Adverse drug reaction reporting in institutions across six Chinese provinces: a cross-sectional study

ABSTRACT

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.

KEYWORDS:

• Adverse drug reaction reporting
• China
• cross-sectional study
• drugstore
• hospital
• pharmaceutical manufacturers
• pharmacovigilance

Acknowledgments

The authors are indebted to all the representatives who participated in this survey. The authors thank the staff of each institution and related departments in the six Provincial ADR Monitoring Centers (Jiangsu, Guangdong, Henan, Hebei, Shaanxi, and Sichuan).

Declaration of interest

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

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].