摘要
目的探讨医院药品不良反应(ADR)上报工作中存在的问题及对策。方法收集贵阳医学院附属医院2008年1月至2012年12月上报国家ADR监测中心并被接收的ADR报告,重点就ADR报告是否符合国家卫生和计划生育委员会2011年关于"个例药品不良反应"上报的要求进行分析。新药监测期内药品(新药)和监测期外药品(老药)分别按批准文号计算上市<5和≥5年统计。结果纳入分析的ADR报告共485例,其中2012年242例(49.9%),2008至2011年243例(50.1%)。2012年上报数量明显增多与贵阳市自2012年实施ADR上报指标量化等措施有关。485例ADR报告中,符合上报要求者107例(22.1%),其中新药所致ADR 22例,老药所致新的或严重的ADR共85例。新药所致22例ADR中严重ADR 5例,一般ADR 17例,涉及18种新药;老药所致ADR共463例,符合上报要求者85例(18.4%),其中新的ADR 9例,严重ADR 76例,涉及药品384种。结论医院ADR上报工作中存在的主要问题是质量不高。量化上报措施对改善报告质量的作用有限。建议细化ADR定义,明确上报范围,完善报告制度,实施可行的新药监测制度,提高ADR报告质量及其可利用价值。
Objective To analyze existing problems and countermeasures during the reporting work of hospital adverse drug reaction （ADR）. Methods ADR reports which were reported by Affiliated Hospital of Guiyang Medical College during the period from January 2008 to December 2012 and received by National Center for ADR Monitoring were collected. Analysis was made to see whether these ADR reports could meet the requirement of ＂An ADR case＂ published by National Health and Family Planning Commission in 2011. The monitoring period of drug （ new drugs） and outside monitoring period of drug （ older drugs） were calculated on approval number respectively listing 〈5 and 1〉5 years. Results Four hundred and eighty- five ADR reports were collected. Of them, 242 cases （49.9%） were received from 2012 and 243 cases （50.1%） were received from 2008 to 2011. Significantly increasing ADR reports in number was associated with the implementation of ADR reporting quantitative measures in Guiyang since 2012. Of the 485 ADR reports, there were 107 cases （22. 1% ） in accordance with the reporting requirement including 22 cases caused by new drugs and 85 cases of new and serious ADR caused by old drugs. The 22 cases caused by new drugs, involving 18 kinds of new drugs, included 5 cases of serious ADR reports and 17 cases of general ADR reports. Old drug-induced ADR reports were 463 cases involving 384 kinds of drugs and, of them, there were 85 cases （ 18.4% ） in accordance with the reporting requirement including 9 cases of new ADR reports and 76 cases of serious ADR reports. Conclusions The main existing problem during the reporting work of hospital ADR is low quality of ADR reports. Implementation of ADR reporting quantitative measures played a limited role in improving the reports quality. Subdividing the definition of ADR, making reporting scope clear, perfecting reporting system, implementing feasible institution of new drugs monitoring, and improving reports quality and their usable value are suggested.
出处
《药物不良反应杂志》
CSCD
2013年第6期320-324,共5页
Adverse Drug Reactions Journal
关键词
药物不良反应报告系统
质量控制
Adverse drug reaction reporting systems
Quality control
