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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.
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
NOTE- JUST WRITE 150 WORDS
MedWatch The FDA Safety Information and Adverse Event Reporting.docx

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