Lessons Learned When Introducing Pharmacogenomic Panel Testing into Clinical Practice

• Published in: Value in health 2017-01, Vol.20 (1), p.54-59
• Main Authors: Rosenman, Marc B., MD, Decker, Brian, MD, PharmD, Levy, Kenneth D., PhD, MBA, Holmes, Ann M., PhD, Pratt, Victoria M., PhD, FACMG, Eadon, Michael T., MD
• Format: Article
• Language: English
• Subjects: Challenges; Chronic illnesses; clinical decision support; Clinical medicine; Clinical outcomes; Clinical standards; Decision making; Decision Support Systems, Clinical; Drugs; Electronic health records; Electronic Health Records - organization & administration; Electronic medical records; Genes; Genomics; Health education; Humans; Implementation; Innovations; Insurance, Health, Reimbursement; Integrated care; Internal Medicine; Medical technology; National Institutes of Health (U.S.); Outcome Assessment (Health Care); Outpatient clinics; Patient education; Patient Education as Topic - organization & administration; Patient Participation - methods; Pharmacoeconomics; Pharmacogenomic Testing - methods; Pharmacogenomics; Precision; Precision medicine; Precision Medicine - methods; Recruitment; Research Design; Safety-net Providers - organization & administration; Systems Integration; Underserved populations; United States; Workflow
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2016.08.727

Abstract Objectives Implementing new programs to support precision medicine in clinical settings is a complex endeavor. We describe challenges and potential solutions based on the Indiana GENomics Implementation: an Opportunity for the Underserved (INGenious) program at Eskenazi Health—one of six sites supported by the Implementing GeNomics In pracTicE network grant of the National Institutes of Health/National Human Genome Research Institute. INGenious is an implementation of a panel of genomic tests. Methods We conducted a descriptive case study of the implementation of this pharmacogenomics program, which has a wide scope (14 genes, 27 medications) and a diverse population (patients who often have multiple chronic illnesses, in a large urban safety-net hospital and its outpatient clinics). Challenges We placed the clinical pharmacogenomics implementation challenges into six categories: patient education and engagement in care decision making; clinician education and changes in standards of care; integration of technology into electronic health record systems; translational and implementation sciences in real-world clinical environments; regulatory and reimbursement considerations, and challenges in measuring outcomes. A cross-cutting theme was the need for careful attention to workflow. Our clinical setting, a safety-net health care system, presented some distinctive challenges. Patients often had multiple chronic illnesses and sometimes were taking more than one pharmacogenomics-relevant medication. Reaching patients for recruitment or follow-up was another challenge. Conclusions New, large-scale endeavors in health care are challenging. A description of the challenges that we encountered and the approaches that we adopted to address them may provide insights for those who implement and study innovations in other health care systems.