Legislation to ensure the safety of children's medications is urgent
【Take the pulse】
Ensuring the safety of children's medication has been a common topic, and all walks of life have called for this for many years.
It is undeniable that in recent years, the review and approval system for children's medication in my country has been continuously improved, the protection of children's medication has been continuously increased, and the level of pediatric medication has been continuously improved.
However, due to the late start of the construction of children's medicines in my country and the weak foundation, children's medicines still face problems such as fewer varieties, fewer dosages, fewer specifications, and insufficient clinical research data.
Data shows that the supply of children's medicines in my country is seriously insufficient. At present, more than 90% of the medicines on the domestic market do not have children's dosage forms, and less than 2% of children's special medicines. Among more than 4,500 pharmaceutical factories across the country, they are specialized in children's research and development and production. There are less than 10 companies, and there are only more than 30 companies that produce children's drugs, and companies that only focus on children's drugs are even rarer.
Inaccurate dosing in children's medicines, insufficient relevant information, single dosage forms and specifications, and lack of product packaging still exist, which has become a "blocker" facing the safety of children's medicines in my country.
Due to the lack of special medicines for children, doctors can only reduce the dosage of adult medicines to children according to the age and weight of the children.
The general "adultization" of children's medication makes it difficult to ensure the safety of children's medication, and it also lays hidden dangers for the health and safety of children in our country.
According to statistics, every year, about 30,000 children in my country are deaf and dumb due to improper use of drugs, and the damage to liver and kidney function and nervous system is difficult to count.
The reason for this phenomenon is that there are shortcomings in the supply, which has led to a shortage of medicine for children.
The main reasons for the shortage of children's drugs and dosage forms in the domestic drug market are the difficulty of research and development, the lack of clinical data, the difficulty of clinical trials, the high cost, and the small profit margins.
Especially compared with adult drugs, the small market for children's drugs, low profits, high risks, and high responsibilities have led to the low enthusiasm of pharmaceutical companies to produce children's drugs.
The predicament faced by children's drug use affects hundreds of millions of families, and is also a problem that cannot be circumvented in my country's deepening of medical reform.
Therefore, to ensure the adequate and safe supply of medicines for children, we must find the crux of the problem and improve and deepen the supply reform.
It is undeniable that in recent years, the policy on children's medication has improved, but on the whole, the attractiveness is still insufficient.
In practice, although there are some preferential policies for children's drugs, there are no mandatory regulations on drug procurement and pricing. The consistency, system and accuracy of the policies need to be improved.
Accordingly, it has become particularly urgent to protect children's drug safety from the legislative level.
Learn from the practices of the European Union, Japan, South Korea and other countries, accelerate the establishment and improvement of corresponding laws and regulations, promote the development and production of children's medicines, and ensure the availability and safety of children's medicines in my country.
At the same time, improve the market circulation management system of children's medicines in accordance with the law, control the quality and safety of medicines, standardize the instructions for children's medicines, and guide parents to use medicines rationally.
Specifically, it is necessary to pass legislation to establish a complete protection system.
On the one hand, actively play a leading role to make up for the shortcomings of the system.
The research and development of children's medicines should be emphasized from the height of the national safety development strategy, and supporting policies and measures to encourage the research, development and production of children's medicines should be established, such as the establishment of a special children's medicine research fund to provide technical guidance for the development, review and approval of children's medicines; The exclusive period or extended period of the new drug market for children's drugs protects the enthusiasm of enterprises in research and development; and provides industrial support policies such as financial subsidies or tax reductions to outstanding children's drug manufacturers.
On the other hand, it is necessary to expedite the review of registration applications for children’s drugs, and establish a special channel for application and review; at the same time, cooperate with drug pricing and bidding procurement departments to research and formulate relevant support and guidance policies to give full play to the protection function of medical insurance for children’s drugs. It is stipulated that suitable dosage forms and specifications for children shall be included in the scope of basic medical insurance payment in a timely manner.
It is recommended that relevant administrative regulations be issued as soon as possible to regulate the behavior of children's drug use, and it is mandatory to stipulate that certain drugs can only be used in children's clothing, instead of continuing the old habit of "adult standard child dose reduction" in the past.
In this way, the safety of medication for children can be effectively guaranteed.
(Author: Liao Haijin, Deputy Secretary of the Party Committee of the Market Supervision Bureau of Yushui District, Xinyu City, Jiangxi Province)