Safety and Efficacy Analysis of Apixaban Compared to Heparins in Hospitalized Non-Critically Ill COVID-19 Patients.

Purpose: Heparin-based regimens are recommended for anticoagulation in hospitalized patients with COVID-19 though a study reported similar mortality with apixaban in critically ill hospitalized COVID-19 patients. Our pilot study sought to determine the differences in all-cause mortality, venous thromboembolism (VTE), and bleeding events between apixaban and therapeutic heparin-based regimens in hospitalized non-critically ill COVID-19 patients. Methods: We conducted a retrospective analysis of non-critically ill COVID-19 patients aged ≥ 18 years admitted to 3 campuses of Montefiore Medical Center during the first (March 2020 to May 2020) and second (January 2021 to February 2021) COVID-19 surges, who received within 48 hours of admission and continued for ≥72 hours a therapeutic dose of low-molecular-weight heparin (LMWH), unfractionated heparin (UFH), or any apixaban dose for VTE prophylaxis. Outcomes data analyzed included mortality, suspected or imaging-confirmed VTE, and bleeding using a defined criteria. Results: Overall, 162 patients met eligibility for analysis. Baseline characteristics were similar between the 2 groups except liver and renal functions. Mortality occurred in 10 (13.3%) patients on apixaban and 23 (26.4%) patients on a heparin-based regimen (P = .059). Confirmed VTE events were not different between the groups (8% vs 13.8%, P = .359), but higher incidence of bleeding occurred in heparin-based group (4% vs 52.9%, P < .001). Conclusion: There were no differences in mortality or confirmed VTE between apixaban and heparin-based regimens except for more bleeding events with the heparins. This study highlights the utility of apixaban in COVID-19.

Bleeding and Elevated INR Secondary to Concomitant Tramadol and Warfarin Administration.

The exact mechanism of a tramadol-warfarin interaction has not been fully determined. The authors present a case study that illustrates the risks.

Development and evaluation of a pilot overdose education and naloxone distribution program for hospitalized general medical patients.

Background: Overdose education and naloxone distribution (OEND) to people at risk of witnessing or experiencing an opioid overdose has traditionally been provided through harm reduction agencies. Expanding OEND to inpatient general medical settings may reach at-risk individuals who do not access harm reduction services and have not been trained. An OEND program targeting inpatients was developed, piloted, and evaluated on 2 general medicine floors at Montefiore Medical Center, a large urban academic medical center in Bronx, New York. Methods: The planning committee consisted of 10 resident physicians and 2 faculty mentors. A consult service model was piloted, whereby the primary inpatient care team paged the consult team (consisting of rotating members from the planning committee) for any newly admitted patient who had used any opioid in the year prior to admission. Consult team members assessed patients for eligibility and provided OEND to eligible patients through a short video training. Upon completion, patients received a take-home naloxone kit. To evaluate the program, a retrospective chart review over the first year (April 2016 to March 2017) of the pilot was conducted. Results: Overall, consults on 80 patients were received. Of these, 74 were eligible and the consult team successfully trained 50 (68%). Current opioid analgesic use of ≥50 morphine milligram equivalents daily was the most common eligibility criterion met (38%). Twenty-four percent of patients were admitted for an opioid-related adverse event, the most common being opioid overdose (9%), then opioid withdrawal (8%), skin complication related to injecting (5%), and opioid intoxication (2%). Twenty-five percent had experienced an overdose, 35% had witnessed an overdose in their lifetime, and 83% had never received OEND previously. Conclusions: Integrating OEND into general inpatient medical care is possible and can reach high-risk patients who have not received OEND previously. Future research should identify the optimal way of implementing this service.

Safety of direct oral anticoagulants vs warfarin in patients with chronic liver disease and atrial fibrillation.

