Simulation specialist who masters simulators is important for a management of simulation center. Okayama university medical school started to train simulation specialists. Now simulation training are familiar in our university through the simulation specialists helps course directors.

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.

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.

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.

Pericardial pacing wire placement may occasionally result in intravascular or intratracheal wire migration, infective endocarditis, and sepsis; reportedly, the incidence of complications is approximately 0.09 to 0.4%. We report a case of a retained epicardial pacing wire that migrated into the pulmonary artery. A 66-year-old man underwent coronary artery bypass grafting for angina pectoris, with placement of an epicardial pacing wire on the right ventricular epicardium, 6 years prior to presentation. Some resistance was encountered during wire extraction; therefore, it was cut off at the cutaneous level on postoperative day 8. Computed tomography performed 6 years postoperatively revealed migration of the pacing wire into the pulmonary artery, and it was removed using catheter intervention. Surgeons should be aware of complications associated with retained pacing wires in patients in whom epicardial wires are retained after cardiac surgery.