医療用医薬品添付文書の肝・腎機能検査の記載方法に関する問題点とその改善

概要

論文の詳細を見る
It is important that laboratory data to be constantly checked according to described package inserts during usage of medicines. However, many hepatic and renal disorders were reported to have strong adverse reactions for prescription drugs. We investigated the necessity of hepatic and renal function checks in package inserts for 3300 prescription drugs. As a result, the number of drugs which recommended checks on hepatic and renal functions were 240 (7.3%) and 209 (6.3%) respectively. The described expression or place regarding checks of hepatic and renal functions on package inserts were various types of unclear information to doctors and pharmacists. We thus found that the present style of package inserts unapprehensive to the necessity of hepatic and neral function checks. So, in our hospital, we decided to provide a list of drugs that required hepatic and renal function checks during administration of drugs. These findings suggest that the need of hepatic and renal functions monitoring during the administration of drugs by the establishment of a new Clinical Checks item in the package inserts is therefore necessary.
日本医療薬学会の論文
2002-10-10