Precision and Protection: Inside Cone Health’s Robotic Compounding Program

As pharmacy operations evolve to meet increasingly complex clinical demands, robotic automation is playing a pivotal role in enhancing accuracy, safety, and reliability in sterile compounding. At Cone Health, the integration of advanced technologies like the APOTECAchemo and Omnicell IV robots is helping to optimize hazardous and high-risk medication preparation across cancer center and acute care settings.

Illustration of a pharmacist's desk with pill bottles, prescriptions, a mortar and pestle. Image Credit: © tynza

In this interview with Pharmacy Times®, Megan Byrne, PharmD, MS, pharmacy manager, oncology at Cone Health; and Austin Price, PharmD, MBA, MS, pharmacy manager of supply chain and compounding automation at Cone Health, share insights into the implementation of robotic compounding systems at Cone Health, the impact on safety protocols and staffing, and the operational challenges and successes that have shaped their program’s growth.

Pharmacy Times: What specific robotic systems are currently being used in Cone Health's compounding pharmacies, and what types of medications do they handle?

Megan Byrne, PharmD, MS: So, across our cancer center pharmacies, we use APOTECA, which is a compounding platform that offers different types of compounding equipment that we can use. So, 2 of our cancer center pharmacies use the APOTECAchemo robot, and that is a compounding robot that helps prepare hazardous medication.

Austin Price, PharmD, MBA, MS: At Cone Health, within our acute care facilities, we have 3 Omnicell IV robots. We are a category 3 program, so we perform batch compounding of items that are used across our acute care facilities, including paralytics and compounded preparations in bags. Most commonly, these preparations are used in our procedural and emergency areas.

Pharmacy Times: How has the implementation of robotics impacted accuracy and safety in sterile and nonsterile compounding at your facility?

Byrne: Implementation of robotics at Cone Health has definitely helped with the overall safety and accuracy of our compounding processes. For us here at the cancer center, having the robot really helps to increase our accuracy by being able to provide more accurate measurements on the medications that they're drawing up. It also allows for more safety for our employees, making sure that they have an additional barrier between the hazardous preparations and where they're working. So, we definitely appreciate the reduced risk of exposure with the robotics.

Price: Omnicell robots at adoption really introduced gravimetric and volumetric reading into our compounding process, and now our reality of sterile compounding includes gravimetric, volumetric, and barcode technology, which in our opinion, is the safest and most efficient way to compound a patient-specific dose.

Pharmacy Times: What roles do pharmacists and technicians play in overseeing or interfacing with the robotic compounding process?

Price: With the Omnicell IV robots, the technology itself is operated daily by pharmacy technician colleagues. Any preparation that is produced on the IV automation is going to be checked by a pharmacist. Like any other preparation that is made in our pharmacy—it is treated no differently.

We do have management oversight. Management oversight within our pharmacy manages the cadence, develops the batch protocols, and ensures quality compliance of that program.

Byrne: It's very similar at the cancer centers with our patient-specific doses. It's run every day by our technicians, and our pharmacists are there to do the verification and checking of the product. Management is involved with making sure that our formulary stays up to date and that our recipes are accurate, as well as making sure that we have the best sort of procedures and processes with running the robot, cleaning the robot, and making sure everything looks good to go.

Pharmacy Times: Have you observed any measurable improvements in workflow efficiency, such as reduced turnaround times or increased batch capacity?

Price: So anytime you're compounding, of course, we live within guidance provided by US Pharmacopeia (USP), which really dictates our batch sizes. We have adopted rapid sterility technology that is noninferior to USP <71> sterility testing, which has allowed us to really adjust our cadence to include smaller batches more often. This has drastically reduced waste and lead time to batch releases from our IV robot program. For us in the acute care setting, it has reduced our reliance on outsourced compounding vendors, so we have much more reliability in the release of our product, making sure that we have it available to take care of our patients.

Byrne: I guess for us at the cancer centers, we haven't really seen improvements in workflow efficiency. It's really a big focus on that safety. So, it still does usually take the same amount of time and number of personnel to run a product and make a product in the robot. So, workflow efficiency, we don't necessarily see a huge difference, but for us, safety is most paramount, as well as accuracy with some of these high-risk hazardous medications.

Pharmacy Times: How does Cone Health validate and maintain quality assurance for compounded products prepared by robotic systems?

