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Adverse
Events Tracking and Reporting Systems
January 1999
Several
systems for tracking and reporting dietary supplement adverse event
reports (AERs) have been created, and others are under development.
To develop effective AER systems, it is imperative that AER system
basics are understood and observed.
An
information database is only as good as the data that goes into
it. Therefore, for an AER system to accurately reflect the dangers
associated with a dietary supplement, it is critical that reports
are properly screened. Information pertinent to each adverse event
report must be gathered.
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It must be established that each report is accurate and
truthful. This requires gathering information about the
consumer reporting the problem while maintaining their confidentiality.
- The
circumstances surrounding the event must be gathered.
What dosage was taken? Were other substances consumed that may
have interacted with the supplement or that may have caused the
adverse event? Were there any precipitating events that may have
brought on the incident such as a trauma or sudden exertion?
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The medical condition of the consumer must be assessed.
Were there any preexisting conditions that may have been the cause,
or a contributing cause, to the adverse event? Did the consumer
have a known allergy or other condition that contraindicates use
of the substance?
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Once information is gathered, there must be screening guidelines
to draw the line between a frivolous complaint and a bona fide
AER. Mechanisms are also needed to determine when, and to whom,
such reports should be disseminated.
Both
manufacturers and consumers can suffer if a false or incomplete report
is publicized. This can unfairly damage a manufacturer's reputation,
encourage false claims by competitors, and cause the recall of products
that are actually quite safe, thereby depriving consumers of their
benefits.
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Read
more about:
Toxicity,
allergies, interactions, and contraindications
Safety
concerns for specific dietary supplements
Contamination
Sources
of contamination
Adverse
events
Adverse
events tracking and reporting systems
Industry
initiatives to track adverse events
Safety
Guidelines
Cautions
& potential hazards
Ephedra
safety guidelines
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