Abstract
Information concerning recalls of products derived from particular biological sources has been provided in the “Recall Information” section of a website containing information on drugs and medical equipment since July, 2003. However, considering that “products derived from particular biological sources” have mostly been recovered when the information is presented on the website, the quantity of the products for recovery is likely to be substantial based on “State of Progression of Retrospective Investigations of Blood Donors”, and that the Red Cross of Japan has provided 24,019 pieces of information to medical organizations in connection with retrospective investigations, recall information concerning “products derived from particular biological sources” differs from that for other products in that its presentation is restricted.
However, the situation has been markedly influenced by the following regulations.
1. The possibility of retrospective investigation was increased by Article 68-9 of the Pharmaceutical Affairs Law enforced on July 30, 2003 : “Preparation and retention of records on biological products”.2)
2. The “Exhaustive review of blood donation histories of blood donors”3) stipulated that information must be provided to medical organizations, and the products in question must be recovered if they have not been used.
In this study, the usefulness of retrospective investigation of recall information of “products derived from particular biological sources” was evaluated.
The results suggest that, in evaluating “recall information”, it is necessary to investigate the total number of products to be recalled and the background of the recalls, and also to consider regulations other than the recall regulations applied to individual drugs.
