Background and importance Safe handling and dispensing of cytotoxic drugs in outpatient setting are of growing concern in hospital pharmacy. However, surface contamination studies mainly focus on the preparation areas. As oral therapy gains significance, it is critical to assess its role as a potential source of contamination in non-compounding environments.
Aim and objectives a) Workflow analysis for critical sample sites selection; b) Designing of a risk matrix considering the contamination level (ng/cm2); c) Implementing corrective measures and sampling frequency according to the risk level.
Materials and methods Drugs selected were 6-Mercaptopurine (6-MP) and Capecitabine (CPC), based on potential risk for the operator (number of dispensations vs. handling level) and 4 critical areas (storage drawer; hood; repackaging bench; dispensing counter). Samples were collected by wipe sampling and sent to analysis by LC-MS/MS, in a certified laboratory (IUTA).1 Two sampling periods were carried out, interposed with corrective measures.
Results Out of five samples collected, two presented results above the reference value of 0.1 ng/cm2 :1 storage drawer (CPC) and hood (6-MP). Following a cleaning procedure in the storage drawer (CPC), a value of 0.014 ng/cm2 was obtained. The remaining results were below the assay’s limit of quantification (LoQ).
Conclusions and relevance The storage areas were identified as of increased risk. However, the limited number of samples conditioned the total mapping of critical areas.
The results analysis led to the definition of risk levels: low risk<LoQ; LoQ> medium risk<0.1 ng/cm2; high risk>0.1 ng/cm2. It is intended to extend the sampling to all dispensing pathways. The development and evaluation of corrective measures and sampling frequency is still pending on future results, although the cleaning methodology has proven to be effective.
There is evidence of contamination from handling oral formulations. The lack of risk perception leads to the undervaluing of routine procedures, such as cleaning, enhancing occupational exposure.
This project aims to ensure that the occupational exposure level is reduced to a value as low as technically possible.
References and/or acknowledgements
Kiffmeyer TK, et al. Application and assessment of a regular environmental monitoring of the antineoplastic drug contamination level in pharmacies-the MEWIP project. Ann Occup Hyg 2013 May;57(4):444–55.
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