Development of a Standardized Reporting Format for Adverse Events Associated with Health Food Consumption and the Evaluation of its Feasibility by Medical Staff

Abstract

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.