著者
久保田 潔 青木 事成 漆原 尚巳 鍵村 達夫 景山 茂 小出 大介 古閑 晃 佐藤 嗣道 中村 敏明 中島 研 畑中 直也 平河 武 宮川 功 望月 眞弓
出版者
一般社団法人 日本薬剤疫学会
雑誌
薬剤疫学 (ISSN:13420445)
巻号頁・発行日
vol.19, no.1, pp.57-74, 2014-06-30 (Released:2014-08-13)
参考文献数
22
被引用文献数
5 4

日本薬剤疫学会では,医薬品リスク管理(Risk Management Plan:RMP)を作成,実行する側の製薬企業と医療現場およびアカデミアからなるタスクフォースを設置し,2012年4月に厚生労働省より発出された医薬品リスク管理計画指針通知に明記されているICH E2E に準拠した安全性監視計画(Pharmacovigilance Plan:PVP)が立案可能となるようなガイダンスを作成した.内容は以下の 6つから構成されている.1.はじめに:市販後安全性監視に係るこれまでの当学会活動や,活動の目的2.安全性検討事項(Safety Specification:SS)の選択と特徴を記述するためのプロセス・SS をどう選択するか・SS をどう特徴付けるべきか・リサーチ・クエスチョン(Research Questions:RQ)にどうつなげるか3.RQ の決定と記述・RQ とは何か・各種ガイドラインではどう扱われているか・PVP へ RQ を記述する方法と具体的事例・PVP 全体としてみた最適とは4.RQ に最適化された PVP・通常の PVP で可能か,追加の PVP が必要か・追加の PVP のデザインの選択について(RQ と研究デザイン,PICO を用いた RQ の記述,評価の指標)・PVP の記載事項チェックリスト作成について5.結語:使用成績調査の位置づけ,背景発現率と比較群の必要性,今後の PVP の課題6.別添:PVP の記載事項チェックリスト以上をもって医薬品リスク管理計画指針に明記されている「ICH E2E ガイドラインに示されている安全性検討事項及びそれを踏まえた医薬品安全性監視計画」が作成,実行できることを期待したい.
著者
森 和義 中村 敏明 小笠原 英子
出版者
防衛大学校
雑誌
基盤研究(B)
巻号頁・発行日
2009

周囲雑音イメージングは自然海中周囲雑音を積極的に利用する革新的なアイディアである.筆者らは,周囲雑音イメージングのプロトタイプシステムの開発を目指し,開口径1 mの非球面レンズを設計・製作した.本レンズは,中心周波数120 kHzで方位解像度1度,視野角±7度を有することが実証された. 2010年11月に内浦湾において,海中周囲雑音のみで無音ターゲットを検出する実海域試験が実施された.多数の突発性雑音からターゲット散乱波を抽出する分類手法が提案された.ターゲット散乱波として分類された突発性雑音を解析したところ, 60 kHz以上の高周波数帯域において,ターゲット方位のパワースペクトル密度レベルは,ターゲット以外の方位のレベルに比べて大きくなることが実証された.この結果は,主にテッポウエビ音によって生成される自然海中周囲雑音によって,ターゲットが成功裏に検出されたことを示している.
著者
五十嵐 敏明 今野 彩 塚本 仁 矢野 良一 渡辺 享平 中村 敏明 政田 幹夫 後藤 伸之
出版者
一般社団法人 日本医薬品情報学会
雑誌
医薬品情報学 (ISSN:13451464)
巻号頁・発行日
vol.20, no.2, pp.66-71, 2018-08-31 (Released:2018-09-12)
参考文献数
10

Objective: We have developed an automatic vigilance system (AVS) that automatically reports adverse drug reactions (ADR) based on laboratory finding abnormalities and symptom keywords in electronic medical records. In this study, we aimed to evaluate the impact of detecting ADR using AVS on medical treatment. Methods: In AVS, drugs and their ADR signals, which would be detected and reported by AVS to pharmacists, were defined. Pharmacists evaluated the severity of these signals to identify whether these signals should be discussed with the doctor, continued to be followed up, or ignored. We investigated detection of ADR at University of Fukui Hospital between April 2016 and March 2017 along with whether prescriptions were modified because of ADR and the contribution of AVS. Assuming that ADR had worsened without appropriate treatment, medical expenses needed for treating severe ADR were calculated. Results: In total, 325 signals were defined for 146 drugs. There were 9,103 ADR signals confirmed by pharmacists for 8,531 subjects. Of these, 12 and 164 signals were discussed with the doctor and continuously observed, respectively. The pharmacist's suggestions based on AVS led to prescription modifications in 10 cases, corresponding to a reduction of 2.56 million yen in medical expenses in the event that these cases become severe. Conclusion: AVS assisted prescription revisions because of ADR and is thought to contribute to the prevention of worsening of ADR and reduction of medical expenses.
著者
橋本 良太 藤井 景子 吉田 和子 下路 静佳 正木 秀典 角山 香織 中村 敏明 恩田 光子
出版者
公益社団法人 日本薬学会
雑誌
YAKUGAKU ZASSHI (ISSN:00316903)
巻号頁・発行日
vol.138, no.9, pp.1217-1225, 2018-09-01 (Released:2018-09-01)
参考文献数
20
被引用文献数
3 3

