In enabling consumers to make thetr own judgments regarding the risks of drugs, it is essntial to share information regarding the risks of drugs among stakeholders (governmental agencies, pharmaceutical companies, healthcare professionals and consumers or patients) and to have communication (risk communication).In particular, the communication between governmental agencies and consumers or patients is given a high priority. Hence, its provisions and strategies should be considered thoroughly.
FDA's risk communication efforts are part of a larger drug safety initiative that began in November 2004. In fact, FDA is engaged in verification and strategies aiming at strengthening drug safety. As a part of these efforts, FDA has published the "Guidance Drug Safety Information-FDA's Communication to the Public" and "FDA Strategic Plan for Risk Communication".
In this article, we present the "FDA Strategic Plan for Risk Communication" translated into Japanese and explain the situation of risk communication for drugs from the FDA perspective. We also examine the future of risk communication in Japan.

OBJECTIVE: The present study assessed the validity of the benchmark, 75 years old, that divides elderly people into an early and a late stage, based on health checkup results for two consecutive years. We also investigated prevalent health problems and improvement trends.
METHODS: This retrospective study was conducted on 1,416 subjects (1,007 early and 409 late elderly subjects) who received health checkups at the Health Care Center of the St. Marianna University School of Medicine Hospital between April 2006 and March 2007. The survey consisted of blood pressure, required blood test results, diagnoses according to the criteria defined by Kawasaki city, outcomes, and the presence or absence of a primary care doctor.
RESULTS: The number of subjects with anemia and/or renal dysfunction was significantly greater in the late elderly than the early elderly (p<0.01). The results of the survey demonstrated that 79.6% of the early elderly and 87.4% of the late elderly had primary care doctors (p<0.01). In the early elderly, 57.0% of the subjects with primary care doctors and 43.2% of those without primary care doctors showed improvement; the subjects with primary care doctors showed significant improvement compared to those without primary care doctors (p<0.05). In the late elderly, 50.2% of the subjects with primary care doctors and 54.2% of those without primary care doctors showed improvement, resulting in no significant difference between the subjects with and without primary care doctors.
CONCLUSIONS: We found differences in the detected health problems and outcomes between the early and late elderly. These results support the appropriateness of the current age segmentation and future prospects for medical care in detecting and managing health problems in the elderly.

The Medication Guides for Patients (MGPs) are being offered as information on prescription drugs for patients by the Ministry of Health, Labour and Welfare (MHLW). The MHLW published the Risk Management Plan in April, 2012, and it noted that the MGPs should be utilized in usual risk minimization activities. It is not clear, however, whether the MGPs are efficiently utilized in actual settings. Hence, we conducted a questionnaire survey of the pharmacists in the pharmacies with dispensing and the hospitals in Mie and Yamagata prefectures to investigate the actual circumstances of MGPs utilization and to understand the existing barriers associated with the use of the MGPs as medication instructions for patients. We sent the questionnaires by mail and obtained responses from 444 facilities (33.9%) of 1,309 facilities. The recognition level of the MGPs was about 30 percent in the dispensing pharmacies, and about 50 percent in the hospitals. The MGPs were utilized as a common communication tool with the patients in approximately 20 percent of the facilities. Many respondents requested that the frequency of important and other adverse reactions should be described in the MGPs, and wider ranges of MGPs should be further implemented.
Moreover, our data suggests the problem is that the present MGPs are mainly applied to special types of patients, such as those with higher literacy level or those who requested a detailed explanation. Thus, it is apparent that it is necessary to review the MGPs contents again to improve their practical benefits and disseminate them more widely.

OBJECTIVESTo evaluate the impacts of health examinations (HE) and smoking on disease mortality risk in Japan.

METHODSBy using the large cohort database of a Japanese life insurance company, 720,611 subjects aged 20 to 80 years, who had contracted for life insurance between April 1, 1995 and March 31, 1998, were followed up until September 30, 1999. Cox's proportional hazard model was used to estimate age-adjusted relative risk (RR) for disease death.

