Nursing: FDA Programs for Medication Safety

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About the Course

Ensuring medication safety is one of the key responsibilities of the U.S. Food and Drug Administration (FDA). The FDA reviews and monitors drug safety and makes this information available to nurses and other health care professionals through a variety of methods. It is critical for the care of all patients that nurses understand the possible safety concerns of the medications their patients are receiving. Nurses should be familiar with the information available from the FDA concerning risks, warnings, and mitigation strategies. This course provides an overview of available FDA medication safety information, including drug labeling, black box warnings, Medication Guides, Risk Evaluation and Mitigation Strategies (REMSs) programs, and available FDA medication safety communication and information for nurses and patients.

Learning Outcomes:
Upon completion of 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.
  • Distinguish the postmarket safety surveillance initiatives used by the FDA, including the Safety First Initiative, the Safe Use Initiative, MedWatch, the Sentinel System, mandatory reporting, and communications.
  • Evaluate drug labeling requirements, including black box warnings and pregnancy and lactation information.
  • Examine the requirements for Medication Guides and REMS programs.
  • Demonstrate how to use FDA medication safety information in patient counseling.

About the Author:
Katie Blair, PharmD, RPh

Katie Blair, PharmD, RPh, is a pharmacist and freelance writer specializing in pharmacy education. She works as a consultant pharmacist in Vancouver, Washington, serving long-term care facilities in the area. Dr. Blair has over six years of experience working as a staff pharmacist at a community pharmacy in Seattle. She graduated from Northeastern University in Boston in 2009 with a doctor of pharmacy degree. Dr. Blair has done freelance work writing and revising continuing education programs for pharmacists, pharmacy technicians, and nurses, as well as writing practice questions for various pharmacy technician exams.

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