With an increase in the consumption of health foods, the associated adverse events have been increasing. Nevertheless, the relevant information is insufficient, and there is a lack of a standardized reporting system in Japan. In this study, we attempted to develop a standardized reporting format for the adverse events associated with health food consumption and investigated its usability in combination with a previously developed causal-relation estimation algorithm, using virtual cases, by medical staff.

We extracted the necessary information from nine reported formats, searched from PubMed, and domestic and international websites, including the websites of pharmaceutical regulatory authorities. Using the developed format, the match rates of format items estimated by 77 medical staff（56 pharmacists, 13 physicians and 8 registered sellers）and those of the causal-relation algorithm items estimated by specialists and medical staff were determined.

The match rates of most items in the reporting format were over 65％, but some items showed lower match rates. Furthermore, the match rates of items in the causal-relation algorithm showed a different tendency in each case.

In conclusion, for its application in clinical practice, the standardized reporting format of adverse events associated with health food has to be improved further.

Objective: In recent years, with increased use of health foods mainly due to raising health awareness, appropriate handling of safety information of health food products, as well as efficacy, has attracted attention. Public and businesses institutions have started developing tools to collect and provide safety information on health foods, but the application is unclear in clinical practice. In this study, we investigated exploratory the use of these information tools in insurance pharmacies to handle safety consultations from health food users and evaluated their usability in clinical practice.

Methods: Information tools were introduced for pharmacists working in insurance pharmacies. Video materials were used to provide explanations. Pharmacists evaluated and responded to consultations related to safety information from health food users.

Results: A survey was conducted on 19 pharmacists. Analysis was performed on 43 consultations. Among these, 33 (77％) of the consultants were 60 years old or older, and the contents of consultations (multiple responses allowed) were as follows: drug-health food interactions, 32 (74％); acceptability of health food use, 12 (28％); and ingredients and characteristics of health food, 3 (7％). Adverse event was consulted in one case. While information tools were helpful in responding when product information and information on drug-health food interactions were available, a lack of information on the frequency of adverse events was also noted.

Discussion: This survey highlighted the status of consultations related to health food safety information, using information tools at insurance pharmacies. We found that pharmacists could decide on whether or not to use health foods and provide information on precautions depending on the user's condition, thereby avoiding adverse events associated with health foods. In contrast, it was also considered to provide adequate and sufficient safety information for decision making of risk avoidance.

サプリメント利用による臨床検査値悪化の頻度を調べるため，全国オンライン調査を実施し，特に肝機能指標に着目して解析した．過去1年以内のサプリメント利用者73,010名の中で，臨床検査値の悪化者は0.5％，肝機能指標の悪化者は0.2％と推定された．臨床検査値の悪化は軽微なものが多いと推定され，その経験者のほとんどがその情報をどこにも報告していなかった．サプリメント利用による下痢や皮膚症状と比較すると，臨床検査値の悪化者は，男性の比率が高く，毎日の利用と長期間の利用が多く，利用製品が特定できない者の割合が高いという特徴があった．肝機能指標の悪化者は多くはなく，大部分が軽微と推定されるが，その影響を利用者自身では判断しにくいことから，利用製品名と利用状況を記録するという対応が重要である．

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.