Children trapped in China: every year 100,000 children die of "medicine" | | medicines for children _ news
Original title: China "children" of the trapped
In the more than 3,500 kinds of drugs available, designed for children of just more than 60 kinds of total 1.7%
At least 50% marked children on pediatric use of medicines use and dosage
Idea that children are "young adults", pediatric medicine is medicine and swallow half, reduction idea is errors
China has about 30,000 children every year due to improper medication into a silent world. Incidence of adverse drug reactions in children is 12.5%, twice times for adults, newborns up to 24.4%, 4 times for adults
Because Pediatric "shortage of doctors and medicine", China 5~14sui children die each year from preventable and treatable diseases, the number could be as many as 100,000
Drug research and development disorders in children are mainly clinical trials and research and development investment, urgent policy help
Detract from North of 5 years 3 years ago inappropriate medication cause deafness, to detract from noble family like Thunderbolt. "I felt a life without hope. "Detract from Connaught mother told the news weekly Outlook.
Detract from Connaught MOM says, almost the whole family traveled all over the hospital, a glimmer of hope is not neglect, but doctors concluded that nerve deafness cannot be cured at present, can only rely on auxiliary hearing aids, there is no cochlear implants.
This kind of pain, detract from Connaught mother realized: drugs, children not adults "miniature", children with children's medicine, wrong medication may affect the child's life.
Detract from Connaught is not alone. According to statistics from China Rehabilitation Research Center for deaf children, China has about 30,000 children every year due to improper medication into a silent world. According to statistics, China's incidence of adverse drug reactions in children 12.5%, twice times for adults, newborns up to 24.4%, 4 times for adults.
Outreach center Yao Hongwen, Director of the China population these figures "to heart". He told the Outlook weekly news commented: "behind these figures, hurt not only the children, also gives the child the family brings many misfortunes, brought heavy burden to society. ”
And behind the grim situation of adverse drug reactions in children, is the child of "lack of medicine" a reality. The 2016 white paper on pediatric drug safety survey (hereafter referred to as the white paper) display: the current number of children in China accounts for the incidence of 19.3%, in the more than 3,500 kinds of drugs available, designed for children of more than more than 60 species accounted for only 1.7%.
By 2014, some 230 million children in China, accounting for 16.5% of the total population. How to change China's children "the lack of medicines" reality, guarantee the basic drug needs of children? Enterprise for children "made to measure" drug and what are the obstacles? Problems, the need to overcome.
Shortage of drugs for children
From more than 20 years ago came to the Beijing children's Hospital, Wang Xiaoling noted a scenario every pharmacist to split-dose tablets crushed into powder. "More than 20 years, change of pharmacist in our hospital, but the scene never changed. ”
Wang Xiaoling, Director of Pharmacy at children's Hospital in Beijing. In her view, split-dose tablets crushed into powder, which means children of drug in dosage form, specifications are not sufficient.
Wang Xiaoling have been entrusted by the State family planning Commission of China's health regulatory Division carried out an investigation. Results showed that in 15 large nationwide children's Hospital pediatric medication list, form rows in front of are injections, tablets, Oral Solution is only 21. "For younger children, this, meaning they could face only tablets can be selected, which requires the tablets into 1/2, 1/4, neonatal, may have 1/8 or less, once shared the uneven, it may cause a drug harm. In addition, the syrup formulations for children is also very limited. ”
In addition to the dosage form, specifications, drug shortages on a number of children also should not be ignored. Said Wang Xiaoling's survey showed that 15 major pediatric hospitals nationwide total number of list of Pediatric drug 1098, child-specific medicines only 45, 4%, the remaining 1053 drugs, usage, dosage for children is about 43%. "This means that at least 50% marked children on pediatric use of medicines use and dosage. The shortage of children's drug usage instructions and information, as well as the usage, dosage of medication in children is not clear, and pediatrician faces legal and clinical dilemmas every day, the slightest mistake could lead to hyper-manual medicine. "Wang Xiaoling said.
According to the white paper revealed that as of June 2016, China's food and drug administration of China-made drug approvals 176,652, drug approvals was 3,517 of which are dedicated to children, total drug approval number 2%. Among them, accounted for more than 68.5% of proprietary Chinese medicines, chemical drugs accounted for more than 31.5%. From the perspective of drug treatment, mainly in the respiratory system, gastrointestinal system, other indications in the field of products is relatively small. "This shows that the existing narrow in drug treatment of children. "Punctuation medical information, General Manager Zhang Buyong said.
