From Friend to Foe: A Case of Naloxone-Induced Pulmonary Edema.

Naloxone, an opioid receptor antagonist, effectively reverses opioid overdose and opioid-induced respiratory depression. A few side effects were reported after naloxone administration, including arrhythmia and pulmonary edema. Although rare, naloxone-induced pulmonary edema can be a severe and sometimes life-threatening complication requiring mechanical ventilation. This condition is predominantly linked to an upsurge in catecholamines after opioid reversal as part of acute withdrawal syndrome, especially seen in patients who chronically use opioids. In this report, we present a case of a 66-year-old patient who developed pulmonary edema following the administration of multiple doses of intravenous and intranasal naloxone for opioid overdose. This case highlights the potential adverse effects associated with naloxone use and discusses how to employ this life-saving medication with minimal side effects.

Comparative Efficacy of Sodium Zirconium Cyclosilicate and Sodium Polystyrene Sulfonate for Acute Hyperkalemia: A Retrospective Chart Review.

Background: Sodium polystyrene sulfonate (SPS) is a nonselective sodium-potassium exchange resin commonly used along with intravenous (IV) insulin, albuterol, furosemide, and/or calcium for the treatment of acute hyperkalemia. Sodium zirconium cyclosilicate (SZC) is a newer non-absorbed exchange resin that preferentially increases fecal potassium excretion from the gastrointestinal tract. Limited data exists on the efficacy of SZC for the treatment of acute hyperkalemia. Objectives: To assess the achievement of normokalemia (serum potassium level [K+] 3.5-5.2 mmol/L) within 24 hours after administration of SZC or SPS in combination with insulin regular IV push. Methods: A multicenter, retrospective chart review (2020-2021) using electronic medical records at an academic health system. The study population included adult patients receiving one or more doses of SZC or SPS in combination with IV insulin for acute hyperkalemia (K+ >5.2 mmol/L). Patients receiving dialysis were excluded. Serum chemistries were assessed at baseline and an additional 2 values within 24 hours to determine normokalemia and hypokalemia at each follow-up. Results: Of 141 patients included, 51 received SZC and 90 received SPS. Normokalemia at the first follow-up was achieved in 51.0% of patients receiving SZC and 46.7% of patients receiving SPS (P = .622) and was sustained in 35.3%versus 44.4% (P = .289) of patients within 24 hours. Mean serum potassium differences from baseline to first follow-up were similar between SZC and SPS groups (0.9 mmol/L vs 1.0 mmol/L). Hypokalemia within 24 hours of administration occurred in 4 patients-1 in SZC, 3 in SPS. Conclusion: Both SZC and SPS yielded similar rates of normokalemia achievement with IV insulin for the treatment of acute hyperkalemia. Further prospective studies are needed to confirm these findings.

Comparison of Standard Versus Intermediate Prophylaxis Dose for Venous Thromboembolism Prophylaxis in Patients Hospitalized With COVID-19 Infection.

Background: COVID-19 infection is associated with a high risk of venous thromboembolism (VTE) events. VTE prophylaxis reduces the risk of these events. The optimal dose of VTE prophylaxis however remains uncertain. Objectives: To compare the incidence of VTE in patients treated with either standard dose VTE versus intermediate dose VTE prophylaxis. Methods: In this retrospective cohort study, we analyzed data from 1786 adult patients admitted into the hospital with polymerase chain reaction confirmed COVID-19 infection between April 2020 to September 2021. For analysis, patients were divided into 2 cohorts: either standard dose prophylaxis treatment group (patients who received either unfractionated heparin 5000units 3 times a day or enoxaparin 30-40 mg daily subcutaneously) or intermediate dose VTE prophylaxis group (patients received either unfractionated heparin 7500 units 3 times daily or enoxaparin 30-40 mg twice a day subcutaneously). The primary outcome was incidence of VTE events described as either deep vein thrombosis (DVT) or pulmonary embolism (PE). Secondary outcome was bleeding events. Results: During the study period, 398 (22%) patients were primarily treated with standard dose VTE prophylaxis, whereas 1388 (78%) patients were treated with intermediate dose VTE prophylaxis. There was a significantly higher incidence of venous thromboembolism events noted in the standard dose prophylaxis treatment group when compared with the intermediate dose prophylaxis group (25/398 (6.3%) vs 35/1388 (2.5%) P < .001, [Odds Ratio 2.6197, 95% confidence interval = 1.5482-4.4327]). Multivariable-adjusted logistic regression, adjusting for age, obesity, and smoking, with the intermediate dose prophylaxis treatment group as the referent category revealed higher odds for incident venous thromboembolism events in the standard dose prophylaxis group. There was no statistically significant difference in bleeding events between the 2 treatment groups (9 (2.3%) for standard dose prophylaxis group vs 46 (3.3%) for intermediate dose prophylaxis group P = .26). Conclusions: Among patients hospitalized with COVID-19 infection, patients receiving intermediate dose VTE prophylaxis experienced lower incident rates of venous thromboembolism events compared to those receiving standard dose VTE prophylaxis without a statistically significant increase in the risk of bleeding events.

