VA Sierra Nevada Health Care System

Most human cells lack sufficient telomerase to maintain telomeres, hence these genetic elements shorten with time and stress, contributing to aging and disease. In January, 2007, a commercial health maintenance program, PattonProtocol-1, was launched that included a natural product-derived telomerase activator (TA-65®, 10-50 mg daily), a comprehensive dietary supplement pack, and physician counseling/laboratory tests at baseline and every 3-6 months thereafter. We report here analysis of the first year of data focusing on the immune system. Low nanomolar levels of TA-65® moderately activated telomerase in human keratinocytes, fibroblasts, and immune cells in culture; similar plasma levels of TA-65® were achieved in pilot human pharmacokinetic studies with single 10- to 50-mg doses. The most striking in vivo effects were declines in the percent senescent cytotoxic (CD8(+)/CD28(-)) T cells (1.5, 4.4, 8.6, and 7.5% at 3, 6, 9, and 12 months, respectively; p = not significant [N.S.], 0.018, 0.0024, 0.0062) and natural killer cells at 6 and 12 months (p = 0.028 and 0.00013, respectively). Most of these decreases were seen in cytomegalovirus (CMV) seropositive subjects. In a subset of subjects, the distribution of telomere lengths in leukocytes at baseline and 12 months was measured. Although mean telomere length did not increase, there was a significant reduction in the percent short (<4 kbp) telomeres (p = 0.037). No adverse events were attributed to PattonProtocol-1. We conclude that the protocol lengthens critically short telomeres and remodels the relative proportions of circulating leukocytes of CMV(+) subjects toward the more "youthful" profile of CMV(-) subjects. Controlled randomized trials are planned to assess TA-65®-specific effects in humans.

BACKGROUND: Recent evidence suggests that autonomic nervous dysfunction may be one of many potential factors contributing to persisting post-concussion symptoms. OBJECTIVE: This is the first systematic review to explore the impact of concussion on multiple aspects of autonomic nervous system functioning. METHODS: The methods employed are in compliance with the American Academy of Neurology (AAN) and PRISMA standards. Embase, MEDLINE, PsychINFO, and Science Citation Index literature searches were performed using relevant indexing terms for articles published prior to the end of December 2016. Data extraction was performed by two independent groups, including study quality indicators to determine potential risk for bias according to the 4-tiered classification scheme of the AAN. RESULTS: Thirty-six articles qualified for inclusion in the analysis. Only three studies (one Class II and two Class IV) did not identify anomalies in measures of ANS functioning in concussed populations. CONCLUSIONS: The evidence supports the conclusion that it is likely that concussion causes autonomic nervous system anomalies. An awareness of this relationship increases our understanding of the physical impact of concussion, partially explains the overlap of concussion symptoms with other medical conditions, presents opportunities for further research, and has the potential to powerfully inform treatment decisions.

Serum concentration of hepatic enzymes are linked to liver dysfunction, metabolic and cardiovascular diseases. We perform genetic analysis on serum levels of alanine transaminase (ALT), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) using data on 437,438 UK Biobank participants. Replication in 315,572 individuals from European descent from the Million Veteran Program, Rotterdam Study and Lifeline study confirms 517 liver enzyme SNPs. Genetic risk score analysis using the identified SNPs is strongly associated with serum activity of liver enzymes in two independent European descent studies (The Airwave Health Monitoring study and the Northern Finland Birth Cohort 1966). Gene-set enrichment analysis using the identified SNPs highlights involvement in liver development and function, lipid metabolism, insulin resistance, and vascular formation. Mendelian randomization analysis shows association of liver enzyme variants with coronary heart disease and ischemic stroke. Genetic risk score for elevated serum activity of liver enzymes is associated with higher fat percentage of body, trunk, and liver and body mass index. Our study highlights the role of molecular pathways regulated by the liver in metabolic disorders and cardiovascular disease.

