Multi-departmental support for favorable policies frequently raises concerns about children's medication problems

Medical Network News, June 9th, for a long time, the supply of special medicines for children has not been able to meet the clinical needs.
Children's medicines have always had the problem of "relying on drug administration and guessing the dosage"
.
In recent years, there has been an increase in children's adverse reactions and even life-threatening cases due to the abuse and misuse of adult drugs
.
To solve the problem of insufficient medicines for children, it is necessary to focus on the research and development and production of medicines
.
However, for pharmaceutical companies, on the one hand, the peculiarities of children's groups make the research and development of children's drugs difficult and profitable; on the other hand, children's clinical trials are high in risk, volunteers are difficult to recruit, and drug research and development lack data support
.

 

Facing the increasing demand for medicines for children, many departments have issued favorable policies to promote the research and development and innovation of children's medicines, and use top-level design to protect the safety and accessibility of medicines for children
.

 

Public opinion trends and key nodes

 

With the monitoring period from January 1, 2020 to June 3, 2021, the media attention and netizen attention of “children's medication” related information both reached their peak in August 2020 (see figure)
.

 

 

Insufficient medicine for children attracts attention

 

Special medicines are not specialized, and division of medicines becomes a problem

 

On December 3, 2019, the "Economic Information Daily" published ""Special Medicines Are Not Specialized"? Three Shortcomings Exacerbate the Scarcity of Children's Medicines", stating that the shortage of children's medicines is an old problem in the field of medicine in China, and the three outstanding shortcomings have intensified The current situation of lack of medicine for children
.
The first is the lack of special formulations; the second is the lack of treatment standards; the third is the lack of information on the efficacy and safety of children's drugs.
It is difficult to develop and market children's drugs, and it is difficult to verify the efficacy and safety of drugs in children
.

 

　　On May 11, 2021, the WeChat public account "Medical Circle" released "5-year-old children in a coma after taking medicine: Chinese children's drug dilemma", which stated that there are now medicine cutters, graduated medicine feeders, and medicine grinders on the market.
Other products, some parents use it to dispense medicine for their children, which has many unknown risks
.
Manual operations such as tablet splitting, tablet grinding, and powder solubilization are difficult to ensure accuracy and uniformity
.
At the same time, self-dispensing medicines and ignoring the doctor's advice also bring children's medication risks
.

 

　　There are two main suggestions for solving the problem of "dispensing medicine"
.
First, it is recommended that pediatricians, pharmacists and other professionals dispense medicine
.
For example, the above-mentioned "5-year-old child comatose after taking medicine: Chinese children's drug dilemma" quoted expert opinions and called for pediatric hospitals to charge drug service fees related to the dispensing of drugs, and to encourage pharmacists to provide higher-quality drug drug services
.
For drugs with high demand for pediatric divided doses, pharmaceutical companies are encouraged to actively study the method and suitability of divided doses, and add corresponding information to the drug inserts
.
At the same time, clinicians should actively explore the effects of divided doses on drug dissolution and stability, and conduct research on the changes in the treatment process, pharmacokinetics and pharmacodynamics of the drugs after the divided doses, and the corresponding clinical risks
.
According to the " Hospital "Breaking Medicine" for Children Is Encouragement" published by Health Daily, the "Breaking of Medicine" by the hospital can greatly alleviate the problem of parents' "inaccurate guessing and uneven distribution"
.
The hospital can open a drug subcontracting window in the outpatient clinic to provide drug distribution services for children
.
The second is to call for the development of easy-to-pack or children-specific dosage forms
.
For example, "Guess the dose, and break the medicine!" published by the client of Beijing Daily.
How to protect the parent's drug dosage for children? According to the report, in the research and development of children's medicines, more convenient dosage forms, such as liquid dosage forms, granular dosage forms, etc.
, should be produced on the basis of existing medicines, and specifications suitable for children's use, such as microtablets, should be provided
.

