The Japanese Ministry of Health, Labor, and Welfare lists interstitial lung disease as an serious adverse drug event.  The Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) databases are available to detect adverse events signals.  We analyzed reports of interstitial lung disease in FAERS and JADER and calculated the reporting fraction and reporting odds ratio (ROR) of drugs potentially associated with interstitial lung disease.  We applied Weibull shape parameter to time-to-event data in JADER.  We found FAERS to contain 3,522,995 reports from January 2004 to March 2013 and JADER to contain 292,720 reports from April 2004 to November 2013.  In FAERS, the reporting fractions of interstitial lung disease for Gefitinib, Bleomycin, and Amiodarone were 7.4% (285/3,856 reports), 3.2% (86/2,663 reports), and 1.9% (357/18,366 reports), and RORs (95% confidence interval [CI]) were 29.26 (25.89-33.07), 11.99 (9.66-14.88), and 7.29 (6.55-8.11), respectively.  In JADER, the reporting fractions of interstitial lung disease for Gefitinib, Bleomycin, and Amiodarone were 45.6% (1,070/2,348 reports), 22.1% (77/348 reports), and 27.9% (468/1,678 reports), and RORs (95% CI) were 18.46 (16.99-20.06), 5.83 (4.52-7.51), and 8.14 (7.31-9.07), respectively.  Adverse event signals of interstitial lung disease were observed in most drugs, which are warned as a suspected drug in the literature.  With the time-to-event analysis using Weibull shape parameter, time-dependency of adverse events in each drug was different.  Therefore, these drugs should be used carefully in clinical practice.

There have been concerns that neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) cause neuropsychiatric adverse events (NPAEs).  We evaluated the number of relevant reports, reporting ratio, and reporting odds ratio (ROR) by using spontaneous reporting database, such as the Japanese Adverse Drug Event Report (JADER) (April 2004 to July 2014).  The RORs of oseltamivir, zanamivir, laninamivir, and peramivir were 11.8 (95% confidence interval (CI), 10.8-13.0), 47.0 (95% CI, 40.0-55.3), 9.5 (95% CI, 6.8-13.2), and 3.3 (95% CI, 2.1-5.1), respectively.  The lower limit of the ROR 95% CI of NPAEs of all neuraminidase inhibitors was ≥1.  We analyzed the association of age and gender with NPAEs in patients treated with oseltamivir using a logistic regression model.  The adjusted ROR of NPAEs was 66.9 (95% CI, 50.3-88.9) in male patients treated with osletamivir aged 10-19 years.  The adjusted RORs of NPAEs were increased in male and female patients under the age of 20 years.  Neuraminidase inhibitors including oseltamivir treatment could be associated with NPAEs.  Therefore, these drugs should be used carefully in clinical practice.

Introduction: Dermatological disorders are one of the adverse events caused by cancer chemotherapy and are a dose-limiting factor for some anti-neoplastic agents.  The severe symptoms associated with these disorders affect the patients’ quality of life (QOL).  Early countermeasures for the onset of dermatological disorders associated with anti-neoplastic agent administration might be important.
Materials and Methods: We analyzed the occurrences of dermatological disorders after administration of an anti-neoplastic agent in the Food and Drug Administration Adverse Event Reporting System (FAERS), and compared the adverse event (AE) reporting ratio of the total reports.  In addition, we studied the association between anti-neoplastic agents and dermatological disorders using cluster analysis.  Reports for 15 anti-neoplastic agents (4 anti-neoplastic agents and 11 molecular target drugs) were analyzed.
Results: After excluding duplicate data in FAERS, 6,157,897 reports were analyzed.  The number of reports that showed a dermatological disorder was 534,934.  The reporting ratio of hand-foot syndrome with sorafenib and capecitabine was 11.20% and 7.05%, respectively.
Conclusions: We set the cluster number at six; cluster features obtained were as follows: (1) the reporting ratio of hand-foot syndrome was especially high, followed by the reporting ratio of rash, (2) the reporting ratio of rash and erythema was high.  Similar anti-neoplastic agents may demonstrate similar occurrence tendencies of AEs and cluster features.  Further studies are required to draw conclusions over these findings.  Information services based on the feature of each cluster might be useful to improve patient QOL at the clinical site.

This paper proposes a method for evaluating and scoring the activities of rehabilitation service users in order to pinpoint the problems with the health service of this kind and set the adequate targets for each user. Sincs the Nursing Care Insurance System was introduced in Japan in 2000, it has been argued that home-visit rehabilitation services should be excluded from home-nursing care services. However, the methods of certifing that nursing care is required are not fully established yet for setting the rehabilitation targets for service users. As things stand, it is recommended that such a method as the Functional Independence Measure (FIM) or the Barthel Index (BI) should be utilized. However, these methods only evaluate “performing activities” (the activities that a user usually performs). In order to set the users' targets, we thought it necessary to establish a method for evaluating “possible activities” (the activities that a user is able to perform at his/her full capacity). We have established a method called Functional Scoring (FS) which evaluates and scores the both performing and possible activities based on the same evaluation items. We conducted experimental evaluations on the home-visit rehabilitation users for one year from October 2005 to September 2006. When the first evaluations in 2005 were compared with the second evaluations in 2006, the total score of the performing activities significantly increased from 44.1±13.7 to 47.8±14.2 (P<0.05). Although the total score of the possible activities did not significantly increase, it demonstrated an upward trend from 49.6±13.2 to 51.6±13.5. The result suggests that our method is useful for distinguishing between the performing and possible activities. The proposed method enables us to adequately recognize the problems each user has, and to set the rehabilitation target for each user, which can be shared between the user, care personnel, and care service provider.
Rehabilitation aspects ; Functional ; FS ; Care given by nurses ; Published Comment

Using the data of 139 ovarian cancer cases at our hospital, we investigated the effect of jingizai on prognosis when it was combined with standard therapy for ovarian cancer and prognosis by histopathological types. Combining jingizai with standard therapy was not effective in cases of stage I-II ovarian cancer, but it was effective in cases of stage III-IV ovarian cancer. Upon examination the effectiveness of jingizai according to histopathological types, we observed some improved prognosis in serous adenocarcinoma and mucinous adenocarcinoma cases ; however, prognosis didn't improve in endometrioid adenocarcinoma and clear cell adenocarcinoma. These results indicate that the effectiveness of combining jingizai with standard therapy may differ depending on histological type of ovarian cancer. When we investigated the difference between the distribution of histopathological types by cancer staging, we frequently found clear cell adenocarcinoma in stage I-II cancer cases. Also, serous adenocarcinoma and poorly differentiated adenocarcinoma had a high frequency among stage III-IV cancer cases. This difference may be the reason that the effectiveness of jingizai is different depending on the advances of each stage. However, no statistical difference was confirmed due to the small number of subjects analyzed. Analysis of larger sample size, which can be collected by performing collaborative studies with other facilities, will be required for more detailed investigation.

The extent to which students’ experiences are enriched by incorporating anthropology into clinical education in undergraduate medical education has not been adequately examined. The authors have collaborated to integrate anthropological fieldwork with clinical education in a clinical clerkship course. Reflection on the course has highlighted that the principles of anthropological fieldwork have stimulated changes in the roles of both faculty and students, as well as their interpersonal dynamics. These changes have the potential to promote an ‘education emerged from serendipity in the field’ approach, which tends to be undervalued in the current clinical training driven by the prevailing outcome-based medical education paradigm.