BACKGROUND: Pregnant women with coronavirus disease 2019 (COVID-19) are at increased risk for severe illness compared with nonpregnant women. Data to assess risk factors for illness severity among pregnant women with COVID-19 are limited. This study aimed to determine risk factors associated with COVID-19 illness severity among pregnant women with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. METHODS: Pregnant women with SARS-CoV-2 infection confirmed by molecular testing were reported during 29 March 2020-5 March 2021 through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). Criteria for illness severity (asymptomatic, mild, moderate-to-severe, or critical) were adapted from National Institutes of Health and World Health Organization criteria. Crude and adjusted risk ratios for moderate-to-severe or critical COVID-19 illness were calculated for selected demographic and clinical characteristics. RESULTS: Among 7950 pregnant women with SARS-CoV-2 infection, moderate-to-severe or critical COVID-19 illness was associated with age 25 years and older, healthcare occupation, prepregnancy obesity, chronic lung disease, chronic hypertension, and pregestational diabetes mellitus. Risk of moderate-to-severe or critical illness increased with the number of underlying medical or pregnancy-related conditions. CONCLUSIONS: Older age and having underlying medical conditions were associated with increased risk of moderate-to-severe or critical COVID-19 illness among pregnant women. This information might help pregnant women understand their risk for moderate-to-severe or critical COVID-19 illness and can inform targeted public health messaging.

BACKGROUND: Current evidence suggests an important role of the interleukin-6 (IL-6) pathway in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related cytokine release storm in severely ill coronavirus disease 2019 (COVID-19) patients. Inhibition of the IL-6 pathway with tocilizumab has been employed successfully in some of these patients but the data is mostly consistent of case reports and series. METHODS: We performed a systematic search of PubMed, Embase, and Medline from 22nd April 2020 and again on 27th April 2020 using the following search terms alone or in combination: "COVID-19," "coronavirus," "SARS-CoV-2," "COVID," "anti-interleukin-6 receptor antibodies," "anti-IL-6," "tocilizumab," "sarilumab," "siltuximab." We included studies that reported individual patient data. We extracted and analyzed individual level data on baseline characteristics, laboratory findings, and clinical outcomes. The primary endpoint was in-hospital mortality. Secondary endpoints included in-hospital complications, recovery rates, effect of patient characteristics on the primary outcome and changes in levels of inflammatory markers. RESULTS: Three hundred fifty-two records were identified through a systematic search, of which 10 studies met the inclusion criteria. A single study currently under review was also added. Eleven observational studies encompassing 29 patients were included in the present review. There were more males (24 [82.8%]), and hypertension was the most common comorbidity (16 [48.3%]). Over an average of 5.4 hospital days, the primary endpoint occurred in 6 (20.7%) patients. Among surviving patients, about 10% had worsened disease and 17% recovered. The most common complication was acute respiratory distress syndrome (8 [27.6%]). The IL-6 level was significantly higher after the initiation of tocilizumab with median (interquartile range) of 376.6 (148-900.6) pg/mL compared to the baseline of 71.1 (31.9-122.8) pg/mL (P = .002). Mean (standard deviation) levels of C-reactive protein (CRP) were significantly decreased following treatment 24.6 (26.9) mg/L compared to baseline 140.4 (77) mg/L (P < .0001). Baseline demographics were not significantly different among survivors and nonsurvivors by Fisher's exact test. CONCLUSION: In COVID-19 patients treated with tocilizumab, IL-6 levels are significantly elevated, which are supportive of cytokine storm. Following initiation of tocilizumab, there is elevation in the IL-6 levels and CRP levels dramatically decrease, suggesting an improvement in this hyperinflammatory state. Ongoing randomized control trials will allow for further evaluation of this promising therapy. IMPORTANCE: Recent data indicate that severe COVID-19 causes a cytokine release storm and is associated with worse clinical outcomes and IL-6 plays an important role. It is suggestive that anti-IL-6 results in the improvement of this hyperinflammatory state. However, to our knowledge, there is no individual patient data systematic review performed to summarize baseline characteristics and clinical outcomes of COVID-19 patients who received tocilizumab.

