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Introduction and Objective: Coronavirus disease 2019 (COVID-19) is associated with respiratory failure and a hypercoagulable state. Studies have shown the use of oral anticoagulants, specifically dabigatran, can significantly decrease mortality from COVID-19. Dabigatran is an oral direct thrombin inhibitor commonly used for nonvalvular atrial fibrillation and for the treatment or prevention of venous thromboembolism. The association of COVID-19-related extensive thrombosis while receiving full therapeutic anticoagulation with dabigatran has not been well-established in current literature. Case Report: We present a 73-year-old male patient with a history of persistent atrial fibrillation anticoagulated with dabigatran presenting with an active COVID-19 infection admitted to the intensive care unit. On hospital day 7, he developed extensive arterial and venous thromboembolisms. To our knowledge, this is the first published case of COVID-19-related extensive thrombosis while receiving full therapeutic anticoagulation with dabigatran. Discussion: Guidelines recommend prophylactic or therapeutic-dose anticoagulation with unfractionated heparin or low-molecular weight heparin for all patients if no contraindications exist; however, recommendations for the use of therapeutic oral anticoagulants have not been well established. Further studies are warranted to establish appropriate use of oral anticoagulants in the setting of COVID-19. Conclusion: Evidence from this report suggests clinicians should closely monitor patients at risk for hypercoagulability regardless of the anticoagulation therapy the patient may be receiving. Additionally, evidence from this case suggests a possible inferiority in the anticoagulation ability of dabigatran in patients with active COVID-19.

Somatostatin analogues, suchas octreotide and lanreotide, are commonly used in the management of enterocutaneous fistula. We report a case of severe and prolonged hyperglycemia that occurred in a patient after receiving a one-time dose of lanreotide, who had previously been stable on octreotide and did not have a history of diabetes mellitus. Management of the patient's hyperglycemia while receiving parenteral nutrition is described.

Background: Drug product shortages, including injectable opioids, are common and have the potential to adversely affect patient care. Objective: To evaluate the impact of an injectable opioid shortage for hospitalized adult patients in the acute postoperative setting. Methods: A single-center, retrospective cohort study of noncritically ill hospitalized, postoperative patients requiring opioids for acute pain management was conducted. Patient cohorts were compared preshortage and postshortage for proportion of total intravenous (IV) opioids used, proportions of specific pain medications used, subjective pain scores, 30-day mortality, respiratory depression, need for opioid reversal, hospital length of stay, and opioid equivalent doses. Results: A total of 275 patients were included, 130 patients in the preshortage cohort and 145 in the postshortage cohort. The proportion of total IV opioid doses was lower in the postshortage cohort versus the preshortage cohort (16.6% vs 20.5%; P < 0.01). Specific medications used were significantly different between the cohorts. The proportion of severe pain scores was lower in the postshortage cohort versus the preshortage cohort (55.6% vs 58.5%; P = 0.04). No significant differences were seen in the overall proportion of nonopioid analgesic use, 30-day mortality, respiratory depression, need for emergent opioid reversal, hospital length of stay, or opioid equivalent doses between cohorts. Conclusion and Relevance: In hospitalized, postoperative adults, an injectable opioid shortage was associated with significant decreases in IV opioid use and severe pain scores but no significant differences in nonopioid analgesic use, safety outcomes, or opioid equivalent doses. These results may assist clinicians in developing strategies for injectable opioid shortages and generating hypotheses for future studies.

