Frequency and component analysis of contaminants generated in preparation of anticancer agents using Closed system drug transfer devices (CSTDs)

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 4,948 treatment cases at Ehime University Hospital with CSTD use. Contaminants occurred more frequently during preparation of monoclonal antibodies than cytotoxic anticancer agents (19.4% versus 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 4,113 treatment cases. Contamination with CSTDs might cause harmful effects on patients 4 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.

Clinical Oncology Society of Australia Position Statement: 2022 update to the safe handling of monoclonal antibodies in healthcare settings

“…Among the relevant literature published since the 2013 Position Statement, literature relating specifically to pertuzumab, 13,14 closed system transfers devices (CSTDs) used with mABs, 3,[18][19][20][21][22] a case report relating to staff sensitization to a mAB 5 , and the nomenclature change to mABs, 17 was identified.…”

“…Institutions utilizing a CSTD should consider user experience and technique. They must also evaluate the device(s) to ensure that when correctly used, protein aggregation does not occur, the medication is compatible with the components of the CSTD 19,20,22 , and there are no significant small volume losses during the reconstitution process or administration. 18,21 7.…”

“…In the last few years, there have been several papers published relating to the use of CSTDs in the preparation and administration of mABs. [18][19][20][21][22] While CSTDs provide enhanced protection against potentially hazardous exposures to healthcare workers, 3,13 performance standards for evaluation of CSTD containment are not yet available. 23 Several publications on device performance have been published, with issues identified including vapor containment 19 and unintended volume loss associated with small-volume products.…”

“…18,21,22 Insoluble fine particles in the final product were detected when CSTDs were used in the preparation of mABs, but the clinical significance of this finding is uncertain. 20,21 Institutions should consider these potential issues when selecting CSTDs.…”