Reliability of chemotherapy preparation processes: Evaluating independent double-checking and computer-assisted gravimetric control

Abstract

Background and objectives Centralized chemotherapy preparation units have established systematic strategies to avoid errors. Our work aimed to evaluate the accuracy of manual preparations associated with different control methods. Method A simulation study in an operational setting used phenylephrine and lidocaine as markers. Each operator prepared syringes that were controlled using a different method during each of three sessions (no control, visual double-checking, and gravimetric control). Eight reconstitutions and dilutions were prepared in each session, with variable doses and volumes, using different concentrations of stock solutions. Results were analyzed according to qualitative (choice of stock solution) and quantitative criteria (accurate, <5% deviation from the target concentration; weakly accurate, 5%-10%; inaccurate, 10%-30%; wrong, >30% deviation). Results Eleven operators carried out 19 sessions. No final preparation (n = 438) contained a wrong drug. The protocol involving no control failed to detect 1 of 3 dose errors made and double-checking failed to detect 3 of 7 dose errors. The gravimetric control method detected all 5 out of 5 dose errors. The accuracy of the doses measured was equivalent across the control methods ( p = 0.63 Kruskal-Wallis). The final preparations ranged from 58% to 60% accurate, 25% to 27% weakly accurate, 14% to 17% inaccurate and 0.9% wrong. A high variability was observed between operators. Discussion Gravimetric control was the only method able to detect all dose errors, but it did not improve dose accuracy. A dose accuracy with <5% deviation cannot always be guaranteed using manual production. Automation should be considered in the future.

Automation of Aseptic Sterile Preparation: Risk Analysis and Productivity Comparison with Manual Process

“…However, when the robot workflow was fairly optimized with standard preparations, its productivity was dramatically improved and confirmed our first results [17]. Moreover, our results were similar to productivity results obtained with other robots such as PharmaHelp ® where authors found a productivity of 10 bags for 60 min44 sec [18] or with APOTECAchemo ® robot, where average time of a preparation from a ready-to-use drug was 5.57 min or 6.11 min from a drug to be reconstituted [7]. For Masini et al [19], on a productivity point of view, the robotic process was interesting for a volume superior to 34 000 preparations per year, however the market is still in progress and depending on the different designs of the robots this limit may be questionable.…”

“…That is why, additional IT system piloting the pump was purposed by the FMECA analysis. In the same way for the manual process, IT system piloting the per-process was also suggested by implementing either camera recording [22] and/or gravimetry [18] software to substitute advantageously the human double check.…”

Automated compounding technology and workflow solutions for the preparation of chemotherapy: a systematic review

“…A total of 5797 unique citations were identified in the electronic searches and after removal of 622 duplicates, 5175 articles were screened by title and abstract. In total, 5103 articles were excluded, and 72 articles were potentially relevant and following full publications review, 18 publications were included 14–31. Hand searching yielded an additional seven publications for inclusion 32–38.…”

Intravenous Chemotherapy Compounding Errors in a Follow-Up Pan-Canadian Observational Study

“…Although standards and guidelines are critical elements of a safe system, they are not sufficient. Automated compounding processes from robotics to bar coding and gravimetric weighing, with built-in error prevention functions, have shown promise in error reduction 18 , 19 , 34 - 36 and may address or eliminate many of the latent errors observed in the current study. Meanwhile, unlike other industries with high-risk production processes, chemotherapy compounding has not adopted live quality control mechanisms that confirm the actual contents of the prepared compounds (with the exception of a few French sites).…”