Is it possible to achieve 100% automated controls in a chemotherapy production unit?
23 November 2020V. Velasco Gonzalvo , A. Acramel, C. Levenbruck, C. Cros, A. Hurgon, L. Escalup. Pharmacy Department, Institut Curie, Paris, France.
A production assistant controlled by Chimio® software, integrating in-process gravimetric control (Cytocontrol® balances) and vial recognition (with barcode labeling) is used for most of the manual preparations carried out in our production unit. For other preparations, the double visual check is used. Our goal is to achieve maximum controlled production without human intervention by considering three major issues: production security, increased productivity and reduced patient waiting time.
We analyzed production data over a period of 4 months (September 1 to December 31, 2019). Then, we assessed the feasibility of extending our reference method and the possibility of implementing additional methods. This evaluation was based on a scientific literature review and feedbacks from centers practicing different control methods.
Over the period studied, 16,339 preparations were carried out: 12,598 (77.1%) were checked by in-process gravimetric control; the remaining part (22.9%) was controlled by double visual check.
The extension of our reference method to 4 cytotoxic drugs requiring to be reconstituted before use (cyclophosphamide, ifosfamide, pemetrexed, vinblastine) will make it possible to check 84.1% of our preparations by in-process gravimetric method.
The acquisition of a workstation equipped with the Drugcam® digital video dedicated to clinical trials (6.6% of our production), products with temporary authorization for use (called “ATU” in France, 0.6%) and intrathecal preparations (1.8%) would increase the proportion of automated controls to 93.1%.
After studying the different control methods available on the market, we first decided to extend our reference method, which required optimizing the process for over-labeling the vials and their pharmaceutical release.
In addition, we have considered the acquisition of a Drugcam® workstation dedicated to clinical trials, “ATU” and intrathecal preparations. Drugcam® would allow us to do away with the human intervention dedicated to double visual check and would improve quality and traceability thanks to the possibility of making a video recording of the preparation.
Analytical methods (QC Prep® and HPLC) were not retained because of too great constraints on our organization.
Finally, we could only reach a rate of 93.1% of automated controls due to the following preparations which nevertheless require a human visual control: intravitreal preparation, oral syringes, complex dilutions and / or non-computerized procedures and volumes to be withdrawn less than 1 milliliter