注射薬混合調製から見た添付文書記載内容の改善点について : TPN製剤及び総合ビタミン剤

概要

論文の詳細を見る
We comparatively studied the descriptive contents of the package inserts supplied with total parenteral nutrition (TPN) and multi-vitamins (MV) using itemization. There was insufficient information regarding the preliminary capacity (one drug), a negative reaction due to combinations (two drugs), and stability after breaking the seal when an injectable drug mixture was made in TPN. However, important differences were seen regarding such basic issues as adverse reactions and clinical examination values in MV. Moreover, when we make injectable medicine mixtures, the information, regarding the stability of the injectable drug mixtures at room temperature and that after mixing the injectable drugs, was insufficient. TPN products are marketed to be used within 24 hours, but the precaution on each MV indicated "use within 12 hours". There is a contradiction between these two documents. As a result, the pharmaceutical company must improve the package inserts. We strongly request that the descriptions on the package inserts of such drugs be revised in order to make them easier to understand.
日本医療薬学会の論文
2002-06-10