a The Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy , Xi'an Jiaotong University , Xi'an , Shannxi , China.
b The Center for Drug Safety and Policy Research , Xi'an Jiaotong University , Xi'an , Shannxi , China.
Expert Opin Drug Saf. 2019 Jan;18(1):51-58. doi: 10.1080/14740338.2019.1559812. Epub 2018 Dec 21.
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.
背景:高质量的药物不良反应(ADR)报告对于药物安全监测在药物警戒中至关重要。本研究旨在评估中国西部目前的 ADR 报告质量,并确定 ADR 报告质量存在的问题。
研究设计与方法:本研究选取了 2015 年 1 月至 2017 年 12 月陕西省 ADR 监测中心收到的 1139 份报告作为样本。采用 ADR 报告质量评价系统评价 ADR 报告质量。
结果:没有一份报告被评为优秀,只有 1.40%(n=16)被评为良好。新报告和严重报告的质量优于一般报告。医疗机构生成的报告质量高于制药企业。护士生成的报告质量高于医生、药剂师和其他专业人员。不同职业的报告人在报告时限、干预 ADR 时间、ADR 终止时间、ADR 干预措施、原始疾病和用药原因等指标的质量上存在显著差异(P=0.000)。
结论:中国西部的 ADR 数据质量较差,低于其他地区以往研究报告的数据质量。迫切需要提高 ADR 报告的质量和可用性。
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