Category: Professional Posters
Purpose: The Investigational Drug Service (IDS) is responsible for dispensing and performing drug accountability for about 550 clinical trials. Approximately 60% of our studies are in oncology and 30% for other internal medicine subspecialties. Our service fully moved into the central pharmacy at the Huntsman Cancer Hospital in April 2019. Before this move, IDS operated from its own location. This report describes the workflow process opportunities and challenges IDS faced following a change in location.
Methods: In the summer of 2018, the IDS staff started to prepare to move into the central pharmacy. The new location created the need to change some major IDS operational workflow processes - study documentation, inventory / drug returns, and study monitor and audit visits. The technicians and a pharmacist developed a process to convert our paper binders to all electronic binders. Key steps included the development of a checklist denoting which binders and sections of each binder were scanned, uploaded, and reviewed. There were at least 2 reviews per binder. Inventory technicians also contacted all study sponsors and clinical research associates (CRAs) for ongoing studies to inquire about saving drug returns and used investigational product vials. Pharmacists informed study sponsors and CRAs about the drug return and destruction processes during site initiation visits. Updated drug return information was entered in to the study file in the IDS electronic drug accountability database. The monitor technicians started to inform CRAs in fall 2018 regarding changes in drug accountability processes during study monitor and auditor visits. These technicians take time-date-stamped pictures of unused investigational product. These pictures are sent the evening prior to the individual coming to conduct the study visit. During the scheduled visit, the CRA may request to view investigational product through a video calling service.
Results: IDS now shares workspace, IV compounding, and storage of hazardous drugs with central pharmacy operations. Moving into the central pharmacy also helped us maintain compliance with proposed USP 800 regulations. Our service transitioned to all electronic documentation for activities associated with study drug accountability and dispensing. All documents formally housed within a binder are now viewable within our electronic drug accountability database. We no longer permit the retention of drug returns or used vials for newly started trials. We were able to reduce the number of returns or saved used vials for ongoing trials by about 50%. This change provides us more shelf space to meet the growing demand of clinical trials. Our study monitor and auditor process was optimized to allow onsite and remote monitoring appointments. Study monitors are not permitted in the new IDS location to perform drug accountability in the traditional way. For drug accountability purposes, a pharmacy technician takes pictures and uses a video calling service. This change has allowed the technicians to optimize their time while a study monitor is here and has helped decrease monitor visit times. All standard operating procedures were updated to reflect new workflow processes.
Conclusion: The optimization of these workflows allowed the IDS staff to meet the demands of our new and shared space with central pharmacy operations and enabled compliance with USP 800 and Utah pharmacy law.