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2021, v.31(12) 938-941+960

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广东省医疗机构制剂现状及风险防控分析
Analysis of the Situation and Risk Prevention and Control of Pharmaceutical Preparations in Medical Institutions of Guangdong Province

纪秋凤;邹海娟;李瑞明;周本杰;
JI Qiufeng;ZOU Haijuan;LI Ruiming;ZHOU Benjie;Department of Pharmacy, The Seventh Affiliated Hospital of Sun Yat-sen University;

摘要(Abstract):

目的分析广东省医疗机构制剂现状及风险防控措施,为医疗机构制剂发展与监管提供建议。方法通过资料收集、现场评估、文献查阅等方法,调研广东省医疗机构制剂配制质量安全现状,分析共性的风险因素并提出风险控制措施。结果医疗机构制剂设施设备不完备、物料管理不当、配制管理不规范、质量管理不完善、人员培训不到位是主要突出的共性问题,较大程度上制约了医疗机构制剂的安全发展。结论强化法治意识和质量意识,构建规范化的制剂质量管理体系,完善科学监管,发挥社会共治力量,是加强医疗机构制剂风险防控,提高制剂配制和质量管理水平的有效手段。
OBJECTIVE To analyse the situation and risk prevention and control of pharmaceutical preparations in medical institutions of Guangdong province, and provide reference for the development and supervision of hospital preparations. METHODS Using data collection, spot assessment, literature review and other forms, the quality safety status of hospital preparations, common risk factors and risk control measures in Guangdong province were investigated and analyzed. RESULTS There were the most prominent and common problems which restrict the development of manufacturing laboratory in medical institutions, including incomplete facility and equipment, improper material managemen.Nonstandard preparation management, undeveloped quality management and poor personnel training. CONCLUSION Enhancing the legal consciousness and quality consciousness, establishing standardized preparation and quality management system, improving scientific supervision, giving play to the social co-governance, are the effective means to strengthen risk prevention and control of hospital preparations and improve preparation management and quality management level.

关键词(KeyWords): 医疗机构;制剂;广东省;现状;风险控制
medical institutions;pharmaceutical preparations;Guangdong province;situation;risk control

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作者(Author): 纪秋凤;邹海娟;李瑞明;周本杰;
JI Qiufeng;ZOU Haijuan;LI Ruiming;ZHOU Benjie;Department of Pharmacy, The Seventh Affiliated Hospital of Sun Yat-sen University;

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