Objective: To establish and improve the monitoring information system of adverse drug reaction (ADR) in order to improve the quantity, quality and timeliness of ADR reports in our hospital. Methods: ADR/ADE reported by the centralized monitoring model from 2014 to 2016 in our hospital was retrospectively and statistically analyzed in terms of report numbers, pass percent, fail report rate (FRR), reporting time, etc. Results: After the application of the ADR reporting and management system derived from PLA ADR monitoring center in our hospital since October 2015, the total number of ADR/ADE increased to 915 in 2016 compared with the number in 2014 (218 cases) and 2015 (709 cases). About 95.41% ADR/ADE in 2016 was qualified while only 23.55% in 2014 and 78.56% in 2015 was qualified. FRR in 2016 was 2.14% while FRR in 2014 and 2015 was 74.53% and 31.03% respectively. The reporting time was decreased from 1080 minutes per month to 164 minutes per month, which achieved an increase of the average work efficiency by 84.81%. Conclusion: ADR reporting and management system in our hospital could automatically extract HIS related data and produce standard reporting data which could be directly forwarded to the national ADR monitoring system. It was beneficial to improve the efficiency of reports, ensure the quality of reports and expand the coverage of monitoring network, which could lay the foundation for scientific evaluation and supervision of drug safety.%目的:利用信息化技术,建立并完善药品不良反应监测信息系统,提高我院不良反应上报的数量、质量和上报的及时性.方法:采用回顾性研究方法,对我院2014 – 2016年采用集中监测模式上报的ADR/ADE从报告的数量、合格率、漏报率及上报所需时间等进行统计分析.结果:自2015年10月起我院采用引自解放军ADR监测中心的"医疗机构ADR报告与管理系统"后,ADR/ADE上报数量由2014年的218例和2015年的709例上升至2016年的915例,ADR/ADE报告合格率由2014年的23.55%和2015年的78.56%上升至2016年的95.41%,ADR/ADE报告漏报率由2014年的74.53%和2015年的31.03%下降至2016年的2.14%,上报时间由每月1080 min节省到每月164 min,平均提高工作效率84.81%.结论:"医疗机构ADR报告与管理系统"自动提取HIS相关数据,并产生标准上报数据,可直接传入国家药品不良反应监测系统;有利于提高报告效率、保证报表质量、扩大监测网络覆盖面,可为药品安全科学评价和监管提供相关依据.
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