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OVERVIEW

The treatment of patients with chronic lymphocytic leukemia (CLL) has evolved from using a combination of alkylating agents and corticosteroids, to fludarabine based-drug regimens that can include the anti-CD20 monoclonal antibody rituximab. Unfortunately, some mutations like deletions 11q and 17p remain predictive of significantly worse outcomes. However, new targeted agents, ibrutinib, venetoclax, and idelalisib allow clinicians to effectively treat patients with these mutations. Ibrutinib was approved as a frontline therapy for the treatment of patients with CLL, and venetoclax was approved for the treatment of patients with CLL who have del(17p), and who have been treated with at least one prior therapy. Finally, combination therapy idelalisib and rituximab has proven effective for patients who had undergone multiple previous treatment regimens, and those with the del(17p) and TP53 mutations. Patients with CLL are susceptible to bacterial, viral, fungal, and opportunistic infections due to iatrogenic immunosuppression and may require antibiotic and antiviral prophylaxis. As therapeutic approaches to CLL evolve, so does the role of the pharmacist, whose function now may include selecting appropriate medication based on the patient's risk factors, reviewing the medication plan to minimize drug-drug interactions, managing side-effects, patient education, and monitoring adherence.

GOAL

This enduring case activity will enable pharmacists to better understand the role of targeted small molecule therapy for patients with CLL and to identify the adverse events and drug-drug interactions associated with small molecule targeted therapies. Pharmacists will also gain an understanding of individualized treatment plans for CLL patients that consider the patient's cytogenetics, history, and quality of life, as well as agent safety profiles.

TARGET AUDIENCE

This enduring case activity is designed for oncology pharmacy specialists, hospital pharmacists, specialty and managed-care pharmacists, all of whom are involved in the care of patients being treated for chronic lymphocytic leukemia (CLL). 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:

• Assess the role of small-molecule targeted therapy as part of CLL treatment paradigms.
• Identify AEs and DDIs associated with small-molecule targeted therapy for CLL.
• Analyze individualized treatment plans for CLL patients considering cytogenetics, agent safety profiles, patient history, and quality-of-life considerations.

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%. CE credit will be submitted to the NABP CE Monitor. UAN:  0064-0000-17-205-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 technicia ns 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: March 15, 2017

Expires: September 15, 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

Christopher A. Fausel, PharmD, BCOP
Clinical Manager, Oncology Pharmacy
Indiana University Health
Chair, Hoosier Oncology Group
Indianapolis, Indiana
Dr Fausel reports serving as a consultant for Dr Reddy's Laboratory as an expert witness in a patent court case.

OFF-LABEL PRODUCT DISCUSSION

In accordance with ACPE Criteria for Quality, the audience is advised that discussions in this CPE activity may include reference(s) to unlabeled, unapproved, or investigational uses of therapeutic agents or biomedical devices, including, but not limited to, the following:

• Acalabrutinib as an investigational inhibitor of Bruton's tyrosine kinase.

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

Shifting Paradigms in the Treatment of Chronic Lymphocytic Leukemia
Christopher A. Fausel, PharmD, BCOP

Postassessment and Evaluation