B. Braun Inc.

Cefazolin, a first-generation cephalosporin, has been used for decades for surgical site infection prophylaxis as well as for treatment for a variety of infections. Little data is available on dosing in obese individuals or those weighing ≥120 kg. The objectives of this analysis were to obtain a better understanding of cefazolin in these patients by conducting a literature search to gather available information on the safety and pharmacokinetics (PK) of high doses of cefazolin in obese individuals. Additionally, a previously-developed population PK model was assessed using the data from patients enrolled in a Phase 1 study who weighed ≥120 kg. Model-based simulations were also conducted to confirm the appropriateness of a 3 g dose in those weighing ≥120 kg. The literature search revealed that cefazolin was well-tolerated at high doses, and that patients weighing ≥120 kg demonstrated PK differences in protein binding, clearance, and volumes of distribution compared to those <120 kg. The previously-developed 2-compartment population PK model required no refinements and provided a robust fit to the data. The model-based simulations indicate that a 3 g dose in patients weighing ≥120 kg provides more consistent exposure than a 2 g dose relative to observed and simulated normal weight (60–120 kg) patients administered 2 g. These results suggest that a 3 g dose, recently approved by the FDA, is more appropriate than the FDA-approved 2 g dose for surgical prophylaxis in patients with body weight ≥ 120 kg in both adults and children aged 10 to 17 years.

Introduction/Rationale for Study: This retrospective, observational analysis evaluated real-world hazardous drug (HD) surface wipe test data collected from U.S. healthcare facilities following implementation of a closed-system transfer device (CSTD). Methods: Wipe test submissions collected between 2018 and 2022 were analyzed to characterize the frequency, magnitude, and distribution of HD contamination across hospital systems, care locations, and drug analytes under routine clinical practice conditions. Although pre-implementation (baseline) wipe data were not available, this analysis reflects real-world effectiveness of CSTD use in minimizing detectable HD surface contamination within participating facilities. Results: Among 5531 wipe samples analyzed, 4.45% demonstrated measurable contamination, with the majority originating from two hospital systems. Higher contamination frequencies were observed in patient administration rooms and infusion areas compared with other locations, with 5-fluorouracil demonstrating higher contamination frequency relative to other analytes. Conclusion: An independent statistical analysis corroborated the initial Sponsor findings, confirming that using the CSTD significantly minimizes contamination and the potential for HD exposure risks. Variability in contamination across facilities and locations highlights the need for standardized cleaning protocols and clear standards for acceptable limits in hazardous drug handling. Overall, these data provide insight into HD contamination patterns observed during routine clinical use of a CSTD and support continued optimization of handling practices, along with prospective studies employing standardized wipe protocols and pre/post implementation designs.

PURPOSE:To assess the comprehensive workflow and time and motion activities associated with hospital pharmacy and nursing staff for a cephalosporin antibiotic in 3 different marketed formulations: (1) a formulation prepared by traditional compounding, (2) a dual-chamber IV bag stored with prefilled diluent in the upper chamber and powdered drug in the lower chamber, and (3) a standard diluent container with an integrated drug vial adaptor that allows for drug admixture after connection to a single-dose powdered drug vial. METHODS:The study was conducted at 3 hospital locations from a single hospital network located in Arkansas. Study procedures were assessed by direct observations of pharmacists, pharmacy technicians, and nurses. Sequences and durations of tasks were observed to identify and document the actual time for each task. RESULTS:Approximately 402 observational hours of data collection occurred, with more than 100 formulated doses observed per formulation, with 98.6% overall study confidence. Use of the dual-chamber IV bag formulation resulted in a 63% decrease in labor time compared to traditional compounding. When comparing the dual-chamber IV bag formulation to the standard diluent formulation, there was about a 22% decrease in labor time. Based on the number of process steps, use of the dual-chamber formulation resulted in approximately 54% fewer opportunities for error versus traditional compounding and 35% fewer opportunities for error than use of the standard diluent formulation. CONCLUSION:Independent descriptive statistical analysis verified that the dual-chamber IV bag cephalosporin antibiotic formulation is a faster, simpler-to-use drug administration platform and associated with less chance of formulation and dosing errors.

Peripheral intravenous catheter (PIVC) insertion is among the most common hospital procedures worldwide, yet first-attempt success rates remain inconsistent. Difficult intravenous access (DIVA), defined as two or more failed attempts combined with non-visible or non-palpable veins or a history of difficult access, is linked to treatment delays, vessel trauma, patient anxiety, and higher costs of care. Patients at greatest risk include those with obesity, chronic illness, prior DIVA, intravenous drug use, and advanced age. The impact of DIVA extends beyond procedural challenges. Repeated failures contribute to unnecessary central line use, increased supply consumption, and diminished patient trust, while also influencing hospital performance metrics tied to patient experience and reimbursement. Evidence supports early identification of at-risk patients and structured intervention as key to improving outcomes. Risk assessment tools, escalation pathways, and vein visualization technologies such as ultrasound and near-infrared imaging improve first attempt success and reduce complications. Longer PIVCs and midline catheters further support vessel preservation in appropriate patients. This position paper, endorsed by the Association for Vascular Access (AVA) outlines the scope and consequences of DIVA in hospitalized adult populations and proposes a comprehensive, evidence-based framework to support earlier recognition and more effective vascular access planning. Key strategies include use of validated risk assessment tools, structured escalation pathways, vein visualization technologies such as ultrasound, and device selection guided by vessel health and preservation principles. The paper also emphasizes the importance of patient-centered communication, clinician education and competency validation, and integration of documentation and clinical decision support tools within the electronic medical record. Together, these practices aim to improve first-attempt success, preserve vascular access sites, enhance patient experience, reduce complications, and promote more efficient use of healthcare resources. Implementing a standardized approach to DIVA supports both safer clinical care and better patient outcomes.