Understanding the FDA's Medication Safety Initiatives

Course Objective 

In 2022 over 6.7 billion prescriptions were dispensed (Matej, 2023). This number increases each year. The U.S. Food and Drug Administration (FDA) and its Center for Drug Evaluation and Research (CDER) agency are responsible for approving, monitoring, educating, and evaluating the safety and effectiveness of both prescription and over-the counter drugs as well as medical devices. This course presents an overview of the FDA’s history and 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 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

Completion of this course will better enable the course participant 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. 

About the Author/Presenter 

June D. Thompson, DrPH, MSN, RN, FAEN, is an educator, clinician, researcher, and writer. She has served as the director of education and research for University Hospitals in Albuquerque, New Mexico, as well as the director of research and development for Florida Hospitals in Orlando Florida. In these capacities, she helped to champion standards of clinical practice based on evidence. She has taught both undergraduate and graduate nursing at Ohio State University and the University of Texas, Houston. Dr. Thompson earned her baccalaureate degree in nursing from Case Western Reserve University, her master’s in nursing from Ohio State University, and her doctorate in public health, injury epidemiology, from the University of Texas, Houston. 
 

How to Receive Credit  

• Read the entire course online or in print.  
• After completion of the course, complete the final examination. A passing grade of 70% is required. Test questions link content to learning outcomes as a method to enhance individualized learning and material retention.  
• Provide required personal information and payment information.
• Complete the mandatory course evaluation.
• Print your Certificate of Completion.

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Identification, Mitigation, and Disclosure of Relevant Financial Relationships

Planners, faculty, and others in control of content (either individually or as a group) have no relevant financial relationship(s) with ineligible companies to disclose.

Sponsorship/Commercial Support and Non-Endorsement

It is the policy of Colibri not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Accreditation Statement     
InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.  

Designation Statement     
InforMed designates this enduring material for a maximum of 4 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.  

Disclaimer

The information provided in this activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition. 

©2024: All Rights Reserved. Materials may not be reproduced without the expressed written permission or consent of Colibri Healthcare, LLC. The materials presented in this course are meant to provide the consumer with general information on the topics covered. The information provided was prepared by professionals with practical knowledge of the areas covered. It is not meant to provide medical, legal, or professional advice. Colibri Healthcare, LLC recommends that you consult a medical, legal, or professional services expert licensed in your state. Colibri Healthcare, LLC has made all reasonable efforts to ensure that all content provided in this course is accurate and up to date at the time of printing but does not represent or warrant that it will apply to your situation nor circumstances and assumes no liability from reliance on these materials. Quotes are collected from customer feedback surveys. The models are intended to be representative and not actual customers.