Implementation of Datamatrix Codes on Vials: A Time-Saving Measure?

Objective
Since 2016, the Oncological Clinical Pharmacy Unit (UPCO) has been equipped by the DRUGCAM^® video-digital control (VDC) system to enhance the safety of the injectable chemotherapy drug preparation process. This VDC system enables in-process control and relies in particular on its ability to read Datamatrix codes to identify vials. In the absence of a Datamatrix, identification is based on an image library. This study aims to assess how the presence of Datamatrix codes on the primary packaging of vials can serve as a lever to improve the safety and efficiency of the injectable chemotherapy production process.

Methods
The study is based on the introduction of Datamatrix codes on Holoxan^® (Ifosfamide) vials in October 2024. Data were extracted via DrugCam^® for two distinct two-month periods: before (November 2023 and September 2024) and after (October and November 2024) implementation. The variables analyzed include preparation time, vial recognition errors, isolator used, batch or individual pharmaceutical release, and day of the week. Preparations that were destroyed or carried out on Sundays were deliberately excluded. A total of 372 preparations were analyzed (211 without Datamatrix, 161 with), using descriptive analyses and comparative tests performed on R Studio^®.

Results
The analysis demonstrated a significant reduction in vial recognition errors following the implementation of Datamatrix codes. In the absence of Datamatrix labelling, errors were observed in approximately 25% of cases, compared to only 6% when vials were equipped with the code (p<0.001). No statistically differences were identified regarding preparation time, isolator assignment, or day of the week. Furthermore, the occurrence of a recognition error did not appear to significantly impact preparation time. Finally, the use of Datamatrix coded vials was associated with a higher proportion of batch releases compared to non-coded vials (74% vs. 63%).

Discussion and Conclusion
The integration of Datamatrix codes on Holoxan^® vials has enhanced identification reliability and reduced task interruptions. Batch release was found to streamline the preparation compared to individual release, which necessitates additional controls and result in more frequent disruptions. While preparation time remained unchanged, the reduction in human interventions enhances organizational efficiency. These findings support the broader implementation of Datamatrix codes on all vials to improve the safety of chemotherapy preparations. However, this objective has yet to be fully achieved: as of January 1, 2025, only 58% of injectable anticancer drug vials (75 out of 129) in our formulary were equipped with a Datamatrix code.

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