Approaches to assessing the provider experience with clinical pharmacogenomic information: a scoping review.

PURPOSE: Barriers to the implementation of pharmacogenomics in clinical practice have been thoroughly discussed over the past decade. METHODS: The objective of this scoping review was to characterize the peer-reviewed literature surrounding the experiences and actions of prescribers, pharmacists, or genetic counselors when using pharmacogenomic information in real-world or hypothetical research settings. RESULTS: A total of 33 studies were included in the scoping review. The majority of studies were conducted in the United States (70%), used quantitative or mixed methods (79%) with physician or pharmacist respondents (100%). The qualitative content analysis revealed five major methodological approaches: hypothetical clinical case scenarios, real-world studies evaluating prescriber response to recommendations or alerts, cross-sectional quantitative surveys, cross-sectional qualitative surveys/interviews, and a quasi-experimental real-world study. CONCLUSION: The findings of this scoping review can guide further research on the factors needed to successfully integrate pharmacogenomics into clinical care.

PARC report: a health-systems focus on reimbursement and patient access to pharmacogenomics testing.

Pharmacogenomics test coverage and reimbursement are major obstacles to clinical uptake. Several early adopter programs have been successfully initiated through dedicated investments by federal and institutional research funding. As a result of research endeavors, evidence has grown sufficiently to support development of pharmacogenomics guidelines. However, clinical uptake is still limited. Third-party payer support plays an important role in increasing adoption, which to date has been limited to reactive single-gene testing. Access to and interest in direct-to-consumer genetic testing are driving demand for increasing healthcare providers and third-party awareness of this burgeoning field. Pharmacogenomics implementation models developed by early adopters promise to expand patient access and options, as testing continues to increase due to growing consumer interest and falling test prices.

Preemptive pharmacogenetic testing: exploring the knowledge and perspectives of US payers.

PURPOSE: Preemptive pharmacogenetic testing aims to optimize medication use by having genetic information at the point of prescribing. Payers' decisions influence implementation of this technology. We investigated US payers' knowledge, awareness, and perspectives on preemptive pharmacogenetic testing. METHODS: A qualitative study was conducted using semistructured interviews. Participants were screened for eligibility through an online survey. A blended inductive and deductive approach was used to analyze the transcripts. Two authors conducted an iterative reading process to code and categorize the data. RESULTS: Medical or pharmacy directors from 14 payer organizations covering 122 million US lives were interviewed. Three concept domains and ten dimensions were developed. Key findings include clinical utility concerns and limited exposure to preemptive germ-line testing, continued preference for outcomes from randomized controlled trials, interest in guideline development, importance of demonstrating an impact on clinical decision making, concerns of downstream costs and benefit predictability, and the impact of public stakeholders such as the Food and Drug Administration and Centers for Medicare and Medicaid Services. CONCLUSION: Both barriers and potential facilitators exist to developing cohesive reimbursement policy for pharmacogenetics, and there are unique challenges for the preemptive testing model. Prospective outcome studies, more precisely defining target populations, and predictive economic models are important considerations for future research.

Priorities for Pediatric Patient Safety Research.

: media-1vid110.1542/5972296743001PEDS-VA_2018-0496Video Abstract BACKGROUND: Developing a research agenda that is focused on the priorities of key stakeholders may expedite implementation and dissemination. Our objective was to identify the highest-priority patient-safety research topics among pediatric clinicians, health care leaders, and families. METHODS: The Children's Hospitals Solutions for Patient Safety Network is a network of >100 children's hospitals working together to eliminate harm due to health care. Parents and site leaders responded to an open-ended, anonymous e-mail survey used to elicit research topics. A key stakeholder panel winnowed related topics and prioritized topics using Likert scale ratings. Site leaders and parents responded to a second anonymous e-mail survey and rated the importance of each topic. Health system executive interviews were used to elicit their opinions regarding top priorities for patient-safety research. RESULTS: The elicitation survey had 107 respondents who produced 49 unique research topics. The key stakeholder panel developed a final list of 24 topics. The prioritization survey had 74 respondents. Top-priority research topics concerned high reliability, safety culture, open communication, and early detection of patient deterioration and sepsis. During 7 qualitative interviews, health system executives highlighted diagnostic error, medication safety, deterioration, and ambulatory patient safety as priority areas. CONCLUSIONS: With this study, we take a first step toward a stakeholder-driven research agenda on the basis of the assumption that stakeholders are best positioned to determine what research will be used to address the problems of most concern to them.

Standardization can accelerate the adoption of pharmacogenomics: current status and the path forward.

Successfully implementing pharmacogenomics into routine clinical practice requires an efficient process to order genetic tests and report the results to clinicians and patients. Lack of standardized approaches and terminology in clinical laboratory processes, ordering of the test and reporting of test results all impede this workflow. Expert groups such as the Association for Molecular Pathology and the Clinical Pharmacogenetics Implementation Consortium have published recommendations for standardizing laboratory genetic testing, reporting and terminology. Other resources such as PharmGKB, ClinVar, ClinGen and PharmVar have established databases of nomenclature for pharmacogenetic alleles and variants. Opportunities remain to develop new standards and further disseminate existing standards which will accelerate the implementation of pharmacogenomics.