BACKGROUND: Few data are available on the supply and consumption of nutrients at the country level. To address this data gap, we aimed to create a database that provides information on availability (ie, supply) of 156 nutrients across 195 countries and territories from 1980 to 2013. METHODS: We matched 394 food and agricultural commodities from the Food and Agriculture Organization of the United Nations Supply and Utilization Accounts (SUAs) to food items in the United States Department of Agriculture Food Composition Database and obtained data on nutrient composition of the SUAs' food items. Then, after adjusting for inedible portion of each food item, we added the contributions of individual food items to the availability of each nutrient and estimated the national availability of macronutrients and micronutrients in each year. We validated our estimates by comparing our results with those of national nutrition surveys from three countries (the USA, South Korea, and Ecuador). Using dietary consumption data from the Global Burden of Disease study and two popular machine learning algorithms (Random Forest and XGBoost [extreme gradient boosting]), we developed predictive models to estimate the consumption of each nutrient based on their national availability. FINDINGS: Globally 2710 kcal (95% UI 2660-2770) were available per person per day in 2013. Carbohydrates were the major contributor to energy availability (70·5%), followed by fats (17·4%), and protein (10·5%). The energy availability and the contribution of macronutrients to total energy widely varied across levels of development. Countries at the higher level of development (high Socio-demographic Index countries) had more energy available per person per day (3270 kcal, 3220-3310); greater contributions from fats (26·0%) and proteins (11·9%) to total energy availability; and lower contributions from carbohydrate (54·8%). During 1980-2013, energy availability and the contributions of protein and fats to energy availability have increased globally and across levels of development while the contribution of carbohydrates to total energy availability has decreased. The supply of the micronutrients has also increased during the same period globally and across levels of development. Our validation analysis showed that, after accounting for waste at the retail and household level, our estimates of macronutrient availability were very close to the consumption data in nationally representative surveys. Our machine-learning models closely predicted the observed intake of nutrients with the out-of-sample correlation of greater than 0·8 between predicted and observed intake for the nutrients included in the analysis. INTERPRETATION: Our global nutrient database provides a picture of the supply of various nutrients at the country level and can be useful to assess the performance of national food systems in addressing the nutritional needs of their population. FUNDING: Bill & Melinda Gates Foundation.

BACKGROUND: Given the paucity of information on dose intensity, the objective of this study is to describe the use of adjuvant chemotherapy for stage III colon cancer, focusing on relative dose intensity (RDI), overall survival (OS) and disease-free survival (DFS). METHODS: Retrospective cohort of 367 patients diagnosed with stage III colon cancer in 2003-2008 and treated at 19 VA medical centers. Kaplan-Meier curves summarize 5-year OS and 3-year DFS by chemotherapy regimen and RDI, and multivariable Cox proportional hazards regression was used to model these associations. RESULTS: 5-fluorouracil/leucovorin (FU/LV) was the most commonly initiated regimen in 2003 (94.4%) and 2004 (62.7%); in 2005-2008, a majority of patients (60%-74%) was started on an oxaliplatin-based regimen. Median RDI was 82.3%. Receipt of >70% RDI was associated with better 5-year OS (p < 0.001) and 3-year DFS (P = 0.009) than was receipt of ≤70% RDI, with 5-year OS rates of 66.3% and 50.5%, respectively and 3-year DFS rates of 66.1% and 52.7%, respectively. In the multivariable analysis of 5-year OS, oxaliplatin + 5-FU/LV (versus 5-FU/LV) (HR = 0.55; 95% CI = 0.34-0.91), >70% RDI at the first year (HR = 0.58; 95% CI = 0.37-0.89) and married status (HR = 0.66; 95% CI = 0.45-0.97) were associated with significantly decreased risk of death, while age ≥75 (versus 55-64) (HR = 2.06; 95% CI = 1.25-3.40), Charlson Comorbidity Index (HR = 1.17; 95% CI = 1.06-1.30), T4 tumor status (versus T1/T2) (HR = 5.88; 95% CI = 2.69-12.9), N2 node status (HR = 1.68; 95% CI = 1.12-2.50) and bowel obstruction (HR = 2.32, 95% CI = 1.36-3.95) were associated with significantly increased risk. Similar associations were observed for DFS. CONCLUSION: Patients with stage III colon cancer who received >70% RDI had improved 5-year OS. The association between RDI and survival needs to be examined in studies of adjuvant chemotherapy for colon cancer outside of the VA.

