Suspect Adverse Drug Events: From Awareness to Opportunity Charity Hudson Jillian Retter Jeffrey...
24
Suspect Adverse Drug Events: From Awareness to Opportunity Charity Hudson Jillian Retter Jeffrey Moore Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th
-
Upload
florence-pierce -
Category
Documents
-
view
213 -
download
0
Transcript of Suspect Adverse Drug Events: From Awareness to Opportunity Charity Hudson Jillian Retter Jeffrey...
Suspect Adverse Drug Events:
From Awareness to Opportunity
Charity HudsonJillian Retter
Jeffrey MooreMid-Year Sales Meeting
Bloomington, INJuly 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?
•