Background: Adherence to guideline-based venous thromboembolism (VTE) prophylaxis recommendations is often inadequate. Effective improvement strategies are needed. Objective: The purpose of this quality improvement initiative was to increase use of the facility’s preferred pharmacologic VTE prophylaxis, reduce unnecessary VTE prophylaxis use, and reduce use of pharmacologic VTE prophylaxis in high bleeding risk patients, in accordance with guideline-based recommendations. Methods: Clinical pharmacists spearheaded the development and implementation of a clinical decision-support tool (CDST) integrated within a Veterans Health Administration electronic health record (EHR). The CDST focused on VTE prophylaxis in acutely ill medical patients and guided prescribers to guideline-based recommendations. Following review and approval, the CDST underwent activation in the EHR. A subsequent intervention occurred, year 2 post-intervention, which embedded this CDST into the EHR admission process and admission menus. A drug message was added in the EHR to alert prescribers that low-molecular-weight heparin was the preferred agent. Measures were evaluated pre-intervention, year 1 post-intervention, and year 2 post-intervention. Results: After intervention, there were statistically significant increases in the proportion of patients receiving the facility’s preferred pharmacologic VTE prophylaxis agent, enoxaparin, and a statistically significant decrease in the proportion of unwarranted VTE prophylaxis. The proportion of inappropriate pharmacologic VTE prophylaxis in high bleeding risk patients decreased, but this result did not reach statistical significance. Conclusion: The improvements observed suggest the beneficial role of CDSTs integrated into the EHR to increase adherence to guideline-based VTE prophylaxis recommendations.

Background Central line–associated bloodstream infection (CLABSI) is a complication of central venous access devices used for parenteral nutrition (PN). PN overfeeding is associated with increased adverse effects; however, whether risk for CLABSI is influenced by PN dosing is uncertain. Objective The purpose of the study was to assess differences in CLABSI risk associated with recommended total energy dosing in hospitalized adult patients receiving PN. Methods A case-control study was conducted in a single United States Veterans Health Administration health system to assess the potential CLABSI risk factor of weight-based PN kilocalorie dosing. Hospitalized adult patients who developed CLABSI while receiving PN were identified and compared to a control group of patients who did not develop CLABSI. The exposures evaluated were overfeeding, defined as greater than 30 kcal/kg/day, and underfeeding, defined as less than 20 kcal/kg/day. Results Twenty-nine cases of CLABSI were identified and compared with 274 controls. Odds of CLABSI were significantly higher in patients receiving greater than 30 kcal/kg/day (OR, 3.63; 95% CI, 1.55-8.48; P < .01). No significant difference in odds was found for patients receiving less than 20 kcal/kg/day (OR, .74; 95% CI, 0.21-2.57; P = .63). Conclusion Increased risk for CLABSI in hospitalized adult patients receiving PN was found to be associated with overfeeding, but not underfeeding. These results may aid clinicians in the management of patients requiring PN and in the generation of hypothesis for future investigations.

BACKGROUND: IV vancomycin is widely used for infections caused by Gram-positive bacteria; however, nephrotoxicity is commonly associated with its use. Clinical trials have shown an increased incidence of acute kidney injury (AKI) using normal saline (NS) for fluid resuscitation. This study evaluated differences in AKI and other patient outcomes associated with vancomycin diluted in NS compared with dextrose 5% in water (D5W). METHODS: This retrospective cohort study conducted at a single US Department of Veterans Affairs hospital included veterans who received vancomycin for at least 48 hours between July 1, 2015 and June 30, 2020. This study compared adverse events (AEs) of patients receiving vancomycin diluted in either NS or D5W. The primary outcome was incidence of AKI. Secondary outcomes included incidence of hyperglycemia, hyperchloremia, hypernatremia, metabolic acidosis, in-hospital mortality, and 30-day posthospitalization mortality. RESULTS: The study included 123 patients in each group (N = 246). The percentage of AKI was 22.8% in the D5W group compared with 14.6% the NS group (P = .14). There were no significant differences in the rates of hyperglycemia, hyperchloremia, hypernatremia, or metabolic acidosis between the 2 groups. In-hospital mortality and 30-day posthospitalization mortality were similar between the groups. CONCLUSIONS: This study comparing the AEs of IV vancomycin diluted in NS and D5W found no significant differences in AKI or other patient outcomes. These study results do not suggest the crystalloid used to dilute IV vancomycin is associated with differences in nephrotoxicity or other relevant AEs.

