Implementing a Pharmacogenomics Program

• Published in: Clinical Lab Products (Online)
• Format: Newspaper Article
• Language: English
• Published: Los Angeles Anthem Media Group 22.05.2017
• Subjects: Clinical medicine; Computerized physician order entry; Consortia; Drug dosages; Drug therapy; Education; FDA approval; Genes; Genomics; Health care; Interoperability; Laboratories; Medicine; Patients; Prescription drugs; Software

When integrated with patient data from electronic health record (EHR), e-prescribing, and laboratory information management systems, a pharmacogenomic profile can be used to help ensure the best treatment and outcomes by delivering testing prompts, genomic-based alerts, and actionable decision support at the point of care. In the case of FDA-approved drugs, the instructions for use may require testing with a companion diagnostic, or recommend the use of a complementary pharmacogenomic test.1 In addition, laboratories should consider using clinically actionable genetic variants and drugs with evidence-based practice guidelines already established by professional societies or pharmacogenomics consortia such as the Clinical Pharmacogenetics Implementation Consortium (CPIC).2 These guidelines are designed to help clinicians understand how available genetic test results should be used to optimize drug therapy (see Table 1). Gene-drug pairs that are the subjects of a clinical practice guideline are based on several criteria and take into consideration: * FDA labeling that requires or recommends pharmacogenomic testing prior to therapy initiation. * Evidence of reimbursement for the test from public and private third-party payors. * Clinical trials demonstrating drug effects linked to functional pharmacogenomic loci. * Narrow therapeutic index drugs (ie, those with a low ratio between toxic dose and therapeutic dose). * Availability of safer and therapeutically equivalent alternatives for drugs associated with a pharmacogenomic concern. * Support of testing from professional organizations (eg, American Heart Association, American Society for Clinical Pharmacology and Therapeutics, American Society of Clinical Oncology). Aside from providing educational materials, laboratories should also give significant consideration to...