Details of a Researcher

Papers - Imai, Shungo

Division display 121 - 123 of about 123 ／ All the affair displays >>

Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions

Masayuki Hashiguchi, Shungo Imai, Keiko Uehara, Junya Maruyama, Mikiko Shimizu, Mayumi Mochizuki

PLOS ONE (PUBLIC LIBRARY SCIENCE) 10 ( 12 ) e0144263 2015.12

Research paper (scientific journal), Accepted, ISSN 1932-6203

We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripiprazole, teriparatide, telithromycin, exenatide, varenicline) were investigated: Changes in the proportional reporting ratio, reporting odds ratio, and information component as indexes of signal detection were followed every 3 months after each drugs release, and the time for detection of signals was investigated. The time for the detection of signal to be detected after drug release in the USA was 2-10 months for known ADRs and 19-44 months for unknown ones. The median lag time for known and unknown ADRs was 99.0-122.5 days and 185.5-306.0 days, respectively. When the FDA released advisory information on rare but potentially serious health risks of an unknown ADR, the time lag to report from the onset of ADRs to the FDA was shorter. This study suggested that one factor affecting signal detection time is whether an ADR was known or unknown at release.

Access to Document (DOI)

Evaluation of Predictive Accuracy between Two Types of Vancomycin TDM Analysis Software

Imai Shungo, Yamada Takehiro, Nishimura Ayako, Oki Hiromitsu, Kumai Masayuki, Miyamoto Takenori, Kasashi Kumiko, Iseki Ken

Iyakuhin Johogaku (Japanese Society of Drug Informatics) 16 ( 4 ) 169 - 178 2015

Research paper (scientific journal), Lead author, Accepted, ISSN 1345-1464

Objective: To attain optimal blood concentration rapidly, it is needed to perform initial dose setting appropriately when vancomycin (VCM) used.  In order to design initial dose settings of VCM more currently, we compared the predictive performance of two types of VCM therapeutic drug monitoring (TDM) analysis software retrospectively. Method: We utilized two TDM analysis software, SHIONOGI-VCM-TDM ver.2009 (VCM-TDM) and “Vancomycin MEEK TDM analysis software Ver. 2.0” (MEEK), based on patient’s background. 112 patients who received VCM and performed TDM were analyzed during the period from October 2011 through September 2012 and compared the actual trough level with the predictive trough level.  The predictive performance was evaluated by calculating ME (mean prediction error), MAE (mean absolute prediction error), and RMSE (root mean squared error).  Age, gender, and a renal function were evaluated as patient’s background. Results: VCM-TDM gave good predictive performance for patients overall.  When classified patient’s background complexly (sex, age, and renal function), as for male patients, VCM-TDM showed good predictive performance except for the group over 65 years old and CCr over 85 mL/min.  For female patients, the difference of predictive performance was not accepted by all groups. Conclusion: These results suggest, for male patients, we should use VCM-TDM for initial dose settings except for the group over 65 years old and over CCr 85 mL/min.  For the other patients, we consider that both of software can be used.  These new findings seem to contribute to proper dosage settings of VCM.

オーダリングシステムと連動した特定抗菌薬使用届出システムの導入とその有用性

山田武宏, 宮本剛典, 川岸亨, 今井俊吾, 沖洋充, 秋沢宏次, 笠師久美子, 石黒信久, 井関健

日本病院薬剤師会雑誌 ((一社)日本病院薬剤師会) 50 ( 3 ) 293 - 297 2014.03

Research paper (scientific journal), Accepted, ISSN 1341-8815

院内感染制御を適正に行うにあたって、抗methicillin-resistant Staphyrococcus aureus(以下、MRSA)薬および広域抗菌薬等の使用は、届出制等によりその適正使用を推進することが求められている。今回、より効率的かつ確実に特定抗菌薬(抗MRSA薬およびカルバペネム系薬)の使用を管理する目的で、処方オーダリングシステムと連動した特定抗菌薬使用届出システム(以下、本システム)の運用を開始した。本システム導入後では、導入前に比してリネゾリド錠の使用量および長期使用件数が著明に減少し、抗MRSA薬使用金額は年間で約2割減少した。また、本システムは、届出内容を臨床検査値や投与履歴と共に一括表示・外部出力する機能を有している。この機能を活用して、効率的な特定抗菌薬の使用状況把握が可能となった。以上より、本システムの活用は抗菌薬適正使用に有用であることが示唆された。(著者抄録)

　 Previous page - Next page 　