The Abuse and Misuse of Over-the-Counter Medicines During COVID-19.

The abuse and misuse of OTC medicines is a common problem in community pharmacies and is expected to escalate during the COVID-19 pandemic. However, there is limited research on the patterns, causes, and consequences of these incidents during the pandemic. This article aims to provide evidence-based insights into the potential impact of COVID-19 on the abuse and misuse of OTC medicines, and suggest strategies for reducing these occurrences for pharmacy practitioners and healthcare managers.

Impact of Postsurgical Opioid Prescription Reduction in General Surgery Patients.

Purpose: Recent studies suggest a large percentage of post-surgical opioid prescriptions are not utilized. This surplus of opioids provides supply for diversion or entry into the waste cycle. Recommendations are available for general surgery procedures which may optimize prescribed quantity while maintaining patient satisfaction which this work was initiated to investigate. Methods: This retrospective patient survey was conducted with Institutional Review Committee approval following adjustments to discharge opioid prescription quantities in an individual General Surgeon practice. Patients were contacted via phone to assess the impact of the reduced opioid quantities. Patients were categorized based on whether they utilized the entire prescription or opioid remained. Data collected include baseline demographics, inpatient stay characteristics, opioid use patterns, and satisfaction with overall pain control. The primary endpoint was to determine if patients were satisfied with their pain control based on response. Secondary endpoints included if patient characteristics could be identified that signal larger opioid quantity use, and whether unused opioids were disposed. Results: Thirty patients utilized all opioid prescribed, 60 had some quantity remaining. Baseline data appear similar aside from age with younger patients using more opioid. Patients were satisfied with their overall pain control in 93% of respondents. A total of 960 opioid tablets (11.4 ± 4.8 tabs/patient) were not prescribed, 8% required refill. Opioid disposal yet to occur in 85% of patients. Conclusion: An evidence-based reduction in opioid discharge prescriptions following general surgery procedures resulted in nearly 1000 opioid tablets not being dispensed without having a negative impact on patient satisfaction.

Materiovigilance in Intensive Care Units: An Active Surveillance.

Background: Medical devices are the vital part of healthcare system. The use of medical devices is higher in the intensive care units leading to increased exposure rendering the exponential rise in incidence of medical device associated adverse events (MDAEs). Timely detection and reporting of MDAEs can help reduce the disease and associated liabilities. Objective: To determine the rate, patterns, and predictors of MDAEs. Methods: An active surveillance was carried out in the intensive care units (ICUs) of a tertiary care teaching hospital located in southern India. The patients were monitored for MDAEs which were reported based on MvPI guidance document 1.2. The predictors were calculated using an odds ratio at 95% confidence interval. Results: A total of 185 MDAEs were reported amongst 116 patients, of which the majority [74 (63.7%)] were males. Most of the MDAEs were attributed to urethral-catheters [42 (22.7%)] among which a high majority of 34 were associated with urinary tract infections (UTI), followed by ventilators [35 (18.9%)] with all events causing pneumonia. Urethral catheters and ventilators are both classified as categories B and C respectively based on device risk classification provided by the Indian Pharmacopoeia Commission (IPC). Over 58% of MDAEs were reported among the elderly. The causality assessment was possible for 90 (48.6%) MDAEs whereas 86 (46.4%) were probable. The majority of the MDAEs reported were serious [165 (89.2%)] and only [20 (10.8%)] were found to be non-serious on the severity scale. Most [104 (56.2%)] of the devices attributed to MDAEs were single-use devices, of which [103 (55.6%)] were destroyed and only [81 (43.7%)] were retained in healthcare facilities. Conclusions: Despite the best possible care in the intensive care units (ICUs), MDAEs are inevitable, adding to the burden of patients in terms of suffering, disease, extended hospital stay, and increased costs. MDAEs require rigorous monitoring of patients, especially in the elderly population and patients with increased exposure to multiple devices.

