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Oncology Pharmacy Consults: Pharmacist-Driven Strategies for Enhancing Patient-Centered Management with the Use of Therapeutic and Supportive Care Biosimilars
Provided by The University of Tennessee College of Pharmacy, in cooperation with ASiM.
Supported by an educational grant from Pfizer Inc.
OVERVIEW
The introduction of biologic pharmaceuticals has been one of most important innovations in medicine in the past 50 years, and its effects have been particularly acute in oncology. The complex processes used to create these large, genetically engineered molecules means that even minute changes in their manufacturing, storage, and handling can dramatically alter their safety and efficacy, seriously impacting the patients who receive them. These costly drugs now comprise almost half of all prescription drug costs, both in the United States (US) and around the world, with the largest portion coming from oncology indications. As a consequence, all classes of payers have felt the financial stress of covering the these expensive medications. Perhaps the most cost-effective alternative to branded biologics are biosimilars. The introduction of these new lower-cost products has the potential to reduce pharmaceutical expenditures, improve access, and enhance outcomes for cancer patients. As of late 2019, several dozen biosimilars have been approved in the US. However, the uptake of these drugs has not been ideal. Despite their myriad advantages, many healthcare professionals and patients have taken an arms-length position regarding their safety and effectiveness. Biosimilars also raise important questions for formulary management, and Pharmacy and Therapeutics committees have been grappling with a host of legal and clinical issues dealing with substitution, interchangeability, pharmacovigilance, patient education, medication reconciliation, and inventory management. These difficult issues are now being addressed, and new solutions are in development, requiring much new insight and understanding from oncology pharmacists to optimize the care of their patients.
GOAL
The goal of this module is to provide oncology pharmacists with an overview of the legal and regulatory landscape covering biosimilar drugs, an understanding of the practical implications of biosimilar use in daily clinical practice, and insight into novel strategies for optimizing the role of biosimilars in the delivery of patient-centered care.
TARGET AUDIENCE
This activity is primarily intended for oncology pharmacists as well as other pharmacists (eg, specialty, managed care, community/retail, health-systems pharmacists) involved in the management of patients with cancer. 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:
- Describe how the FDA uses a "totality of evidence" approach to evaluate biosimilar compounds.
- Evaluate current safety and efficacy data for biosimilar agents for the treatment of cancer.
- Examine current safety and efficacy data for supportive care biosimilars.
- Discuss key clinical considerations associated with the use of biosimilars in the treatment and supportive care of cancer.
- Review biosimilar implementation pathways in clinical practice, including coverage and reimbursement.
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) reading the learning objectives and faculty disclosures; 2) studying the educational activity; 3) evaluating the activity; and, 4) completing the self-assessment instrument with a score of at least 70%. UAN: 0064-9999-19-203-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: https://nabp.pharmacy/cpe-monitor-service/cpe-monitor-faqs/. To receive credit for your participation in this activity, all pharmacists must include their NABP e-Profile ID number, along with their month and date 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 days of when the CE activity was presented) 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
Media: Internet
Fee Information: There is no fee for this educational activity.
Estimated time to complete activity: 60 minutes
Published
December 9, 2019
Expires
September 9, 2020
HOW TO EARN CREDIT
Participants must complete the activity as described above in the Continuing Education Information Section. 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
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP (Course Director)
Clinical Coordinator
Hematology/Oncology Department of Pharmacy
University of Arizona Cancer Center
Tucson, Arizona
Dr McBride reports serving as a consultant for Sandoz.
John Valgus, PharmD, MHA, BCOP
Assistant Professor of Clinical Education
UNC Eshelman School of Pharmacy
UNC School of Medicine
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
Dr Valgus reports serving as a consultant for Genentech, Inc.
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, provider, faculty member or other individual wanting to file a grievance with respect to any aspect of an activity provided or co-provided by the UTCOP may contact the Director of Continuing Professional Development in writing at jwheeler@uthsc.edu. 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 of 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
Oncology Pharmacy Consults: Pharmacist-Driven Strategies for Enhancing Patient-Centered Management with the Use of Therapeutic and Supportive Care Biosimilars
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP, and John Valgus, PharmD, MHA, BCOP
Postassessment and Evaluation
