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美国药品主动监测系统中制药企业参与的机制、具体路径和行为准则研究及启示
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| 篇名： | 美国药品主动监测系统中制药企业参与的机制、具体路径和行为准则研究及启示 |
| TITLE： | Study on the mechanism ，specific path and code of conduct of pharmaceutical enterprises ’participation in American active surveillance system and its enlightenment |
| 摘要： | 目的 为我国开展药物警戒工作和建设制药企业广泛参与的主动监测系统提供参考。方法通过中国知网、PubMed等数据库和观测医疗结果合作项目（OMOP）官方网站检索相关的文献和资料，探究OMOP中制药企业参与的机制及其运行模式，并对制药企业参与主动监测系统建设的具体路径和行为准则进行分析，最后针对我国现实情况提出相应的建议。结果与结论OMOP中的制药企业通过公私合作伙伴（PPP）机制参与了项目建设和运行，并发挥了项目资助、项目治理和项目研究的作用；参与OMOP的制药企业需遵照广泛的合作、透明度和公开性、保护患者隐私的行为准则开展活动。在未来我国主动监测系统实践中，应当推进主动监测相关立法，强调制药企业的主动监测责任，建立产学研一体的PPP机制，形成良好的治理生态，并加强对患者隐私的保护。 |
| ABSTRACT： | OBJECTIVE To provide reference for developing pharmacovigilance and constructing an active surveillance system with extensive participation of pharmaceutical enterprises in China. METHODS Retrieving the literature and data from databases such as CNKI ，PubMed，and the official website of observational medical outcomes partnership （OMOP），the mechanism of pharmaceutical enterprises ’participation and its operation mode were investigated ，while specific path and code of conduct for pharmaceutical enterprises to participate in active surveillance system were analyzed. Finally ，the corresponding suggestions were put forward according to the actual situation of China. RESULTS & CONCLUSIONS Pharmaceutical enterprises in OMOP participated in project construction and operation through public private partnership （PPP）mechanism，and played the role of project funding ，project governance and project research. Pharmaceutical enterprises participating in OMOP need to carry out activities in accordance with the code of conduct of extensive cooperation ，transparency and openness and the protection of patient privacy. In the future practice of active surveillance system in China ，it is necessary to promote the relevant legislation of active monitoring system ，emphasize the responsibility of active surveillance of pharmaceutical enterprises ，establish a PPP mechanism of industry-university-research integration ，form a good governance ecology and strengthen the protection of patients ’privacy. |
| 期刊： | 2022年第33卷第15期 |
| 作者： | 葛斯羿，陈炜，吴明洋，徐一鸣，梁毅 |
| AUTHORS： | GE Siyi，CHEN Wei，WU Mingyang ，XU Yiming ，LIANG Yi |
| 关键字： | 主动监测系统；药物警戒；制药企业；观测医疗结果合作项目；公私合作伙伴 |
| KEYWORDS： | active surveillance system ； pharmacovigilance； pharmaceutical enterprise ； observational medical outcomes |
| 阅读数： | 322 次 |
| 本月下载数： | 8 次 |
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