医薬品適正使用のための添付文書のあり方に関する比較調査

抗生物質について

抄録

Pharmacists are responsible for supplying appropriate drug information to other medical staff from the enormous amount of drug information available. While the most common source of such information is package inserts, their content is standardized by law and the information in them is often insufficient for administration planning and determining the optimal dosage. In this study, we compared the content of the Physicians' Desk Reference (PDR) published in the USA with that of Japanese package inserts for antibiotics to evaluate the current situation of drug information provision in Japan. The PDR contained more drug information than the package inserts, its content was sufficient for administration planning and descriptions were clear. On the other hand, parts of package inserts were unclear and the information given inadequate for making administration plans. The results of this comparison suggest that the content of package inserts needs to be improved to ensure the optimal use of drugs.