全球药品短缺管理及其对我国的启示
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摘要
药品供应与百姓的健康福祉息息相关,是民生保障的重要内容。我国已经对部分易短缺药品采取定点生产等保障措施,但目前仍然面临原料药、儿童用药、部分临床必须小用量药品供应不足等一系列挑战。美国、加拿大等国家针对短缺药品已经制定了比较完善的管理办法。借鉴国际经验,明确药品短缺的定义,加强短缺药品管理,提出解决问题的政策建议,逐步完善我国药品供应保障体系。
Supply of medicines is closely associated with people's health and benefits. It is an important part of the goal for ensur-ing people's well-being. Even though China has already taken several actions that consist of consigning certain manufacturers to pro-duce medicines at a great risk of stock-outs,currently China is still facing a series of challenges including insufficient supply ofAPI,pediatric medicines as well as some medicines of little usage amount. United States and Canada introduced sound policies formanagement of medicine shortage. By learning from international experience,it needs to clarify the definition of medicine shortage,enhance management of unavailable medicines,propose policy recommendation to solve the problem,and improve guarantee systemfor pharmaceutical supply gradually.
Supply of medicines is closely associated with people's health and benefits. It is an important part of the goal for ensur-ing people's well-being. Even though China has already taken several actions that consist of consigning certain manufacturers to pro-duce medicines at a great risk of stock-outs,currently China is still facing a series of challenges including insufficient supply ofAPI,pediatric medicines as well as some medicines of little usage amount. United States and Canada introduced sound policies formanagement of medicine shortage. By learning from international experience,it needs to clarify the definition of medicine shortage,enhance management of unavailable medicines,propose policy recommendation to solve the problem,and improve guarantee systemfor pharmaceutical supply gradually.
引文
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[13]DECAMP M,JOFFE S,FERNANDEZ C,et al.Chemo-therapy drug shortages in pediatric oncology:a consensusstatement[J].Pediatrics,2014,133(3):716-724.
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[15]LIU H.Adopting solutions to orphan drug shortages[R].Cali-fornia:University of California Davis,2015.
[16]GU A,WERTHEIMER A,BROWN B,et al.Drug short-ages in the US-causes,impact,and strategies[J].Innova-tions in pharmacy,2011,2(4):1-8.
[17]吴芳,周迎波,崔茉莉.国际环境下的我国孤儿药产业发展策略研究[J].中国医药工业杂志,2015,46(4):428-434
[2]World Health Organization.Concept note of consultation on managing global stock-outs of essential medicines[R].Gene-va:World Health Organization,2015.
[3]International Pharmaceutical Federation.Report of the inter-national summit on medicine shortage[R].Toronto:Interna-tional Pharmaceutical Federation,2013.
[4]LINK M,HAGERTY K,KANTARJIAN H.Chemotherapydrug shortages in the United States:Generics and potentialsolutions[J].Journal of clinical oncology,2012,30(7):692-694.
[5]NIXON H,PERALTA F.Drug shortages:where are we andwhere are we going[J].American society of anesthesiologists,2013,77(5):20-22.
[6]WEERDT E,SIMOENS S,HOMBROECKX L,et al.Causes of drug shortages in the legal pharmaceutical frame-work[J].Regulatory toxicology and pharmacology,2015,1(5):1-8.
[7]SHADER R.Pediatric drug shortages:a deplorable fact anda political problem[J].Clinical therapeutics,2014,36(2):151-152.
[8]GRAY A.Medicine shortages-unpicking the evidence from ayear in South Africa[J].Australian medical journal,2014,7(5):208-212.
[9]常峰,刘洪强.美国药品集中采购组织实施效果研究及其对我国药品采购的启示[J].中国卫生经济,2015,34(10):93-96.
[10]FRISKE E.Addressing looming prescription drug shortagesthrough legislative and regulatory approaches[R].Minneso-ta:University of Minnesota,2013.
[11]QUILTY S,HARRIS L,KEWLEY J,et al.A Pandora’s box:sustainable pharmaceutical supply[J].The medicaljournal of Australia,2011,195(9):510-511.
[12]BESAN ON L.FIP Experience and feedback.Technical con-sultation on preventing and managing global stocks outs ofmedicines[C].Geneva:World Health Oragnization,2015.
[13]DECAMP M,JOFFE S,FERNANDEZ C,et al.Chemo-therapy drug shortages in pediatric oncology:a consensusstatement[J].Pediatrics,2014,133(3):716-724.
[14]Management Sciences for Health,Inc.The development ofMDS-3:managing access to medicines and health technolo-gies[M].Arlington:Management Sciences for Health,2012:462.
[15]LIU H.Adopting solutions to orphan drug shortages[R].Cali-fornia:University of California Davis,2015.
[16]GU A,WERTHEIMER A,BROWN B,et al.Drug short-ages in the US-causes,impact,and strategies[J].Innova-tions in pharmacy,2011,2(4):1-8.
[17]吴芳,周迎波,崔茉莉.国际环境下的我国孤儿药产业发展策略研究[J].中国医药工业杂志,2015,46(4):428-434