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Centre Régional de Lutte Contre le Cancer Léon Bérard
Several clinical and laboratory studies have proved that most cytotoxic agents have carcinogenic, teratogenic and/or mutagenic effects.(1) Authors reported acute and chronic reactions associated with occupational exposure of healthcare workers (pharmacists, pharmacy technicians and nurses) during preparation and administration of these drugs: skin diseases, such as contact dermatitis, eczema and urticaria, but also nausea and obstetrical side-effects.(2) Trace concentrations of antineoplastic agents have been detected in the urine of staff handling these drugs, suggesting a real exposure.(3,4) However, in many of these studies, the authors did not say whether staff received specific training on drug handling practices, whether a suitable system of protection (downward-airflow biological safety cabinet or isolator) was used for the preparation of these agents or if special guidelines were established and followed in the hospitals. This article briefly reviews the most important recommendations for the safe handling of cytotoxic agents during their preparation.
Standard operating procedures for drug preparation
The preparation of cytotoxic drugs involves the use of either a downward-airflow biological safety cabinet or an isolator. When they are correctly used, these two devices provide the same efficiency for staff protection.(5) Air from the preparation room and from the HEPA (high-efficiency particulate air) filter of the downward-airflow biological safety cabinet must be exhausted outside the working area. This system avoids occupational exposure of staff by inhalation. The use of a closed-system device with or without a biological safety cabinet, such as PhaSeal® (Carmel Pharma) or Tevadaptor® (Teva Pharmaceuticals Europe), offers a solution to reduce contamination as far as possible.
When using a downward-airflow biological safety cabinet or an isolator, these recommendations must be followed:
Training and evaluation of operators
Training and regular evaluation of operators involved in the preparation of antineoplastic drugs are essential to improve compliance with general handling procedures and, thus, to reduce occupational exposure. The training method using a fluorescent dye solution as a safe simulated liquid cytotoxic allows to assess each operator’s preparation technique. Pharmacists ask pharmacy technicians to prepare several fluorescein solutions. At the end of each preparation, an ultraviolet (UV) light lamp (365nm) is used to estimate surface contamination (by counting the number of projections on several surfaces, such as work trays, absorbent papers, gloves and gowns).
Despite the publication of several safety standards for the handling of cytotoxic drugs during the past decade, awareness of the potential risks of exposure is not universal.
The only way to implement the recommended guidelines is to set up training and evaluation programmes for operators.