• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Pharmacoepidemiology and drug safety >Automated support for pharmacovigilance: a proposed system.
【24h】

Automated support for pharmacovigilance: a proposed system.

机译：药物警戒的自动支持：建议的系统。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Governments, manufacturers, and other entities are interested in adverse event surveillance of marketed medical products. FDA's Center for Drug Evaluation and Research redesigned the post-marketing adverse reaction surveillance process to use the advantages of new technology. As part of this effort, a 'Pharmacovigilance Working Group' designed a new strategy for the review and analyses of adverse event reports received by FDA. It created requirements which divided signal detection into five tiers: (1) Single 'urgent' reports would be sent to reviewers' workstations nightly for immediate attention. Reviewers would be able to customize definitions of 'urgent' (events that should not wait for aggregate review). (2) Single urgent reports would be placed in a context matrix containing historical counts of similar events to aid in initial interpretation. (3) In this first level of aggregate review, graphical displays would highlight patterns within all the reports, both urgent and non-urgent, and (4) periodic drug-specific tabled-based reports would display the newly received reports across a pre-defined variety of displays. These four tiers would produce passive and criteria-based results which would be presented to safety reviewers' electronic workstations. (5) Active query capabilities (routine, such as age, sex, and year distributions, as well as ad hoc) would be available for exploring alerted issues. The historical database would be migrated into the new format. All historical and new reaction data would be coded with the new MedDRA (Medical Dictionary for Regulatory Activities) scheme. The strategy was to design a full data capture system which effectively exploits current computing advances and technical performance to automate many aspects of initial adverse event review, supporting more efficient and effective clinical assessment of safety signals.
机译：政府，制造商和其他实体对市售医疗产品的不良事件监控感兴趣。 FDA的药物评估和研究中心重新设计了上市后不良反应监测程序，以利用新技术的优势。作为这项工作的一部分，“药物警戒工作组”设计了一种新策略，用于审查和分析FDA收到的不良事件报告。它创建了将信号检测分为五层的要求：（1）每晚将单个“紧急”报告发送到审阅者的工作站以立即引起注意。审阅者将能够自定义“紧急”（不应等待汇总审阅的事件）的定义。 （2）将单个紧急报告放在上下文矩阵中，其中包含类似事件的历史计数，以帮助进行初步解释。 （3）在第一级汇总审核中，图形显示将突出显示所有紧急和非紧急报告中的模式，以及（4）特定于药品的定期基于表格的报告将在预先报告中显示新收到的报告。定义各种显示。这四个层次将产生被动的和基于标准的结果，这些结果将呈现给安全审查员的电子工作站。 （5）主动查询功能（例行程序，例如年龄，性别和年份分布以及临时性）将可用于探索警报问题。历史数据库将被迁移为新格式。所有历史和新的反应数据都将使用新的MedDRA（管制活动医学词典）方案进行编码。该策略是设计一个完整的数据捕获系统，该系统可有效利用当前的计算机技术进步和技术性能，以使初始不良事件复查的许多方面实现自动化，从而支持对安全信号进行更有效的临床评估。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号