Study on the mechanism ，specific path and code of conduct of pharmaceutical enterprises ’participation in American active surveillance system and its enlightenment
- VernacularTitle: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
- Author:
Siyi GE
1
;
Wei CHEN
1
;
Mingyang WU
1
;
Yiming XU
1
;
Yi LIANG
1
Author Information
1. School of International Pharmaceutical Business，China Pharmaceutical Universi ty，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
active surveillance system;
pharmacovigilance;
pharmaceutical enterprise;
observational medical outcomes
- From:
China Pharmacy
2022;33(15):1799-1805
- CountryChina
- Language:Chinese
-
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.
