Understanding the FDA’s Medication Safety Initiatives

About the Course 
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

• 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. 

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 which requires a 4-hour commitment of time. 
• After completion of the course, complete the final examination.  A passing grade of 75% is required. Test questions link content to learning outcomes as a method to enhance individualized learning and material retention. 
• Note to Nursing professionals: Depending on your state requirements, you will be asked to either affirm that you have completed the course, or you will be required to complete the Post-test included in the course.
• Provide required personal information and payment information.
• Complete the mandatory course evaluation.
• Print your Certificate of Completion.

Resolution of Conflict of Interest 
Colibri Healthcare, LLC implemented mechanisms prior to the planning and implementation of the continuing education activity, to identify and resolve conflicts of interest for all individuals in a position to control content of the course activity.

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.

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.

Accreditations and Approvals 
Colibri Healthcare, LLC is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.

Colibri Healthcare, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. (Provider #0607). Your hours will be reported to CPE Monitor within 10 business days after course completion. Colibri Healthcare, LLC is also approved through the Florida Board of Pharmacy (Provider #50-4007).

   
Colibri Healthcare, LLC is accredited by the Accreditation Council of Pharmacy Education (ACPE) as a provider of continuing pharmaceutical education. (Provider #0607).