Nursing: FDA Programs for Medication Safety
28.95
Online
Elective
Please select your state to enroll in this course
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, 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. Katie also 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. Katie 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.

How to receive credit:
  • Read the entire course online or in print which requires a 3-hour commitment of time.
  • Complete the self-assessment quiz questions which are at the end of the course or integrated throughout the course. These questions are NOT GRADED. The correct answer is shown after you answer the question. If the incorrect answer is selected, the rationale for the correct answer is provided. These questions help to affirm what you have learned from the course.
  • Depending on your state requirements you will then be asked to complete either:
    • An affirmation that you have completed the educational activity
    • A mandatory test (a passing score of 70 percent is required). Test questions link content to learning objectives as a method to enhance individualized learning and material retention.
  • If requested, provide required personal information and payment information.
  • Complete the mandatory Course Evaluation
  • Print your Certificate of Completion.

Disclosures:

Resolution of Conflict of Interest

In accordance with the ANCC Standards for Commercial Support for continuing education, 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 Healthcare, LLC 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 ©2020: 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.

Course Verification
All individuals involved have disclosed that they have no significant financial or other conflicts of interest pertaining to this course. Likewise, and in compliance with California Assembly Bill No. 241, every reasonable effort has been made to ensure that the content in this course is balanced and unbiased.

 
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FDA Programs for Medication Safety - N33922

28.95
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, 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. Katie also 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. Katie 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.

How to receive credit:
  • Read the entire course online or in print which requires a 3-hour commitment of time.
  • Complete the self-assessment quiz questions which are at the end of the course or integrated throughout the course. These questions are NOT GRADED. The correct answer is shown after you answer the question. If the incorrect answer is selected, the rationale for the correct answer is provided. These questions help to affirm what you have learned from the course.
  • Depending on your state requirements you will then be asked to complete either:
    • An affirmation that you have completed the educational activity
    • A mandatory test (a passing score of 70 percent is required). Test questions link content to learning objectives as a method to enhance individualized learning and material retention.
  • If requested, provide required personal information and payment information.
  • Complete the mandatory Course Evaluation
  • Print your Certificate of Completion.

Disclosures:

Resolution of Conflict of Interest

In accordance with the ANCC Standards for Commercial Support for continuing education, 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 Healthcare, LLC 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 ©2020: 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.

Course Verification
All individuals involved have disclosed that they have no significant financial or other conflicts of interest pertaining to this course. Likewise, and in compliance with California Assembly Bill No. 241, every reasonable effort has been made to ensure that the content in this course is balanced and unbiased.