Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (4): 212-214.

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Practice and Discussion on Active Surveillance by China Hospital Pharmacovigilance System

HOU Yongfang, SONG Haibo, LIU Hongliang, LI Xilin*   

  1. Center for Drug Reevaluation, NMPA, Beijing 100022, China
  • Received:2019-05-09 Revised:2019-05-09 Online:2019-04-20 Published:2019-05-09

Abstract: Objective To summarize China Hospital Pharmacovigilance System(CHPS), so to provide reference for active surveillance using real-world electronic medical data. Methods We have built CHPS by establishing China ADR Sentinel Surveillance Alliance to build cooperation mechanisms, and establishing Chinese Hospital Pharmacovigilance System to open data channels between data sources, and establishing risk analysis models to verify drug safety issues. Results & Conclusion CHPS, as an attempt to active surveillance, has been initially established, which can improve the efficiency and quality of adverse drug reaction reports, reduce missing cases of adverse reactions, and share drug safety information. It can play a role in verifying risk signals in the future.

Key words: active surveillance, adverse drug reaction, common data model, sentinel

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