臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
原著
医療用医薬品添付文書における「腎機能」に関する記載内容についての検討
神田 藍川崎 淳史森田 理恵子武者 愛美櫻田 大也小林 江梨子佐藤 信範
著者情報
ジャーナル フリー

2013 年 44 巻 4 号 p. 313-318

詳細
抄録

As the number of chronic kidney disease patients increases every year, a concomitant increase in drug use among patients with renal impairment is anticipated in daily clinical practice. For patient safety, drug information should be useful and meet the needs of medical workers. The aim of this study was to investigate the problem of the descriptions in package inserts of prescription drugs regarding: 1) drug administration to patients with renal impairment, and 2) effects of the drug on the kidney (hereinafter “information on renal function” ). Also, we evaluated the usefulness of the renal function information for medical workers. For this survey, 337 prescription drugs that require careful attention for use in patients with renal impairment were selected. We extracted “the information on renal function” described in the package inserts of these 337 prescription drugs from the website of Pharmaceuticals and Medical Devices Agency. We compared the contents of the information regarding the pharmacokinetics of patients with renal impairment described in the package insert with those described in the corresponding interview form. In 44.8% of the 337 package inserts, information on pharmacokinetics in patients with renal impairment was not included. Only 21.2% of the inserts contained useful information on drug administration to such patients, such as clear dose adjustment. Therefore, our survey suggests that the package inserts do not provide sufficient information on “renal function” for medical workers. In conclusion, improvement of the information regarding “renal function” in the prescription drug package inserts is necessary in order to meet the needs of medical workers. (Jpn J Clin Pharmacol Ther 2013; 44(4): 313-318)

著者関連情報
© 2013 日本臨床薬理学会
前の記事 次の記事
feedback
Top