In-process gravimetric control coupled with vial recognition and dematerialization of chemotherapy production: an option to promote the autonomy of operators and the safety of chemotherapy preparations
1 Departement of Pharmacy, Curie Institute, Paris, France
2 Departement of Radio-pharmacology, Institut Curie, Paris and Saint-Cloud, France
The dematerialization of the production with gravimetric control in process started in 2010 to replace the double visual check in our unit (> 50,000 preparations / year). Initially used for quantitative control and anticipated production, we have recently extended gravimetric control to daily production and quality control (identification of the active substance by barcode scanning of the vials). The aim of this work is to present a feedback on this important transition in the dynamics of our unit.
The manual production is carried out using a production assistant controlled by Chimio® software, integrating the gravimetric control in process (Cytocontrol® weighing scales), the vial recognition (with barcode labelling) and the traceability of manufacturing steps archived as a report. The manufacturing data extracted from Chimio® software and the opinions of the operators evaluated by a questionnaire were compared before and after this extension over one-year periods. A 4-weeks prospective study completed these data.
Until March 2018, 2 workstations were equipped (> 40 preparations / day), then 3 (> 80 preparations / day) and at last 4 (> 100 preparations / day). Productivity, percentage of pharmaceutical interventions and percentage of weighing errors represented respectively over the periods studied: 7,108 / 0.6% / 4.0% vs. 20,667 / 0.4% / 7.6%. Considering our automated production (20%), in-process controlled preparations increased from 40% to more than 70%. The average wait times for our adult day hospital center remained the same (68 vs. 65 min). This method, which was perceived as slow and impractical, is today considered time efficient, safe, in favor of autonomy and quite practical according to the operators (n1 = 18) and the pharmacists (n2 = 6). Negative points were reported and observed: computer dependence, workstation clutter, vial labeling, non-recognition of reconstitution and dilution solvents, and batch number management.
Gravimetric control in process has increased our quality level and reduced double visual check. The adhesion of our operators allows an optimization of our production. Interventions have increased in the management of technical problems and nonconformities. Preparations requiring reconstitution or small volumes (< 1mL) and complex preparations (clinical trials, per os) remain excluded from our gravimetric control. In a near future, it should include the identification of solvents, solve recurring computer problems, and add the products to be reconstituted to optimize this method of control.