T/CAPC 011-2023 零售药店经营自体嵌合抗原受体T细胞(CAR-T)治疗药品服务规范

ICS03.080.01

CCSA16

团体标准

T/CAPC011—2023

零零售药店经营自体嵌合抗原受体T细胞(CAR-T)治疗药品服务规范

Standardizedmethodforpharmaceuticalserviceof

pharmaciesretailingChimericantigenreceptorTcell

2023-06-06发布2023-06-06实施

中国医药商业协会  发布

T/CAPC011—2023

目次

前言.................................................................................III

1范围................................................................................1

2规范性引用文件......................................................................1

3术语和定义..........................................................................1

4总体要求............................................................................1

5人员与培训..........................................................................1

人员配备与能力要求..............................................................2

培训要求........................................................................2

资质认证考核....................................................................2

6经营服务环境与设施..................................................................2

经营服务环境要求................................................................2

咨询服务区要求..................................................................2

患教区要求......................................................................2

信息系统与设备要求..............................................................2

存储专区要求....................................................................3

配送设备要求....................................................................3

档案管理要求....................................................................3

7细胞治疗药品供应链及经营服务........................................................3

建立标准操作程序（SOP）.........................................................3

签署购药协议及支付..............................................................3

采购与验收......................................................................3

存储与配送......................................................................4

药品交付........................................................................4

8细胞治疗药品药学服务................................................................4

咨询服务........................................................................4

处方审核........................................................................4

用药教育........................................................................5

治疗后随访......................................................................5

药物警戒........................................................................5

档案管理........................................................................5

9特殊情况处置........................................................................5

突发问题处理....................................................................5

延期交付........................................................................6

更换冷链运输装置................................................................6

退货............................................................................6

10质量控制与持续改进.................................................................6

质量控制...