Objective To provide thought and references for the promotion of ADR monitoring in China, suggestions on the secondary use of observational data for maximizing the benefit and minimizing the risk of drug use. Methods The data organization and access models of the Observational Medical Outcomes Partnership in US and the Common Data Model were studied and analyzed. Results and Conclusion The establishment and implementation of OMOP has obvious characteristics. In order to use existing multiple observational healthcare databases for active drug safety and benefit monitoring, the critical factor and the basis on the technical levels are the construction, improvement and unification of the medical information standards. The CDM design, development and evaluation can provide good thought and references for secondary use of observational data and active drug safety surveillance by establishing partnership and using a variety of data sources in China.%目的：为进一步加强药品安全性监测与评价工作提供思路和参考，为开展观察性数据二次利用实现药品使用利益最大化风险最小化提出建议。方法研究美国观察医疗结果合作项目及其数据组织、访问技术和模型，对通用数据模型进行了研究与分析。结果与结论观察医疗结果合作项目的创建与实施具有明显特征；利用多来源的医疗保健数据开展药物安全性主动监测，在技术层面的关键和基础是医疗卫生信息标准的建立、完善和统一应用；通用数据模型的设计、应用及效果评估，能够为我国开展多方合作、利用多数据源进行观察性数据二次开发、开展上市后产品安全性主动监测提供思路和方法。
展开▼