The current study aimed to examine the outcomes of pharmacists' involvement with elderly people in special nursing homes. We analyzed 58 cases involving regular visits by community pharmacists to 41 residents. The residents' mean age was 87.8±6.9 years, and 68.3% were prescribed 6 or more types of medication. Antipsychotic and insomnia medication was taken by 24.4% and 31.8% of residents, respectively. Pharmaceutical consultation following medication use accounted for 60.3% of pharmacists' involvement with residents. The outcomes of these consultations included improvements in prescription content; the identification and prevention of adverse drug events; improvement in activities of daily living; and improvement in test results, sleep, and urination/bowel control. The results also suggested that pharmacists' intervention reduced drug costs. Information that facilitated involvement was most frequently acquired via conversations (67.2%) and conferences (24.1%) in the facilities. The most common information sources were care workers (72.4%), followed by nurses (37.9%), physicians (6.9%), and functional training instructors (6.9%). Information was also acquired from patients (3.4%) and their family members (5.2%). The findings indicated that regular visits by pharmacists to facilities for elderly people and conversations between residents, their family members, and physicians, nurses and various other professionals improved various pharmacotherapy outcomes.
著者
平野 陽子 古俵 孝明 五十嵐 敏明 松嶋 あづさ 川道 美里 小島 慶之 高橋 翠 松井 友里恵 渡瀬 友貴 山下 慎司 宇野 美雪 上谷 幸男 渡辺 享平 矢野 良一 塚本 仁 中村 敏明 岩崎 博道
出版者
一般社団法人日本医療薬学会
雑誌
医療薬学 (ISSN:1346342X)
巻号頁・発行日
vol.43, no.9, pp.502-508, 2017-09-10 (Released:2018-09-10)
参考文献数
9
被引用文献数
2

In February 2015, we introduced a drug verification and quantity management system using personal digital assistants and medicine barcodes to prevent dispensing errors. We evaluated the effect of this system by comparing the number of dispensing errors and incident cases for one year before and after the introduction. The time required for dispensing was prolonged from about 28.4 seconds to 37.3 seconds per drug, about 1.3 times. The number of dispensing errors for one year before and after system introduction significantly decreased from 33.8 ± 4.7 per month to 5.8 ± 0.8 per month (P < 0.01). In addition, the number of incidents significantly decreased from 6.0 ± 0.9 per month to 3.2 ± 0.5 per month (P = 0.02). The system seems to be useful as a tool of medical safety measures because it significantly lowers the number of dispensing errors and incidents.
著者
中村 敏明 岩尾 岳洋 東 高士 谷 大輔 矢野 良一 政田 幹夫
出版者
一般社団法人日本医療薬学会
雑誌
医療薬学 (ISSN:1346342X)
巻号頁・発行日
vol.37, no.9, pp.551-558, 2011 (Released:2012-09-10)
参考文献数
13

Paclitaxel injection [NK] (PTX [NK]) is a generic of Taxol® Injection (Taxol) but no non-clinical study comparing the safety of the 2 drugs has been conducted because the active ingredient is the same.We compared the safety of PTX [NK] and Taxol in rats to see if there were any differences. PTX [NK] and Taxol were intravenously administered to CD (SD) male rats at doses of 2.0 and 4.0 mg/kg/day for 9 days. There were very slight differences in toxicological findings regarding such items as clinical observations, food consumption, gross necropsy, organ weight and histopathology. These differences, however, were generally observed after administration of a cytocidal anticancer drug. Therefore, such differences were not thought to be toxicologically significant and we concluded that the safety of PTX [NK] was no different from that of Taxol in rats.
著者
渡辺 享平 矢野 良一 五十嵐 敏明 塚本 仁 中村 敏明 政田 幹夫
出版者
一般社団法人日本医療薬学会
雑誌
医療薬学 (ISSN:1346342X)
巻号頁・発行日
vol.35, no.9, pp.622-628, 2009 (Released:2011-01-14)
参考文献数
12

