The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China

ABSTRACT

Background: High-quality adverse drug reaction (ADR) reports are essential for conducting drug safety monitoring in pharmacovigilance. The study aim was to assess the current quality of ADR reports in western China, and to identify problems with ADR report quality.

Research design and methods: A sample of 1139 reports received by the Shaanxi ADR Monitoring Center from January 2015 to December 2017 was selected. ADR report quality was evaluated using an ADR report quality evaluation system.

Results: None of the reports were rated as excellent and 1.40% (n = 16) as good. Report quality was better for new and serious reports than for general reports. Medical institutions generated higher quality reports than pharmaceutical manufacturers. Nurses generated higher quality reports than doctors, pharmacists, and other professionals. Reporters of different occupations showed significant differences in the quality of the indicators Reporting time limit, Intervention ADR time, ADR termination time, ADR intervention measures, Original disease, and Cause of medication (P = 0.000).

Conclusions: The ADR data quality was poor in western China, and of lower quality than reported data from previous research in other regions. Improvements in the quality and availability of ADR reports are urgently needed.

KEYWORDS:

• Spontaneous reporting
• adverse drug reactions
• quality assessment
• drug safety
• pharmacovigilance

Acknowledgments

The authors thank the Shaanxi Provincial ADR Monitoring Centers.

Author contributions

BL Feng and R Niu conceived and designed the study; R Niu, YF Xiang, TT Wu and Y Chen evaluated the reports; R Niu performed the data analyses and wrote the manuscript; BL Feng helped perform the analysis with constructive discussions; R Niu submitted and revised the manuscript. BL Feng make the final approval of the version to be published, and all authors agree to be accountable for all aspects of the work.

Declaration of interest

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This work was supported by the Project of the National Social Science Foundation of China [No.18XGL019].