Performance evaluation of the compounding robot, APOTECAchemo, for injectable anticancer drugs in a Japanese hospital

Iwamoto, Takuya; Morikawa, Takuya; Hioki, Miki; Sudo, Hirofumi; Paolucci, D; Okuda, Masahiro

doi:10.1186/s40780-017-0081-z

Cited by 38 publications

(65 citation statements)

References 15 publications

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“…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.…”

Section: Resultsmentioning

confidence: 99%

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

Batson¹,

Mitchell

Lau

et al. 2019

Eur J Hosp Pharm

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ObjectivesThe current systematic review (SR) was undertaken to summarise the published literature reporting the clinical and economic value of automation for chemotherapy preparation management to include compounding workflow software and robotic compounding systems.MethodsLiterature searches were conducted in MEDLINE, Embase and the Cochrane Library on 16 November 2017 to identify publications investigating chemotherapy compounding workflow software solutions used in a hospital pharmacy for the preparation of chemotherapy.Results5175 publications were screened by title and abstract and 18 of 72 full publications screened were included. Grey literature searching identified an additional seven publications. The SR identified 25 publications relating to commercial technologies for compounding (Robotic compounding systems: APOTECAchemo (n=12), CytoCare (n=5) and RIVA (n=1); Workflow software: Cato (n=6) and Diana (n=1)). The studies demonstrate that compounding technologies improved accuracy in dose preparations and reduced dose errors compared with manual compounding. Comparable levels of contamination were reported for technologies compared with manual compounding. The compounding technologies were associated with reductions in annual costs compared with manual compounding, but the impact on compounding times was not consistent and was dependent on the type of compounding technology.ConclusionsThe published evidence suggests that the implementation of chemotherapy compounding automation solutions may reduce compounding errors and reduce costs; however, this is highly variable depending on the form of automation. In addition, the available evidence is heterogeneous, sparse and inconsistently reported. A key finding from the current SR is a ‘call to action’ to encourage pharmacists to publish data following implementation of chemotherapy compounding technologies in their hospital, which would allow for evidence-based recommendations on the benefits of chemotherapy compounding technologies.

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Section: Resultsmentioning

confidence: 99%

“…Therefore, a total of 25 publications met the inclusion criteria (figure 1). 14–38 All studies were published from 2009 onwards. A summary of study design and results is provided in the online supplementary file, table 2.…”

Section: Resultsmentioning

confidence: 99%

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

Batson¹,

Mitchell

Lau

et al. 2019

Eur J Hosp Pharm

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“…Theoretically, other cytotoxic drugs could vaporize more easily. However, these two drugs are commonly used in studies investigating contamination and are therefore appropriate for comparison with results from other studies …”

Section: Discussionmentioning

confidence: 99%

“…In addition, contamination was tested on four infusion bags. Two of the infusion bags prepared by the robotic system had contamination . Until now, no clinical study has been published concerning external cross‐contamination from one product to the next using a robotic system for iv cytotoxic drug preparation.…”

Section: Introductionmentioning

confidence: 99%

The assessment of environmental and external cross-contamination in preparing ready-to-administer cytotoxic drugs: a comparison between a robotic system and conventional manual production

Buning

Geersing

Crul

2019

International Journal of Pharmacy Practice

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Objectives The primary aim of the study was to compare environmental and external (cross-) contamination of traces of cytostatics, during preparation of 5-fluorouracil and cyclophosphamide using a robotic system (APOTECAchemo) or the conventional manual compounding procedure. The secondary aim was to validate the cleaning procedure of the robot. Methods Eighty ready-to-administer (RTA) infusion bags with 5-fluorouracil, cyclophosphamide or sodium chloride were compounded using both techniques on 3-5 days. Wipe samples were taken from several locations in the compounding room before and after cleaning, and also from the technician's gloves. These samples were analysed for 5-fluorouracil and cyclophosphamide concentrations using GC/MS/MS. Key findings A total of 284 wipe samples were collected during the study (113 from the manual and 171 from the robotic process). External contamination on the outside of infusion bags was 3.75% for both manual and robotic compounding. For manual compounding, external cross-contamination occurred on 2.5% of the prepared infusion bags. External cross-contamination occurred on 1.25% of the infusion bags for the robotic procedure. Inside the compounding room, 9% of the environmental wipe samples were contaminated in case of manual production and 24% for robotic compounding. Since 50% of the contaminated environmental samples for the robotic system were taken after cleaning, the cleaning procedure was extended and parameter setting for cyclophosphamide handling was performed. After this, residual environmental or external contamination was no longer detectable. Conclusion Comparison of both preparation methods showed that external (cross-)contamination of infusion bags was lower using the robotic system. An optimized cleaning procedure showed the best results in environmental contamination for the robot.

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“…The manual preparation of sterile injectable preparations has always been considered a high-risk activity given the prolonged exposure to dangerous drugs during handling and the extreme personalization of therapies, which multiplies the possibility of error [1]. Different axes were implemented: centralization of the preparations, controls during process or at the end (e. g. human double check, gravimetric control, analytic) and recently the automation [2]. Since the centralization of sterile injectable preparations, our pharmacy has been faced with a constant increase in the number of sterile preparations, without additional human resources, despite the recommendations of scientific societies [3].…”

Section: Introductionmentioning

confidence: 99%

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

Heloury

Bouguéon

Deljehier

et al. 2019

Pharmaceutical Technology in Hospital Pharmacy

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Abstract Two automation methods for aseptic preparation in hospital pharmacy, robot and peristaltic pump, were compared to manual process both for risk analysis using Failure Modes Effects and Criticality Analysis (FMECA) method and for productivity using time analysis grids built for each process. The results obtained with the different workflow organizations showed that the worst-case conditions for productivity was production “on demand” of tailor-made preparations. in that case, the manual process was not significantly different from the robotic process (p-value=0.72). For the standardized preparations, the semi-automatic process preparing a batch from bulk solution from “to be reconstituted” drugs was significantly superior to the robotic process preparing repetitive series of doses (p-value<0.01). Productivity of the robot was dramatically increased when the robot performed standardized preparations either from ready to use solutions or mixed cycles due to the robot design. When different processes were FMECA analyzed for risk analysis the robotic process was found as the safer process in comparison to others with a total of Criticality Indexes of 1060, 719, 656 for manual, semi-automatic and robot, respectively. Except for the robotic, semi-automatic and manual processes needed additional IT control systems to limit the risk of failures.

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Performance evaluation of the compounding robot, APOTECAchemo, for injectable anticancer drugs in a Japanese hospital

Cited by 38 publications

References 15 publications

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

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

The assessment of environmental and external cross-contamination in preparing ready-to-administer cytotoxic drugs: a comparison between a robotic system and conventional manual production

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

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