我国药品不良反应监测工作中存在的问题及对策探讨

目的：探讨我国药品不良反应（ADR）监测工作中存在的问题并提出相应对策。方法：检索2007-2012年国内的文献资料,结合现行政策法规,调研各类涉药机构ADR监测工作的开展情况,分析ADR监测工作中存在的问题并提出相应对策。结果与结论：我国的ADR监测工作虽然取得了一定进步,但还存在着一些亟待解决的问题。一是涉药单位ADR监测工作开展不平衡,医疗机构上报数量较多,药品生产、经营企业上报数量较少;二是公众对ADR认知度有待进一步提高;三是监测机构对ADR报表的真实性、规范性、完整性尚需进一步加强;四是ADR资源的分析利用水平不高,风险预警作用发挥不充分等。必须进一步加强ADR监测体系建设,努力拓宽ADR报告覆盖面,提高报告质量;加强宣传培训,夯实监测工作基础;完善ADR相关法律法规体系,在ADR损害救济及损害程度分级上与国际接轨。

Discussion on the Problems and Countermeasures of Adverse Drug Reactions Monitoring in China

OBJECTIVE： To investigate the problems of adverse drug reaction （ADR） monitoring in China and put forward the corresponding suggestions. METHODS： By retrieving domestic literature during 2007--2012, combined with the policy, laws and regulations, researching the ADR monitoring in all kinds of medicine institutions, the relevant problems were analyzed to put forward the corresponding countermeasures. RESULTS＆CONCLUSIONS： Although ADR monitoring has made some progress in China, there were still some problems to be solved. Firstly, the monitoring work of drug-related units is imbalanced, a large number is reported by medical institutions, but too little by pharmaceutical manufacturers and enterprises. Secondly, awareness of the public about ADR needs to be further improved. Thirdly, the authenticity, normalization and integrity of the ADR reports need to be further strengthened. Fourth, the utilization of ADR resource is not enough, and the ADR monitoring plays inadequate role of risk warning. Therefore, it is necessary to further strengthen ADR monitoring system, make efforts to broaden the same report coverage and improve report quality; strengthen advocacy and training, reinforce the basis of the monitoring; improve ADR legal system to be geared to international standards on damage compensation and the classification of damage in ADR.