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| 药品生产企业药物警戒工作实践 |
| Pracitice of Drug Manufacturers to Establish Pharmacovigilance System |
| 投稿时间：2019-08-21 修订日期：2019-11-06 |
| DOI： |
| 中文关键词: 药品生产企业 药物警戒 不良反应监测 实践 百批不良反应发生率 |
| 英文关键词: drug manufacturer pharmacovigilance ADR monitoring practice ADRs/100Batch |
| 基金项目: |
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| 中文摘要: |
| 摘要：目的 探讨如何构建有效的药品生产企业药物警戒体系。方法 通过回顾药物警戒体系的现状和要素，结合本企业药物警戒工作工作实践，从组织机构、制度与文件、日常实施、关键指标设计和信息挖掘等方面进行实例分析。结果与结论 药品生产企业应主动实施药物警戒体系建设工作，可以将企业生产信息与药物警戒信息关联设计药物警戒信号指标，提供药品真实世界的警戒能力；相关监管机构应当提供和共享更多药物警戒信息。 |
| 英文摘要: |
| Abstract: Objective Discussing how to construct an effective drug manufacturers' pharmacovigilance(PV) system. Methods By reviewing the current situation and key elements of PV system, and combining with the practice of PV work in our enterprise, examples a're analyzed from the aspects of organization, system and documents, daily implementation, key index design and information mining. Results and Conclusion Drug manufacturers should take the initiative to implement the construction of PV system, which can correlate production information with PV information to design alert signal indicators and provide real-world alert capability of drugs. Relevant authorities should provide more information on PV. |
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