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Pharmacogenomics Implementation at the National Institutes of Health Clinical Center.

ABSTRACT: The National Institutes of Health Clinical Center (NIH CC) is the largest hospital in the United States devoted entirely to clinical research, with a highly diverse spectrum of patients. Patient safety and clinical quality are major goals of the hospital, and therapy is often complicated by multiple cotherapies and comorbidities. To this end, we implemented a pharmacogenomics program in 2 phases. In the first phase, we implemented genotyping for HLA-A and HLA-B gene variations with clinical decision support (CDS) for abacavir, carbamazepine, and allopurinol. In the second phase, we implemented genotyping for drug-metabolizing enzymes and transporters: SLCO1B1 for CDS of simvastatin and TPMT for CDS of mercaptopurine, azathioprine, and thioguanine. The purpose of this review is to describe the implementation process, which involves clinical, laboratory, informatics, and policy decisions pertinent to the NIH CC.

SUBMITTER: Sissung TM

PROVIDER: S-EPMC5657584 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Pharmacogenomics Implementation at the National Institutes of Health Clinical Center.

Sissung Tristan M TM McKeeby Jon W JW Patel Jharana J Lertora Juan J JJ Kumar Parag P Flegel Willy A WA Adams Sharon D SD Eckes Ellen J EJ Mickey Frank F Plona Teri M TM Mellot Stephanie D SD Baugher Ryan N RN Wu Xiaolin X Soppet Daniel R DR Barcus Mary E ME Datta Vivekananda V Pike Kristen M KM DiPatrizio Gary G Figg William D WD Goldspiel Barry R BR

Journal of clinical pharmacology 20171001

The National Institutes of Health Clinical Center (NIH CC) is the largest hospital in the United States devoted entirely to clinical research, with a highly diverse spectrum of patients. Patient safety and clinical quality are major goals of the hospital, and therapy is often complicated by multiple cotherapies and comorbidities. To this end, we implemented a pharmacogenomics program in 2 phases. In the first phase, we implemented genotyping for HLA-A and HLA-B gene variations with clinical deci ...[more]

PMID: 28921647

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Project description:Policy has a tremendous potential to improve population health when informed by research evidence. Such evidence, however, typically plays a suboptimal role in policymaking processes. The field of policy dissemination and implementation research (policy D&I) exists to address this challenge. The purpose of this study was to: (1) determine the extent to which policy D&I was funded by the National Institutes of Health (NIH), (2) identify trends in NIH-funded policy D&I, and (3) describe characteristics of NIH-funded policy D&I projects.The NIH Research Portfolio Online Reporting Tool was used to identify all projects funded through D&I-focused funding announcements. We screened for policy D&I projects by searching project title, abstract, and term fields for mentions of "policy," "policies," "law," "legal," "legislation," "ordinance," "statute," "regulation," "regulatory," "code," or "rule." A project was classified as policy D&I if it explicitly proposed to conduct research about the content of a policy, the process through which it was developed, or outcomes it produced. A coding guide was iteratively developed, and all projects were independently coded by two researchers. ClinicalTrials.gov and PubMed were used to obtain additional project information and validate coding decisions. Descriptive statistics--stratified by funding mechanism, Institute, and project characteristics--were produced.Between 2007 and 2014, 146 projects were funded through the D&I funding announcements, 12 (8.2 %) of which were policy D&I. Policy D&I funding totaled $16,177,250, equivalent to 10.5 % of all funding through the D&I funding announcements. The proportion of funding for policy D&I projects ranged from 14.6 % in 2007 to 8.0 % in 2012. Policy D&I projects were primarily focused on policy outcomes (66.7 %), implementation (41.7 %), state-level policies (41.7 %), and policies within the USA (83.3 %). Tobacco (33.3 %) and cancer (25.0 %) control were the primary topics of focus. Many projects combined survey (58.3 %) and interview (33.3 %) methods with analysis of archival data sources.NIH has made an initial investment in policy D&I research, but the level of support has varied between Institutes. Policy D&I researchers have utilized a variety of designs, methods, and data sources to investigate the development processes, content, and outcomes of public and private policies.

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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Pharmacogenomics Implementation at the National Institutes of Health Clinical Center.

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Pharmacogenomics Implementation at the National Institutes of Health Clinical Center.

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