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

SBIR 第一阶段：开发追踪药物条形码标签

• 批准号: 1548577
• 负责人: Michael Krenzke
• 金额: $ 15万
• 依托单位: ConsortiEX, Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-01-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1548577&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Track; Trace

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project, if successful, will be 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 the operations of many third party suppliers, thus creating drug 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. Key objectives include a new use of barcode standards, a proprietary encryption algorithm, and a method to send and extract secure serial code to and from Electronic Health Record (EHR) providers. 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. The encryption and extraction method must not require special handling or software by the EHR. Success of this project will be label readability by existing hospital scanners and retrieval of the serialized data from the EHR.

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，如果成功的话，将改善医疗保健患者的结果，可能挽救生命，并降低医疗保健成本。2013年的《药品质量和安全法》对无菌注射复合药物制定了更严格的制造标准，关闭了许多第三方供应商的业务，从而造成药品短缺和价格上涨。 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。 主要目标包括条形码标准的新用途，专有加密算法，以及向电子健康记录（EHR）提供商发送和提取安全序列码的方法。 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。 加密和提取方法不得要求EHR进行特殊处理或软件。 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。