Introduction Septic shock is defined as a dysregulated host response to infection characterized by hemodynamic instability. Concern for the increased risk of acute kidney injury (AKI) with piperacillin-tazobactam in combination with vancomycin may prompt more use of alternative broad-spectrum antipseudomonal beta-lactam antibiotics, such as cefepime. This study assessed whether cefepime was associated with improved outcomes compared to piperacillin-tazobactam in patients with septic shock. Methods This retrospective cohort study included veterans treated for septic shock between September 1, 2008, and August 31, 2018. This study compared cefepime and piperacillin-tazobactam as initial antibiotic management for septic shock. Outcomes included AKI, Clostridioides difficile infection (CDI), hospital length of stay, intensive care unit mortality, and mortality within 30 days of hospitalization. Results In total, 240 patients were included in this study (120 in each cohort). The proportion of AKI was 60.0% in the piperacillin-tazobactam cohort compared to 58.3% in the cefepime cohort (p = 0.90). Mortality was significantly higher in the cefepime cohort. There were no significant differences in CDI or hospital length of stay. Conclusion The results of this study do not suggest that the use of the antipseudomonal beta-lactam antibiotic used in the initial management of septic shock is associated with differences in the AKI or CDI. The higher mortality observed with cefepime may warrant further investigation.

Background Involvement of Clinical Pharmacy Specialists (CPS) in the care of patients with diabetes mellitus (DM) has been demonstrated to be beneficial. Whether this positive impact applies to increased use of cardiovascular risk-reducing medications is less well established. Objective To determine the association of CPS co-management on the prescription of diabetes medications with proven cardiovascular benefits for patients with DM and established cardiovascular disease in the primary care setting. Methods This retrospective cohort study evaluated patients in a Veterans Affairs health-system in primary care settings from February 1, 2019, through January 31, 2020. Patients were included if they had type 2 DM treated with at least one medication and had CVD. Patients were grouped into two cohorts for comparison, those with CPS co-management and those without. The primary outcome was the proportion of patients in each group with new prescriptions for empagliflozin or liraglutide initiated during the study timeframe. Results In total, 8058 patients were found eligible for inclusion in the study. Clinical co-management by a CPS was provided to 2099 patients. Study medications were prescribed, approved, and initiated in 596 patients during the study period, including 391 (18.6%) in the CPS group and 205 (3.4%) in the non-CPS group (P < .001). Conclusion This study showed CPS involvement is associated with increased prescribing of diabetes medications with proven cardiovascular benefits.

Diabetic ketoacidosis (DKA) is defined as a biochemical triad of hyperglycemia (blood glucose >250 mg/dL), ketonemia/ketonuria, and high anion-gap metabolic acidosis (AGMA). Although hyperglycemia is a distinct characteristic in DKA (1), a euglycemic DKA (EDKA) variant exists in which a patient’s blood glucose is normal or mildly elevated on presentation. Sodium–glucose cotransporter 2 (SGLT2) inhibitors such as empagliflozin and dapagliflozin, approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes, have been reported to increase the risk of EDKA, especially in patients with type 1 diabetes (2). We present a unique case of EDKA associated with SGLT2 inhibitor use that was complicated by ketosis induced by a ketogenic diet and unmasking underlying type 1 diabetes in a patient previously treated as having type 2 diabetes. A 70-year-old Caucasian woman with a medical history significant for type 2 diabetes and hypothyroidism presented to the emergency department (ED) with shortness of breath and dizziness for 4 days, associated with one episode of nausea and vomiting. On presentation, she had normal vital signs except for tachycardia. The remainder of her physical exam was unremarkable. Her BMI was 21.8 kg/m2. Her initial diagnostic work-up is summarized in Table 1. View this table: TABLE 1 Laboratory Values on Presentation and Associated Reference Ranges Six months before her presentation, the patient relocated and began receiving primary care in our health system. Before that time, her diabetes was comanaged by a different primary care provider and an endocrinologist. Oral agents had not adequately controlled her blood glucose, and she had been transitioned to insulin. On initial evaluation in our health system, her diabetes was inadequately controlled (as reflected by an A1C of 8.7%) with long-acting subcutaneous insulin glargine 10 units daily …

IN BRIEF “Quality Improvement Success Stories” are published by the American Diabetes Association in collaboration with the American College of Physicians, Inc., and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes an effort to improve the safety of hyperglycemic crisis management at a Veterans Affairs Medical Center by making clinical pharmacy specialists available to the critical care team 24 hours/day.

