Xinling Li1, Haona Li2,3, Jianxiong Deng4, Feng Zhu5, Ying Liu5, Wenge Chen6, Zhihua Yue7, Xuequn Ren3, Jielai Xia8. 1. Center for Drug Reevaluation, China Food and Drug Administration, Beijing, China. 2. Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, No.169 Changle West Road, Xi'an, 710032, Shaanxi, China. 3. Huaihe Hospital of Henan University, Henan University, Kaifeng, Henan, China. 4. Guangdong Pharmacological Society, Guangzhou, Guangdong, China. 5. Adverse Drug Reaction Monitoring Centre of Guangdong Province, Guangzhou, Guangdong, China. 6. School of Mechanical and Electrical Engineering, Guangdong University of Technology, Guangzhou, Guangdong, China. 7. Chinese Pharmacopoeia Commission, Beijing, China. 8. Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, No.169 Changle West Road, Xi'an, 710032, Shaanxi, China. xiajielai@fmmu.edu.cn.
Abstract
BACKGROUND: The effectiveness of active pharmacovigilance depends on the specific methods adopted and the work patterns put into place. Over the past few years, much attention has been paid to the importance of implementing such systems in China. However, less has been done to evaluate the state of implementation and future needs of such systems. METHODS: This paper reviews China's recent approaches to active pharmacovigilance by examining: (1) information collected from scientific articles and the websites of the China Food and Drug Administration and the China National Center for Adverse Drug Reaction Monitoring, (2) information available on China's spontaneous reporting systems (SRS) and active pharmacovigilance system, and (3) annual reports and internal reports on this subject. RESULTS: Areas that improved most meaningfully for China's active pharmacovigilance in recent years appear to include: (1) quicker reporting and more intelligent scanning methods for adverse drug reactions (ADRs), (2) the use of pharmacovigilance approaches to mine electronic hospital records, and (3) the development of integrated systems including the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program. CONCLUSION: Not only has the national online SRS system provided a platform for passive pharmacovigilance, it has also become an important platform for various explorations of active pharmacovigilance in China. Quick reporting and intelligent scanning of ADRs, facilitated by automated ADR detection based on electronic hospital records, have accelerated to capabilities for active pharmacovigilance. The outcomes of the programs, such as the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program, usher in a new era for China's active pharmacovigilance. These are particularly important to bridge the information system of sentinel hospitals and ADR research centers, but gaps remain. Thus, much work needs to be done before a high-level active pharmacovigilance system is sufficiently mature to ensure drug safety in the country.
BACKGROUND: The effectiveness of active pharmacovigilance depends on the specific methods adopted and the work patterns put into place. Over the past few years, much attention has been paid to the importance of implementing such systems in China. However, less has been done to evaluate the state of implementation and future needs of such systems. METHODS: This paper reviews China's recent approaches to active pharmacovigilance by examining: (1) information collected from scientific articles and the websites of the China Food and Drug Administration and the China National Center for Adverse Drug Reaction Monitoring, (2) information available on China's spontaneous reporting systems (SRS) and active pharmacovigilance system, and (3) annual reports and internal reports on this subject. RESULTS: Areas that improved most meaningfully for China's active pharmacovigilance in recent years appear to include: (1) quicker reporting and more intelligent scanning methods for adverse drug reactions (ADRs), (2) the use of pharmacovigilance approaches to mine electronic hospital records, and (3) the development of integrated systems including the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program. CONCLUSION: Not only has the national online SRS system provided a platform for passive pharmacovigilance, it has also become an important platform for various explorations of active pharmacovigilance in China. Quick reporting and intelligent scanning of ADRs, facilitated by automated ADR detection based on electronic hospital records, have accelerated to capabilities for active pharmacovigilance. The outcomes of the programs, such as the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program, usher in a new era for China's active pharmacovigilance. These are particularly important to bridge the information system of sentinel hospitals and ADR research centers, but gaps remain. Thus, much work needs to be done before a high-level active pharmacovigilance system is sufficiently mature to ensure drug safety in the country.
Entities:
Keywords:
Active pharmacovigilance; Data partner cooperation; Drug safety; Spontaneous reporting system
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