Implementation of a video-traceability system (Drugcam^®) for the compounding of injectable investigational anticancer drugs: experience from a hospital compounding unit

Background
The compounding of injectable investigational anticancer drugs requires stringent traceability in compliance with Good Clinical Practice. Video-traceability systems such as Drugcam^® (DC) support both in-process and retrospective checks. The Clinical Trials (CT) module developed by Eurekam automatically identifies patient allocation numbers and detects traceability data on vials (batch number, INN, study name). Our unit implemented this module to secure a process that until then relied on a visual double check against a paper compounding worksheet, and to increase technician autonomy.

Materials and methods
Implementation was carried out over three months on the CT-dedicated isolator. After installation and vendor qualification, a pharmacy working group identified the trials compatible with DC. Operational and performance qualification used DC test and Chimio^® test. Allocation-number management was activated in Chimio^® so that it could be traced in DC. Vials from the selected studies were configured with a pharmaceutical double check. Technicians were trained over two weeks under supervised operation, followed by competency sign-off.

Results
Of the 14 ongoing protocols involving injectable drugs (33 INNs), 11 (23 INNs) were considered DC-compatible and integrated. Once implementation was complete, 275 clinical-trial preparations were compounded, 157 of them (57%) through DC. Residual use of the visual double check was due to a one-week IT breakdown, four days of unavailability of the dedicated isolator, 40 preparations excluded from the module (no study name on the vials, unsupported dilutions), and the addition of new drugs during the period. Placebos and specific injection devices were handled by manual photographs. DC detected a single error (volume error), and no failure to correctly read vial data was observed.

Discussion / Conclusion
This implementation demonstrates the operational feasibility of a video-based digital double check in the clinical-trial setting. The 57% rate reflects circumstantial constraints rather than intrinsic limitations of the system. Compounding time was longer for preparations requiring prior reconstitution, as vials had to be presented twice. One limitation was reported to the vendor: the vial-reading interval between two items (1 s vs 3 s in the conventional module) creates a risk of reading the same vial twice. Provided these technical issues are resolved, DC is a relevant tool to secure and strengthen the clinical-trial compounding process. An internal procedure is being drawn up to deploy the module to all new trials as soon as the first patient is included.

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