The Mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level

doi:10.19803/j.1672-8629.2022.02.14

Abstract

Abstract: Objective To explore the working mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level. Methods Based on ways of monitoring in Shandong Province, the patterns and characteristics of adverse drug reaction cluster signals were summarized, specific requirements were clarified and advice on improving the monitoring of ADR cluster signals was given. Results and Conclusion The monitoring and disposal of adverse drug reaction cluster signals requires that the main responsibilities of drug marketing authorization holders are fulfilled, risk control be given the top priority, multi-sided collaboration and closed-loop disposal be ensured.

Key words: adverse drug reaction, drug marketing authorization holder, cluster, signal, disposal

CLC Number:

R95R994.11

LU Changfei, CUI Xiaokang, LIU Wenwen, ZHANG Huaqi, GAO Wenzheng, WU Shifu. The Mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 180-184.

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