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Scientific challenges and implementation barriers to translation of pharmacogenomics in clinical practice.

ABSTRACT: The mapping of the human genome and subsequent advancements in genetic technology had provided clinicians and scientists an understanding of the genetic basis of altered drug pharmacokinetics and pharmacodynamics, as well as some examples of applying genomic data in clinical practice. This has raised the public expectation that predicting patients' responses to drug therapy is now possible in every therapeutic area, and personalized drug therapy would come sooner than later. However, debate continues among most stakeholders involved in drug development and clinical decision-making on whether pharmacogenomic biomarkers should be used in patient assessment, as well as when and in whom to use the biomarker-based diagnostic tests. Currently, most would agree that achieving the goal of personalized therapy remains years, if not decades, away. Realistic application of genomic findings and technologies in clinical practice and drug development require addressing multiple logistics and challenges that go beyond discovery of gene variants and/or completion of prospective controlled clinical trials. The goal of personalized medicine can only be achieved when all stakeholders in the field work together, with willingness to accept occasional paradigm change in their current approach.

SUBMITTER: Lam YW

PROVIDER: S-EPMC3603526 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Scientific challenges and implementation barriers to translation of pharmacogenomics in clinical practice.

Lam Y W Francis YW

ISRN pharmacology 20130228

The mapping of the human genome and subsequent advancements in genetic technology had provided clinicians and scientists an understanding of the genetic basis of altered drug pharmacokinetics and pharmacodynamics, as well as some examples of applying genomic data in clinical practice. This has raised the public expectation that predicting patients' responses to drug therapy is now possible in every therapeutic area, and personalized drug therapy would come sooner than later. However, debate cont ...[more]

PMID: 23533802

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Project description:Considerable efforts have been exerted to implement Pharmacogenomics (PGx), the study of interindividual variations in DNA sequence related to drug response, into routine clinical practice. In this article, we first briefly describe PGx and its role in improving treatment outcomes. We then propose an approach to initiate clinical PGx in the hospital setting. One should first evaluate the available PGx evidence, review the most relevant drugs, and narrow down to the most actionable drug-gene pairs and related variant alleles. This is done based on data curated and evaluated by experts such as the pharmacogenomics knowledge implementation (PharmGKB) and the Clinical Pharmacogenetics Implementation Consortium (CPIC), as well as drug regulatory authorities such as the US Food and Drug Administration (FDA) and European Medicinal Agency (EMA). The next step is to differentiate reactive point of care from preemptive testing and decide on the genotyping strategy being a candidate or panel testing, each of which has its pros and cons, then work out the best way to interpret and report PGx test results with the option of integration into electronic health records and clinical decision support systems. After test authorization or testing requirements by the government or drug regulators, putting the plan into action involves several stakeholders, with the hospital leadership supporting the process and communicating with payers, the pharmacy and therapeutics committee leading the process in collaboration with the hospital laboratory and information technology department, and healthcare providers (HCPs) ordering the test, understanding the results, making the appropriate therapeutic decisions, and explaining them to the patient. We conclude by recommending some strategies to further advance the implementation of PGx in practice, such as the need to educate HCPs and patients, and to push for more tests' reimbursement. We also guide the reader to available PGx resources and examples of PGx implementation programs and initiatives.