Background: Limited studies have been published examining dofetilide’s postmarketing use and its recommended monitoring. Objective: To evaluate the impact of a collaborative pharmacy-cardiology antiarrhythmic drug (AAD) monitoring program on dofetilide monitoring. Methods: This retrospective cohort study was performed to assess if a novel monitoring program improved compliance with dofetilide-specific monitoring parameters based on the Food and Drug Administration’s Risk Evaluation and Mitigation Strategy. Results: A total of 30 patients were included in the analysis. The monitoring parameters evaluated included electrocardiogram, serum potassium, serum magnesium, and kidney function. The primary outcome evaluated was the composite of these dofetilide monitoring parameters obtained in each cohort. In the standard cohort, 245 of 352 (69.6%) monitoring parameters were completed versus 134 of 136 (98.5%) in the intervention group ( P < 0.05). Conclusion: A collaborative pharmacy-cardiology AAD monitoring program was associated with a significant improvement in dofetilide monitoring. This improvement could potentially translate into enhanced patient safety outcomes, such as prevention of adverse drug reactions and decreased hospitalizations.

Background: The use of an intravenous insulin infusion protocol (IIP) is recommended for management of hyperglycemia in the intensive care unit (ICU); however, limited evidence of comparison has been made with subcutaneous (SC) insulin regimens. Objective: This study aims to evaluate the safety and effectiveness of an IIP compared with SC insulin regimens in an ICU patient sample since the implementation of an IIP using a computerized clinical-decision support tool. Methods: This investigation was a retrospective cohort study of patients who were treated for hyperglycemia while admitted to any of the ICUs at a Veterans Affairs Medical Center. Patients who were treated with either an IIP or a scheduled SC insulin regimen between May 1, 2015, and May 25, 2016, were included for evaluation. Results: Blood glucose (BG) was within the normoglycemia range (70-180 mg/dL) for 63.0% of the measurements in patients treated with an IIP (n = 171) compared with 45.7% in those treated with SC insulin regimens (n = 121; P < 0.01). Overall, patients managed with an IIP had a lower proportion of hypoglycemic BG measurements (1.2% vs 2.1%, P < 0.01), a lower proportion of hyperglycemic BG measurements (35.8% vs 52.2%, P < 0.01), and a lower mean BG (172.4 vs 194.3 mg/dL, P < 0.01). Conclusion and Relevance: The results of this study suggest that an IIP in a sample of adult ICU patients was associated with better BG control and lower occurrence of hypoglycemia compared with SC insulin regimens.

ObjectiveParenteral nutrition (PN) overfeeding is a potential risk factor in the development of infections and other complications including hyperglycaemia, refeeding syndrome and liver dysfunction. This study was conducted to evaluate the impact of a quality improvement initiative to reduce PN overfeeding.DesignRetrospective cohort study of a quality improvement initiative.SettingA health system comprised of two US Department of Veterans Affairs medical centres.PatientsPatients receiving PN.InterventionsMethods to reduce overfeeding included the use of standardised PN products with lower dextrose to amino acid ratios, reduced use of intravenous lipid emulsion (ILE), and use of adjusted body weights or guideline-recommended predictive equations for energy requirements.Main outcome measuresThe primary outcome measures were the doses of kilocalories, amino acids and ILE in each cohort. The proportions of patients developing complications before and after the intervention were evaluated.ResultsThe mean maximum total daily kilocalorie dose was 30.2 kcal/kg/day in the preintervention group (n=86) vs 23.4 kcal/kg/day in the postintervention group (n=62) (pConclusionsA quality improvement initiative to reduce PN overfeeding was effective in reducing kilocalorie and ILE doses while maintaining similar amino acid doses. Observed complications were reduced following the intervention.

