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Crack the children's drug safety dilemma-children's drug“Medicine” more cautious to act

2022-09-16 06:32:19


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Pharmacy Network 全国领先的互联网药师集团,

The author | Liu Wei

Editor-in-chief |

This article is total 4456 Word, just read 7 minutes

“我的世界很安静,听不到一点声音……”

事实上,像她这样

这段3分钟短片让不少人了解到,不安全用药导致少儿突聋并非只是影视剧里赚人眼泪的悲情桥段。/ 央视《5岁聋儿:我想对妈妈说》

中国关心下一代工作委员会和国家食品药品监督管理总局联合进行的“儿童安全用药大调查”显示,

Due to improper medication, in addition to about 30,000 children deafening every year, China also caused about 7,000 children to die.

  • On December 30, 2017, an 8-year-old boy in Xi'an City, Shaanxi Province, went to the hospital for infusion treatment because of a cold and fever, and not long after, the child suddenly spat out white foam and died after being rescued by the hospital.

  • 2017年12月2日,陕西省华阴市10岁男童在注射一种注射液时,突然休克死亡。

  • 2016年1月24日,江苏省丹阳市一名3岁幼童在当地卫生院输液过程中发生不适,后经抢救无效死亡。

Children are the flowers of the motherland, the future of the country, what is the reason for their drug safety threat?

家长:
给孩子吃成人药

Xino took an adult cold medicine because of his fever, causing hearing loss experience, so that Bao's mother, Ms. Li, could not help but think of her own mistake to give the child medicine and a chill ran down her back.

One night, Ms. Li's daughter suddenly had a fever. When the family ran out of cold medicine, Ms. Li broke off half of the cold tablets she had taken for her daughter to take.

"I thought my daughter would get better quickly after taking the fast-acting drugs, but who knew that she suddenly became serious after eating."Ms. Li blamed herself and said, "After the child took the medicine, not long after, there was a whole body hot and a little delirious, fortunately, I took a wet towel to cool her down, the temperature on the body gradually receded, and the consciousness began to wake up."”

Except for Ms. Lee,

The survey shows that parents have a vague understanding of“Children's medicine”, and there are many hidden dangers in feeding medicine. /xinhuanet data news

Zhao Ning, deputy director of Peking University First Hospital and founder of "Pharmaceutical Affairs Network" Tell 39 to take a deep breath (ID:shenhuxi39) ,“儿童正处于生长发育阶段,病情变化比成年人快,同时肝肾功能、神经和内分泌系统不像成年人那样健全,对药物的代谢和成人差别很大。

“我知道宝宝要吃专门的药品,但是,现在针对宝宝的药太少,医生有时开的药也是成人药,所以我们有时给孩子吃成人药也是迫不得已。”宝妈刘女士无奈说道。

企业:
儿童药研发风险大

At present, the number of children in our country is 220 million, among which the number of sick children accounts for 20% of the total sick population in China.

但是,在这样一个儿童药需求量较大环境下,儿童药种类相对成人药却少得可怜。

调查显示,感冒、发烧、咳嗽是儿童高发病。/ 新华网数据新闻

根据国家食药监局相关数据显示,

同时,很多药品的说明书及有关文献,都缺乏儿童用药的资料,如无具体的儿童用法用量、安全性及有效性资料不明确、资料不全等,也为儿童用药带来了巨大的安全隐患。

“每次给宝宝买的药,我都会认真看说明书,但

有学者曾对某儿童医院正在使用的550份药品的说明书进行分析,发现标注有儿童用法用量的国内和国外(合资)药品均只有48%,标注有儿童注意事项的国内药品仅有39%,国外(合资)药品仅32%。

某止咳口服液的说明书。/ 资料图片

旺盛的医疗需求本该带来巨大的市场潜力,面对儿童药如此大的市场空间,为什么我国药厂在儿童用药的研发和生产上没有太大的积极性?

某药业集团营销中心常务副总经理告诉39深呼吸 (ID:shenhuxi39) ,“研发儿童新药需要花费很长时间,而当新药研发成功,未必能在临床实验中通过效果测试。药品如果能通过最终临床测试,投入到市场中,市场反馈的好坏也是一个未知数。因此,面对研发新的儿童药品种需要承担这么多风险,儿童药生产企业更倾向于收购。”

另外,相对成人药品,儿童药在生产上还需要考虑药品的剂型、服用方式、口感等因素,使儿童药生产成本大大增加。

其次,现代药物的研发都需要经过临床试验,而儿科的临床试验尤为困难。

国家食药监局药品注册司化学药品处处长董江萍 介绍,“在全国344家临床试验机构中,具有儿科相关专业的临床试验机构仅42家,占12.21%。同时,出于伦理方面的考虑,政策规定,新药不首先在孕产妇以及婴幼儿身上做临床试验。加上知情同意者难、试验者招募难等原因,

医院:
儿科医生匮乏严重

In addition to the shortage of child-specific drugs, the lack of pediatricians is also one of the factors affecting the safety of drug use in children.

According to the White Paper on the Status quo of Pediatric Resources in China, according to the "Healthy China 2020 Strategic Research Report", the target of 0.69 pediatricians per 1,000 population in 2020 is proposed.

现在每千名儿童配比的医师仅0.63名,相当于1580名儿童配比1名儿科医生。/ 新京报

The great loss of pediatricians and nurses has led to the fact that there are now almost no pediatricians in small hospitals, while there are pediatricians in big hospitals but they are hard to find. It is often even more difficult for children to see a doctor than for adults.

