Securing the CAR-T-cells (Chimeric Antigenic Receptor – T) supply chain management: Welcome to cognitive aids !

Background
CAR-T-cells are advanced therapy drugs in full development. Their long and complex medication system is subject to specific regulations. It is essential to control all the stages in this circuit and any unexpected risk situations that may arise. The aim of this project is to establish a risk management strategy and improve the safety of this process. The tool envisaged is the use of digital cognitive aids.

Method
A multimodal approach was used: cross-analysis of protocols, risk mapping analysis, various existing documentary supports analysis for the CAR-T-cells circuit and a questionnaire to identify the user needs. This preliminary datas were used to customise personalized digitalized cognitive aids via an application (MAX Medae^® - a customisable cognitive assistant for complex or unexpected professional situations).

Results
Five cognitive aids have been created: Check-list (CL) Reception watch, CL Reception, CL Injection watch, CL Preparation defrosting, CL Defrosting. Each cognitive aid sequences the actions to be carried out into groups of blocking or non-blocking steps. Validation of the step consists of ticking actions, entering data and answering a question. A final report is produced at the end of the procedure, enabling the process to be traced and statistical data to be extracted for each operator. Logging in using a nominative code means that traceability requirements can be met. Incident management scenarios have been included in the cognitive aids. Each cognitive aid was validated by consensus with the pharmaceutical team before being implemented. Deployment has been gradual. Operators are still being trained in their use.

Discussion-Conclusion
This project allowed to strengthen the security of the critical stages of the CAR-T-cell circuit in an innovative way. Initially, paper-based CL and traceability are kept in parallel with MAX^®. The operators identified the harmonization of practices, the time saved in traceability and a high level of safety and risk prevention. Cognitive aids reduced operators’s mental workload in complex or high-risk routine situations. MAX^® is easy to use and it is always possible to improvement. Communication around the project is essential in order to raise awareness and train users in the use of MAX©. This will gradually be extended to other pharmaceutical areas.