How to make children's medicines

Children take medicine basically rely on "掰" and "Irrigation"

Liu Ying’s daughter, who was less than two years old, repeatedly had a high fever. She sent her child to a local hospital. However, she was diagnosed as “bacterial infection” by the night doctor after the blood test was normal. Separated by half an hour to eat, plus two kinds of anti-fever medicine, equal to feeding the baby to stop taking medicine from day to night." Liu Ying said.

Liu Ying’s children faced “hard irrigation” and quickly developed a cough response, vomiting almost all of the hard-to-drink medicine. “Seeing the child suffer, the parents are both anxious and sad.” Liu Ying said, “At that time, I think it would be better if the medicine for children is better."

In the case of Wang Tao, a citizen of Jilin City, Jilin Province, his 10-year-old daughter's minor illness also caused him to worry about these two days: When doctors prescribe drugs for their children, a western medicine can only take one tablet at a time. After returning home, Wang Tao couldn’t cope with tablets less than 1 cm in diameter. “How can this be awkward? Also, does the simple 'half reduction' take into account the child’s own physiological developmental characteristics? Will the medication be severe? Side effects?” said Wang Tao.

Wang Song, chief physician of the Children's Hospital of Jilin City, Jilin Province, said that the children's body has not yet matured, and the tolerance and response to drugs is different from that of adults. In fact, the choice of drug for children needs to take into account the characteristics of human development in different age groups from variety, dosage form and dosage, and it is not possible to refer to adult drug use at will.

At present, many types of pharmaceutical preparations that are common in the market do not have children's dosage forms. After children's illegal use of prescription drugs occurred in kindergartens in some areas of our country, the safety hazards in the children's special drug fields have attracted widespread attention. Experts suggest that while severely penalizing non-compliance kindergartens, the supervision and registration system for professional children's medicines in China should be improved as soon as possible.

High clinical cost is difficult to market new drugs

Xu Zhong, director of pediatrics at the Second Hospital of Jilin University, said that at present, most of the medications for pediatric patients use the “transformation by weight” method. "Some people need to take 1 milligram of a kilogram of body weight, some of them are 5 milligrams. This principle is regulated by the Pharmacopoeia, and besides serious illnesses, it is necessary to calculate a little more or less often without causing any harm to children." Xu Zhong said, "However, over 90% of prescription drugs are not professional children's dosage forms. I hope similar circumstances can change."

In stark contrast to the expectations of doctors and parents of children, at present, China's specialized manufacturers of children's drugs still remain in single digits. Expert analysis of the pharmaceutical industry believes that the current situation of child-specific drug shortages is mainly caused by three factors: first, the current difficulties in the clinical trials of children's drugs; the level of clinical trials is reduced due to the difficulty of recruitment of children's subjects; followed by the development and production of children's drugs The investment is extremely high, but the profit is relatively low, and the driving force for pharmaceutical companies is small. Third, the regulations for children's use of drugs in China are missing, and the registration and supervision of children's drug use is currently impossible.

Yang Jie, general manager of Shandong Dain Marine Biopharmaceutical Co., Ltd., said that neither the Chinese Drug Administration Act nor its regulations nor the current drug registration management practices have put forward any special regulations for children's drug use. That is, children have been treated with drugs in laws and regulations. As a result, registration and supervision of children's drug use in China are free from special regulations. The law that lacks a risk benefit evaluation system is obviously inadequate for the protection of children groups.

Xu Zhong emphasized that the current difficulty in recruitment is also an important reason for children's specialty drug innovation being blocked. “The vast majority of children are now only children, especially Jin Gui. Even if a pharmaceutical company wants to do clinical trials, the parents of children are sure. Reluctant to accept." Xu Zhong said, "The clinical needs of pharmaceutical companies require multiple participants, let alone to do clinical trials, that is, we usually pump blood to check all parents are always guilty, and go on like this. It is actually very difficult for enterprises to obtain first-hand information on children's subjects."

Experts: Efforts to Improve Children's Pharmaceutical Creation Environment

Yang Jie said that compared to adult drugs, children's drug formulations, accessories and other technical indicators of high technical requirements, the process is relatively complex, companies in research and development, production and other aspects of the input of human, material and time cost is high; In addition, the respiratory tract, digestive tract Children's diseases such as diseases are seasonally strong, so how to solve the problem of idle production lines in the off-season and ensure that companies can make money all year round, which is of great significance for pharmaceutical companies.

In response to the difficulties of drug companies, Xu Zhong suggested that relevant departments should give necessary promotion policies in the areas of children's drug R&D, production, circulation, use, pricing, and tendering. In addition, they should also pay attention to the protection of intellectual property rights and improve drug companies' creation of new children's medicines. Enthusiasm.

“In addition, the relevant regulatory authorities should fully meet the public’s right to information and explain the reasons why China’s children’s pharmaceutical products are inconsistent with the standards of Western developed countries.” Xu Zhong said, “In this way, the public’s understanding of children’s clinical trials The degree and degree of tolerance will be greatly increased. With the increasing number of clinical children in children, all children in the country will benefit."

Fu Cheng, director of the Social Research Institute of the Jilin Provincial Academy of Social Sciences, analyzed that the most important issue at present is to establish a regulatory system for children's drug registration and supervision in China as soon as possible, and to fill the regulatory gap in children's drug levels. “After the establishment of the Jianzhang system, market chaos can be regulated. If the protection mechanism for children in clinical trials is established, companies that really want to develop new drugs will be respected, understood and protected by the people.”