title: What is needed to incorporate clinical pharmacogenetic tests into the practice of psychopharmacotherapy?
abstract: This editorial considers two questions in psychopharmacotherapy: 1) What is needed to market pharmacogenetic tests in the US, since the US appears to lead other countries? and 2) What is needed for US-marketed pharmacogenetic tests to be incorporated by prescribers into long-term practice? US marketing of pharmacogenetic tests requires 1) understanding the pharmacological complexity of drug response, 2) modifying the oversight of non-FDA regulatory agencies, 3) clarifying the FDA's role and 4) promoting innovative marketing. The incorporation of pharmacogenetic tests into long-term practice requires 1) not jeopardizing pharmacogenetic testing by short-sighted marketing of non-validated tests, 2) educating prescribers about benefits, 3) educating patients about limitations and 4) considering the differences between isolated testing and generalized testing incorporating big data.
authors.affiliation: a University of Kentucky Mental Health Research Center , Eastern State Hospital , Lexington , KY , USA.|b Psychiatry and Neurosciences Research Group (CTS-549), Institute of Neurosciences , University of Granada , Granada , Spain.|c Biomedical Research Centre in Mental Health Net (CIBERSAM), Santiago Apóstol Hospital , University of the Basque Country , Vitoria , Spain.
authors.forename: Jose
authors.initials: J
authors.lastname: de Leon
authors.affiliation: d Department of Clinical and Experimental Medicine , University of Messina , Messina , Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Spina
mesh_terms: D004335:Drug and Narcotic Control; D005820:Genetic Testing / Q000379:methods; D006801:Humans; D010353:Patient Education as Topic; D010597:Pharmacogenetics / Q000379:methods*; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011619:Psychotropic Drugs
keywords: Biological markers; United States Food and Drug Administration; cytochrome P-450 enzyme system/genetics; genotype; histocompatibility testing; pharmacogenetics; psychotropic drugs/administration and dosages