ADR工作制度.doc

目 录 一、药品不良反应监测管理规定···············································1 二、ADR 监测组工作任务·····················································3 三、ADR监测组工作内容························································4 四、ADR监测工作程序···························································5 五、ADR监测常规流程···························································7 六、新的、严重的ADR监测流程·················································8 七、群体性ADR监测流程························································9 八、ADR病例报告制度·························································10 九、ADR报表收集登记制度·················································11 十、ADR病例评价制度························································12 十一、ADR监测信息反馈制度·················································13 十二、ADR监测咨询服务制度················································14 十三、ADR咨询服务流程······················································15 十四、ADR监测组工作职责··············································16 十五、ADR监测组成员工作职责·······································17 十六、ADR监测专家组成员工作职责······································18 十七、ADR监测微机档案室管理制度·········································19 安徽省立医院药事管理委员会 药品不良反应监测管理规定 根据安徽省立医院药事管理委员会（下称药事会）章程，药品不良反应（ADR）监测领导小组（下称ADR监测组）负责全院ADR监测的组织和业务指导工作。 ADR监测组由院分管领导、医务处、护理部、药剂科等有关部门负责人和专家组成，院分管领导任组长，医务处主任、护理部主任、药剂科主任或副主任任副组长。内设ADR监测专家组、秘书、ADR监测员、ADR监测联络员。日常办公地点设在药剂科。 ADR监测专家组分别由临床经验丰富的医学专家和药剂科的药学专家担任，负责对ADR的因果关系提供专业理论和专业技术的判断、咨询、和评价，指导院内ADR监测学术水平的持续提高。 ADR监测组秘书由药剂科指定专职人员承担。工作职责是：协助制订ADR监测工作计划和方案、协调和指导临床开展ADR监测工作、收集整理ADR报告表并上报省ADR监测中心，及时向ADR报告人反馈关联性评价意见。 ADR监测员分别由临床科室（病区）的住院总医师、护士长或主管护师等担任；ADR监测联络员由各药房负责人担任。各监测员、联络员分别负责本部门ADR监测的联络、组织和报告工作。 ADR监测员、ADR监测联络员应密切关注可疑的ADR病例，对涉及到的病人隐私应保密；严重病例（尤其是死亡病例）应立即报告，避免严重ADR的重复发生。 ADR监测组应不定期举行全院性的ADR监测工作会议，增强医务人员对公众用药安全的责任感；每年举办一次ADR知识培训班，强化全院医务人员报告ADR的意识，提高ADR报告表的填写质量，确保院内ADR监测工作的正常开展。 ADR监测组应与国家ADR监测中心和省ADR监测中心建立电话、书信与网络联系，掌握国内外有关ADR报告的监测信息，及时向药事会提出在用药品的安全信息警报（报告必须停止使用的药品或需要限制使用的药品），确保临床用药安全。 安徽省立医院药事管理委员会 ADR监测组工作任务 在院药事会的领导下，对全院ADR监测工作进行全面管理和业务指导。 承