Pharmacogenomics in Clinical Therapeutics

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The system has been previously described in detail 3 , with highlights described below See Figure 1. A key consideration when we were initially designing the GPS was ensuring that the system could be easily integrated into provider workflows. This meant surmounting the challenge of presenting complex genomic data to individuals who may not have had prior formal genetics or genomics training.

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Given this potential barrier of lack of provider knowledge, we designed the GPS with universally known iconography: the traffic light. This provided an easily recognizable signal with intuitive meaning. Each drug associated with a pharmacogenomic variant for which we test is assigned a traffic light; red lights correspond to high genomic risk of non-response or side effects, yellow lights represent cautionary—but not necessarily contraindicatory—genomic information, while green lights represent favorable genomic signals. In addition to using traffic lights, we also designed the GPS to have concise clinical decision support CDS summaries, which provide, when applicable, pharmacogenomically favorable alternative medications or patient-specific dose recommendations, alongside links to the primary literature from which the CDS summary was derived.

Importantly, the GPS data only conveys drug-genetic relationships not, for example, drug-drug information, nor information about use of drugs in certain disease states like renal dysfunction , as we designed it to supplement other pertinent clinical data sources that providers already consider when prescribing medications. Further, we devised GPS to be a passive system, meaning that it does not employ pop-up alerts regarding patient results.

We felt this was important to avoid alert fatigue, although we are considering for the future active alerting, which involves push notifications to providers about the highest risk-genomic signals. While we created GPS initially as a stand-alone system, its integration with our EHR over 2 years ago has provided the opportunity for more seamless incorporation into provider workflows.

User considerations in assessing pharmacogenomic tests and their clinical support tools

Within the EHR, a link enables providers to launch the GPS user interface easily as an internal browser window, using institutional authentication credentials to log in. A final, critical functionality of the GPS is the dynamic drug and disease search field. This functionality is vital when a large number of variants have been tested preemptively, as it allows providers to search any disease or drug with return of patient-specific pharmacogenomic results.

In fact, we tested the utility of this functionality among a cohort of more than 1, genotyped patients. We have found that delivering preemptive pharmacogenomic results to participating study providers leads to measurable benefits for providers and patients. We analyzed data comprised of more than 2, outpatient clinic visits over a 3-year period for unique preemtively genotyped patients enrolled in our institutional implementation program 6.

They did not access GPS at some visits, for example, due to time constraints. Importantly, more than one-third of medications that patients were currently taking at the time of the visits in question were associated with pharmacogenomic information. We determined whether these patient-specific pharmacogenomic results influenced prescribing by analyzing medication change rates and found that both red and yellow light medications were changed more often than medications with no pharmacogenomic information.

The OR of a red light medication being changed was Alongside analyzing provider behavior in response to pharmacogenomic results availability, we also studied patient perspectives through surveys and focus groups. We found that when providers considered pharmacogenomic results, patients perceived increased doctor-patient empathy and privacy, a better understanding of medical decision-making, and most significantly, a greater sense of personalized care from their providers Results from patient focus groups also showed that those who were previously genotyped were open-minded about the use of their pharmacogenomic results in the clinic Regardless of whether patients had been genotyped, they expressed concerns about employment discrimination and insurance coverage based on pharmacogenomic results.

Taken together, we believe our results on patient perspectives represent vital considerations for implementation efforts, as patients are key stakeholders in widespread adoption of pharmacogenomic testing. Importantly, our efforts would not have been possible without early engagement and support from key institutional stakeholders, including insitutional leadership laboratory personnel, the research informatics and hospital informatics teams, and the willing early-adopter physicians and patients.


The last major challenge to wider adoption of pharmacogenomic testing is the currently limited scope of insurance reimbursement for germline pharmacogenomic tests. Simultaneously, the Centers for Medicare and Medicaid Services issued a preliminary national coverage determination for the test. All of these tests offer the potential to inform the use of multiple drugs at once by interrogating multiple genes simultaneously and preemptively.

We wonder whether this sea change in approach could eventually be extended to germline pharmacogenomic testing. One could argue that—not dissimilarly to oncology—a critical mass of clinically actionable germline pharmacogenomic variants now exists.


With these variants informing the use of various different drugs, panel-based preemptive testing for a set of germline pharmacogenomic markers—especially in certain populations at risk for near-future or lifetime poly-pharmacy—could be a sound and cost-effective strategy to evaluate in future implementation efforts.

We have highlighted important considerations for preemptive pharmacogenomic testing, many of which are relevant to clinical laboratorians. Choosing when to genotype, along with how to translate and deliver results, are critical considerations for any implementation effort. We have taken an individualized approach to overcome common barriers, including leveraging public resources to aid in genotype-to-phenotype translations, creating a dynamic results-reporting system that is accessible both outside of and within our institutional EHR, and delivering CDS in a way that is compatible with provider workflows.

Our implementation program has positively impacted provider prescribing in a way that is aimed at reducing patient risk of non-response or medication toxicity. The doctor-patient relationship, along with both provider and patient attitudes toward pharmacogenomic testing, has facilitated this process, and our program has received overwhelmingly positive feedback. We believe our model is one example of how to realize the era of precision medicine. Click to view More Pharmacogenetics. Content Types A limited number of items are shown.

Click to view More Electronic books. Physical Details 1 online resource p. Summary Pharmacogenomics is the process of analyzing patients' genes to predict the onset of adverse reactions or forecast the effectiveness of therapeutic drugs.

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This useful text is written to discuss both the theory and the clinical application of the principles of pharmacogenomics. Current research has clearly established that a range of treatments may be greatly improved through genetic profiling of individual patients before certain therapies begin. Aimed at clinicians, pharmacologists, and clinical laboratory professionals this book discusses the important role of laboratory tests in the practice.

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Nicholson, MD, PharmD. Langman, PhD and Christine L. Snozek, PhD. Sepulveda, MD, PhD. Borgman, PhD and Mark W. Linder, PhD. See All Customer Reviews. Shop Textbooks.

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