Regulations will be issued in the near future

Source: Legal Daily reported on January 30, 2018 that "Regulations on drug use security for children" has been submitted to the Legal Affairs Office of the State Council and is expected to be published in the near future During the fifth session of the 12th National People's Congress, 31 deputies to the National People's Congress, including Li Suyan, put forward proposals on speeding up the legislation of drug use for children and safeguarding their health The bill proposed that, according to the characteristics of children's physical and mental development and the development and demand of children's medical and health undertakings, we should legislate and regulate the appropriate procurement methods and clinical use rules of children's special drugs, so as to ensure that children can obtain safe and effective special drugs in time Measuring cups of various capacities, electronic scales accurate to milligrams, disposable syringes Ms Wang, who lives in Beijing, recently bought a lot of tools that seem to be needed only for laboratories But she wasn't trying to do any scientific experiments, she was trying to give her children medicine "The flu is so bad this time More than half of my daughter's classmates have been sick and asked for leave She has always been in good health, but this time she didn't avoid it." In the case of high fever for several days, Ms Wang took her child to the hospital for relevant examination and prescription But when she returned home to give her baby medicine, Ms Wang made a mistake According to the doctor's order, she needs to give the child 85% of the adult dose every time A small piece of medicine with a diameter of no more than 1cm, how to feed 85% accurately has become a big problem But, in order to give the child accurate medication, Ms Wang bought a series of special tools Data shows that there are more than 3500 kinds of pharmaceutical preparations in China, of which only 60 are for children Due to the lack of special drugs for children, the vast majority of children can only take adult drugs in proportion But children are not simple adult miniatures They need special attention in medication So, what can we do to ensure the medication safety of children patients? How to standardize the management of children's drugs? How to solve the shortage of children's specialized drugs? The reporter recently learned from the education, science, culture and Health Committee of the National People's Congress that the revision of the drug administration law has been included in the legislative plan of the Standing Committee of the National People's Congress At present, the State Food and drug administration is studying and drafting a revised draft, which will stipulate preferential review and approval, conditional approval, market monopoly period and other incentive policies at the legal level, and explicitly include children's drug use in the scope of encouragement The National People's Congress's education, science, culture and Health Committee has recommended that the relevant departments of the State Council speed up the legislative process, actively study and absorb the opinions and suggestions of the deputies to the National People's Congress, and constantly improve the drug use security system for children It is reported that the regulations on drug use guarantee for children have been submitted to the Legislative Affairs Office of the State Council and are expected to be promulgated in the near future The safety of children's medication makes their parents worry "The medicine can't be eaten indiscriminately If you eat less, it won't work If you eat more, it will definitely damage your body." Children can't take medicine carelessly We don't want to be in such trouble, but we can't " Ms Wang's experience is not uncommon More than 80% of the interviewees said that they had ever encountered the problem of safe medication for their children, and had ever broken the capsule, crushed the tablet, etc "I want to say to my mother, my world is very quiet, there is no sound Mom said that when I was one year old, I would call Mom and dad I especially like to laugh and dance when I hear music My mother said that three years ago, after I had a high fever and improper medication, my hearing became weaker and weaker I knew that the voice was all around me I tried to hear it, but I couldn't hear it " It's Xinuo, a five-year-old deaf child, who said this to the camera At the age of five, I should have been a carefree childhood I can sing loudly and communicate warmly But these laughter belongs to other children only Many people who are deaf due to drug problems can only struggle in the silent world Recently, this public service advertisement about "children's medicine" on CCTV burst the circle of friends and made people cry after watching it The white paper of 2016 child drug safety investigation report points out that: due to improper drug use, about 30000 children are deaf every year in China, and about 7000 children die In China, the adverse drug reaction rate of children is 12.5%, which is twice as high as that of adults, and that of newborns is 4 times as high as that of adults The drug-induced damage caused by unreasonable and wrong use of drugs in children is more serious In the children group, drug poisoning accounted for the proportion of all poisoning children, from 53% in 2012 to 73% in 2014 From the perspective of poisoning age, the children aged 0 to 14 years old with drug poisoning accounted for the largest proportion of children aged 1 to 4 years old Children are short of drugs and pediatricians this winter, and flu is rampant Data shows that in December last year, Beijing reported more than 5000 cases of influenza in a week Because of their weak resistance, many children have been "recruited" They not only have recurrent fever, but also have a high fever for 3 to 5 days, which makes many parents extremely anxious The pediatrics in major hospitals are also overcrowded At the same time, a handwritten unofficial "children's medicine manual" has been widely spread in the circle of friends, which has been sought after by many parents and regarded as the standard of self diagnosis medicine by many people In this regard, some