Abstract
Occupational exposure of anticancer agents during their preparation has been recognized as a serious hazard. Closed system drug transfer devices (CSTDs) enable “safe” preparation of agents for medical personnel and ensure a safe hospital environment. However, artificial particles of infusion materials have been reported during CSTD use. Here, the incidence of insoluble fine particles during preparation of anticancer agents using CSTDs was examined. Visible insoluble fine particles were found in 465 (9.4%) of 4948 treatment cases at Ehime University Hospital with CSTD use. Contaminants occurred more frequently during preparation of monoclonal antibodies than cytotoxic anticancer agents (19.4% vs. 4.1%, respectively, P < 0.01). A similar survey was conducted at nine hospitals to investigate the incidence of insoluble fine particles with or without CSTDs. Insoluble fine particles were detected in 113 (15.4%) of 732 treatment cases during preparation of monoclonal antibodies with CSTD use. In contrast, the occurrence of insoluble fine particles without CSTDs was found in only 3 (0.073%) of 4113 treatment cases. Contamination with CSTDs might cause harmful effects on patients during cancer therapy. We strongly recommend the use of in-line filters combined with infusion routes after CSTD use to avoid contamination-associated adverse events.
Highlights
Occupational exposure of anticancer agents during their preparation has been recognized as a serious hazard
In early 2018, some pharmacists noticed the existence of insoluble fine particles generated during preparation of anticancer agents with Closed system drug transfer devices (CSTDs)
After checking for these contaminants, we examined the frequency of insoluble fine particles during preparation of each anticancer agent for 1 year
Summary
Occupational exposure of anticancer agents during their preparation has been recognized as a serious hazard. Very fine substances recognized with careful observation and scientific analysis are designated as insoluble fine particles These fine particles are sometimes difficult to remove from materials during medical procedures, and may cause biological effects on patient health outside of the original medical treatment. Intravenous administration of insoluble fine particles and glass ampoules has been noted to cause damage to the vein, lung, liver, and spleen in rare cases.[2,3,4,5,6,7,8] insoluble fine particles are potential health hazards and should be carefully removed from medical procedures in patients receiving long-term treatment, such as cancer patients
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