TY - JOUR
T1 - Adverse drug reaction reporting in institutions across six Chinese provinces
T2 - a cross-sectional study
AU - Zhang, Xuemei
AU - Niu, Rui
AU - Feng, Bianling
AU - Guo, Jiadong
AU - Liu, Ying
AU - Liu, Xinyu
N1 - Funding Information:
This work was supported by the Project of the National Social Science Foundation of China [No.13BGL132] and the Project of the Social Development Science and Technology Research Foundation of Shaanxi Province [No. 2016SF-159].
Publisher Copyright:
© 2018, © 2018 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2019/1/2
Y1 - 2019/1/2
N2 - Background: Although China’s adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems. Research design and methods: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April–December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity. Results: Of 720 questionnaires distributed, the response rate was 81.8%. About 93% (n = 371) of pharmaceutical companies and medical institutions had established ADR monitoring departments/units. Few institutions (26%, n = 104) allocated an ADR budget; 7% (n = 30) had received ADR monitoring funding in the last year (2013). Almost all institutions (99%, n = 555) had computers and 47% (n = 263) had a network database. Many institutions conducted public education about drug safety (49%, n = 283), medicine utilization reviews/quality surveys (28%, n = 158), and medicine consultation services (88%, n = 511). Institutions in eastern, central, and western China differed significantly on implementation of existing regulations and pharmacovigilance activities. Conclusions: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities.
AB - Background: Although China’s adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems. Research design and methods: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April–December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity. Results: Of 720 questionnaires distributed, the response rate was 81.8%. About 93% (n = 371) of pharmaceutical companies and medical institutions had established ADR monitoring departments/units. Few institutions (26%, n = 104) allocated an ADR budget; 7% (n = 30) had received ADR monitoring funding in the last year (2013). Almost all institutions (99%, n = 555) had computers and 47% (n = 263) had a network database. Many institutions conducted public education about drug safety (49%, n = 283), medicine utilization reviews/quality surveys (28%, n = 158), and medicine consultation services (88%, n = 511). Institutions in eastern, central, and western China differed significantly on implementation of existing regulations and pharmacovigilance activities. Conclusions: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities.
KW - Adverse drug reaction reporting
KW - China
KW - cross-sectional study
KW - drugstore
KW - hospital
KW - pharmaceutical manufacturers
KW - pharmacovigilance
UR - http://www.scopus.com/inward/record.url?scp=85059043922&partnerID=8YFLogxK
U2 - 10.1080/14740338.2018.1486820
DO - 10.1080/14740338.2018.1486820
M3 - Article
C2 - 29883236
AN - SCOPUS:85059043922
SN - 1474-0338
VL - 18
SP - 59
EP - 68
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
IS - 1
ER -