健康食品製造販売事業者を対象とした健康食品の摂取に伴う有害事象の統一報告フォーマットの実用性調査

抄録

In recent years, the use of health foods has grown, and along with this, health hazards associated with the consumption of health foods have been reported. To collect the relevant information and use it to prevent the spread of health hazards, it is necessary to establish a unified collecting system that picks up adverse events from the stage when the causal relationship is not clear and to establish a causal relationship evaluation method. We have already developed a unified standardized reporting format and causal-relation estimation algorithm for the collection of information on the adverse events associated with the consumption of health foods and evaluated the feasibility of its use by medical staff. In this study, we explored the practicality of the partially modified standardized reporting format and algorithm for health food manufacturers and sellers, who are likely to receive consumption claims on adverse events as well as medical staff, using fictitious cases. The match rate for each item by the raters and the match rate between the estimates by specialists and the raters were calculated.

Evaluations were requested from 90 companies belonging to the Japan Health and Nutrition Food Association, which deals with health foods, and were obtained from 33 companies（37％）and 59 raters. The rate of agreement among the raters was generally high for many items in the reporting format and the algorithm sheet（6 items: More than 70％), but a low agreement was observed for some items. There was a possibility of having a certain level of reliability and validity for the causal relationship in the algorithm. In this study, for health food manufacturers and sellers, as for the medical staff, the potential for practicality in the collection of adverse events information was suggested, but some items had issues and needed to be improved.