生产/流通企业视角下四川省医疗机构药品短缺原因分析及对策研究
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摘要
目的:从生产/流通企业角度了解四川省医疗机构药品短缺的原因并提出相应对策,为建立药品短缺供应保障机制提供参考。方法:采用问卷调查的方式对该省78家医疗机构2015年1月-2017年6月期间的药品短缺情况进行调查;对短缺药品涉及的生产企业和流通企业进行溯源调查,综合问卷调查及实地调研,了解该省出现药品短缺的原因,并提出应对措施。结果:本次调研共向医疗机构发放78份调查问卷,回收率、有效率均为100%;78家医疗机构共上报了206种药品,共计240个品规出现短缺。向短缺药品涉及的生产企业和流通企业分别发放140、68份调查问卷,回收率和有效率均为100%;结合现场实地调研,共获得212个品规的短缺药品调研结果。从生产企业角度出发,造成药品短缺的最主要因素是生产性成本上涨(占66.51%)和流通成本上涨(占26.88%);从药品流通企业角度出发,造成药品短缺的最主要因素是货源供应不足或缺货(占75.47%)、库存管理问题(占16.51%)和价格倒挂(占11.32%)。结论:导致药品短缺的生产/流通企业方原因主要包括生产性成本和流通成本的提高、药品价格倒挂、库存管理及招标采购问题。建议通过完善药品招标定价制度、调动企业积极性,完善企业短缺药品预警机制、加强信息沟通,建立短缺药品储备机制、组织短缺药品的应急生产,加强短缺药品供应链管理、净化市场不良风气,完善短缺药品紧急处置办法、提高短缺药品的供应保障能力等措施,多部门协同合作,减少药品短缺现象的出现,保障临床持续获得安全、有效的药品。
OBJECTIVE:To investigate the reasons for drug shortage in medical institutions of Sichuan province and put forward relevant countermeasures, and to provide reference for establishing supply security mechanism of drug shortage.METHODS:Questionnaire survey was conducted to investigate drug shortage in 78 medical institutions of the province during Jan.2015-Jun. 2017. Traceability investigation was conducted from manufacturers and distribution enterprises involved in drug shortage.Questionnaire survey and field investigation were combined to analyze the reasons for drug shortage in Sichuan province and put forward countermeasures. RESULTS:Totally 78 questionnaires were sent out to medical institutions with recovery rate and effective rate of 100%. A total of 206 drugs were reported by 78 medical institutions,involving 240 specifications for shortage in total.Totally 140 questionnaires and 68 questionnaires were distributed to the manufacturers and distribution enterprises involved in drug shortage,and the recovery rate and effective rate were all 100%. Combined with the field survey,survey results of shortage drugs of 212 specifications were obtained. From the perspective of manufacturers,the most important factors causing drug shortage were the increase of production cost(66.51%)and circulation cost(26.88%). From the perspective of distribution enterprises,the main factors causing drug shortage were insufficient supply of drugs(75.47%),inventory management(16.51%) and price inversion (11.32%). CONCLUSIONS:Main reasons of drug shortage from manufacturers and distribution enterprises include the increase of production cost and circulation cost,drug price inversion,inventory management and bidding procurement. It is suggested that measures should be taken to improve the bidding and pricing system of drugs,mobilize the enthusiasm of enterprises;improve the early warning mechanism of drug shortage on the enterprises,strengthen information communication;establish the mechanism of drug shortage reserve, organize the emergency production of drug for shortage; strengthen the management of drug shortage supply chain,purify the unhealthy atmosphere in the market;improve the emergency disposal methods of drug shortage,and improve the supply guarantee ability of drug shortage. Departments cooperate to reduce the emergence of drug shortage and ensure the continuous access to safe and effective drugs in clinic.