Chinese Academy of engineering, Pharmacology experts Li lianda told the news weekly Outlook, there is a misconception that children are "young adults", pediatric medicine is medicine and swallow half, reduction, that's wrong. Because child growth and development regularity and physiological and pathological characteristics of children in the development of disease and prognosis has its particularities. "Even children and adults have the same disease, its development is not the same, prescription drug usage, precautions, and rules are not the same. ”
Wang Xiaoling said that because of Pediatric "shortage of doctors and medicine", China 5~14sui children, who die from preventable and treatable diseases could be as many as 100,000. "Global 125 children a day died from poisoning, poisoning is children's injuries, the leading cause of death in China. ”
The 2015 child safety report shows that in children, drug poisoning as a proportion of all poisoning the children patients, from 2014, up 2012 in 73%. From this data, "more serious harm to the child. "Wang Xiaoling said.
Causes for accidental ingestion of drug poisoning in children. This means that drug instruction book on pediatric medication safety is critical. Wang Xiaoling said Chinese drug instruction book chaos, Kinetics data of children seriously inadequate. "We hoped that the country would require businesses to hang the latest drug shangguan network, even as developed countries do drug database and comprehensive evaluation of children's clinical system and a system of active surveillance of adverse reactions in children, establish child kinetics database, give the children more and more reliable scientific information and data. ”
Since 2007 focusing on children's medicines, sunflower medicine industry has been in the drug market work for nearly 10 years. Chairman Guan Yanbin told the news weekly Outlook: "spring river plumbing duck Prophet, our children ' lack of drugs and drug safety problems has a blind spot. ”
According to Guan Yanbin introduction, sunflower pharmaceutical group has 69 children drugs in 2015, children's medicines already on the market more than 5 billion yuan in retail sales, has become a domestic production of children's medicine Enterprise banner.
Nevertheless, the sunflower medicine still feel deeply for the children "made to measure" the various hard drugs.
Guan Yanbin said, drug research and development disorders in children are mainly clinical trials and research . From the perspective of clinical trials, few mothers would let their child to assume risk of clinical trials, the challenges facing the world. And from development input see, although children medication with adult medication also are is input big, and cycle long, and risk big, but usually for, children drug of profit to far below adult drug, like, a adult drug development success Hou of years sales may reached billions of, and Shang billion, but children drug of years sales usually only 100 million or 200 million, up to 200 million or 300 million, so, enterprise development children drug of enthusiasm does not high, children drug of production manufacturers also number little.
China pharmaceutical industry association survey shows that over more than 6,000 pharmaceutical companies in the country, specializes in the production of children's drugs only more than 10, including children first pharmaceutical factory of Beijing, Tianjin pharmaceutical factories, Harbin pharmaceutical factory of children. In addition, there are children drug manufacturing sector more than just more than 30 enterprises, such as sunflower pharmaceutical group, Guangzhou baiyunshan pharmaceutical company limited, North China Pharmaceutical Corporation, 90%, children's medicine medical market share occupied by few foreign-funded enterprises.
From the perspective of children's medicine market, the market for children's medicine in China in 2011 to 38.35 billion in 2014 to 52.66 billion yuan, compound annual growth rate reached 11.2%, but more than 10,000 pharmaceutical market overall, only about 4%.
Urgent policy help
Children's drug research and development is a clear need for more policy support.
Relevant policies and regulations of Chinese children since back in 2003,2014 introduction the opinions regarding the protection of children (hereinafter referred to as the opinion) can be called the first comprehensive guidance documents. The opinion by the National Health Commission, national development and Reform Commission and six ministries jointly issued, to encourage research and innovation, accelerate the approval and to ensure that production and supply, strengthen quality supervision, promoting the rational use of drugs and many other areas are specifically requested.
After landing the opinion, bidding policy change followed. February 2015 , China's State Council issued on improving guidance for drug centralized purchasing in public hospitals, the "generic drugs specialist, acute on women and children (Rob) saving transfusion, clinical medicine, basis of small amount of drug (these drugs the scope determined by the various provinces and municipalities) and lower-priced drugs in common use, centralized screen, direct procurement by the hospital."
