探讨药品监管部门对药品不良反应的有效监测和应对策略

Explore the Effective Monitoring and Coping Strategies of Drug Regulatory Authorities for Adverse Drug Reactions

目的探讨并分析药品监管部门在药品不良反应监测方面的有效监测方法和应对策略。方法选取本地区2021年6月至2022年6月期间多家医疗机构上报的96例药品不良反应事件作为研究对象,并对96例药品不良反应事件中所涉及到的药品种类以及不良反应的主要症状信息进行整理分析。根据这些信息对目前药品监管部门在药品不良反应监测工作中所存在的不足进行总结和应对策略的制定,促进药品监管部门对药品不良反应的监测有效性能够提升。结果发生药品不良反应的主要药品种类包括抗生素、中成药、微量元素离子类药品,其中涉及的系统以皮肤、心血管和免疫系统为主。结论对药品监管部门在药品不良反应监测工作中的不足之处进行总结,同时进行针对性的应对策略制定,能够提升药品不良反应质量管理的有效性,有助于减少患者的药物治疗风险,提升其控制率,可以推动药物警戒生态的进程,维护群众安全用药。

OBJECTIVE To explore and analyze the effective monitoring methods and coping strategies of drug regulatory authorities in the monitoring of adverse drug reactions.METHODS 96 ADR cases reported by multiple medical institutions in the region from June 2021 to June 2022 were selected as the research objects,and the drug types involved in 96 ADR cases and the main symptoms of ADR were analyzed.Based on this information,we summarized the shortcomings of the current drug regulatory authorities in the monitoring of adverse drug reactions and formulated countermeasures to promote the effectiveness of drug regulatory authorities in monitoring adverse drug reactions.RESULTS The main types of ADRs were antibiotics,Chinese patent medicines,trace element ion drugs,and the involved systems were mainly skin,cardiovascular and immune systems.CONCLUSION Summarizing the deficiencies in the work of drug regulatory departments in monitoring adverse drug reactions,and formulating targeted coping strategies can improve the effectiveness of adverse drug reaction quality management,help reduce the risk of drug treatment for patients,improve their control rate,promote the process of pharmacovigilance ecology,and maintain the safety of drug use for the masses.