Activity Overview
Please read the following information about this continuing pharmacy education (CPE) activity before accessing the presentations using the link located at the bottom of this page.
Release Date: February 15, 2013 Expiration Date: August 1, 2014
Accreditation for Pharmacists
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity provides 2 hours (0.2 CEUs) of continuing pharmacy education credit (ACPE activity #0204-0000-12-437-H01-P).
Methods and Format
This is an online activity consisting of audio and slides, an assessment (post-test), and a course evaluation. Participants should claim continuing education credit for this internet-based educational activity only if they have not claimed credit for the live activity. Participants must view the entire presentation, take the activity assessment, and complete the course evaluation to receive continuing education credit. A minimum score of 70% is required on the test for credit to be awarded, and participants may print their official statements of continuing education credit immediately. The estimated time to complete this activity is 2 hours. This activity is provided free of charge.
Target Audience
This continuing pharmacy education activity was planned to meet the needs of pharmacists in a variety of practice settings, and it would be particularly beneficial for pharmacists, clinical specialists, pharmacy managers, leaders, and educators who are interested about the science, legislative status, and patient safety concerns of biosimilars.
Activity Content
This educational activity will cover in depth the scientific and legislative issues associated with biosimilars, including patient safety concerns, such as immunogenicity, pharmacovigilance programs, substitution rules, and interchangeability. Expert faculty will discuss pertinent issues for pharmacists such as the manufacturing and production process of biopharmaceuticals compared with traditional chemical drugs; EMEA’s 2003 guidelines and lessons learned from biosimilar approvals in Europe; current U.S. legislation and updates on FDA regulations regarding biosimilars.
The activity will discuss the importance of pharmacovigilance programs and the role of providers in that process. The activity will conclude with a review of risks and benefits as they relate to patients and providers and important clinical information that will be required when presenting biopharmaceuticals and biosimilars to decision-making groups, such as the pharmacy & therapeutics committee.
Learning Objectives
After attending this application-based educational activity, participants should be able to
- Review the intricate scientific process used to produce biopharmaceutical agents and compare it with the process used to create traditional chemical drug products.
- Discuss the development of the European Union and the U.S. biosimilar regulatory pathway and the impact of emerging FDA guidance on the evaluation and approval of biosimilars in the U.S.
- Examine potential approaches to monitoring and identifying unique adverse events that could emerge with biosimilars.
- Review key information that will be needed to evaluate biosimilars for formulary consideration.
- Develop a plan for the introduction of biosimilars into routine health system practice, including an approach to transitions of care.
Faculty
James M. Hoffman, Pharm.D., M.S., BCPS, Program ChairMedication Outcomes and Safety Officer
St. Jude Children’s Research Hospital
Associate Professor of Clinical Pharmacy
College of Pharmacy
University of Tennessee Health Science Center
Memphis, Tennessee
Dr. James M. Hoffman, Pharm.D., M.S., BCPS, is Medication Outcomes and Safety Officer and Associate Member in Pharmaceutical Sciences at St. Jude Children’s Research Hospital in Memphis, Tennessee. Dr. Hoffman is also an associate professor of clinical pharmacy at the University of Tennessee Health Science Center. In his position at St. Jude, Dr. Hoffman leads medication use policy, medication safety, and research pharmacy services.
Dr. Hoffman received both his Bachelor of Science in Pharmacy and Doctor of Pharmacy degrees from the Philadelphia College of Pharmacy. In addition, he received a Master of Science degree in pharmacy administration from the University of Wisconsin-Madison. He also completed a residency in pharmacy administration and a fellowship in outcomes research at the University of Wisconsin Hospital and Clinics.
Dr. Hoffman is a Board Certified Pharmacotherapy Specialist (BCPS). He is an active member of the American Society of Health-System Pharmacists (ASHP), including serving on the Council on Pharmacy Practice, in the ASHP House of Delegates, and on the editorial board of the American Journal of Health-System Pharmacy (AJHP). He is currently a Director-at-Large for the Section of Pharmacy Practice Managers Executive Committee. Additionally, he has served on committees for other national organizations, including the National Quality Forum and the National Comprehensive Cancer Network (NCCN). In 2011, he served on the NCCN biosimilars work group, and he was the senior author of the group’s white paper on biosimilars published in the Journal of the National Comprehensive Cancer Network. Dr. Hoffman also has extensive experience analyzing various aspects of medication use and policy. Since 2004, he has been a lead author of the annual special feature in AJHP that projects medication expenditures.
Edward Li, Pharm.D., BCOPAssociate Professor
Department of Pharmacy Practice
University of New England College of Pharmacy
Portland, Maine
Edward Li, Pharm.D., BCOP, is Associate Professor in the Department of Pharmacy Practice at the University of New England (UNE) College of Pharmacy in Portland, Maine. Dr. Li earned his Doctor of Pharmacy degree from the Philadelphia College of Pharmacy. He also completed a pharmacy practice residency at the University of Wisconsin Hospital and Clinics in Madison, and an oncology pharmacy practice residency at the University of Maryland School of Pharmacy in Baltimore. He is also a board-certified oncology pharmacist.
