Return on 7 years-experience of automation of the production of chemotherapies

A. Hurgon , FA. Chastang, A. Chassin, A. Pelloquin, L. Escalup Department of Pharmacy, Institut Curie, Paris, France

Objective

Automating the production of chemotherapy is one of the methods developed to improve the quality of preparations and productivity in our unit. The objective of this work is to provide experience on automation.

Method

The production of standard dose batches is performed by an automated process (PharmahelpV1) controlled by gravimetry coupled with digital camera recognition. Data (productivity, quality, maintenance, resources) were collected over a 7-year period (2011-2017).

Results

Between 2011 and 2017, 73,373 preparations were produced (10,481 / year), representing on average 21% of total production. Average productivity increased from 52 (2011) to 68 (2017) preparations / day / 1 operator. 10 drugs and 23 products have been developed. In 2016, the distribution of production was 40% for cyclophosphamide, 30% for paclitaxel, 14% for 5FU. Paclitaxel accounted for 21% of production in 2011 compared to 53% in 2017.
Off-specification preparations (deviation> 5%) represented on average 0.6% of production over this period (0.9% in 2011 vs 0.2% in 2017). The nonconformities were caused by technical and human errors: 90% and 17% in 2011 vs 43% and 57% in 2017. The immobilization time for maintenance represented 14 days in 2017. Automated production requires human interventions representing 1 full-time technician / day and 0.5 time pharmacist / day.

Discussion-Conclusion

The optimized acquisition of the technique over time has allowed the increase of productivity and the reduction of nonconformities. The distribution of production by drug and their integration have followed the evolution of clinical practices. The high nonconformities rate of vinorelbine (8.5%) justified the stop of his automated production and defined the limits of automation (commercial presentation and low volume therapeutic dose). Highly sensitive loading operations increase the risk of human error. The risk of immobilization leads to favoring the production of preparations in advance.

Automation must always be an institutional project. It is a strategy that has guaranteed stable productivity, support for increased activity with a constant workforce, to reach a high level of quality with a positive impact on the activity of outpatient services.

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