OBJECTIVE:To investigate the reasons for drug shortage in medical institutions of Sichuan province and put forward relevant countermeasures, and to provide reference for establishing supply security mechanism of drug shortage.METHODS:Questionnaire survey was conducted to investigate drug shortage in 78 medical institutions of the province during Jan.2015-Jun. 2017. Traceability investigation was conducted from manufacturers and distribution enterprises involved in drug shortage.Questionnaire survey and field investigation were combined to analyze the reasons for drug shortage in Sichuan province and put forward countermeasures. RESULTS:Totally 78 questionnaires were sent out to medical institutions with recovery rate and effective rate of 100%. A total of 206 drugs were reported by 78 medical institutions,involving 240 specifications for shortage in total.Totally 140 questionnaires and 68 questionnaires were distributed to the manufacturers and distribution enterprises involved in drug shortage,and the recovery rate and effective rate were all 100%. Combined with the field survey,survey results of shortage drugs of 212 specifications were obtained. From the perspective of manufacturers,the most important factors causing drug shortage were the increase of production cost(66.51%)and circulation cost(26.88%). From the perspective of distribution enterprises,the main factors causing drug shortage were insufficient supply of drugs(75.47%),inventory management(16.51%) and price inversion (11.32%). CONCLUSIONS:Main reasons of drug shortage from manufacturers and distribution enterprises include the increase of production cost and circulation cost,drug price inversion,inventory management and bidding procurement. It is suggested that measures should be taken to improve the bidding and pricing system of drugs,mobilize the enthusiasm of enterprises;improve the early warning mechanism of drug shortage on the enterprises,strengthen information communication;establish the mechanism of drug shortage reserve, organize the emergency production of drug for shortage; strengthen the management of drug shortage supply chain,purify the unhealthy atmosphere in the market;improve the emergency disposal methods of drug shortage,and improve the supply guarantee ability of drug shortage. Departments cooperate to reduce the emergence of drug shortage and ensure the continuous access to safe and effective drugs in clinic.
引文
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[14]杨悦,黄果,初智铭,等.美国处理药品短缺问题的经验及其对我国的启示[J].中国药房,2008,19(28):2173-2176.
[15]国家卫生计生委药物政策与基本药物制度司.关于改革完善短缺药品供应保障机制的实施意见[EB/OL].(2017-06-28)[2018-12-12].http://www.nhc.gov.cn/yaozs/s358-1/201706/ec2c5910ba4341559e0176e5e237d5e6.shtml.
[16]赵益华,朱茜.医疗机构部分药品短缺的原因及建议[J].中国实用医药,2013,8(5):269-270.
[2]世界卫生组织.世卫组织与非国家行为者交往的框架[EB/OL].(2017-06-10)[2018-12-12].http://www.who.int/mediacentre/news/releases/2016/wha69-28-may-2016/zh/.
[3]GRAY A,MANASSE HR JR.Shortages of medicines:a complex global challenge[J].Bull World Health Organ,2012,90(3):158.
[4]张伶俐,陈哲,曾力楠,等.全球短缺药品监测制度的循证评价[J].中国药房,2017,28(34):4753-4758.
[5]武丽娜,方宇,杨才君,等.我国药品短缺问题研究进展评述[J].中国药事,2016,30(5):458-465.
[6]蔡文芳,杨才君,沈倩,等.国内外药品短缺问题研究进展[J].中国药事,2016,30(12):1190-1199.
[7]盛亚楠,李勇,马爱霞,等.我国短缺药品供应保障政策研究[J].卫生经济研究,2017(8):57-60.
[8]国家卫生计生委药物政策与基本药物制度司.两种短缺药品市场撮合工作顺利完成[EB/OL].(2017-07-13)[2018-12-12].http://www.moh.gov.cn/yaozs/s7652/2017-07/050478537afb411bb8e5aae408dcd326.shtml.
[9]U.S.Food and Drug Administration.Drug shortage management[EB/OL].(2018-11-31)[2018-12-12].https://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesprocedures/ucm079936.pdf.
[10]江苏省卫生厅,江苏省经济和信息化委员会,江苏省财政厅,等.关于印发《江苏省短缺药品供应保障方案》的通知[EB/OL].(2013-01-15)[2018-12-12].http://jsggzy.jszwfw.gov.cn/ypcg/017005/20130115/6a755400-63cd-4996-8962-ec864b8ecc77.html.
[11]吕英刚,臧恒昌.新医改体制下中成药制造成本分析优化[J].齐鲁药事,2012,13(10):615-617.
[12]刘晓慧,彭六保,邓楠,等.湖南省21家三级医院常用药品与急救药品短缺现象分析[J].中南药学,2015,13(8):880-883.
[13]WEERDT ED,SIMOENS S,CASTEELS M,et al.Toward a European definition for a drug shortage:a qualitative study[J].Front Pharmacol,2015.DOI:10.3389/fphar.2015.00253.
[14]杨悦,黄果,初智铭,等.美国处理药品短缺问题的经验及其对我国的启示[J].中国药房,2008,19(28):2173-2176.
[15]国家卫生计生委药物政策与基本药物制度司.关于改革完善短缺药品供应保障机制的实施意见[EB/OL].(2017-06-28)[2018-12-12].http://www.nhc.gov.cn/yaozs/s358-1/201706/ec2c5910ba4341559e0176e5e237d5e6.shtml.
[16]赵益华,朱茜.医疗机构部分药品短缺的原因及建议[J].中国实用医药,2013,8(5):269-270.