Objective: Confirmation by pharmacists of brought-in drugs is not only limited to identification of drugs, but also requires prescription design and proposals based on the background of patients and evaluation of associated information. In this study, we analyzed the content of brought-in drugs related PreAVOID reports in our hospital according to the years of pharmacist experience in order to help educate pharmacist for better brought-in drugs confirmation.Method: Various interventions regarding brought-in drugs were compared between two groups: pharmacists with >6 years of experience (group H) and those with < 5 years of experience (group L). PreAVOID reports, which related to drugs brought in by patients admitted to the Ogaki Municipal Hospital between April 1, 2018 and March 31, 2019 were assessed.Result:The PreAVOID reporting rate for the number of brought-in drugs confirmed was higher in group H (1.56%) than in group L (1.12%) (odds ratio 1.399, p = 0.023). The PreAVOID reporting rate when reporting was based solely on prescription information did not differ between these two groups, but when patient background, including disease-related information, was included with prescription information, the rate was higher in group H (0.80%) than in group L (0.30%) (odds ratio 2.725, p < 0.001). Group H provided more reports related to unnecessary drugs.Conclusion: The involvement of pharmacists in the evaluation of brought-in drugs is important when reviewing subsequent medical treatments. Our findings suggest that to improve the quality of treatment, it is necessary to provide appropriate newcomer education, such as conducting case studies using PreAVOID cases.

The aim of this article is to describe the 2017 revised consensus criteria for the clinical diagnosis of dementia with Lewy bodies (DLB) with future directions for the diagnostic criteria. The criteria for the clinical diagnosis of probable and possible DLB were first published as the first consensus report in 1996 and were revised in the third consensus report in 2005. After discussion at the International DLB Conference in Fort Lauderdale, Florida, USA, in 2015, the International DLB Consortium published the fourth consensus report including the revised consensus criteria in 2017. The 2017 revised criteria clearly distinguish between clinical features and diagnostic biomarkers. Significant new information about previously reported aspects of DLB has been incorporated, with increased diagnostic weighting given to rapid eye movement (REM) sleep behavior disorder (RBD) and iodine-123-metaiodobenzylguanidine (MIBG) myocardial scintigraphy. Future directions include the development of the criteria for early diagnosis (prodromal DLB) and the establishment of new biomarkers that directly indicate Lewy-related pathology, including α-synuclein imaging, biopsies of peripheral tissues (skin, etc.) for the demonstration of α-synuclein deposition, and biochemical markers (cerebrospinal fluid/blood), as well as the pathological evaluation of the sensitivity and specificity of the 2017 revised diagnostic criteria. In conclusion, the revised consensus criteria for the clinical diagnosis of DLB were reported with the incorporation of new information about DLB in 2017. Future directions include the development of the criteria for early diagnosis and the establishment of biomarkers directly indicative of Lewy-related pathology.

In Japan, the National Health Insurance (NHI) prices of new drugs are set according to the NHI Drug Price Standard (NHI Price Standard).　The NHI Price Standard was notified by the Ministry of Health, Labour, and Welfare based on the ”Drug Price Calculation Criteria” proposed by the Central Social Insurance Medical Council (Chuikyo) in Japan.　The NHI Price Standard affects the research and development strategy of pharmaceutical companies.　In order to discover undetected relationships, the factors influencing the ”drug price” were evaluated through the association rule mining technique.　We surveyed the Chuikyo‐documents about NHI price listing over the period October 27, 2006 to February 8, 2007.　The number of approved new drugs was 874, while that of drugs completed (”drug price per day”) was 314.　The numbers of new compounds corresponding to a drug price per day of ”below 200 yen,” ”between 200 yen and 1,000 yen,” ”between 1,000 and 10,000 yen,” and ”above or equal to 10,000 yen” were 87 (27.7%), 91 (29.0%), 79 (25.2%), and 57 (18.2%), respectively.　In the association rule mining method, we observed high lift values of the combined items ”above or equal to 30,000 patients expected to be administrated” and ”drugs affecting sensory organs” in the group of drug price per day below 200 yen.　The lift values of the combinations of ”biological preparations” and ”similar efficacy comparison‐based price setting (Ⅱ)” or ”below 30,000 patients expected to be administrated” and ”antineoplastic drug” in the group of ”above or equal to 10,000 yen of drug price per day” were high.　These results provide a basis for the development and application of new drugs in Japan.

