Medical network - July 7 for a long time, because of a shortage of children decongestion, many children in the medicine are being treated as a "smaller versions of adult", according to the principle of "reduction" pediatrics take adult medicine, there are great safety hidden trouble. According to the white paper on children's drug safety survey 2016, about 30,000 children in China are deaf every year due to improper use of medicines.
What are the short boards for the development, production and promotion of children's special drugs? How to make up for it as soon as possible? To mobilize the enthusiasm of scientific research institutions and pharmaceutical companies, let them look at children's patients, how can policies be made? Our reporter investigated this.
- Ed
The dosage of children's medication is difficult to determine, the instruction information is blurred
The proportion of children under 2 years old is less than 2%, and the proportion of children under 2 years old is not high. Only 47% of the instructions were used for children's usage
"What do you mean by a child's discretion? How much less?" Many parents have this problem when they take their medicine. A large number of drug manuals on the market are not labeled "children's use" and only a vague "child's reduction". Either you don't take the medicine, or you can only estimate it. Tablet, a pill breaks into two or even four...
"Children's discretion" is also a problem for pediatric pharmacists. Their "cuts" can't be arbitrary, they need to grind the tablet into powder, and each dose of it can be used to give children younger, especially newborn babies. However, the effect can be affected by the release of the tablets, the powder of the intestines, or the opening of the capsules.
Affiliated to the capital university of medical sciences, the temple of heaven, Beijing hospital authority always pharmacists frank zhao, director of the cqi, said children less clinical application in our country, the domestic plants with the approval number about 180000, more than 3000 children's drugs, accounted for less than 2%, only involving more than 400 varieties. That's not enough for the country's 220 million children and 12 percent of the population.
Suitable dosage forms and specifications for children are very scarce, especially for young children and newborns. "Has been approved for listing on the market at present the number of children apply medicine about more than 1400, the overall look, children can meet the demand of clinical drug varieties, but there is a lack of appropriate types and specifications, manual medicine information lack of children, children's special drug problems such as less than developed countries." The director of the national health and family planning commission said.
Affiliated to the capital university of medical sciences, Beijing children's hospital, according to a survey of 231 children used prescription drugs, dosage form in the first three injection, tablet and oral liquid, and is suitable for children of dosage forms, such as powder inhaler, suppositories, syrup is very little.
Drug instruction is an important basis for parents to give their children medication. However, the lack of information or lack of information and the broad content of the content have caused a great deal of confusion to parents, and even if they want to wear the powder, it is difficult to determine the dosage. Children's hospital, a pharmacist who done led the country for pediatric drugs commonly used specifications subject, from the base directory and 15 pediatric hospital pediatric drug directory to select 341 varieties, compared the two instructions the same variety of domestic and imported drugs. Marked "children" in the domestic children's medicine, indications of the manual is only 7.97%, with children's biggest dosage, treatment course and the usage of newborn babies, dosage of only 47%, children's usage, dosage of ambiguous species accounted for 2.93%. In addition, there are problems such as children's adverse reactions, inappropriate labeling of children's taboos, and disunity of location.
The reasons for the above mentioned problems are analyzed by experts, and the first is the imperfect management of the information on drug use in the instruction of medicines in China, including the lack of guiding principles or guidelines and lack of enforcement. Secondly, there is no unified template to guide the enterprise; Third, because the drug did not carry out the child clinical trial, causes the child to use the data to be deficient, there is no the "children's medicine information database" that can be used in the country, the hospital reference.
Only 0.1 per cent of companies specialise in medicines for children
Children's organs are not mature, the characteristics of the disease, the process, the absorption mechanism and compliance of drugs are different, the r&d and production costs of drugs are high, and the production enthusiasm of enterprises is not high
Because of the lack of children's use, dosage, children's use of drugs, the risk of adverse reactions in children is higher. According to zhao, the rate of adverse drug reactions in China is 12.9 percent, while the number of newborns is 24.4 percent, 2 times and 4 times higher than in adults. National food drug safety administration of adverse drug reaction, according to a report released recently 2016 report the number of children under 14 years old (including) accounted for 10.6% of total report, including severe adverse reactions accounted for 5.5% of total children report report.
Why are there so few special medicines for children? Analysis by the special researcher of the department of staff of the state council:
First, there is a lack of the relevant institutions of regulation and use. On children's drugs listed in food for examination and approval of the agency, policy management in the health sector, clinical use in medical institutions, reserve management in the ministry departments, each responsible for a while, regulations, standards don't match, not unified, have a disconnect.
The second is the risk of clinical trial process, which affects the clinical development of new drugs. "Baby, who is willing to take their children to do drug clinical trials? This is also serious problems in the children's medicine industry in the world. In developed countries, is the premise of clinical trials and volunteers signed the informed consent, for the insured accident insurance and necessary economic compensation, research and development that the biggest spending." Pharmaceutical companies say that they want to complete the data collection of clinical trials and need other relevant work to follow up.