Project description:Electronic health records (EHRs) allow for meaningful usage of healthcare data. Their adoption provides clinicians with a central location to access and share data, write notes, order labs and prescriptions, and bill for patient visits. However, as non-clinical requirements have increased, time spent using EHRs eclipsed time spent on direct patient care. Several solutions have been proposed to minimize the time spent using EHRs, though each have limitations. Digital scribe technology uses voice-to-text software to convert ambient listening to meaningful medical notes and may eliminate the physical task of documentation, allowing physicians to spend less time on EHR engagement and more time with patients. However, adoption of digital scribe technology poses many barriers for physicians. In this study, we perform a scoping review of the literature to identify barriers to digital scribe implementation and provide solutions to address these barriers. We performed a literature review of digital scribe technology and voice-to-text conversion and information extraction as a scope for future research. Fifteen articles met inclusion criteria. Of the articles included, four were comparative studies, three were reviews, three were original investigations, two were perspective pieces, one was a cost-effectiveness study, one was a keynote address, and one was an observational study. The published articles on digital scribe technology and voice-to-text conversion highlight digital scribe technology as a solution to the inefficient interaction with EHRs. Benefits of digital scribe technologies included enhancing clinician ability to navigate charts, write notes, use decision support tools, and improve the quality of time spent with patients. Digital scribe technologies can improve clinic efficiency and increase patient access to care while simultaneously reducing physician burnout. Implementation barriers include upfront costs, integration with existing technology, and time-intensive training. Technological barriers include adaptability to linguistic differences, compatibility across different clinical encounters, and integration of medical jargon into the note. Broader risks include automation bias and risks to data privacy. Overcoming significant barriers to implementation will facilitate more widespread adoption.Supplementary informationThe online version contains supplementary material available at 10.1007/s12553-021-00568-0.

Project description:BackgroundPharmacogenomics (PGx) holds promise to revolutionize modern healthcare. Although there are several prospective clinical studies in oncology and cardiology, demonstrating a beneficial effect of PGx-guided treatment in reducing adverse drug reactions, there are very few such studies in psychiatry, none of which spans across all main psychiatric indications, namely schizophrenia, major depressive disorder and bipolar disorder. In this study we aim to investigate the clinical effectiveness of PGx-guided treatment (occurrence of adverse drug reactions, hospitalisations and re-admissions, polypharmacy) and perform a cost analysis of the intervention.MethodsWe report our findings from a multicenter, large-scale, prospective study of pre-emptive genome-guided treatment named as PREemptive Pharmacogenomic testing for preventing Adverse drug REactions (PREPARE) in a large cohort of psychiatric patients (n = 1076) suffering from schizophrenia, major depressive disorder and bipolar disorder.FindingsWe show that patients with an actionable phenotype belonging to the PGx-guided arm (n = 25) present with 34.1% less adverse drug reactions compared to patients belonging to the control arm (n = 36), 41.2% less hospitalisations (n = 110 in the PGx-guided arm versus n = 187 in the control arm) and 40.5% less re-admissions (n = 19 in the PGx-guided arm versus n = 32 in the control arm), less duration of initial hospitalisations (n = 3305 total days of hospitalisation in the PGx-guided arm from 110 patients, versus n = 6517 in the control arm from 187 patients) and duration of hospitalisation upon readmission (n = 579 total days of hospitalisation upon readmission in the PGx-guided arm, derived from 19 patients, versus n = 928 in the control arm, from 32 patients respectively). It was also shown that in the vast majority of the cases, there was less drug dose administrated per drug in the PGx-guided arm compared to the control arm and less polypharmacy (n = 124 patients prescribed with at least 4 psychiatric drugs in the PGx-guided arm versus n = 143 in the control arm) and smaller average number of co-administered psychiatric drugs (2.19 in the PGx-guided arm versus 2.48 in the control arm. Furthermore, less deaths were reported in the PGx-guided arm (n = 1) compared with the control arm (n = 9). Most importantly, we observed a 48.5% reduction of treatment costs in the PGx-guided arm with a reciprocal slight increase of the quality of life of patients suffering from major depressive disorder (0.935 versus 0.925 QALYs in the PGx-guided and control arm, respectively).InterpretationWhile only a small proportion (∼25%) of the entire study sample had an actionable genotype, PGx-guided treatment can have a beneficial effect in psychiatric patients with a reciprocal reduction of treatment costs. Although some of these findings did not remain significant when all patients were considered, our data indicate that genome-guided psychiatric treatment may be successfully integrated in mainstream healthcare.FundingEuropean Union Horizon 2020.

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Scientific challenges and implementation barriers to translation of pharmacogenomics in clinical practice.

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Scientific challenges and implementation barriers to translation of pharmacogenomics in clinical practice.

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