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Overview of Generic Substitution

15
4.5

Course Overview
The goal of this application-based activity is to help pharmacists and pharmacy technicians in all settings learn about generic drugs and generic substitution and apply this knowledge when recommending or helping patients select appropriate and cost-effective treatments.

Learning Outcomes 
Upon the completion of this course, the learner should be able to:

  • Explain the process of generic drug approval and marketing.
  • Compare the various types of exclusivities for brand and generic drugs granted by the Food and Drug Administration (FDA).
  • Evaluate the differences in the definitions of therapeutic equivalence, bioequivalence, and pharmaceutical equivalence.
  • Recommend how to use the Orange Book to identify drug products that are therapeutically equivalent.
  • Discuss the substitution of biological drugs, including the requirements for products to be approved as biosimilar or interchangeable.

About the Author/Presenter 
Vickie Danaher, PharmD, is an Associate Editor at TRC Healthcare. She earned her Doctor of Pharmacy degree from Midwestern University Chicago College of Pharmacy and completed a PGY1 community pharmacy practice residency with Albertsons Companies. Before joining TRC in 2015, Vickie held various roles in pharmacy operations, education, and clinical programs at Albertsons, including serving as Clinical Coordinator, where she implemented and managed patient care services nationwide. Her professional interests include pharmacist and pharmacy technician education, pharmacy-based clinical services including medication therapy management, and medication safety.

Audience/Accreditations and Approvals 
TRC Healthcare/ NetCE 
In support of improving patient care, this activity has been planned and implemented by TRC Healthcare/ NetCE. TRC Healthcare/NetCE is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. 
This course is designed for the following healthcare professions (select your profession for details): 
Pharmacy

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