Third, the market of children's drug use is not high, the drug companies profit low, the production enthusiasm is not high. At present, the number of children in China, the amount of medicine that gets sick every year is roughly stable, and the size of the market for children's medicine is not very large. Children not adults, a smaller version of the organ is not mature, the clinical characteristic and the process mechanism of drug absorption, compliance, need special formula, preparation and taste, makes the drug research and development production process, the cost is high, more leading companies reluctant to engage in the r&d, production and sale of children decongestion.
In order to encourage enterprises to produce special medicines for children, China has made it clear that non-patented drugs can be purchased directly from the Internet. Medicine for children but at the moment, some places still requires "a net at the lowest possible price, shall not be higher than purchase price history", companies are reluctant to do business at a loss, of course, as a result of myrrh is available, this is also the reason of children an important drug shortage.
According to data from the China pharmaceutical industry information center, there are 8,812 pharmaceutical companies in China, with only 0.1 percent of the companies specializing in the production of medicines for children. In the registration of drug clinical trials, the registered information of domestic drugs reached 165,151, of which only 2,698 were children's medicine, accounting for 1.63%. Only 2.35 per cent of children's medicines are registered in clinical trials, compared with more than 20 per cent in developed countries such as the us.
In the study, scholars have found that there is a general lack of pharmacokinetic data for domestic children's drug manuals, and even if there are, there are many foreign children data. In some domestic drug instructions, the children's clinical trial data are basically copied and imported into the original pharmaceutical instruction manual. "However, there is a difference between children and adults and children of different ethnic groups. It is necessary for Chinese children to have clinical trial data to make their efficacy more accurate. Our clinical data is far from enough." Experts say.
We will encourage special research and development to establish a comprehensive evaluation system for clinical drug use in children
71 have been published to encourage research and development declaration and establish a special channel for the declaration and evaluation; To explore the use of imported children's medicines; Establish a clinical database to facilitate the docking of clinical and r&d production requirements
Medicine for children in order to solve security problems, encourage and support research and development of enterprises, in May 2014, the state development planning commission and other six departments issued "several opinions about guarantee children's drugs, on the one hand require drug manufacturers to timely supplement improve children's clinical trial data, on the other hand to speed up the use of foreign listed but lack of domestic children's medicine to declare the review process.
Since last year, the health development planning commission, ministry of industry and food drug safety administration announced two batches of encourage r&d declare children drug list, a total of 71 varieties, and to the "listing" drugs through the establishment of clear, according to the review of special channel in Hong Kong, Macao and Taiwan regions have been used for years, clinical curative effect is good and it is safe to use, but not listed on the mainland children need drugs, explore import using pilot, in the drug registration review import children allow direct references to Hong Kong, Macao and Taiwan area children clinical medication data as a declaration of the basis, to speed up the review for approval. In addition, through the national "major drug discovery" major projects of science and technology, biological medicine and vaccine major innovation and development of protein engineering, integration of collaborative innovation advantage unit, guide and encourage enterprises to research and development production. In terms of guaranteeing the production supply, the corresponding children's drug production enterprises will be supported by the policy, which will promote the product upgrading and the technological transformation of the production line.
Ni xin, dean of the Beijing children's hospital, has led a major new drug initiative, the development of children's drug use and key technologies. According to the characteristics of the children's drugs and clinical requirements, the production, study and research, medical combination, develop children's common disease, frequently-occurring disease, a rare disease such as clinical medicine for children in urgent need of the innovation of the preparation and dosage form. It is a good idea to lead the development of children's medicine by clinical hospitals, which will facilitate the docking of the needs of clinical and research and development production, and produce drug dosage forms and specifications that are more suitable for children.
Recently, nine ministries jointly issued by the perfect shortage drug supply security mechanism on the reform of the implementation opinions "clear, the demands for key crowd clinical medication, the establishment of national, provincial shortage of two levels of drug inventory management system, step by step implementation departments shortage drug listing information linkage, within the organization to carry out the listing medicine clinical evaluation, constantly optimize the listing, realize the dynamic management of shortage list. The research and development, production, circulation, use, reimbursement and other supporting policies of children's medicines have been decided, and the next step is to cooperate and implement them in collaboration with various departments.
"Children's organ function is immature and the distribution of drug absorption is different from that of adults. The lack of information about children's medication is a common problem in the world." Shen kun ling, a member of the commission on children's drug use, noted that too little has been done in the past to build children's drug databases. "Drug authorities should timely summarize experience and data, form a medication guide, establishes a comprehensive evaluation system of children in clinical medicine and clinical database, improve the level of clinical rational drug use, at the same time that drug companies can share resources such as data from the advantages of the unit, make the drug research and development enterprise of pharmaceutical standards, some lower development costs."
The reporter was informed that the state had entrusted the relevant institutions to undertake the above work. Experts believe that support for children's use of drugs will soon be alleviated. |
