Transcript Suspect ADEs: Reporting How?

Suspect Adverse Drug
Events:
From Awareness to Opportunity
Charity Hudson
Jillian Retter
Jeffrey Moore
Mid-Year Sales Meeting
Bloomington, IN
July 13th – 17th
Agenda
Awareness
Reporting
Experiences
Opportunities
Suspect ADEs: Awareness
What is an Adverse Drug Event?
As defined by FDA, 21 CFR 314.80:
“Any adverse event associated with the use of a drug in
humans, whether or not considered drug related, including
the following: An adverse event occurring in the course of
the use of a drug product in professional practice; an
adverse event occurring from drug overdose whether
accidental or intentional; an adverse event occurring from
drug abuse; an adverse event occurring from drug
withdrawal; and any failure of expected pharmacological
action.”
Suspect ADEs: Awareness
How are Adverse Events classified by FDA?
Serious / Non-Serious
Un-expected / Expected
Suspect ADEs: Awareness
How are Adverse Events classified by FDA?
Serious:
Death
Life-threatening
Hospitalization
Disability
Congenital anomaly
Requires intervention to Prevent Permanent
Impairment or Damage
Suspect ADEs: Awareness
How are Adverse Events classified by FDA?
Unexpected / Expected
Unexpected: Not part of the product labeling
Suspect ADEs: Awareness

QUIZ:
Which of the ADEs needs reported?
a. A non-serious, expected event
b. A non-serious, un-expected event
c. A serious, expected event
d. A serious, un-expected event
e. All of the above
Agenda
Awareness
Reporting
Experiences
Opportunities
Suspect ADEs: Reporting
Why do we report suspect ADEs?
Because we are required to do it. (FDA and company
policy).
Because if we do not, the customer can report the events
straight to FDA, without us even being involved.
Why else?
Because we want to both follow the rules and provide
superior service to our customers.
Suspect ADEs: Reporting
What do we absolutely have to report?
identifiable patient
identifiable reporter
at least one suspected active substance/product
at least one suspected adverse reaction
Suspect ADEs: Reporting
How?
Call / Text / e-mail Charity
Do I or my customers have to use the form?
Not necessarily
When?
ASAP
Suspect ADEs: Reporting
Why do we need to report ASAP?
Completion of forms
Submission to HQ
HQ creation of formal report
Submission to FDA
Many factors involved in appropriately reporting.
Your front line help ensures a smooth system, both for
customer and for USHQ and HQ.
Suspect ADEs: Reporting
Questions about reporting?
Agenda
Awareness
Reporting
Experiences
Opportunities
Suspect ADEs: Experiences
Jill Retter
Arlington Memorial Hospital
Hexabrix
Management of the situation:
Education
Reporting
Closed sale
Suspect ADEs: Experiences
Jeffrey Moore
West Suburban Hospital, Oak Park
Hexabrix
Management of the situation:
Looked into the situation further…
Education
Reporting
Customer Service
Agenda
Awareness
Reporting
Experiences
Opportunities
Suspect ADEs: Opportunities
Where?
At all facilities, in all situations
How?
Customer Service by MCP
Customer Service by USHQ
Management of the situation:
Educate
Report the event
Follow Up
Suspect ADEs: Opportunities
Management of the situation:
Assess the situation
Utilize your experience, clinical knowledge and sales
skills to determine the next course of action
Commit to the customer to reporting the event
Report the event to USHQ
Follow Up with the customer
Suspect ADEs: Opportunities
Why?
Provide excellent Customer and Patient Care
Demonstrate Guerbet’s commitment to appropriate
reporting
Maintain Competitive Advantage
Learn more about your customer and your products
Suspect ADEs: Opportunities
Why?
Scenario:
Suspect ADEs:
Why?
Questions?
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