 

　　Adult medicine and children use, there is a risk of drug abuse

 

　　On May 19, 2021, the "Food and Drug Administration finally launched!" released by the WeChat public account "Eight O'clock Health News"! Can the dark history of children's cold medicine be ended? According to the report, in the United States, compound anti-cold drugs that are banned for children under the age of 2 are called "children" in China, and have become a "big variety" with an annual sales volume of several hundred million yuan
.
Both the antipyretic drug "Nimesulide" and the compound anti-cold drug "Ucardan" have caused adverse reactions in children
.

 

　　On January 8, 2021, the "Class 10 Drugs, Use with Caution in Children" published by the "China Medical News" stated that some drugs that can be used normally by adults may need to be banned or cautious for children in a special period of growth and development.
Use, such as antibacterial drugs, antipyretic drugs, anthelmintics, acid inhibitors, anti-allergic drugs, antidiarrheal drugs, gastric motility drugs, nervous system drugs, sedative hypnotics and traditional Chinese medicine
.

 

　　Parents buy medicine without authorization, hidden dangers of children's medicine

 

　　Not all of the children's medicines that parents are keen on overseas are safe
.
On October 19, 2020, the "Japanese Popular Children's Cold Syrup Recalls Approximately 7.
75 Million Bottles" broadcast on CCTV's "Tianxia Finance" said that the Internet celebrity cold medicine Ikeda Model Hall's "Anpanman Children's Cold Syrup" was widely used in Japan.
The scale of the recall is expected to reach 7.
75 million bottles
.
It is worth noting that the company's "Anpanman cough syrup" was exposed by CCTV in 2017 or contained ingredients that are prohibited by Chinese children
.
China Net, Overseas Net, Beijing Business Daily and other media reprinted and reported relevant information
.
On the Weibo platform, @ and @21 also paid attention to the incident
.
Netizens believe that foreign popular drugs should not be superstitious
.

 

　　Medicines for rare diseases in children are neglected

 

　　On May 25, 2020, the interface press released "Cannot be "rarely ruled"! Proposal of the Two Sessions: It is recommended that drugs for rare diseases in children be included in medical insurance" said that Sun Wei, deputy to the National People's Congress, suggested that drugs for rare diseases in children should be included in medical insurance
.
There are many children suffering from rare diseases in our country, but the society pays little attention to them
.
Representative Sun Wei proposed to do a good job in the diagnosis, treatment and prevention of rare diseases in children, and gradually include drugs for rare diseases in children into medical insurance
.

 

　　The R&D investment in children's special drugs is more demanding

 

　　On December 10, 2020, "Why does the "Children's Drug Market" Show a False Prosperity" published by the WeChat public account "Imida Industry Research"? According to the report, in recent years, China's children's medicine market has grown rapidly, but there are very few children's medicines and manufacturers
.
The production of children's medicines is mainly in small batches and multiple batches, and the process is relatively complicated.
The production cost of some children's medicines is more than 10% higher than that of adult medicines
.
Coupled with the limited applicable population and insufficient price advantage, although the market potential of children's medicine is huge, the company's R&D and production power is insufficient
.

 

　　On May 6, 2021, the WeChat public account "Funxue" published an article stating that companies must conduct professional R&D for children's physical and psychological characteristics, bringing additional R&D expenditures
.
At the same time, the production process of children's medicine is complicated, which pushes up the production cost
.
In addition, in order to prevent unreasonable and peculiar dosage forms from raising the price of medicines, relevant government departments reduce the specifications and dosage forms of the same medicine as much as possible during the bidding.
However, children's medicines just need dosage form innovation, and many children's medicines fail the bid, which has also led to children's medicine manufacturers.
The quantity is small
.

 

　　On May 20, 2021, the WeChat public account "People's Daily Review" released "Guess the dose and break the medicine".
How can children's medication be more accurate? According to the report, unlike adult drugs, children's drugs face a small number of people, and the market demand is far less than that of adult drugs, but the R&D investment is large and the requirements are high
.
At the same time, limited by parents' willingness to allow children to participate in clinical trials, it is more difficult for children's drugs to carry out clinical trials, and it is even more difficult to collect data
.
Since childhood onset is often characterized by short time and rapid progress, the requirements for clinical trial bases are higher and more detailed
.
High investment, high requirements, and small market size have discouraged many pharmaceutical companies
.
It will take time to develop and improve systems for children's drug research and development, clinical trials, supply, use, and payment
.

