The benefits of the Global Risk Assessment (GRA) to secure the centralized production of chemotherapies

23 November 2020

S. HOUARI1, F. CAMUS1, A. GOHARI1, F. TENDJAOUI1, C. DUVERNET1, M. YAV1, G. BENOIT1, J. FILLON1 1 - Pharmacy Department; Tenon University Hospital (AP-HP)

The management of the risks linked to the chemotherapy production requires the use of retrospective approaches such as Feedback Committees (CREX) or prospective methods. The French National Authority for Health (HAS) recommends the use of prospective analyzes using qualitative and quantitative methods. The purpose of this study is to implement prospective analysis using the GRA method in order to assess its feasibility and evaluate the impacts of the final results.

Materials and method
The prospective analysis was carried out during 8 30-minutes meetings set between November 2017 and June 2018 by a working group of pharmacists and pharmacy technicians from the chemotherapy preparation unit. The first step was to proceed a functional analysis of the entire production process, from the reception of the prescriptions to the delivery of the preparations to the clinical ward. Following this analysis, cartography of dangerous situations (DS) has been constructed by the working group, and a priority index has been assigned to each DS. The priority DS were broken down into scenarios to which a likelihood and severity index were associated. From these two indices an initial criticality index (Ci) (acceptable C1, tolerable under control C2 or unacceptable C3) has been determined. Scenarios Ci = C2 or C3 were addressed with risk reduction actions (RRA) to achieve a residual criticality level (Cr) under Ci. The required resources for the implementation of the RRAs were quantified using an effort scale defined by the working group. Their effects were hierarchized according to their expected effectiveness.

The working group has identified 82 DS, of which 15 were considered as priorities, resulting in 44 accident scenarios, including 1 with unacceptable criticality (remainder mishandling). The study has highlighted that the higher risk is the human risk, which considers all the risks related to the human workforce (61% of the scenarios) gathering all the human errors is the most represented. The results also demonstrate that the production stage in the isolator is the most critical post in the production line as 48% of the scenarios were identified there. A risk reduction action plan with 9 RRAs has been drawn up, covering all the priority scenarios. This plan led to a reduction in the number of acceptable scenarios under control (18% to 5%) and helped resolving the unacceptable scenario (by revising our procedures and improving the visual controls traceability). 1 RRA requires a low effort, 3 RRAs a medium effort and 1 RRA needs a high effort. Among the risk reduction plan, 2 RRAs are very effective (standardization of the process), 2 moderately effective and 5 RRAs has a lower effectiveness level.

Discussion / Conclusion
The GRA method allowed us to quickly identify; prioritize and manage the risks in the production process. This method is a suitable method for risk assessment in chemotherapy production units, and can be implemented for each major production change. GRA method has demonstrated itself to be an efficient way to improve the quality level of the chemotherapy production unit.

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