Impact of a Medication Reconciliation Pharmacist Program on Appropriateness of Community-Acquired Pneumonia Treatment Durations at Hospital Discharge.

Background: Antimicrobial stewardship programs have made large efforts to minimize the inappropriate use of antibiotics. Implementation of these programs can be challenging, since many institutions have limited resources. Utilizing resources that already exist may be beneficial, including medication reconciliation pharmacist (MRP) programs. This study aims to evaluate the impact of a MRP program on appropriateness of community-acquired pneumonia (CAP) treatment durations at hospital discharge. Methods: This study was a retrospective, observational, single-center study comparing the total days of antibiotic therapy for CAP in the preintervention period (9/2020-11/2020) versus the post-intervention period (9/2021-11/2021). Implementation of a new clinical intervention occurred between the 2 periods and included education to MRPs on appropriate CAP treatment durations and on documentation of recommendations. Data was collected utilizing a chart review of the electronic medical record of patients diagnosed with CAP using ICD-10 codes. The primary objective of this study was to compare the total days of antibiotic therapy in the pre-intervention period versus the postintervention period. Results: One-hundred fifty-five patients were included in the primary analysis. When observing total days of antibiotic therapy, there was no change from the pre-intervention period at 8 days compared to the postintervention period (P = .109). When analyzing antibiotic days of therapy at discharge, there was a decrease from 4.55 days in the preintervention period compared to 3.8 days in the post-intervention period (P = .109). The incidence of those with appropriate treatment durations, defined as 5 to 7 days of antibiotic therapy, was higher in the post-intervention period (26.5% in the pre-intervention group vs 37.9% in the post-intervention group, P = .460). Conclusions: There was a non-statistically significant decrease in median days of antimicrobial therapy for CAP at hospital discharge after implementation of a new clinical intervention targeting antibiotic days of therapy. Though median total antibiotic days of therapy were similar between both time periods, patients had an overall increase in incidence of appropriate duration of therapy, defined as 5 to 7 days, after intervention. Further studies are necessary to show how MRPs have a positive impact on improving outpatient antibiotic prescribing at hospital discharge.

Sugammadex Efficacy and Dosing for Rocuronium Reversal Outside of Perioperative Settings.

Background: Sugammadex is approved for postoperative recovery from rocuronium neuromuscular blockade with train-of-four (TOF) guided dosing. Data for non-perioperative sugammadex efficacy and dosing are limited when TOF is not available and reversal is not immediate. Objective: This study evaluated the efficacy, safety, and dose of sugammadex when administered in the emergency department (ED) or intensive care unit (ICU) for delayed rocuronium reversal when TOF guidance was not consistently available. Methods: This single-center, retrospective cohort study included patients over a 6-year period who received sugammadex in the ED or ICU at least 30 minutes after rocuronium administration for rapid sequence intubation (RSI). Patients who received sugammadex for intra-operative neuromuscular blockade reversal were excluded. Efficacy was defined as successful reversal documented in progress notes, TOF assessment, or improvement in Glasgow Coma Scale (GCS). Dose was evaluated in patients with successful reversal by correlating sugammadex and rocuronium dose with reversal time after paralysis. Results: Thirty-four patients were included with 19 (55.9%) patients receiving sugammadex in the ED. Sugammadex indication was acute neurologic assessment in 31 (91.1%) patients. Twenty-nine patients (85.2%) had successful reversal documented. The remaining 5 patients had fatal neurologic injuries with GCS 3 limiting non-TOF efficacy assessment. The median (IQR) sugammadex dose was 3.4 (2.5-4.1) mg/kg administered 89 (56.3-158) minutes after rocuronium. No correlation was identified between sugammadex dose, rocuronium dose, and administration time. No adverse events were noted. Conclusion: This pilot investigation demonstrated safe and effective rocuronium reversal with sugammadex 3 to 4 mg/kg administered in the non-operative setting 1 to 2 hours after RSI. Larger, prospective studies are necessary to determine the safety in patients outside of the operating room when TOF is not available.

Anticoagulation Prescribing Patterns in Intensive Care Unit Patients Admitted with Prehospital Direct Oral Anticoagulant Therapy: A Single Academic Center Experience.

