Compounding plays a critical role in serving patients with specialized needs—creating custom medication dosages for children, preparing formulations for patients with allergies, or providing complex treatments for transplant or oncology patients. As the demand for personalized medicine grows, so does the need for safe and efficient compounding facilities.

Cleveland Clinic’s flagship outpatient pharmacy is committed to staying at the forefront of compounding innovation. To this end, the facility recently completed a multi-phase renovation of its ambulatory compounding space to expand patient care, increase safety, and create a space that meets the most stringent USP <795> and <800> standards, all while supporting the pharmacy team in delivering care.

To meet USP <795> and <800> requirements, the renovation necessitated specialized equipment, enhanced ventilation, and dedicated spaces for both hazardous and nonhazardous compounding. Beyond meeting these standards, the design aimed to create a compounding complex that serves to enhance workflow, reduce waste, and increase efficiency while delivering the highest quality care to our patients (see FIGURE 1).

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Plan for Success

Undertaking a large-scale renovation is no small feat, and efficient communication and collaboration are vital for success. Throughout the initial planning stages and until the end of construction, ensure regular communication occurs with all relevant parties regarding the status of construction and renovation. Get insight and preferences from the compounding team when making crucial design decisions.

Facilitate communication through frequent, ongoing conversations. Cleveland Clinic instituted a multidisciplinary meeting every two weeks for one year prior to commencing construction, and this continued until the project’s completion. The project team consisted of an enterprise project manager, construction managers, mechanical engineers, electrical engineers, pharmacy compliance specialists, HVAC specialists, design planners, art department, IT, pharmacy informatics, parking directors, environmental safety, access control/security, facility management, and vendors (eg, for cabinets, countertops, etc).

Each department had significant influence on the planning phases. Designs relied heavily on user preferences for decisions such as materials used, and referenced applicable state and federal regulations. Designers similarly shared insight on the complexity and costs of user requests, allowing the project management team to present these requests to finance for approval and ensure budgetary limitations were considered.

Of note, technician staff can provide crucial insight during construction planning, helping to improve designs and, subsequently, workflow. During the design of the outpatient compounding space, technicians helped determine the layout of the hoods and cabinetry to ensure efficiency and ease of use for their workflow, while accounting for equipment and utensil storage. The technicians also made recommendations for workstation and drawer placement in the workroom.

Strategic Design Improves Supervision

Cleveland Clinic aimed to improve several areas while designing the updated compounding complex. For pharmacies looking to optimize operations, design elements like pass-through systems and enhanced visibility are beneficial components to consider. Pass-through systems limit unnecessary foot traffic and reduce PPE waste, which can lead to significant cost savings. Glass partitions and integrated technologies allow for real-time monitoring, reducing errors, and ensuring safety. Furthermore, consider prioritizing integrated audio-visual tools to support oversight and enhance communication.

Increase Visibility

Improving visibility throughout the compounding space was a top priority during the renovation to simplify pharmacist oversight. Incorporating glass walls ensures a clear line of sight to all compounding activities at any given time. This enhances direct supervision and fosters better communication between the team, helping to improve workflow and patient safety. Without leaving their designated areas, pharmacists can monitor tasks, assist where necessary, and intervene quickly should issues arise within the compounding space.

In addition to physical transparency, the new space features integrated audio and visual technologies that complement the glass design. These technologies provide additional layers of oversight, allowing for real-time communication and alerts, and reducing the need for staff to constantly enter and exit the compounding space, which minimizes interruptions and helps limit foot traffic. For example, technicians have foot pedals in the compounding spaces to initiate audio with the workroom. The workroom staff can also initiate audio with compounders through a central touchscreen. The technology also allows for communication with both the hazardous and nonhazardous compounding spaces and the workroom at once, which improves efficiency and teamwork.

Video feeds are available within each hood and of a wider view of the entire compounding space. Pharmacists regularly monitor these feeds, and the technicians can initiate Microsoft Teams meetings with the pharmacists during pre-checks before initiating compounding. Note that the videos are supplemental to the physical oversight achieved with the glass design. Videos are available 30 days after recording and can be used as a training tool. The option to save videos beyond 30 days is also available if needed.

Incorporate Pass-throughs

Another major feature of the renovation was the introduction of a workroom, which serves as an area for oversight, final verification, and dispensing of batched compounds. The workroom is staffed with two pharmacists and a technician during operations. Each pharmacist is responsible for overseeing the compounding area they are facing. We have six compounding technicians and two pharmacists on staff daily. Typically, one or two technicians focus on compounding in the dedicated space. The two hoods in each room allow for an increased capacity of up to four compounders in production at a time with a maximum ratio of 1:2 pharmacist-to-technician oversight of compounding activities.

