Children's drug dilemma: only 2% of exclusive drugs are used by guessing dosage and breaking off

Source: Beijing News, June 13, 2017: due to the lack of special drugs for children, some parents have to use adult drugs for children according to the principle of "children's discretionary reduction" through various conversions However, the consequence is very serious According to some data, the adverse drug reaction rate of children in China is twice that of adults, and that of newborns is four times Data shows that there are more than 10 enterprises specializing in the production of children's drugs in China, and more than 30 enterprises in the production department of children's drugs Among the listed pharmaceutical enterprises, there is only one single manufacturer that mainly deals with children's medicine Recently, the state health and Family Planning Commission, the Ministry of industry and information technology and the State Food and Drug Administration issued the second batch of list of drugs for children to encourage research and development and application, with 39 children's drugs on the list On June 1, 2016, after the first batch of drugs encouraging research and development and declaration for children was released, 22 of the 32 listed drugs have entered the priority review channel Thanks to this, the new indication of Shanghai Roche pharmaceutical product "systemic juvenile idiopathic arthritis" was even listed in China four years ahead of schedule With the support of this series of favorable policies, can we improve the problems of fewer drug manufacturers, fewer varieties and fewer dosage forms for children in China? Experts in the industry believe that, in addition to the encouragement of research and development, if there is no enforcement to regulate clinical medication habits, enterprises should still be cautious to enter the field of children's drugs Under the favorable policies, 71 kinds of children's drugs have been applied for research and development In the list of the second batch of children's drugs that encourage research and development to apply for research and development recently, 39 children's drugs that have not yet been registered and listed in the mainland and are urgently needed in clinic are listed Including the first batch of 32 drugs on the list, 71 children's drugs have entered the list of application for encouraging research and development In fact, the lack of drug varieties and suitable dosage forms for children has long attracted the attention of relevant departments In December 2015, the State Food and Drug Administration issued the basic principles for the evaluation of varieties for the application of priority review and approval of children's drug use in clinical urgent need, and determined the conditions for the priority review of new varieties for children, new dosage forms or specifications, and imitated varieties In March 2016, the State Food and Drug Administration issued the guiding principles for clinical trials of drugs in pediatric population, which gave detailed guidance on ethical considerations, data and safety supervision, subject age stratification, pediatric dosage form selection, etc Among them, in the research and development of dosage forms, it is particularly mentioned that the acceptance of dosage forms by the pediatric population will be affected by the taste, smell and texture of the drug itself, and attention should be paid to "the size and shape of the tablet" On June 1, 2016, the list of the first batch of drugs for children to encourage R & D and application was released The national health and Family Planning Commission called this act to promote the R & D, creation and application review of appropriate varieties, dosage forms and specifications for children, so as to meet the clinical drug demand of Pediatrics On May 12 this year, the State Food and Drug Administration released the relevant policies on encouraging innovation of drugs and medical devices to protect the rights and interests of innovators (Draft for comments), which specifically proposed that 10-year data protection period should be given to both innovative drugs and drugs for rare diseases and special drugs for children; 3-year data protection period should be given to drugs for rare diseases and special drugs for children belonging to improved new drugs An expert from the children's medicine expert committee of the national health and Family Planning Commission once told the media that the main reason for the frequent occurrence of current favorable policies for children's medicine is that "it's time to pay attention to children's medicine" There are only more than 60 kinds of special drugs for children, accounting for only 2% Although the scale of China's children's drug market has been rising in recent years, from 38.35 billion yuan in 2011 to 52.66 billion yuan in 2014, it is far from the overall market scale of trillion level medicine According to the data of the 2016 survey report on drug use safety for children issued by the South Institute of pharmaceutical economics of the State Food and drug administration, as of June 2016, of the 176652 domestic drug approvals, only 3517 were for children (children's specific drug refers to the drug that clearly states children's drug use, excluding the drug used for children but not for children in the general name Drugs), accounting for only 2% In terms of varieties, of more than 3500 conventional drugs, there are only 60 special varieties for children Li Lianda, academician of the Chinese Academy of engineering, believes that the research investment in children's drug use is large, the cycle is long, the risk is large, the profit is not high, and the enthusiasm of enterprises' production is affected "If an adult drug is successfully developed, the annual sales volume can reach billions, tens of billions, but it's very good that children's drug use can reach one or two billion, two or three billion." The head of sunflower pharmaceutical industry also said in an interview with the Beijing news that the most direct driving force for enterprises to develop drugs is to obtain greater profits Most of the previous policies did not specifically cover children's drug use, there were some unreasonable factors, and the enthusiasm for developing children's drugs failed to be effectively encouraged Tong Ben, President of Beijing Kyoto Hospital, said that children's drug use has long been affected by the pricing level of adult drugs, but the small dosage and low profit of children's drug use have also become the reason why some enterprises are reluctant to produce children's drugs, and the particularity of children's drug use has not been considered There are less than 20 third-party pharmaceutical service systems involving children's drugs listed on the market The founder of McConnell told the media that many enterprises think that the production of children's drugs is very simple and only need to slightly change the dosage of adult drugs In fact, this is not the case Children's drugs must be different from adult drugs for research and development, which is a short board for some enterprises According to the survey of the pharmaceutical industry guild of the all China Federation of industry and commerce, of the 6000 pharmaceutical factories in China, only more than 10 specialized in children's medicine, such as Beijing Shouer