Preparing and administering chemotherapy and other hazardous drugs (HDs) poses a safety risk to health care workers and patients who may come into contact with these medicines. Closed system drug-transfer devices (CSTDs), such as PhaSeal, protect staff from exposure when preparing and administering HDs. CSTD use is becoming more prevalent, driven by an increased understanding of the risks of exposure, as well as the requirement in USP <800> for nursing to use CSTDs during HD administration and recommendation for CSTD use in the pharmacy when preparing HDs, which will be enforceable as of July 1, 2018.

The Ohio State University Wexner Medical Center (OSUMC) comprises six hospitals with a total of 1367 beds. Among these is The James Cancer Hospital and Solove Research Institute (The James), which comprises 350 inpatient cancer and critical care beds, and utilizes the majority of HDs across the health system. In addition, across six outpatient locations, a total of 178 infusion beds and chairs are available to deliver chemotherapy and supportive care medications to cancer patients. Approximately 1500 doses of chemotherapy are prepared system-wide weekly. Chemotherapy is compounded at the inpatient pharmacy and at the six infusion pharmacy outpatient locations. Within the cleanrooms, Class II, type B2 biological safety cabinets (BSCs) are utilized at most of these locations, with one location utilizing a compounding aseptic containment isolator (CACI).

Evaluating the HD Handling Process

Following the 2004 publication of NIOSH’s Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, The James developed a multidisciplinary team, comprising administration, quality, nursing, pharmacy, environmental services, and employee health, to define HD handling practices. Each team discipline utilized a gap analysis tool to assess its processes and compare them to the recommendations in the NIOSH document. One resulting recommendation was implementing CSTDs to minimize staff exposure to chemotherapy during drug preparation and administration.

Choosing a CSTD

The multidisciplinary team evaluated all of the available CSTDs to identify which device would best suit our requirements. At the time of the analysis, the group determined that only two available CSTDs provided a truly closed system. The PhaSeal CSTD creates a closed system from vial to syringe, syringe to IV bag, and IV bag to patient, thus preventing chemotherapy from contaminating work surfaces, employees, and patients.

The James began a pilot study utilizing PhaSeal at one outpatient location before expanding use across the system in 2005. Ultimately, the team decided on PhaSeal for a variety of reasons, including positive feedback from our front line staff, supply chain stability, and product maturity. The multidisciplinary team continues to evaluate new CSTDs as they come to market.

Staff Training

Staff meetings were held to explain the safety benefits of CSTD use, and were extremely effective in gaining staff buy-in for using the device. The reduction in surface contamination, as demonstrated by internal wipe studies, helped to reinforce this benefit. Wipe studies are repeated across the health system every 6 months; 36 surface samples are taken from various locations that may come in contact with chemotherapy, such as inside the BSC, the pharmacy floor, the pharmacist’s checking table, the nursing station, and in patient rooms. The results have been consistently negative for trace chemotherapy contamination.

Implementing a CSTD impacted both pharmacy and nursing workflows. Although new processes had to be developed, staff quickly became accustomed to using the device, and the initial preparation time increases diminished with device mastery. Staff continue to express satisfaction with the device, as it greatly reduces their risk of HD exposure.

The vendor representatives and training materials have proven effective in educating interns, technicians, and nurses on device manipulation. Trainees typically spend a half-day learning the different PhaSeal components and the processes for compounding different products. Following component and process training, new hires undergo hands-on training using the device, first outside the cleanroom, and ultimately within the BSC utilizing saline.

Conclusion

Implementing CSTDs throughout the health system has promoted safe handling practices and ensured staff safety throughout the preparation and administration processes. Moving forward, regular training, competency evaluations, and wipe studies help ensure staff continue appropriate use of the CSTD, thus preventing HD exposure.

Ryan W. Naseman, PharmD, MS, BCPS, is the assistant director of pharmacy and infusion services at The Ohio State University (OSU) James Cancer Hospital in Columbus, Ohio, where he manages the ambulatory infusion program, investigational drug services, and nuclear pharmacy. He received his PharmD from Ohio Northern University, and an MS in health-system pharmacy administration from OSU while completing a combined PGY1/PGY2 residency in health system pharmacy administration at the OSU Wexner Medical Center. Ryan’s professional interests include automation and technology, workflow/efficiency and productivity analysis, and hematology/oncology pharmacy practice.