RESULTSAfter adjusting for age, disease mortality in smokers was significantly higher than that in non-smokers (men, RR 1.51, 95% CI: 1.25-1.81; women, RR 1.54, 95% CI: 1.12-2.11). Meanwhile, disease mortality in HEees (those who had got HE within the past 2 years) was significantly lower than that in non-HEees (men, RR 0.70, 95% CI: 0.56-0.88; women, RR 0.71, 95% CI: 0.54-0.92). The magnitude of the impact of HE on disease mortality risk varied according to smoking status. Non-smokers showed a significantly lower risk associated with HE, whereas smokers did not.

CONCLUSIONSHE may allow an appreciable reduction in disease mortality, however, the reduction effect may be limited to non-smokers. Smoking cessation may be essential to improve the preventive effects of HE.

OBJECTIVESTo examine the effective preventive strategy for hypertension in a Japanese male population, based on attributable risk measures.

METHODSA 7-year follow-up study of hypertension among 6,306 middle-aged male office workers in a Japanese telecommunication company.

RESULTSIn terms of population attributable risk percentage (PAR%), regular alcohol intake and physical inactivity showed great contributions to the development of hypertension in the population no less than obesity. The PAR% of each risk factor varied by age group, and the total PAR% of the three modifiable risk factors was considerably higher in the 30-39 year old group (71%) than in the older groups.

CONCLUSIONSReduced alcohol intake and increased physical activity, as well as weight control, may have a larger impact on prevention of hypertension in younger groups than in older groups.

OBJECTIVESTo examine the relationships between body image, body satisfaction and dieting behavior in the context of pubertal changes in Japanese preadolescents.

METHODSA cross-sectional study of dieting behavior among 5,244 preadolescents (2,452 boys and 2,792 girls aged 12-13) born in Toyama prefecture.

RESULTSThe percentages of those who perceived themselves fat, wanted to be thinner, and had tried dieting, which increased with body mass index (BMI), were significantly higher in girls than in boys (34.2% vs. 20.0%, 58.0% vs. 26.0%, and 17.3% vs. 5.7%, respectively). Independent of sex and BMI, those who wanted to be thinner and those who had tried dieting were more frequently observed in those who perceived themselves fat, and those who had tried dieting were more frequently observed in those who wanted to be thinner. Pubertal changes were significantly associated with dieting behavior, but their relationships to body image and body satisfaction differed between sexes; for boys, those who perceived themselves fat were more frequently observed in those without pubertal changes; whereas for girls, those who wanted to be thinner were more frequently observed in those with pubertal changes.

CONCLUSIONSDieting behavior of Japanese preadolescents was associated with whether they perceived themselves fat and wanted to be thinner, sometimes independent of whether they were actually overweight. Pubertal changes might induce a positive perspective of growing fat among boys and a desire to be thinner among girls, with the consequence that dieting behavior would be reinforced in those with pubertal changes.

OBJECTIVESTo examine parental influence on the development of obesity in 9-year-old Japanese children.

METHODSA 6-year follow-up study of obesity among 6,102 children born in Toyama prefecture.

RESULTSAfter adjusting for obesity at age 3, either paternal obesity or maternal obesity at the age 3 survey more than double the risk of obesity at age 9 in both genders. Increases in parental body mass indexes (BMIs) from the age 3 survey through the age 9 survey were significantly associated with obesity at age 9 in girls.

CONCLUSIONSNot only parental obesity but also increases in parental BMIs were likely to be associated with development of obesity in children.

OBJECTIVESTo analyze the path to dieting behavior in Japanese preadolescents.

METHODSA cross-sectional study of dieting behavior among 5,244 preadolescents (2,452 boys and 2,792 girls aged 12-13) born in Toyama prefecture.

RESULTSWhile increasing with body mass index (BMI), the percentage of those who had tried dieting was higher in those who perceived themselves fat than in those who perceived themselves thin or average. Of those who wanted to be thinner, 16.1% of boys and 26.8% of girls had tried dieting. Path analysis in nonobese subjects (2,116 boys and 2,334 girls) showed that (1) body image was primarily based on BMI, (2) body image led to body dissatisfaction, and (3) body dissatisfaction led to dieting behavior. Pubertal changes had a significant effect on body image (path coefficient <0)for boys and body satisfaction (path coefficient >0) for girls, in addition to that on BMI. Maternal BMI had a significant effect on BMI but not on body image, body satisfaction, or dieting behavior.

