Children's medication problems urgently need to be solved

In mid-March, the original Ministry of Health announced a new edition of the National Essential Drug List. After reading this list, Henan's doctor Yan was somewhat disappointed.

"There is no improvement in the lack of children's dosage forms." Dr. Yan expressed his concerns on Weibo.

After comparing the old national basic drug list, Dr. Chu found that the newly published basic drug list is still the same as before in the children's drug types. There are more antibiotics and proprietary Chinese medicines, more children's dosage forms, and several antipyretic analgesics, but Almost no other kind.

"Sedative, anti-epileptic, anti-allergic, cardiovascular, corticosteroids, and other more commonly used drugs, almost all children do not have type." Hey said.

This is not only a physician's concern. At the two sessions this year, several members of the National Committee of the Chinese People's Political Consultative Conference (CPPCC) from the medical and health care system reminded that the whole society should pay attention to the shortage of drugs for children.

According to data provided by Liu Yinglong, member of the National Committee of the Chinese People's Political Consultative Conference and director of the Anzheng Hospital's Pediatric Cardiac Center, there are more than 3,500 kinds of western medicines in China, but there are only 60 kinds of children's dosage forms. Children's medications are problematic.

Children in China account for 20% of the population, but children’s medicines only account for 2% of drugs.

Children's medication is not a reduced version of adult drugs. The National Committee of the Chinese People's Political Consultative Conference (CPPCC), deputy dean of Tianjin First Central Hospital and director of ophthalmology Sun Fengyuan brought the problem of shortage of children's medication to the two sessions of the country.

At this year's National Conference, in the face of many senior officials including the former Deputy Minister of Health and the former Deputy Director of the State Food and Drug Administration, Sun Fengyuan spoke of the plight of children's medication.

"In our clinical use of drugs, children's medication is a big problem." Sun Fengyuan said that there are very few prescriptions and specifications for medicines specifically designed for children. There is no way but to divide adult medicines into 1/4 and 1/8. Then take it for children. The problem is here. Children respond quickly to medicines. If the dosage is not accurate, there will be many risks. How can the safety of children's medications be guaranteed by the fact that nurses only cut pills?

In Sun Fengyuan's view, the shortage of children's medications does not mean that there is a shortage of medicines. Currently, the types of medicines on the market can basically meet the demand. However, there are very few medicines and dosage forms for children.

The question of Sun Fengyuan’s headaches has caused a lot of enthusiasm among the first-line doctors.

Liu Yinglong said that because of the lack of children's pharmaceutical preparations, the Ahn Jung Hospital where he was staying gave each child medicine every time. The nurse used a big pair of scissors to cut adult tablets into 1/4, 1/8, or even 1/10. "The medicine itself is very small, and cutting it into more pieces will become a technology."

In Anzhen Hospital Pediatric Cardiac Center, many children with congenital heart disease were admitted. Many children are only a few months old, but those children who are several months old should also use adult medicine.

"It is not only unsanitary for nurses to use scissors to dispense medicine to children, but it is difficult to achieve accurate doses," said Liu Yinglong.

There was once a grandson of a member of the National Committee of the Chinese People's Political Consultative Conference (CPPCC) who was sick. According to the doctor's advice, the tablets were cut into small pieces before they were taken. The CPPCC member went back home and tried several times, but every time he did not cut it well, he called the health department and complained that he did not even know how to cut the pills and could not make the grandson take medicine.

"It is not just the problem of children's drug use and the lack of dosage forms. Our drug companies do not consider children for comfort in their use of drugs. Existing children's drugs are bitter, and children are particularly strenuous to eat." said Liu Yinglong, a child. Not to be inferior to adults, there is a lack of endurance to the bitterness of medicines and it is necessary to improve the taste. In foreign countries, children have apple-flavored, orange-flavored foods, etc. They have good taste and are easy for children to eat. It seems that companies in China that produce drugs for children are not paying enough attention to this issue.

