药品不良反应监测与药品市场监管工作联动机制的探讨

Relationship Mechanism between Adverse Drug Reactions Monitoring and Drug Market Administration

目的:探讨药品不良反应(ADR)监测与药品市场监管工作的关系,以促进2项工作的共同发展。方法:以深圳市ADR监测工作开展情况为例进行分析和探讨。结果与结论:ADR监测与药品市场监管工作是紧密结合在一起的,ADR信息为药品质量监管提供参考依据,并可为药品安全突发事件提供预警;而合理使用药品市场监管手段可提高ADR监测工作的主动性与积极性,并可提高ADR报告评价的准确性。但两者有时也存在一定冲突,需要妥善处理和有效衔接,通过两者协同发展,更好地保证公众用药安全、有效。

OBJECTIVE： To explore the relationship between adverse drug reactions （ADR） monitoring and drug market administration,and to improve the development of it.METHODS： The development of Shenzhen ADR monitoring was analyzed and explored.RESULTS CONCLUSIONS： ADR monitoring and drug market administration are combined closely.ADR information provides reference for drug quality administration and alert for drug safety incidents.Rational use of drug market administration methods can improve the initiative and activity and the accuracy of ADR report evaluation.Sometimes there is confliction between them,which should be resolved appropriately.The coordinated development of ADR monitoring and drug market administration can ensure the safe and effective use of drugs.