PillStream: Agile High-Throughput Assembly of Custom Multi-Medication Packaging

描述(由申请人提供)：长期护理机构(LTCF)居民在给药方面的错误威胁到居民的安全，并为医疗保健系统增加了大量不必要的成本。使用单位剂量药物需要LTCF工作人员每天手动分类和组装特定患者的药物~4次，可能会导致高达42%的错误率，总错误中有7%具有显著的潜在危害。在一个典型的100个常驻LTCF中，仅准备给药就估计每天消耗6-8个人小时，或者在所有美国LTCF中估计消耗16,000个全时当量，从而减少了工作人员可用于其他职能的时间。另一项不必要的成本，仅在美国疗养院估计就高达50亿美元，原因是由于处方变更和患者更替而浪费的药物。从2013年1月1日起生效的医疗保险和医疗补助服务中心的新规定，目标是减少药物浪费，要求“短周期”填写(d14天)，而不是传统的30天“宾果卡”。然而，即使这达到了减少处方药浪费的预期结果，业内消息人士预测，使用周期较短的宾果卡可能会增加LTCF工作人员的时间，并可能出现与更多单位剂量包的额外手动分类相关的错误。建议的解决方案。Artaic的新型PillStreamTM系统结合了久经考验的先进敏捷制造技术，用于我们成功开发的高速低成本马赛克即时制造TileJet机器人。PillStream专为高精度、高产量的定制多种药物包装(CMPTM)生产而设计，这将使中央填充药店能够以更低的成本向其LTCF客户提供短周期的配药，并具有能够退回未使用的药物的闭路能力。在SBIR第一阶段，我们创建了PillStream原型，该原型超过了我们的主要成功标准-替代药丸和明胶胶囊e99.9%的放置精度，同时超过了我们的目标充填率(100个水泡/分钟)50%。明确的目标。在这项为期24个月的第二阶段SBIR中，我们建议：1)建立和测试一个更大的全功能Pill-Stream原型，能够直接从批发药瓶分配多达48粒“快速移动”药丸/胶囊；2)修改机载PS48软件，以实现与药房管理软件的集成；以及3)在最多2家中央填充药店进行Beta测试，使用它来填充包含“快速移动”药物的日常患者特定中医，以便与现有方法的准确性和成本进行比较。在真实的中央灌装药房环境中，成功满足我们在精度(e99.99%)和吞吐量(e100个水泡/分钟和e10个每日CMPS/分钟)方面的目标SBIR第二阶段工程规范，应使Artaic能够筹集第三阶段资金用于PS48和更大的PS100和PS200的商业生产。

DESCRIPTION (provided by applicant): Errors in the administration of medications to residents of long-term care facilities (LTCFs) threaten resident safety and add significant unnecessary costs to the healthcare system. Use of unit dose medications that require LTCF staff to manually sort and assemble specific patient medications ~4 times per day can result in error rates as high as 42%, with 7% of total errors having significant potential for harm. Just preparing medications for administration consumes an estimated 6-8 person hours/day in a typical 100 resident LTCF, or an estimated 16,000 full time equivalents in all US LTCFs, reducing staff time available for other functions. Another unnecessary cost, estimated at $5 billion in US nursing homes alone, arises from medications that are wasted due to prescription changes and patient turnover. New regulations from the Centers for Medicare and Medicaid Services, effective 1 January 2013, target reduced medication waste by requiring "short cycle" fills (d14 days) instead of the traditional 30 day "bingo cards". However, even if this has the desired result of reducing prescription drug waste, industry sources predict that use of shorter cycle bingo cards may increase LTCF staff time and possibly errors associated with additional manual sorting of more unit dose packages. Proposed Solution. Artaic's novel PillStreamTM system incorporates proven advanced agile manufacturing technology, utilized in our successful TileJet robot developed for high speed low-cost mosaic just-in-time manufacturing. PillStream is designed for high accuracy, high throughput production of Custom Multi-medication Packages (CMPTM) that will enable Central-Fill pharmacies to provide their LTCF customers with short cycle dispensing at reduced cost and with closed-loop capability enabling return of unused medications. In SBIR Phase I we created a PillStream prototype that exceeded our primary success criterion of e99.9% placement accuracy for surrogate pills and gelatin capsules while exceeding our target fill rate (100 blisters/min) by 50%. Specific Aims. In this 24-month Phase II SBIR we propose to: 1) build and test a larger fully functional Pill- Stream prototype able to dispense up to 48 "fast mover" pills/capsules directly from wholesale medication bottles; 2) modify the onboard PS48 software to enable integration with pharmacy management software; and 3) beta test the PS48 in up to 2 Central-Fill pharmacies, using it to fill daily patient-specifc CMPs containing "fast mover" medications in order to compare accuracy and cost to existing methods. Success in meeting our target SBIR Phase II engineering specifications for accuracy (e99.99%) and throughput (e100 blisters/min and e10 daily CMPs/minute) in a real Central-Fill pharmacy setting should enable Artaic to raise Phase III funds for commercial production of PS48 and larger PS100 and PS200 units.