January 2016 , approval of policy adjustment. The State food and drug administration review approval centers publish the clinical needs of children drugs for priority review and approval of basic principles for the evaluation of proposed to combat child disease and significant clinical advantage can speed up the review of an application for registration and approval.
In June this year , the National Health Commission jointly issued the first batch of encouraging research and development report of the Office of children's medicines list specifically, list includes medicines, its declared policies encouraging.
Facing the spread of favorable policies, Guan Yanbin said he looks forward to is very simple: "our business is that good policy can be put into implementation. The State has promulgated a series of a few years ' benefits ' policies, but the links there are still some problems in policy implementation. From the enterprise level, industry promotion of State policy has not implemented, also requires all sectors of the Community action, to work together to make steady progress. ”
Specific to the approval policies, for example, Guan Yanbin said, some traditional Chinese medicines for children are very classic, is also very easy to use, but there is always a big issue, is not good, the children refuse to eat. While their administration is not very convenient, mainly powder, needs water and taken with open, such children is not good for Chinese medicine to accept, so parents children tend to pinch the nose hard into her mouth filling. For the traditional Chinese medicine, if we alter its preparations by modern science and technology, tastes, such as turning them into jelly, jelly-like drugs, let them taste the strawberry flavor, the taste of Orange, will improve the acceptance of children, taking more convenient. But for now, this improved dosage forms on the premise to ensure quality, changing tastes, although has been recognized by the fast-track approval policy, but in some places have not really implemented.
China Medicine Association Chairman Fang Shuting pointed out that children in the development, transfer, production and use, sales and other areas still need more policy support, need more attention from the Government, so that enterprises can more actively for children "made to measure" drugs.
