Active pharmacovigilance in China: recent development and future perspectives

  • Xinling Li
  • Haona Li
  • Jianxiong Deng
  • Feng Zhu
  • Ying Liu
  • Wenge Chen
  • Zhihua Yue
  • Xuequn Ren
  • Jielai Xia
Review

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.

Key words

Active pharmacovigilance Spontaneous reporting system Drug safety Data partner cooperation 

Notes

Acknowledgments

The authors gratefully acknowledge Frances J Richmond, from University of Southern California, for her critical review of the manuscript which has greatly improved this work.

Authors’ contributions

XL, HL, JD, FZ,YL,WC, ZY, XR, and JX were all involved in study design, data analysis, and interpretation, drafting revision, and approval of the article.

Compliance with ethical standards

Conflict of interest

The authors have no conflicts of interest to declare.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Center for Drug ReevaluationChina Food and Drug AdministrationBeijingChina
  2. 2.Department of Health Statistics, School of Preventive MedicineFourth Military Medical UniversityXi’anChina
  3. 3.Huaihe Hospital of Henan UniversityHenan UniversityKaifengChina
  4. 4.Guangdong Pharmacological SocietyGuangzhouChina
  5. 5.Adverse Drug Reaction Monitoring Centre of Guangdong ProvinceGuangzhouChina
  6. 6.School of Mechanical and Electrical EngineeringGuangdong University of TechnologyGuangzhouChina
  7. 7.Chinese Pharmacopoeia CommissionBeijingChina

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