基于CHPS的全国药品不良反应监测哨点联盟的研究

目的：为政府部门、医院、制药企业等机构的相关人员对基于CHPS的全国药品不良反应监测哨点联盟的认识和了解提供参考。方法：采用基于文献调查和实践观察的规范研究方法，对比分析中美两国的药品不良反应监测哨点联盟的监测方法，并对我国药品不良反应监测哨点联盟建立的作用、意义及其运行情况进行阐述和分析。结果：CHPS在哨点联盟中可以及时、准确、完整地收集药品不良反应信息，促进哨点联盟成员高效率、低成本、高质量地完成药物上市后的研究。结论：哨点医院联盟的建立，为建设和完善我国药品上市后科学评价体系以及药品安全的智能监管体系，提供了新的实现平台。

Research on National Sentinel Alliance for Adverse Drug Reaction Surveillance Based on CHPS

Objective: To provide a platform for relevant personnel of government departments, hospitals, pharmaceutical enterprises and other institutions to understand the national sentinel alliance for adverse drug reaction (ADR) surveillance based on Chinese Hospital Pharmacovigilance System (CHPS). Methods: The surveillance methods of the sentinel alliance for ADR between China and the United States were contrasted and analyzed by using the normative research method through literature survey and practical observation. The roles, significance and operation of the sentinel alliance for ADR surveillance in China were elaborated and analyzed. Results: CHPS in the sentinel alliance could collect the information of ADR timely, accurately and completely, and could promote the members of the sentinel alliance to complete the drug post-marketing research with high efficiency, low cost and high quality. Conclusion: The establishment of sentinel hospital alliance provides a new implementation platform for the construction and improvement of post-marketing scientific evaluation system of drugs and the intelligent supervision system for drug safety in China.