Proposal of limit values for surface contamination by cytotoxic drugs in pharmacies and hospitals

Overview

Introduction: Cytotoxic drugs (cytostatics), widely used in the treatment of not only cancer diseases, are substances with potentially dangerous properties for healthcare personnel. Long-term daily exposure to cytostatics is associated with the possible manifestation of their genotoxic, carcinogenic and teratogenic effects. Handling of these drugs (during receipt, storage, preparation, packaging, transport, administration) can lead to contamination of the workplace and thus to exposure of healthcare personnel present.

Objective: The aim of our work was to propose, based on previous results and experience gained from long-term monitoring, a limit threshold value for surface contamination with cytotoxic drugs.

Methodology: As part of the long-term monitoring (2008–2021) of surface contamination by cytostatics in pharmacies and hospitals in the Czech and Slovak Republics, the presence of eight drugs (cyclophosphamide, ifosfamide, methotrexate, irinotecan, paclitaxel, fluorouracil, gemcitabine and platinum as a representative of platinum cytostatics –⁠ oxaliplatin, carboplatin, cisplatin) was monitored. Samples were taken by employees of individual healthcare facilities and surface contamination was evaluated by the RECETOX Research Center of Masaryk University Brno using liquid chromatography with tandem mass spectrometry and inductively coupled plasma mass spectrometry.

Results: our study evaluated the surface contamination of cytostatics in 40 pharmacies (N = 1,277 samples) and 43 hospitals (N = 946 samples). Based on the results obtained and in accordance with currently known knowledge, we propose a threshold value of 100 pg/cm2 as the limit value of permissible contamination of cytostatics for most areas in pharmacies and hospitals (reception, storage, packaging, transport, application). On the one hand, contamination in isolator areas, where cytostatics are prepared in a controlled environment and using effective protective equipment and where their increased presence can therefore be "expected", should be perceived differently, and on the other hand, areas in administrative facilities and day rooms, where no protective equipment is used and contamination should therefore be zero.

Conclusions: Knowledge of the level of contamination in healthcare facilities working with cytotoxic drugs helps to set up work processes so that the working environment is safe for employees. Regular monitoring is an important tool. The proposal of a value of 100 pg/cm2 as an exposure hygiene limit represents the first step towards implementing mandatory monitoring into national legislation.

Keywords:

Cytostatics – cytotoxic drugs – surface contamination – monitoring of the working environment