YAKUGAKU ZASSHI
Online ISSN : 1347-5231
Print ISSN : 0031-6903
ISSN-L : 0031-6903
一般論文
インターネットサイトと他の情報経路における添付文書改訂情報に関する比較検討
奥山 清寺澤 路子高橋 利幸山田 安彦
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2005 年 125 巻 8 号 p. 639-642

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  To obtain revised information on drug package inserts, we evaluated the quality and comprehensibility of such information provided by the Web site of the Pharmaceuticals and Medical Devices Agency (PMDA site), medical representatives (MRS), Drug Safety Updates (DSUS), and informational publications of the wholesale distributor Company F (wholesaler F). In the comparison of the total amount of revised information obtained from April 2003 to March 2004, the PMDA site was 90% or greater of comprehensible. In comparison with the distribution information on the notice of the Ministry of Health, Labor and Welfare, an informational delay or lack occasionally occurred and variations among pharmaceutical companies were observed. Moreover, on the PMDA site, the number of revisions was 1972. Among them, clinically important information, such as warnings, contraindications, adverse effects, and drug interactions, totaled 37%. From these results, it is suggested that there are variations in the information from each pharmaceutical company on the PMDA site although the site is excellent in terms of comprehensibility.
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© 2005 by the PHARMACEUTICAL SOCIETY OF JAPAN
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