Construction of a drug safety assurance information system based on clinical genotyping.

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.

Pharmacogenomics training using an instructional software system.

OBJECTIVES: To implement an elective course in pharmacogenomics designed to teach pharmacy students about the fundamentals of pharmacogenomics and the anticipated changes it will bring to the profession. DESIGN: The 8 sessions of the course covered the basics of pharmacogenomics, genomic biotechnology, implementation of pharmacogenetics in pharmacy, information security and privacy, ethical issues related to the use of genomic data, pharmacoepidemiology, and use and promotion of GeneScription, a software program designed to mimic the professional pharmacy environment. ASSESSMENT: Student grades were based on completion of a patient education pamphlet, a 2-page paper on pharmacogenomics, and precourse and postcourse survey instruments. In the postcourse survey, all students strongly agreed that genomic data could be used to determine the optimal dose of a drug and genomic data for metabolizing enzymes could be stored in a safe place. Students also were more willing to submit deoxyribonucleic acid (DNA) data for genetic profiling and better understood how DNA analysis is performed after completing the course. CONCLUSIONS: An elective course in pharmacogenomics equipped pharmacy students with the basic knowledge necessary to make clinical decisions based on pharmacogenomic data and to teach other healthcare professionals and patients about pharmacogenomics. For personalized medicine to become a reality, all pharmacists and pharmacy students must learn this knowledge and these skills.

Drug safety assurance through clinical genotyping: near-term considerations for a system-wide implementation of personalized medicine.

The rationale and overall system-wide behavior of a clinical genotyping information system (both DNA analysis and data management) requires a near-term, scalable approach, which is emerging in the focused implementation of pharmacogenomics and drug safety assurance. The challenges to implementing a successful clinical genotyping system are described, as are how the benefits of a focused, near-term system for drug safety assessment and assurance overcome the logistical and operational challenges that perpetually hinder the development of a societal-scale clinical genotyping system. This rationale is based on the premise that a focused application domain for clinical genotyping, specifically drug safety assurance, provides a transition paradigm for both professionals and consumers of healthcare, thereby facilitating the movement of genotyping from bench to bedside and paving the way for the adoption of prognostic and diagnostic applications in clinical genomics.