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In part 1 of this blog, the current state of the industry in sterile compounding robotics is explored, including an overview of available solutions, benefits and challenges of implementation, and strategies for success.

Angela Yaniv, PharmD, BCSCP is the Director of Sterile Products for the Cleveland Clinic. She has extensive experience with implementation and utilization of robotics for sterile compounding for both hazardous and non-hazardous medications. Her experiences are highlighted in multiple peer-reviewed publications, and in ASHP’s Compounding Sterile Preparations text. Dr. Yaniv expands on her experience in the Q&A below.  

Briefly tell us about your experience with using sterile compounding robots 

We began working with sterile compounding robots roughly 13-14 years ago. Our cancer center has utilized a robot to prepare oncology medications for the past 12 years. When we recently moved into a new cancer center, we implemented a second oncology robot as well given our larger cleanroom space and the need to serve additional patients. For our non-hazardous medications and batched items, we partnered with our robot vendor to develop machines to support these workflows as well. We are now focused on increasing speeds of batching in bags with a new robot which has been recently implemented. 

Overall, our main campus utilizes five total robots, one of which is focused on support for our pediatric patient population. This allows us to leverage the benefits of gravimetric compounding technology. We highly value the processes of preparing hazardous medications utilizing robots to minimize our staff exposure to these compounds. We have collaborated with our vendor to develop gravimetric assist devices which incorporate barcode scanning, some photo capture, and video documentation in combination with gravimetric technology, because we also recognize the value of gravimetric verification for compounds that can’t be made in the robots. This allows us to integrate our manual compounding workflows with our sterile compounding robotics from a single vendor. 

What drugs or types of sterile products do you use the robot to compound? 

We utilize our oncology robots to compound hazardous medications. Our other robots prepare pediatric medications and batches of medications in bags and syringes – all of these are non-hazardous preparations. The robots which are tailored to prepare syringes and bags exclusively support our batching operations. Historically, we have also used robots which could support both patient-specific compounds and batches, but found that these are less efficient than targeting the machine to a particular type of workflow. Our state regulations limit the ability to prepare compounds for other sites, but this could be a benefit for sites where local regulations allow it. 

Tell us about your staffing and education models used for the robot. Do you use a small core team versus everyone in operations is cross trained? 

Everyone is trained to complete basic tasks on the robot – everyone should be able to load it, unload it, etc., to ensure that the robot operates as continuously as possible with minimal downtime. Our “super users” have additional training to perform troubleshooting when any issues are encountered. We generally find that users who have a good understanding of the robots’ needs and the timing required to achieve a high degree of throughput can have great success in operating the robot. These users are often good candidates to become super users. 

On initial implementation of a robot, the vendor provides first-time training and onboarding. As we have progressed in our knowledge and use of robots over time, we now leverage a combination of vendor-provided and site-specific materials to support a process to train new caregivers as they join the team and learn to operate the robots effectively. 

What challenges have you experienced since implementing the robot? 

One of the challenges we initially encountered was not specific to robots but was more general to the transition from volumetric compounding practices to gravimetric processes. Under this umbrella, we found that management of tolerances was a challenge. For example, in our pediatric populations, small volume withdrawals can be challenging to complete successfully within the limitations of the technology. If the technology allows a tolerance within a particular percentage range, the unavoidable volume losses to “dead space,” needles, etc. can be a larger proportion of the available tolerance range compared to larger-volume withdrawals which are typical for our adult populations. To combat this, standard concentrations can be helpful. Utilizing the robot to instead prepare standard bags (rather than very small volume withdrawals) can be more efficient. These standard bags can then streamline downstream preparations and workflows. 

An additional challenge in the transition to gravimetric processes can be pharmacist understanding and perception. Since syringe accuracy rates also have a level of variability, visual inspection may have slight differences between syringe markings and reported volumes when preparations are compounded gravimetrically. To address these concerns, education is critical to ensure understanding of these possible variations and to provide pharmacists with a holistic understanding of this adjustment and the goals and benefits of gravimetric compounding processes. 

More generally, the initial process of change management can include the challenges of setting expectations of changes in staff workflows – for example, establishing which processes will be automated and which will remain manual. It’s critical to understand where the robot can perform at its best and to leverage those workflows in automation to be most successful. Some workflows will be less successful-keep these manual until technology can add more value. Once your processes have been defined, it’s important to set expectations with staff to ensure that robotics are utilized at the rates expected, and exceptions only occur when absolutely necessary. Close vendor partnerships are key for success, to enable quick adjustments where needed if failure rates rise. 

Finally, sites should understand the lifespan of these machines and develop plans around these timelines. These machines do not last forever. As technology advances, we must plan for maintenance, replacement, and upgrades to ensure that our processes maintain the levels of accuracy and throughput that we have worked so hard to achieve. 

What strategies do you recommend to employ safe practices around robotic compounding? 

It’s important to understand your safeguards within the system. On installation, it’s very important to complete an FMEA and understand what mitigations should be taken to prevent and address potential errors within the system. When system parameters are changed, you must understand any potential for failure as a result of these changes. Communication is key here – users may rely heavily on the system and its outputs and recommendations. Thus, ensuring that they are aware of any changes which could impact these helps these users to critically analyze any subsequent outputs and address any unintended consequences. 

What is the best part of having a sterile compounding robot as part of your pharmacy operations? 

They’re really cool! 

We also love that they provide better protection for our compounders against hazardous medications – this decreases their risk of exposure. Further, we have better tracking of the events which happen in the compounding process. We know exactly what the robot did and exactly what’s in the bag in the event of any questions or recalls. 

These are very helpful in the batching process. The benefit here is twofold – both in prevention against repetitive strain injuries and in increasing throughput. Articulated arm robots are not necessarily faster than human compounders, but are not susceptible to the repetitive strain injuries which plague human compounders, especially in production of large batches. It’s also possible to utilize one technician to staff two robots, thus increasing throughput by more than would be possible otherwise with manual processes. 

For new sites looking to implement a sterile compounding robot, what advice do you have for them? 

First, know your goal for implementing a sterile compounding robot. Then, gain an understanding of the most effective workflow types for the robot you’re considering. This helps to assess whether the robot you’re considering is a good fit for your goals. More general robots (which can support more types of workflows) can do more things, but may be less efficient. Our most efficient robots do the same thing over and over again, very fast. You should understand the tradeoffs to find the best fit for your goals. 

If possible, take a site visit to see the machine you’re interested in. Watch the robot in action. Understand how it’s being used, and how successful the site is with it. This is incredibly helpful in matching a particular robot to your goals, and understanding ways where your site might be successful with a certain model as well. 

Involve the staff who will be using the device. Consult them early in the process – they will have ideas and questions which will help ease implementation, and they may contribute innovative ideas for maximizing use of the robot. Further, this helps to navigate any staff fears around implementation of technology, including concerns around job replacement. We have found that robot implementations typically involve utilization of staff in new and more innovative ways, rather than reducing the number of staff overall. Thus, involving your staff in this process increases their buy-in and comfort levels as your site makes this transition.