GMKBClinical Pharmacology & Therapeutics – Hospital systems increasingly utilize pharmacogenomic testing to inform clinical prescribing. Successful implementation efforts have been modeled at many academic centers. In contrast, this report provides insights into the formation of a pharmacogenomics consultation service at a safety-net hospital, which predominantly serves low-income, uninsured, and vulnerable populations. The report describes the INdiana GENomics Implementation: an Opportunity for the UnderServed (INGENIOUS) trial and addresses concerns of adjudication, credentialing, and funding.
Physician Response to Implementation of Genotype-Tailored Antiplatelet Therapy
Clinical Pharmacology & Therapeutics – Physician responses to genomic information are vital to the success of precision medicine initiatives. We prospectively studied a pharmacogenomics implementation program for the propensity of clinicians to select antiplatelet therapy based on CYP2C19 loss-of-function (LOF) variants in stented patients.
Toward rapid learning in cancer treatment selection: an analytical engine for practice-based clinical data
Journal of Biomedical Informatics – The promise of leveraging vast medical record data to guide clinical decision making has created growing support for the development of “Rapid Learning Systems” (RLS) that gather and leverage practice-based clinical evidence for real-time clinical decision support. The need for such systems is particularly evident within the field of oncology, where controlled clinical trial evidence is only available to guide therapy in a minority of patients.
FDA’s Draft Guidance on Laboratory-Developed Tests Increases Clinical and Economic Risk to Adoption of Pharmacogenetic Testing
The Journal of Clinical Pharmacology – The US Food and Drug Administration (FDA) notified Congress July 31, 2014,1 of its intent to regulate laboratory developed tests. These encompass thousands of clinical assays currently used in medical practice including most pharmacogenetic tests. This guidance has the potential to impact the innovation and sustainability of pharmacogenetic research and its clinical implementation.
The IGNITE network: a model for genomic medicine implementation and research
BMC Medical Genetics – Patients, clinicians, researchers and payers are seeking to understand the value of using genomic information (as reflected by genotyping, sequencing, family history or other data) to inform clinical decision-making. However, challenges exist to widespread clinical implementation of genomic medicine, a prerequisite for developing evidence of its real-world utility.
Hypertension pharmacogenomics: in search of personalized treatment approaches
Nature Reviews Nephrology – Cardiovascular and renal diseases are associated with many risk factors, of which hypertension is one of the most prevalent. Worldwide, blood pressure control is only achieved in ~50% of those treated for hypertension, despite the availability of a considerable number of antihypertensive drugs from different pharmacological classes. Although many reasons exist for poor blood pressure control, a likely contributor is the inability to predict to which antihypertensive drug an individual is most likely to respond.
Emerging Roles for Pharmacists in Clinical Implementation of Pharmacogenomics
Pharmacotherapy – Pharmacists are uniquely qualified to play essential roles in the clinical implementation of pharmacogenomics. However, specific responsibilities and resources needed for these roles have not been defined. We describe roles for pharmacists that emerged in the clinical implementation of genotype-guided clopidogrel therapy in the University of Florida Health Personalized Medicine Program, summarize preliminary program results, and discuss education, training, and resources needed to support such programs. Planning for University of Florida Health Personalized Medicine Program began in summer 2011 under leadership of a pharmacist, with clinical launch in June 2012 of a clopidogrel-CYP2C19 pilot project aimed at tailoring antiplatelet therapies for patients undergoing percutaneous coronary intervention and stent placement.
Prerequisites to Implementing a Pharmacogenomics Program in a Large Healthcare System
Clinical Pharmacology & Therapeutics – Pharmacogenomics (PGx) technology is advancing rapidly; however, clinical adoption is lagging. The Indiana Institute of Personalized Medicine (IIPM) places a strong focus on translating PGx research into clinical practice. We will describe what have been found to be the key requirements that must be delivered in order to ensure a successful and enduring PGx implementation within a large healthcare system.
Meaningful Use of Pharmacogenetics
Clinical Pharmacology & Therapeutics – Although some might wish to see randomized clinical trials (RCTs) for every pharmacogenetic example, we argue that for many examples current evidence supports the implementation of preemptive genotyping to guide prescribing.
Implementation and utilization of genetic testing in personalized medicine
Pharmacogenomics Personalized Medicine – This review aims to summarize the current state of implementing genetic testing for personalized medicine, with an emphasis on clinical pharmacogenetic testing.