Effect evaluation of adverse drug reactions monitoring based on the Chinese hospital pharmacovigilance system

doi:10.19803/j.1672-8629.20210011

Abstract

Abstract: Objective To study the role of the Chinese hospital pharmacovigilance system (CHPS) in the monitoring of adverse drug reactions (ADR) in medical institutions. Methods The ADR that occurred in our hospital between 2019 to 2020 were collected. The ADR reported in 2019 were assigned to the pre-operation group, while those reported in 2020 to the post-operation group based on the time the CHPS started to operate in China. The ADR reports before and after the operation of the CHPS were analyzed. The numbers, sources, types and quality of ADR reports as well as drugs and organ and systems involved were compared. Results Two hundred and sixty ADR reports were collected before the operation of the CHPS and 573 after that. The number of ADR reports increased by 120.38%. The proportion of reports by the medical staff increased from 13.08% to 36.30% (P<0.001). New/serious ADR reports increased by 363.16%. The proportion of serious ADR reports increased from 7.69% to 24.43% (P<0.001). The standardization of reports, completeness of drug information, timeliness of reports and the efficiency of reporting were significantly improved (P<0.001). Conclusion The CHPS can identify and monitor suspicious ADR, improve the quantity and quality of ADR reports, deliver risk signal warning, and provide technical support for the safety of hospital medications.

Key words: Chinese hospital pharmacovigilance system, adverse drug reaction, effect evaluation, medication safety, retrospective analysis

CLC Number:

R951
R994.11

BAI Hehe, NIE Xiaojing, XIA Li, MA Li, WANG Jinping, PENG Lirong. Effect evaluation of adverse drug reactions monitoring based on the Chinese hospital pharmacovigilance system[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1136-1139.

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