Research progress on quality evaluation methods for adverse drug reaction reports at home and abroad
10.3760/cma.j.cn114015-20230727-00558
- VernacularTitle:国内外药品不良反应报告质量评价方法的研究进展
- Author:
Xin WANG
1
;
Chen LIU
;
Yanhong ZHANG
;
Bingxin JI
;
Haodong CAI
Author Information
1. 首都医科大学宣武医院医务处，北京 100053
- Publication Type:Journal Article
- Keywords:
Drug-related side effects and adverse reactions;
Adverse drug reaction reporting systems;
Causality;
Quality control;
Evaluation method
- From:
Adverse Drug Reactions Journal
2023;25(11):683-689
- CountryChina
- Language:Chinese
-
Abstract:
Conducting quality evaluation of adverse drug reaction (ADR) case report and obtaining accurate, objective and scientific data is related to the level and quality of the entire monitoring work, and is an important basis for drug regulatory departments to formulate safety regulatory measures. The research progress and application status of the methodology of quality evaluation of ADR reports abroad were investigated through literature search in this paper. It mainly includes 3 different evaluation methods (WHO quality evaluation method, clinical documentation tool, ADR report quality algorithm) from Uppsala Monitoring Centre, Netherlands and Australia. There are currently 2 versions of ADR report quality evaluation methods in China, which are included in the appendices of the 2005 and 2012 editions of the "Adverse Drug Reaction Reporting and Monitoring Work Manual". Different ADR report quality evaluation methods have different focus points, and it is necessary to develop a scientific evaluation method suitable to provide reference for the quality supervision and management of ADR in China.
