Environmental contamination, product contamination and workers exposure using a robotic system for antineoplastic drug preparation

Sessink, P.J.M.; Leclercq, Gisèle; Wouters, Dominique-Marie; Halbardier, Loïc; Hammad, Chaïma; Kassoul, Nassima

doi:10.1177/1078155214522840

Cited by 41 publications

(55 citation statements)

References 45 publications

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“…It is important to evaluate environmental and product contamination when robotic preparation system is newly introduced in the clinical setting [15]. Recently, a wipe test investigated environmental and product contaminations by CPA in the robotic preparation with APOTECAchemo and manual preparation was published [16].…”

Section: Discussionmentioning

confidence: 99%

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

Iwamoto

Morikawa

Hioki

et al. 2017

J Pharm Health Care Sci

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BackgroundThe accuracy, safety and feasibility of, the compounding robot APOTECAchemo were evaluated in the clinical practice of Japan.MethodsAccuracy and precision of robotic preparations by APOTECAchemo was evaluated in 20 preparations of fluorouracil (FU) and cyclophosphamide (CPA) infusions by four pharmacists. Environmental and product contaminations with FU and CPA were evaluated by wipe testing. Robotic performance was compared with manual preparation in a biological safety cabinet. The number of robotic products, total compounding time and total pre-reconstitution time of lyophilized drugs between January 1, 2014 to December 31, 2015 were investigated.ResultsRobotic preparation resulted more accurate and precise (mean absolute dose error and coefficient of variation were 0.83 and 1.04% for FU and 0.52 and 0.59% for CPA) than those of manual preparation (respective values were 1.20 and 1.46% for FU and 1.70 and 2.20% for CPA). Drug residue was not detected from any of the prepared infusion bags with the robotic preparation, whereas FU was detected in two of four analyzed infusion bags with manual preparation. Average total time to make single anticancer drug preparation (compounding plus reconstitution of lyophilized drugs) was 6.11 min in the second half of 2015. During the study period, the highest percentage of production covered by APOTECAchemo was 70.4% of the total inpatient pharmacy activity.ConclusionRobotic preparation using APOTECAchemo should give substantial advantages in drug compounding for accuracy and safety and was able to be successfully worked in Mie university hospital.

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Section: Discussionmentioning

confidence: 99%

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

Iwamoto

Morikawa

Hioki

et al. 2017

J Pharm Health Care Sci

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“…(1–7) Similar methodology has been successfully employed in other occupational settings for toxic agents such as lead, chromium VI, beryllium, arsenic, cadmium and nickel, (8) asbestos, polychlorinated biphenyls, pesticides and antibiotics. (9–12) Ashley et al (13) identify the three primary reasons for conducting surface wipe sampling: (1) evaluation of the potential health risk; (2) hazard management or evaluation of the source; and (3) hazard compliance.…”

Section: Introductionmentioning

confidence: 99%

Surface wipe sampling for antineoplastic (chemotherapy) and other hazardous drug residue in healthcare settings: Methodology and recommendations

Connor

Zock

Snow³

2016

Journal of Occupational and Environmental Hygiene

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Purpose Surface wipe sampling for various hazardous agents has been employed in many occupational settings over the years for various reasons such as evaluation of potential dermal exposure and health risk, source determination, quality or cleanliness, compliance, and others. Wipe sampling for surface residue of antineoplastic and other hazardous drugs in healthcare settings is currently the method of choice to determine surface contamination of the workplace with these drugs. The purpose of this article is to review published studies of wipe sampling for antineoplastic and other hazardous drugs, to summarize the methods in use by various organizations and researchers, and to provide some basic guidance for conducting surface wipe sampling for these drugs in healthcare settings. Methods Recommendations on wipe sampling methodology from several government agencies and organizations were reviewed. Published reports on wipe sampling for hazardous drugs in numerous studies were also examined. The critical elements of a wipe sampling program and related limitations were reviewed and summarized. Results Recommendations and guidance are presented concerning the purposes of wipe sampling for antineoplastic and other hazardous drugs in the healthcare setting, technical factors and variables, sampling strategy, materials required, and limitations. The reporting and interpretation of wipe sample results is also discussed. Conclusions It is recommended that all healthcare settings where antineoplastic and other hazardous drugs are handled consider wipe sampling as part of a comprehensive hazardous drug ‘safe handling’ program. Although no standards exist for acceptable or allowable surface concentrations for these drugs in the healthcare setting, wipe sampling may be used as a method to characterize potential occupational dermal exposure risk and to evaluate the effectiveness of implemented controls and the overall the safety program. A comprehensive safe-handling program for antineoplastic drugs may utilize wipe sampling as a screening tool to evaluate environmental contamination and strive to reduce contamination levels as much as possible, using the industrial hygiene hierarchy of controls.

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“…Our results imply smaller contamination rates for both manual and robotic compounding than previous research did. Earlier studies suggested that variability in surface contamination could be associated with different methods of drug preparation, which can influence work techniques, that is proximity of the storage area relative to the preparation area, as well as the size of the compounding area where drugs are handled.…”

Section: Discussionmentioning

confidence: 41%

“…In the manual compounding group, lower contamination rates were found compared to other studies, including studies with closed‐system devices. This suggests that the use of these spikes does not result in a positive bias for the robotic procedure …”

Section: Discussionmentioning

confidence: 95%

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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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Environmental contamination, product contamination and workers exposure using a robotic system for antineoplastic drug preparation

Cited by 41 publications

References 45 publications

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

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

Surface wipe sampling for antineoplastic (chemotherapy) and other hazardous drug residue in healthcare settings: Methodology and recommendations

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

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