Wang Xiaoling said Chinese manufacturers less likely to children, child drug-specific specifications, formulations are also less, resulting in many disease with no cure, or adult drugs for children, increases the risk of child safety. "We look forward to more of the policies encouraged by the more exclusive drugs available for children to, optional, let doctors no longer as there is no ' weapons ', lacks ' weapon ' to worry about. ”
Responsible editor: Wei chun
Article keywords:Medicines for children
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中国儿童用药之困:每年10万孩子死于“缺药”|儿童|药物_新闻资讯
原标题：透视中国“儿童用药”之困
现有的3500多种药品中，专供儿童使用的仅60多种，占总数的1.7%
◆ 至少50%多的药品在儿科使用时没有标注儿童的用法、用量
◆ 那种认为儿童就是“小大人”，儿科用药就是内科药掰半、减量的观点是错误的
◆ 中国每年有约30000名儿童因用药不当陷入无声世界。儿童药物不良反应发生率为12.5%，为成人的2倍，新生儿高达24.4%，为成人的4倍
◆ 由于儿科“缺医少药”，中国每年5~14岁孩子死于可预防和可治疗疾病的人数可能多达10万
◆ 儿童药的研发障碍主要是临床试验和研发投入，亟待政策助力
5岁的付浠诺3年前因用药不当导致耳聋，对浠诺全家仿佛晴天霹雳。“我感觉生活里没有一点希望。”浠诺妈妈告诉《瞭望》新闻周刊。
浠诺妈妈说，全家为此几乎跑遍各大医院，一丝希望都不敢怠慢，但医生的结论是，神经性耳聋目前不能治愈，只能依靠辅助助听器，实在不行就植入人工耳蜗。
这种切肤之痛，使浠诺妈妈意识到：在用药方面，孩子不是成人的“缩小版”，儿童要用儿童药，错误用药可能影响孩子一生。
浠诺并非孤例。据中国聋儿康复研究中心统计，中国每年有约30000名儿童因用药不当陷入无声世界。另据统计，中国儿童药物不良反应发生率为12.5%，为成人的2倍，新生儿高达24.4%，为成人的4倍。
中国人口宣教中心主任姚宏文对这些数字“耿耿于怀”。他向《瞭望》新闻周刊评论说：“这些数字的背后，受到伤害的不仅是孩子，也给孩子家庭带来诸多的不幸，给社会带来沉重的负担。”
而在儿童药物不良反应的严峻形势背后，是中国儿童“缺医少药”的现实。《2016年儿童用药安全调查报告白皮书》（下称《白皮书》）显示：目前中国儿童患病数量占患病人数的19.3%，现有的3500多种药品中，专供儿童使用的只有60多种，仅占总数的1.7%。
截至2014年，中国约有2.3亿儿童，约占总人口的16.5%。如何改变中国儿童“缺医少药”的现实，保障儿童基本用药需求？企业为儿童“量身定制”药物又面临哪些障碍？种种问题，亟待突破。
儿童用药短缺之患
从20多年前来到北京儿童医院工作，王晓玲就注意到一个场景：每天药师都要把片剂碾成粉再分剂量。“20多年来，我们医院的药师几经更迭，但这个场景不曾改变。”
王晓玲是北京儿童医院药剂科主任。在她看来，片剂碾成粉再分剂量，意味着儿童药物在剂型、规格上的不充足。
王晓玲曾受国家中国卫生计划生育委员会药政司委托开展一项调查。结果显示，在全国15家大型儿童医院的儿科用药目录中，剂型排在最前面的是注射剂、片剂，口服溶液剂只有21种。“这对低龄儿童来说，意味着他们可能面临只有片剂可以选择的情况，这就需要把片剂分成1/2片、1/4片，对新生儿来说，可能就得1/8片甚至更小，一旦分得不匀，就可能造成药物伤害。此外，糖浆剂等适合儿童的剂型品种也非常有限。”
在剂型、规格之外，儿童药数量上的短缺也不容忽视。前述王晓玲开展的调查表明，全国15家大型儿科医院的儿科目录共有药物1098种，儿童专用药品只有45种，占4%，其余1053种药物中，有儿童用法、用量的品种约43%。“这意味着，至少50%多的药品在儿科使用时没有标注儿童的用法、用量。儿童用药说明书和用药信息的短缺，以及儿童用药的用法、用量不明确，也使儿科医生每天都面临着法律与临床的两难抉择，稍有不慎即可能导致超说明书用药。”王晓玲说。
另据《白皮书》披露，截至2016年6月，中国食品药品监督管理总局共有中国国产药品批文176652条，其中专用于儿童的药品批文为3517条，占药品总体批文数量的2%。其中，中成药占比68.5%，化学药占比31.5%。从药物治疗作用看，主要集中在呼吸系统、胃肠系统，其他领域的适应症产品比较少。“这说明现有儿童药物的治疗领域偏窄。”标点医药信息有限公司总经理张步泳说。
