Development and Application of MAH Production Line Risk Warning System Based on ADR Report Data
- VernacularTitle:基于ADR报告数据的MAH生产线风险预警系统的研发与应用
- Author:
Baohuan LEI
1
;
Mengdan XU
1
,
2
;
Jianxiong DENG
3
;
Yue YANG
4
;
Wenge CHEN
5
;
Xin ZHU
6
Author Information
1. School of Clinical Pharmacy，Guangdong Pharmaceutical University，Guangzhou 510006，China
2. NMPA Key Laboratory for Pharmacovigilance Technology Researoh and Evaluation，Guangzhou 510006
3. Guangdong Pharmacological Society，Guangzhou 510080，China
4. School of Pharmacy，Tsinghua University，Beijing 100084，China
5. School of Mechanical and Electrical Engineering，Guangdong University of Technology，Guangzhou 510090，China
6. Guangzhou Pinyi Techno logy Co.，Ltd.，Guangzhou 510095，China
- Publication Type:Journal Article
- Keywords:
Adverse drug reaction report;
Marketing
- From:
China Pharmacy
2021;32(8):904-910
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To provide technical met hods for marketing authorization holder （MAH）to effectively use the data of adverse drug reaction （ADR），actively monitor and control the production quality risk ，and carry out drug production risk management. METHODS ：Through establishing three-dimensional risk matrix and risk trend model ，the risk early warning system of MAH production line based on ADR report data is designed and developed ；the main functions of the system were applied and analyzed according to the actual ADR report data of a certain company. RESULTS ：MAH production line risk warning system was established preliminarily. The main framework included data source and and processing module ，model construction module （three-dimensional matrix model included possibility index ，severity index and sensitivity index ，risk trend model was set according to the principle of product production batch number preparation ），and result output & analysis module. Five major functional modules included system configuratio ，production line signal detection ，visual statistical early warning ，ADR report management and standard data management. The application and analysis of ADR report data of a certain company showed that the system could realize detection and warning of the company ’s production line risk ，which intuitively reflected its high-risk production lines ，varieties and batch numbers. It was consistent wit h the actual safety sit uation of the company ’s varieties. CONCLUSIONS：The system can help MAH make use of ADR report data to actively monitor drug production quality risks in a timely manner ，investigate risk factors for high-risk production lines ， high-risk varieties and high-risk batch numbers，and assist in decision-making on the direction of risk investigation.
