PRACTICAL GENETICS
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Baptist Health is taking a lead on this front . The health system launched a pilot pharmacogenomics project in 2020 , two years in the making , with a clinical decision support tool based on enrolled patient ’ s genomic profiles . The project aims to integrate the support tool directly into the electronic health record Epic , in the case of Baptist Health , as part of current practitioner workflows . The technical integration will be achieved using ActX as a “ middleware ” provider to integrate this into the EHR and workflows . The initial project will enroll 2,900 employees , on a voluntary basis . Each enrollee will submit a cheek swab to be sent for genomic testing . The testing will focus on 17 genes with 60 variants and four drug groups ( antidepressants , antithrombotics , beta blockers and analgesics ). A pharmacy team will reconcile the study patient ’ s medication list with the pharmacogenomics profile and provide recommendations for any needed changes . The recommendations will be submitted to the patient ’ s primary care physician via their EHR in-basket . The physician will be responsible for , and will make the decision , on medication changes . Additional features will include a search tool to search medications by name within a patient ’ s genomic profile , as well as a search tool by general problem for a list of recommended meds . The physician may access the patient ’ s profile in their EHR for any new prescribing . Finally , the program will provide an automatic notification of any problems at the time of prescribing new medications , whether or not the profile was accessed during that encounter or prescribing event .
Looking into the future it is likely that , most importantly , our patients will come to demand pharmacogenomics as part of their treatment . Baptist Health as part of its project launch has cited data that shows patients are more adherent to medicine recommendations from their providers when they know these are based on genomics . Dr . Oliver notes , “ While the trial and error approach for meds ( e . g . antidepressants ) can be costly and lead to side effects that pharmacogenomics knowledge can help avoid , it is also the thought that a patient ’ s depression is treated right the first time that is so exciting to me . I often wonder , if it takes 6-12 months to potentially treat some patient ’ s depression , what is lost ?”
While Dr . Oliver aims for the project at Baptist to provide a meaningful clinical outcome , he hopes to utilize the data to answer medical economic questions , as well . “ My goal is to show the cost reduction for our own employees and then present this to the payers , asking them to cover the cost of the test . We can use existing infrastructure and processes to offer this precision care to more patients .”
Any clinician , particularly those intrigued by the coming waves of technology and change in medicine , can easily learn more about pharmacogenomics . Many resources , available and free on the internet , demonstrate not only the wide breadth of applicability of pharmacogenomic data but also the public-private partnerships designed to coordinate data and usher pharmacogenomics into the clinical realm . The FDA Office of Clinical Pharmacology is active both in genomics in drug development as well as labeling and post marketing data collection on pharmaceuticals . The FDA maintains on its website a public , online list of 431 drugs with specific , relevant biomarkers and associated drug labeling information . The National Institutes of Health maintains the Pharmacogenomics Knowledgebase ( PharmGKB ), encompassing clinical information including dosing guidelines and drug labels , potentially clinically actionable gene-drug associations and genotype-phenotype relationships . PharmGKB , in partnership with the collaborative research network , Pharmacogenomics Research Network , created the shared project The Clinical Pharmacogenomics Implementation Consortium ( CPIC ). According to CPIC ’ s website , CPIC is an international consortium whose goal “ is to address the barrier to clinical implementation of pharmacogenetic tests by creating , curating , and posting freely available , peer-reviewed , evidence-based , updatable , and detailed gene / drug clinical practice guidelines .” Notably , CPIC guidelines are indexed in PubMed as clinical guidelines . Indeed , as suggested by Dr . Oliver , CPIC has emerged as one of the most used clinical applications for pharmacogenomics research findings . All of these resources are easily found online and can provide a good introduction to the field for the practicing clinician .
The use of technological tools and integration of technological systems is certainly key in adapting to many changes in medicine . These changes are exciting , though they can feel overwhelming for many . A review of any of the above referenced websites may , indeed , feel overwhelming , particularly when considering how to integrate the data into daily practice . The pilot project at Baptist truly aims to address the integration of a seemingly gargantuan amount of data into the workflows of the electronic health record . Ultimately , though , what matters is where the rubber meets the road : patient care . The application of pharmacogenomics can help eliminate a trial and error approach to prescribing , resulting in fewer side effects , follow-ups and failed medications . Patients can rest in the knowledge of some level of predictability of how they personally will react to a new medication , and be warned of interactions with current medications . All of this will certainly contribute to value based care goals , but patients will actually feel the difference in their care while face-to-face with their physicians in the clinic and at the bedside . Ultimately , Dr . Oliver sums it all up nicely for the clinician noting , “ I love that we get the right medication to the right patient at the right time .”
References
1 . Pharmacogenomics FAQS . National Human Genome Research Institute . https :// www . genome . gov
2 . Pharmacogenomics Research Network . https :// www . pgrn . org
3 . What is CPIC ?. Clinical Pharmacogenomics Implementation Consortium . https :// www . cpicpgx . org
4 . Table of Pharmacogenomic Biomarkers in Drug Lableing . U . S . Food and Drug Administration . https :/// www . fda . gov Dr . Kolter is a practicing internist with Baptist Health .
10 LOUISVILLE MEDICINE