OBJECTIVE: To describe the current prescribing practices of direct oral anticoagulants (DOACs) in intensive care unit (ICU) patients and the associated clinical outcomes, including the incidence of major bleeding episodes and the need for intervention (endoscopic, surgical, or interventional radiology guided). DESIGN: Observational, retrospective chart review. SETTING AND PARTICIPANTS: Single large academic center study. Participants included patients with critical illness who were admitted to the intensive care units (ICU) at Mayo Clinic from January 1st, 2012, until May 4th, 2018. Adult ICU patients with a DOAC (apixaban, rivaroxaban, dabigatran, or edoxaban) listed as one of the active medications at the time of hospital admission were included. RESULTS: 37 249 patients in medical and surgical intensive care units were screened for the study period. After excluding patients who did not qualify, 558 unique encounters were included. The median age was 69 (IQR 59-78) years; most patients were male, white Caucasians, and had a median SOFA score of 4. After excluding the patients who had major bleeding episodes in the first 24 hours, 188 (39%) were continued on the same DOAC therapy, 204 (42%) were discontinued without transitioning to another agent, and 95 (20%) were transitioned to another agent. Finally, 410 (84%) were dismissed on DOAC therapy at the end of hospitalization. The difference in the continuation rate of the same DOAC agent beyond 24 hours, discontinuation without transition to an alternate agent, or discontinuation of DOAC with a transition to an alternate anticoagulation agent was not statistically significant (P = .60). A total of 52 major bleeding events were identified. Gastrointestinal bleeding was the most common bleeding complication [n (%): 34 (65)], followed by intra-abdominal and peri-procedural bleeding [7 (13.5) and 7 (13.5)]. Thirty-three (65%) patients had a major bleeding complication requiring intervention. CONCLUSIONS: Our single-center retrospective study describes the current prescribing practices and preliminary outcomes in ICU patients with prehospital use of DOACs. Up to 20% of the patients were transitioned to a different agent within 24 hours of ICU admission, whereas a significant proportion of patients (42%) had anticoagulation discontinued altogether. Most patients who suffered a major bleeding episode required either endoscopic or surgical intervention to control bleeding.

Evaluation of the Quality and Safety of Venous Thromboembolism Prophylaxis Among Gastroenterology Inpatients at a Tertiary Hospital in Australia.

Background and objective: Hospital acquired venous thromboembolisms (VTEs) are common and preventable. The Queensland Health VTE prophylaxis guidelines, developed in 2018, provide guidance for risk assessment, and prescribing of anticoagulation for prophylaxis and treatment of hospital inpatients. Currently, there are limited recommendations for gastroenterology patients. This study investigated the completion of VTE risk assessments, and the appropriateness of VTE prophylaxis regimens, in accordance with Queensland Health guidelines for gastroenterology patients. The quality and safety of VTE prophylaxis regimens was assessed based on their VTE risk and bleeding risk. Method: A retrospective study was conducted by obtaining a random sample of gastroenterology patients admitted to a tertiary Australian hospital, from 1st May 2019 and 1st May 2020, to determine the compliance of VTE risk assessment and thromboprophylaxis prescribing with state-wide VTE guidelines. The quality and safety of thromboprophylaxis was evaluated using the modified Caprini and HASBLED scores, and subsequent thromboprophylaxis-related complications. Results: Of the 94 patients reviewed, 68 did not have contraindications to thromboprophylaxis. Of these 68 patients, 32 (47%) had no VTE risk assessment recorded in their clinical records and were not prescribed any thromboprophylaxis during the hospitalization. There was no significant difference between thromboprophylaxis prescribing for patients with low VTE risk, compared to moderate to high VTE risk (P = .075). There was a trend for decrease in thromboprophylaxis prescribing as HASBLED bleeding risk score increased, and patients with moderate-high bleed risk were less likely to be prescribed thromboprophylaxis (P = .006). There were no thromboprophylaxis related complications identified. Conclusion: It is essential that all patients have a clearly documented risk assessment and are prescribed thromboprophylaxis according to best practice guidelines. The prescription of venous thromboembolism prophylaxis should continue to be individualized, with each patient assessed holistically.

Opioid Use in Vaso-Occlusive Crisis During Intravenous Opioid Drug Shortage.

