Securing the Preparation Process for Sterile Injectable Anticancer Drugs in a Cytotoxic Safety Cabinet

Introduction & Background
The preparation of sterile injectable anticancer drugs is a complex process for which risks must be controlled. The increase in corrective maintenance of isolator sterilizers, together with their planned replacement, has increased activity in the cytotoxic safety cabinet (CSC), representing a critical transition period.

Objective
To perform a risk assessment in order to identify system vulnerabilities and implement an appropriate risk management plan.

Materials & Methods
A Preliminary Risk Analysis (PRA), based on the A. Desroches method, was conducted. A multidisciplinary working group (WG) modelled the system by defining the boundaries of the process. The system-level PRA consisted of identifying hazardous situations (HS) arising from interactions between system phases and associated hazards, and assigning each situation a prioritization index. Only HS with an index of 1 (strong to very strong interaction requiring immediate action) were retained for the scenario-based PRA. This analysis made it possible to identify, describe, and assess the initial criticality of scenarios and their consequences, and then to develop a risk management plan and estimate residual criticality after its implementation. Results were presented according to generic hazards and operational phases using Farmer and Kiviat diagrams.

Results
The process extended from receipt of a preparation order in the CSC to completion of the preparation. A total of 276 HS with an index of 1 were identified by cross-referencing the 5 system phases with the 10 associated generic hazards. The preparation and material provision phases were identified as the most vulnerable. A total of 559 scenarios were identified, including 222 (40%) with a C2 criticality level (tolerable under control) and 117 (21%) with a C3 level (unacceptable). The most critical generic hazards were related to operational factors (27%) and human factors (25%). The most critical operational phases were preparation (41% of C3 scenarios) and material provision (22.2%). Thirty-three risk-reduction actions were defined and prioritized. Of these, 57% involved training (healthcare simulation) and 33% involved document management.

Conclusion & Discussion
The PRA showed that the most critical risks were more closely related to human factors (stress, workload), operational factors (recruitment, worn equipment), and professional factors (training) than to technical failures. A risk management plan combining training, documentation, and organizational solutions was developed to reduce the likelihood of adverse events. However, organizational challenges and certain limitations must be considered, including a degree of subjectivity in scenario development, the large number of scenarios identified, and the exclusion of the most extreme scenarios.

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