BACKGROUND: A complication of chronic liver disease (CLD) is the abnormality of coagulation. In clinical practice, this increased risk of bleeding has not been identified as a protective factor against stroke or systemic embolism associated with atrial fibrillation (AF). The objective of this study was to assess the safety of direct oral anticoagulant (DOAC) agents vs warfarin in CLD patients with AF. METHODS: This was a retrospective cohort study of patients with CLD and AF initiated on oral anticoagulants. Rates of all-cause bleeding were compared between warfarin and DOAC agents. Secondary endpoints included rates of major bleeding and other risk factors for bleeding on anticoagulant therapy. RESULTS: The all-cause bleeding rates were similar between the groups, with 8.4% per year in the DOAC (n = 75) group and 8.8% in warfarin (n = 158) group (HR 0.9, 95% CI 0.4-1.8). No significant difference was noted in the rate of major bleeding. In the multivariable model, higher MELD-XI score and previous bleed were risk factors associated with increased bleeding. CONCLUSION: No significant differences in bleeding rates were noted in patients treated with warfarin and DOAC agents. Further studies evaluating DOAC agents are needed to better understand the optimal anticoagulation strategy in setting of CLD.

Yosprala: A Fixed Dose Combination of Aspirin and Omeprazole.

Cardiovascular disease is the leading cause of morbidity and mortality in the United States. Patients who survive a primary cerebrovascular or cardiovascular event are at increased risk of a subsequent occurrence. Antiplatelet therapy plays an essential role for secondary prevention in individuals with stroke, transient ischemic attack, acute or chronic artery disease, or peripheral arterial disease. Maintaining high-risk patients on low-dose aspirin therapy is a fundamental component of management. However, poor adherence, secondary to the drug's gastrointestinal side effects, has been associated with negative cardiovascular outcomes. Numerous studies have indicated that proton-pump inhibitors significantly reduce the risk of upper gastrointestinal adverse events in aspirin-treated patients. The US Food and Drug Administration approved Yosprala (Aralez Pharmaceuticals), a fixed-dose combination of delayed-release aspirin and immediate-release omeprazole, on September 15, 2016. It is the first product to become available in the United States that combines these 2 pharmacologic drug classes, and represents a new therapeutic option for patients and healthcare providers who strive to improve adherence to daily aspirin therapy.

New Novel Treatment Approaches for Heart Failure With Reduced Ejection Fraction.

Despite availability of standardized drug therapies with proven beneficial outcomes, heart failure is associated with poor quality of life, increased hospital readmission, and high mortality rate. In the recent years, comprehensive understanding of the pathophysiological mechanisms of heart failure has led to the development and approval of 2 new pharmacological agents, sacubitril-valsartan and ivabradine. These agents are currently approved for use in heart failure with reduced ejection fraction (HFrEF) and present as novel approaches to further improve prognosis and outcomes in patients with HF. They offer alternative treatment options for patients who are intolerant or continue to be symptomatic despite utilization of standard HF drug therapies at optimally tolerated dosages. A review of these 2 novel agents in HFrEF, including information on pivotal trials that led to its approval and its place in therapy for HFrEF, is presented.

Benzocaine-Induced Methemoglobinemia: A Case Report.

Topical anesthetics, such as benzocaine, have been reported to cause methemoglobinemia, in which hemoglobin is unable to release oxygen effectively to body tissues. The pathophysiology, symptoms, and treatment of a 46-year-old patient are examined.

Customized order-entry sets can prevent antiretroviral prescribing errors: a novel opportunity for antimicrobial stewardship.

