Medical network on June 13 - due to fewer drugs for children, some parents have to through a variety of conversion, according to the principle of "reduction" children, the adult medicine for use in children. The consequences were severe, with data showing that Chinese children were twice as likely to have adverse effects as adults, with four times the rate of adverse reactions in newborns. 

 

Statistics show that there are more than 10 enterprises in our country specializing in the production of children's medicines, and more than 30 enterprises with children's drug production departments. Among listed companies, there is only one producer of drugs for children. 

 

Recently, the state development planning commission, the ministry of industry and information technology, food drug safety administration issued by the list of the second batch of encouraging research and development to declare the children's medicine, 39 children drugs on the list. As of June 1, 2016, the first batch of 32 medicines listed in the 32 listed medicines were given priority reviews. Thanks to this, the new adaptation of the Shanghai roche pharmaceutical product, yamamuro, has been listed in China for four years in advance. 

 

In this series of positive policies, can we improve our children's drug production enterprises, fewer varieties, fewer dosage forms? 

 

Industry experts believe that in addition to encourage research and development level, if there is no compulsory execution to a standardized clinical medication habits, companies are still children should be careful to enter the medicine field. 

 

The policy benefits 71 children's drug declaration and development 

 

In the recently released the list of the second batch of encouraging research and development to declare the children's medicine, 39 listed within the territory of the People's Republic of China has not been registered and urgent clinical needs of the children's medicine. The first batch of 32 drugs were included in the list, with 71 children being given access to research and development lists. 

 

In fact, the problem of the children's medicine variety and the lack of suitable dosage forms has aroused the attention of the relevant departments. 

 

Released in December 2015, the national food administration of drug safety in the clinical medicine for children need to apply for priority review approval for evaluation of variety of basic principles, determined the new varieties used in the pediatric population, change of dosage forms or new specifications varieties and varieties of generic priority review shall meet the conditions. 

 

Released in March 2016, the state administration of food drug safety in the pediatric population technical guiding principles of drug clinical trials, considering from ethics, the data and safety monitoring, participants age stratification, made detailed guidance pediatric dosage form selection, etc. Among them, in the choice and dosage form development special mention pediatric population acceptance of dosage forms will be affected by the taste, smell and texture of the drug itself, pay attention to the "pill size and shape. 

 

On June 1, 2016, announced the list of the first encourage r&d to declare the children's medicine, national health development planning commission said the move to promote children's suitable varieties, dosage form, specification development initiatives and declare review, meet the demand of pediatric clinical drug use. 

 

Released on May 12 this year, the administration of drug safety "about to encourage pharmaceutical medical equipment innovation policies of protection of innovators (draft)", specifically to belongs to belong to the rare diseases and innovative drug medication, children decongestion, give 10 years data protection; It is a rare medical treatment for new drugs, children's special medicine, and three-year data protection period. 

 

National medicine for children who planning commission an expert of the committee of experts have said the media, the current children's medicine is the main reason of the positive policy using "it's time to pay attention to children's drugs. 

 

There are only about 60 children who have a specific drug, accounting for just 2 percent 

 

Although children's medicine market is rising in recent years in China, up from 38.35 billion yuan in 2011 to $2014 in 52.66 billion, but that compared with trillion-dollar medicine overall size of the market, also. 

 

According to the national food administration of drug safety institute of medicine economic south, release the 2016 children's medication safety survey data show that as of June 2016, in 176652 domestic drug approval, only 3517 article is dedicated to children's medicines (children decongestion refers to the common name specified in the children's drugs, does not contain but didn't explain the common name for children is the children's drugs), accounted for only 2%. From the variety, more than 3,500 conventional medicines have only 60 species of children. 

 

Investigate its reason, the Chinese academy of engineering lian-da argues that children's drugs research into big, cycle is long, risk, profit is not high, enterprise production enthusiasm affected, "an adult medicine developed, can achieve billions, annual sales of tens of billions, but children's drugs can achieve a couple of hundred million, two or three very good." 

 

Sunflower pharmaceutical relevant head of the Beijing news reporter interview, also said the most direct drug research and development power is greater profit, after some of the policies are not specifically about children's drugs, there are some unreasonable factors, develop the enthusiasm of the children's medicine failed to effective incentive. 

 

Beijing Kyoto hospital children rush has said that medicine for children affected by adult drug pricing level for a long time, but the children small dosage, low profits, it also become a part of the reason of don't want to make children's medicines, the particularity of medicine for children is not be considered. 

 

Fewer than 20 listed companies are involved in children's medicines 

 

Third-party medical service system MaiSiKang lai founder told media that many companies believe that the production of children's medicine is very simple, only need to change slightly on adult dosage of drugs, in fact is not the case, children must be different from adult drug research and development, which is short for part of the enterprise. 

 

According to the national federation of industry and pharmaceutical industry associations according to the survey, the national more than 6000 pharmaceutical factory, specializing in the production of children's drugs only more than 10, the first son companies such as Beijing, tianjin children's pharmaceutical industry, etc.; There are more than 30 companies with children's pharmaceutical production, such as baiyunshan pharmaceutical in guangzhou. Among a-share listed companies, there are no more than 20 companies that produce A single drug for children, as well as for adults and children. 