CONCLUSIONSBody image and body satisfaction play important roles in the path to dieting behavior in Japanese preadolescents. Pubertal changes may reinforce dieting behavior, but the mechanism may differ by sex.

We conducted a fact­finding survey about the difficulties of handling the telephone consultations at a Kampo medicine outpatient clinic. We extracted the details of consultations that could not be handled by an outpatient nurse alone from the descriptive data of the telephone responses described by the nurses in the sur­vey. We, then, identified the factors that were involved in the difficulties encountered in these consultations, and countermeasures were established and implemented. One year later, we compared and examined the status of telephone consultations between before and after the fact-­finding survey. We classified the telephone con­sultations that were difficult for the outpatient nurses to handle alone into four categories : (1) consultation about a physical disorder, (2) questions about prescribed Kampo medicines, (3) reports and questions based on the patient's own judgment, and (4) questions about treatment and hospitalization. Some of the questions about Kampo medicines included the continued use of the medicine and drug interactions, and the main topics of the survey's nurse self-­judgment reports were dose reductions and changes in Kampo medicine regimens. As a re­sult of the introduction of guidelines prepared by the nurses together with physicians at the clinics, the outpa­tient nurses became able to handle telephone consultations about frequently asked questions (FAQs). At 1 year after the survey, the number of cases of difficulties in handling telephone consultations decreased to less than half the original value, and no telephone consultations were made within 1 week after the patients' first visits to the outpatient clinic.

Purpose: Our previous study compared the characteristics of middle-aged persons who regularly take hot bathtub baths with those who do not and found taking hot bathtub baths helped to have good sleep and increase self-rated health. However, few studies have focused on this habit among young people. This study therefore compared the characteristics of young persons who regularly take hot bathtub baths with those who do not and clarify the potential effects of habitual bathtub bathing on their health. Methods: In this cross-sectional study, a self-reported questionnaire on bathtub bathing habits and general health and lifestyle was distributed to 483 university students between May and June 2013. Respondents were divided into two groups: those who took 3 or more bathtub baths per week (high-frequency group) and those who took 2 or fewer bathtub baths per week (low-frequency group). Differences between the groups were determined for sex, age, living with or apart from one’s family, quality of sleep, sense of fatigue, and self-rated health. Prior to conducting the study, the study protocol was approved by the Institutional Review Board of Daito Bunka University. Results: We obtained 394 responses (response rate: 81.6%) and analyzed 376 valid responses. Those who answered the question on bathtub bathing habits were divided into a high-frequency group (176 persons, 47%) and a low-frequency group (200 persons, 53%). The high-frequency group (52% men, 43% women, 5% sex was unknown) had a slightly greater proportion of men than in the low-frequency group (p=0.07). The two bathing frequency groups did not significantly differ by age group(p=0.43), and the age distribution in the high-frequency group age was 51% among 18 year olds, 45% among 19 year olds, 39% among 20 year olds, 48% among 21 year olds, and 61% among 22 year olds and older. Significantly more of the high-frequency group lived with their family (70% versus 23% living alone) than the low-frequency group (p<0.001). In terms of quality of sleep, 62% of the high-frequency group and 60% of the low-frequency group reported having good sleep (p=0.72). For sense of fatigue, 27% of the high-frequency group and 23% of the low-frequency group reported they did not experience fatigue (p=0.36), and for self-rated health, 81% of the high frequency group and 76% of the low-frequency group reported they were healthy (p=0.30). While there were no significant differences between the two groups, the findings suggest that those in the high-frequency group experienced good health. Results of logistic regression analysis adjusted for living with or apart from family showed the following odds ratios (95% confidence intervals) in the high-frequency group: good quality of sleep 1.02 (0.63-1.66), no fatigue 1.37 (0.76-2.46), and self-rated health 1.61 (0.90-2.89). Conclusion: Among university students in this study, men and persons living with their families were highly likely to take hot bathtub baths regularly. While there were no significant differences between the high and low frequency bathers, taking hot bathtub baths may marginally help to reduce fatigue and increase self-rated health. Competing interests: The authors declare no conflicts of interest.