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Chunk #10 — Current Status of Drug Labeling and Pharmacogenomic Testing Guidelines

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Pharmacogenomic testing for neuropsychiatric drugs: current status of drug labeling, guidelines for using genetic information, and test options.
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The Clinical Pharmacogenetics Implementation Consortium (CPIC) was established in 2009 and consists of members from the Pharmacogenomics Research Network (PGRN), Pharmacogenomics Knowledge Base (PharmGKB) affiliates, and experts in the area of pharmacogenomics.22 The consortium was formed in order to establish evidence-based guidelines and to disseminate them to clinicians. These peer-reviewed guidelines are published and are readily available on the PharmGKB Web site and represent comprehensive and up-to-date assessments of this topic at this time. They are designed to assist and guide drug therapy in situations when genetic information is available, but they do not specifically advocate for if and for whom tests should be obtained. Currently, there are 10 published guidelines. With respect to neuropsychiatric medications, guidelines for TCAs, SSRIs, carbamazepine, phenytoin, and valproic acid are either published or are in progress (www.pharmgkb.org). The following sections in this review summarize initial guidelines for neuropsychiatric medications as well as other selected agents with product labeling that has incorporated actionable pharmacogenomic information (e.g., dosing recommendations) into the warning or dosing sections with relevance to patient safety. For other drugs, a summary of the labeling information is included in Table 1.