现代医院2025，Vol.25Issue(7)：991-994,997,5.DOI:10.3969/j.issn.1671-332X.2025.07.002
药物警戒制度下广东省65家医疗机构药品不良反应监测现状分析
Analysis of adverse drug reaction monitoring status in 65 medical institutions in guangdong province under the pharmacovigilance system
摘要
Abstract
Objective To investigate the current status of adverse drug reaction(ADR)monitoring in medical institu-tions under China's pharmacovigilance framework in Guangdong Province,and to propose evidence-based strategies for enhancing institutional monitoring capabilities.Methods A cross-sectional survey was conducted using a structured questionnaire devel-oped in alignment with national regulatory requirements and expert consensus.Data were collected from 65 medical institutions,including general hospitals,traditional Chinese medicine hospitals,and maternal/children's hospitals,across 21 prefecture-level cities in Guangdong.Descriptive and comparative analyses were performed to evaluate institutional practices.Results All 65 in-stitutions submitted valid responses.Among them,63(96.9％)had established standardized ADR reporting protocols,with 93.8％(61/65)delegating oversight to pharmacy departments.ADR data were predominantly collected via institutional informa-tion systems(67.7％,44/65),though these systems focused on passive reporting and basic data aggregation,lacking functional-ities for active signal detection or risk alert mechanisms.Significant disparities(P＜0.05)were observed across hospitals of dif-ferent tiers in reporting modalities,system sophistication,analytical frequency,and early warning implementation.Notably,mo-nitoring practices for conditionally approved drugs(e.g.,emergency-authorized therapeutics)exhibited systemic deficiencies.Conclusions To address these gaps,the following measures are recommended:Accelerating the adoption of intelligent monito-ring systems to enable real-time ADR detection and predictive analytics;Implementing tiered resource allocation policies to ensure equitable capability development;Establishing specialized protocols for high-risk pharmaceuticals,particularly conditionally ap-proved and fast-tracked drugs;Strengthening interdisciplinary training programs to improve pharmacovigilance literacy among healthcare practitioners.These interventions aim to foster a proactive risk management culture and advance patient safety within China's evolving healthcare landscape.关键词
药物警戒/药品不良反应/问卷调查/医疗机构/监测现状Key words
Pharmacovigilance/Adverse drug reactions(ADRs)/Questionnaire survey/Medical institutions/Monito-ring status分类
医药卫生引用本文复制引用
蔡权周,刘颖,朱飞跃,钱鑫,庞佩珊,吴莉莉,许燕..药物警戒制度下广东省65家医疗机构药品不良反应监测现状分析[J].现代医院,2025,25(7):991-994,997,5.基金项目
广东省药品监督管理局2023年市县药品监管综合改革创新项目(ZG-DS-2023029) （ZG-DS-2023029）
广东省药品不良反应监测中心委托项目(20230821) （20230821）