 

　　Favorable policies for children's drug research and development frequently appear

 

　　In recent years, the National Food and Drug Administration, the National Health Commission, and the National Medical Insurance Administration have successively introduced a number of policies and measures to encourage the development, production, and use of children's drugs
.

 

　　On March 30, 2020, the State Administration for Market Regulation issued the newly revised "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production" to include urgently needed clinically needed drugs, children's drugs, and rare disease drugs into the scope of accelerated listing and registration
.
The “Notice of the General Office of the National Health Commission on Strengthening the Monitoring of the Clinical Application of Antimicrobial Drugs in Children and Monitoring of Bacterial Resistance” issued in July 2020 clarified that all secondary and above medical institutions that set up pediatric diagnosis and treatment subjects should include all antimicrobial drugs nationwide.
Clinical Application Monitoring Network, which monitors and reports clinical application data
.
In August 2020, the Center for Drug Evaluation of the National Food and Drug Administration (hereinafter referred to as the Center for Drug Evaluation) issued the "Technical Guidelines for the Development and Evaluation of Children's Drugs Supported by Real-World Research (Trial)", clarifying that the current stage of real-world research supports China Common situations and concerns in the development of children's medicines, and give examples and explanations
.
In December 2020, the Center for Drug Evaluation issued the "Guiding Principles for Pharmaceutical Development of Children's Drugs (Chemical Drugs) (Trial)" and "Technical Guidelines for Clinical Pharmacology Research of Pediatric Drugs" to provide R&D ideas and technical guidance for the development of children's drugs and pharmacy, and further clarify Technical requirements for clinical pharmacology research of pediatric drugs
.
In April and May 2021, the Center for Drug Appraisal of the People's Republic of China issued technical guidance on the "Technical Guidelines for Clinical Trials of Modified New Drugs for Children's Chemical Drugs (Draft for Comment)" and "Technical Guidance on Children's Drug-related Information in the Instructions for Chemicals and Biological Products for Treatment The Principles (Draft for Solicitation of Comments)" openly solicit opinions, and further strengthen the technical guidance of children's medication
.

 

　　Since 2020, the State Food and Drug Administration has issued multiple announcements and notices to cancel some children-related drugs or require revision of the children-related part of the drug label.
The types of drugs involved include antipyretic, anti-tumor, and psychiatric drugs
.
At the same time, innovative children's drugs will be included in the priority review channel
.
According to the "Efforts to Solve the Problem of Child Drug Shortage" published by the "China Medical News", as of the end of May this year, a total of 32 children's drugs have been approved for marketing through the priority review channel, and 12 children's drugs have been approved since 2021 Listing, the number of completions and the speed of review have been significantly improved
.
On May 31, 2021, the "Children's Medication Column" was officially opened on the website of the Center for Drug Evaluation
.
The column gathers information on policies, regulations, technical guidelines and other information in the field of children's drug use.
In the future, it will become an important window for enterprises, doctors, and the public to understand the national children's drug policies and regulations, grasp R&D technical requirements, and interact with the drug regulatory authorities
.

 

　　In addition, it is also good for children's medication in terms of medical insurance catalogue and industrial organization
.
2020 National Medicare negotiation results show that included a total of seven kinds of pediatric medicine, including pediatric qingrening particles, particles faropenem children, children bezoar pure heart scattered, pediatric cough particles Jing apricot, Ann child rather particles, mostly to the pharmaceutical species
.
These 7 drugs all fully consider the safety and effectiveness of the drugs.
The specifications and dosage forms are more in line with the characteristics of children, and there are clear regulations on the dosage for children
.
On October 24, 2020, the China Children’s Drug R&D and Industrialization Alliance kick-off meeting was held in Beijing.
The Ministry of Industry and Information Technology and the National Health Commission jointly supported the establishment of the Children’s Drug R&D and Industrialization Alliance
.
The alliance concentrates advantageous resources in the pharmaceutical industry, closely coordinates R&D, production and clinical needs, promotes multi-disciplinary and cross-field cooperation, and promotes the development of the children's drug industry
.
(Zhan Ni, Public Opinion Monitoring Center of China Health Media Group)