Introduction: In October 2017, the Food and Drug Administration announced a shortage of intravenous (IV) opioid medications. Patients with sickle cell disease (SCD) are particularly vulnerable, as high amounts of IV opioid medications are standard therapy during vaso-occlusive crises (VOC). Our institution responded to the crises by implementing IV to oral (PO) conversions of opioid therapies and encouraging multimodal pain management with non-opioid medications. Objectives: The primary objective was the assessment of IV opioid medication utilization before and during the shortage. Secondary objectives included total opioid consumption, length of stay, and prescribing of non-opioid analgesics. Methods: This single-institution retrospective study included patients >18 years of age admitted to adult medicine teams with VOC during February 2017 or February 2018. The amount of opioid medication administered to patients during both periods was assessed, and quantities were then converted to PO morphine milligram equivalents and compared between years. The number of patients receiving scheduled non-opioid medications were also compared. Length of stay and readmissions were compared between years. Results: Between 2017 and 2018, IV opioid use for VOC decreased by 52% on inpatient services, and there was a 34% reduction in overall opioid use. Oral opioid use more than doubled during the period (10.2% in 2017 vs 39.1% in 2018, P < .01). LOS between 2017 and 2018 (6 vs 6 days, P = .4774) and total number of ED visits (27 vs 8, P = .276) were similar. There were significantly fewer 30-day readmissions in 2018 versus 2017 (15 vs 28, P = .025). Conclusion: The implementation of IV opioid restrictions resulted in a decrease in IV opioid use in treatment of VOC in patients with SCD without causing increases in length of stay or readmissions. Oral opioids should be considered an option for VOC management in patients with SCD.

Assessing Nephrotoxicity Associated With Different Vancomycin Dosing Modalities in Obese Patients at a Community Hospital.

Background: Vancomycin requires therapeutic drug monitoring (TDM) based on its pharmacokinetic properties, and guidelines have shifted to analyzing area under the curve over 24 hours (AUC24) rather than trough concentrations due to nephrotoxicity concerns and correlation to efficacy. Obesity is an established risk factor for vancomycin-induced nephrotoxicity due to increased drug exposure based on dosing calculations and volume of distribution estimation. The aim of this study is to assess the relationship between AUC-based versus trough-based dosing and nephrotoxicity among obese patients receiving vancomycin. Methods: This research project was conducted as a retrospective, observational, single-centered study which included obese adults who received at least 48 hours of vancomycin. The electronic medical record provided data for patients with vancomycin pharmacokinetic consults either evaluated with trough-only or AUC-based dosing. The primary objective was to compare the development of nephrotoxicity after vancomycin initiation, while secondary objectives included vancomycin loading dose exposure, total daily dose of vancomycin, and whether target TDM was attained. Nominal data were evaluated utilizing the chi-square test and continuous data using the independent samples t-test or Mann-Whitney test. The a priori level of significance was .05. Data analysis was performed using Microsoft Excel and SAS statistical software. Results: Two hundred fifty-four patients were included in the primary analysis. Four patients in the AUC cohort (6.3%) developed nephrotoxicity compared to 32 (17.4%) in the trough cohort (P = .035). Both cohorts received a median of 4 days of therapy; however, the median loading dose per actual body weight in the AUC cohort was 20 mg/kg as compared to 16 mg/kg in the trough cohort. Of the 130 patients with available TDM in the trough cohort, 97 (74.6%) did not meet target attainment as compared to 15 of the 57 in the AUC cohort (26.3%) (P < .001). Conclusions: AUC dosing was associated with a statistically significant reduction in AKI occurrence despite overall higher loading dose exposure as compared to the trough cohort. Though maintenance dose exposure was similar between both cohorts, patients in the AUC cohort maintained therapeutic concentrations at a higher percentage than the trough cohort.

Retrospective Indication-Matched Cohort Study of Reference Product and Biosimilar: Bevacizumab Versus Bevacizumab-Awwb.

