药物不良反应监测在澳大利亚经验与教训PPT课件2.ppt

* * * * * * Studies of dispensing and co-dispensing co-prescribing of “gastrointestinal drugs” in patients taking alendronate and calcitriol (unpublished) Co-prescribing with cisapride (in progress) Triple whammy = Extent of co-prescribing of ACE inhibitors, diuretics and NSAIDS. This combination is associated with acute renal failure in vulnerable patients. * * * * * 14791 first dispensings of leflunomide in 31 months were identified * * * * * * * * * * * * * * * * * * * * * * * Privacy act legally prevents TGA releasing certain details of a report (name or reporter, patient, addresses, hospital). This is thought necessary to encourage reporting. Some events reported consistent with inadequate clinical care and incriminate reporter or colleagues. These details can be subpoenaed – has happened once in last 10 years. * * * * * * * * * * * * * * * * * * * * * * Address for reporting: TGA website→ A-Z guide link →Adverse Drug Reactions → Report electronically * * * * * * * * * 处理报告 报告者电子报告全部原始数据 审阅者登录审阅和增加资料除非登录太花费时间（报告打印和传递到书记工作人员） * 处理报告 进一步信息报告 ADR报告数量鉴别 →扫描→ 审阅者 审阅者修改进入数据库除非登录太花费时间（通过书记工作人员） * 处理报告 任何报告的询问由审阅者回答 * 后面内容直接删除就行 资料可以编辑修改使用 资料可以编辑修改使用 * 主要经营：网络软件设计、图文设计制作、发布广告等 公司秉着以优质的服务对待每一位客户，做到让客户满意！ * 致力于数据挖掘，合同简历、论文写作、PPT设计、计划书、策划案、学习课件、各类模板等方方面面，打造全网一站式需求 * * * * * * * * * * * * * The single most important event leading to the development of a system for assessing the safety of medicines in Australia was the identification of thalidomide embryopathy in 1961 * * * Australian Drug Evaluation Committee (ADEC) First meeting in 1963. Members are independent clinical experts Initial role was as a “Safety Committee” with much of its attention devoted to establishing a registry of adverse reactions to medicines. ADEC then became increasingly concerned with applications to register for new medicines. * * * * * * * * * * * Important historic features of the Australian monitoring scheme High proportion of direct reporting by health professionals (in