To capitalize on the vast potential of patient genetic information to aid in assuring drug safety, a substantial effort is needed in both the training of healthcare professionals and the operational enablement of clinical environments. Our research aims to satisfy these needs through the development of a drug safety assurance information system (GeneScription) based on clinical genotyping that utilizes patient-specific genetic information to predict and prevent adverse drug responses. In this paper, we present the motivations for this work, the algorithms at the heart of GeneScription, and a discussion of our system and its uses. We also describe our efforts to validate GeneScription through its evaluation by practicing pharmacists and pharmacy professors and its repeated use in training pharmacists. The positive assessment of the GeneScription software tool by these domain experts provides strong validation of the importance, accuracy, and effectiveness of GeneScription. 1. Introduction The utilization of a clinical patient’s genetic data to aid diagnostic and prognostic healthcare represents the ultimate achievement of fifty years of genomic research. However, some operational, ethical, and educational challenges hinder the implementation of a societal-scale clinical genotyping system even though the technologies to carry out clinical genotyping do exist. To overcome these hurdles, we have developed a data management system (GeneScription) that utilizes patient-specific genotyping to predict and prevent adverse drug responses and thus supports the prescription drug process from physician to pharmacist to consumer. The system uses specific allelic variables associated with drug metabolism, as well as other common laboratory tests, to identify patients that are predisposed to an adverse drug reaction, and make recommendations as to the best course of action for a particular drug and patient. The GeneScription system represents the first software system of its kind in that it supports a key component of healthcare (prescription drugs) that is not ethically constrained by the prediction and prognosis of serious disease through patient-specific DNA variance and is therefore acceptable to the healthcare consumer. Moreover, since most practicing physicians and pharmacists were trained long before the utilization of human genomic information was seriously considered as a component of healthcare, educating these healthcare professionals is paramount to the future clinical genotyping adoption. To address this need, GeneScription also provides in depth training
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