Introduction: Due to the abbreviated approval pathway and extrapolation to non-studied indications, an increased importance is placed on post-marketing surveillance of biosimilars to supplement existing evidence and enhance patient and provider confidence. Bevacizumab-awwb (ABP 215, Mvasi) was the first biosimilar approved to bevacizumab (Avastin), a recombinant humanized monoclonal IgG1 antibody that inhibits the vascular endothelial growth factor (VEGF). Purpose: To evaluate utilization, safety, and financial outcomes of bevacizumab-awwb compared to bevacizumab at a national cancer institute (NCI)-designated cancer center. Methods: A single center, retrospective, 1:1 indication-matched cohort study of adult patients who received bevacizumab or bevacizumab-awwb between October 1, 2019 and October 1, 2020 was performed. Thirty-four patients received bevacizumab-awwb during the study period and were matched by indication to 34 randomly selected patients who received bevacizumab. Indications for both groups included: colorectal cancer (n = 19), gynecologic cancer (n = 10), glioblastoma (n = 3), hepatocellular carcinoma (n = 1), and lung cancer (n = 1). Results: Baseline and medication utilization characteristics were similar for this indication-matched cohort of 68 patients receiving bevacizumab-awwb or bevacizumab. Patients in the bevacizumab group had a higher proportion of public payer coverage (64.7% vs 38.2%, P = .029). A higher proportion of patients in the bevacizumab-awwb group remained on active treatment at the end of the study period (52.9%) as compared to the bevacizumab group (35.3%); however, differences in final treatment status and reasons for discontinuation were not statistically significant (P = .218). Rates of worsened hypertension (44.1% vs 44.1%) and worsened proteinuria (38.2% vs 23.5%, P = .077) were common in both groups. Grade 3 adverse drug events in the bevacizumab group included: gastrointestinal perforation (n = 1), gastrointestinal bleed (n = 1), hypertension (n = 2), and venous thromboembolism (n = 2). Grade 3 adverse drug events in the bevacizumab-awwb group included: epistaxis (n = 1), gastrointestinal bleed (n = 1), hypertension (n = 1), intracerebral hemorrhage (n = 1), venous thromboembolism (n = 3), and arterial thromboembolism (n = 1). One patient in the bevacizumab-awwb group experienced grade 4 hypertension. Median drug cost per dose and per milligram for bevacizumab-awwb was less than bevacizumab, representing a 15.8% and 12.1% discount, respectively. Conclusion: Utilization and safety outcomes were similar for this indication-matched cohort of 68 patients receiving bevacizumab or bevacizumab-awwb across a wide range of disease states.

Prophylactic Enoxaparin in Critically Ill Trauma Patients: Evaluation of the Initial Dose.

Background: Trauma patients are at increased risk of developing venous thromboembolism given alterations in the coagulation cascade. Chemoprophylaxis with standard dosing of enoxaparin 30 mg subcutaneously twice daily has evolved to incorporate the use of anti-factor Xa (AFXa) trough level monitoring given concerns for decreased enoxaparin bioavailability in this patient population. Current available evidence suggests low rates of goal AFXa trough level achievement with standard enoxaparin dosing. Our study aims to identify the incidence of critically ill trauma patients that did not achieve goal AFXa trough levels and attempts to identify predictors that may influence the lack of achievement of goal levels. Methods: This was a retrospective, cohort analysis performed at a single academic medical center. Adult patients 18 years or older admitted to the surgical intensive care unit secondary to trauma who were initiated on standard prophylactic enoxaparin and had at least 1 AFXa trough level representative of steady state were included. Patient demographics and clinical data were collected, and descriptive statistics were utilized. All statistical tests were 2-tailed and a P < .05 was considered significant. Variables with a P < .10 on univariable analysis were included in a multivariable logistic regression analysis. Results: A majority of our patient population did not achieve goal AFXa trough levels while receiving standard doses of prophylactic enoxaparin (82.4% [108/131]). Sub-target AFXa levels were associated with higher creatinine clearance values. Positive predictors of obtaining target AFXa levels included automobile versus pedestrian mechanism of injury and requiring an enoxaparin dose escalation to at least 40 mg twice daily. Conclusions: Our study found low rates of achievement of goal AFXa trough levels in critically ill trauma patients receiving standard prophylactic enoxaparin dosing. Certain variables were identified as negative and positive predictors for achievement of goal AFXa trough levels, although the biologic plausibility of these predictors is questionable and requires further investigation.

Safety and Efficacy of Urea for Hyponatremia.