Before joining UNE, Dr. Li was a member of the faculty at Wilkes University, Nesbitt College of Pharmacy and Nursing in Wilkes-Barre, Pennsylvania, and most recently was Oncology Pharmacy Manager at The National Comprehensive Cancer Network, a not-for-profit alliance of 21 of the world's leading cancer centers, that is dedicated to improving the quality and effectiveness of care provided to patients with cancer.
Dr. Li’s research interests include public health policy issues relating to oncology practice, such as comparative effectiveness and Risk Evaluation and Mitigation Strategies (REMS), as well as utilization of secondary data sources to analyze practice trends and outcomes.
James G. Stevenson, Pharm.D., FASHPChief Pharmacy Officer
University of Michigan Health System
Professor and Associate Dean for Clinical Sciences
University of Michigan College of Pharmacy
Ann Arbor, Michigan
James G. Stevenson, Pharm.D., FASHP, is Chief Pharmacy Officer at the University of Michigan Health System, as well as Professor and Associate Dean for the Department of Clinical Sciences at the University of Michigan College of Pharmacy.
Dr. Stevenson received his Bachelor of Science and Doctor of Pharmacy degrees from Wayne State University in Detroit, Michigan. He then joined the faculty at the West Virginia University School of Pharmacy in Morgantown.
Dr. Stevenson’s previous appointments include Assistant Director for Clinical Services, and subsequently Associate Director for Patient Care, Education and Research Services in the Department of Pharmaceutical Services at West Virginia University Hospitals, before being appointed Director of Pharmaceutical Services. He has also served as Director of Pharmacy Services at Detroit Receiving Hospital and University Health Center, Director of the Graduate Program in Health Systems Pharmacy Management in the Wayne State University College of Pharmacy, and Executive Director of Pharmacy Services for the Detroit Medical Center.
He is a Fellow of the American Society of Health-System Pharmacists (ASHP) and has been recognized as Pharmacist of the Year by both the Michigan Society of Health-System Pharmacists and the Michigan Pharmacists Association. He has also been honored with the Distinguished Alumnus Award by the Wayne State University College of Pharmacy and the Joseph Oddis Leadership Award by the Michigan Society of Health-System Pharmacists. He recently completed a term of service on the ASHP Board of Directors and received the John W. Webb Lecture Award in 2010. In 2012, Dr. Stevenson was appointed to the Michigan Board of Pharmacy.
Dr. Stevenson's major research interests include pharmacy practice management, pharmacoeconomics, pharmacy informatics, and medication safety.
Disclosure Statement
In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Guidelines for Standards for Commercial Support, ASHP Advantage 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 or his or her spouse/partner has a financial relationship (e.g., employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or services 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 presentations.
All faculty and planners for ASHP Advantage education activities are qualified and selected by ASHP Advantage and required to disclose any relevant financial relationships with commercial interests. ASHP Advantage identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity.
The faculty and planners report the following relationships:
James M. Hoffman, Pharm.D., M.S., BCPS
Dr. Hoffman declares that he has no relationships pertinent to this activity.
Edward Li, Pharm.D., BCOP
Dr. Li declares that he has no relationships pertinent to this activity.
James G. Stevenson, Pharm.D., FASHP
Dr. Stevenson declares that he has no relationships pertinent to this activity.
Susan R. Dombrowski, M.S., B.S.Pharm.
Ms. Dombrowski declares that she has no relationships pertinent to this activity.
Erika Thomas, M.B.A., R.Ph.
Ms. Thomas declares that she has no relationships pertinent to this activity.
ASHP staff has no relevant financial relationships to disclose.
This activity is supported by an educational donation provided by Amgen
and an educational grant from Pfizer, Inc.
Agenda (120 minutes total)*
Introduction
James M. Hoffman, Pharm.D., M.S., BCPS, Program Chair (10 minutes)
The Role of Biologics in Patient Care and an Overview of Biosimilar Science
Edward Li, Pharm.D., BCOP
(35 minutes)
Developing the Biosimilar Pathway in the United States
James M. Hoffman , Pharm.D., M.S., BCPS
(30 minutes)
Introducing Biosimilars to the Health System: The Pharmacist's and P&T Committee's Leadership Roles
James G. Stevenson, Pharm.D., FASHP (30 minutes)
Questions and Answers All faculty
(optional, 15 minutes)
*Allow additional time to complete the assessment and evaluation.
Download Assessment and Handout
Print the assessment (post-test) and handout of slides for your reference; however, your assessment must be submitted online.
Process CE
When you reach the end of the activity, follow instructions to complete the online process (i.e., take assessment test and complete evaluation) and obtain CE credit.
Additional Resources
For additional education and resources about this topic or to sign-up to be notified when new resources are available, visit www.biosimcentral.org.