1316 POSTER Oral Chemotherapy Administration Practices in Ireland

Abstract

Multivariate regression analysis was performed to evaluate the impact of the establishment of the Japanese regulatory agency Pharmaceuticals and Medical Devices Agency (PMDA) in 2004 with respect to the contents of guidance for proper usage. Results: From 91 approved oncology pharmaceuticals, we obtained 59 guidance for proper usage for 50 approved oncology pharmaceuticals. The median total number of pages in the guidance for proper usage was 48 (range, 11−98 pages). The proportions of pages in the guidance that discussed toxicity, drug information, and the results of registration trials were 30%, 26%, and 11%, respectively. After the PMDA was established, the total number of pages and the proportion of pages discussing the results of registration trials significantly increased (p = 0.007 and p = 0.002, respectively). On analyzing guidance published for different types of drugs, we observed that the total number of pages and the proportion of pages discussing toxicity in the case of molecular-targeted drugs was significantly greater (p < 0.001 and p = 0.008, respectively) than that for the other types of drugs, whereas the proportion of pages discussing indications was significantly lower (p = 0.001) than that for the other types. Conclusion: The guidance for proper usage distributed to medical oncologists in Japan include drug information that is not provided in package inserts. The establishment of the PMDA and the type of drugs for which the guidance for proper usage were distributed may have influenced the contents of and trends with regard to the guidance for proper usage.