At Children’s Hospital Los Angeles—a 365-bed, academic, pediatric medical center—the pharmacy department prepares multiple compounded injectable medication batches of patient-specific doses throughout the day. These batches include several standardized concentrations per medication to meet the diverse needs of a population with a wide age and weight range.
The California State Board of Pharmacy requires a record be kept for each compounded sterile drug product that includes the date the product was compounded; the pharmacy personnel who compounded it; the pharmacist who reviewed and verified the final product; the quantity of each component used during compounding; the manufacturer, expiration date, and lot number of each component used; the pharmacy-assigned reference or lot number for the compounded product; the expiration date of the final compounded product; and the quantity or amount of drug product compounded. The pharmacy must maintain and retain these records in the pharmacy in a readily retrievable form for at least three years.
Until recently, all our compounded sterile preparations (CSPs) were documented using a paper-based system. The manual nature of this documentation process, as well as the effort and physical space necessary to store and sort through paper records in the event of a problem or product recall, was deemed inefficient and prone to error. We determined a need for a safer and more effective system for documenting our compounding processes in late 2012.
Remote Validation of Compounding Processes
The layout of our central pharmacy imposes certain logistical challenges to efficient workflow, as the department consists of three decentralized pharmacy satellites dispersed on different floors connected by a single pharmacy-dedicated elevator. Therefore, substituting staff during breaks or shift changes, or recalling a pharmacist to the cleanroom to validate a CSP under our manual process was highly inefficient. The key for us was to find a technology that could enable remote visualization and checking of the compounding steps by a pharmacist from various locations within the pharmacy, rather than always from within the cleanroom. Given our unique needs, we chose to implement Grifols’ PhocusRx, a camera-based system that offered this capability through photo capture.
The PhocusRx was implemented and activated in May 2013 and we found it instantly easy to use. The system’s camera is installed in the ceiling of the cleanroom within a sealed, clear-domed container, and is linked to a monitor interface located on the side of the compounding hood. With proper placement of CSP source products, the high-resolution camera is able to capture the above-mentioned final product information from within the hood. A designated pharmacist is then able to check each step performed in the compounding process and use the system to validate or reject the final product against the original order. All image files are saved on our facility’s cloud server, which can be searched by date, drug, lot number, and patient in order to obtain documentation in case of a recall or other medication-related issue.
Installation and Training
Representatives from Grifols came on-site to install the system and appropriately focus the camera. They were helpful in troubleshooting any issues, such as our initial difficulty with focusing the camera on the various sized labels used on our IV bags, versus the smaller labels used for syringes and vials. They ultimately set up the camera so we could zoom in and out on every label size for accurate documentation. PhocusRx is a fairly simple tool to master, nonetheless, Grifols did provide training to our end users and provided support to help us establish our policies and procedures.
Benefits and Future Expansion
This system has proven particularly effective for our operation, especially during the night shifts when we have only two pharmacist FTEs on schedule. For any CSP, we can review the photographic files to ensure proper products and amounts were used in the appropriate manner. Because California’s sterile compounding regulations require hospitals to document the production process of all CSPs, this system allows us to maintain the necessary information without the labor-intensive practices of a paper-based system.
While the PhocusRx does not replace the specialized skill sets of the technicians creating CSPs or the pharmacists verifying those CSPs, it does provide a quality tool to demonstrate that proper protocols are being followed and the attendant assuredness of visually documented process steps. Most important, it has enabled us to improve patient safety, meet regulatory requirements for sterile compounding, and provide a more efficient working environment for our employees. We currently have a single camera system set up within the main compounding cleanroom of our pharmacy, but our plan is to implement the system in all the different areas CSPs are created, including our oncology compounding cleanroom and our offsite infusion center slated to open later this year.
Carol Taketomo, PharmD, serves as the director of pharmacy and clinical nutrition at Children’s Hospital Los Angeles and as an adjunct assistant professor of pharmacy practice at University of Southern California School of Pharmacy. She received her PharmD from the University of Southern California School of Pharmacy and completed an ASHP-accredited residency at University of California at San Diego’s University Hospital.