For a very long time, hospital pharmacies have relied on 503B Compounding facilities to outsource to or from which to purchase a variety of supplies, such as ready-to-use critical care drips, OR syringes and high-use medications.

THE PROBLEM

The problem is, the supply of medications from these 503B facilities is not reliable, and shortages make it challenging to maintain the demand required for proper patient care, said Arpit Mehta, PharmD, director of pharmacy at Allegheny General Hospital, a 650-bed academic medical center in Pittsburgh, Pennsylvania. 

Mehta says he has seen situations where 503B facilities reduce or outright stop the allocation of medications without advanced notice, making the mitigation of the shortages quite challenging.

"Ensuring the product is truly safe and sterile for our patients is another aspect for 503B facilities. We have to ensure the facilities are safe to use," he explained. "This requires review of the FDA inspection reports, QA data, site-visits, etc. – all of which requires time and effort. With shortages, health system pharmacies generally partner with multiple 503B facilities, requiring thorough review of all such partner facilities. And even then, there still can be problems.

"Beyond the issues around potential shortages and verification of quality, there also is a significant financial burden on the organization as the health systems pay a premium price to procure these medications as ready-to-use with extended room-temperature beyond-use-dating," he added.

PROPOSAL

Allegheny General's idea for a solution was centered on finding a way to in-source the purchased medications, using IV robotics via an RIIS program (service program). Vendor Omnicell offered this service in a way that was not just leveraging robotics (a device) to compound the product, Mehta observed.

Specifically, the Omnicell service offered a technician team that would help run the robot – a team of experts on the device and its operations – that is fully dedicated to compounding these medications.

"Less than 6% of hospitals across the country use IV robotics, because there is a fear of the unknown. However, the program makes sense, and it is worth an evaluation by all medium to large facilities."

Arpit Mehta, PharmD, Allegheny General Hospital

"Both IV bags and OR syringes could be compounded on the robot, with the same extended room temperature BUD," he noted. "Most important, we would have control over our inventory, allowing us to adjust as needed based on usage, thus reducing waste and mitigating shortages.

"We also would have data and control over the sterility of compounded products as we would be doing so in our own clean rooms," he continued. "Financially, this meant we would see a significant savings, since we would in-source and compound these medications ourselves and not pay the premium price to 503B facilities."

MEETING THE CHALLENGE

Allegheny General worked with Omnicell to implement the IV RIIS robotics program to meet its challenges. Omnicell helped the hospital draft an ROI, which the hospital validated and presented to its leadership. Once approved, hospital staff began working on the project with Omnicell throughout the entire implementation.

"As the details were being finalized, we worked with Omnicell to recruit pharmacy technicians to run the robotics," Mehta recalled. "These would be the vendor's technicians who would work with us every day to compound our needed medications, dedicated to our hospital. They would be part of our team.

"We worked with the vendor in identifying the medications that we would begin compounding on the robot, medications that were on shortage, and we had critical need for them," he added. "We began with one IV Robot at our flagship hospital to begin compounding some of the medications that were critical for our needs, in order to ensure steady supply. We produced OR syringes, critical care drips and the like, to mitigate all our concerns on availability of these vital components."

During all of this, staff worked closely with the trainer, engineer and team from Omnicell to ensure successful go-live – and then tweaks and optimizations to ensure they had the best yield of the products they were compounding.

The goal in mind was centered on minimizing waste and increasing efficiencies. Staff met at a scheduled cadence to continue to discuss the program; evaluate opportunities, growth capacity and cost savings; and continue to improve yield. Staff soon are adding a second device to help increase the number of compounded products on the robot.

RESULTS

From May 2020 to April 2021, Allegheny General produced 46,909 products on the IV Robot, generating a total of $1.2 million in savings. Savings are calculated by taking into consideration the outsourced cost compared to in-sourced cost, which includes medication cost, supplies, cost for IV RIIS program, sterility testing, USP71 testing and shipping cost.

ADVICE FOR OTHERS

"Less than 6% of hospitals across the country use IV robotics, because there is a fear of the unknown. However, the program makes sense, and it is worth an evaluation by all medium to large facilities," Mehta advised. "It is important to engage all stakeholders early on – IT, facilities, etc. – to ensure that the hospital has the capability to take on the IV robotics.

"Key things to consider beyond normal IT review are space and the availability of data and power in the sterile compounding area," he concluded. 

"If this needs renovation or construction, that is a challenge and additional expense. If the pharmacy is not in the basement, there may also be need for structural support due to the size and weight of the robot, and so it is important for facilities to consider this. IV robotics may have specific data and power requirements, so reviewing this in advance as part of the project plan is crucial."

Twitter: @SiwickiHealthIT
Email the writer: bsiwicki@himss.org
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