In the ward of the pediatric cardiac center of Anzhen Hospital, it is very difficult for children to take adult drugs that are cut. Because the taste is very difficult to eat, children may easily vomit after eating, causing aspiration, which in turn increases the burden on the heart and lungs. Liu Yinglong told reporters that once parents had feedback to the hospital, they said that in order to allow the children to take medicine smoothly, they tried to add medicines to juice and milk, and the finding was still unsuccessful. Even if you add these things, the taste is still very bad. "A strange smell, the children are more difficult to swallow."

In the eyes of many parents, this can only be an accepted fact, reducing adult drug use to children as much as possible. However, in the eyes of professionals, such practices pose potential risks to children.

Yao Ke, vice president of Yabao Pharmaceutical Group, told reporters that children's growth and development are not yet mature. Physiological structure and body environment are different from those of adults. The absorption, metabolism, adverse drug reactions and organ damage of drugs are also different from those of adults. The traditional method is to use adult medicine according to body weight to reduce the use of children, lack of scientific evidence and evidence based evidence.

In the past two years, there have been children's drug safety incidents such as nimesulide and children's cold medicine containing amantadine hydrochloride, all of which have caused severe adverse reactions in children.

Last year, according to data from the Center for Adverse Drug Reaction Monitoring of the Ministry of Health, hundreds of people died each day from poor medications in China, including 32% of children.

Why pharmaceutical companies do not pay attention to child-specific drugs Actually, the shortage of drugs for children is no longer a new problem. As early as five or six years ago, many doctors had already called for a solution to this problem. However, the problem of shortages has not been solved for several years.

An executive from a foreign drug company told reporters that she has served in several large pharmaceutical companies in the United States, Europe, and Japan. But it is strange that the pharmaceutical factories she worked for did not seem to have paid special attention to children's medicines. R & D and investment.

“Pharmaceutical companies basically have four directions in choosing their own input fields.” The above executives told reporters that the first is the area where the drug companies are good at, followed by the diseases that have not yet been cured, and once again the unsatisfied The medical needs, and finally, there are a lot of drugs, but the patient population is very large. Children's medications are difficult to enter the pharmaceutical factory's line of sight in these areas.

Some members of the National Committee of the Chinese People's Political Consultative Conference (CPPCC) visited many drug manufacturers with this problem. The answer was that the children's drug market is small, R&D, investment, approval is complex, and there is no policy support.

Yabao Pharmaceutical Group is a company specializing in the production of children's drugs. Tang Ke, vice president of the group, told reporters that the market size of children's medications is very limited compared to the adult drug market, especially the elderly chronic drug market.

There have been research institutions estimating that the annual demand for children's drug use in China is around 50 billion yuan. On the surface, the market size is not small, but this market is different from the adult drug market.

A researcher at a drug research institution told the reporter that children are instinctively unstable during their growth and development, their sickness cycle is relatively short, their unique diseases are not many, and the seasonality of many childhood diseases is very strong. . This has caused the children's drug market to be very unstable. It is probable that a child's drug will be sold steadily in a certain season, but after that season, the probability of a child's illness will be greatly reduced and the drug will not be sold.

Market instability is only a relatively secondary reason. The more critical reason is that the development of children's medicine has encountered medical ethical issues.

“General drug development and marketing must be conducted in human trials, clinical trials must be done, and adverse reactions should be controlled within a reasonable range before they can be listed. However, human trials of children taking drugs have been opposed by many people and no one is willing to take this risk. "The above-mentioned researchers told the reporter that this problem has been a problem that has plagued children's drug development for many years and is very difficult to solve. Which parents are willing to let their children do the guinea pig medicine?

This is a headache. In the public perception, children cannot be accepted as volunteers for drug testing. But on the other side of the matter, it is because of the inability of effective human trials of children's medicines that all children are forced to become drug testers.

