RxVision™: A Compendium of Knowledge-Part 3

A patient’s genetics is only one of several important factors that may impact their response to a medication. However, the amount of pharmacogenomics information available is quite expansive—with some known gene‑drug interactions being more clinically established than others. It is generally recognized that the following pharmacogenomics/pharmacology resources are the most reliable and current:

• The United States Food and Drug Administration (FDA): gene-drug interaction found on their tables and within drug labels

• The Clinical Pharmacogenetics Implementation Consortium (CPIC): Level A and B gene-drug pairs and clinical practice guidelines

• The Pharmacogenomics Knowledge Database (PharmGKB): Level 1 and 2 clinical annotations

• The American Molecular Pathology Association: evidence-based expert consensus regarding alleles that should be included in clinical pharmacogenomic tests

• IBM Micromedex: drug-drug, drug-food, drug-alcohol, and drug-lab interactions

RxVision™, Admera Health’s clinical decision support system (CDSS), allows for the highest threshold of pharmacogenomics information to be integrated into a physician’s workflow by providing clinical insight into gene‑drug interactions and drug-interactions (including drug-drug, drug-food, drug-alcohol, and drug-lab interactions).

The United States Food and Drug Administration (FDA):

The FDA’s mission includes protecting public health by ensuring the safety, efficacy, and security of human drugs and biological products. The FDA recognizes that pharmacogenetic tests, along with other information about patients and their condition, can play an essential role in medication therapy. Additionally, when a health care provider considers prescribing a medication, knowledge of a patient's genotype may be used to aid in determining a therapeutic plan, determining an appropriate dosage, and assessing the likelihood of benefit or toxicity. The FDA has the following resources publicly available:

• The FDA Table of Pharmacogenomics Associations illustrates patient subgroups with specific genetic variants or genetic variant-inferred phenotypes that are likely to have altered drug metabolism, and in some instances, differential therapeutic effects, including differences in adverse event risks

• The Table of Pharmacogenomic Biomarkers in Drug Labeling lists therapeutic products from the Drugs@FDA website with pharmacogenomic information in their drug labeling

Clinical Pharmacogenetics Implementation Consortium (CPIC®):

The Clinical Pharmacogenetics Implementation Consortium (CPIC) is an international consortium of individual volunteers and a small dedicated staff of members with an interest in pharmacogenomics from academia, industry, patient advocacy groups, government, and non-governmental organizations with credentials. CPIC is funded by the National Institutes of Health (NIH) and managed by Stanford University & St. Jude Children’s Research Hospital. The mission of CPIC is to accelerate the proper use of pharmacogenomic tests in the clinic and attempts to do so by addressing the difficulty in translating genetic laboratory test results into actionable prescribing decisions for affected drugs that are a significant barrier to the clinical implementation of pharmacogenomics. CPIC creates, curates, and posts available, peer-reviewed, evidence-based, updatable, and detailed gene-drug clinical practice guidelines.

Pharmacogenomics Knowledge Database (PharmGKB):

PharmGKB is a knowledge resource whose mission is to provide pharmacogenomics information, including potentially actionable gene-drug associations, genotype-phenotype relationships, as well as clinical guidelines and drug labels. The National Human Genome Research Institute (NHGRI), which is part of the National Institutes of Health (NIH), currently funds PharmGKB.

American Molecular Pathology Association (AMP):

The Association for Molecular Pathology (AMP) is an international professional and medical association representing approximately 2,500 doctoral scientists, physicians, and medical technologists who perform or are involved with laboratory testing based on knowledge derived from genetics, genomics, and molecular biology. Professionals from the government, academic medicine, private and hospital-based clinical laboratories, in addition to the in vitro diagnostic industry make-up AMP's membership. As a not-for-profit scientific society that advances the clinical practice, science, and excellence of molecular and genomic laboratory medicine through education, innovation, and advocacy—AMP’s mission is to enable the highest quality health care. As such, AMP has formed the AMP Pharmacogenomics (PGx) Working Group and is currently developing a series of evidence-based expert consensus opinion recommendations for alleles that should be included during genotyping for clinical pharmacogenomic tests.

IBM Micromedex:

IBM Micromedex is one of the most extensive online drug information, toxicology, disease, acute care, and alternative medicine reference databases whose goal is to help support safe and effective drug therapy decisions at the point of care. Micromedex’s inhouse editorial staff undergo meticulous training, and the process used to develop the content in Micromedex has received accreditation from the National Institute for Health and Care Excellence (NICE).
From IBM Micromedex, Admera Health sources drug-drug, drug-food, drug-alcohol, and drug-lab interactions, as well as drug information including therapeutic class and mechanism of action.

RxVision™ allows providers to view Admera Health’s PGxOne™ Plus test results in an easy-to-use, dynamic format. This post serves as part-three in the RxVision™ blog series, that will touch upon the following topics:

• RxVision™ is able to provide longer-term functionality for users with their PGx results—versus other static PGx reports

• New medications can be checked against available PGx results for gene-drug interactions

• RxVision™ combines drug-drug, drug-food, drug-alcohol, and drug-lab interactions from a medication knowledge-base commonly used in EHRs, along with the patient's pharmacogenomics test results in one central data hub. Thus, eliminating the need to check for drug-drug, drug-food, and drug-lab interactions separately

• This Clinical Decision Support System (CDSS) platform provides physicians the capability to print and share the report with other providers who see the same patient, as well as the ability to refer to other providers, that the patient or physician recommends

• RxVision™ can be used in preemptive PGx workflows in addition to reactive PGx workflows