Corticosteroids for the management of immune-related adverse events in patients receiving checkpoint inhibitors.

INTRODUCTION: Due to enhanced T-cell activity, immune checkpoint inhibitors cause immune-related adverse effects. Corticosteroids are the mainstay of immune-related adverse effect management but the optimal strategy has not been determined, putting patients at risk for steroid-related adverse effects and potentially decreased efficacy of immunotherapy. This study aims to characterize the use of corticosteroids for the management of immune-related adverse effect. METHODS AND MATERIALS: A retrospective, single-center evaluation of patients receiving checkpoint inhibitors was conducted. The primary objective was to evaluate corticosteroid use for immune-related adverse effects, including starting dose, taper strategy, total duration, and resumption of immunotherapy. Secondary objective was to describe the incidence and significance of hyperglycemia. RESULTS: One hundred and three patients met inclusion criteria and experienced 123 immune-related adverse effects. Prednisone was used most commonly (67%) at an average starting dose of 0.88 mg/kg (range 0.07-17.0). On average, steroid tapers began 9.2 days after initiation (range 0-89) and were continued for a total of 84.2 days (range 3-693). In 21.1% of cases, checkpoint inhibitor therapy was not delayed and 68.6% resumed checkpoint inhibitors, while the patient was taking steroids (30.4 mg prednisone on average, range 5-80). On average, checkpoint inhibitor therapy was resumed 18.6 days after detection of immune-related adverse effect (range 0-150). Clinically relevant hyperglycemia occurred in 8.9%. CONCLUSION: Utilization of steroids for immune-related adverse effect at our institution is highly variable. The majority of patients received prolonged courses of steroids and resumed checkpoint inhibitor therapy with concomitant steroids above recommended doses. Additional monitoring for hyperglycemia and other steroid associated adverse effects should be considered.

Effects of a hospitalwide pharmacy practice model change on readmission and return to emergency department rates.

PURPOSE: The impact of an innovative medication reconciliation and discharge education program on 30-day readmissions and emergency department (ED) visits was evaluated. METHODS: An observational pre-post analysis was conducted at an academic medical center to compare rates of hospital readmissions and return to ED visits during three-month periods before and after implementation of a restructured pharmacy practice model including (1) medication reconciliation at transitions of care for every patient and discharge education for a high-risk subgroup, (2) new or expanded services in the preanesthesia testing clinic and ED, (3) a medication reconciliation technician team, and (4) pharmacist-to-patient ratios of 1:30 on acute care floors and 1:18 on critical care units. The primary outcome was the composite of rates of readmissions and return to ED visits within 30 days of discharge. RESULTS: A total of 3,316 patients were included in the study. Pharmacy teams completed medication reconciliation in 95.8% of cases at admission and 69.7% of cases at discharge. Discharge education was provided to 73.5% of high-risk patients (defined as those receiving anticoagulation therapy or treatment for acute myocardial infarction, chronic obstructive pulmonary disease, congestive heart failure, or pneumonia). No significant difference was observed between the preimplementation and postimplementation groups with regard to the primary outcome. In the high-risk subgroup, there was a significant reduction in the 30-day rate of hospital readmissions, which declined from 17.8% to 12.3% (p=0.042); cost projections indicated that this reduction in readmissions could yield annual direct cost savings of more than $780,000. CONCLUSION: Implementation of a team-based pharmacy practice model resulted in a significant decrease in the rate of 30-day readmissions for high-risk patients.

Evaluation and implications of natural product use in preoperative patients: a retrospective review.

BACKGROUND: Medication Reconciliation and Medication Safety are two themes emphasized in a variety of healthcare organizations. As a result, health care facilities have established methods for obtaining a patient's medication history. However, these methods may vary among institutions or even among the health care professionals in a single institution, and studies have shown that patients are reluctant to disclose their complementary and alternative medicine use to any health care professional. This lack of disclosure is important in surgical patients because of potential herbal interactions with medications and drugs used during the surgical procedure; and the potential for adverse reactions including effects on coagulation, blood pressure, sedation, electrolytes or diuresis. Therefore, the objectives of this study are to identify patterns of natural product use, to identify potential complications among patients scheduled for surgery, to improve existing medication reconciliation efforts, and to develop discontinuation guidelines for the use of these products prior to surgery. METHODS: A retrospective review of surgery patients presenting to the Anesthesia Preoperative Evaluation Clinic (APEC) at the University of Kansas Hospital was conducted to identify the prevalence of natural product use. The following data was collected: patient age; gender; allergy information; date of medication history; number of days prior to surgery; source of medication history; credentials of person obtaining the history; number and name of prescription medications, over-the-counter medications and natural products; and natural product dosage. Following the collection of data and analysis of the most common natural products used, possible complications and interactions were identified, and a protocol regarding the pre-operative use of natural products was developed and implemented. RESULTS: Approximately one-fourth of patients seen in the APEC indicated the use of natural products. Patients taking natural products were significantly older, were more likely to undergo cardiac or chest surgery, and were more likely to be taking more prescription and non-prescription medications (all p < 0.001). CONCLUSION: Based on the results of this study, it is concluded that there is a need for established guidelines regarding discontinuation of selected natural products prior to surgery and further education is needed concerning the perioperative implications of natural products.

Risk-stratified evaluation of amiodarone to prevent atrial fibrillation after cardiac surgery.

BACKGROUND: Amiodarone prophylaxis (AMP) reduces the prevalence of postoperative atrial fibrillation (POAF) after cardiac surgery. We investigated the impact of AMP on the frequency and duration of POAF, the intensive care unit and hospital length of stay, and its cost-effectiveness in a risk-stratified cohort. METHODS: A retrospective, observational analysis of 509 patients who underwent cardiac surgery in 2003 was performed. Data sources included The Society of Thoracic Surgeons national database; medical and medication administration records; and the activity-based cost data from our institution. Risk stratification for POAF was determined using a validated risk index. Cost-effectiveness was determined from the hospital's perspective. RESULTS: The mean patient age was 63 years, 27% were female, 80% underwent coronary artery bypass grafting, and 29% underwent valve surgery. When a risk-stratified evaluation was made, 50% of patients were at an elevated risk for having POAF develop. When compared with nonprophylaxed patients, those receiving AMP (59%) experienced less POAF (31% vs 22%; p = 0.027) and shorter durations of POAF (4.7 vs 2.7 days; p = 0.025). In the elevated-risk group, AMP clinically (but not significantly) reduced length of stay in the intensive care unit (101 vs 68 hours; p > 0.05) and post-procedural hospital length of stay (9.7 vs. 7.9 days, p > 0.05). In the elevated-risk group, AMP was robustly cost-effective in reducing POAF. CONCLUSIONS: Amiodarone prophylaxis reduced the prevalence and duration of POAF. Baseline risk for POAF was a major determinant of the overall cost-effectiveness of AMP. The greatest cost savings with AMP was seen in patients at an elevated risk for POAF. These findings suggest the need for risk stratification when prescribing AMP.