With USP <800>’s impending enforcement date of July 1, 2018, many organizations are focusing their energies on designing and building compliant compounding pharmacies. In late 2016, Valley Health System in northern New Jersey renovated its outpatient center’s pharmacy, while also designing and building a compliant cleanroom. Our primary motivations for this project were to ensure the safety of our compounded sterile preparations (CSPs), become USP <797> and <800> compliant, increase the segregated compounding area’s square footage from 147 to 520 square feet, improve efficiency and workflow, and create a work environment conducive to staff collaboration.
Keys to Success
Partnering with an experienced, knowledgeable consultant was key to a successful project. Our consultant was chosen based on his extensive USP-compliance expertise to ensure pharmacy renovations were in line with <797> and <800>. In addition, his knowledge of real-world pharmacy operations was integral to ensuring an efficient workflow and designing the pharmacy with future growth in mind. Involvement from pharmacy leadership, pharmacy staff, nursing, and the construction team also was vital to an efficient design and renovation process, which was accomplished in 6 months from conception to completion. Soliciting input from all stakeholders ensured a sense of staff ownership of the process, as well as satisfaction with the outcome.
The compounding pharmacy opened for business over Thanksgiving weekend in 2016. Operating from 7am to 6:30pm, Monday through Thursday, the pharmacy is staffed by seven pharmacists, two pharmacy technicians, and an inventory coordinator. As required by USP <800>, the pharmacy has a separate area for hazardous drug (HD) compounding with three chemotherapy biological safety cabinets (BSCs) utilized for compounding in this area. The HD cleanroom also has separate space for pharmacist verification. One regular BSC is located in our non-HD cleanroom for non-HD compounding.
Chemotherapy and oncology products comprise the majority of medications compounded in the pharmacy, although we also compound supportive medications, infliximab, antibiotics, and IVIG. Our monthly compounding volume is approximately 4800 CSPs. Looking toward the future, we expect an increase in volume as our patient population expands. It is anticipated that stringent USP <800> requirements for compounding will prompt physicians’ offices to send more patients to our facility for chemotherapy treatment.
The pharmacy renovation has provided numerous benefits in terms of medication safety, USP compliance, workflow, and staff satisfaction. The most significant benefits include:
- Safety and Compliance. Pharmacy is confident that we are compounding safely and in compliance with USP <797> and USP <800>, following NIOSH guidelines, and in line with New Jersey Board of Pharmacy (BoP) requirements. In fact, a recent BoP inspection revealed no deficiencies.
- Improved Workflow. The addition of an extra chemotherapy BSC in the HD cleanroom provides compounding redundancy and ensures patients receive the medications they require. The negative pressure cleanroom is large enough to allow multiple staff members to work together safely and provides sufficient space for compounding, pharmacist verification, and medication storage.
- Staff Satisfaction. Soliciting input from compounding staff and pharmacists regarding the new pharmacy’s layout and features has ensured buy-in and satisfaction with the outcome.
Plans are underway for further expansion of the outpatient center. In late 2018/early 2019 we plan to build another new pharmacy, complete with an HD cleanroom. This pharmacy/cleanroom will likely be used to compound HDs and also shared with Valley’s research department.
See the photo spread on the following pages for images and details about the pharmacy renovation and cleanroom build.
The Central Pharmacy
Ronald J. Krych, RPh, MPA, is the director of pharmacy at The Valley Hospital in Ridgewood, New Jersey.
Carlo Lupano, RPh, MBA, CCP, FASHP, is the pharmacy manager for ambulatory services at The Valley Hospital in Ridgewood, New Jersey.
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