A pharmacy-led United States Pharmacopeia (USP) chapter 800 compliance collaborative at an academic medical center.

PURPOSE: One academic medical center's efforts to move toward compliance with requirements of United States Pharmacopeia (USP) chapter 800 through a multidepartmental collaborative initiative are described. SUMMARY: Requirements of USP general chapter 800 (enforceable as of December 2019) address the handling of hazardous drugs (HDs) throughout the entire operational and clinical cycle, from receiving to compounding, administration, and waste disposal. Due to the variety of pharmacy operational areas in which HDs are encountered at University of North Carolina Medical Center (UNCMC), multiple pharmacy managers oversee the safe handling of HDs. To determine baseline compliance with USP chapter 800 requirements, a common assessment tool was developed to ensure a standardized approach to compliance assessment in all areas. An interdepartmental workgroup was created to ensure institutionwide support for a collaborative compliance initiative, a uniform understanding of compliance risks, and robust action planning. UNCMC has taken a number of steps toward USP chapter compliance in areas such as engineering controls, environmental quality and controls, use of personal protective equipment, hazard communication programs, personnel training, spill control, and medical surveillance. CONCLUSION: Achieving USP chapter 800 compliance presented several operational, clinical, and financial challenges for the medical center, requiring months of preparation and diligence by the hospital leadership. The pharmacy department-led compliance collaborative allowed departments to proactively align while implementing practice and quality standards to foster safety for patients, workers, and the environment.

Financial Effect of a Drug Distribution Model Change on a Health System.

Background: Drug manufacturers change distribution models based on patient safety and product integrity needs. These model changes can limit health-system access to medications, and the financial impact on health systems can be significant. Objective: The primary aim of this study was to determine the health-system financial impact of a manufacturer's change from open to limited distribution for bevacizumab (Avastin), rituximab (Rituxan), and trastuzumab (Herceptin). The secondary aim was to identify opportunities to shift administration to outpatient settings to support formulary change. Methods: To assess the financial impact on the health system, the cost minus discount was applied to total drug expenditure during a 1-year period after the distribution model change. The opportunity analysis was conducted for three institutions within the health system through chart review of each inpatient administration. Opportunity cost was the sum of the inpatient administration cost and outpatient administration margin. Results: The total drug expenditure for the study period was $26 427 263. By applying the cost minus discount, the financial effect of the distribution model change was $1 393 606. A total of 387 administrations were determined to be opportunities to be shifted to the outpatient setting. During the study period, the total opportunity cost was $1 766 049. Conclusion: Drug expenditure increased for the health system due to the drug distribution model change and loss of cost minus discount. The opportunity cost of shifting inpatient administrations could offset the increase in expenditure. It is recommended to restrict bevacizumab, rituximab, and trastuzumab through Pharmacy & Therapeutics Committees to outpatient use where clinically appropriate.