Feedback from 2 years of reinforced visual control to secure the chemotherapy compunding

Numerous approaches, using analytical or video-assistance systems, are implemented to guarantee the quality of chemotherapy preparations. In our unit, analytical control (AC) by flow injection analysis (FIA-UV) or chromatographic analysis (HPLC-UV) coupled with UV detection enables the control of 70% produced preparations. To secure the remainder of production, a strategy of reinforced visual control with validation by a third person has been put in place. During production, the reconstitution, the name and volume of the drug, and volume withdrawal if necessary, are noted by an operator blind to the production sheet, on a form with the Chimio® label. This form is sent to the control laboratory for reconciliation of the information via an Excel^® table. Compliant preparations (right product at the right dose +/-5%) are validated for dispensing. The aim of this study was to assess the factors influencing the performance of the double visual control system.
A retrospective analysis of visual checks from January 2021 to December 2022 was carried out. Molecules were classified into two product types: clinical trial or non-trial, by operator who inspected (dedicated or non-dedicated personnel). Days on which the AC failed were indicated as critical. According to our process, for AC failure rate less than 50%, the visual control are carried out by a PPH operator in the production area, in addition to his daily work. Above 50% of AC in visual inspection, one person is dedicated to the visual control. A multiple linear regression model was developed using R software to identify the factors influencing preparation conformity.
A total of 20,629 preparations were checked by visual control, including 133 non-compliant preparations (0.65%). 12% of preparations showed an error in the type of reconstitution solvent, 31% an error in the volume of reconstitution solvent, and 77% an error in the quantity of active ingredient. Many of these errors were linked to visual control failures. The number of non-conformities is notably linked to the control of products to be reconstituted (OR = 4.31, p-value =0.001) or the type of product to be controlled (OR = 3.45, p-value = 0.028) on so-called critical days when visual control is carried out by PPHs.
Thus, the reconstitution step and the person carrying out the control appear to be key points. To consolidate this step, the organization of the production unit has been revised. A person dedicated to double-checking has since been added to the team on days identified as critical. Despite the human failings associated with double visual control, this tool remains a reliable means of ensuring the safety of the chemotherapy circuit and guaranteeing 100% control of the preparations produced in our unit.

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