Nursing: Management of Drug Challenges: Generic vs. Branded Drugs

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About the Course

With health care and drug costs continuing to be high, there is continuing dialogue about the differences between brand name and generic drugs. This course is appropriate for all nurses and advanced practice nurses who have responsibility for managing or prescribing medications for select individuals.  The course addresses the history of brand versus generic drugs, the many controversies, the science behind the preparation differences, and the cost effectiveness of preventative care when using generic versus brand name drugs. 

Learning Outcomes:
Upon completion of this course, the learner should be able to:
  • List the properties that are identical in an FDA-approved brand and a generic drug. 
  • Identify two goals of a new drug application.
  • Identify why a generic drug could be “B” rated by the FDA.
  • Name the biologic drug term analogous to generic drug.
  • Quantify the portion of health care spending attributed to the cost of medications.
  • Identify two types of testing required for FDA approval of a biosimilar.
  • Realize the ratio of lobbying dollars spent by the generic drug industry relative to the brand name industry.
  • Compare the cost effectiveness of preventive care when using generic versus brand name drugs.

About the Author:
Diana M. Sobieraj, PharmD, FCCP, BCPS

Diana M. Sobieraj earned her doctor of pharmacy degree from the University of Rhode Island and subsequently completed a pharmacy practice residency at Hartford Hospital, University of Connecticut (UConn) School of Pharmacy. Dr. Sobieraj joined the faculty at University of Connecticut School of Pharmacy, where she has worked for the past 12 years, during which she completed her research training. Currently, Dr. Sobieraj is an assistant professor in the Department of Pharmacy Practice in the tenure track.  Her scholarly interests focus on comparative effectiveness and health outcomes research, where she has more than 60 publications in the peer-reviewed literature, including journals such as JAMA, Annals of Internal Medicine, and the Journal of the American Geriatrics Society. Dr. Sobieraj has over $2.5 million in research grants and serves as a senior investigator and program manager for the AHRQ-funded UConn Evidence-Based Practice Center. Her most recent accomplishment is serving as the principal investigator for the AHRQ-funded evidence review commissioned by the National Heart, Lung and Blood Institute for updating the EPR-3 guidelines for the management of asthma. She is a preceptor in the UConn Health Outcomes Fellowship program and for the PGY-1 Residency program at Hartford Hospital where she serves as a research adviser and preceptor for an academic rotation. Dr. Sobieraj is a member of ACCP, the chair of the ACCP Health Outcomes PRN, and a member of the Community Advisory Panel of the ACCP Practice-Based Research Network.

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