很多家长因为大医院排不上号,孩子的病又耽误不得,只能带着孩子去附近的小医院或者药店去买药,但是,这些地方的大部分医生,儿童用药剂量把握不准,给孩子开的药存在很大风险。

近日,网友 @儿科医生蓬蕊 在微博上称,一个咳嗽一周无发热的三岁孩子竟然被医生开了足足8种药,不知道是要告诉家长实话,还是要“科普”家长尊重医生,把这些药都给孩子吃下去?!

Netizen @ pediatrician Peng Rui posted the medicine prescribed by the doctor./ Screenshot of Weibo

陈女士最近也因为给孩子看病的事情让她气愤不已。她3岁的宝宝因为经常出现干咳,便去附近医院给孩子看看,医生简单问了问情况,就开抗生素给她,还要求她带宝宝做雾化。

“一个小孩子就有点干咳,就要吃抗生素和做雾化,这不是乱开药嘛。”陈女士生气地说,随后她换了一家大医院给孩子看病。

面对医师用药水平参差不齐的问题,国家卫生健康委员会也曾指出,我国一些临床医师存在用药水平不高,尤其是基层医务人员整体较低,对药物适应症、禁忌证等掌握不够。

政府:
政策力度需加强

其实,面对儿童用药问题,政府已经针对性地采取了系列措施,只是效果并不明显。

目前,针对儿童专用药研发和儿童药生产的问题,国家已陆续发布了

In March 2015, the Health and Family Planning Commission established the Children's Medicine Expert Committee./ National Health Commission website

但是,企业研发药品的最直接动力是获得利润。由于儿童药物在上市注册以及上市后药品定价、招标采购、医保等市场准入政策等相关配套政策的不完善,使得各个药品生产企业在面临巨大研发成本面前望而却步。

The person in charge of a pharmaceutical production enterprise believes that the state should provide financial and technical support for drug research and development to improve the enthusiasm of pharmaceutical enterprises in research and development and production.At the same time, the establishment of a children's drug re-evaluation system, the use of existing drug resources, through the safety, efficacy, dosage and other evaluations, so that more marketed drugs are reasonably applied to children, to meet clinical needs.

In the face of the shortage of pediatricians, in 2016, the National Health and Family Planning Commission proposed that it would coordinate with the Ministry of Education

据媒体报道, 广医儿科学院学生可享学费全额资助。/ 奥一网截图

全国人大代表丁明 也曾在两会中呼吁,政府应重点帮扶基层儿科医院,以政策鼓励高质量医生流向基层医院,提高基层医院的人才水平,为基层孩子提供更安全的治疗。

北京协和医院儿科主任宋红梅 则表示,“要想留住并吸引更多人从事儿科事业,首要问题是提高儿科医生的待遇,让儿科医生拥有与目前高强度、高压力的工作相匹配的收入,这样才能吸引更多医生从事儿科工作。”

PARENTS:
自觉提高用药意识

在儿童“缺医少药”的环境下,为了避免用药错误给孩子带来伤害,作为跟孩子接触紧密的家长,提高正确用药意识尤为重要。

赵宁表示,家长需自觉树立一种观念,

1、抗菌药物滥用

有些家长发现孩子感冒发烧,便盲目使用抗菌药物,容易造成孩子过敏、休克等严重不良反应,因此,抗菌药物不要随意乱吃。


2、认为中药更安全

担心西药副作用大,很多家长更偏向于买中药给孩子服用。但是,有些中药说明书上写着“不良反应尚不明确”,并不代表它没有副作用,而是说明它暂时没有相应的临床试验数据,建议家长还是选择说明书上详细交代了相应的禁忌症和不良反应的药品。另外,中药使用讲究辩证施治,家长并没有这方面的判断能力,所以不可盲目自行选用。


3、服药方式不对

儿童服用一般药片可以整片吞咽,不需嚼碎,但一些药物则需要孩子嚼碎了吃,比如酵母片等,而胶囊剂应直接口服,如果把胶囊中的西药粉倒出来吃,有些刺激性药物可能会灼伤口腔和食道。如果家长不知道正确的服药方式,建议提前咨询医生。


4、用药过量

有些家长见孩子生病就会很着急,误以为药吃得越多,病就好得越快,事实上,过量药物会积蓄在孩子的体内,容易给孩子的身体带来损伤。因此,家长在给孩子用药时,一定要遵医嘱按时按量用药。在带孩子去看病时,还要清楚告诉医生孩子吃过、用过的药物,防止医生重复开药。


5、保健品当糖果吃

为了吸引孩子,市面上很多儿童保健品口味都是水果味,很多家长认为保健品百利而无一害,会默许孩子当零食吃。但是,营养补充过量也会给孩子带来不良反应,如过量补充维生素A,婴幼儿会出现皮肤干燥的症状。

生活中,衣食住行,我们总是给孩子专属的呵护,但最需要专属的药品,不知何时我们也能这般提供……

(At the request of the interviewer, the characters in the article are pseudonyms)

Resources:

[1]“Deaf 5-year-old: I want to say to my mother”, CCTV short for public welfare. September 8,2016

[2] "8-year-old boy admitted to the hospital with fever and died in the afternoon of the same day", Shaanxi City Channel.2017-12-30

[3]《江苏丹阳——3岁幼儿输液后死亡或因过敏性休克》,新京报. 2016-01-25

[4]“Why are Chinese children medicated?”, Shower Fallin. October 8,2018



来源:经授权转载自39深呼吸 (ID:shenhuxi39)


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