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The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China |
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| Authors: | Rui Niu Yufang Xiang Tingting Wu Zhi Zhang Yue Chen |
| Institution: | 1. The Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi’an Jiaotong University, Xi’an, Shannxi, China;2. The Center for Drug Safety and Policy Research, Xi’an Jiaotong University, Xi’an, Shannxi, China;3. Xi’an Office for Food and Drug Control, Xi’an, Shannxi, China;4. Shannxi Institute for Food and Drug Control, Xi’an, Shannxi, 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 |