pharmaceutical factory, Tianjin Children's pharmaceutical factory, etc.; there are only more than 30 enterprises with children's medicine production departments, such as Guangzhou Baiyunshan Pharmaceutical Co., Ltd Among the A-share listed pharmaceutical enterprises, there are no more than 20 enterprises that are solely engaged in the production of children's drugs, and involve adult drugs and children's drugs at the same time Among them, Kangzhi pharmaceutical industry is one of the few listed enterprises in China that produce paediatric drugs Children's diarrhea and digestion series products are the leading products, accounting for more than half of the company's children's medicine sector In 2016, with a revenue of 322 million yuan, Longmu Zhuanggu granules and Qiangyue cream of Jianmin group accounted for 68.33% of children's drug business were selected into the research topic of "policy recommendations on traditional Chinese medicine for children" by the national health and Family Planning Commission, and several children's drugs such as Niuhuang Xiaoer Tui tie, Xiaoer Xuanfei Zhike syrup are also under development Sunflower pharmaceutical industry is an enterprise involving adult medicine and children's medicine In addition to the "little sunflower" often seen on TV, children's chaigui antipyretic granules are also one of its main products In the aspect of research and development, the company is carrying out the preliminary research on children's lung heat cough and asthma aerosol inhalation agent, the pre clinical research on children's lung heat cough and asthma oral liquid to increase the treatment of mycoplasma pneumonia indications, and has 5 children's drug varieties under research, such as children's Artemisia qinkanggan granules In 2016, the production and sales volume of Yabao pharmaceutical industry, whose main product is dinggui'er umbilical patch for children, decreased by 70% and 53% respectively year on year due to the influence of marketing channel reform and control factors As a pillar area of the company, its paediatric products revenue fell nearly 60% in 2016 In the first quarter of this year, the profitability still fell year on year The incidence of adverse drug reactions in children is higher than that in adults Wang Xiaoling, director of Pharmacy Department of Beijing Children's Hospital Affiliated to Capital Medical University, said in the 2016 survey report on drug use safety for children that insufficient drug use for children includes drug shortage, insufficient information on drug use for children, and insufficient pediatric doctors Taking the lack of information on children's drug use as an example, according to the related subjects of the Department of drug administration undertaken by Beijing Children's Hospital in 2011, there are 1098 kinds of drugs in the paediatric drug list of 15 large paediatric hospitals in China, of which only 45 are special drugs for children Among the remaining 1053 kinds of drugs, 43% of them have instructions related to the usage and dosage of children The dosage forms for children are also limited In the paediatric drug list of these 15 children's hospitals, the most dosage forms are injection and tablet, and there are only 21 kinds of oral solution The dosage forms suitable for children, such as syrup, are very limited Another problem is that the safety of children's drug use has attracted much attention when children's drug use depends on breaking for a long time and reducing the amount according to adult standards According to the data of China Rehabilitation Research Center for deaf children, about 30000 children under 14 years old are deaf every year due to improper use of drugs Liver and kidney function, nervous system and other injuries are also common consequences of improper use of drugs According to the 2012 document "analysis of the role of hospital pharmacists in children's rational use of drugs", about 7000 children die of medication errors every year in China Wang Xiaoling believes that the shortage of special drugs for children and the shortage of pediatricians lead to the lack of terminal service ability Compared with adults, the consequences of improper use of drugs for children are more serious According to some data, the adverse drug reaction rate of children in China is 2 times that of adults and 4 times that of newborns If the clinical medication habits are not standardized, pharmaceutical companies should be careful to enter the market with favorable policies, and the children's medication market also ushered in a demographic dividend Since January 1, 2016, the "comprehensive two child" policy has been officially implemented According to the statistics of the National Bureau of statistics, in 2016, China's new born population was 18.67 million, an increase of 11% over 2015, and the total population increased by 1.91 million In 2016, 45% of the new born population's contribution rate came from two child families Shi lichen believes that under the influence of favorable policies and demographic dividend, the children's drug market has indeed ushered in important development opportunities, but the existing drug habits need to be standardized For a long time, children's drug use in clinic follows the principle of reducing the use according to adult standard, which has been formed "This is an important factor in the rise of the children's drug market We should regulate children's use of drugs by administrative means, like "anti drug restriction order" (restriction of antibiotic use), for example, some drugs can only be used in children's clothing " The so-called "anti drug restriction order" refers to the government's policies to restrict the use of antibiotics in clinical practice In August 2015, the national health and Family Planning Commission and the State Administration of traditional Chinese Medicine issued the notice on Further Strengthening the management of clinical application of antibacterial drugs, which stipulates that doctors can be restricted from prescribing antibiotics for more than three times without justified reasons "It's not a long-term solution for children's drug market to really rise, only encourage at the level of research and development, and lack of mandatory regulations at the level of drug use." According to Mr Shi lichen, children's drugs are still lack of competitiveness in bidding and drugstores under the existing drug habits If this habit cannot be standardized, enterprises should also be careful to enter the field of children's drugs ■ don't use candy or snacks to cheat children to take medicine Children are very resistant to taking medicine Parents can try to encourage them, such as watching TV for children or playing games with children In addition, it can also assist children to take medicine with some drug feeding tools, such as spoon, drug dropper, syringe type drug feeder, etc It should be noted that when taking drugs, children should not be deceived into taking candy or other snacks, because candy or snacks cause relatively little damage to the body, while drugs may have certain side effects, or even cause poisoning, so parents should instill the concept of sick medical treatment in children, so that they can understand that drugs will not cause harm to them, but help them recover health It should be noted that the digestive system of children under 1 year old is not well developed