As the effect of the filling process of portable pumps on the homogeneity of drug concentrations had not been investigated,in this study,we examined the influence of the filling process of the anticancer agent 5-fluorourcil (5-FU) and saline in this respect.We used 3 types of pump and filled the pump in 3 different ways (5-FU first and then saline,saline first and then 5-FU,and mixing 5-FU and saline beforehand and then filling).There was a significant variation in the 5-FU concentration when 5-FU and saline were added separately but the drug concentration did not vary when 5-FU and saline were mixed before filling the pumps.The result also varied with the type of pump.Our findings suggested that the drug and saline were not mixed uniformly in some types of pump when 5-FU and saline were added separately.Therefore,it is important to mix the drug and saline well before filling pumps.
著者
根來 寛 矢野 良一 谷 大輔 渡辺 享平 塚本 仁 五十嵐 敏明 中村 敏明 脇屋 義文 後藤 伸之 横山 照由 政田 幹夫
出版者
一般社団法人日本医療薬学会
雑誌
医療薬学 (ISSN:1346342X)
巻号頁・発行日
vol.34, no.4, pp.320-327, 2008 (Released:2009-09-04)
参考文献数
23
被引用文献数
2 1

During cancer chemotherapy,myelosuppression is a frequently observed toxicity manifestation which may sometimes cause severe infections.In this regard,though leukopenia-induced infections are more closely related to neutrophil counts than leukocyte counts,it is important to evaluate both leukocyte counts and neutrophil counts as markers of myelosuppression.Neutrophil counts,however,are sometimes estimated to be half leukocyte counts without conducting differential leukocyte counts.In the present study,the authors evaluated the necessity of differential leukocyte counts during cancer chemotherapy using pooled laboratory data at the University of Fukui Hospital.Variation in the percentage of neutrophils in leukocytes was observed in each leukocyte range,with the neutrophil count decreasing in pace with decreases in the leukocyte count.As an alternative index to the neutrophil count,the utility of the leukocyte count is thus considered to be low in cancer chemotherapy.There was also a divergence between adverse event grade between neutrophil and leukocyte numbers.In addition,neutrophil counts in 14.8% of the patients (26)were less than 1000/μL in spite of the fact that their leukocyte counts were higher than 3000/μL,and it was noted that 23 of them had undergone a paclitaxel-containing regimen.These results suggested that leukocyte differential counts should be measured during cancer chemotherapy,especially during the nadir period and when receiving chemotherapy containing paclitaxel.
著者
矢野 良一 中村 敏明 谷 大輔 西里 洋平 後藤 伸之 脇屋 義文 政田 幹夫
出版者
一般社団法人日本医療薬学会
雑誌
医療薬学 (ISSN:1346342X)
巻号頁・発行日
vol.33, no.12, pp.998-1002, 2007 (Released:2009-09-04)
参考文献数
9
被引用文献数
3 5

The purpose of this study was to evaluate the quality of the original and 3 generic formulations of Iopamidol injection.To do this,the free iodine concentration and osmotic pressure were measured.In addition,impurities were tested for using high performance liquid chromatography-tandem mass spectrometry.There were no major differences between the original and generic formulations as regards free iodine concentration and osmotic pressure measurements,though one lot of the original formulation failed the free iodine concentration test.However,in the HPLC analysis,some substances not present in the original product were detected in the generic formulations.One of them was identified as DM 1/2,a substance related structurally to Iopamidol.
著者
森 和義 小笠原 英子 中村 敏明 土屋 健伸 遠藤 信行
出版者
一般社団法人電子情報通信学会
雑誌
電子情報通信学会技術研究報告 = IEICE technical report : 信学技報 (ISSN:09135685)
巻号頁・発行日
vol.113, no.317, pp.25-30, 2013-11-23

自然海中雑音を音源としてターゲット映像を取得する周囲雑音イメージングを実現するため非球面レンズを用いたプロトタイプシステムを開発し,海上試験を行った.この報告では,レンズ設計,海上試験,データ解析結果等,過去5年程度の研究成果をダイジェストで紹介する.