北京地区医院含苯酚制剂的风险控制  

Risk control of phenol-containing preparation in hospital in Beijing

作　　者：赵慧[1] 陈志刚[1] 崔岩峥[1] 曾蔚欣[2] 吴彬 

机构地区：[1]北京积水潭医院,北京100035 [2]首都医科大学附属世纪坛医院,北京100038 [3]北京市食品药品监督管理局,北京100053

出　　处：《中国医院药学杂志》2015年第9期838-841,共4页Chinese Journal of Hospital Pharmacy

基　　金：北京市医疗机构制剂标准评价体系及标准提高研究项目(编号:Z121100000312005);首都卫生发展科研专项项目(编号:首发2011-2008-01)

摘　　要：目的:分析含苯酚医院制剂的风险因素,探索有效的预防措施进行风险控制。方法:统计《医疗单位制剂规程》、《中国医院制剂规范》中含苯酚医院制剂的所有品种,检索和查阅相关文献、法律法规、标签和说明书,分析存在的问题,探讨可能造成此类制剂风险的原因。结果:含苯酚医院制剂风险环节主要为处方合理性有待商榷、原辅料管理欠规范、职业暴露、质量标准和检验手段落后及疗效和安全性评价不足。结论:采取有效的风险管理措施,严格实施GPP建设,加强原辅料的质量控制、完善质量标准和检验手段、监测不良反应和用药错误,最大程度降低风险危害。OBJECTIVE To analyze the risk factors of phenol-containing preparations in hospital and explore effective pre- ventive measures. METHODS All varieties of phenol-containing preparations were summarized from ＂Hospital Preparation Regulation＂ and ＂Chinese Hospital Preparation Norms＂, related literature, regulations, the statements of drug labels and in- structions, and problems were analyzed to find the risk factors. RESULTS Risk factors of phenol-containing preparations mainly included questionable prescriptions, inferior standardized management of raw materials, occupational exposure, back- wardness of quality standards and inspection methods, insufficient evaluation of efficacy and safety. CONCLUSION Risks can be minimized by taking effective management measures, implementation of GPP, strengthening quality control of raw materi- als, improving; quality standards and testing methods and monitoring of adverse reactions and medication errors.

关 键 词：医院制剂 苯酚 风险控制 

分 类 号：R95[医药卫生—药学]