Risk analysis relating to the implementation of a circuit of advanced therapies medicinal products in a comprehensive cancer center

Objective

Advanced therapies medicinal products (ATMP) represent a therapeutic revolution in patient care. These biological drugs are subject to specific regulations, which require the implementation of a risk analysis system. In 2021, the pharmacy department of our hospital decided to set up a circuit of ATMP, especially for the safe handling of viruses, as part of clinical trials upon request of oncologists. The aim of this project was to establish a risk map relating to each stage of this circuit.

Methods
A failure mode effects and criticality analysis (FMECA) was carried out from reception to administration in care services by a multidisciplinary working group composed of pharmacists, health managers, quality managers and engineers. The first step was to analyze each step of the circuit. For all of them, potential failures have been detected and quoted according to Frequency (F) and Severity (S) of occurrence. F and S were determined with a 5-level scale and Ci with a 3-level scale. The product of F and S gave an initial level of criticality (Ci): F x S = Ci. After the implementation of preventive actions, 5 levels of risk control (M) were determined. The product of Ci and M gave a second level of criticality, the residual Criticality (Cr), rating from 1 to 3: Ci x M = Cr

Results
Risk analysis allowed to identify 28 risks relating to the implementation of this ATMP circuit. Of these 28 risks and considering risk control level, 22 (78.6%) were so-called “acceptable” risks, for which there are means of prevention with an overall satisfactory level of control. Only 6 (21.4%) were risks “to be monitored”, for which there are means of prevention, but with a lower level of control and often independent of the pharmacy unit. None of the risks was considered to be "to be dealt with". Thirteen risks were assigned to a moderate initial level of criticality such as the risk of unusability of ATMP storage room (power failure, fire, etc.) and none with a high initial level of criticality.

Discussion-Conclusion}
This project allowed us to identify critical points to consider before the initiation of clinical trials. The risk analysis will be used for training staff in good practices of ATMP reconstitution and must be reassess in a statement of non-compliance.

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