BACKGROUND: Patients with human immunodeficiency virus (HIV) infection on antiretroviral (ARV) therapy are at increased risk for medication errors during transitions of care between the outpatient and inpatient settings. This can lead to treatment failure or toxicity. Previous studies have emphasized the prevalence of medication errors in such patients, but few have reported initiatives to prevent errors from occurring. METHODS: The study was conducted in a 1,400-bed health care center with a state-designated Acquired Immunodeficiency Syndrome (AIDS) Center in the Bronx, New York. The antimicrobial stewardship team and HIV specialists developed customized order-entry sets (COES) to guide ARV prescribing and retrospectively reviewed their effect on error rates of initial ARV orders for inpatients before reconciliation. Patient records were reviewed in six-month periods before and after intervention. The student's t-test or Mann-Whitney U test was used to compare continuous variables; chi-square or Fisher's exact test was used for categorical variables. RESULTS: A total of 723 and 661 admissions were included in the pre-intervention and post-intervention periods, respectively. Overall, error rates decreased by 35% (38.0% to 24.8%, P < 0.01) with COES. Wrong doses and drug interactions decreased by more than 40% (P < 0.005). Error reductions were observed in protease inhibitor (PI)-based (43.6% versus 28.7%, P < 0.01) and non-PI-based (38.0% versus 24.4%, P = 0.02) regimens with COES. A shift in predominant drug-class errors was observed as there was a trend toward increased usage of non-PI regimens post-intervention. Admission in the pre-intervention period (adjusted odds ratio [AOR], 1.79; 95% confidence interval [CI], 1.39-2.31) and use of PI-based regimens (AOR, 2.03; 95% CI, 1.53-2.70) remained significantly associated with ARV prescribing errors after controlling for confounding factors. CONCLUSION: Detailed COES improved ARV prescribing habits, reduced the potential for prescribing incorrect regimens, and can prove useful and cost-effective where HIV-specific medication reconciliation is unavailable.

Medication-induced hypokalemia.

A potassium deficiency can impair metabolic functions, and medications cause hypokalemia through a variety of mechanisms. The authors report on a 58-year-old female suffering from fatigue and weakness after a recent diagnosis of adrenal insufficiency.

Active-learning implementation in an advanced elective course on infectious diseases.

OBJECTIVES: To describe the development, implementation, and assessment of an advanced elective course on infectious diseases using active-learning strategies. DESIGN: Pedagogy for active learning was incorporated by means of mini-lecture, journal club, and debate with follow-up discussion. Forty-eight students were enrolled in this 4-week elective course, in which 30% of course time was allocated for active-learning exercises. All activities were fundamentally designed as a stepwise approach in complementing each active-learning exercise. ASSESSMENT: Achievement of the course learning objectives was assessed using a 5-point Likert scale survey instrument. Students' awareness of the significance of antimicrobial resistance was improved (p ≤ 0.05). Students' ability to critically evaluate the infectious-disease literature and its application in informed clinical judgments was also enhanced through these active-learning exercises (p ≤ 0.05). Students agreed that active learning should be part of the pharmacy curriculum and that active-learning exercises improved their critical-thinking, literature-evaluation, and self-learning skills. CONCLUSION: An elective course using active-learning strategies allowed students to combine information gained from the evaluation of infectious-disease literature, critical thinking, and informed clinical judgment. This blended approach ultimately resulted in an increased knowledge and awareness of infectious diseases.

Hospital emergency preparedness: Push-POD operation and pharmacists as immunizers.

OBJECTIVE: To describe Montefiore Medical Center's participation in a point-of-distribution (POD) exercise in which pharmacists were drilled on the ability to provide immunizations in the face of an emergency. SETTING: New York City on October 9, 2007. SUMMARY: Rapid and appropriate response to a terrorism event can limit morbidity and mortality. After the events of September 11, 2001, the New York City Department of Health and Mental Hygiene (DOHMH) recognized the need to develop a uniform procedure in the case of a potential health disaster. During the fiscal year occurring between September 1, 2006, and August 31, 2007, DOHMH requested that all citywide hospitals participate in a POD drill. All participating hospitals were required to have a team of five health professionals, including one pharmacist, one physician, two nurses, and another member of the institution. The drill was to be conducted within a 4-hour interval to simulate a situation of mass prophylaxis using influenza as a surrogate vaccine or pharmaceutical agent needed in the event of a public health emergency. MAIN OUTCOME MEASURE: Number of health care workers immunized in 4-hour period. RESULTS: During the 4-hour period, the team was able to immunize 942 heath care workers. Predicting a 24/7 operation in the event of a biological terrorism event, the Push-POD operation would have the capacity to immunize 12,000 health care workers-the approximate population of the hospital-in 48 hours. This exercise was replicated for the 2008 influenza program, and the results were identical. CONCLUSION: By allowing pharmacists to expand their scope of practice, New York State will inevitably see a drastic improvement in its adult immunization rates for influenza and pneumococcal vaccinations through greater public awareness and expanded vaccine access.