Monitoring surface contamination for thirty antineoplastic drugs: a new proposal for surface exposure levels (SELs)

Abstract

Background: Chemotherapy drugs are widely used to treat cancer, but their active compounds represent a danger for workers who could be exposed to them. However, they aren't yet included in directive CE No. 1272/2008 and the European Biosafety Network has only recommended a limit value of 100 pg/cm² for surface contamination. Thus, it is crucial to assess surface contaminations in healthcare environments. Currently, the technique of choice is surface wipe test combined with liquid chromatography tandem mass spectrometry to achieve high sensibility.

Material and methods: A campaign involving Careggi University Hospital (Florence, Italy) was performed from January 2020 to December 2021, collecting 1449 wipe samples between administration units, preparation unit, and personnel gloves. From the obtained data, the 90th percentile was calculated for 30 antiblastic drugs and proposed as surface exposure levels (SELs); while from data concerning personnel glove contamination, weekly contamination was estimated.

Results: In the 2-year period only 417 wipe samples were found positive (28.8%), the majority of which regard samples coming from administration unit bathrooms. The proposed SELs are almost all <100 pg/cm², except for few drugs which produce higher contamination on bathroom surfaces. Also, the estimation of pharmacy personnel's glove contamination highlighted very low results (ng/week).

Conclusions: Deeply established protocols and procedures for safe handling of ADs allow for obtaining excellent cleaning results and thus a safer work environment, however, the risk of cytostatic contaminations cannot be avoided in healthcare workplaces, and thus a harmonization of classification and labeling of chemotherapy drugs throughout the European Union should be done. Med Pr. 2022;73(5):383-96.

Keywords: antineoplastic drugs; health risk assessment; surface exposure level; tandem mass spectrometry; ultra-high performance liquid chromatography; wipe test.