Hypertension is a significant and costly public health problem. It is a major, but modifiable contributor for the development of cardiovascular disease. Randomized controlled trials have shown that controlling hypertension reduces the risk of stroke, coronary artery disease, congestive heart failure, end-stage renal disease, peripheral vascular disease, as well as overall mortality. The risk of developing these hypertension-related complications is continuous, starting at a blood pressure level as low as 115/75 mm Hg. Despite the inherent health risks associated with uncontrolled hypertension, elevated blood pressure remains inadequately treated in the majority of patients. This article reviews guidelines for optimal evaluation of hypertension and current therapeutic options available to combat this common yet pervasive disease.

AIMS: Among people with diabetes, 10-25% will experience a foot ulcer. Research has shown that supplementation with arginine, glutamine and β-hydroxy-β-methylbutyrate may improve wound repair. This study tested whether such supplementation would improve healing of foot ulcers in persons with diabetes. METHODS: Along with standard of care, 270 subjects received, in a double-blinded fashion, (twice per day) either arginine, glutamine and β-hydroxy-β-methylbutyrate or a control drink for 16 weeks. The proportion of subjects with total wound closure and time to complete healing was assessed. In a post-hoc analysis, the interaction of serum albumin or limb perfusion, as measured by ankle-brachial index, and supplementation on healing was investigated. RESULTS: Overall, there were no group differences in wound closure or time to wound healing at week 16. However, in subjects with an albumin level of ≤ 40 g/l and/or an ankle-brachial index of < 1.0, a significantly greater proportion of subjects in the arginine, glutamine and β-hydroxy-β-methylbutyrate group healed at week 16 compared with control subjects (P = 0.03 and 0.008, respectively). Those with low albumin or decreased limb perfusion in the supplementation group were 1.70 (95% CI 1.04-2.79) and 1.66 (95% CI 1.15-2.38) times more likely to heal. CONCLUSIONS: While no differences in healing were identified with supplementation in non-ischaemic patients or those with normal albumin, addition of arginine, glutamine and β-hydroxy-β-methylbutyrate as an adjunct to standard of care may improve healing of diabetic foot ulcers in patients with risk of poor limb perfusion and/or low albumin levels. Further investigation involving arginine, glutamine and β-hydroxy-β-methylbutyrate in these high-risk subgroups might prove clinically valuable.

Previous data indicate that immune mechanisms may be involved in developing capillary leakage during Sin Nombre virus (SNV) infection. Therefore, we investigated production of tumor necrosis factor alpha (TNF-alpha) by human alveolar macrophages and human umbilical vein endothelial cells (HUVEC) after infection with SNV. In addition, we examined the effect of TNF-alpha on HUVEC monolayer leakage. Our results reveal that although TNF-alpha decreases accumulation of viral nucleoproteins, TNF-alpha levels do not change in SNV-infected cells. In addition, supernatants from SNV-infected human alveolar macrophages did not cause a significant increase in endothelial monolayer permeability.

The pharmaceutical industry has contributed to many life-saving innovations in medicine and has become one of the most successful industries in the world. As a result, pharmaceutical industry financial and marketing influences extend to federal regulatory agencies, professional organizations, medical journals, continuing medical education, scientific researchers, media experts, and consumer advocacy organizations. These extensive influences have created conflicts of interest that have undermined the credibility of medical research and education. As professional psychology pursues and achieves prescription privileges, it will likely be faced with increasing influences from the industry. To preserve the integrity of psychological science, the authors propose an aspirational "firewall" designed to separate industry marketing from the science of psychology.

