Oncology Pharmacy Specialty Home Study Syllabus for Recertification: Module 1A-B (Cert # L209128)

ACPE Numbers: Various – see listing below
Pre-Sale Date: 02/19/2020
Content Release Date: 03/25/2020
Expiration Date: 09/08/2020
Activity Type: Application-based
CE Credits: 8.0 hours (BPS and ACPE)
Activity Fee: $160 (ASHP member); $215 (non-member)

Accreditation for Pharmacists

American Society of Health-System Pharmacists and the American College of Clinical Pharmacy are accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education.

Target Audience

These recertification activities are intended for board certified pharmacists seeking to update their knowledge and skills in:

  • Renal-Cell Carcinoma
  • GYN Malignancies
  • Oncology Practice Management
  • Chronic Leukemia
  • Pediatric Malignancies
  • Hepatocellular Carcinoma
  • Oncology Drug Literature: Biostats and Study Design

Activity Overview

The Home Study Syllabus is intended for board certified pharmacists in need of recertification credit and is designed based on the content outline developed by the Board of Pharmacy Specialties (BPS). This module consists of 2 online home study activities (see table below). Each activity is designed to assess the learners’ ability to analyze and apply peer-selected contemporary articles to practice.

Learners will be required to review the content of the articles and complete the associated online assessments. The learner must be able to correctly answer the questions based upon their interpretation of the content, as well as “baseline specialty specific knowledge and/or easily retrievable information.” For purposes of this course, “baseline specialty specific knowledge and/or easily retrievable information” is defined as product labeling and well-established standards of practice in the specialty practice.

These activities are part of the ASHP and ACCP professional development program for BCOP recertification approved by the BPS. 

Recertification Credit*

Board certified pharmacists are eligible to receive up to 8.0 hours of recertification credit for completing this module. To earn recertification credit, learners must review the activity content and successfully complete the online assessments by the deadline. Only completed assessments will be eligible for credit; no partial or incomplete assessments will be processed. You are allowed only one attempt to successfully complete this assessment.

Learning Activity

ACPE Number

Credit Hours

*Assessment Pass Point

Oncology Home Study Syllabus Module 1A: Renal-Cell Carcinoma, GYN Malignancies, Onc Practice Mgmt

0204-9999-20-932-H01-P

4.00

80%

Oncology Home Study Syllabus Module 1B: Chronic Leukemias, Pediatric Malignancy, Oncology Drug Literature: Biostatistics and Study Design, Hepatocellular Carcinoma

0204-9999-20-933-H01-P

4.00

78%


Articles and Learning Objectives

Oncology Home Study Syllabus Module 1A: Renal-Cell Carcinoma, GYN Malignancies, Oncology Practice Management
0204-9999-20-932-H01-P

Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019; 380:1116-27.

Learning Objectives:

  • Identify appropriate diagnostic, prognostic, and treatment-related tests for renal cell carcinoma.
  • Discuss the dosing, administration, and toxicity profile that patients may experience with pembrolizumab/axitinib or sunitinib in metastatic renal cell carcinoma.
  • Describe the efficacy of pembrolizumab/axitinib compared with sunitinib in metastatic renal cell carcinoma.

Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018; 379:2495-505.

Learning Objectives:

  • Apply the findings of the SOLO1 trial as they relate to patients with newly diagnosed ovarian cancer.
  • Use patient-specific clinical data to formulate therapeutic treatment and monitoring values for patients with newly diagnosed ovarian cancer.
  • Explain the adverse-effect profile of olaparib maintenance for patients with newly diagnosed ovarian cancer.

Mackler E, Segal EM, Muluneh B, et al. 2018 Hematology/Oncology Pharmacist Association Best Practices for the Management of Oral Oncolytic Therapy: Pharmacy Practice Standard. J Oncol Pract. 2019; 15:e346-e355.

Learning Objectives:

  • Assess oral oncolytic workflows to ensure that safe prescribing practices, comprehensive patient education, and appropriate follow-up measures are in place to optimize medication adherence and mitigate toxicity.
  • Apply a strategy for procuring oral oncolytic therapy for patients in the home setting that considers financial implications to patients and/or caregivers.
  • Evaluate practice management approaches to promote interprofessional collaboration to ensure that reasonable benchmarking measures are in place for oral oncolytic management programs.

