Evaluation of the risk of occupational exposure to antineoplastic drugs in healthcare sector: part II - the application of the FMECA method to compare manual vs automated preparation.

Healthcare workers handling antineoplastic drugs (ADs) in preparation units run the risk of occupational exposure to contaminated surfaces and associated mutagenic, teratogenic, and oncogenic effects of those drugs. To minimise this risk, automated compounding systems, mainly robots, have been replacing manual preparation of intravenous drugs for the last 20 years now, and their number is on the rise. To evaluate contamination risk and the quality of the working environment for healthcare workers preparing ADs, we applied the Failure Mode Effects and Criticality Analysis (FMECA) method to compare the acceptable risk level (ARL), based on the risk priority number (RPN) calculated from five identified failure modes, with the measured risk level (MRL). The model has shown higher risk of exposure with powdered ADs and containers not protected by external plastic shrink film, but we found no clear difference in contamination risk between manual and automated preparation. This approach could be useful to assess and prevent the risk of occupational exposure for healthcare workers coming from residual cytotoxic contamination both for current handling procedures and the newly designed ones. At the same time, contamination monitoring data can be used to keep track of the quality of working conditions by comparing the observed risk profiles with the proposed ARL. Our study has shown that automated preparation may have an upper hand in terms of safety but still leaves room for improvement, at least in our four hospitals.

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

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.