A 58-year-old man underwent renal transplantation 26 years previously and had been treated with immunosuppressive drugs. He presented at the local hospital with backache symptoms during the waiting period prior to repair of an abdominal aortic aneurysm. Computed tomography revealed a retroperitoneal hematoma around the abdominal aortic aneurysm. He was admitted to our hospital and emergency straight graft replacement was performed. After clamping of the aorta, we performed axillo-common iliac perfusion to protect the transplanted kidney. The patient recovered without transplanted kidney dysfunction.

Objective: The aim of this study was to analyze the factors influencing the addition of clinically significant adverse reactions (CSDR) section in drug package inserts in Japan.
Methods: The summaries of investigation results from August 2011 to July 2014 were evaluated.  The revisions were classified into revisions based only on case reports from Japan ([Revision Y]) and revisions based on other information and/or case reports from Japan ([Revision X]).  The revisions were classified into MedDRA system organ class (SOC).  As index of amount of information from domestic case reports, the number of accumulated cases ([Case A]), cases for which a causal relationship to the product could not be ruled out ([Case B]), and fatal cases ([Case C]) were used.  In each SOC, as index of causal relationship to the product, [Index B/A] ([Case B]/[Case A]) was calculated.  Relationship of [Index B/A] to [Revision X]/all revisions, or to the number of [Case A] in [Revision Y] were evaluated.  Deference of drug lag between [Revision X] and [Revision Y] was evaluated.
Results: Three hundreds twenty-three revisions with respect to the addition of CSDR section were identified.  [Revision Y] was 203 revisions (63%).  The number of [Case A], ([Case B], and ([Case C]) that were required for [Revision X] (120 revisions) were significantly lower than that were required for [Revision Y] (p<0.0001 for all comparisons).  [Index B/A] tended to inversely correlate with [Revision X]/all revisions (r=−0.52, p=0.066), and the number of [Case A] in [Revision Y] (r=−0.61, p=0.025).  Drug lag of [Revision X] was significantly longer than that of [Revision Y] (p<0.001).
Conclusions: In future, it would especially needed to pay attention to adverse reactions with a low [Index B/A] of which revisions relatively depend on other information.

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.

A 73-year-old man who underwent redo aortic valve replacement due to dysfunction of tissue heart valve developed hypoxemia with bilateral infiltrates on frontal chest radiograph and hypotension shortly after his operation. Due to the presence of progressive hypotension and hypoxemia, we inserted an intra-aortic balloon pump and, furthermore, provided percutaneous cardiopulmonary support. We ruled out cardiogenic pulmonary edema based on information from various examinations, including echocardiography, and subsequently diagnosed possible transfusion-related acute lung injury (possible TRALI). The patient was treated by mechanical ventilation and circulatory support under close supervision, showing a trend of improvement from postoperative day 2 and discontinuing mechanical ventilation on postoperative day 11. The patient made an uneventful recovery and was discharged on postoperative day 50. Cardiac surgery patients are at particular risk for TRALI, so physicians should consider TRALI whenever a patient develops hypoxemia during or shortly after transfusion. Rapid diagnosis and appropriate treatment of TRALI are especially important in cardiac surgery patients.

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.

We performed entry closure for the chronic type B dissecting aneurysms by open surgical procedure or endovascular stent-graft placement. The purpose of this study is to evaluate the mid-term results of these patients with respect to mortality, morbidity, change of aneurysm diameter and outcome of the false lumen. From 1996 to 2003, entry closure was performed on 8 patients with chronic dissecting aortic aneurysm with an entry site in the descending aorta and visceral arteries that originated from the true lumen. The study population consisted of 4 men and 4 women with a mean age of 63.8±10.9 years. One patient had a DeBakey type III a and 7 patients had a DeBakey type III b dissecting aneurysm. Five patients underwent surgical entry closure and 3 patients underwent endovascular stent-graft placement. The mean follow-up period was 40±29 months. No operative mortalities, complications of paraplegia or visceral ischemia occurred. A leak was identified in 3 patients, 1 patient underwent an open repair with descending aortic replacement and 1 patient required additional stent-grafting. In the follow-up period, 1 patient died of cancer, but there were no dissection-related mortalities or re-operations for increase in size. With the exception of 1 case with a graft replacement, complete thrombosis of the thoracic aortic false lumen was achieved in 6 cases. There were no significant differences in the pre- and postoperative aortic diameter. Overall, complete thrombosis of the thoracic aortic false lumen was achieved with a high rate of success without a dissection-related mortality. Long-term follow-up, however, is necessary because a reduction in size did not occur in some cases.