Oncology Home Study Syllabus Module 1B: Chronic Leukemias, Pediatric Malignancy, Oncology Drug Literature: Biostatistics and Study Design, Hepatocellular Carcinoma

Venetoclax and obinutuzumab in patients with CLL and coexisting conditions

Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019; 380:2225-36.

Learning Objectives:

  • Interpret efficacy and safety data for a treatment regimen used in chronic lymphocytic leukemia.
  • Design patient-specific treatment, supportive care, and monitoring plans for patients with chronic lymphocytic leukemia.
  • Manage toxicities associated with a treatment regimen used in chronic lymphocytic leukemia.
Improved survival for children and young adults with T-lineage acute lymphoblastic leukemia: results from the Children’s Oncology Group AALL0434 methotrexate randomization

Winter SS, Dunsmore KP, Devidas M, et al. Improved survival for children and young adults with T-lineage acute lymphoblastic leukemia: results from the Children’s Oncology Group AALL0434 methotrexate randomization. J Clin Oncol. 2018; 36:2926-34.

Learning Objectives:

  • Design patient-specific treatment and monitoring plans for children and young adults with T-lineage acute lymphoblastic leukemia.
  • Manage toxicities associated with treatment regimens for patients with T-lineage acute lymphoblastic leukemia.
  • Interpret the efficacy and safety results of the Winter et al. study comparing two methotrexate regimens.
Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial

Zhu AX, Kang YK, Yen CJ, et al. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019; 20:282-96.

Learning Objectives:

  • Evaluate the outcomes of the REACH-2 in patients with advanced hepatocellular carcinoma.
  • Assess patients with advanced hepatocellular carcinoma to determine whether they are eligible for treatment with ramucirumab.
  • Design a supportive care plan for patients with advanced hepatocellular carcinoma receiving ramucirumab.
Master protocols to study multiple therapies, multiple diseases, or both

Woodcock J, LaVange LM. Master protocols to study multiple therapies, multiple diseases, or both. N Engl J Med. 2017; 377:62-70.

Learning Objectives:

  • Explain the differences between the types of master protocols and in what therapeutic areas these studies most commonly occur.
  • Describe areas of innovation for master protocols.
  • Design basket, umbrella, and platform protocols to answer oncology-related questions.
Ado-trastuzumab emtansine for patients with HER2-mutant lung cancers: results from a phase II basket trial

Li BT, Shen R, Buonocore D, et al. Ado-trastuzumab emtansine for patients with HER2-mutant lung cancers: results from a phase II basket trial. J Clin Oncol. 2018; 36:2532-7.

Learning Objectives:

  • Explain the differences between the types of master protocols and in what therapeutic areas these studies most commonly occur.
  • Describe areas of innovation for master protocols.
  • Design basket, umbrella, and platform protocols to answer oncology-related questions.

Planners, Presenters and Reviewers

Courtney C. Cavalieri, Pharm.D., BCOP*
Clinical Oncology Pharmacist
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah 
Assistant Professor of Pharmacy Practice, Duquesne University School of Pharmacy
Clinical Pharmacy Specialist, University of Pittsburgh Medical Center at Passavant
Pittsburgh, Pennsylvania
Clinical Manager, Oncology Pharmacy
Indiana University Simon Cancer Center
Indianapolis, Indiana
H. Lee Moffitt Cancer Center
Tampa, Florida 
Pharmacy Manager, Investigational Drug Service
University of Utah Health
Salt Lake City, Utah
Hematology/Oncology Clinical Pharmacy Specialist
Memorial Sloan Kettering Cancer Center
New York, New York
Danielle Roman, Pharm.D., BCOP*
Manager - Clinical Pharmacy Services
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvania
Christine M. Walko, Pharm.D., FCCP, BCOP*
Personalized Medicine Specialist
H. Lee Moffitt Cancer Center
DeBartolo Family Personalized Medicine Institute
Associate Professor - Department of Oncologic Sciences
USF Morsani College of Medicine
Tampa, Florida
Clinical Pharmacy Specialist
Cincinnati Children’s Hospital Medical Center
Cincinnati, Ohio 

*Content Matter Experts

Angela T. Cassano, Pharm.D., BCPS, FASHP
Susan R. Dombrowski, M.S., R.Ph.

