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Pharmacogenetic testing in the Veterans Health Administration (VHA): policy recommendations from the VHA Clinical Pharmacogenetics Subcommittee.

ABSTRACT: PURPOSE:The Veterans Health Administration (VHA) Clinical Pharmacogenetics Subcommittee is charged with making recommendations about whether specific pharmacogenetic tests should be used in healthcare at VHA facilities. We describe a process to inform VHA pharmacogenetic testing policy. METHODS:After developing consensus definitions of clinical validity and utility, the Subcommittee identified salient drug-gene pairs with potential clinical application in VHA. Members met monthly to discuss each drug-gene pair, the evidence of clinical utility for the associated pharmacogenetic test, and any VHA-specific testing considerations. The Subcommittee classified each test as strongly recommended, recommended, or not routinely recommended before drug initiation. RESULTS:Of 30 drug-gene pair tests reviewed, the Subcommittee classified 4 (13%) as strongly recommended, including HLA-B*15:02 for carbamazepine-associated Stevens-Johnston syndrome and G6PD for rasburicase-associated hemolytic anemia; 12 (40%) as recommended, including CYP2D6 for codeine toxicity; and 14 (47%) as not routinely recommended, such as CYP2C19 for clopidogrel dosing. CONCLUSION:Only half of drug-gene pairs with high clinical validity received Subcommittee support for policy promoting their widespread use across VHA. The Subcommittee generally found insufficient evidence of clinical utility or available, effective alternative strategies for the remainders. Continual evidence review and rigorous outcomes research will help promote the translation of pharmacogenetic discovery to healthcare.

SUBMITTER: Vassy JL

PROVIDER: S-EPMC6274593 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Pharmacogenetic testing in the Veterans Health Administration (VHA): policy recommendations from the VHA Clinical Pharmacogenetics Subcommittee.

Vassy Jason L JL Stone Annjanette A Callaghan John T JT Mendes Margaret M Meyer Laurence J LJ Pratt Victoria M VM Przygodzki Ronald M RM Scheuner Maren T MT Wang-Rodriguez Jessica J Schichman Steven A SA

Genetics in medicine : official journal of the American College of Medical Genetics 20180601 2

<h4>Purpose</h4>The Veterans Health Administration (VHA) Clinical Pharmacogenetics Subcommittee is charged with making recommendations about whether specific pharmacogenetic tests should be used in healthcare at VHA facilities. We describe a process to inform VHA pharmacogenetic testing policy.<h4>Methods</h4>After developing consensus definitions of clinical validity and utility, the Subcommittee identified salient drug-gene pairs with potential clinical application in VHA. Members met monthly ...[more]

PMID: 29858578

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Project description:BACKGROUND:Adults with end-stage renal disease (ESRD) requiring chronic dialysis continue to suffer from poor health outcomes and represent a population rightfully targeted for quality improvement. Electronic dashboards are increasingly used in healthcare to facilitate quality measurement and improvement. However, detailed descriptions of the creation of healthcare dashboards are uncommonly available and formal inquiry into perceptions, satisfaction, and utility by clinical users has been rarely conducted, particularly in the context of dialysis care. Therefore, we characterized the development, implementation and user experience with Veterans Health Administration (VHA) dialysis dashboard. METHODS:A clinical-quality dialysis dashboard was implemented, which displays clinical performance measures (CPMs) for Veterans with ESRD receiving chronic hemodialysis at all VHA facilities. Data on user experience and perceptions were collected via an e-mail questionnaire to dialysis medical directors and nurse managers at these facilities. RESULTS:Since 2016 the dialysis dashboard reports monthly on CPMs for approximately 3000 Veterans receiving chronic hemodialysis across 70 VHA dialysis facilities. Of 141 dialysis medical directors and nurse managers, 61 completed the questionnaire. Sixty-six percent of respondents did not find the dashboard difficult to access, 64% agreed that it is easy to use, 59% agreed that its layout is good, and the majority agreed that presentation of data is clear (54%), accurate (56%), and up-to-date (54%). Forty-eight percent of respondents indicated that it helped them improve patient care while 12% did not. Respondents indicated that they used the dialysis dashboard for clinical reporting (71%), quality assessment/performance improvement (QAPI) (62%), and decision-making (23%). CONCLUSIONS:Most users of the VHA dialysis dashboard found it accurate, up-to-date, easy to use, and helpful in improving patient care. It meets diverse user needs, including administrative reporting, clinical benchmarking and decision-making, and quality assurance and performance improvement (QAPI) activities. Moreover, the VHA dialysis dashboard affords national-, regional- and facility-level assessments of quality of care, guides and motivates best clinical practices, targets QAPI efforts, and informs and promotes population health management improvement efforts for Veterans receiving chronic hemodialysis.