 

The Kang Zhi pharmaceutical industry is one of the few to son medicine production, one of the listed company of child diarrhea and digesting series products are the leading product, the company more than half of the children's medicine plate fraction. Revenue was 322 million yuan in 2016 and 68.33 percent of the children's drug business 

 

Jianmin group dragon bones negundo particles, qiang on cream to be included in the national development planning commission "herbal medicine for children related policy recommendations" research topic, bezoar infantile back stick, infantile releasing lungs cough syrup, and other children's drugs are also under development. 

 

Sunflower pharmaceutical industry is involved in adult and children's medicines enterprise, in addition to can often see on television's "sunflower", pediatric Indian bay leaf antifebrile grain is also one of its flagship product. In research and development, the company's ongoing children lungs heat to cough and gasp the atomization inhalation prophase research, increased children lungs heat to cough and gasp the oral liquid in the treatment of mycoplasma pneumonia indications of preclinical studies, at the same time with infantile artemisia Qin anti sense of particles such as the five children's drugs in research. 

 

Medicine for children with Ding Gui son navel stick as the main product of talc pharmaceutical industry, the marketing channel reform goods caused by factors, production and sales in 2016 fell by 70% and 53% respectively. As a pillar of the company, its paediatric products fell nearly 60 per cent in 2016, while profitability continued to decline in the first quarter of this year. 

 

The incidence of adverse reactions in children was higher than that of adults 

 

Xiao-ling wang, director of the Beijing children's hospital affiliated to the capital university of medical sciences, pharmacy department in the 2016 children's medication safety investigation report released has said the lack of children's drugs including drug shortages, insufficient information and pediatricians, children's drugs. Medicine for children with insufficient information, for example, according to the Beijing children's hospital in 2011, according to the drug administration department of the related subject in the national 15 large pediatric hospital pediatric medicine directory, a total of 1098 kinds of medicine, in which only 45 kinds of medicines for children. Of the remaining 1,053 drugs, there were 43 percent of the instructions for children's usage. There are also limited available dosage forms for children. This 15 children's hospital pediatric medicine directory, dosage form for injection, tablet, oral solution is only 21, for children dosage forms, such as syrups, very limited. 

 

Another problem is that the safety of children's use of drugs is closely watched in the context of the long-term use of children's drugs and the reduction in adult standards. According to the China rehabilitation research centre for deaf children, according to our country existing in children under the age of 14, about 30000 children each year for drug use undeserved cause deafness, liver and kidney function, nervous system damage is also common consequences of drug use in children. According to the 2012 document "the role of hospital pharmacists in the rational use of children," it shows that about 7, 000 children die every year in China from drug errors. Xiao-ling wang believes that children's drug shortages and the shortage of pediatricians, lacking the ability to lead to terminal services, compared with adults, children's drugs improperly consequences is more serious. According to the data, the adverse reaction rate of children in China is twice as high as that of adults. 

 

If the clinical practice is not regulated, the drug companies should enter cautiously 

 

In the context of good policy, the market for children's medicines also has a demographic dividend. From January 1, 2016, the "total two children" policy effect, according to the national bureau of statistics data, 2016 new born population of 18.67 million in China, compared to 2015 increased by 11%, increased by 1.91 million, total 2016 new born population 45% of contribution from the second child of the family. 

 

Shi Lichen thinks that the policy is good, under the influence of demographic dividend, children's drugs market did in the important opportunity of development, but the existing custom specifications. For a long time, the practice of drug use in the clinic has been developed in accordance with the principle of reduced use of adult standards. "This is one of the important factors. Children's medicine market rise should be like 'resistance to limit" (limit of antibiotics use), with administrative means to regulate children's drugs, such as some medicine can only be used with children." 

 

The resistance to limit ", refers to the government level through policy limit in the clinical use of antibiotics, which in August 2015, published by the state development planning commission, the state administration of traditional Chinese medicine "on further strengthening the management of clinical application of antibacterial drugs notice, including regulation, physicians prescribe exceptional antimicrobial drugs and more than 3 times without justifiable reasons, ChuFangQuan can be limited. 

 

"In children's medicine market to really rise, encourage research and development level, the lack of the law on the compulsory execution of drug use level, this is not a long-term solution." Shi Lichen argues that under the existing drug habit, children's medicine still lack of competitiveness in bidding and pharmacy, if the habit cannot specification, enterprises should also be careful into the children's medicine domain. 

 

The children are given a small dose of medicine 

 

Don't cheat children with sweets or snacks 

 

Children are resistant to taking medicine, and parents can try to encourage them, such as putting on TV or playing games with their children. In addition, you can also use some feeding tools to help children take the medicine, such as a medicine spoon, a medicine dropper, and a needle tube. 

 

It is important to note that in a given drug, cannot coax child medicine is candy or other snacks, because sweets or snacks to the body damage is relatively small, while the drug will have certain side effects, even can cause poisoning, so parents should give children instill the notion of ill go to a doctor, let him understand drugs will not harm him, but to help him back to health. 

 

It is worth noting that because the digestive system of children under the age of 1 is not fully developed, the gastrointestinal tract is more sensitive and prone to drug stimulation and vomiting. Vomiting is usually a few minutes to an hour after the baby has taken the medicine, and the drug is not yet absorbed or absorbed in a small part of the gastrointestinal tract. And there is a wide range of safe doses for children, and they can be replenishing.