Uncovering Fraud in Drug Development and Distribution
Course Overview
In this course, we will explore the critical importance of data integrity across all phases of drug development, from initial discovery and testing to manufacturing and packaging. Ensuring that data remain accurate is essential for meeting stringent quality standards and safeguarding public health, as breaches can lead to compromised drug approvals and limited market availability. We will analyze case studies of scientific misconduct to understand how fraudulent practices, such as data manipulation, undermine research validity and erode public trust. Additionally, we will examine the typical life cycle of new drugs, including the impact of patent expiration and aggressive marketing strategies used by pharmaceutical companies. Ethical and legal issues, including off-label marketing, misbranding, and the role of the Anti-Kickback Statute in preventing unethical financial transactions, will also be discussed. Further, we will review the importance of postmarketing surveillance in monitoring drug safety, the role of current good manufacturing practice (cGMP) in maintaining drug quality, and the regulatory measures designed to address risks associated with counterfeit and contaminated drugs, thereby ensuring the integrity of the U.S. drug supply.
Learning Outcomes
Upon the completion of this course, the learner should be able to:
- Recognize fraudulent practices in data collection and analysis during the premarket phase of drug development and key indicators of data manipulation.
- Summarize the typical life cycle of new drugs and the role of postmarketing surveillance in tracking the safety and effectiveness of approved drugs.
- Interpret market dynamics and marketing strategies within the healthcare industry and their ethical and legal implications related to patient care and healthcare costs.
- Identify the critical role of maintaining drug quality for consumer safety and public health, distinguishing between contaminated and counterfeit products.
About the Author/Presenter
Katherine Moore, PharmD, BCMTMS, is a lecturer at the University of Texas at San Antonio teaching healthcare fraud and compliance investigations for the Health, Aging, and Society undergraduate program. She is also an adjunct assistant professor with Beyond Campus Innovations teaching graduate-level courses in health law and ethics, healthcare systems, and healthcare insurance. She graduated in 2012 from the University of the Incarnate Word Feik School of Pharmacy in San Antonio, Texas. She has since practiced pharmacy in both managed care and community settings. Her additional experience in higher education includes facilitating case-based, small group discussions with the UIW School of Medicine and facilitating interprofessional education classes at the University of Colorado Anschutz Medical Campus.
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, Psychology
If you require special accommodations, please contact Colibri Healthcare Support by clicking here: Contact Us
