SBIR-STTR Award

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 manual sorting of unit dose packaging. Proposed Solution: Short-cycle custom medication packaging (CMP), containing all the "right medications needed for the right patient at the right time", has the potential to reduce risk of medication errors and LTCF staff time required for medication assembly as well as prescription drug waste. Altaic's goal is to create the Pill Stream, a novel robot for high accuracy, high throughput production of CMPs in a variety of facility-specified formats, enabling more Central-Fill (C-F) pharmacies to provide their LTCF customers with shorter turnaround times at reduced cost. Specific Aims: In this 6-month Phase I SBIR we propose to 1) to build a small scale prototype of the PillStream, and 2) evaluate its performance with respect to CMP filling accuracy, rate of production, and costs. The PillStream will incorporate proven advanced agile manufacturing technology, utilized in Artaic's successful TileJet robot developed for high speed low-cost mosaic manufacturing. Feasibility of PillStream approach will be demonstrated if the prototype can produce CMP blisters containing different mixtures of pills at a rate of at least 100 CMP blisters/min with an accuracy of at least 99.9%. Assuming Phase I success, in Phase II we will develop a commercial scale PillStream capable of handling 50% of the workload of a typical C-F pharmacy, and pilot it in two C-F pharmacies serving a total of 10,000 beds.

Public Health Relevance:
Current packaging of prescription medications provided to long-term care facilities (LTCFs) by central fill pharmacies generally utilizes unit dose packaging. This requires LTCF staff to manually assemble the medications to be taken by a given resident at each administration time (typically 7-12 medications and 4 times per day), a task that: 1) is associated with high error rates, some harmful to the recipient; 2) significantly decreases time available for other nursing functions; and 3) increases costs. The proposed PillStream robot is expected to allow central fill pharmacies to create custom multi-medication packaging (single blisters containing all medications required by a single resident at a single time during his/her day), thereby removing the error-prone manual assembly tasks from the LTCF staff, freeing time and reducing waste.

Public Health Relevance Statement:
Current packaging of prescription medications provided to long-term care facilities (LTCFs) by central fill pharmacies generally utilizes unit dose packaging. This requires LTCF staff to manually assemble the medications to be taken by a given resident at each administration time (typically 7-12 medications and 4 times per day), a task that: 1) is associated with high error rates, some harmful to the recipient; 2) significantly decreases time available for other nursing functions; and 3) increases costs. The proposed PillStream robot is expected to allow central fill pharmacies to create custom multi-medication packaging (single blisters containing all medications required by a single resident at a single time during his/her day), thereby removing the error-prone manual assembly tasks from the LTCF staff, freeing time and reducing waste.

NIH Spending Category:
Bioengineering; Clinical Research; Health Services

Project Terms:
Age; base; Beds; Bulla; Capital; capsule (pharmacologic); Cells; Cessation of life; Color; Computer software; cost; Custom; design; Discipline of Nursing; dosage; Dose; Drug Packaging; Drug Prescriptions; Eating; flexibility; Generations; Goals; Healthcare Systems; Hour; Individual; Industry; Label; Letters; Long-Term Care; Manuals; Marketing; Measurable; Medication Errors; Methods; novel; Nursing Homes; Nursing Staff; Oral; Patient Rights; Patients; Performance; Persons; Pharmaceutical Preparations; Pharmaceutical Services; Pharmacy facility; Phase; pill (pharmacologic); Production; prototype; Regulation; Research; Risk; Rivers; Robot; Robotics; Safety; Services; Site; Skilled Nursing Facilities; Small Business Innovation Research Grant; Solid; Solutions; Sorting - Cell Movement; Source; Specific qualifier value; Speed (motion); Stream; success; System; Technology; Time; Travel; United States Centers for Medicare and Medicaid Services; wasting; Workload

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 medi- cations 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. Anoth- er 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 reduc- ing 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 man- ufacturing. 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 bot- tles; 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-specific 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.

Public Health Relevance Statement:


Public Health Relevance:
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. Artaic is developing a novel Pill- StreamTM system (PS48) that incorporates proven advanced agile manufacturing technology to provide high accuracy, high throughput production of Custom Multi-medication Packages (CMPTM) that will enable Central- Fill pharmacies to provide their LTCF customers with patient-specific daily pills at reduced cost and with closed-loop capability enabling return of unused medications. This grant application requests funds to complete the development of the PS48, the first commercial scale PillStream model, and to test it on the assembly floor of up to two Central-Fill pharmacies.

NIH Spending Category:
Bioengineering; Clinical Research; Health Services; Patient Safety

Project Terms:
Applications Grants; Beds; Bulla; Capital; Capital Financing; capsule (pharmacologic); Cessation of life; Color; commercialization; Computer software; cost; Custom; design; Development; Discipline of Nursing; dosage; Dose; Drug Packaging; Drug Prescriptions; Engineering; flexibility; Floor; Funding; Gelatin; Generations; Goals; Healthcare Systems; Hour; Industry; Letters; Long-Term Care; Manuals; Measurable; Medication Errors; meetings; Methods; Modeling; novel; Nursing Homes; Nursing Staff; Oral; Patients; Performance; Persons; Pharmaceutical Preparations; Pharmacy facility; Phase; pill (pharmacologic); Production; prototype; public health relevance; Regulation; Request for Applications; Risk; Robot; Robotics; Safety; Services; Site; Skilled Nursing Facilities; Small Business Innovation Research Grant; Solid; Solutions; Sorting - Cell Movement; Source; Speed (motion); Stream; success; System; Technology; Testing; Time; United States Centers for Medicare and Medicaid Services; wasting