Price: At Cone Health on the acute care side with our Omnicell IV robots, because we operate as a category 3 compounding program, we follow all guidance provided by USP <797>, regarding category 3 sterile preparations. That includes the stability studies that we use to reference our protocols, that includes our environmental monitoring and staff competency cadence, and it also includes things like sterility testing that allow us to make sure that the preparations we're making on our automation are the safest possible preparations for our patients.

Byrne: Only thing I will add from the cancer center side is so a lot of our work lives within USP <800> as well as USP <797>, so in addition to some of the things that Austin highlighted, we do have some specific trainings and competencies focused around manipulation and handling of hazardous drug therapy as well as the use and utilization of the equipment itself.

Other than that, though, we do have a great relationship with our vendor, APOTECA. They keep us updated on our failure rates and have sort of goal failure rates for us to achieve to make sure that the robot is performing as it's supposed to. So, we really do just collaborate very well with Loccioni, who makes APOTECAchemo, to make sure that our robot is performing appropriately and able to maintain the quality preparations.

Pharmacy Times: What were some of the key challenges in adopting robotic technology in the compounding environment, and how were they addressed?

Price: So, adopting IV automation definitely comes with challenges and barriers that you have to overcome. One of the most important and key considerations is physical space to house a large piece of IV compounding technology. At Cone Health and Moses Cone, specifically where our IV robots are located, we adopted our IV robots in 2019, which is the same year we built our new pharmacy facility. So, I highly encourage adopting this technology; you have to make sure you have the space to do it. And we happen to be in an era of our pharmacy where we built the space to accommodate that IV automation.

Outside of that, how to staff the IV automation is also another challenge. There are different ways that you can staff these advanced compounding technologies within the acute care setting. We actually partner with our technology vendor Omnicell, who hires these contract staff, who are Omnicell employees to run the robots. Now they abide by all certification requirements, like any of our other frontline compounders, but they are part of our technology partner. It creates a great opportunity to link us to our technology partner, and really kind of breeds excellence through that relationship because of those shared resources.

Pharmacy Times: How has the use of robots affected staffing levels or the types of skills needed within your pharmacy team?

Byrne: So, implementation of our robots across the cancer centers has not really affected staffing levels. We still need an expert technician to load and run and maintain the robot, and so these robots are not replacing our technicians. However, it is allowing them a really great growth opportunity, because it does require a level of skill and expertise and familiarity with the process. So we get a lot of technicians who join our team who really enjoy getting to learn more about the robot and all the nuances associated with it. So, I think it's a really great addition to have for those growth opportunities for our technicians.

Pharmacy Times: Are there specific medications or patient populations where robotic compounding has been particularly advantageous?

Byrne: So of course, across the cancer centers, we frequently compound high-risk chemotherapies, and a lot of these regimens, the doses are very, very patient specific. It depends on the patient's labs, their weights and their specific regimen. And so, making sure that we have the most precise and accurate measurement of these medications is crucial. Like I said, these are hazardous medications, and so there's always a potential for hazardous exposure or risk with personnel. So having this robot to really help manage both that precision as well as the safety of the manipulation of the drug is so advantageous, and it's really done wonders for our team.

Pharmacy Times: What feedback have you received from clinical teams regarding the reliability and performance of compounded products prepared robotically?

Price: Within the acute care setting, as I mentioned, the IV compounding automation through the IV robot allows us to reduce our reliance on traditionally unreliable outsourcing vendors. By insourcing, we ensure a consistent pipeline of critical medications that are used in our procedural mother baby and emergency areas without relying on an external source to provide those to us. So we appreciate and are really feeling much more secure with our pipeline of these critical medications, and that would probably be the biggest benefit—not having to tell our clinical providers that we are out or a medication is on back order and hasn't arrived yet.

Pharmacy Times: What advice would you give to other health systems considering robotic automation in their compounding practices, especially in terms of cost justification and implementation planning?

Price: I understand that this is definitely a priority when considering IV automation. Of course, you have to look at an [return on investment], but I always challenge anyone that's open to adopting IV automation to really understand your why for adopting IV automation. Implementing technology that includes gravimetric, volumetric, and barcoding technology is going to allow you to care for your patients in the best possible way and the safest possible way. If you approach a project with that in mind, making sure that it aligns with your organizational goals and your organizational commitments, everything else will fall into place.