Background and Importance As part of a quality assurance approach, a UV-visible spectrophotometer has been installed in 2021 in the cytotoxic reconstitution unit (CRU), enabling pre-release analytical control of cytotoxic preparations. This new step has led to a new risk analysis using the FMECA method (Failure Modes, Effects and Criticality Analysis).

Aim and Objectives The aim was to evaluate the entire injectable chemotherapy process compared to an initial FMECA carried out in 2016 in order to assess the added value of the DrugLog® tool.

Material and Methods The FMECA was carried out between June and September 2023. Six multidisciplinary working meetings were held, attended by two pharmacists, one intern and one pharmacy technician. The failure modes (FM) identified in 2016 were reassessed for a total of 97 FM in 2023, divided into 10 themes. For each FM, a criticality index (CI) based on frequency (F), severity (S) and detectability (D) was calculated using the formula: CI=F×S×D. The CIs were divided into three categories: mild (CI<25), moderate (25<CI<50) and severe (CI>75).

Results Of the 97 FMs identified, 94 were of mild criticality (97%), three moderate (3%) and 0 severe. In 2016 and 2023, 70 items were common. The cumulative CIs were similar (806 in 2016 compared with 809 in 2023). A decrease in cumulative CI was observed in the personnel (-58%), validation (-69%) and release (-46%) themes. However, a sharp increase was observed in the premises (+55%), equipment (+31%), tray preparation (+48%), and transports (+41%) areas.

The FMECA was used to assess DrugLog®: 18 FM were selected: 100% were of mild criticality, for a cumulative CI of 163.

Conclusion and Relevance FMECA’s comparison confirms the added value of DrugLog®. Its implementation secures the release process. All the FM specific to DrugLog® are of mild criticality and make it a useful tool for the CRU process.

Conflict of Interest No conflict of interest.