How to protect children's medication safety

The safe use of children has long been a topic of concern in public opinion. Many of the common drugs on the market today do not have specialized children's dosage forms, which brings hidden dangers to children's drug safety. Industry insiders call that the whole society should pay attention to the development and safe use of children's drugs, develop and produce more drugs suitable for children, and ensure the availability and safety of children's medications.

In recent days, reports of childcare violations by children in individual areas of China have collectively taken prescription drugs for children, raising concerns about the safety of infant drug use. At present, what is the production and R&D of children's drug use in the pharmaceutical market in China? How to reduce the safety risk of children's medications through standardized production? The reporter interviewed related experts on the above issues.

On March 30th, the reporter visited a number of pharmacies in Beijing and discovered that many of the various types of pharmaceutical preparations currently on the market do not have children's dosage forms. There are only dozens of specialized children's medicines. In this regard, Ms. Fu Ying profound experience, "the last three-year-old son had a fever, the hospital opened three kinds of drugs, are adult drugs, all rely on 'chicken' to control the dosage." Ms. Fu said Compared to adult medicine, children use very little drugs. In addition, the reporter also learned that due to the limited variety of specialty drugs for children, many mainland parents purchase infant and infant drugs from Hong Kong and other places. Hong Kong pharmacies like Bao Ying Dan, intestinal pain, and children's Jianweibao often sell out of stock.

The data shows that out of more than 3,500 chemical preparations in China, only 60 (including proprietary Chinese medicines) for children are used, accounting for about 1.7% of the total pharmaceutical preparations. Shen Kunling, deputy dean of the Beijing Children's Hospital and chairman of the Pediatrics Section of the Chinese Medical Association, said that from 2011 to 2013, a survey of domestic drug use among children in Beijing Children's Hospital of Beijing Medical University showed that there were 6020 kinds of drugs in 15 medical institutions. (Not including proprietary Chinese medicines) For children's medications, only 45 children-specific drugs are used. Among the 1098 pediatric drugs used in 15 units, only 47.3% had children's medication information (usage and dosage).

"The types of drugs used by children are limited, and they basically focus on treating fever, cough and gastrointestinal diseases, and there are also less dosage forms and specifications." Gu Qinglong, director of the Otolaryngology Department of the Capital Institute of Children's Studies, told reporters that so far clinical drugs for children are mostly adult drugs. The reduction, there is no data for children's clinical trials, is often accumulated after years of experience in adult medicine, and then try to use children. In particular, it should be noted that most of the drugs do not have information on the use of drugs for children under six months of age. This means that the use of drugs for children under six months is almost entirely based on the experience of doctors. This is a considerable risk. Once a problem arises, it is difficult to pursue accountability.

Gu Qinglong said that children as a special group are in the stage of growth and development. The development of liver and kidney functions, central nervous system and endocrine system is not yet complete. The pharmacokinetics and pharmacodynamic characteristics of drugs in their bodies are different from those of adults. The drug metabolism, excretion and tolerance are poor, and the incidence of adverse reactions is high. At the same time, children have different medication characteristics at different stages of growth and development, and there is great uncertainty. In addition, the accuracy of the manually resolved drugs is poor, and their stability is also degraded. Therefore, it is important to choose the right medicine, proper dosage form and appropriate dosage for children.

Children's medications are administered in adult doses or they have to be used in excess, which poses a greater safety and health risk. According to statistics, child deaths resulting from abuse, accumulation poisoning, and overdose account for 55.56% of pediatric deaths. In addition, according to incomplete statistics, of the more than 6,000 pharmaceutical companies in the country, only about 10 specialize in the production of children's drugs, and there are only 30 companies that include children's drugs in their products. Speaking of the reasons for the slow progress in the development of drug use in children in China, Gu Qinglong believes that the high cost, time-consuming, high-risk, heavy-duty, and other difficulties have caused the company's production enthusiasm to be low. Especially because of the ethical limitations, our country's new drugs do not first conduct clinical trials on children. With the difficulty of obtaining informed consent and taking blood, many medicines in China do not have children's drug test data.

To better develop children's drug use, the state should establish a set of mechanisms for the study, evaluation, development, production, and use of children's drug use. Gu Qinglong suggested that the government introduce a policy to open up a green channel for the development of children's drug use under the premise of strictly controlling the quality of drugs, and effectively speed up the development and marketing of children's drug use in China; organize relevant national technical units, medical institutions, and research institutes. Drug companies conduct special studies on children's drug research and development, registration review, clinical trial management, etc.; study comprehensive incentives for children's drug use in bidding, pricing, and medical insurance; and establish a national pediatric drug clinical trial collaboration network for children in China. The new drug certification medical information; the establishment of the National Children's Adverse Drug Reaction Monitoring Center to monitor the long-term application of drugs in children in a large number of security, and to achieve data sharing.