AdventHealth Orlando, Orlando, FL, USA.
Pharmfusion Consulting, LLC, Midlothian, VA, USA.
Am J Health Syst Pharm. 2022 Jul 22;79(15):1281-1289. doi: 10.1093/ajhp/zxac116.
The process and challenges associated with an initiative to pivot from insourcing the batch compounding of high-volume sterile preparations to insourcing patient-specific compounding of parenteral nutrition (PN) at a health-system central fill pharmacy (CFP) serving 8 hospitals in central Florida are described.
The insourcing initiative was prompted by a need for greater oversight of sterile compounding to ensure patient safety and the potential for cost savings. In 2014 the health system opened a CFP to provide replenishment of automated dispensing machines and insourcing of 19 compounded sterile preparations (CSPs) as the hub of a hub-and-spoke distribution system for 8 local hospitals. The need to comply with a 2016 proposed Food and Drug Administration requirement limiting the distribution by 503A pharmacies of non-patient-specific CSPs beyond 1 mile and the state of Florida's scope of practice definition related to sterile compounding prompted the CFP to switch from CSP insourcing to PN insourcing. The business case was based on substantial projected cost savings of more than $900,000 annually from PN insourcing versus outsourcing. A hybrid model for insourcing PN preparation was developed by using the PN compounding device, solutions, and additives from different vendors. Standardization of PN formulations and order templates streamlined the ordering process and reduced the unnecessary use of additives and associated costs.
With careful planning, the CFP successfully pivoted from insourcing CSPs to insourcing PN. A collaborative approach with early and frequent communication among key health-system and vendor stakeholders was vital to the success of the initiative.
描述了将大容量无菌制剂的内部批量配制转变为为服务于佛罗里达州中部 8 家医院的医疗系统中央灌装药房（CFP）内部配制患者特定的肠外营养（PN）的计划的过程和挑战。
内部配制计划的启动是为了加强对无菌配制的监督，以确保患者安全并节省潜在成本。2014 年，该医疗系统开设了一家 CFP，以提供自动化配药机的补充服务，并将 19 种复合无菌制剂（CSP）作为 8 家当地医院辐射式配送系统的中心进行内部配制。需要遵守 2016 年食品和药物管理局提出的要求，限制 503A 药房将非患者特定的 CSP 超出 1 英里的范围进行配送，以及佛罗里达州与无菌配制相关的实践范围定义，这促使 CFP 从 CSP 内部配制转变为 PN 内部配制。内部配制 PN 的商业案例是基于每年从内部配制 PN 中节省超过 90 万美元的大量预计成本节约。通过使用来自不同供应商的 PN 配制设备、溶液和添加剂，开发了一种混合模式用于内部配制 PN 制剂。PN 配方和订单模板的标准化简化了订购流程，减少了不必要的添加剂使用和相关成本。
在精心计划下，CFP 成功地从内部配制 CSP 转变为内部配制 PN。在关键医疗系统和供应商利益相关者之间进行早期和频繁的沟通的协作方法对该计划的成功至关重要。
