Verification of Feasibility of Post-marketing Monitoring and Discussion of Signal Detection Methods

Abstract

 Signal detection methods using data, such as adverse drug reactions reporting, have been developed for post-marketing drugs. These methods have been examined in Japan by the Pharmaceuticals and Medical Devices Agency. However, no survey method has been established to study the food borne health disorder resulting from post-marketing foods. In this study, we utilized the post-marketing surveillance for the early detection of food borne health disorder and examined the feasibility of post-marketing monitoring. We obtained consent from the union members of the Japanese Consumers' Co-operative Union (JCCU) and collected product purchase data at the JCCU to conduct a daily health survey using Internet questionnaires. We calculated the signal detection indexes for some combinations of foods and symptoms, referring to the procedures for adverse drug reaction, and detected several signals that indicated health disorder. Our results demonstrate the feasibility of post-marketing monitoring. In the future, we will determine the threshold of alert about health problems using various signal detection methods to improve the precision of analysis based on post-marketing monitoring.