机构改革下药品监管部门药品不良反应监测工作的探讨

Research on the Monitoring of Adverse Drug Reactions in Drug Regulatory Departments Under Institutional Reform

关键词:  药品不良反应  监测  药品监管

Key words:  adverse drug reactions  monitor  drug regulation

摘要:

目的 探讨机构改革新形势下推进南京市药品不良反应监测工作的方法。方法 通过分析南京市药品不良反应监测体系现状，对发现的问题提出建议。结果 南京市药品不良反应监测体系虽已基本建立，但在机制和技术等方面还需从监测体系建立、监测评价能力、监测工作水平等方面不断推进和完善。结论 药品安全与人民健康密切相关，药品不良反应监测工作是保障药品安全的重要手段。南京市各级监管部门需积极配合省级药品不良反应监测评价机构，不断完善药品不良反应监测工作，以适应在机构改革新形势下的药品监管。

Abstract:

OBJECTIVE To explore the methods to improve the monitoring of adverse drug reactions in Nanjing under the new situation of institutional reform. METHODS By analyzing the current situation of adverse drug reaction monitoring system in Nanjing, suggestions were put forward for the problems found. RESULTS Although the Nanjing monitoring system of adverse drug reaction had been basically established, it still needed to be continuously promoted and improved from the aspects of monitoring system establishment, monitoring evaluation ability and monitoring work level. CONCLUSION Drug safety is closely related to people's health, and the monitoring of adverse drug reactions is an important means of ensuring drug safety. The Nanjing drug regulatory department should continuously improve the monitoring of adverse drug reactions and cooperate with provincial adverse drug reaction monitoring agency to adapt to drug supervision under the new situation of institutional reform.