抄録
We investigated the situation of early post-marketing phase vigilance reports prepared by pharmaceutical companies for medical institutions. To do this we collected reports prepared by pharmaceutical companies for this purpose and investigated their contents during the period October 2001 to April, 2003. The number of medicines targeted by our investigation was 51.
We found that most pharmaceutical companies were preparing final reports for medical institutions a few months after the early post-marketing phase vigilance was over. However, reports differed greatly regarding such aspects as contents, items reported and analysis methods and information on important adverse effects was difficult to understand. We thus feel that there is a need to standardize the format of early post-marketing phase vigilance reports to make the information in them more useful.
