Simulation of a worst case scenario of cytotoxic chemotherapy production without informatics data processing

Aims

Informatics data processing is a major lock in securing production of chemotherapies. In a major informatics disruption, establishment of a degraded procedure should guarantee usual levels of quality and safety. The process including production management documents and a thesaurus of information on protocols and molecules is required. Procedure and related documents have been evaluated and tested in simulation.

Methods
Procedure and related documents were evaluated by all pharmacy technicians (PT). Degraded Steps of the procedure are :

• Dose calculations and manufacturing form completed by the pharmacist;
• Double check on manufacturing form and labels completed by PT;
• Double check on labels by the pharmacist
• Stock management form completed by PT.

Worst case simulation of one hour of production with two PT, controlled by two pharmacists.
Times of preparations, encountered difficulties and critical points were noted.

Results

The elaborate forms were estimated readable and ergonomic, applicable for all types of packaging. Only the stock management form require better readability for the management of bottle remainders. Based on 10 preparations made, an average of 13 additional minutes per preparation was estimated. No differences were observed at the dose calculations.

Discussion and conclusions

In the absence of informatics data processing, the additional preparation time would require the presence of an additional PT. The procedure will be included in the training program and annual reassessment of PT. The informatics data processing eliminates risks of errors related to human, anticipating its interruption is essential. This annual simulation exercise will be extended to complete chemotherapy process integrating care units.