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

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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.