我院2 295例药品不良反应报告质量分析
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篇名: 我院2 295例药品不良反应报告质量分析
TITLE:
摘要: 目的:了解我院药品不良反应(ADR)上报的总体质量,为进一步提高ADR报告质量、推进医院ADR监测工作提供数据支持。方法:收集我院2011年1月-2015年12月的ADR报告,分别从报告类型、监测期内药品(新药)与监测期外药品(老药)ADR报告情况、报告人职业、报告科室、ADR临床表现和原始报表缺项等方面进行统计分析。结果:共收集2 295例ADR,其中已知一般的ADR报告例数最多,共1 943例(占84.66%),新的严重的ADR报告仅有20例(占0.87%);老药引起的ADR共2 136例(占93.07%);报告人职业以护士为主,共1 999例(占87.10%),医师和药师分别占7.28%和5.62%;上报科室以门诊注射室为主,共1 473例(占64.18%),手术和非手术科室分别占15.08%和15.16%;ADR临床表现以已知的常见症状为主,共1 938例(占97.48%),罕见症状仅占2.52%;原始报表缺项项目以相关重要信息、ADR过程描述和关联性评价为主,分别占81.92%、69.19%和57.08%。结论:我院ADR报告总体质量不高。应改变当前ADR监测药师的工作模式,深入临床进行ADR报表核实、宣传,提高ADR报告的质量,并建立ADR上报长效机制。
ABSTRACT: OBJECTIVE: To investigate the overall quality of ADR report in our hospital, in order to further improve the quality of ADR report, promote the hospital ADR monitoring and provide data support.  METHODS: ADR reports were collected from our hospital during Jan. 2011- Dec. 2015, and were analyzed statistically in respects of report type, ADR reports during monitoring period (new drugs) and outside monitoring period (previous drugs), reporter’s occupation, departments, ADR clinical manifestations and original report missing item, etc. RESULTS: A total of 2 295 cases of ADR were collected, the number of known general ADR reports were the most, being 1 943 cases (84.66%), but there were 20 cases of new severe ADR (0.87%); 2 136 ADR cases were induced by previous drugs (93.07%). Most of reporters were nurse, including 1 999 cases in total (87.10%), and physicians and pharmacists accounted for 7.28% and 5.62%, respectively. More of reports were from outpatient injection room, including 1 473 cases in total (64.18%), and surgical and non-surgical departments accounted for 15.08% and 15.16%, respectively. ADR clinical manifestations were mainly common symptoms, involved in 1 938 cases (97.48%); only 2.52% were rare symptoms. The original report missing items mainly included relevant important information, the description of the ADR process and correlation evaluation, accounting for 81.92%, 69.19% and 57.08%. CONCLUSIONS: On the whole, the quality of ADR reports in our hospital are poor. It is necessary to change the current ADR monitoring mode of pharmacists, check and propaganda ADR reports in the clinic, improve the quality of ADR reports and establish long-term mechanism of ADR reports.
期刊: 2017年第28卷第2期
作者: 周歧骥,冉春艳,伍尚梅,刘承统,何思陆,黄锁义
AUTHORS: ZHOU Qiji,RAN Chunyan,WU Shangmei,LIU Chengtong,HE Silu,HUANG Suoyi
关键字: 药品不良反应;报告;质量;工作模式
KEYWORDS: ADR; Report; Quality; Working mode
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