One of the target points in the PMDA 2nd midterm plan (FY2009-2013) is reinforcement and enhancement of the system for safety evaluation for pharmaceuticals using expanded data sources beyond spontaneous reports of adverse drug reactions (ADRs). To achieve this goal, PMDA started investigation in FY2009 to develop methodology to utilize electronic medical information for secondary purpose of safety evaluation of pharmaceuticals. (MIHARI project- Medical Information for Risk Assessment Initiative)
Data sources targeted in MIHARI project are claims data, diagnosis procedure combination (DPC) data, hospital information system (HIS) data, etc.
Secondary use of electronic medical information for safety evaluation is expected to enable safety evaluation based on quantitative analysis, which has been difficult so far. It will also provide faster and easier way of evaluation compared to collecting primary data from study planned and conducted just for the purpose.
PMDA intends to establish the system to utilize electronic medical information (eg. claim data, DPC data, HIS data) practically for safety evaluation by the end of FY2013. Aiming for this, PMDA is conducting various pilot studies using currently available data in the MIHARI project. Here we report on recent developments of this project.

Medical interviewing skills were assessed with the objective structured clinical examination using simulated/standardized patients (SP) in 36 5th-year medical students. ultaneously, assessment of cognitive-behavioral characteristics was performed using 7 kinds of scales (locus of control, social skills, self-esteem, general self-efficacy, medical interviewing-specific self-efficacy, person perception of self, and person perception of the patient) on the same students to clarify correlations with medical interviewing skills. Students who had attended a small-group mini-workshop session for medical interviewing skills showed only a significantly better ability to summarize. Personal familiarity with the patient was the only factor among the cognitive-behavioral factors studied which was a significantly correlated with medical interviewing skills. Among the six medical interviewing skills, only summarization and confirmation skills were positively correlated with the students' self-efficacy and the objective assessment with the objective structured clinical examination. We conclude that 1) medical interviewing skills can be taught regardless of the cognitive-behavioral abilities of each student; 2) teaching summarization and confirmation skills are especially valuable and important in teaching medical interviewing to medical students.

PMDA started MIHARI project in FY2009 to enhance drug safety assessment by developing ways to utilize electronic medical information as additional data sources to spontaneous adverse drug reaction reports. The project has been established according to PMDA's second midterm plan. In this article, we will introduce latest two studies (pilot studies No. 4 and 5) using data of standardized electronic medical record(EMR) called SS-MIX (standardized structured medical record information exchange) data out of our several pilot studies. SS-MIX is a standard specification published by the Ministry of Health, Labour and Welfare. In these studies, anonymized SS-MIX data were provided by six collaborative hospitals respectively. In pilot study No. 4, we explored approaches for evaluating the impact of regulatory action which instructed relevant manufacturers to revise package inserts of sitagliptin phosphate hydrate (sitagliptin) to call physician's attention. The revision was about reducing dose of sulfonylurea (SU) to avoid serious hypoglycemia when it is prescribed concomitantly with sitagliptin. As indicators of the impact, we evaluated changes in proportion of concomitant use and average SU dose before and after the action and estimated the risk of hypoglycemia in concomitant users compared to SU alone users before and after the action. In conclusion, evaluating impact of the regulatory action using SS-MIX data was technically feasible; however, it was difficult to analyze with adequate accuracy due to limited size of the data. In pilot study No. 5, we examined validity of outcome definitions for hyperthyroidism which were applied to combinations of some data elements of SS-MIX data to identify the patients. Three types of outcome definitions were prepared; 1) definitive diagnosis of hyperthyroidism, 2) prescription of medication for hyperthyroidism, 3) prescription of medication for hyperthyroidism in or after the month in which definitive diagnosis of hyperthyroidism was given. Criteria for case ascertainment were determined according to relevant clinical guidelines. After the cases were ascertained, positive predictives values were calculated. The results suggested that using information on prescription of medication improves validity of definition of outcome. The findings from pilot studies in MIHARI project have been utilized in another project which PMDA is carrying forward now (EMR network project). The findings would be also helpful when we use data from this network. (Jpn J Pharmacoepidemiol 2013；18(1)：23-29)

The purpose of this study was to clarify the relationship between frequency of bathing in a spa and at home and the characteristics of the body, blood, and lifestyle of white-collar and blue-collar male employees.
To recruit subjects, two baseline data for randomized controlled trials in two places in Shimane Prefecture and in Nagano Prefecture were used. In the two-month period between August and September 2006, 43 of 311 white-collar male employees aged between 30 and 57 years in the Unnan municipal office volunteered to participate in this study. Similarly, 44 blue-collar workers in Nagano Prefecture volunteered to be involved in this study as a result of an appeal for volunteers in local newspapers and public information journals published by large local enterprises from September through November 2006. A total of 87 men were subjects of this study. Items evaluated in this study with respect to physique included height, weight, body mass index, waist circumference, hip circumference, and percent of body fat. With respect to strength, they were grip strength, abdominal strength, back strength, and anteflexion. With respect to characteristics of the blood, they were serum glucose, hemoglobin A1c, fructosamine, lactic acid, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, free fatty acid, GOT, GPT, γ-GTP, cholinesterase, natural killer cell activity, T cell, B cell, CD4+, CD8+, CD4/8 and uric acid. With respect to mood, Profile of Mood States was evaluated. With respect to lifestyle, the frequency of monthly bathing in a spa and at home was evaluated.
No significant correlation was revealed between frequency of monthly spa bathing and the health indices in the white and blue-collar male workers. The items that were significantly correlated (p<0.05) with frequency of monthly bathing at home were GOT (positive), CD8+ (positive), and mental stress (negative).
In this study, frequency of monthly spa bathing was found to have no significant correlation with the health indices.

The decrease in physical activity in elementary school children is an important problem in Japan. Previous studies have shown that physical activity during the summer vacation is lower than during the school days, and a program for increase in physical activity during the summer vacation are required. Therefore, the purpose of this study is to assess the effectiveness of physical education homework and exercise events during summer vacation in elementary school children. A total of 67 children in grade 4 were assigned to the two groups for each school: the control school (n = 39) or the intervention school (i.e., did physical education homework and participated in exercise events; n = 28). Physical education homework was constituted of four exercise programs per day. Additionally, exercise events were carried out four times during the summer vacation. Physical activity before and during the summer vacation were measured by accelerometer (Lifecorder EX). The decline in physical activity of the intervention school was less than the control school, and significant interactions were indicated by two-way repeated ANOVA (Step count: F (1, 65) = 6.704; Light-intensity physical activity, LPA: F (1, 65) = 4.365; Moderate- to vigorous-intensity physical activity, MVPA: F (1, 65) = 6.088, all P < 0.05, respectively). After adjusted for sex, percentage of overweight, participation of sport activity, and each physical activity, significant trends of interactions about the step count, LPA, and MVPA were shown (Step count: F (1, 61) = 3.982, P = 0.050; LPA: F (1, 61) = 3.243, P = 0.077; MVPA: F (1, 61) = 2.916, P = 0.093). These results suggest that combined use of physical education homework and exercise events are effective to attenuate the decrease in physical activity during summer vacation in elementary school children.