Development, application and assessment of a regular ambient monitoring of the antineoplastic drug contamination in pharmacies - The MEWIP-Study

TK. Kiffmeyer1, J. Tuerk1, H. Stuetzer2, M. Hahn2, C. Hadstein3, A. Heinemann4, U. Eickmann4 1 Institute of Energy and Environmental Technology, IUTA, Duisburg, Germany
2 Institute of Medical Statistics, Computer Science & Epidemiology, IMSIE, Köln, Germany
3 Institute of Applied Pharmacy IFAP, Köln, Germany
4 Institution for Statutory Accident Insurance and Prevention in the Health and Welfare Services, BGW, Köln, Germany

The overall aim of the study was the creation of a standardised ambient monitoring to be applied for future regular contamination control in accordance with legal requirements. In addition, an overview of the current contamination situation in antineoplastic drug preparing units and influencing factors should be obtained. Finally a scientific basis for recommendations and future guidance values should be created.

55 pharmacies (monitoring group) carried out monitoring every three months (5 cycles) and received their results. 75 pharmacies (control group) took wipe samples only at the beginning and the end of the study and received their results afterwards. Sampling spots were : the floor in front of the safety cabinet, the most intensively used countertop and the front door of the fridge including the door handle. Samples were taken from a 900cm2 area by pharmacy personnel after the end of the daily work but before cleaning of the respective surfaces. LODs ranged from 3.7 to 37 pg/cm2 for Cyclophosphamide, Etoposide, 5-Fluorouracil, Ifosfamide, Gemcitabine, Methotrexate, Paclitaxel and Docetaxel.
Details of the work practise and working environment have been registered using a 16 pages questionnaire.

From the investigated surfaces 61% were found to be contaminated with at least one drug. Values ranged from below the detection limits up to1.888 ng/cm2. Cyclophosphamide was detected most frequently (37%) followed by Gemcitabine (32%), 5-Fluorouracil (31%) and Ifosphamid (21%). These substances also account for more then 95% of the total area contamination. The 90. percentiles were 0.121 ng/cm2 for 5-Fluorouracil, 0.048 ng/cm2 for Cyclophosphamide 0.035 ng/cm2 for Gemcitabine and 0.014 ng/cm2 for Ifosfamide. From the three investigated surfaces, the floor in front of the safety cabinet revealed to be more often (73%) and higher (90. percentile = 0.020 ng/cm2) contaminated than the work tops (61%, 0.011 ng/cm2)) and the fridge door (49%, 0.007 ng/cm2). There was no correlation observed between amounts handled and the number of preparation and cleaning frequency and the contamination level. Use of safety cabinets with outgoing instead of re-circulated air and wipe disinfection in contrast to spraying leads to lower contamination of the workplace. The study revealed a significant decrease of the contamination frequency and level for the most frequently used compounds in the pharmacies carrying out regular monitoring.

The MEWIP monitoring can be applied as a reliable and affordable tool to control, compare and minimise contamination levels. Due to the standardisation of the monitoring procedure the individual health care unit receives valuable information on it´s relative position within the collective and the change in the contamination level over time. Furthermore, the obtained data will be used by scientists and regulative bodies to identify best practise of drug handling, to optimise guidelines and to establish guidance values.

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