As evidenced by the recent introduction of USP <800> Hazardous Drugs—Handling in Healthcare Settings, greater regulatory focus is being directed on the safe handling and manipulation of hazardous medications, including chemotherapy. With this in mind, it is vitally important to maintain an isolated area for the production and storage of chemotherapy within the pharmacy in order to protect staff from exposure. By limiting access only to those trained in the receiving, stocking, preparation, and disposal of chemotherapy, exposure risk is mitigated for all other staff in the department.
The lack of a separate, dedicated space for chemotherapy storage and preparation clearly exacerbates both the risk of exposure to everyone who accesses the physical location, including housekeeping and supplemental staff, as well the risk of contaminating other, non-hazardous compounded medications, this same risk exists when the same preparation area is used for both chemotherapy and non-chemotherapy compounding. Recognizing the safety and practice benefits of segregating chemo from other cleanroom-centric operations is one thing, but creating an operational workflow that facilitates isolation and segregation is another.
Create Layers of Isolation
Brigham and Women’s Hospital (BWH) in Boston began using its current sterile products room (SPR) in 2001, which comprises an anteroom and staging area (both ISO Class 8), and a main compounding buffer area (ISO Class 7). In addition, there are three pass-through windows between the staging room and the compounding room, one of which is specifically dedicated to transferring chemotherapy and related products. Within the staging area, there is a dedicated location for chemotherapy dose setup and for checking those doses once they have been completed, and within the compounding room, there is a hood used exclusively for chemotherapy compounding.
The number of staff members stationed in the SPR at any given time ranges from one to eleven depending on the time of day, the day of the week, and the present workload. However, the bulk of medication compounding is performed between 7AM and 11PM, including chemotherapy, which is always patient specific. One pharmacist and one technician are perpetually assigned to prepare, compound, and check chemotherapy, exclusively from 7am to 3:30pm (weekdays). From 3:30PM to 11PM (as well as weekends), the pharmacist and technician have additional duties. Although designating specific areas for storing, preparing, compounding, and checking chemotherapy doses is a worthwhile endeavor for limiting exposure and contamination risk, BWH is pushing for further isolation of these activities. By the end of 2014, the pharmacy at BWH will operate a wholly separate, negative pressure SPR dedicated solely to storing and preparing chemotherapy.
Product Proximity is Key
In an effort to locate the products needed for chemotherapy compounding as close as possible to the actual compounding process, BWH decided to place automated dispensing cabinets (ADCs) within the SPR staging area. Thus, all products are stored in a dedicated ADC that includes an attached refrigerator unit. By closing the proximity between storage and processing areas, we have reduced the frequency with which staff members must enter and exit the SPR. BWH also utilizes the ADCs in the SPR to facilitate efficient and streamlined inventory and drug ordering processes. As products are removed from the inventory during the course of the day, the ADC’s software generates a daily report that is automatically sent to the purchasing department. Purchasing is then able to place an order for any medication products that have fallen below pre-established reorder levels.
Segregate Chemotherapy Products
Maintaining non-chemotherapy medications in close proximity to compounding activities, especially high-use products, also fosters efficiency. Thus, BWH pharmacy maintains a separate ADC in the SPR for non-chemotherapy medications that are most frequently used, such as antibiotics, as well as other medications that are exclusively manipulated within the SPR, such as liposomal amphotericin B, IV IgG, epoprostenol, treprostinil, and belimumab. As with the chemotherapy products, SPR-specific medication reorders are automatically triggered through the cabinet software when the inventory drops below predetermined levels. This ability to communicate with our purchasing department and the ease of making adjustments to the par levels in the cabinets allows us to react quickly in the event of transient increases or decreases in usage, and helps us avoid stock-outs.
The items stored in the ADCs are easily transitioned on an as needed basis. For example, the pharmacy recently experienced increased orders for patient specific compounding of labetalol infusions. The vials were previously stored in the central pharmacy area and as the orders increased, staff had to leave the SPR to acquire replacement quantities as frequently as every 30 minutes. By adding labetalol vials to the SPR cabinet and setting an adequate par level, we were able to greatly reduce the traffic in and out of the SPR.
Adjusting par levels in the ADC software is a straightforward process. After a recent usage review of different sized bottles of IV IgG—we were carrying 10 g, 20 g, and 30 g bottles, with 10 g bottles accounting for the bulk of the inventory—we found that the 10 g bottle actually was used least often. The technicians preferred to pull the 20 g or 30 g bottles because those volumes were easier to pool for the doses needed. After discovering this, we were able to easily adjust our inventory by decreasing the ADC par level for 10 g bottles and increasing the par levels of 20 g and 30 g bottles. This has reduced the amount of expired or near-expired IgG in our inventory.
