Ensuring the safety of children's medication has become a commonplace topic, and all sectors of society have called for many years. It is undeniable that in recent years, the examination and approval system for children's medication in China has been continuously improved, the safety of children's medication has been continuously strengthened, and the level of pediatric medication has been continuously improved. However, due to the late start and weak foundation of the construction of children's medication in China, children's medication still faces problems such as less varieties, less dosage, less specifications and insufficient clinical research data. Statistics show that the supply of drugs for children in China is seriously insufficient. At present, more than 90% of drugs in the domestic market do not have children's dosage forms, and less than 2% are special drugs for children; Among the more than 4,500 pharmaceutical companies in China, there are less than 10 companies specializing in children's R&D and production, and there are only more than 30 companies that produce children's medicines, especially those that only focus on children's medicines. There are still some phenomena in children's medication, such as inaccurate dosage, insufficient relevant information, single variety and specification of drug dosage forms, and lack of product packaging, which have become a "roadblock" for children's medication safety in China.
Due to the lack of special drugs for children, doctors can only reduce adult drugs according to children's age and weight. The general "adult" of children's medication makes it difficult to guarantee the safety of children's medication, and also lays a hidden danger for the health and safety of children patients in China. According to statistics, about 30,000 children in China are deaf and dumb every year due to improper drug use, and the damage to liver and kidney function and nervous system is difficult to count.
The reason for this phenomenon is that there is a short supply, which leads to a gap in children's medication. The main reasons for the shortage of children's drugs and dosage forms in the domestic pharmaceutical market are the difficulty in research and development, the lack of clinical data, the difficulty in carrying out clinical trials, the high cost and the small profit margin. Especially compared with adult drugs, children's drugs have small market, low profit, high risk and great responsibility, which leads to the low enthusiasm of pharmaceutical companies to produce children's drugs.
The dilemma of children's drug use affects hundreds of millions of families, and it is also an unavoidable problem in deepening medical reform in China. Therefore, to ensure the sufficient and safe supply of drugs for children, we must find the crux of the problem and improve and deepen the supply reform. Admittedly, the drug policy for children has improved in recent years, but overall, it is still not attractive enough. In practice, although there are some preferential policies for children's medication, there is a lack of mandatory provisions on drug procurement and pricing, and the consistency, systematicness and accuracy of the policies need to be improved.
Therefore, it is particularly urgent to ensure the safety of children's medication from the legislative level. Learn from the practices of the European Union, Japan, South Korea and other countries, speed up the establishment and improvement of corresponding laws and regulations, promote the research and development of children's medication, and ensure the accessibility and safety of children's medication in China. At the same time, improve the circulation management system of children's drugs market according to law, control the quality and safety of drugs, standardize the instructions of children's drugs, and guide parents to use drugs rationally.
Specifically, it is necessary to establish a complete security system through legislation. On the one hand, actively play a leading role and fill in the shortcomings of the system. We should attach great importance to the research and development of children's drugs from the perspective of national security development strategy, and establish supporting policies and measures to encourage the research and development and production of children's drugs, such as setting up a special research fund for children's drugs to provide technical guidance for the research, evaluation and approval of children's drugs; Establish an exclusive period or an extended period for the market of children's drugs and new drugs to protect the enthusiasm of enterprises for research and development; Give financial subsidies or tax relief and other industrial support policies to outstanding children's drug production enterprises.
On the other hand, it is necessary to speed up the review of children's drug registration applications and establish a special channel for declaration and review; At the same time, cooperate with the drug pricing and bidding departments to study and formulate relevant support and guidance policies, give play to the guarantee function of medical insurance for children's medication, and timely include the dosage forms and specifications suitable for children's medication into the basic medical insurance payment scope according to regulations.
It is suggested that relevant administrative regulations should be issued as soon as possible to regulate children's drug use behavior, and it is mandatory that certain drugs can only be used in children's wear, and the old habit of "reducing the number of children by adult standards" cannot be continued. Only in this way can the safety of children's medication be effectively guaranteed.
(Author: Liao Haijin, Deputy Secretary of the Party Committee of Yushui District Market Supervision Bureau, Xinyu City, Jiangxi Province)