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LSRO releases report on monitoring adverse events related to dietary supplements.

The General Accounting Office estimates that there are some 1500 manufacturing and repacking facilities for dietary supplements in the U.S., according to the Washington, D.C.-based Life Sciences Research Office (LSRO), and that these facilities produce approximately 29,000 unique formulations that are packed into more than 75,000 distinctly labeled products and made readily available to the public through supermarkets, retail outlets, the Internet and television infomercials. Protecting the health of those that consume dietary supplements is of great importance to public health agencies like the Food and Drug Administration (FDA) and the product manufacturers. As such, LSRO says its newly released report may further help consumers, regulators and manufacturers learn more about the safety of dietary supplements.

The report, entitled "Recommendations for Adverse Event Monitoring Programs for Dietary Supplements," is the latest scientific review to be released by LSRO, an internationally renowned, nonprofit organization that provides independent expert evaluation of issues, opportunities, data, programs and proposals in the food, health and bioscience sectors. LSRO says while post-market surveillance programs are similar across a variety of product categories since they follow similar information processing principles, in the dietary supplements sector, voluntary post-market surveillance is uncommon and no accepted surveillance standards exist.

According to LSRO, proposed changes in federal regulation of the dietary supplement industry have spurred some manufacturers to consider their monitoring systems. Taking this first step was Metabolife International Inc. (MET), San Diego, CA, which retained LSRO. LSRO was asked to determine how a system for handling consumer inquiries could be tailored to the task of monitoring the safety of dietary supplements.

The LSRO in conjunction with an expert committee of scientists completed its study in two phases. Phase I examined 200 post-market surveillance individual data records (IDRs) collected by the FDA and 200 IDRs reports collected by MET relating to Metabolife 356[R] and other ephedrine alkaloid-containing supplements. The goal of Phase I was to determine how useful these data were as signals in detecting product problems. Phase II examined noteworthy post-market surveillance programs currently in use for other products regulated by FDA with an eye toward making recommendations for the design and implementation of an effective monitoring system for adverse events relating to dietary supplements.

In its Phase I review, the committee found that the records collected by MET were qualitatively less informative than those collected by the FDA and posed a greater challenge for application in public health-related analyses. As the MET IDRs were not intended to support an adverse event reporting system, consumer complaints were collected in most cases during a single telephone contact at a customer service center. The researchers found that while both the FDA and the MET IDRs had sufficient information to permit the preliminary step in detection of potential product problems (signal detection), a substantially greater number of FDA IDRs had sufficient information to permit prioritizing the signals, because (1) a relatively high percentage of FDA reports were from healthcare professionals and (2) most MET IDRs lacked follow up and physician evaluation.

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 healthcare professional-driven) nature of supplement-associated adverse event reporting.

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 post-market 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.

The LSRO says its report provides a framework for building a post-market surveillance system for dietary supplements that can be implemented by individual manufacturers or by the industry as a whole. Building on this framework could be a significant step in helping to assure consumer safety for the one in three adult Americans who routinely use dietary supplements.
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Title Annotation:INDUSTRY NEWS; Life Sciences Research Office
Publication:Nutraceuticals World
Geographic Code:1USA
Date:Dec 1, 2004
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