Analysis of adverse drug reaction monitoring status in 65 medical institutions in guangdong province under the pharmacovigilance system
10.3969/j.issn.1671-332X.2025.07.002
- VernacularTitle: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
- Author:
Quanzhou CAI
1
;
Ying LIU
;
Feiyue ZHU
;
Xin QIAN
;
Peishan PANG
;
Lili WU
;
Yan XU
Author Information
1. 佛山市食品药品检验检测中心药品不良反应监测室 广东佛山 528000
- Publication Type:Journal Article
- Keywords:
Pharmacovigilance;
Adverse drug reactions(ADRs);
Questionnaire survey;
Medical institutions;
Monito-ring status
- From:
Modern Hospital
2025;25(7):991-994,997
- CountryChina
- Language:Chinese
-
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.
