背景:由于抗肿瘤药物的高毒性,处理他们的包装可能导致医院环境的化学污染和暴露风险的医疗保健专业人员和病人。这项研究旨在评估两个主要表面的污染情况:瑞士市场上可获得的口服抗肿瘤药物制剂的外部初级包装(n=36)和可注射抗肿瘤药物制剂的次级包装(n=60)。瑞士一家医院的药房和用于运输的载体(n=5)。
方法:使用经验证的擦拭取样方法收集样品。24种抗肿瘤药物的同时分析:5-氟尿嘧啶,白消安,卡铂,环磷酰胺,阿糖胞苷,达卡巴嗪,柔红霉素,多西他赛,阿霉素,表柔比星,依托泊苷,吉西他滨,伊达比星,异环磷酰胺,伊立替康,甲氨蝶呤,奥沙利铂,紫杉醇,培美曲塞,雷替曲塞,托泊替康,曲硫丹,长春碱,长春新碱)和1种抗病毒化合物(更昔洛韦)通过UHPLC-MS/MS进行。
结果:口服化学疗法的初级包装和可注射制剂的次级包装总共获得了58%和90%的阳性结果,分别。在口服化疗药物的初级包装和密闭防漏袋表面发现的最高数量是111ng甲氨蝶呤和19ng吉西他滨,分别。吉西他滨(69%)和环磷酰胺(38%)是可注射制剂和载体包装上最常见的两种污染物,不管化疗的准备。
结论:在所有评估的药品的大多数表面上都可以发现痕量(ng)的抗肿瘤药物。因此,适当的个人防护设备是强制性的医疗保健专业处理抗肿瘤药物。
BACKGROUND: Due to the high toxicity of antineoplastic drugs, handling their packaging could lead to the chemical contamination of hospital environments and exposure risks to healthcare professionals and patients. This study aimed to assess the contamination of two main surfaces: the outer primary packaging of oral antineoplastic drug formulations (n = 36) available on the Swiss market and the surface of secondary packaging of injectable antineoplastic drug preparations (n = 60) produced by the pharmacy of a Swiss hospital and carriers used for transport (n = 5).
METHODS: Samples were collected using a validated wipe sampling method. The simultaneous analysis of 24 antineoplastic drugs: 5-fluorouracil, busulfan, carboplatin, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, docetaxel, doxorubicin, epirubicin, etoposide, gemcitabine, idarubicin, ifosfamide, irinotecan, methotrexate, oxaliplatin, paclitaxel, pemetrexed, raltitrexed, topotecan, treosulfan, vinblastine, vincristine) and 1 antiviral compound (ganciclovir) was performed by UHPLC-MS/MS.
RESULTS: A total of 58% and 90% positive results were obtained for the primary packaging of oral chemotherapies and for the secondary packaging of injectable preparations, respectively. The highest quantities found on the primary packaging for oral chemotherapies and on the surface of closed leak-proof bags were 111 ng of methotrexate and 19 ng of gemcitabine, respectively. Gemcitabine (69%) and cyclophosphamide (38%) were the two most common contaminants found on the packaging of injectable preparations and carriers, regardless of the chemotherapy preparations.
CONCLUSIONS: Trace levels (ng) of antineoplastic drugs can be found on most surfaces of all evaluated pharmaceutical products. Thus, suitable personal protective equipment is mandatory for healthcare professional handling antineoplastic drugs.