Abstract

Pharmacy technicians are exposed to volatile organic compounds, like the disinfectant isopropyl alcohol (IPA), during the process of aseptic compounding of parenteral cytotoxic drugs. The occupational exposure to nebulized IPA during aseptic compounding has not been investigated. The aim of this study was to investigate the exposure to IPA during aseptic compounding of parenteral cytotoxic drugs and to assess compliance with legal and regulatory limits. As a secondary endpoint, the difference between two disinfection methods was compared regarding the exposure to IPA. The exposure to IPA was measured during five working shifts of 8 hr and one shift of 4 hr. The concentration IPA was measured by using a six-gas monitor. Total daily exposure was calculated as 8-hr Time Weighted Average (TWA) air concentration in mg/m³ and compared with an Occupational Exposure Limit (OEL) value of 500 mg/m³ and incidental peak exposure of 5,000 mg/m³. To assess whether the 8-hr TWA air concentration meets the legal and regulatory limits the Similar Exposure Groups (SEG) compliance test was used. A paired sample t-test was conducted to assess difference in exposure between two disinfection methods. The average 8-hr TWA exposure to IPA during the six measurements varied from 2.6 mg/m³ to 43.9 mg/m³ and the highest momentary concentration measured was 860 mg/m³. The result of the SEG compliance test was 3.392 (U_r value) and was greater than the U_t value of 2.187 which means the exposure to IPA is in compliance with the OEL value. No significant difference in exposure was shown between two disinfection methods (p = 0.49). In conclusion, exposure to IPA during aseptic compounding of parenteral cytotoxic drugs showed compliance to the OEL values with no significant difference in exposure between two disinfection methods.

摘要

在注射细胞毒性药物的无菌复合过程中，药学技术人员会接触到挥发性有机化合物，如消毒剂异丙醇 (IPA)。尚未研究在无菌复合过程中职业暴露于雾化 IPA。本研究的目的是调查在胃肠外细胞毒性药物的无菌复合过程中对 IPA 的暴露，并评估对法律和监管限制的遵守情况。作为次要终点，比较了两种消毒方法在 IPA 暴露方面的差异。在 8 小时的五班工作和 4 小时的一班工作期间测量 IPA 的暴露量。浓度 IPA 是通过使用六种气体监测仪测量的。每日总暴露量计算为 8 小时时间加权平均 (TWA) 空气浓度，单位为 mg/m ³并与 500 mg/m ³的职业接触限值 (OEL)和 5,000 mg/m ^{3 的}偶然峰值接触进行比较。为了评估 8 小时 TWA 空气浓度是否符合法律和监管限制，使用了类似暴露组 (SEG) 合规性测试。进行配对样本 t 检验以评估两种消毒方法之间的暴露差异。在六次测量期间，平均 8 小时 TWA 暴露于 IPA 从 2.6 毫克/米³到 43.9 毫克/米³不等，测得的最高瞬时浓度为 860 毫克/米³。SEG 符合性测试的结果为 3.392（U _r值）并且大于 U _t值 2.187，这意味着 IPA 的暴露符合 OEL 值。两种消毒方法之间的暴露没有显着差异（p = 0.49）。总之，在胃肠外细胞毒性药物的无菌复合过程中暴露于 IPA 显示符合 OEL 值，两种消毒方法之间的暴露没有显着差异。