DB37/T 4530-2022 医疗机构药品不良反应监测与信息交流技术规范

ICS03.160

CCSA90

37

山东省地方标准

DB37/T4530—2022

医疗机构药品不良反应监测与信息交流

技术规范

Technicalspecificationsforinformationcommunicationofadversedrugreactions

monitoringwithmedicalinstitution

2022-07-25发布2022-08-25实施

山东省市场监督管理局发布

DB37/T4530—2022

目次

前言.................................................................................II

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

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

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

4基本原则...........................................................................1

4.1双向性.........................................................................1

4.2针对性.........................................................................1

4.3及时性.........................................................................1

4.4充分性.........................................................................1

4.5专业性.........................................................................2

5交流方式...........................................................................2

5.1药品安全咨询...................................................................2

5.2药品不良反应安全信息反馈.......................................................2

5.3有因直接交流...................................................................2

5.4处方事件询问...................................................................3

5.5风险信号沟通...................................................................3

5.6监管信息沟通...................................................................4

6交流实施...........................................................................4

6.1启动时机.......................................................................4

6.2实施流程.......................................................................4

7交流质量评价与改进.................................................................5

7.1评价方式.......................................................................5

7.2持续改进.......................................................................5

附录A（资料性）模式构建流程图.......................................................6

参考文献..............................................................................7