北美抗肿瘤药物擦拭取样方法的特点:六家供应商的比较

Claire Chabut, J. Bussières
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We specified the objective of our study and described the information needed and the variables of interest with standardized questions. Additional questions were sent by emails or via teleconferences. No statistical analyses were performed. Results We identified six providers offering services to Canadian hospitals, either based in Canada or in the United States. Five of these providers were private companies and one was a public organization. Each service provider was able to measure trace contamination of 3–17 antineoplastic drugs. Five of the providers quantified drugs using ultra performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MSMS), which allowed for lower LODs. The sixth provider offered quantification by immunoassay, which has higher LODs, but offers near real-time results; the surface area to be sampled with this method was also smaller than with UPLC-MSMS. The services offered varied among the service providers. The information about LODs supplied by each provider was often insufficient and the units were not standardized. A cost per drug quantified could not be obtained, because of variability in the scenarios involved (e.g. drug selection to be quantified, number of samples, nondisclosure of ancillary costs). Four of the six service providers were unable to report LOQ values. Conclusions Few data are available from Canadian service providers concerning the characteristics of wipe sampling methods for antineoplastics. This study identified six north-American providers. Their characteristics were very heterogeneous. Criteria to consider when choosing a provider include the validation of their analytical method, a low limit of detection, the choice of drugs to be quantified and the sites to be sampled, obtaining details about the method and understanding its limits, and price. 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引用次数: 3

摘要

几个协会已经发布了指导方针,以限制工人的职业暴露。其中一些指南建议对制备和施用抗肿瘤药物的特定地点进行定期(一年一次或两次)环境监测。然而,大多数指南没有提供关于应该监测哪些抗肿瘤药物、首选取样地点、适当的测试方法或检测限度的指导。本研究的目的是表征供应商量化抗肿瘤药物测量表面。方法采用横断面描述性研究。为了确定提供环境监测测试的服务提供商,我们搜索了PubMed数据库并使用了Google搜索引擎。我们在2020年6月3日至6月15日期间通过电子邮件联系了每个服务提供商。我们明确了研究的目的,并用标准化的问题描述了所需的信息和感兴趣的变量。其他问题通过电子邮件或电话会议发送。未进行统计学分析。结果:我们确定了六家为加拿大医院提供服务的供应商,他们要么在加拿大,要么在美国。这些供应商中有五家是私人公司,一家是公共组织。每个服务提供者能够测量3-17种抗肿瘤药物的痕量污染。5家供应商使用超高效液相色谱-串联质谱(UPLC-MSMS)进行药物定量,从而降低了lod。第六家供应商提供免疫测定定量,lod更高,但提供接近实时的结果;该方法的采样面积也比UPLC-MSMS小。服务提供商提供的服务各不相同。每个供应商提供的lod资料往往不够充分,单位也没有标准化。由于所涉及的情况(如要量化的药物选择、样本数量、未披露辅助费用)的可变性,无法获得每种药物的量化成本。六个服务提供商中有四个无法报告LOQ值。结论加拿大服务提供者关于抗肿瘤药物擦拭取样方法特点的资料很少。这项研究确定了六家北美供应商。它们的特征非常不同。选择供应商时要考虑的标准包括分析方法的验证、检测下限、要定量的药物和取样地点的选择、获得方法的详细信息并了解其限制以及价格。这应该是每个中心结构化多学科方法的一部分。
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Characteristics of wipe sampling methods for antineoplastic drugs in North America: comparison of six providers
Abstract Objectives Several societies have published guidelines to limit the occupational exposure of workers. Several of these guidelines recommend periodic (once or twice a year) environmental monitoring of specific sites where antineoplastic drugs are prepared and administered. However, most of the guidelines provide no guidance concerning which antineoplastic drugs should be monitored, the preferred sampling sites, appropriate test methods or limits of detection. The aim of this study was to characterize providers that quantify antineoplastic drug measured on surfaces. Methods This was a cross-sectional descriptive study. To identify service providers offering environmental monitoring tests, we searched the PubMed database and used the Google search engine. We contacted each service provider by email between June 3rd and June 15th, 2020. We specified the objective of our study and described the information needed and the variables of interest with standardized questions. Additional questions were sent by emails or via teleconferences. No statistical analyses were performed. Results We identified six providers offering services to Canadian hospitals, either based in Canada or in the United States. Five of these providers were private companies and one was a public organization. Each service provider was able to measure trace contamination of 3–17 antineoplastic drugs. Five of the providers quantified drugs using ultra performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MSMS), which allowed for lower LODs. The sixth provider offered quantification by immunoassay, which has higher LODs, but offers near real-time results; the surface area to be sampled with this method was also smaller than with UPLC-MSMS. The services offered varied among the service providers. The information about LODs supplied by each provider was often insufficient and the units were not standardized. A cost per drug quantified could not be obtained, because of variability in the scenarios involved (e.g. drug selection to be quantified, number of samples, nondisclosure of ancillary costs). Four of the six service providers were unable to report LOQ values. Conclusions Few data are available from Canadian service providers concerning the characteristics of wipe sampling methods for antineoplastics. This study identified six north-American providers. Their characteristics were very heterogeneous. Criteria to consider when choosing a provider include the validation of their analytical method, a low limit of detection, the choice of drugs to be quantified and the sites to be sampled, obtaining details about the method and understanding its limits, and price. This should be part of a structured multidisciplinary approach in each center.
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