医薬品等の回収情報に関する調査・研究（第２報）―狂牛病関連情報に対する製薬会社等の対応―

Abstract

Beginning in 1986, a large number of cattle were found to be infected with BSE in England, eventually reaching approximately 180, 000 cattle in 2001. On March 20, 1996, the Consultative Institution of the Agriculture Ministry in England issued a statement that Variant Creutzfeldt-Jakob Disease is closely related to BSE. In Japan, an outbreak of BSE was confirmed in 2001.BSE has become a big social problem in Japan. Urgent Warnings and announcements appear on the front page of the web site of the Ministry of Health, Labour and Welfare. Regarding pharmaceutical materials that originate in cattle, the Ministry of Health, Labour and Welfare has instructed as follows : The use of materials from England is prohibited (1996); The country of origin and the internal organs used in cattle-derived products must be specified, and materials from high risk countries must be substituted with others (December 12, 2000); The use of products from countries with unknown risks must be discontinued, and all prohibited materials that have been repackaged for market must be recalled (October 2, 2001). The Ministry subsequently announced additional measures : Recall information related to BSE would be carried on a new pharmaceutical information providing system. This program continued until January 10, 2002.At Uwajima City Hospital, we decided in December 2000, to stop using cattle products, and in October 2001, we asked pharmaceutical companies to report their measures regarding the country of origin and cattle body parts of their products.According to the recall information carried on the web site (http://www.pharmasys.gr.jp/) of The Organization for Pharmaceutical Safety and Research, and the answers received from the pharmaceutical companies, we investigated what measures had been taken. Any prohibited medical materials which were still being supplied in December 2000 were requested to be recalled according to the risk classification. We found that we did not have enough information from the pharmaceutical companies. In particular, when we did not actively inquire, the information reported was insufficient. Although the recall of products related to BSE is preventive, it is important that reliable information be provided to medical institutions in order to use unrecalled products without worry. We ought not to depend on passive information, and should always deal with such a crisis actively under the guidance of the authorities, as reported on the web site of the Ministry of Health, Labour and Welfare.