YouScript IMPACT (Improving Medication Protocols and Abating Cost of Treatment) Registry

BACKGROUND AND RATIONALE:

Genelex Corporation is a leader in comprehensive medication management based on the YouScript clinical decision support tool and DNA drug sensitivity testing. Controlling prescription drug adverse event risk is complex because more than 85% of patients have significant DNA based variation in activity of the cytochrome p450 (CYP) enzymes that metabolize the majority of the most commonly prescribed medicines. Polypharmacy, common in the elderly and chronically ill further increases the risk of an adverse drug event (ADE). The public healthcare problem resulting from these factors costs an estimated $289 billion per year in excess health care costs.

The goal of the YouScript personalized prescribing system is to improve patient outcomes by preventing ADEs caused by drug-drug, drug-gene and drug-drug-gene interactions. ADEs are defined to include prescription and over-the-counter (OTC) drug overdose toxicity, adverse drug reactions (ADRs), and treatment failures generally caused by properly prescribed medications. The YouScript system prevents ADEs by the combined analysis of patient drug regimens and individual genetics. YouScript DNA drug sensitivity testing includes five enzymes in the cytochrome P450 (CYP) group (CYP2D6, CYP2C9, CYP2C19, CYP3A4, and CYP3A5). YouScript synthesizes decades of publicly funded basic and clinical research to provide actionable information to physicians treating patients.

Elderly patients are at greater risk of an ADE. Two-thirds of adults age 65 or older take one or more prescription drugs daily. Patients age 60 years and older account for 10-17% of hospitalizations and 51% of the deaths from ADEs, although this age group represents just 17% of the U.S. population. Following discharge, 50% of patients with ADRs declined in one or more activities of daily living, compared to 24% of patients without ADRs.

Although the value of pharmacogenetic testing and comprehensive gene-based medication management is being recognized by clinicians, it is still not endorsed by many expert committees and third party payers for most prescription drugs. The purpose of this study is to meet the need for evidence that better demonstrates the impact of such comprehensive gene-based medication management on healthcare resource utilization (HRU), clinical decision-making, and patient outcomes. Therefore, the proposed study aims to assess the impact of the YouScript Personal Prescribing System on HRU, clinical decision-making, and clinical outcomes.