title: Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan.
abstract: OBJECTIVE
  The provision of pharmacogenomic information in drug package inserts (PIs) has become more common in recent years. The content of PIs can be tailored to meet specific requirements of the target populations. Our objective was to identify, assess and report on differences in pharmacogenomic information in PIs from the United States (USA), the United Kingdom (UK) and Japan.
  
  
  METHODS
  Package inserts were obtained from the US Food and Drug Administration (FDA) Table of Pharmacogenomic Biomarkers in Drug Labels on 1 October 2012. Corresponding PIs were obtained concurrently from Japan and the UK. We compared the pharmacogenomic information included, where the information was located, the therapeutic class of the drug, the type and purpose of the biomarker and the initial US approval year.
  
  
  CONCLUSIONS
  One hundred eighteen PIs were included in the FDA table. Of the 118 PIs, 29 provided information on drug targets, 69 on metabolizing enzymes and 20 on other aspects. Genomic biomarkers were described in 71 PIs from the UK and 44 from Japan. Consistency in labelling across the three jurisdictions was greater in the 'Indications' section of the PIs than that in the 'Precautions' section. There appears to be greater concordance across countries for the biomarker information in the 'Indications' sections (UK 65% and Japan 48% relative to the US information) than that in the 'Precautions' sections (UK 41% and Japan 17%).
  
  
  CONCLUSIONS
  There are substantial differences in the pharmacogenomic information included in PIs from the USA, the UK and Japan. The differences varied according to the PI sections, and type and purpose of the biomarkers. The differences appeared to vary according to the strength of the evidence supporting use of the biomarkers. Further analyses are necessary to determine the causes of these differences.
authors.affiliation: Center for Clinical and Translational Research, Kyushu University, Fukuoka, Japan.
authors.forename: R
authors.initials: R
authors.lastname: Shimazawa
authors.forename: M
authors.initials: M
authors.lastname: Ikeda
mesh_terms: D015415:Biomarkers; D000075202:Contraindications; D004348:Drug Labeling / Q000592:standards; D004358:Drug Therapy / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D004798:Enzymes / Q000378:metabolism; D006801:Humans; D033181:Information Dissemination; D007564:Japan; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000378:metabolism; D010597:Pharmacogenetics / Q000379:methods*; D011153:Population; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D004798:Enzymes; D004364:Pharmaceutical Preparations
keywords: biomarker; package inserts; personalized medicine; pharmacogenomics; polymorphism