中国工程院院士、中药药理学专家李连达告诉《瞭望》新闻周刊，目前存在一种误解，认为儿童就是“小大人”，儿科用药就是内科药掰半、减量，这是错误的。因为儿童有其生长发育规律和生理病理特点，儿童在疾病的发生、发展和转归上有其特殊性。“即使儿童和成人得同一种病，其发展规律也不相同，选方用药、注意事项、用药规律也不一样。”
王晓玲说，由于儿科“缺医少药”，中国每年5~14岁的孩子，死于可预防和可治疗疾病的人数有可能多达10万。“全球每天有125名儿童因中毒死亡，中毒也是中国儿童伤害、死亡的主要原因。”
《2015年儿童用药安全报告》显示，在儿童群体中，药物中毒占所有中毒就诊儿童的比例，从2012年的53%上升到2014年的73%。从这个数据看，“对儿童的伤害比较严重。”王晓玲说。
儿童药物中毒的原因多为误服。这意味着，药品说明书对儿科用药安全至关重要。王晓玲表示，目前中国的药品说明书还比较混乱，儿童的药动力学数据严重不足。“我们希望国家能够要求企业把最新的药品说明书挂上官网，甚至像发达国家那样建立药品说明书的数据库，以及对儿童临床用药的综合评价体系和对儿童不良反应的主动监测体系，建立儿童的药动力学数据库，让儿童用药有更多、更可靠的科学信息和依据。”
自2007年专注儿童药，葵花药业已经在儿药市场耕耘近10年。董事长关彦斌告诉《瞭望》新闻周刊：“春江水暖鸭先知，我们对儿童‘缺医少药’和安全用药的问题早有觉察。”
据关彦斌介绍，葵花药业集团拥有儿童药69个，2015年已上市儿童药零售额超过50亿元，已成为目前国内儿童药生产企业的一面旗帜。
尽管如此，葵花药业仍深深感受到为儿童“量身定制”药物的种种艰难。
关彦斌说，儿童药的研发障碍主要是临床试验和研发投入。从临床试验看，几乎没有母亲愿意让自己的孩子去承担临床试验的风险，这是全世界都面临的难题。而从研发投入看，虽然儿童用药跟成人用药同样都是投入大、周期长、风险大，但通常来说，儿童药的利润要远低于成人药，比如，一个成人药研制成功后的年销售额可能达到几十亿、上百亿，但儿童药的年销售额通常只有一两个亿，至多两三个亿，因此，企业研发儿童药的热情并不高，儿童药的生产厂家也为数寥寥。
全国工商联药业商会的调查显示，全国6000多家药厂中，专门生产儿童用药的仅10余家，其中包括北京首儿药厂、天津市儿童药厂、哈尔滨儿童制药厂有限公司等。此外，有儿童药品生产部门的企业也仅30多家，如葵花药业集团、广州白云山制药股份有限公司、华北制药股份有限公司等，但儿童用药医疗市场90%以上的份额被为数不多的外资企业占领。
另从儿童药的市场规模看，中国儿童药的市场规模虽然由2011年的383.5亿元上升到2014年的526.6亿元，复合增长率达到11.2%，但就一万多亿的药品市场总体来看，仅占约4%。
亟待政策助力
儿童药的研发显然需要更多的政策支持。
回溯2003年以来中国儿童用药的相关政策法规，2014年出台的《关于保障儿童用药的若干意见》（下称《意见》）堪称国内第一个综合性指导文件。《意见》由国家卫生计生委、国家发展改革委等六部委联合印发，对鼓励研发创新、加快申报审批、确保生产供应、强化质量监管、推动合理用药等多个环节均提出具体要求。
《意见》落地后，招标政策的变动紧随其后。2015年2月，中国国务院办公厅发布《关于完善公立医院药品集中采购工作的指导意见》，提出“对妇儿专科非专利药品、急（抢）救药品、基础输液、临床用量小的药品（上述药品的具体范围由各省区市确定）和常用低价药品，实行集中挂网，由医院直接采购”。
2016年1月，审批政策调整。国家食品药品监督管理总局审评审批中心发布《临床急需儿童用药申请优先审评审批品种评定的基本原则》，提出对于防治儿童疾病且具有明显临床优势的药品注册申请可以加快审评审批。
今年6月，国家卫生计生委办公厅等联合印发《首批鼓励研发申报儿童药品清单》明确，清单内包括的药品，其研发申报受到政策鼓励。
面对不断传出的利好政策，关彦斌说他的期待非常简单：“我们企业就是希望这些好政策能够真正落实。这几年国家陆续出台了一系列的‘惠儿’政策，但是在政策贯彻执行的环节还是存在一些问题。从企业层面来看，国家政策带来的产业推动还没有落到实处，还需要社会各界积极行动，共同携手来稳步推进。”
具体到审批政策，关彦斌举例说，一些传统儿童用中药非常经典，也非常好用，但它们往往存在一个很大的问题，就是不好吃，孩子不愿意吃。同时它们的给药也不太方便，主要是散剂，需要用水和开后服用，这样的中药孩子不大好接受，所以家长常常会捏着孩子的鼻子硬往嘴里灌。对于这样的传统中药，如果我们通过现代化的科学技术改变其剂型、口味，比如把它们变成果冻状的、软糖状的药物，让它们的口味变成草莓味的、橙子味的，孩子的接受度就会提高，服用也会更方便。但从目前来看，这种在保证质量前提下的改良剂型、改变口味，虽然在审批政策上已经获得快速审批的认可，但在一些地方还没有真正实施。
中国中药协会会长房书亭指出，儿童用药在研发、转让、生产、使用、销售等环节仍然需要更多的政策扶持，需要政府给予企业更多的关注，让企业能够更积极地为儿童“量身定制”药物。
王晓玲说，目前中国儿童药的生产厂家较少，儿童药专用的规格、剂型也比较少，导致很多疾病患儿无药可用，或者成人药儿童用，增加了儿童用药安全的风险。“我们期待更多的政策鼓励下，孩子们能够有更多专属药物可用、可选，也让我们医生不再为没有‘武器’、缺少‘武器’而担忧。”
责任编辑：隗俊
文章关键词： 儿童 药物
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