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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.

  1. 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.

  2. 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?

  3. 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?

  4. 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.

 

   
 

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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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.