Many antineoplastic drugs are known to be mutagenic or teratogenic. Medical personnel handling antineoplastic drugs are at a high risk of occupational exposure. Therefore, in collaboration with Yaskawa Electric Corporation and Nikka Micron Co., Ltd, we developed the Cancer Drug Compounding Assist System (CDCAS). The CDCAS is an automated robotic system designed to efficiently facilitate the accurate preparation of drugs based on dose. In this study, we evaluated the CDCAS for accuracy, site contamination, and washing performance in the preparation of antineoplastic drugs.
5-Fluorouracil (5-FU; 600, 800, or 1200 mg) was added to 100 mL of saline; 5 samples of each formulation were prepared. The weight of the mixed drugs prepared using the CDCAS was compared to those prepared by a pharmacist, and the accuracy of each preparation was calculated in terms of percentage relative error. The acceptable variance was set at ± 5%. To test for contamination, cyclophosphamide (800 mg) was continuously added to 50 bags of 100 mL saline solution. Then, 25 locations inside the isolator were identified for measurement. Cyclophosphamide was collected from those sites by using a sampling sheet method. Twenty of those samples revealed adherence of 5-FU (300 µL) to the infusion bag surface. Ozonated water was used to wash 5-FU from the surface of the infusion bags. After the washing process, any 5-FU remaining on the infusion bag surface was recovered via a wiping method.
The average weight error ratio for the CDCAS and the pharmacist was −0.62% and 2.69%, respectively. Contamination of cyclophosphamide was confirmed at eight sites. Pollution of 5-FU was confirmed for two samples, and the removal rate was ≥ 99.9%.
Our study demonstrated that the CDCAS’s preparation accuracy and cleaning performance are within acceptable limits. Thus, the CDCAS could be used to potentially reduce occupational exposure to antineoplastic drugs.
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All authors have declared no conflicts of interest.