　　Medical Network News, June 9th, for a long time, the supply of special medicines for children has not been able to meet the clinical needs.
Children's medicines have always had the problem of "relying on drug administration and guessing the dosage"
.
In recent years, there has been an increase in children's adverse reactions and even life-threatening cases due to the abuse and misuse of adult drugs
.
To solve the problem of insufficient medicines for children, it is necessary to focus on the research and development and production of medicines
.
However, for pharmaceutical companies, on the one hand, the peculiarities of children's groups make the research and development of children's drugs difficult and profitable; on the other hand, children's clinical trials are high in risk, volunteers are difficult to recruit, and drug research and development lack data support
.

 

　　Facing the increasing demand for medicines for children, many departments have issued favorable policies to promote the research and development and innovation of children's medicines, and use top-level design to protect the safety and accessibility of medicines for children
.

 

　　Public opinion trends and key nodes

 

　　With the monitoring period from January 1, 2020 to June 3, 2021, the media attention and netizen attention of “children's medication” related information both reached their peak in August 2020 (see figure)
.

 

 

　　Insufficient medicine for children attracts attention

 

　　Special medicines are not specialized, and division of medicines becomes a problem

 

　　On December 3, 2019, the "Economic Information Daily" published ""Special Medicines Are Not Specialized"? Three Shortcomings Exacerbate the Scarcity of Children's Medicines", stating that the shortage of children's medicines is an old problem in the field of medicine in China, and the three outstanding shortcomings have intensified The current situation of lack of medicine for children
.
The first is the lack of special formulations; the second is the lack of treatment standards; the third is the lack of information on the efficacy and safety of children's drugs.
It is difficult to develop and market children's drugs, and it is difficult to verify the efficacy and safety of drugs in children
.

 

　　On May 11, 2021, the WeChat public account "Medical Circle" released "5-year-old children in a coma after taking medicine: Chinese children's drug dilemma", which stated that there are now medicine cutters, graduated medicine feeders, and medicine grinders on the market.
Other products, some parents use it to dispense medicine for their children, which has many unknown risks
.
Manual operations such as tablet splitting, tablet grinding, and powder solubilization are difficult to ensure accuracy and uniformity
.
At the same time, self-dispensing medicines and ignoring the doctor's advice also bring children's medication risks
.

 

　　There are two main suggestions for solving the problem of "dispensing medicine"
.
First, it is recommended that pediatricians, pharmacists and other professionals dispense medicine
.
For example, the above-mentioned "5-year-old child comatose after taking medicine: Chinese children's drug dilemma" quoted expert opinions and called for pediatric hospitals to charge drug service fees related to the dispensing of drugs, and to encourage pharmacists to provide higher-quality drug drug services
.
For drugs with high demand for pediatric divided doses, pharmaceutical companies are encouraged to actively study the method and suitability of divided doses, and add corresponding information to the drug inserts
.
At the same time, clinicians should actively explore the effects of divided doses on drug dissolution and stability, and conduct research on the changes in the treatment process, pharmacokinetics and pharmacodynamics of the drugs after the divided doses, and the corresponding clinical risks
.
According to the " Hospital "Breaking Medicine" for Children Is Encouragement" published by Health Daily, the "Breaking of Medicine" by the hospital can greatly alleviate the problem of parents' "inaccurate guessing and uneven distribution"
.
The hospital can open a drug subcontracting window in the outpatient clinic to provide drug distribution services for children
.
The second is to call for the development of easy-to-pack or children-specific dosage forms
.
For example, "Guess the dose, and break the medicine!" published by the client of Beijing Daily.
How to protect the parent's drug dosage for children? According to the report, in the research and development of children's medicines, more convenient dosage forms, such as liquid dosage forms, granular dosage forms, etc.
, should be produced on the basis of existing medicines, and specifications suitable for children's use, such as microtablets, should be provided
.

 

　　Adult medicine and children use, there is a risk of drug abuse

 

　　On May 19, 2021, the "Food and Drug Administration finally launched!" released by the WeChat public account "Eight O'clock Health News"! Can the dark history of children's cold medicine be ended? According to the report, in the United States, compound anti-cold drugs that are banned for children under the age of 2 are called "children" in China, and have become a "big variety" with an annual sales volume of several hundred million yuan
.
Both the antipyretic drug "Nimesulide" and the compound anti-cold drug "Ucardan" have caused adverse reactions in children
.