This report provides perspectives concerning dual roles of serum ferritin as a measure of both iron status and inflammation. We suggest benefits of a lower range of serum ferritin as has occurred for total serum cholesterol and fasting blood glucose levels. Observations during a prospective randomized study using phlebotomy in patients with peripheral arterial disease offered unique insights into dual roles of serum ferritin both as an iron status marker and acute phase reactant. Robust positive associations between serum ferritin, interleukin 6 [IL-6], tissue necrosis factor-alpha, and high sensitivity C-reactive protein were discovered. Elevated serum ferritin and IL-6 levels associated with increased mortality and with reduced mortality at ferritin levels <100 ng mL-1. Epidemiologic studies demonstrate similar outcomes. Extremely elevated ferritin and IL-6 levels also occur in individuals with high mortality due to SARS-CoV-2 infection. Disordered iron metabolism reflected by a high range of serum ferritin level signals disease severity and outcomes. Based upon experimental and epidemiologic data, we suggest testing the hypotheses that optimal ferritin levels for cardiovascular mortality reduction range from 20 to 100 ng mL-1 with % transferrin levels from 20 to 50%, to ensure adequate iron status and that ferritin levels above 194 ng mL-1 associate with all-cause mortality in population cohorts.

Various findings of the Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers (IMPROVE) study are reviewed. Suggestions for future methodologies that will enhance this study are discussed. The IMPROVE study is one of the largest pharmaceutical care studies conducted. Although it was an intervention study that examined global outcomes following management by pharmacists, it was designed as an effectiveness study. Several new practice and research methods were developed, including a method to identify patients at high risk for drug-related problems utilizing pharmacy databases, a method to identify chronic diseases using pharmacy databases, a method to evaluate the structure and process for delivering pharmaceutical care in Veterans Affairs medical centers (VAMCs), and guidelines for providing care to patients in the IMPROVE study. Nine VAMCs participated in the study, and 1054 patients were randomized to either an intervention group (n = 523) or a control group (n = 531). Pharmacists documented a total of 1855 contacts with the intervention group patients and made 3048 therapy-specific interventions over the 12-month study period. There was no meaningful difference in patient satisfaction or quality of life in the two groups. Selected disease-specific indicators found an improved rate of measurement of hemoglobin A1c tests and better control of total and low-density-lipoprotein (LDL) cholesterol levels in the intervention group compared with the control group. Total health care costs increased in both groups over the 12-month period. The mean increase in costs in the intervention group was $1020, which was lower than the control group's value of $1313. The lessons learned from the IMPROVE study suggest to future investigators how to study and measure the effects of clinical pharmacy services on patient outcome.

The purpose of this study was to describe and evaluate the activities and interventions provided by ambulatory care clinical pharmacists during the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study. A total of 523 patients were randomized into the intervention arm at nine Veterans Affairs medical centers if they were considered to be at high risk for drug-related problems. Patients randomized to the control group had no interventions and they are not reported. Using a standard form, pharmacists were asked to document the length of visit, method of contact, medical conditions addressed, and drug-related problems addressed and resolved during each contact. Seventy-eight ambulatory care clinical pharmacists documented 1855 contacts over 12 months, an average of 3.54 +/- 2.31/patient. The length of visits was 15 minutes or more for 73% of contacts. In-person contacts accounted for 1421 visits (76.6%), with the remainder being telephone contacts. During each contact the average number of drug-related problems addressed and resolved were 1.64 +/- 1.16 and 1.14 +/- 0.98, respectively. More drug-related problems were addressed and resolved when visits were 15 minutes or longer (p=0.001) and when the contact was in person (p=0.001). These data may provide information to clinical pharmacists developing pharmacy-managed clinics for patients at high risk for drug-related problems. The information may be a benchmark for types of interventions that can be made, as well as the time commitments required to make them.

