(Management Case Study) Implementation Considerations Associated with a High-Speed Intravenous (IV) Syringe Compounding Robot at a Large Academic Medical Center

Purpose: The purpose of this project is to implement a high-speed IV syringe compounding robot. The regulatory landscape, hospital drug utilization, and current 503B drug expense were evaluated to identify which compounded sterile syringe products will be prepared by the high-speed IV syringe compounding robot. The project will develop an implementation plan to operationalize the use of the high-speed IV syringe compounding robot to ensure regulatory compliance. The implementation plan will include the development of training materials and procedures, personnel competency, library maintenance, equipment maintenance, workflow diagrams, staffing models, and business continuity plans.

Methods: 503B and McKesson purchase data for calendar year 2021 were obtained to evaluate product specific costs and identify potential sterile compounded IV syringes to insource. A comprehensive cost analysis included the initial capital cost of automation, proprietary disposable costs (ex. syringes), and third-party lab costs that included method validation, extended beyond use dating (BUD) testing, and sterility testing. Drug products selected are high cost, high utilization and provide a significant cost-savings opportunity once insourced compared to outsourcing from a 503B compounding pharmacy. A review of new United States Pharmacopeia (USP) Chapter < 797>, Maryland Board of Pharmacy Code of Maryland Regulations (COMAR), Food and Drug Administration (FDA) guidance, and industry standards was completed to identify regulatory strategies and ensure compliance. Drugs that are selected will undergo extended stability testing in order to extend BUDs to maximize cost savings. Workflow determination included the location of the robot, standard operating procedures (SOPs), batch sizes and volumes, training, education, competencies, business continuity planning, sterility testing, and par levels for drug vials and disposables. Additional considerations included label colors for compounded sterile syringes to align with anesthesia guidance and safety best practices.

Results: A financial analysis was completed for thirteen products. Eight drug products were identified as cost saving targets. Implementation of all eight drug products would yield $450,000 in yearly savings with a financial breakeven point of eight months. Based on projected cost-savings, workload capacity, and utilization, it was determined to initially make four of the products to start. The four products are nitroglycerin, succinylcholine, neostigmine, and glycopyrrolate. Exclusion criteria for initial product selection and implementation included products that were controlled substances leading to additional operational hurdles, lower yield cost savings, or volumes that exceeded workload capacity. The robot is being utilized approximately four hours weekly to produce 960 syringes weekly of the four initial products. After a stable workflow with the robot has been established with the initial four drug products, additional products will be added to the robot to scale production and maximize cost savings.

Conclusion: The implementation of a high-speed IV syringe compounding robot involves a variety of variables for consideration including regulations and compliance, workflows, safety, quality, informatics, and cost. The implementation of this technology to insource sterile compounded IV syringes will lead to a higher level of reliability, control, and significant cost savings to the organization.