The Surveillance for Contents of Pharmacogenomics Information in Package Inserts and Interview Forms / 医薬品情報学

ABSTRACT

<b>Objective: </b>Pharmacogenomics (PGx) is the study of the relationship between the efficacy and/or safety of drugs and the genetic polymorphism.  Since PGx information can be used to personalize medical treatments, there has been a recent increase in the development of drug and companion diagnostic devices based on genome-wide analyses.  Therefore, we surveyed the contents of PGx information in package inserts and interview forms (IF) of Japanese pharmaceuticals, and investigated potential problems with the PGx information supplied by Japanese pharmaceuticals.<br><b>Methods: </b>PGx information content in package inserts and the IF used by Japanese pharmaceuticals was compared with that listed in the U.S. pharmaceuticals “Table of Pharmacogenomic Biomarkers in Drug Labeling.”<br><b>Results: </b>There were 166 PGx information content listings for 137 drugs described in the “Table of Pharmacogenomic Biomarkers in Drug Labeling.”  However, there were 31 PGx information content listings for 20 biomarkers of 24 drugs that were described in the U.S. but not the Japanese package inserts.  In addition, there was no PGx information for 17 biomarkers of 20 drugs in both the Japanese package inserts and the IF.  We additionally found that 57.7% of the biomarkers with PGx information listed in the package inserts were for drugs that are normally covered by <i>in vitro </i>diagnostic medical insurance.  These biomarkers were mainly the gene mutations and expression of the target molecules.<br><b>Conclusions: </b>The Japanese PGx information associated with gene mutations and expression of the target molecules was similar to the U.S. PGx information.  However, the contents of the PGx information for drug-metabolizing enzymes differed widely among each of the drugs.  In order to more effectively use PGx information, a more careful inspection of the information regarding efficacies and side effects will need to be undertaken to ensure better evaluations of patient therapies.