1 相关信息和其他资源 ................................................................................................ 6 2 简介 ...................................................................................................................... 7 2.1 立法要求 .............................................................................................................. 7 2.1.1 实施立法要求的指南 ...................................................................................... 7 2.2 定义 ...................................................................................................................... 8 3 工作健康安全 ............................................................................................................. 10 3.1 人员管理 ............................................................................................................. 10 3.1.1 个人防护设备 ............................................................................................. 10 3.1.2 健康监测 ............................................................................................................. 11 3.1.3 员工暴露报告和记录保存 ............................................................................. 11 3.1.4 计划生育、妊娠和哺乳 ............................................................................................. 13 3.2 系统管理 ............................................................................................................. 13 3.2.1 封闭系统转移设备 (CSTD) .................................................................................. 13 4 员工教育和培训 .................................................................................................. 14 4.1 医务人员认证................................................................................................14 4.1.1 危险药物 ..............................................................................................14 4.1.2 抗肿瘤药物 ..............................................................................................14 4.2 护理人员配备认证 ..............................................................................................14 4.2.1 步骤 1：口服药物给药认证途径 ........................................................14 4.2.2 步骤 1.1：肠外生殖危险药物认证途径 ..................................................14 ...........................................................................................................................14 4.2.3 步骤 2：危险肠外用药认证途径，例如免疫抑制剂/抗病毒药物/单克隆抗体等。 ...........................................................14 4.2.4 步骤 2.1：非肿瘤患者抗肿瘤药物管理认证途径（例如风湿病和肾病患者） ...........................................................14 4.2.5 步骤 3：抗肿瘤认证途径（肿瘤学） .........................................................................15 4.2.6 步骤 3.1：非癌症环境中肿瘤患者抗肿瘤药物管理认证途径 - 仅限 SCH ......................................................................................15 4.2.7 生物危害药物/转基因生物 ..............................................................................................15 4.2.8 维持认证 ................................................................................................................15 4.2.9 评估员 ......................................................................................................................15 4.3 护理文档 ......................................................................................................................16 4.4 药学培训和教育 .............................................................................................................16 4.5 清洁/家政服务培训和教育 .............................................................................................16 4.6 病理学培训和教育 .............................................................................................................16 5 危险和细胞毒性药物 ................................................................................................17 5.1 处方 .............................................................................................................................17 5.1.1 危险药物 .............................................................................................................17 5.1.2 抗肿瘤药物................................................................................17 5.2 检查药物 ......................................................................................................17 5.2.1 步骤 1-检查危险口服药物 ..............................................................................17 5.2.2 步骤 2-检查危险肠外药物（如免疫抑制剂/抗病毒药物/单克隆抗体等） .............................................................................................18.................................................................17 5.1.1 危险药物 ......................................................................................................17 5.1.2 抗肿瘤药物 ................................................................................................17 5.2 检查药物 ..............................................................................................................17 5.2.1 步骤 1-检查危险口服药物 .............................................................................17 5.2.2 步骤 2-检查危险肠外药物（如免疫抑制剂/抗病毒药物/单克隆抗体等） .............................................................................18.................................................................17 5.1.1 危险药物 ......................................................................................................17 5.1.2 抗肿瘤药物 ................................................................................................17 5.2 检查药物 ..............................................................................................................17 5.2.1 步骤 1-检查危险口服药物 .............................................................................17 5.2.2 步骤 2-检查危险肠外药物（如免疫抑制剂/抗病毒药物/单克隆抗体等） .............................................................................18