Emergent reversal of oral anticoagulation (OAC), including vitamin K antagonist (VKA) and direct-acting oral anticoagulant (DOAC) therapy, continues to be an important aspect of OAC due to the potential for serious bleeding events. Four-factor prothrombin complex concentrate (4F-PCC) is commonly

Objective The purpose of this study is to compare estimated blood volume (EBV) versus weight-based (WB) dosing of unfractionated heparin in terms of safety and ability to achieve therapeutic antifactor-Xa (AF-Xa) levels. Methods This was a retrospective, cohort study including 32 male veterans who received UFH. Primary outcome measures included time until therapeutic anticoagulation, number of adjustments needed to achieve therapeutic anticoagulation, median AF-Xa levels and the percentage of patients who were therapeutic after the first and second levels. Safety was determined as the incidence of major and minor bleeding. Results EBV dosing may be associated with a decrease in the average time to therapeutic range (20.4 ± 16.7 hours with EBV vs. 26.8 ± 26 hours with WB; p = 0.404) and an increase in the percentage of patients achieving therapeutic anticoagulation after the first AF-Xa level (50% with EBV vs. 35.7% with WB; p = 0.611) although these results were not statistically significant. WB dosing required fewer adjustments (2.7 ± 2.9 with WB vs. 4 ± 2.6 with EBV; p = 0.192) with more patients within the therapeutic range after the second AF-Xa level (42.9% with WB vs. 33.3% with EBV; p = 0.897). There was one major and three minor bleeds in the WB dosing group versus one minor bleed for the EBV dosing cohort ( p = 0.438 and p = 0.323, respectively). Conclusion EBV dosing achieved quick therapeutic anticoagulation with less bleeding compared to WB dosing in a veteran population. Due to the study’s limitations, larger, randomized, comparative trials are needed to confirm our findings.

Parenteral nutrition product shortages are common and place vulnerable patients at risk for nutrient deficiencies. This case report describes a parenteral nutrition–dependent patient who was found to have zinc deficiency during a parenteral nutrition product shortage. The management of the patient’s zinc deficiency is described.

BACKGROUND: Efficacy of ranolazine in the treatment of chronic stable angina (CSA) has been established; however, pivotal trials did not require the optimization of conventional antianginal drug therapy (CADT) prior to use in a veteran population. OBJECTIVE: To determine whether ranolazine, when added to optimized doses of CADT, improves angina in a veteran population with CSA and refractory symptoms. METHODS: In an observational retrospective study, 35 patients prescribed ranolazine and having a baseline Seattle Angina Questionnaire (SAQ) administered at a Veterans Affairs medical center in Gainesville, FL, were evaluated. Patients who were prescribed ranolazine by a provider from outside the institution and did not obtain a baseline SAQ were excluded. The primary outcome measure was the change in SAQ scores from baseline to 1 and 3 months after initiation of ranolazine treatment. Secondary measures included clinically significant QTc interval prolongation (>500 msec or an increase of at least 60 msec from baseline), adverse drug reactions, discontinuation rates, and drug-drug interactions. RESULTS: The addition of ranolazine to optimized CADT was associated with improvement in all dimensions of the SAQ scores at 1 and 3 months compared to baseline scores (p < 0.001 for all dimensions). Mean changes in SAQ dimension scores at 1 and 3 months, respectively, were as follows: physical limitation, +9.86 and +11.94; angina stability, +39.29 and +32.69; angina frequency, +26.79 and +25.38; treatment satisfaction, +11.38 and +10.66; and disease perception, +16.85 and +18.59. Improvments in all dimensions, except treatment satisfaction, were clinically significant as defined by set criteria. Of the 7 patients whose ranolazine dosages were increased to 1000 mg twice daily, only 2 patients were able to maintain treatment at that dosage. CONCLUSIONS: Ranolazine added to optimized doses of CADT demonstrated an improvement in angina symptoms when given to a veteran population with persistent CSA.

