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OVERVIEW

Cancer remains the nation's most visible public health concern. Thanks to improved and earlier diagnosis, along with the availability of new treatment modalities, the risk of dying from cancer has diminished greatly in recent years. Among the most important new therapeutic strategies are the multiple classes of immunotherapeutic drugs. Unlike cytotoxic chemotherapies, which work by targeting processes associated with tumor-cell replication and growth, immune therapies address specific components of the innate and adaptive immune systems. In so doing, these novel drugs help overcome the tumor cell's ability to avoid immune surveillance, bringing into play the effects of the body's T-cell response to foreign tissue. A number of immune therapies, most importantly immune checkpoint inhibitors, have become the standard of care in treating patients with advanced melanoma and second-line treatment options for patients with non-small–cell lung cancer and renal-cell carcinoma. These and other investigative immunotherapies are also being evaluated to treat a broad range of solid and hematologic tumors. This activity is designed specifically to: help guide pharmacists' understanding of immunotherapies' place of in the cancer-drug armamentarium and in managing patients for whom these treatments are indicated; review various types of cancer drugs and their mechanisms of actions, as well as the clinical evidence supporting the use of immune-checkpoint inhibitors; explore the unique response patterns of immunotherapies and the best criteria with which to evaluate them; and, describe patients' key treatment-emergent adverse events associated with immunotherapies and the role of pharmacists in managing patients experiencing them.

GOAL

This activity will enable pharmacists to better understand the role of immune-system drugs in the cancer therapeutic paradigm, the safety and efficacy of the newly approved agents for melanoma, lung cancer, and renal-cell carcinoma, and how best to evaluate their effects and manage associated toxicities.

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:

• Differentiate the mechanisms of active immunotherapies from that of targeted and cytotoxic therapies.
• Evaluate clinical trial data and uses of PD-1/PD-L1 and CTLA-4 inhibitors in malignancies.
• Recognize unique disease response patterns associated with immunotherapy treatment.
• Identify strategies to recognize and manage adverse events related to immunotherapies.

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 hour 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%. UAN:  0064-0000-16-219-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

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: August 30, 2016
Expires: August 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

R. Donald Harvey, PharmD, FCCP, BCOP
Associate Professor, Hematology/Medical Oncology
Director, Phase 1 Clinical Trials Section
Winship Cancer Institute of Emory University
Atlanta, Georgia

Dr Harvey reports receiving grants/research support from Amgen Inc, AstraZeneca, Bristol-Myers Squibb Company, Boston Biomedical, Eli Lilly, Halozyme Inc, Merck & Co Inc, Pfizer Inc, Regeneron Pharmaceuticals Inc, and Syndax; and reports serving as a consultant for Bristol-Myers Squibb Company.

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

New and Emerging Immuno-Therapy Treatment Options in Oncology
R. Donald Harvey, PharmD, FCCP, BCOP

Postassessment and Evaluation