 

　　On January 8, 2021, the "Class 10 Drugs, Use with Caution in Children" published by the "China Medical News" stated that some drugs that can be used normally by adults may need to be banned or cautious for children in a special period of growth and development.
Use, such as antibacterial drugs, antipyretic drugs, anthelmintics, acid inhibitors, anti-allergic drugs, antidiarrheal drugs, gastric motility drugs, nervous system drugs, sedative hypnotics and traditional Chinese medicine
.

 

　　Parents buy medicine without authorization, hidden dangers of children's medicine

 

　　Not all of the children's medicines that parents are keen on overseas are safe
.
On October 19, 2020, the "Japanese Popular Children's Cold Syrup Recalls Approximately 7.
75 Million Bottles" broadcast on CCTV's "Tianxia Finance" said that the Internet celebrity cold medicine Ikeda Model Hall's "Anpanman Children's Cold Syrup" was widely used in Japan.
The scale of the recall is expected to reach 7.
75 million bottles
.
It is worth noting that the company's "Anpanman cough syrup" was exposed by CCTV in 2017 or contained ingredients that are prohibited by Chinese children
.
China Net, Overseas Net, Beijing Business Daily and other media reprinted and reported relevant information
.
On the Weibo platform, @ and @21 also paid attention to the incident
.
Netizens believe that foreign popular drugs should not be superstitious
.

 

　　Medicines for rare diseases in children are neglected

 

　　On May 25, 2020, the interface press released "Cannot be "rarely ruled"! Proposal of the Two Sessions: It is recommended that drugs for rare diseases in children be included in medical insurance" said that Sun Wei, deputy to the National People's Congress, suggested that drugs for rare diseases in children should be included in medical insurance
.
There are many children suffering from rare diseases in our country, but the society pays little attention to them
.
Representative Sun Wei proposed to do a good job in the diagnosis, treatment and prevention of rare diseases in children, and gradually include drugs for rare diseases in children into medical insurance
.

 

　　The R&D investment in children's special drugs is more demanding

 

　　On December 10, 2020, "Why does the "Children's Drug Market" Show a False Prosperity" published by the WeChat public account "Imida Industry Research"? According to the report, in recent years, China's children's medicine market has grown rapidly, but there are very few children's medicines and manufacturers
.
The production of children's medicines is mainly in small batches and multiple batches, and the process is relatively complicated.
The production cost of some children's medicines is more than 10% higher than that of adult medicines
.
Coupled with the limited applicable population and insufficient price advantage, although the market potential of children's medicine is huge, the company's R&D and production power is insufficient
.

 

　　On May 6, 2021, the WeChat public account "Funxue" published an article stating that companies must conduct professional R&D for children's physical and psychological characteristics, bringing additional R&D expenditures
.
At the same time, the production process of children's medicine is complicated, which pushes up the production cost
.
In addition, in order to prevent unreasonable and peculiar dosage forms from raising the price of medicines, relevant government departments reduce the specifications and dosage forms of the same medicine as much as possible during the bidding.
However, children's medicines just need dosage form innovation, and many children's medicines fail the bid, which has also led to children's medicine manufacturers.
The quantity is small
.

 

　　On May 20, 2021, the WeChat public account "People's Daily Review" released "Guess the dose and break the medicine".
How can children's medication be more accurate? According to the report, unlike adult drugs, children's drugs face a small number of people, and the market demand is far less than that of adult drugs, but the R&D investment is large and the requirements are high
.
At the same time, limited by parents' willingness to allow children to participate in clinical trials, it is more difficult for children's drugs to carry out clinical trials, and it is even more difficult to collect data
.
Since childhood onset is often characterized by short time and rapid progress, the requirements for clinical trial bases are higher and more detailed
.
High investment, high requirements, and small market size have discouraged many pharmaceutical companies
.
It will take time to develop and improve systems for children's drug research and development, clinical trials, supply, use, and payment
.