The pharmacists complete mid-prep checks prior to compounding activities commencing and can easily review selected materials and measurements on a shelf under the glass window. Pharmacists can also view the compounding activities and measurements within the hood with the use of live video. The technician staffing the workroom helps to prepare batched medication fills for patient prescriptions as well as other key aspects of pharmacy workflow. 

The pass-through design allows materials and medications to be safely transferred into the compounding space without disrupting the environment or workflow. This setup significantly reduces unnecessary movement in and out of the compounding spaces, protects the integrity of the workspace and also saves time and resources. Reduced foot traffic means fewer PPE changes, which in turn cuts down on waste, which improves sustainability over the long term. Likewise, pharmacists can access properly labeled compounds and complete final verification prior to releasing them for patient dispensing without needing to garb up and enter the compounding area.

Managing Phased Construction

A key challenge in any large-scale renovation is maintaining the day-to-day operations. Cleveland Clinic remained fully operational throughout the 14 months of construction with a carefully planned phased approach (see FIGURE 2). This approach supported full service levels without disrupting patient care or pharmacy operations. Using the existing walls during the construction process was a critical element, as it allowed us to safely section off areas and complete each construction phase while keeping the rest of the pharmacy fully operational.

We relied on existing walls to separate compounding activities and construction, which limited flexibility in terms of room size, but allowed for safe working conditions and the elimination of any temporary barriers in compounding spaces. Phasing the construction also allowed for a proactive shifting of equipment and resources to ensure that all service areas remained functional. For example, we did not shut down the existing travel vaccine administration space until the new vaccine room was fully operational.

Expanding Consultation and Vaccine Services

The first phase of the renovation focused on creating a new patient consultation room and vaccine room to accommodate our expanding vaccination services. These new spaces were essential for expanding patient access and enhancing the range of services offered, including new travel vaccine clinics. During this phase, the nonsterile compounding space was expanded into the existing supply room, which meant that we had to build a new supply room to accommodate the displaced materials.

Managing Supplies

The second phase involved constructing the new supply room, located where the original consultation room had been. This phase was crucial for maintaining an organized and efficient workflow, ensuring that all supplies were easily accessible from within the pharmacy while the renovation continued. We also created a workstation in the supply room to make prescription packaging more efficient.

Anteroom, Workroom, and Nonhazardous Room

The third phase focused on constructing the new anteroom, workroom, and nonhazardous compounding room. These new spaces are critical for separating the hazardous and nonhazardous compounding activities, allowing for better compliance with USP standards and improved workflow. Again, leveraging the existing wall of the compounding area as a construction barrier allowed our services remain operational in the current compounding space. Once completed, operations moved into the newly renovated areas, allowing the old space to be transformed into the new hazardous compounding space (see FIGURE 3). It is important to review the dimensions of the new spaces (including doorways) to ensure installation of countertops and hoods is easily achieved.

Completing the Hazardous Compounding Space

The final phase was the construction of the hazardous drug compounding area, which is connected to the anteroom via a sliding door and the workroom via a pass-through. This design ensures the safe handling of hazardous medications while allowing for efficient workflow. With the pass-through system, materials can be transferred safely between rooms without the need for staff to enter the hazardous area unnecessarily, further minimizing exposure and PPE waste.

Ensuring proper ventilation systems to maintain the required negative pressure and prevent exposure is critical in the hazardous compounding area. The facility utilizes double-HEPA filtered hoods to avoid external ventilation in a multilevel building, while maintaining flexibility to rearrange the space without major adjustments to current systems. Pressure sensors and airflow monitors help ensure staff work in safe spaces while compounding.

Celebrating Hard Work

After 3.5 years of planning, construction, and phased transitions, Cleveland Clinic completed the compounding area renovation in 2024 with a ribbon-cutting ceremony to not only mark the completion of the renovation, but also to celebrate the dedication and collaborative efforts of the technicians, pharmacists, leadership, and construction teams who endeavored to ensure patient care was not interrupted during the renovation.

The facility now dispenses approximately 350 complex nonsterile compounds per week and remains committed to expanding patient access, enhancing efficiency, and continuously improving operations. Dosage forms include creams, ointments, suppositories, capsules, suspensions, solutions, enemas, etc.

Conclusion

The completion of this renovation marks a significant milestone for Cleveland Clinic’s pharmacy services. By investing in a creative design with dedicated compounding areas separated by an anteroom and pass-through, leveraging innovative technologies, and maintaining strict adherence to USP <795> and <800> standards, the newly renovated space enhances our ability to serve the most vulnerable patients in our community.

Trey Tietz, PharmD, MHA, is the Euclid Avenue ambulatory pharmacy manager at Cleveland Clinic. Trey is an award-winning member of the Ohio Pharmacist Association (OPA) and actively participates in their Compounding Special Interest Group. He also played a pivotal role on Ohio’s Board of Pharmacy USP 800 Task Force, shaping hazardous drug handling regulations across the state.