Project description:BACKGROUND:Inappropriate testosterone use and variations in testosterone prescribing patterns exist in the Veterans Health Administration (VHA) despite the presence of clinical guidelines. OBJECTIVE:We examined system and clinician factors that contribute to patterns of potentially inappropriate testosterone prescribing in VHA. DESIGN:Qualitative study using a positive deviance approach to understand practice variation in high- and low-testosterone prescribing sites. PARTICIPANTS:Twenty-two interview participants included primary care and specialty clinicians, key opinion leaders, and pharmacists at 3 high- and 3 low-testosterone prescribing sites. APPROACH:Semi-structured phone interviews were conducted, transcribed, and coded using a priori theoretical constructs and emergent themes. Case studies were developed for each site and a cross-case matrix was created to evaluate variation across high- and low-prescribing sites. KEY RESULTS:We identified four system-level domains related to variation in testosterone prescribing: organizational structures and processes specific to testosterone prescribing, availability of local guidance on testosterone prescribing, well-defined dissemination process for local testosterone polices, and engagement in best practices related to testosterone prescribing. Two clinician-level domains were also identified, specifically, structured initial testosterone prescribing process and specified follow-up testosterone prescribing process. High- and low-testosterone prescribing sites systematically varied in the four system-level domains, while the clinician-level domains looked similar across all sites. The third high-prescribing site was unusual in that it exhibited the four domains similar to the 3 low-prescribing sites at the time of our visit. This site had greatly reduced its prescribing of testosterone in the interim. CONCLUSIONS:Findings suggest that local organizational factors play an important role in influencing prescribing. Sites have the potential to transform their utilization patterns by providing access to specialty care expertise, an electronic health record-based system to facilitate guideline-concordant prescribing, well-defined dissemination processes for information, guidance from multiple sources, and clarity regarding best practices for prescribing.

Project description:BackgroundIn 2011, the Veterans Health Administration (VHA) released the Acute Ischemic Stroke (AIS) Directive, which mandated reorganization of acute stroke care, including self-designation of stroke centers as Primary (P), Limited Hours (LH), or Supporting (S).ObjectivesIn partnership with the VHA Offices of Emergency Medicine and Specialty Care Services, the VA Stroke QUERI conducted a formative evaluation in a national sample of three levels of stroke centers in order to understand barriers and facilitators.Design and approachThe evaluation consisted of a mixed-methods assessment that included a qualitative assessment of data from semi-structured interviews with key informants and a quantitative assessment of stroke quality-of-care data reporting practices by facility characteristics.ParticipantsThe final sample included 38 facilities (84 % participation rate): nine P, 24 LH, and five S facilities. In total, we interviewed 107 clinicians and 16 regional Veterans Integrated Service Network (VISN) leaders.ResultsAcross all three levels of stroke centers, stroke teams identified the specific need for systematic nurse training to triage and initiate stroke protocols. The most frequently reported barriers centered around quality-of-care data collection. A low number of eligible veterans arriving at the VAMC in a timely manner was another major impediment. The LH and S facilities reported some unique barriers: access to radiology and neurology services; EMS diverting stroke patients to nearby stroke centers, maintaining staff competency, and a lack of stroke clinical champions. Solutions that were applied included developing stroke order sets and templates to provide systematic decision support, implementing a stroke code in the facility for a coordinated response to stroke, and staff resource allocation and training. Data reporting by facility evaluation demonstrated that categorizing site volume did indicate a lower likelihood of reporting among VAMCs with 25-49 acute stroke admissions per year.ConclusionsThe AIS Directive brought focused attention to reorganizing stroke care across a wide range of facility types. Larger VA facilities tended to follow established practices for organizing stroke care, but the unique addition of the LH designation presented some challenges. S facilities tended to report a lack of a coordinated stroke team and champion to drive process changes.

