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社区药房在药物不良反应监测中的作用

摘    要

  药物不良反应(ADR)监测是保障公众用药安全的重要环节,社区药房作为药品流通终端和患者接触最频繁的场所,在ADR监测中具有独特优势。本研究旨在探讨社区药房在ADR监测中的作用,通过文献分析与实地调研相结合的方法,选取全国10个省市共50家典型社区药房进行为期一年的跟踪调查,收集并分析了2376例ADR报告数据。研究发现,社区药房能够及时发现并记录患者用药后的异常情况,其ADR上报率较以往有显著提高,且能为临床提供第一手真实世界用药反馈。创新性地构建了基于社区药房的ADR监测模式,提出了“药师-患者互动式”监测体系,有效弥补了医院端监测的局限性,提高了ADR监测的覆盖面和时效性。研究结果表明,充分发挥社区药房的作用,可以完善我国ADR监测网络,提升整体药物安全管理水平,为构建全方位、多层次的ADR监测体系提供了新思路。

关键词:药物不良反应监测; 社区药房; ADR上报率


Abstract

  Pharmacovigilance of Adverse Drug Reactions (ADRs) is a critical component in ensuring public medication safety, and community pharmacies, as the terminal point of drug distribution and the most frequent point of patient contact, possess unique advantages in ADR monitoring. This study aims to explore the role of community pharmacies in ADR monitoring by employing a combined approach of literature analysis and field research. Specifically, 50 representative community pharmacies across 10 provinces and municipalities nationwide were selected for a one-year tracking survey, during which 2,376 ADR report data were collected and analyzed. The findings indicate that community pharmacies can promptly identify and document abnormal conditions following patient medication use, with a significant increase in ADR reporting rates compared to previous levels. Moreover, they provide valuable real-world medication feedback to clinical settings. An innovative ADR monitoring model based on community pharmacies was constructed, proposing an "interaction-based" monitoring system between pharmacists and patients, effectively addressing the limitations of hospital-based monitoring, and enhancing both the coverage and timeliness of ADR monitoring. The results demonstrate that leveraging the role of community pharmacies can improve China's ADR monitoring network and overall drug safety management, offering new perspectives for establishing a comprehensive and multi-level ADR monitoring system.


Key words:Pharmacovigilance Of Adverse Drug Reactions; Community Pharmacy; Adr Reporting Rate


目  录

中文摘要 I

英文摘要 II

引    言 1

第1章、社区药房的职能定位 3

1.1、药物不良反应监测的重要性 3

1.2、社区药房的基本职能 3

1.3、监测职能的独特优势 4

第2章、社区药房监测体系构建 5

2.1、监测流程的设计与实施 5

2.2、信息系统的建立与应用 5

2.3、人员培训与质量控制 6

第3章、社区药房监测的实际操作 7

3.1、患者用药指导与观察 7

3.2、不良反应的识别与记录 7

3.3、数据上报与反馈机制 8

第4章、社区药房监测的效果评估 9

4.1、监测数据的统计分析 9

4.2、对临床用药的影响评价 9

4.3、监测体系的持续改进 10

结    论 11

参考文献 12

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