title: Lessons Learned When Introducing Pharmacogenomic Panel Testing into Clinical Practice.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA; Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: marc.rosenman@northwestern.edu.
authors.forename: Marc B
authors.initials: MB
authors.lastname: Rosenman
authors.affiliation: Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Decker
authors.affiliation: Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Levy
authors.affiliation: Department of Health Policy and Management, Richard M. Fairbanks School of Public Health, IUPUI, Indianapolis, IN, USA.
authors.forename: Ann M
authors.initials: AM
authors.lastname: Holmes
authors.affiliation: Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Victoria M
authors.initials: VM
authors.lastname: Pratt
authors.affiliation: Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Michael T
authors.initials: MT
authors.lastname: Eadon
mesh_terms: D020000:Decision Support Systems, Clinical; D057286:Electronic Health Records / Q000458:organization & administration*; D006801:Humans; D007349:Insurance, Health, Reimbursement; D009316:National Institutes of Health (U.S.); D017063:Outcome Assessment, Health Care; D010353:Patient Education as Topic / Q000458:organization & administration; D010358:Patient Participation / Q000379:methods; D000071185:Pharmacogenomic Testing / Q000379:methods*; D057285:Precision Medicine / Q000379:methods*; D012107:Research Design; D064876:Safety-net Providers / Q000458:organization & administration; D018511:Systems Integration; D014481:United States; D057188:Workflow
keywords: clinical decision support; electronic health records; pharmacogenomics; precision medicine