SBIR Phase II: Development of a Track-and-Trace Medication Barcoded Label

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力旨在改善医疗患者的预后，可能挽救生命，并降低医疗成本。2013年的《药品质量和安全法》对无菌注射复合药物设定了更严格的制造标准，关闭了许多第三方供应商，从而造成短缺和价格上涨。 作为回应，美国医院药学协会预计，到2018年，美国市场的40%，即2000家医院将获得内购化合物。 医院希望通过外包降低成本，提高产品质量，改善患者安全。 如今，内包医院通常拥有多个信息系统，并使用纸质记录拼凑化合物的制造方式和给药对象。 当成分召回发生时，医院花费数百个工时来确定问题来源和受影响的患者。为了防止进一步的患者风险，需要速度。SBIR第一阶段项目将为医院提供端到端的质量管理能力，跟踪每个生产过程步骤，并将药物追溯到患者。 医院将能够防止患者接受召回的药物，并确定质量生产的妥协，从而改善患者的治疗效果，并可能挽救生命。 拟议的项目是一种新的药物条形码标签加密技术，与现有的医院扫描仪兼容，以提供静脉药物化合物的跟踪和追踪能力。 主要目标包括患者特定和预期的标签工作流程，用于混合质量控制的被动审核管理系统，以及改善手术室环境药物条形码扫描合规性的创新。 如今，医疗保健提供商利用多种条形码标签技术，在不同的系统中嵌入最少的药物数据。 药物标签可以成为这些系统的链接，以实现成分可追溯性。 然而，现有的解决方案不足以满足2013年立法规定的可追溯性要求。 该项目发明将加密条形码标签内的序列化字段，将特定药物连接到其生产数据，并最终连接到患者。 配料过程数据，如成分，环境条件和生产说明，将连接到个人药物标签和存储在病人？的电子记录。 当一种成分被召回或发现可疑的过程时，提取算法将从EHR中提取加密数据，并将其连接到生产数据。该项目的成功将是现有医院扫描仪的标签可读性和从EHR中检索序列化数据

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is aimed at improving healthcare patient outcomes, potentially saving lives, and decreasing healthcare costs. The Drug Quality and Security Act of 2013 set stricter manufacturing standards on sterile injectable compounded medications that have closed many third party suppliers, thus creating shortages and higher prices. In response, the American Society of Hospital Pharmacists expects 40% of the US market, 2000 hospitals, by 2018 to receive insourced compounds. Hospitals that insource hope to decrease their costs and improve patient safety with higher quality product. Today, insourcing hospitals often have multiple information systems and use paper records cobbling together how a compound is made and to whom it has been administered. When an ingredient recall occurs, hospitals spend hundreds of man-hours identifying the problem source and affected patients. To prevent further patient risks speed is demanded. This SBIR Phase I project will provide hospitals the capability of an end-to-end quality management that will track every production process step and tracing medications to patients. Hospitals will be able to prevent patients from receiving recalled medications and identify quality production compromises thus improving patient outcomes and potentially saving lives. The proposed project is a novel medication barcoded label encryption technology compatible with existing hospital scanners to provide track and trace capabilities of intravenous medication compounds. Key objectives include both patient specific and anticipatory workflows with labels, a Passive Auditing management system for compounding quality control, and an innovation to improve operating room environment medication barcode scanning compliance. Today, healthcare providers utilize multiple barcoded label technologies with minimal embedded medication data across disparate systems. Medication labels could be the link across these systems for ingredient traceability. However, existing solutions are inadequate to meet 2013 legislative traceability mandates. The project invention will encrypt serialization fields within the barcoded label connecting a specific medication to its production data, and eventually to the patient. Compounding process data, such as ingredients, environmental conditions, and production instructions, will be connected to individual medication labels and stored in the patient?s electronic record. When an ingredient is recalled or questionable process identified, an extraction algorithm will pull the encrypted data from the EHR and will be connected to production data. Success of this project will be label readability by existing hospital scanners and retrieval of the serialized data from the EHR