OBJECTIVE: The purpose of this study was to determine if a novel workplace stress management program, delivered either face-to-face or by self-help, would reduce illness and health services utilization among participants. METHODS: Five hundred one volunteers were randomly allocated to one of three groups: full intervention, which received assessment and personalized self-study feedback and was offered six face-to-face, small-group sessions; partial intervention, a self-help group that received assessment and personalized feedback by mail; and a wait-list control group. All participants completed questionnaires for stress, anxiety, and coping at the start of the study and 6 and 12 months later. Health reports were completed at 0, 3, 6, 9, and 12 months. A subsample of subjects who subscribed to a single health maintenance organization provided objectively recorded doctor visit data across the study year. RESULTS: All three groups reported significant improvement in their stress, anxiety, and coping across the year. Full intervention participants showed a more rapid reduction in negative responses to stress than did participants from the other groups. Full-intervention subjects also reported fewer days of illness than subjects in the other groups. Objectively measured physician visits showed a large (34%) reduction in healthcare utilization for full intervention subjects in the HMO subsample. CONCLUSIONS: These results indicated that a work-site program that focuses on stress, anxiety, and coping measurement along with small-group educational intervention can significantly reduce illness and healthcare utilization.

Most research studies of stress and coping in a person's life utilize only one or two measures. As scientists, therefore, we become accustomed to seeing these topics in a limited perspective. As health care practitioners, however, we profit from a broader view of these fields. Practitioners of health promotion strive to alert patients and clients to several areas of life adjustment pertinent to health and disease. The Stress and Coping Inventory (SCI) was designed for this kind of health promotion, primarily as an educational instrument and secondarily as a research tool. Reliability testing, using Cronbach alpha correlations, was performed utilizing a sample of 1772 individuals. Intercorrelations run between SCI stress and coping indicators were all in the predicted direction and several were at moderately high orders of magnitude. Analysis of variance was carried out for stress and coping measures according to subjects' reports of recent health problems. Finally, stepwise multiple regression analysis was done, including validation, cross-validation. Copyright © 2000 John Wiley & Sons, Ltd.

BACKGROUND: Antibiotic time-outs can promote critical thinking and greater attention to reviewing indications for continuation. OBJECTIVE: We pilot tested an antibiotic time-out program at a tertiary care teaching hospital where vancomycin and piperacillin-tazobactam continuation past day 3 had previously required infectious diseases service approval. METHODS: The time-out program consisted of 3 components: (1) an electronic antimicrobial dashboard that aggregated infection-relevant clinical data; (2) a templated note in the electronic medical record that included a structured review of antibiotic indications and that provided automatic approval of continuation of therapy when indicated; and (3) an educational and social marketing campaign. RESULTS: In the first 6 months of program implementation, vancomycin was discontinued by day 5 in 93/145 (64%) courses where a time-out was performed on day 4 versus in 96/199 (48%) 1 year prior (P = .04). Seven vancomycin continuations via template (5% of time-outs) were guideline-discordant by retrospective chart review versus none 1 year prior (P = .002). Piperacillin-tazobactam was discontinued by day 5 in 70/105 (67%) courses versus 58/93 (62%) 1 year prior (P = .55); 9 continuations (9% of time-outs) were guideline-discordant versus two 1 year prior (P = .06). A usability survey completed by 32 physicians demonstrated modest satisfaction with the overall program, antimicrobial dashboard, and renewal templates. CONCLUSIONS: By providing practitioners with clinical informatics support and guidance, the intervention increased provider confidence in making decisions to de-escalate antimicrobial therapy in ambiguous circumstances wherein they previously sought authorization for continuation from an antimicrobial steward.

