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In Phase II, LSRO's Expert Committee concluded that if a voluntary surveillance program were to be adopted by dietary supplement companies, it would be inappropriate to use the methods being used for mandatory surveillance programs for prescription medications. The study authors noted that surveillance systems for dietary supplements had to be tailored to accommodate the voluntary and consumer-driven (as opposed to health care professional-driven) nature of supplement-associated adverse event reporting.

Conclusions and Recommendations
Analyses of MET IDRs and a review of existing surveillance programs led the LSRO experts to make several recommendations, which they noted, should be broadly applicable to dietary supplements and not to any one particular type of supplement or manufacturer. The LSRO Committee concluded that an effective postmarket surveillance program can enhance the likelihood that true adverse effects, unknown at the time of marketing, are identified. The recommendations include specific, detailed advice concerning the required components of such a system, as well as recommended enhancements to improve the effectiveness of the system including: (1) a proposal of a surveillance program for the dietary supplements sector that would make such a system practical and auditable; (2) a user-friendly approach for consumers that was simple and concise, and available 24-hours a day, 365 days per year; (3) creation of a standardized questionnaire that would facilitate the collection of data that are useful for detecting, prioritizing and evaluating adverse event signals in order to establish and maintain the integrity of the process; and (4) ways in which issues regarding signaling, issues resolution and risk management, and quality assurance could be addressed.

Next Steps<
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Contact: Donna Krupa
djkrupa1@aol.com
703-527-7357
Life Sciences Research Office
15-Nov-2004