Background and Objective: Urea is an alternative for treatment of hyponatremia however, its use has not been widely studied. The purpose of this study was to evaluate the safety and efficacy of urea for the treatment of hyponatremia. Methods: A retrospective cohort of patients with hyponatremia (serum sodium <135 mEq/L) of any cause who received at least 1 dose of urea during hospitalization and no prior use of urea. Serum sodium levels were collected at baseline and for 4 days or until urea was discontinued, whichever occurred first. The primary outcome was the serum sodium change between baseline and discharge or urea discontinuation. Results: Median serum sodium increased 2 [IQR, 0-4] mEq/L per day after urea administration at a median dose of 30 g/day. A significant difference in serum sodium was observed between baseline and discharge or discontinuation (124.2 ± 4 vs 130.1 ± 5.1; P < .001) and serum blood urea nitrogen (BUN) levels (18.4 ± 13.1 vs 41.1 ± 26.6; P ≤ .001). Serum sodium overcorrection (increase >8 mEq/L in 24 hours) occurred in 6 patients (8%). Urea was discontinued in 39 patients (53%); 20 discontinuations were due to patient intolerance. Conclusion: Urea appears to be an effective treatment for hyponatremia; however, patient tolerance, the rate of serum sodium overcorrection, and outpatient affordability may limit its use.

Comparison of Patiromer to Sodium Polystyrene Sulfonate in Acute Hyperkalemia.

Background: Patiromer and sodium polystyrene sulfonate (SPS) are cation-exchangers approved for the treatment of chronic hyperkalemia. Data regarding their efficacy acutely is lacking. Despite this, both drugs are frequently used in the emergent setting. Objective: The purpose of this study was to compare the potassium reduction of patiromer to SPS within 6 to 24 hours following a single dose. Methods: This retrospective quality improvement project included hyperkalemic patients receiving 1 dose of patiromer or SPS and had a second potassium level drawn in 6 to 24 hours. Doses of 8.4 g of patiromer and 15 g of SPS were considered "low dose" while 16.8 g of patiromer and 30 g of SPS were considered "high dose." The presence of a dose-response relationship was assessed through a linear regression analysis. Results: Mean (SD) potassium reduction was higher in SPS than patiromer [0.76 (0.63) mEq/L vs 0.32 (0.65) mEq/L, (P = .001)]. A dose response relationship was not demonstrated in low versus high dose groups [-0.21 (0.14), P = .13] and CKD, ESRD, and renal transplant patients when compared to patients with normal renal function [0.11 (0.17), P = .51, -0.07 (0.19), P = -0.07 (0.19), P = .73, and -0.10 (0.22), P = .65]. Conclusions: This study suggests a clinically significant reduction in potassium with SPS compared to patiromer. Although SPS was successful in demonstrating this outcome, due to well-documented adverse reactions in the literature and a time to onset of 6 hours, it cannot be recommended for use in acute hyperkalemia either.

Exploring Cost Savings with Specialty Biologic Drugs Administered to Adult Inpatients with Inflammatory Bowel Disease.

Background: Specialty infusion and self-injectable biologic drugs for the treatment of inflammatory bowel disease (IBD) are high-cost medications. When administered to hospital-admitted patients, these medications are not reimbursed on an individual basis but rolled into a per diem payment by most payers in the United States (US). Therefore, choosing to administer these medications in the inpatient setting may reveal negative financial implications for some health care institutions. Selecting an alternative site of care to administer these medications during the clinical management process may lead to cost savings. Objective: Review the clinical necessity of inpatient specialty biologic administrations for the treatment of IBD to identify and quantify potential cost saving opportunities. Methods: Using patient medical records at a US academic medical center, we retrospectively identified inpatient administrations of specialty infusion and self-injectable biologic medications for IBD treatment from June 1, 2016 to May 31, 2017. Guided by a standardized form, an evaluation team consisting of 3 of the investigators determined the clinical necessity of each specialty biologic medication administration within the inpatient setting. Costs and reimbursement rates for administration in both the inpatient and outpatient settings were procured and tabulated. Results: Seventeen inpatient specialty biologic administrations for IBD during the 12 month study period were identified. Of these, 11 administrations were given for the treatment of Crohn's disease (CD) and 6 for ulcerative colitis (UC). The evaluation team determined that 65% of these administrations were clinically necessary as inpatient administrations, and that 35% were not. The sum of the wholesale acquisition costs (WAC) for clinically necessary inpatient biologic administrations totaled $54 737, and the WAC for those administrations deemed not clinically necessary totaled $43 702. Further analysis of administration events revealed that the institution could have realized an estimated $13 817 in additional revenue above the cost of the drug if eligible inpatient biologic administrations had been received in the institution's outpatient clinic setting instead. Conclusion: Administering specialty biologic drugs for the treatment of IBD in the care setting best aligned with existing reimbursement structures may lead to institutional cost savings.