Objective: To evaluate current evidence for the use of lacosamide in the treatment of refractory status epilepticus. Data Sources: Literature was accessed via PubMed (through July 2011) using the terms lacosamide and status epilepticus. Study Selection and Data Extraction: All reports on the use of lacosamide in patients with status epilepticus were included for evaluation. Reviews and animal data were excluded. Data Synthesis: Treatment of status epilepticus is challenging, and most patients fail to respond to initial treatment. Recently, several reports have been published on the use of lacosamide for status epilepticus. Eleven reports (5 case reports and 6 case series) were identified. Lacosamide was credited with successful termination of status epilepticus in a majority of these reports, However, the data are weakened by the heterogeneity of the reports, their descriptive nature, and the common divergence from current recommendations for the treatment of status epilepticus, Conclusions: While lacosamide has been reported as an effective treatment for refractory status epilepticus, there is insufficient evidence for its routine use. For cases in which the risks associated with anesthetizing drugs are believed to outweigh the benefits, such as in complex partial status epilepticus, lacosamide may be a reasonable option after more established drug therapies fail.

To evaluate the effect of age, symptom duration, symptom presentation, presenting location, and type of acute upper respiratory tract infection (URI) on the receipt of inappropriate antibiotic prescriptions in adult patients.A retrospective cross-sectional study was conducted within a U.S. Department of Veterans Affairs health system. A total of 500 adult patients with acute URI during a 1-year study period were randomly selected and evaluated for receipt of antibiotic prescriptions. Patients were excluded if they had an indication for antibiotics based on Centers for Disease Control and Prevention criteria, concomitant infection, or unreviewable patient record. Patients were grouped and compared by age, symptom duration, symptom presentation (purulence of secretions), presenting location, and type of URI.Overall, antibiotics were prescribed to 77% (219 of 283) of patients included in the study. Patients with purulent symptoms received a higher proportion of antibiotic prescriptions compared with those without purulent symptoms (P0.01). Patients seen in routine primary care received a lower proportion of antibiotic prescriptions compared with those seen in the emergency department or urgent care/primary care walk-in clinic (P0.01). No significant difference was observed in the proportion of antibiotic prescriptions based on symptom duration (P = 0.99) or age (P = 0.19). Patients with acute sinusitis or bronchitis received a higher proportion of antibiotics than those with acute pharyngitis or nonspecific URI (P0.01).Despite evidence-based practice guidelines for the rational use of antibiotics in patients with upper respiratory tract infections, these conditions are being treated inappropriately. Patient and provider factors play a role in the receipt of antibiotics. Further efforts, including those by pharmacists, are needed to improve the use of antibiotics for acute URI in adult patients.

Objective: To report a case of acute hepatic injury associated with varenicline. Case Summary: A 53-year-old white male with underlying alcoholic liver disease and history of hepatitis C virus infection experienced elevated aminotransferase and alkaline phosphatase levels consistent with acute hepatic injury after initiation of varenicline for smoking cessation. The hepatic injury manifested 4 weeks after initiation of varenicline therapy at 0.5 mg once daily for 3 days, 0.5 mg twice daily for 4 days, and then 1 mg twice daily. Following discontinuation of varenicline, the patient's aminotransferase levels continued to rise for 2 days before steadily decreasing and returning to baseline levels in approximately 4 months. Alkaline phosphatase continued to rise for 8 days after discontinuation of varenicline before returning to baseline within 1 month. Rechallenge was not attempted. Discussion: Varenicline is a novel, first-line agent for smoking cessation. The presentation of this patient is most consistent with an acute hepatic injury related to drug toxicity. The pattern of the patient's elevated hepatic enzyme levels is not consistent with his underlying alcoholic liver disease or hepatitis C. Using the Naranjo probability scale, as well as the Counsel for International Organizations of Medical Science/Roussel Uclaf Causality Assessment Method algorithm for drug-induced liver toxicity, we determined that varenicline was the probable cause of the acute hepatic injury. Varenicline was a possible cause of the acute hepatic injury using the algorithm for drug-induced liver toxicity developed by Maria and Victorino. To our knowledge, this is the first report of acute hepatic injury associated with varenicline. Conclusions: While the benefits of smoking cessation are likely greater than the risk of hepatic injury, clinicians should be cognizant of this reaction associated with varenicline.