CAJ | 학술논문

目的：通过对2013年度中山市药品不良反应（ADR）报告表进行质量评估，以期提高 ADR 报告和评价能力。方法采用回顾性研究方法，随机抽取2013年度中山市18家监测单位报告的155份 ADR 报告表开展质量评估。包括现场核查 ADR 报告表的原始资料和按《药品不良反应病例报告质量评估评分标准》进行质量评分。结果所有监测单位建立了 ADR 报告和监测制度，部分单位未及时更新和落实不到位。ADR 报告表信息可追溯，未发现虚假报告。ADR 报告表质量评分总体良好，在报告时限、ADR 过程描述、用药信息等方面仍需改进。结论定期开展 ADR 报告表质量评估是市级监测机构一项重要工作，提高 ADR 报告表的数量和质量，为药品风险监测提供科学依据。
목적：통과대2013년도중산시약품불량반응（ADR）보고표진행질량평고，이기제고 ADR 보고화평개능력。방법채용회고성연구방법，수궤추취2013년도중산시18가감측단위보고적155빈 ADR 보고표개전질량평고。포괄현장핵사 ADR 보고표적원시자료화안《약품불량반응병례보고질량평고평분표준》진행질량평분。결과소유감측단위건립료 ADR 보고화감측제도，부분단위미급시경신화락실불도위。ADR 보고표신식가추소，미발현허가보고。ADR 보고표질량평분총체량호，재보고시한、ADR 과정묘술、용약신식등방면잉수개진。결론정기개전 ADR 보고표질량평고시시급감측궤구일항중요공작，제고 ADR 보고표적수량화질량，위약품풍험감측제공과학의거。
Objective To analyze the quality of adverse drug reaction (ADR) reports in Zhongshan in 2013, so as to improve the ability of ADR reporting and assessment. Methods By using the method of retrospective study, 155 ADR reports in 18 monitoring units were chosen at random to evaluate the authenticity, integrity and accuracy. We verified the original data of ADR reports on site and gave a mark according to the scoring criteria to assess the quality of ADR reports. Results All monitoring units established the ADR system of reporting and monitoring, some of which did not update and put it in place. All of ADR reports could be traced and proved to be true. The quality score of ADR reports was generally good, but it needs to be improved in reporting time, ADR process description, drug information and so on. Conclusion Regular quality evaluation of ADR reports is an important job for municipal monitoring organization. Improving the quantity and quality of ADR reports can provide the scientific basis for drug risk monitoring.