Freimuth, R. R., Formea, C. M., Hoffman, J. M., Matey, E., Peterson, J. F. and Boyce, R. D. (2017), Implementing Genomic Clinical Decision Support for Drug-Based Precision Medicine. CPT Pharmacometrics Syst. Pharmacol.. Accepted Author Manuscript. doi:10.1002/psp4.12173
The explosive growth of patient-specific genomic information relevant to drug therapy willcontinue to be a defining characteristic of biomedical research. To implement drug-based personalized medicine (PM) for patients, clinicians need actionable information incorporated into electronic health records (EHRs). New clinical decision support (CDS) methods and informatics infrastructure are required in order to comprehensively integrate, interpret, deliver, and apply the full range of genomic data for each patient(1). Numerous challenges exist to the routine personalization of drug therapies using genomic data. The implementation of clinical decision support for pharmacogenomics (PGx) is becoming more common but there are still many barriers that must be surmounted. Our experience implementing PGx CDS provides some insight into the resources and informatics infrastructurethat will be required to support CDS that is based on more comprehensive PM data. In this perspective, we use the Agency for Healthcare Research and Quality (AHRQ) “Five Rights” framework (Table 1)(2) to explore challenges to implementing effective PGx CDS. These issues are also likely to be encountered as other types of genomic CDS are implemented. The challenges encountered when integrating genomic data into clinical systems (Table 1) can be grouped into two general categories: those that are related to information, including data representation and knowledge management, and those that are related to the delivery of information through clinical systems and workflows in the form of CDS interventions. Common challenges encountered by sites implementing PGx CDS are summarized below.