FDA Medication Safety Program

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About the Course

Audience: This course will benefit all nurses who administer and counsel patients about medications. Nurse practitioners with medication prescribing authority will also benefit from this course.

Course overview: Ensuring medication safety is one of the key responsibilities of the Food and Drug Administration (FDA). 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 in the care of any patient that nurses understand the possible safety concerns of the medications their patients are receiving. The nurse should be familiar with the information available from FDA concerning risks, warnings, and mitigation strategies. This course will provide an overview of available FDA medication safety information, including drug labeling, black box warnings, medication guides, REMS programs, and available FDA medication safety communication and information for nurses and patients. 

Learning Objectives

  • Describe the role of FDA in the monitoring and regulating of medication safety throughout the drug lifecycle.
  • Discuss opportunities and challenges of postmarket surveillance and notification of adverse drug events.
  • Identify the different medication safety programs and notifications provided by  FDA, including how to access these resources.
  • Explain the rationale for FDA medication safety programs/information, especially REMS, medication guides, and black box warnings.
  • Distinguish between the new and old pregnancy and lactation labeling rules followed by FDA for drug product labels.
  • Understand application of FDA medication safety information and procedures when caring for patients.

About the Author

Kathleen Vieson, PharmD, is a clinical pharmacist living in the Tampa, Florida, area. Kathy graduated from the Ohio State University in 1989 with a bachelor of science degree in pharmacy. Kathy gained clinical and hospital pharmacy experience during a general hospital residency at the University of Cincinnati Medical Center. She then went on to receive her doctor of pharmacy degree from the University of Kentucky in 1991 and completed an oncology specialty pharmacy residency at the Pittsburgh Cancer Institute/University of Pittsburgh School of Pharmacy in 1993. After completing her training, Kathy worked as clinical pharmacist at the H. Lee Moffitt Cancer Center in Tampa,  where her experience included oncology, malignant and nonmalignant hematology, pain management, critical care, and oncology ambulatory care. Kathy then spent the next part of her career at Gold Standard/Elsevier where she held various roles, including oncology specialty editor, managing editor, drug databases, vice president, clinical drug information resources (clinical pharmacology and ToxED), editor-in-chief, clinical drug information, and vice president, diagnosis, treatment, and care content. Over her time at Elsevier, she developed numerous drug information applications and clinical decision support databases and tools and directed content development for physicians, nurses, pharmacists, and patients. Currently, Kathy is a clinical specialist at Clinical Pharmacology Services, a specialty pharmacy practice site that provides clinical research, medication therapy management, drug information, clinical toxicology, and forensic services.

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