Course Goals:

In 2022 over 6.7 billion prescriptions were dispensed (Matej Mikulic, 2023, September 15).  This number increases each year.  The U.S. Food and Drug Administration (FDA) and its Center for Drug Evaluation and Research (CDER) agency is responsible for approving, monitoring, educating, and evaluating the safety and effectiveness evaluation of both prescription and over-the counter drugs as well as medical devices.  This course presents an overview of the FDA’s history, its current role in safety monitoring, drug effectiveness, and supply of medications in the United States.  The agency maintains many different databases and publications related to drug safety and availability which are available to both the healthcare professionals and consumers.  As healthcare providers, it is critical to understand many of these resources and to know which ones are applicable to your profession.   This course provides an overview of many of the important resources that the FDA provides as well as how to access the information, how to report concerns and how to stay current as the landscape of drug availability continually changes in the United States.   

Learning Outcomes:

After completing this course, the learner will be able to:

• Interpret significant legislation that led to the creation and expansion of the FDA.  
• Illustrate the role of the FDA in monitoring and regulating medication safety throughout the drug life cycle. 
  
• Evaluate drug labeling requirements, including box warnings and pregnancy and lactation information.  
  
• Distinguish the post market safety surveillance initiatives used by the FDA, including the Safety-First Initiative, the Safe Use Initiative, MedWatch, the Sentinel System, drug shortages, mandatory reporting, and communications.  
  
• Examine the requirements for Medication Guides and REMS programs.  
  
• Demonstrate how to use FDA medication safety information to ensure accurate information in clinical practice and patient counseling.