A Safety Analysis of Programmed Death 1 Pathway Inhibitors in Patients With Solid Tumor Malignancies and Preexisting Autoimmune Disease.

OBJECTIVE: The aim of this study was to characterize the safety of programmed death 1 inhibitors in patients with preexisting autoimmune disease. METHODS: A medical records review study was conducted on adults with solid tumor malignancies who received ≥1 dose of pembrolizumab or nivolumab at Emory Healthcare from September 4, 2014 until December 31, 2019. All autoimmune patients were included (n = 77), whereas the nonautoimmune patients were randomized and the first 156 patients were included in a 2:1 ratio to autoimmune patients. The primary objective was the comparison of incidence of immune-related adverse events (irAEs) between patients with preexisting autoimmune disease and those without. Secondary objectives included irAE characterization, irAE treatment, and survival analyses. RESULTS: Preexisting autoimmune disease was controlled in all of the autoimmune patients before immunotherapy initiation. The rate of irAE was 32.7% in the nonautoimmune group and 42.9% in the autoimmune group (odds ratio, 0.65; 95% confidence interval, 0.37-1.14; p = 0.130). In the patient population diagnosed with a rheumatologic autoimmune disease, 23.81% of irAEs were considered to be a flare of their preexisting autoimmune disease. Less patients in the autoimmune group experienced a grade ≥3 irAE (21.21% vs 37.25%, p = 0.379) and received systemic corticosteroids (54.55% vs 67.35%, p = 0.241) for the treatment of the irAE. CONCLUSIONS: These results suggest that pembrolizumab and nivolumab can be safely administered in patients with controlled preexisting autoimmune diseases without a significant increase in irAE compared with patients without autoimmune diseases. Inclusion of patients with preexisting autoimmune diseases in prospective clinical trials is warranted.

Evaluation of density variations to determine impact on sterile compounding.

PURPOSE: To determine the density variation between (1) the measured density and manually calculated density, (2) density variation of different lots, and (3) density variation of different drug manufacturers in order to support institutions using gravimetric compounding methods. SUMMARY: Seventeen sterile injectable ingredient (drug) vials frequently used to make compounded sterile products (CSPs) were identified based on the ability to ensure that for each drug there were vials produced by 2 different manufacturers and 2 lots produced by the same manufacturer. Each drug's density was measured using a density meter and by manual calculation using the institution's density formula. Density differences were compared between the 2 different methods. Overall, the average drug density difference between the measured versus calculated density was determined to be 0.022. Further analysis revealed the average difference between the different lot numbers of the same manufacturers was 0.005 for the nonhazardous drugs and 0.0001 for the hazardous drugs. The average difference between the different manufacturers of the same drug was determined to be 0.008 for the nonhazardous drugs and 0.001 for hazardous drugs. CONCLUSION: No clinically meaningful difference exists when manually calculating a drug's density compared to measuring a drug's density using a density meter. In addition, there does not appear to be a sizeable density variation between the same drugs in separate lots or produced by different manufacturers.

Multicenter study to evaluate the benefits of technology-assisted workflow on i.v. room efficiency, costs, and safety.

PURPOSE: The benefits of technology-assisted workflow (TAWF) compared with manual workflow (non-TAWF) on i.v. room efficiency, costs, and safety at hospitals with more than 200 beds are evaluated. METHODS: Eight hospitals across the United States (4 with TAWF, 4 without) were evaluated, and the characteristics of medication errors and frequency of each error type were measured across the different institutions. The average turnaround time per workflow step and the cost to prepare each compounded sterile preparation (CSP) were also calculated, using descriptive statistics. RESULTS: The TAWF hospital sites detected errors at a significantly higher rate (3.13%) than the non-TAWF hospital sites (0.22%) (p < 0.05). The top error reporting category for the TAWF sites was incorrect medication (63.30%), while the top error reporting category for the non-TAWF sites was incorrect medication volume (18.34%). Use of TAWF was associated with a preparation time decrease of 2.82 min/CSP, a compounding time decrease of 2.94 min/CSP, and a decrease in overall cost to prepare of $1.60/CSP. CONCLUSION: The use of TAWF in the i.v. room was associated with the detection of 14 times more errors than the use of non-TAWF, demonstrating different frequency of error in the results. TAWF also led to a faster preparation time that had a lower cost for preparation.

Multicenter study to evaluate the benefits of technology-assisted workflow on i.v. room efficiency, costs, and safety in small community hospitals.

PURPOSE: To evaluate the benefits of technology-assisted workflow (TAWF) compared to manual workflow (non-TAWF) on i.v. room efficiency, costs, and safety at community hospitals with less than 200 beds. METHODS: Four hospitals in the United States (2 with and 2 without TAWF) were evaluated, and characteristics of medication errors and frequency of each error type were measured across the institutions. The average turnaround time per workflow step and cost to prepare each compounded sterile product (CSP) were also calculated. The results were evaluated using descriptive and inferential statistics. RESULTS: The TAWF hospital sites detected errors at a significantly higher rate (3.78%) compared to the non-TAWF hospital sites (0.13%) (p < 0.05). The top error-reporting category for the TAWF sites was incorrect medication (71.66%), whereas the top error-reporting category for the non-TAWF sites could not be determined because of the small number of errors detected. Use of TAWF may be associated with a decrease in turnaround time and a decrease in overall cost to prepare a CSP. CONCLUSION: Significantly more errors were detected in small community hospitals that use TAWF in the i.v. room compared to those not using it. There were differences in error types observed between technology and nontechnology groups. The use of TAWF was associated with faster preparation times and lower costs of preparation per CSP.