 

　　Favorable policies for children's drug research and development frequently appear

 

　　In recent years, the National Food and Drug Administration, the National Health Commission, and the National Medical Insurance Administration have successively introduced a number of policies and measures to encourage the development, production, and use of children's drugs
.

 

　　On March 30, 2020, the State Administration for Market Regulation issued the newly revised "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production" to include urgently needed clinically needed drugs, children's drugs, and rare disease drugs into the scope of accelerated listing and registration
.
The “Notice of the General Office of the National Health Commission on Strengthening the Monitoring of the Clinical Application of Antimicrobial Drugs in Children and Monitoring of Bacterial Resistance” issued in July 2020 clarified that all secondary and above medical institutions that set up pediatric diagnosis and treatment subjects should include all antimicrobial drugs nationwide.
Clinical Application Monitoring Network, which monitors and reports clinical application data
.
In August 2020, the Center for Drug Evaluation of the National Food and Drug Administration (hereinafter referred to as the Center for Drug Evaluation) issued the "Technical Guidelines for the Development and Evaluation of Children's Drugs Supported by Real-World Research (Trial)", clarifying that the current stage of real-world research supports China Common situations and concerns in the development of children's medicines, and give examples and explanations
.
In December 2020, the Center for Drug Evaluation issued the "Guiding Principles for Pharmaceutical Development of Children's Drugs (Chemical Drugs) (Trial)" and "Technical Guidelines for Clinical Pharmacology Research of Pediatric Drugs" to provide R&D ideas and technical guidance for the development of children's drugs and pharmacy, and further clarify Technical requirements for clinical pharmacology research of pediatric drugs
.
In April and May 2021, the Center for Drug Appraisal of the People's Republic of China issued technical guidance on the "Technical Guidelines for Clinical Trials of Modified New Drugs for Children's Chemical Drugs (Draft for Comment)" and "Technical Guidance on Children's Drug-related Information in the Instructions for Chemicals and Biological Products for Treatment The Principles (Draft for Solicitation of Comments)" openly solicit opinions, and further strengthen the technical guidance of children's medication
.

 

　　Since 2020, the State Food and Drug Administration has issued multiple announcements and notices to cancel some children-related drugs or require revision of the children-related part of the drug label.
The types of drugs involved include antipyretic, anti-tumor, and psychiatric drugs
.
At the same time, innovative children's drugs will be included in the priority review channel
.
According to the "Efforts to Solve the Problem of Child Drug Shortage" published by the "China Medical News", as of the end of May this year, a total of 32 children's drugs have been approved for marketing through the priority review channel, and 12 children's drugs have been approved since 2021 Listing, the number of completions and the speed of review have been significantly improved
.
On May 31, 2021, the "Children's Medication Column" was officially opened on the website of the Center for Drug Evaluation
.
The column gathers information on policies, regulations, technical guidelines and other information in the field of children's drug use.
In the future, it will become an important window for enterprises, doctors, and the public to understand the national children's drug policies and regulations, grasp R&D technical requirements, and interact with the drug regulatory authorities
.

 

　　In addition, it is also good for children's medication in terms of medical insurance catalogue and industrial organization
.
2020 National Medicare negotiation results show that included a total of seven kinds of pediatric medicine, including pediatric qingrening particles, particles faropenem children, children bezoar pure heart scattered, pediatric cough particles Jing apricot, Ann child rather particles, mostly to the pharmaceutical species
.
These 7 drugs all fully consider the safety and effectiveness of the drugs.
The specifications and dosage forms are more in line with the characteristics of children, and there are clear regulations on the dosage for children
.
On October 24, 2020, the China Children’s Drug R&D and Industrialization Alliance kick-off meeting was held in Beijing.
The Ministry of Industry and Information Technology and the National Health Commission jointly supported the establishment of the Children’s Drug R&D and Industrialization Alliance
.
The alliance concentrates advantageous resources in the pharmaceutical industry, closely coordinates R&D, production and clinical needs, promotes multi-disciplinary and cross-field cooperation, and promotes the development of the children's drug industry
.
(Zhan Ni, Public Opinion Monitoring Center of China Health Media Group)