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タイトル: 製造販売後調査における調査票の現状と標準化の提案
その他のタイトル: Present Situation of Post Marketing Surveillance Survey Sheets and Proposal for Their Standardization
著者: 高月, 公博
古川, 裕之 link image
松嶋, 由紀子
宮本, 謙一 link image
Takamatsu, Masahiro
Furukawa, Hiroyuki
Matsushima, Yukiko
Miyamoto, Kenichi
発行日: 2008年12月10日
出版社(者): 日本医療薬学会 = Japanese Society of Phamaceutical Health care and Sciences
雑誌名: 医療薬学
ISSN: 1346-342X
巻: 34
号: 12
開始ページ: 1105
終了ページ: 1112
キーワード: post marketing surveillance
survey sheet
adverse event
standardization
information item
抄録: Post Marketing Surveillance (PMS) is conducted to obtain information on the frequency of adverse events, quality, efficacy, and safety of medicines when used in medical care. Rules for PMS are established in GPSP (Good Post marketing Study Practice) departmental regulations, and companies are required to determine the design of the survey sheets and survey items as well as the procedures for PMS in compliance with them. However, there are no rules for the design of the survey sheets and survey items. With this in mind, we studied the standardization of survey sheets by investigating the information items and response choices used by pharmaceutical companies for PMS. The results of our investigation revealed that survey sheets lacked unity; for example, the types and titles of survey items and the number of choices varied among companies. There was also variation among companies as regards the format of survey sheets (layout of information items and coloration). We felt that there would be benefits from standardizing sheets by eliminating these variations. First of all, there would no longer be the need to conform to a particular survey sheet for each company which would decrease mistakes in filling them out as well as the time required, enabling more safety-and efficacy-related information to be collected. In addition, the cooperation of physicians with PMS would be likely to increase. The extra information obtained would contribute to further raising the quality of medical care provided to patients.
DOI: 10.5649/jjphcs.34.1105
URI: http://hdl.handle.net/2297/28423
関連URI: http://www.jsphcs.jp/
http://ci.nii.ac.jp/naid/110007005323
JST.JSTAGE/jjphcs/34.1105
資料種別: Journal Article
権利関係: Copyright (c) 2010 日本医療薬学会
版表示: publisher
出現コレクション:1. 査読済論文

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