Chemotherapy orders placed in the computerized physician order entry (CPOE) system appear in the pharmacy order approval system (POAS) once they have been signed off by the physician and activated by the nurse. As orders appear in the POAS, a pharmacist will assess then approve the orders. For chemotherapy orders, a second pharmacist’s approval is required before the orders will appear on the dashboard of the pharmacy verification system. Once an order is routed to the dashboard, its specific label will print with an associated bar code in the SPR’s anteroom. The medication and diluent are then removed from the ADC and scanned into the dashboard, which includes the lot number and expiration date of the medication. A preparation label will print and the items for the order are placed in the chemo-specific pass through window for the technician to prepare. Once completed, the dose is then retrieved through the same pass through window by the pharmacist who electronically verifies the dose using the label bar codes and visually confirms that the order was made properly. Verified chemotherapy doses are then individually bagged in chemotherapy-labeled bags prior to being brought out to the central pharmacy where they are placed in bins to be delivered to the floors.
In addition to the forthcoming negative pressure SPR for chemotherapy compounding, BWH also is implementing a workflow assist device and robotic IV compounding technology. Our goal is to conduct all chemotherapy compounding using technology with gravimetric control.
BWH has realized excellent practice benefits from storing both chemotherapy and non-chemotherapy medications in ADCs in the SPR. Maintaining these products in close proximity enables quick turnaround without requiring staff to exit and re-enter the clean areas repeatedly throughout the day. Furthermore, since inventory data managed through the ADC’s software can be retrieved electronically and reports can be generated automatically, we are able to continually assess and refine our inventory leading to a low overhead. We no longer have to count inventory manually and can generate a usage report for any individual item at any time. This is particularly helpful during our large-scale fiscal year inventory process.
Current best practices dictate that all hazardous medication storage and compounding should occur in a negative pressure cleanroom. Therefore, it is wise to review your current ADC technology to see if it can be used for storage and inventory within the cleanroom or anteroom; it is easier to assimilate technology that is already in use and your staff is familiar with. Also, make sure the technology can actively generate the data and reports necessary to enable automatic inventory management and reordering. Likewise, if new technology is required, be sure it can interface with your current hardware and software systems, especially those used by the purchasing staff.
Lastly, do not underestimate the need for staff training in the proper use of ADC technology in the cleanroom setting. Accountability is key and undisciplined use of the ADCs may result in incorrect inventory counts. The electronic inventory and ordering systems will not work properly if the actual quantity on hand does not match what is indicated on the ADC. Such inaccuracies easily can lead to improper or unnecessary ordering and resulting stock-outs. Conversely, a well maintained ADC system for both hazardous and non-hazardous medications used in a sterile area can greatly improve operations while maintaining medication safety for patients and practitioners.
Caryn Domenici Belisle, RPh, MBA, is the pharmacy manager of sterile products and robotics at Brigham and Women’s Hospital. She received her BS in pharmacy from the Massachusetts College of Pharmacy and her MBA from the University of Massachusetts. Caryn currently holds the office of President-Elect of the Massachusetts Society of Health-System Pharmacists. Her areas of expertise include USP <797>, sterile product robotic and workflow technology, and pharmacy operations.
Josephine H. Leung, PharmD, MBA, is a senior pharmacist at Brigham and Women’s Hospital. She received her PharmD from University of Maryland, School of Pharmacy and her MBA from University of Baltimore, Merrick School of Business. Josephine’s primary role for the last three years has been as the BWH ambulatory infusion clinic pharmacist. Her areas of expertise include rheumatoid arthritis, Crohn’s disease, and other immune-mediated diseases, as well as USP <797>.
Remember to Clean Storage Areas
Regardless of whether you store medications on static shelves in the central pharmacy or inside an ADC within the cleanroom, ensuring cleanliness—especially when hazardous medications are involved—is paramount. Whether this is done by pharmacy staff, housekeeping or maintenance staff, or an outside services supplier, the key is making sure cleaning is performed correctly and regularly, and to document this process.
At BWH, the pharmacy contracts with an outside cleaning company that performs all cleaning activities in the SPR. The ADCs housed in the SPR are cleaned daily using rotating disinfectants and sterile 70% isopropyl alcohol (IPA) wipes. The top of the ADCs are cleaned monthly using the rotating disinfectants and sterile 70% IPA.