Active pharmacovigilance in China: recent development and future perspectives
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.
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.
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.
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 wordsActive pharmacovigilance Spontaneous reporting system Drug safety Data partner cooperation
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.
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.
This research was funded/supported by National Science and Technology Major Project (No. 2017ZX09304005-003); China Postdoctoral Science Foundation (No. 2017M623372); Key Research Projects of Henan provincial colleges and universities (No. 18A330001) and Henan Provincial Project of Science and Technology (No. 182102311157)
Compliance with ethical standards
Conflict of interest
The authors have no conflicts of interest to declare.
- 1.World Health Organization (2002) The importance of pharmacovigilance-safety monitoring of medicinal products. Available at: http://apps.who.int/medicinedocs/en/d/Js4893e/. Accessed 10 Nov 2017
- 4.Lemozit JP, De La Rhodiere GP, Lapeyre-Mestre M et al (1996) A comparative study of adverse drug reactions reported through hospital and private medicine. Br J Clin Pharmacol 41(2):166–168. https://doi.org/10.1111/j.1365-2125.1996.tb00177.x CrossRefPubMedGoogle Scholar
- 9.Bortnichak EA, Dai WS (1999) Epidemiologists and adverse event data–a challenge to the field. Pharmacoepidemiol Drug Saf 8(6):457–461. https://doi.org/10.1002/(sici)1099-1557(199910/11)8:6<457::aid-pds452>3.0.co;2-s CrossRefPubMedGoogle Scholar
- 11.Institute of Medicine (2007) The Future of Drug Safety: Promoting and Protecting the Health of the Public. The National Academies Press, Washington, DCGoogle Scholar
- 15.Shen L, Liu W, Fan Y et al (2012) Discussion on the technical development period of adverse drug reaction monitoring in China. Chinese Journal of Pharmacovigilance 9(3):146–149. https://doi.org/10.3969/j.issn.1672-8629.2012.03.006 CrossRefGoogle Scholar
- 18.China Food and Drug Administration (2016) Annual ADR report on national ADR monitoring. Available at: http://www.sda.gov.cn/WS01/CL0844/172167.html. Accessed 10 Nov 2017
- 22.Wang L (2015) Study on adverse drug reaction monitoring based on hospital information system. Chinese Journal of Pharmacovigilance 12(4):229–231Google Scholar
- 25.Deng J, Wang L, Zhang Y et al (2015) Research and application of adverse drug reaction rapid reporting and intelligent searching system based on HIS. Chinese Journal of Pharmacovigilance 12(12):731–734Google Scholar
- 26.Shu T, Chen W, Hou Y et al (2017) Research and application of the sentinel hospital pharmacovigilance system based on HIS. China Pharmacy 28(25):3468–3471. https://doi.org/10.6039/j.issn.1001-0408.2017.25.04 CrossRefGoogle Scholar
- 27.Chen C, Guo D, Xue W et al (2013) Development of alarming system to actively monitor and assess the adverse drug events in hospitalized patients. Chinese Journal of Pharmacovigilance 10(7):411–414, 418. https://doi.org/10.3969/j.issn.1672-8629.2013.07.008 CrossRefGoogle Scholar
- 28.Wang Y, Liu G, Zhang Y et al (2010) Study on automatic monitoring technology of adverse drug reaction in inpatients. Chinese Journal of Drug Application and Monitoring 7(2):70–73. https://doi.org/10.3969/j.issn.1672-8157.2010.02.002 CrossRefGoogle Scholar
- 29.Chen C, Xu Y, Guo D et al (2014) Application of Computer Technology in Drug Safety Monitoring of Medical Institutions. China Pharmacy 25(5):461–464. https://doi.org/10.6039/j.issn.1001-0408.2014.05.26 CrossRefGoogle Scholar
- 30.Zhu M, Chen C, Guo D et al (2014) The active surveillance of vancomycin-related nephrotoxicity. Chinese Journal of Drug Application and Monitoring 11(1):26–29. https://doi.org/10.3969/j.issn.1673-4130.2015.18.015 CrossRefGoogle Scholar
- 31.Wang W, Chen C, Guo D et al (2014) The active surveillance of anemia caused by gemcitabine. Chinese Journal of Drug Application and Monitoring 11(1):29–30Google Scholar