Focused Acceptance & Commitment Therapy (FACT) is a brief intervention based on traditional Acceptance and Commitment Therapy (ACT). Although there is a growing body of research on the efficacy of ACT for a variety of populations and disorders, there is little research to date on the use of FACT in group settings. This project is 1 of the first of its kind, as it examines data on psychological flexibility, health and mental health status, and symptom reduction from a 4-week FACT group. Participants in this study were 51 patients who attended this group as part of routine clinical care in a VA integrated primary care and mental health setting. They completed pre- and posttreatment measures of well-being, depression, anxiety, stress, psychological flexibility, and perceptions of physical and mental health functioning. Pre- to posttreatment analyses of variance demonstrated large effects for quality of life, F(1, 51) = 21.29, p < .001, η2 = 0.30, moderate effects for depressive symptoms, F(1, 51) = 11.47, p < .001, η2 = 0.08, and perceptions of mental health functioning (MCS scale), F(1, 51) = 9.67, p = .003, η2 = 0.11, and small effects for perceptions of perceived stress, F(1, 51) = 4.08, p = .04, η2 = 0.03, and physical health functioning (PCS scale), F(1, 51) = 6.60, p = .01, η2 = 0.08. There was a statistical trend for reductions in anxiety, F(1, 51) = 3.29, p = .07, η2 = 0.01, and a nonsignificant effect for psychological flexibility, F(1, 51) = 2.05, p = .16, η2 = 0.04. These data provide initial support for the implementation of a group-based FACT protocol within a VA primary care setting and help to lay a foundation for further, more controlled studies on Group FACT in future research. (PsycINFO Database Record

Objectives Patients treated with oral chemotherapy appear to have less contact with the treating providers. As a result, safety, adherence, medication therapy monitoring, and timely follow-up may be compromised. The trend of treating cancer with oral chemotherapy agents is on the rise. However, standard clinical guidance is still lacking for prescribing, monitoring, patient education, and follow-up of patients on oral chemotherapy across the healthcare settings. The purpose of this project is to establish an oral chemotherapy monitoring clinic, to create drug and lab specific provider order sets for prescribing and lab monitoring, and ultimately to ensure safe and effective treatment of the veterans we serve. Methods A collaborative agreement was reached among oncology pharmacists, a pharmacy resident, two oncologists, and a physician assistant to establish a pharmacist-managed oral chemotherapy monitoring clinic at the VA Sierra Nevada Healthcare System. Drug-specific electronic order sets for prescribing and lab monitoring were created for initiating new drug therapy and prescription renewal. The order sets were created to be provider-centric, minimizing clicks needed to order necessary medications and lab monitoring. A standard progress note template was developed for documenting interventions made by the clinic. Patients new to an oral chemotherapy regimen were first counseled by an oncology pharmacist. The patients were then enrolled into the oral chemotherapy monitoring clinic for subsequent follow up and pharmacist interventions. Further, patients lacking monitoring or missing provider appointments were captured through a Clinical Dashboard developed by the US Department of Veterans Affairs (VA) Regional Office (VISN21) using SQL Server Reporting Services. Between September 2014 and April 2015, a total of 68 patients on different oral chemotherapy agents were enrolled into the clinic. Results Out of the 68 patients enrolled into the oral chemotherapy monitoring clinic, 31 patients (45%) were identified as having a therapy-related problem with their oral chemotherapy regimen on a gross measure for safety and appropriateness of medication management during the course of eight months follow-up between September 2014 and April 2015. In addition, the clinic helped to reestablish care for three patients (4.4%) who were lost to follow-up. The clinic identified 12 patients (17.6%) non-adherent to their prescribed regimen in some degree, where patients were suspected to miss doses due to delay in refilling prescriptions at least three days later than the expected date. However, these patients denied non-adherence. Among them, six patients (8.8%) were truly non-adherent. These patients stated that they had missed at least one day of therapy or were not taking the medication as prescribed. Medication regimen errors were discovered for five patients, accounting for a 7.3% medication-related error rate. Finally, seven patients (10.3%) were found to have an adverse reaction attributed to their oral chemotherapy. Two of them (2.9%) developed severe adverse reactions (Grade 3 and 4), which required hospitalization or immediate dose de-escalation. Conclusions The pilot clinic was able to identify current deficiencies and gaps in our practice settings for managing oral chemotherapy in a Veterans population. The oral chemotherapy monitoring clinic played a proactive role to identify preventable medication errors, monitor medication therapy, improve adherence, manage adverse drug reactions and re-establish care for patients who were lost to follow-up. The results suggest that close monitoring and follow-up of patients on oral chemotherapy is crucial to achieve therapeutic goals, improve patient safety and adherence, and to reduce drug adverse events and health care cost.