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1. Effectiveness of a Closed-System Transfer Device in Reducing Surface Contamination in a New Antineoplastic Drug-Compounding Unit: A Prospective, Controlled, Parallel Study.

Author

Nicolas Simon, Michèle Vasseur, Marine Pinturaud, Marion Soichot, Camille Richeval, Luc Humbert, Michèle Lebecque, Ousseini Sidikou, Christine Barthelemy, Pascal Bonnabry, Delphine Allorge, Bertrand Décaudin, and Pascal Odou

Subjects
Medicine, Science
Abstract

The objective of this randomized, prospective and controlled study was to investigate the ability of a closed-system transfer device (CSTD; BD-Phaseal) to reduce the occupational exposure of two isolators to 10 cytotoxic drugs and compare to standard compounding devices.The 6-month study started with the opening of a new compounding unit. Two isolators were set up with 2 workstations each, one to compound with standard devices (needles and spikes) and the other using the Phaseal system. Drugs were alternatively compounded in each isolator. Sampling involved wiping three surfaces (gloves, window, worktop), before and after a cleaning process. Exposure to ten antineoplastic drugs (cyclophosphamide, ifosfamide, dacarbazine, 5-FU, methotrexate, gemcitabine, cytarabine, irinotecan, doxorubicine and ganciclovir) was assessed on wipes by LC-MS/MS analysis. Contamination rates were compared using a Chi2 test and drug amounts by a Mann-Whitney test. Significance was defined for p

Published
2016
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2. Effectiveness of a Closed-System Transfer Device in Reducing Surface Contamination in a New Antineoplastic Drug-Compounding Unit: A Prospective, Controlled, Parallel Study

Author

Marine Pinturaud, Camille Richeval, Luc Humbert, Bertrand Décaudin, Nicolas Simon, Pascal Odou, Christine Barthélémy, Pascal Bonnabry, Michèle Lebecque, Delphine Allorge, Michèle Vasseur, Ousseini Sidikou, M. Soichot, Université de Lille, CHU Lille, Institut Pasteur de Lille, IMPact de l'Environnement Chimique sur la Santé humaine (IMPECS) - ULR 4483, Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA], Impact de l'environnement chimique sur la santé humaine - ULR 4483 [IMPECS], Toxicologie et Génopathies [CHRU Lille], CIC CHU ( Lille)/inserm, Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 (GRITA), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Impact de l'environnement chimique sur la santé humaine - ULR 4483 (IMPECS), Pôle de Biologie Pathologie Génétique [CHU Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, University of Lausanne (UNIL), Université de Lausanne = University of Lausanne (UNIL), and Université de Lille, LillOA

Subjects
[SDV]Life Sciences [q-bio], lcsh:Medicine, Pharmacology, Pharmacists, Deoxycytidine, 0302 clinical medicine, Medicine and Health Sciences, Prospective Studies, lcsh:Science, media_common, Drug Distribution, Multidisciplinary, Ifosfamide, Pharmaceutics, Cytarabine, Drugs, Contamination, 030210 environmental & occupational health, [SDV] Life Sciences [q-bio], Professions, 030220 oncology & carcinogenesis, Fluorouracil, Drug Contamination, Research Article, medicine.drug, Drug, Ganciclovir, Drug Administration, Drug Compounding, media_common.quotation_subject, Dacarbazine, Antineoplastic Agents, Irinotecan, 03 medical and health sciences, Drug Therapy, Occupational Exposure, medicine, Humans, Pharmacokinetics, Cyclophosphamide, Drug Screening, Pharmaceutical Processing Technology, business.industry, lcsh:R, Technicians, Gemcitabine, Methotrexate, Compounding, People and Places, Camptothecin, Population Groupings, lcsh:Q, business
Abstract

International audience; BACKGROUND: The objective of this randomized, prospective and controlled study was to investigate the ability of a closed-system transfer device (CSTD; BD-Phaseal) to reduce the occupational exposure of two isolators to 10 cytotoxic drugs and compare to standard compounding devices. METHODS AND FINDINGS: The 6-month study started with the opening of a new compounding unit. Two isolators were set up with 2 workstations each, one to compound with standard devices (needles and spikes) and the other using the Phaseal system. Drugs were alternatively compounded in each isolator. Sampling involved wiping three surfaces (gloves, window, worktop), before and after a cleaning process. Exposure to ten antineoplastic drugs (cyclophosphamide, ifosfamide, dacarbazine, 5-FU, methotrexate, gemcitabine, cytarabine, irinotecan, doxorubicine and ganciclovir) was assessed on wipes by LC-MS/MS analysis. Contamination rates were compared using a Chi2 test and drug amounts by a Mann-Whitney test. Significance was defined for p

Published
2016

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