- 32.Pei F, Chen C, Guo D et al (2014) The active surveillance of abnormally elevated transaminase caused by atorvastatin. Chinese Journal of Drug Application and Monitoring 11(1):31–33Google Scholar
- 33.Guo D, Chen C, Ma L et al (2014) Analysis and evaluation of the active monitoring data from five hospitals by ADE warning systems for hospitalized patients. Chinese Journal of Drug Application and Monitoring 11(6):368–371Google Scholar
- 34.Chen C, Guo D, Wang D et al (2014) The active surveillance of linezolid-related thrombocytopenia. Chinese Journal of Drug Application and Monitoring 11(1):22–25Google Scholar
- 35.Guo D, Chen C, Li Q et al (2013) Analysis of risk factors associated with the development of thrombocytopenia in 6 hospital’s 414 case of patients who received linezolid therapy. Chinese Journal of Pharmacoepidemiology 22(3):109–113Google Scholar
- 36.Chen C, Guo D, Cao X et al (2012) Analysis on the risk factors associated with the development of thrombocytopenia in patients who received linezolid therapy. Chinese Journal of Pharmacovigilance 9(2):71–76. https://doi.org/10.3969/j.issn.1672-8629.2012.02.003 CrossRefGoogle Scholar
- 37.Guo D, Wang L, Chen C et al (2011) Risk factors analysis and evaluation of linezolid used in 410 inpatients. Chinese Journal of Drug Application and Monitoring 8(2):69–74. https://doi.org/10.3969/j.issn.1672-8157.2011.02.002 CrossRefGoogle Scholar
- 38.Pan Y, Xu H, Zhu J (2011) Design and application of the monitoring software for hematological adverse drug reactions of chemotherapeutic drugs. China Pharmacy 22(1):87–89Google Scholar
- 39.Lu X, Liu H, Zhang J (2012) Study on the automatic monitoring system for ADR by elevated liver enzymes based on HIS. China Pharmacy 23(22):2080–2082. https://doi.org/10.6039/j.issn.1001-0408.2012.22.24 CrossRefGoogle Scholar
- 40.Wang M, Wang D, Zhou L et al (2014) Monitoring and analysis of drug induced liver injury by using hospital information system. Chinese Journal of Pharmacoepidemiology 23(2):88–91Google Scholar
- 41.Geng K, Liu S, Shen A et al (2012) Construction of active monitoring system for adverse drug reactions in hospital information system. Chinese Journal of Hospital Pharmacy 32(14):1147–1149Google Scholar
- 43.China Food and Drug Administration (2016) National adverse drug reaction monitoring sentinel (medical institutions) union rules: draftGoogle Scholar
- 44.FDA’s Sentinel Initiative. Sentinel system website. Available at: https://www.sentinelinitiative.org/. Accessed 09 Nov 2017
- 47.Observational Medical Outcomes Partnership. Common data model. Available at: http://omop.org/CDM/. Accessed 04 Nov 2017
- 48.Observational Health Data Sciences and Informatics (OHDSI). Available at: https://github.com/OHDSI/CommonDataModel. Accessed 04 Nov 2017
- 50.Stang PE, Ryan PB, Racoosin JA et al (2010) Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 153(9):600–606. https://doi.org/10.7326/0003-4819-153-9-201011020-00010 CrossRefPubMedGoogle Scholar
- 51.Center for Drug Reevaluation, China Food and Drug Administrationm (2016) Nine hospitals including Xiyuan Hospital of China Academy of Traditional Chinese Medicine joined the National Adverse Drug Reaction Sentinel hospital Alliance. Available at: http://188.8.131.52/tzgg/ywgz/201609/t20160927_17918.html. Accessed 10 Nov 2017
- 52.Center for Drug Reevaluation, China Food and Drug Administrationm (2017) CFDA: Awarding ceremony for new members of sentinel hospital alliance program. Available at: http://www.cdr-adr.org.cn/txw/201712/t20171214_19835.html. Accessed 28 Feb 2018
- 53.Lin J, Zhen X (2011) Applications Studies of Information Database in Medical Insurance. China Medicine & Pharmacy 1(12):135–136 139Google Scholar
- 55.China Cancer Database. Available at: http://cancernet.cicams.ac.cn/index.html. Accessed 04 Nov 2017
- 56.National Center for Cardiovascular Diseases. http://www.nccd.org.cn/. Accessed 04 Nov 2017