Is P&T Ready to Add Rapid Cycle Analytics to Formulary?

Purpose: The intent of this article is to evaluate a novel approach, using rapid cycle analytics and real world evidence, to optimize and improve the medication evaluation process to help the formulary decision making process, while reducing time for clinicians. Summary: The Pharmacy and Therapeutics (P&T) Committee within each health system is responsible for evaluating medication requests for formulary addition. Members of the pharmacy staff prepare the drug monograph or a medication use evaluation (MUE) and allocate precious clinical resources to review patient charts to assess efficacy and value. We explored a novel approach to evaluate the value of our intravenous acetaminophen (IV APAP) formulary admittance. This new methodology, called rapid cycle analytics, can assist hospitals in meeting and/or exceeding the minimum criteria of formulary maintenance as defined by the Joint Commission Standards. In this particular study, we assessed the effectiveness of IV APAP in total hip arthroplasty (THA) and total knee arthroplasty (TKA) procedures. We assessed the correlation to same-stay opioid utilization, average length of inpatient stay and post anesthesia care unit (PACU) time. Conclusion: We were able to explore and improve our organization's approach in evaluating medications by partnering with an external analytics expert to help organize and normalize our data in a more robust, yet time efficient manner. Additionally, we were able to use a significantly larger external data set as a point of reference. Being able to perform this detailed analytical exercise for thousands of encounters internally and using a data warehouse of over 130 million patients as a point of reference in a short time has improved the depth of our assessment, as well as reducing valuable clinical resources allocated to MUEs to allow for more direct patient care. This clinically real-world and data-rich analytics model is the necessary foundation for using Artificial or Augmented Intelligence (AI) to make real-time formulary and drug selection decisions.

A Focus on Evaluating Major Study Limitations in Order to Apply Clinical Trials to Patient Care: Implications for the Healthcare Team.

Background: With more than a million new biomedical articles published annually, healthcare providers must stay up to date in order to provide optimal evidence-based patient care. The concise ROOTs (relevance, observe validity, obtain clinically significant results, and translate results to clinical practice) format is a valuable tool to assist with literature evaluation. Purpose: To illustrate how major study limitations found in clinical trials might inhibit the ability to adopt the findings of such studies to patient care. Methods: Examples from published clinical trials that contain major study flaws were used to illustrate, if taken at face value, would lead to erroneous assumptions, and if adopted, could potentiallly harm patients. Conclusion: When evaluating the literature, it is crucial to identify limitations in the published literature that might reduce the internal validity, affect the results, or limit the external validity of clinical trials, hence affecting the usability of literature for patient care. This article provides examples of clinical trials that contain major study limitations with potentially erroneous assumptions. These illustrations are meant to show how important it is to delve deeper into an article before conclusions are drawn.

Inpatient Perioperative Formulary Restriction of Intravenous Acetaminophen at Vizient Partner Hospitals: A National Survey of Pharmacists.

Purpose: Despite potential benefits of intravenous (i.v.) administration of acetaminophen (APAP), consistent outcome data are lacking. This, combined with the higher acquisition cost of the drug, has led to variation in i.v. APAP management strategies. This project evaluated the contemporary formulary status and restrictions of i.v. APAP in the perioperative setting. Methods: A survey focusing on i.v. APAP formulary restriction in the perioperative setting was developed by the Vizient Pharmacy Research Committee and distributed to Vizient Pharmacy Program participant listservs for Pharmacy Directors or Drug Information Pharmacists. The four survey domains included hospital characteristics, perioperative i.v. APAP formulary status and prescribing restrictions, perioperative i.v. APAP use, and perioperative i.v. APAP medication use evaluation (MUE) results. Responses were collected and summarized, and primary outcomes were evaluated using Fisher's exact test. Results: A total of 1195 surveys were distributed with a response rate of 19%. Respondents were equally distributed between academic medical centers (AMC) and non-academic medical centers (non-AMC). Two cohorts were examined: those with i.v. APAP on formulary and those without. The non-AMCs showed a larger proportion of hospitals with the medication on formulary (P = .041). Regarding formulary decision-making, the AMCs were more considerate of value. Several different practices were employed to limit or restrict i.v. APAP. Conclusion: A survey of directors of pharmacy and drug information specialists revealed that the majority of hospitals have i.v. APAP on formulary for perioperative use, but use is restricted. Differences in i.v. APAP formulary practices between AMCs and non-AMCs warrant further consideration.