【作者】 王楠；

【导师】 马骏；

【作者基本信息】 天津医科大学 ， 流行病与卫生统计学， 2009， 硕士

【摘要】 目的:《药品经营质量管理规范》(GSP)认证是国家食品药品监督管理局依法对全国药品经营企业强制实行的行政管理工作。天津市从2003年开始推行GSP认证工作以来,到2008年第一次经历GSP认证的药品零售企业认证证书已陆续到期,需重新认证。此次研究拟通过了解天津市已通过GSP认证的药品零售企业经营状况,发现存在的问题,为重新认证工作的顺利开展提供参考意见,并对药品零售企业未来的发展趋势进行探讨。方法:以天津市通过GSP认证的药品零售企业为调查对象,对其发放调查问卷。调查问卷从企业专职质量管理人员情况、质量管理体系制定及操作情况、药品购销情况、培训情况、企业今后发展方向等7个方面制定。通过近两年来天津市食品药品监督管理部门对全市药品零售企业GSP跟踪检查报告进行统计发现,有近70%的药品零售企业在经营中有违反GSP要求的情况,根据公式N=u_α~2(1-P)/δ~2P=1.96~2(1-0.70)/0.1~2×0.70≈164(其中α=0.05容许误差δ=0.1 P=0.70)按照10%的失访率估计本次需要的样本量力n_t大约为180。在2008年底共发放调查问卷220份,回收问卷198份,回收问卷经检查筛选,剔出缺失数据过多的问卷2份,得到有效问卷196份,有效回收率为99.98%,对回收有效问卷统计分析后进行研究,得出结论。结果:天津市药品零售企业实施GSP认证过程中,被调查企业在企业专职质量管理人员情况方面,有91.8%的企业专职质量管理人员对药品GSP规范了解掌握的程度较好,他们熟悉自身的工作职责和工作内容,对企业药品质量有一定的否决权。在企业质量管理体系制定和操作情况方面,有94.9%的企业其质量管理体系基本健全;有99.5%的企业其质量管理制度能够定期检查并考核。在企业购销药品管理方面,有91.0%的企业在销售药品过程中能够做到以药品质量为前提,完善了对药品经营各环节进行质量控制的措施。在企业店堂环境整洁及硬件设施方面,有93.4%的企业店堂内整洁无污染物,地面墙面平整、货架柜台齐全、标识醒目、药品分类摆放合理,店内温控、通风、避光、消防安全、照明等硬件设施设备齐全、运行良好。在企业员工定期培训方面,企业能够定期对员工进行培训,但培训效果有待提高。结论:《药品经营质量管理规范》的实施维护了天津市药品零售市场秩序、促使药品零售企业加强质量管理、提高了药品流通领域的质量保证水平,但还存在专职质量管理人员缺乏权威性、企业质量管理制度欠完善、考核力度差、人员综合素质待提高的现象。药品零售单店有加盟药品零售连锁企业的趋势。更多还原

【Abstract】 Objective:The "Drugs Management Quality control Standard"(GSP) authentication is the National Food Drugs Administration legally administering the work which forces the national drugs management enterprise to implement.Tianjin has started since 2003 to carry out the GSP authentication work,first time experiences the GSP authentication to 2008 the drugs retail sales enterprise to authenticate the certificate to expire one after another,must authenticate.This research plans through to understand Tianjin through the GSP authentication drugs retail sales enterprise management condition,to discover the existing question,to authenticate the work the smooth development to provide the advisory opinion,and will carry on the discussion to the drugs retail sales enterprise future trend of development.Method:The questionnaire takes the drug-retail enterprises with GSP Certification in Tianjin as its study object.The questionnaire arises from seven aspects,which are respectively the status of professionals on quality control,quality control system and operation,purchase and sales of medication,training and development orientation of these enterprises.The track survey report launched by Tianjin Food and Drug Administration citywide reveals that nearly 70%drug retail enterprises somewhat run counter to GSP rules.Following the formula N=u_α~2(1-p)/δ~2p=1.96~2(1-0.70)/0.1~2×0.70≈164 and in consideration of the admissible error and 10%bounce rate,N is calculated to be around180.By the end of 2008,a total number of 220 questionnaires are handed out,of which,198 copies were fed back.And 196 questionnaires,being sieved and sorted,prove to be effective,with the effective feedback rate of 99.98%.And then based on systematic analysis and study of the effective questionnaire,the conclusion is drawn.Results:The Tianjin Drugs Retail sales Enterprise specialty quality control personnel is good to the drugs GSP standard understanding grasping degree,is familiar with own work responsibility and the work content,has certain veto to the enterprise drugs quality.Enterprise quality control system is essentially perfect.The quality control system can periodically inspect,achieve in the sales drugs process take the drugs quality as the premise,and consummate various links to the drugs to carry on the quality control the measure.The enterprise salesroom environment does not have the pollutant neatly,the ground wall surface smoothly,the complete shelf counter,and the strike marking.The drugs classification place is reasonable,in the shop warm light,fire security,illumination well appointed hardware facilities and so on controls, ventilates,evades.The movement is good.The enterprise can regularly carry on training to the staff,but training effect pending enhancement.Conclusion:The survey finds that 91.8%professionals on quality control in enterprises have a good commanding of GSP rules.These professionals,well acquainted with their work responsibility and scope,have their deciding vote on the drug quality in enterprises.In the aspect of quality control system and operation, 94.9%enterprises have sound system in place and 99.5%enterprises conduct inspection and assessment on their systems regularly.As regard to management on the purchase and sales of drugs,91.0%enterprises exercise and improve strict control over sales operation for the high quality of drugs.In terms of the tidiness and infrastructures,93.4%enterprises keep their drug storage(store) spick and span with complete drug shelves,clear labels,and drugs in order.The hardware facilities for ventilation,shading,fire-fighting and lighting are complete and in good working state. While employees normally receive regular training,the training effectiveness needs further improvement.更多还原