Simple Analysis on How to Establish Rapid Alert System and Emergency Response Mechanism for Drug Safety Based on the Events of Medicinal Capsules with Excessive Chromium
10.3969/j.issn.1008-049X.2018.03.030
- VernacularTitle:从药用胶囊铬超标系列事件浅析如何建立我国药品安全快速预警与应急处置机制
- Author:
Qiu ZHANG
1
;
Hui CHEN
;
Lihui YAO
Author Information
1. 国家食品药品监督管理总局高级研修学院 北京100073
- Keywords:
Series events of medicinal capsules with excessive chromium;
Early alert;
Emergency response
- From:
China Pharmacist
2018;21(3):472-474
- CountryChina
- Language:Chinese
-
Abstract:
To further hold drug safety defense,rapid alert and emergency response should be done well for drug safety events in order to provide reference for effective prevention and response to drug safety incidents. The disposal process of the series events of me-dicinal capsules with excessive chromium was reviewed,and the features were analyzed to explore the emergency response and alert sys-tem for drug safety in China. To set up drug safety emergency monitoring mechanism,risk analysis and assessment mechanisms,proce-dures startup mechanism,crisis ending and follow-up assessment mechanism,appropriate public opinion guide mechanism,and a clear legal status of rapid test in the disposal of drug safety incidents are effective means to improve drug safety rapid alert and emergency re-sponse,which can provide necessary guarantees for drug safety and regulation.
