How to solve the problem of children's medicine

Some children's medications.

Photo by our reporter Chen Yin/Guangming Picture

Medicine is a magic weapon to save people, but if it is not used properly, it can be very harmful.

"It is a three-point drug". For adults, improper use of drugs may be harmed. If it is placed on children, it may cause more serious consequences.

According to statistics, due to improper medication, about 30,000 children in my country are deaf each year, and about 7,000 children die each year due to improper medication.

The adverse drug reaction rate for children in my country is 12.5%, which is twice that of adults, and that for newborns is four times that of adults. The drug-induced damage caused by unreasonable medication and medication errors in children is more serious.

Among children, drug poisoning accounted for 53% of all children who were poisoned in a doctor's office. In 2012, it rose to 73%.

From the age of poisoning, among the drug-poisoned children between 0 and 14 years old, children between 1 and 4 years old accounted for the largest proportion.

Behind the groups of numbers, it is not only the children who are hurt, but also the families behind them.

Children are the future of the motherland, and the importance of protecting children's medication is self-evident.

Although the pill is small, it is a matter of people's livelihood.

What should I do with children's medicine to be safe and effective?

1. "Bye", "guess" and "minus", can children use these drugs?

　　At the turn of the seasons, there is a high incidence of sickness in children.

However, giving medicine to children is a headache for many parents.

The big problem is the dosage.

　　"Oral. 15~30ml each time, three times a day, the children should reduce it." "One to three years old one sachet at a time, four to six years old one and a half sachets." These are the instructions for the two medicines.

　　Ms. Wang from Dongcheng District, Beijing, saw such instructions and said, “It’s too difficult!” “How much is the reduction? How can I accurately separate the half bag? Will more of it hurt? Will less of it hurt? The effect of the medication?" This is not a question of Ms. Wang alone.

At present, there is a widespread shortage of special medicines for children in my country, which leads to the fact that children often rely on "breaking", "guessing" and "reducing" medicines, which adds to the problem of drug safety for parents.

　　"At this stage, with the great attention of governments and society at all levels, the development of children's health in my country is actively improving, but there are also unmet medical needs for children and shortages of special medicines for children." Zhou Chongchen, director of Henan Children's Hospital In the "Healthy Chinese" roundtable forum, it was pointed out that there are still hidden safety hazards in children's medication, such as improper drug specifications, low safety, insufficient dosage forms, high incidence of adverse reactions, and inappropriate taste of children's medications.

　　Studies have shown that among the more than 3,500 pharmaceutical preparations in my country, only 1.7% of children’s dosage forms.

Since children’s bodies are in the developmental stage, their organs are immature, and their physiological structure is very different from that of adults. However, most of the medicines used by children in my country are not exclusively for pediatrics. The existing types, dosage forms and specifications of medicines available for children are available. Very rarely, there is uncertainty about its effectiveness and safety.

　　In fact, children are in the stage of growth and development, and the development of various organs and immune systems is not yet perfect. The adverse reactions and toxic side effects of some drugs often cause irreparable harm, and severely can cause disability or even death.

In recent years, with the rapid economic and social development and the adjustment of birth policies, my country’s child population will continue to grow, which has brought greater challenges to the lack of pediatric medical resources. Therefore, more specialized dosage forms should be developed for children. Drugs, so that parents no longer "difficult to use drugs."

2. I don’t want to take medicine, can I take it with milk or juice?

　　The child was crying and crying unwilling to take the medicine, and the parents couldn't bear it, so they thought of various feeding methods such as crushing the medicine for the child, eating in a reduced amount, and delivering fruit juice.

In fact, this is another potential safety hazard in children's medication-parents' lack of awareness of safe medication.

　　The survey shows that 84.9% of children's medications have potential safety hazards. Most parents lack awareness of safe medication, and irrational medication or even wrong medication frequently occurs.

For example, many parents increase or decrease the dose of the drug by themselves, and stop the drug after it gets better, and some people mix the drug in milk or fruit juice when giving the drug to the child.

　　Do parents really give medicine to their children?

Xu Xiaolin, a pharmacist in charge of the Department of Pharmacy at the National Children’s Medical Center and Beijing Children’s Hospital Affiliated to Capital Medical University, said that in order to solve the problem of children’s difficulty in taking medicine, parents think that it is very “witty” to use good milk or juice to deliver the medicine, but in fact It is not feasible to take the medicine together with milk and juice, or to take them one after the other.

For example, milk is rich in trace elements such as calcium and magnesium. They combine with certain components of the drug to form insoluble macromolecules, which may prevent the drug from entering the blood and exert its efficacy; for example, the acidic substances in the fruit juice may It will chemically neutralize with alkaline drugs, causing the drug to fail.

　　"In other words, the medicine that we took pains to help our children not only failed to achieve the goal, but also may form some toxic substances that could cause harm to the children's body." Xu Xiaolin said.

　　For lack of dosage forms, when children need to take 1/5 or even 1/10 dose, Xu Xiaolin does not recommend crushing the pills by herself.

She said that although this is a helpless move, the problem can be temporarily solved by purchasing a medicine feeder and taking accurate measurements.

Or crush the medicine, dissolve it evenly in water, and suck the corresponding amount of liquid through the medicine feeder to give the child the corresponding dose.

　　In addition, Xu Xiaolin also reminded parents to develop the habit of reading manuals.

