Kelly K Filipski1, Michael A Pacanowski, Anuradha Ramamoorthy, William Gregory Feero, Andrew N Freedman. 1. aEpidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville bOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland cMaine Dartmouth Family Medicine Residency Program, Augusta, Maine, USA.
Abstract
OBJECTIVE: Pharmacogenomic studies have established the important contribution of drug-metabolizing enzyme genotype toward drug toxicity and treatment failure; however, clinical implementation of pharmacogenomics has been slow. The aim of this study was to systematically review the information on drug-metabolizing enzyme pharmacogenomics available in the US drug labeling, practice guidelines, and recommendations. METHODS: Drug-metabolizing enzyme genotype and phenotype information was assessed in US FDA drug labeling, clinical practice guidelines, and independent technology assessors to evaluate the consistency in information sources for healthcare providers. RESULTS: Eighty four gene-drug pairs were identified as having drug-metabolizing enzyme genotype or phenotype information within the label. The manner in which pharmacogenomic information was presented was heterogeneous both within the label and between clinical practice recommendations. CONCLUSION: For proper implementation of pharmacogenomics in clinical practice, information sources for healthcare providers should relay consistent and clear information for the appropriate use of biomarkers.
OBJECTIVE: Pharmacogenomic studies have established the important contribution of drug-metabolizing enzyme genotype toward drug toxicity and treatment failure; however, clinical implementation of pharmacogenomics has been slow. The aim of this study was to systematically review the information on drug-metabolizing enzyme pharmacogenomics available in the US drug labeling, practice guidelines, and recommendations. METHODS: Drug-metabolizing enzyme genotype and phenotype information was assessed in US FDA drug labeling, clinical practice guidelines, and independent technology assessors to evaluate the consistency in information sources for healthcare providers. RESULTS: Eighty four gene-drug pairs were identified as having drug-metabolizing enzyme genotype or phenotype information within the label. The manner in which pharmacogenomic information was presented was heterogeneous both within the label and between clinical practice recommendations. CONCLUSION: For proper implementation of pharmacogenomics in clinical practice, information sources for healthcare providers should relay consistent and clear information for the appropriate use of biomarkers.
Authors: Alexandr A Kalinin; Gerald A Higgins; Narathip Reamaroon; Sayedmohammadreza Soroushmehr; Ari Allyn-Feuer; Ivo D Dinov; Kayvan Najarian; Brian D Athey Journal: Pharmacogenomics Date: 2018-04-26 Impact factor: 2.533
Authors: Claudine Manach; Dragan Milenkovic; Tom Van de Wiele; Ana Rodriguez-Mateos; Baukje de Roos; Maria Teresa Garcia-Conesa; Rikard Landberg; Eileen R Gibney; Marina Heinonen; Francisco Tomás-Barberán; Christine Morand Journal: Mol Nutr Food Res Date: 2016-11-15 Impact factor: 5.914