著者
竹内 裕紀 大野 能之 和泉 智 鎌田 直博 田中 章郎 長谷川 功 三宅 健文 奥田 真弘
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.42, no.3, pp.160-167, 2016-03-10 (Released:2017-03-16)
参考文献数
14
被引用文献数
1 1

The dosage and administration of renally excreted drugs to patients with decreased renal function need to be optimized in accordance with their renal function. However, drug package inserts do not necessarily have sufficient information. Therefore, we identified and classified the issues regarding this lack of information and investigated the percentage of affected package inserts.We investigated 341 oral drugs in the Clinical Practice Guidebook of Chronic Kidney Disease 2012.1. The shortcomings in the description of urinary excretion parameters, which is needed for dose adjustment in accordance with renal function, are classified as follows: (1) unchanged drugs and metabolites are not indicated (28%, 95/341), (2) bioavailability for oral dosage is not taken into account (84%, 286/341), and (3) sufficient recovery time for urinary excretion is not acknowledged (3.5%, 12/341).2. With respect to the dosage regimen of renally excreted drugs, the following information was absent: (1) dosage and dosing interval in accordance with renal function are not described (63%, 70/111) and (2) considerations for dose reduction are not provided (32%, 36/111).3. A major shortcoming in the description of drug administration for anuric dialysis patient is that nephrotoxic drugs, such as, nonsteroidal anti-inflammatory drugs, are described as being contraindicated (100%, 11/11).We found that the current information in package inserts of several drugs is insufficient to understand the required dose adjustment or the correct method of administration to patients with decreased renal function. We aim to improve the information in drug package inserts to allow for effective and safe pharmacotherapy.

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添付文書に、腎機能低下患者に対する記載がどのようにされているかを調査した報告。 ・未変化体と代謝物の区別なし:28% ・腎機能に応じた用量調節の記載なし:63% ・バイオアベイラビリティの記載なし:84% 医療薬学.42(3):160-7,(2016) https://t.co/PNETQx4ZAV
https://t.co/BZQNqo9wcf 添付文書における腎機能関連データ記載の問題点
調剤台のカセットもそろそろ手入れの時期 手に取るときに気をつけたほうがよいことを付箋で貼っているけど、いつのまにか風景になってしまうやつもいる https://t.co/33bkA0VVAp
例)経口剤でバイオアベイラビリティ(F)を考慮せずに全投与量に対する割合で尿中排泄率が記載されている 添付文書の注意点 https://t.co/vZzee9Em9L

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