Because the instructions are the most important reminder, "We must clarify the precautions of the medicine, such as not taking it with anything, whether it can be taken with milk, juice, etc. If there is no time or it is difficult to read, we can take the medicine. The medication consultation center of the hospital asked the pharmacist to give us an accurate answer."

3. The lack of clinical data on medication for children makes it difficult for doctors to take medication

　　For children, it is difficult not only for parents, but also for doctors.

This is because there are few drugs suitable for children, and the difficulty of clinical trials for children is relatively high. Most drugs in my country, including some drugs that have been approved for marketing for children, generally suffer from insufficient data in children’s clinical trials, which also leads to adverse drug reactions in children. One of the reasons for frequent occurrence.

The lack of data in children's clinical trials, especially the lack of data on products that have been approved for marketing, has laid a huge hidden danger for the safety of children's drug use.

　　Zhou Wei, clinical director of the Pediatric Respiratory Department of Peking University Third Hospital, said that it is very important to promote drugs to supplement children's clinical data, both before and after the drug is marketed.

To adopt children's clinical trials or other feasible methods, pharmaceutical companies should provide children-related data on supplementary drugs.

In clinical practice, for example, some generic drugs, although the ingredients are exactly the same, may have big problems when used in children.

Drugs that do not have children's data will cause great medication difficulties for clinicians.

　　In this regard, the problem of children's drug use mainly focuses on the development of children's drugs, pre-market evaluation, post-market re-evaluation and clinical use.

Wang Xiaoling, director of the Pharmacy Department of the National Children's Medical Center and Beijing Children's Hospital affiliated to Capital Medical University, said that to improve this situation and solve the problem, it is necessary to tailor-made for children in the research and development stage.

Before the new drug is marketed, conduct necessary pediatric population clinical research to obtain data on children's drug use.

Standardize the use, rational use of drugs, and individualized drug use after the market, strengthen the comprehensive evaluation of drug use in children, and supplement information and data on children's drug use.

　　Wang Xiaoling pointed out that clinical research is one of the factors restricting the development of innovative drugs in my country, a bottleneck in the development and innovation of medicines for children, and the only way to solve the problem of medicines for children.

If no child subjects participate in clinical trials, more children can only become subjects in clinical trials with no termination period.

We must strengthen the risk management and control of the whole life cycle of children's medicine.

　　When talking about how to ensure the safety of children’s drugs on the market, Wang Hao, a researcher at the National Engineering Research Center for Pharmaceutical Preparations, also said that the research and development of children’s drugs is a problem facing the world. To improve the safety of children’s drugs, it is necessary to strengthen the observation and safety of children’s drugs. Detection, collection of adverse reactions, etc.

At the same time, in order to ensure the safety of children's medication, companies should be encouraged to carry out pre-market clinical research before the market. Full pre-clinical research is also very helpful to improve the clinical success rate and safety.

　　Wang Hao also pointed out that the Drug Evaluation Center of the National Medical Products Administration issued the "Technical Guidelines for the Development and Evaluation of Children's Drugs Supported by Real-World Research (Trial)" last year, which is encouraging for the clinical research of children's drugs. file.

4. Build a "double insurance" to solve the "difficult medication"

　　In recent years, the issue of children’s safe drug use has attracted attention, and relevant departments have also formulated a clear development policy framework, starting from the review of new drugs, policy formulation, and functional supervision to ensure the safety of children’s drug use.

At the same time, in order to meet my country's growing demand for drugs, the country has continuously promoted the consistency evaluation of generic drugs and has made significant progress.

　　With the deepening of the consistency evaluation work, the centralized procurement of the country will also include more children's medicines.

However, due to the very special group of children and the general lack of clinical data on drugs suitable for children.

Many experts believe that the government needs to consider safety more in the selection process of collectively-sourced varieties, and even give policy preference.

For example, drugs that are already on the market due to insufficient clinical research for children need to be treated more cautiously. For drugs that are suitable for children, experts need to be more fully demonstrated. If necessary, comprehensive clinical evaluation of drugs should be adopted to ensure the quality and safety of drugs.

　　At the same time, given that children's medicines and adult medicines have completely different characteristics, some experts believe that children's medicines should be differentiated and focused in terms of management and supply guarantee.

At present, there are fewer varieties and dosage forms of children's medicines on the market, which cannot fully meet the demand. Therefore, special attention should be paid to ensuring supply in the procurement and design of children's medicines.

For example, it is possible to try to include a variety of drugs for children with stable dosages into the provincial or national medical reserves to ensure the clinical needs of medical institutions in the province.

　　In view of the fact that children are a special group that uses drugs, the number of subjects in clinical trials is small, the ethical challenges are large, and the experimental difficulties are high, and the development of children's drugs is relatively difficult.

In order to ensure supply, when purchasing children's medicines, a variety of procurement methods can be considered comprehensively, such as inviting bidding, inquiry procurement, and designated production, etc., and use multiple procurement methods to mobilize the enthusiasm of enterprises.

　　At the same time, hospitals and clinicians, as the ultimate implementers of the treatment plan, also need to strictly control the clinical use of drugs, and build a "double insurance" for the safety of children's drug use.

Experts said that clinically, it is possible to encourage the priority use of drugs with children's clinical trial data. Drugs lacking in children's clinical data should be treated with caution. They can be used in small batches and then expanded in steps.

(Our reporter Zhan Yuan)