8 巻 (2012) 1 号 p. 9-17
Great advances in genomic research on the susceptibility to multifactorial genetic diseases and drug sensitivities have broadened the use of genetic information in clinical practice. In the United States, pharmacogenomic information is included in drug package inserts (labels). The United States Food and Drug Administration releases a list of drugs and valid genomic biomarkers for public use. Also in Japan in June 2008 information on the relationship between UGT1A1 variants and the anticancer drug irinotecan was included in the drug label, followed by insurance coverage of genetic testing for UGT1A1 in November of the same year. Such developments signal the start of the age of personalized medicine. Appropriate application of genetic information to personalized medicine in Japan requires different approaches to genetic information, as the current way of handling genetic information regarding single gene disorders in research and clinical practice is based solely on genetic exceptionalism. However, specific issues in introducing pharmacogenomics (PGx) to clinical practices remain unclear. Large differences exist in the implementation of personalized medicine among institutions. The number of genes related to personalized medicine will surely increase in the coming years. The issues that surround personalized medicine will need to be specified and clarified.