Hospital Pharmacy最新文献

Background: Andexanet alfa (AA), a recombinant coagulation factor Xa, is approved as an antidote for the treatment of bleeding secondary to rivaroxaban and apixaban. While thromboembolism may serve as a risk with reversal of therapeutic anticoagulation, several landmark trials demonstrate higher rates with AA versus usual care.

Objective: The purpose of this study was to identify independent patient-specific and hospital-associated risk factors corresponding to the development of thrombus in patients who have received AA.

Methods: This was a retrospective cohort study conducted across six institutions comprised of academic and community settings. Patients aged 18 years and older who received AA from November 1, 2021 through June 30, 2024 during an inpatient hospitalization were included. The primary outcome evaluated the presence of select risk factors on thrombus development within 45 days of AA administration.

Results: One hundred thirty-eight patients met inclusion criteria. Identification of thrombus occurred in 19/138 (13.8%) after receiving AA. Of the risk factors evaluated, a multivariate analysis demonstrated major surgery within 30 days of reversal (OR 3.72, 95% CI: 1.14-12.08, P = .03) served as a strong predictor for the development of thrombus after AA administration.

Conclusion: A strong association existed between major surgery within 30 days and thrombotic complications following AA administration. Larger studies are needed to validate these findings and refine risk stratification post-AA administration.

Objective: To analyze and evaluate adverse drug event (ADE) signals for two GC-C receptor agonists, Linaclotide and Plecanatide, thereby enhancing understanding of their clinical safety.

Methods: Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023. Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).

Results: A total of 12 275 ADE reports for Linaclotide and 811 for Plecanatide were retrieved, resulting in 28 123 and 2230 ADE signals, respectively, across 24 and 19 System Organ Classes (SOCs). Both drugs predominantly exhibited gastrointestinal ADEs, including abdominal pain, bloating, and diarrhea. Linaclotide was associated with signals for urinary retention, incontinence, and bladder pain, which are not documented in its prescribing information. Plecanatide demonstrated signals for muscle spasms and sleep disorders, also absent from its instructions. Additionally, both drugs revealed signals related to water and electrolyte disorders.

Conclusion: Clinical utilization of GC-C receptor agonists should take into account not only the prevalent gastrointestinal ADEs but also emerging signals associated with the urinary system, metabolic and nutritional disorders, and the nervous system. A comprehensive understanding of these signals is essential for evaluating medication risks and ensuring appropriate drug administration.

Background: Pharmacokinetic and pharmacodynamic optimization of β-lactams, including meropenem, using extended infusion are recommended by contemporary guidance to overcome elevated MICs and high interpatient pharmacokinetic variability associated with severe illness. Logistical challenges including drug stability must be considered when employing extended infusion meropenem. Although meropenem stability has been determined in a variety of settings to allow for extended infusion, confirmation for use of ready to use dispensing devices would be of interest. The purpose of this study was to assess meropenem concentrations using commercially available 2 g vials when diluted in 100 mL normal saline prepared via addEASE connectors.

Methods: Five replicate bags were prepared and sampled at 0, 1, 2, 3, 4, 5, and 6 hours. Samples were stored frozen at ~-70ºC until meropenem concentrations determination using validated HPLC-UV and LC-MS/MS methods. Stability was defined as >90% recovery at the individual time point relative to the 0-hour concentration.

Results: Starting concentrations were similar across all five replicates with an average (range) of 21.2 (20.2-21.9) and 19.4 mg/mL (17.7-20.5 mg/mL) for HPLC-UV and LC/MS-MS, respectively. No time point resulted in < 90% meropenem recovery from the starting concentration as determined by either assay method.

Conclusion: These data demonstrated meropenem concentrations using 2 g vials diluted in 100 mL normal saline when prepared using addEASE connectors remained >90% of the initial concentration over 6 hours at room temperature. This supports extended infusion administration of meropenem per contemporary guidance when prepared using this methodology. Since this method allows storage of doses in automated dispensing cabinets and bedside preparation, this may streamline pharmacy workflows and potentially reduce time to administration.

Objectives: The objectives of this case report are to describe the hospitalization of a patient due to a preventable adverse event caused by dulaglutide after restarting therapy following a previous hospitalization where it was held, and to summarize suggested guidance on managing glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) during transitions of care.

Case summary: A 70-year-old female was admitted with epigastric pain that began a week before admission. One month prior, she was hospitalized for chest pain and diagnosed with a left anterior descending artery occlusion, requiring a 3-vessel CABG. The pharmacy transitions of care service discovered that during her prior stay, she missed 2 doses of dulaglutide and resumed it at the previous dose of 4.5 mg on discharge. After a comprehensive workup, she was diagnosed with gastritis. Her pain improved over the course of 4 days, and she was discharged with instructions to hold the dulaglutide upon discharge and consult her primary care physician for re-titration.

Conclusion: This case highlights the need for clearer guidance on the reinitiation of GLP-1 RAs after missed doses while in the hospital. Using available literature, algorithms were generated to provide recommendations when more than 1 weekly GLP-1 RA dose is missed. These algorithms provide guidance for providers during transitions of care and may be studied prospectively to validate their application in a real-world setting.

Introduction: The ability to obtain a quantitative drug level for apixaban and rivaroxaban exists using drug-specific calibrated anti-Xa assays; however, no standard exists defining when to obtain direct oral anticoagulant (DOAC) concentrations or how to adjust medication regimens based on the results.

Objective: Describe the incidence of DOAC levels obtained, identify trends in prescribing DOAC levels in clinical practice, and qualitatively assess level appropriateness and actions taken based on level results.

Methods: A qualitative, retrospective analysis was conducted using the electronic medical record to identify adult inpatients within a 10-hospital health system with a calibrated apixaban or rivaroxaban anti-Xa level result from April 1, 2020, to November 1, 2022. The primary endpoint was the incidence of DOAC levels drawn. Secondary outcomes included the percentage of DOAC concentrations that prompted a dose change, association between dose or agent change and concentrations outside the on-therapy range, and association between indication for obtaining DOAC levels and resultant concentrations.

Results: One-hundred thirty-two calibrated anti-Xa levels were obtained in 101 inpatients during the study period, representing a level drawn in 0.48% of all apixaban and rivaroxaban orders. Eighty-three (63%) patients were on apixaban. Primary reasons to draw DOAC levels were extreme body weight (35%), treatment failure concerns (23%), bleeding concerns (18%), and drug interactions (14%). Only 42 (31.8%) of all levels were drawn appropriately as a peak. Seventeen (40.4%) of the peak levels were within the on-therapy range. Of the 25 levels outside the on-therapy range, 14 (56%) resulted in no change in therapy. For all levels drawn, 70 (53%) resulted in no change to therapy.

Conclusions: DOAC concentrations are often drawn at inappropriate times and seldom influence a dose or agent change. Future research is needed to determine if DOAC concentrations may be clinically meaningful in a select subgroup of patients.