医薬品添付文書の最近の改訂状況

概要

論文の詳細を見る
Package insert is used primarily as a source of information for drug action, indication, dosage, formulation, adverse reaction and interaction. Therefore, the package insert is frequently revised to offer the most recent information. Questionnaires on the revision of package inserts were sent to 105 manufacturers of 1638 drugs used in our hospital. From January 1985 to June 1986, 1180 package inserts (72%) had been revised once or more. The most frequently revised information was ゛precautions for use". In drug information center of our hospital pharmacy, only 284 of the revised 1514 package inserts (19%) were obtained in this period. The time required to obtain the revised package inserts was relatively long, 3.8 months on the average. Subsequently, a computer-assisted system for maintaining package inserts was developed and implemented from September 1986. In the twelve-months from April 1987 after the implementation of the new system, the acquisition rate of the revised package inserts was enhanced by 69%. The average time required to obtain the revised package inserts was 3.0 months. This system seems to be effective in fulfillment of drug information service by the revised package inserts.
日本医療薬学会の論文
1988-08-20