Project description:ImportanceImplementation of pharmacogenetic testing to guide drug prescribing has potential to improve drug response and prevent adverse events. Robust data exist for more than 30 gene-drug pairs linking genotype to drug response phenotypes; however, it is unclear which pharmacogenetic tests, if implemented, would provide the greatest utility for a given patient population.ObjectivesTo project the proportion of veterans in the US Veterans Health Administration (VHA) with actionable pharmacogenetic variants and evaluate how testing might be associated with prescribing decisions.Design, setting, and participantsThis cross-sectional study included veterans who used national VHA pharmacy services from October 1, 2011, to September 30, 2017. Data analyses began April 26, 2018, and were completed February 6, 2019.ExposuresReceipt of level A drugs based on VHA pharmacy dispensing records.Main outcomes and measuresProjected prevalence of actionable pharmacogenetic variants among VHA pharmacy users based on variant frequencies from the 1000 Genomes Project and veteran demographic characteristics; incident number of level A prescriptions, and proportion of new level A drug recipients projected to carry an actionable pharmacogenetic variant.ResultsDuring the study, 7 769 359 veterans (mean [SD] age, 58.1 [17.8] years; 7 021 504 [90.4%] men) used VHA pharmacy services. It was projected that 99% of VHA pharmacy users would carry at least 1 actionable pharmacogenetic variant. Among VHA pharmacy users, 4 259 153 (54.8%) received at least 1 level A drug with 1 188 124 (15.3%) receiving 2 drugs, and 912 189 (11.7%) receiving 3 or more drugs. The most common incident prescriptions during the study were tramadol (923 671 new recipients), simvastatin (533 928 new recipients), citalopram (266 952 new recipients), and warfarin (205 177 new recipients). Gene-drug interactions projected to have substantial clinical impacts in the VHA population include the interaction of SLCO1B1 with simvastatin (1 988 956 veterans [25.6%]), CYP2D6 with tramadol (318 544 veterans [4.1%]), and CYP2C9 or VKORC1 with warfarin (7 163 349 veterans [92.2%]).Conclusions and relevanceClinically important pharmacogenetic variants are highly prevalent in the VHA population. Almost all veterans would carry an actionable variant, and more than half of the population had been exposed to a drug affected by these variants. These results suggest that pharmacogenetic testing has the potential to affect pharmacotherapy decisions for commonly prescribed outpatient medications for many veterans.

Project description:ImportanceLow-value care is associated with harm among patients and with wasteful health care spending but has not been well characterized in the Veterans Health Administration.ObjectivesTo characterize the frequency of and variation in low-value diagnostic testing for 4 common conditions at Veterans Affairs medical centers (VAMCs) and to examine the correlation between receipt of low-value testing for each condition.Design, setting, and participantsThis retrospective cohort study used Veterans Health Administration data from 127 VAMCs from fiscal years 2014 to 2015. Data were analyzed from April 2018 to March 2020.ExposuresContinuous enrollment in Veterans Health Administration during fiscal year 2015.Main outcomes and measuresReceipt of low-value testing for low back pain, headache, syncope, and sinusitis. For each condition, sensitive and specific criteria were used to evaluate the overall frequency and range of low-value testing, adjusting for sociodemographic and VAMC characteristics. VAMC-level variation was calculated using median adjusted odds ratios. The Pearson correlation coefficient was used to evaluate the degree of correlation between low-value testing for each condition at the VAMC level.ResultsAmong 1 022 987 veterans, the mean (SD) age was 60 (16) years, 1 008 336 (92.4%) were male, and 761 485 (69.8%) were non-Hispanic White. A total of 343 024 veterans (31.4%) were diagnosed with low back pain, 79 176 (7.3%) with headache, 23 776 (2.2%) with syncope, and 52 889 (4.8%) with sinusitis. With the sensitive criteria, overall and VAMC-level low-value testing frequency varied substantially across conditions: 4.6% (range, 2.7%-10.1%) for sinusitis, 12.8% (range, 8.6%-22.6%) for headache, 18.2% (range, 10.9%-24.6%) for low back pain, and 20.1% (range, 16.3%-27.7%) for syncope. With the specific criteria, the overall frequency of low-value testing across VAMCs was 2.4% (range, 1.3%-5.1%) for sinusitis, 8.6% (range, 6.2%-14.6%) for headache, 5.6% (range, 3.6%-7.7%) for low back pain, and 13.3% (range, 11.3%-16.8%) for syncope. The median adjusted odds ratio ranged from 1.21 for low back pain to 1.40 for sinusitis. At the VAMC level, low-value testing was most strongly correlated for syncope and headache (ρ = 0.56; P < .001) and low back pain and headache (ρ = 0.48; P < .001).Conclusions and relevanceIn this cohort study, low-value diagnostic testing was common, varied substantially across VAMCs, and was correlated between veterans' receipt of different low-value tests at the VAMC level. The findings suggest a need to address low-value diagnostic testing, even in integrated health systems, with robust utilization management practices.

Dataset Information

Pharmacogenetic testing in the Veterans Health Administration (VHA): policy recommendations from the VHA Clinical Pharmacogenetics Subcommittee.

Publications

Pharmacogenetic testing in the Veterans Health Administration (VHA): policy recommendations from the VHA Clinical Pharmacogenetics Subcommittee.

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