for your credit to appear on CPE Monitor.

Type of Activity: Knowledge

Published: June 30, 2016
Expires: June 30, 2017

Media: Internet

Fee Information: There is no fee for this educational activity.

Estimated time to complete activity: 60 minutes

HOW TO EARN CREDIT

Participants must complete the activity as described above in the Credit Designation Statement. To answer the questions, click on your selected choice for each answer then proceed to the next question. We recommend that you print a copy of your answers before you submit them to us. Once completed, click on Submit Post-test 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 CE credit will be made available immediately. Click on View Certificate and print the CE 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.

FULL DISCLOSURE POLICY AFFECTING CPE ACTIVITIES

As an accredited provider by the Accreditation Council for Pharmacy Education (ACPE), it is the policy of The University of Tennessee College of Pharmacy to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation. The Course Director and Participating Faculty reported the following:

PARTICIPATING FACULTY

Daniel Zlott, PharmD, BCOP (Course Director/Author)
Clinical Pharmacy Specialist
NCI Surgery and Immunotherapy Programs
National Institutes of Health
Clinical Center Pharmacy Department
Bethesda, Maryland
Dr Zlott reports having no relevant financial or advisory relationships with corporate organizations related to this activity.

OFF-LABEL PRODUCT DISCUSSION

In accordance with ACPE Criteria for Quality, the audience is advised that authors in this CPE activity may include reference(s) to unlabeled, unapproved, or investigational uses of therapeutic agents or biomedical devices. The authors will inform the reader of when they discuss or reference an unapproved, unlabeled, or investigational use of therapeutic agent or biomedical device.

DISCLAIMER STATEMENT

The opinions and recommendations expressed by faculty and other experts whose input is included in this activity are their own. This activity is produced for educational purposes only. Use of The University of Tennessee College of Pharmacy name implies review of educational format, design, and approach. Please review the complete prescribing information of specific drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects, before administering pharmacologic therapy to patients.

GRIEVANCE POLICY

A participant, sponsor, faculty member, or other individual wanting to file a grievance with respect to any aspect of an activity sponsored or cosponsored by The University of Tennessee College of Pharmacy may contact the Associate Dean for Continuing Education in writing at gfarr@utasip.com. The grievance will be reviewed and a response will be returned within 45 days of receiving the written statement. If not satisfied, an appeal to the Dean of the College of Pharmacy can be made for a second level review.

ACTIVITY

The following is an interactive case simulation designed to help you gauge your basic knowledge of the topic and then direct you to areas you may need to focus on. It consists of 3 sections: an unaccredited pre-test, an interactive case study, and a CPE post-test, and evaluation. All 3 sections must be completed to receive CPE credit. A statement of credit will be available online immediately following successful completion of the activity.

REQUIRED COMPUTER HARDWARE/SOFTWARE

Please ensure the computer 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.
• Peripherals: Computer speakers or headphones
• Monitor Screen Resolution: 320 x 480 or higher
• Media Viewing Requirements: Adobe Reader, Microsoft Power Point, Flash Player & HTML5

TABLE OF CONTENTS

Preassessment

Advances in Managing NSCLC: What Pharmacists Need to Know
Daniel Zlott, PharmD, BCOP

Postassessment