MedWatch: The FDA Safety Information and Adverse Event Reporting Program

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MedWatch: The FDA Safety Information and Adverse Event Reporting Program

As noted earlier, there are mandatory and voluntary error reporting requirements. Executive leaders need to be aware of both types and be a part of the decisional team tasked with determining participation in voluntary errors. Ethics directs healthcare leaders to participate in all activities designed to improve patient safety. Policies need to be developed as well as staff training. It is common for all error reporting forms to be routed to leadership and risk management.

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Generate an error report.

Include the following aspects in the discussion:

  • Access the form from MedWatch: For VOLUNTARY reporting of adverse events, product problems and product use errors
  • Using a prior error that you can remember, complete the form (this form will not be submitted; it is for personal practice only)
  • Discuss if, as a nurse executive, you would choose to participate in voluntary error reporting
  • Discuss the risks and benefits of your decision. MedWatch: The FDA Safety Information and Adverse Event Reporting Program

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