The former director of the State Food and Drug Administration, Li Yin, said in an interview that the physiological conditions of children determine that clinical trials face more ethical obstacles. He said that some adult diseases, such as hypertension, obesity, diabetes and other chronic diseases will appear in childhood. None of these treatments are new compounds, but for children to be treated, it is necessary to conduct human trials in children and find suitable doses. Parents want their children to have medicinal properties, but they are reluctant to participate in experiments with their children.

Ethical barriers, market instability, followed by a sharp rise in R&D production costs.

Tang Ke told reporters that the development and approval of children's medicines are more difficult than adult medicine, more difficult and costly. The market for children's medication is limited, and the ratio of input to output is higher than that of adults. Clinical trials are difficult, and implementation is complicated, resulting in slower approval and longer approval cycles. Children's medications need to be suitable for children's dosage forms and tastes, which requires more research and development and production. cost.

In Tang Ke’s view, focusing on the development and production of children’s drug use, it is not always possible to compare which drugs are more profitable. Now Yabao Pharmaceutical Group's product line is mainly focused on children's digestion, respiratory medicine and nutritional products. Only products that continue to expand pediatric drug use can fully utilize and integrate the company's own resources, channel resources, and brand resources to achieve ultimate profitability.

However, for most drug manufacturers, this account needs to be carefully calculated. Several difficulties have been calculated, and there are few pharmacists who have the guts to develop drugs for children's drug use. Most companies often choose to make money for adult drugs, chronic diseases drugs for R & D and production.

Children's medication outlets A researcher at a pharmaceutical research institute told reporters that the living standards of the Chinese have improved, and the probability of children suffering from infectious diseases and parasitic diseases has been greatly reduced, but at the same time children's physical activity has been greatly reduced, resulting in the current resistance of children themselves. The force drops. On the other hand, the current parents’ tolerance for children is also decreasing. The two aspects of the reality put forward higher requirements for children's drug development and production.

However, the difficulties facing pharmaceutical manufacturers have not diminished.

The manager of a pharmaceutical production company once told reporters that according to some regulations, the pricing of children's medication is based on equal pricing method. Suppose a 0.5 gram adult uses aspirin to sell 1 cent, and a 0.05 gram child uses aspirin. It can sell 1 cent, but the processing of the two production lines is exactly the same, and the production cost of pharmaceutical raw materials is not much different.

At the two sessions this year, many members of the Chinese People's Political Consultative Conference (CPPCC) proposed that relevant departments should make policy decisions regarding the R&D and production of children's drugs.

Sun Fengyuan even suggested that government departments or national research institutes should invest in the preliminary study of children's pharmacy type, and then study the molding and then transfer them to the production enterprise to solve the problem of children's pharmacy shortage.

Yin Li acknowledged in an interview that China's current pharmaceutical manufacturing enterprises for children have insufficient guidance and encouragement in policies, and enterprises lack input in this regard. But he does not think this is an unsolvable problem. His idea is to actively increase the application of children's dosage forms in the development of new drugs, and it is recommended to give priority to the use of medicines in bidding and procurement.

In February of this year, the former State Food and Drug Administration issued the "Opinions on Deepening the Innovation of Drug Review, Approval, and Reform to Further Encourage Innovation." This opinion mentioned that in the future, children's drug use should be given priority approval and enterprises should be encouraged to research and develop drugs for children.

At the two sessions of this year, Jiao Hong, member of the National Committee of the Chinese People's Political Consultative Conference and former deputy director of the State Food and Drug Administration, told reporters that the R&D power of children for drug use by enterprises is not enough, and the management of clinical standards is not good enough. The lack of relevant policies has led to many drug manufacturers. Without strength and unwillingness to produce, the problem of children's shortage of drugs has not been resolved.

“The drug regulatory department has already issued encouragement policies. However, after limited approval, companies are willing to be unwilling to produce, how to price products, and how to go public. They also need multiple departments to introduce supporting measures. Through the cooperation of various departments, the development of children’s drug use can be promoted. Production." Jiao Hong said. Source China Youth Daily.