Kyle Adkins, Pharm.D., BCOP, BCPS
Robert Appell, PHARM.D., BCOP
Brandon Benson, Pharm.D., BCOP
Michael Bly, Pharm.D., BCOP
Ju Hyang Cheon, BCOP
Michelle Choi, Pharm.D., BCOP
Linda Elnazir, Pharm.D., BCPS, BCOP
Sara Fleszar, Pharm D BCOP
Seema Ganatra, Pharm.D., BCPS, BCOP
Jamey Groff, Pharm.D. BCOP
Benjamin Gruseck, Pharm.D., BCOP
Elisabeth Hébert, BCOP
Mitchell Hughes, Pharm.D., BCPS, BCOP
Rebecca Hunt, Pharm.D., BCOP
Minhee Kang, Pharm.D., BCOP, BCPS
Shraddha Kansagra, Pharm.D., BCOP
Elizabeth Kelley, Pharm.D., BCPS, BCOP
Ibrahim Lala, Pharm.D, BCPS, BCOP
Lesli Lavery, Pharm.D., BCOP, CPP
Michael Leung, Pharm.D., BCOP
Whitney Lewis, Pharm.D., BCOP
Valerie  Lindeborg, Pharm. D., BCOP, BCSCP
Robin Lockhorst, Pharm.D., BCPS, BCOP
Bob Luschen, Pharm.D., BCOP
Yaser Mahfouz, B.Sc., BCOP
Jonathan Malara, Pharm.D., BCOP
Donald Moore, Pharm.D., BCPS, BCOP, DPLA
Chukwuemeka Nzelibe, Pharm.D, MBA, BCOP
Carol Peek, Pharm.D.
Megan Pinter, MA, Pharm.D., BCOP
Laura Poggi, Pharm.D., BCOP
Britny Rogala, Pharm.D., BCOP
Kaylee Shin, Pharm.D., BCOP
Shayna Simon, Pharm.D., BCOP
Sunao Slayton, Pharm.D., BCOP
Sunao  Slayton, Pharm.D. BCOP
Chia Jie Tan, BPharm (Hons), BCOP
Chen Xu, Ph.D., BCOP
Lily Yan, Pharm.D., BCOP

Disclosures

In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Standards for Commercial Support, ASHP and ACCP requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual of his or her spouse/partner has a financial relationship (e.g. employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring the in the last 12 months with a commercial interest whose products or series may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on the content.

All faculty and planners for ASHP and ACCP education activities are qualified and selected by ASHP and ACCP and required to disclose any relevant financial relationships with commercial interests. ASHP identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity. Anyone who refuses to disclose relevant financial relationships must be disqualified from any involvement with a continuing pharmacy education activity.

  • Karen M. Fancher, Pharm.D., BCOP: Consultant, AstraZeneca, LP
  • Anthony J. Perissinotti, Pharm.D., BCOP: Consultant, Servier
  • Christine M. Walko, Pharm.D., BCOP, FCCP: Consultant, Foundation Medicine; MTB Consultant, Jackson Genetic Laboratories; MTB Consultant, Intermountain Healthcare
  • All other planners, presenters, reviewers, ASHP and ACCP staff and others with an opportunity to control content report no financial relationships relevant to this activity.

Methods and CE Requirements

Activities consist of educational materials, assessments, and activity evaluations. In order to receive continuing pharmacy education credit, learners must:

  • Complete the attestation statement
  • Review all content
  • Complete and pass the assessments
  • Complete the evaluations 

Follow the prompts to claim, view, or print the statement of credit within 60 days after completing the activity. 

System Technical Requirements

Courses and learning activities are delivered via your Web browser and Acrobat PDF. For all activities, you should have a basic comfort level using a computer and navigating web sites. 

View the minimum technical and system requirements for learning activities. 

Development

These activities were developed by ASHP and ACCP.