professionals pointed out that this "treasure code" is not completely scientific, and pediatric diseases are ever-changing, so there is no "treasure code" for drug use, let alone the use of adult drugs for children at will But the reality is that even if many parents take their children to the hospital for treatment, they still can't get around the lack of special drugs for children They still drive home a bunch of adult drugs "The main reason for the lack of children's specialized drugs is that there are no interests to plan, and the manufacturers are unwilling to produce Many children's drugs that are good for clinical use are slowly gone because they are cheap and good in quality, and the manufacturers do not make money." A pediatrician at a top three hospital in Beijing, who didn't want to be named, told reporters that in the past, there were many small oral medicines for children in pediatrics, as well as some self-made powder medicines for children's digestion, which were cheap and could solve problems, but now they are gradually gone "As a pediatrician, we are also in a dilemma Drugs are scarce We should consider not only the safety of drugs, but also the cost of patients' medical treatment Many parents who spend money but don't get the ideal treatment effect will end up throwing their grievances on the hospital and the doctors, which creates a fierce conflict in other aspects " The doctor was rather helpless "Without solving this deep-seated problem of interests, the problem of drug shortage in children cannot be fundamentally solved The State shall increase investment, establish or support some pharmaceutical production enterprises with public welfare, produce special drugs for children with clinical needs, adopt subsidies and other ways to maintain the normal operation of enterprises " In addition, the safety of drug use in children is also a big problem According to the adverse drug reactions report issued by the State Food and drug administration, in 2016, the number of children under 14 years old (including) accounted for 10.6% of the total number of reports, among which the number of serious adverse reactions accounted for 5.5% of the total number of reports Because of the high risk, many doctors are reluctant to go to pediatrics, which leads to the shortage of pediatrician resources The pediatrician suggested that the state should establish a special research institute for children's drug use, and equip the front-line clinical experienced personnel, especially the specialized pediatricians to participate in it, and learn from the advanced experience of foreign countries "The safety of children's drugs can not be guaranteed by documents alone Not only the efficacy, but also the taste, convenience of swallowing and safety of packaging should be considered." Children's drug legislation calls high In May 2014, six departments including the national health and Family Planning Commission jointly issued several opinions on the protection of children's drug use, which is the first comprehensive guidance document on children's drug use in China The opinions include encouraging research and development, speeding up application and review, ensuring production and supply, strengthening quality supervision, promoting rational drug use, improving system construction, and improving comprehensive capacity The specific requirements for children's drug use were put forward However, at present, there is no law specifically for children's drug use in China Neither the drug administration law of the people's Republic of China nor the measures for the administration of drug registration put forward special provisions for children's drug use During the fifth session of the 12th National People's Congress held in March last year, 31 deputies to the National People's Congress, including Li Suyan, put forward proposals on speeding up legislation on drug use for children and ensuring their health The bill proposed that, according to the characteristics of children's physical and mental development and the development and demand of children's medical and health undertakings, we should legislate and regulate the appropriate procurement methods and clinical use rules of children's special drugs, so as to ensure that children can obtain safe and effective special drugs in time In the first half of 2017, the Standing Committee of the National People's Congress carried out the inspection of drug administration law enforcement, and listened to and deliberated the special report of the State Council on drug administration The law enforcement inspection report clearly proposes to accelerate the revision of drug administration law, vigorously support and encourage the development and innovation of drugs, and strengthen the drug use guarantee for special groups such as clinical urgently needed drugs, drugs in short supply, children's drugs and drugs for rare diseases The relief mechanism should be established by legislation: "children are in a rapid growth and development period, their organs have not developed well, if the drug is used improperly, it is easy to produce poisoning and other events." In addition, the incidence of children is generally more acute, there are some blind drug use behavior in clinical practice " Liu xuanlin, executive director of the China Society of health law and associate professor of the Department of health law of Capital Medical University, believes that children's safe drug use needs to be intervened and regulated through legislation, and proposes to solve the legislative difficulties and pain points of children's drug use safety from three aspects: First of all, we should add a new content to Chapter II "citizens' health rights and obligations" of the draft law on basic health care and health promotion just submitted to the Standing Committee of the National People's Congress for deliberation, that is, the general provisions on special groups, including children's patients, and add that "the state and society should respect, protect and realize citizens' right to health, children, women, the elderly and disabled The right to health of people and other special groups should be specially guaranteed Secondly, the relief mechanism should be established in the legislation of drug use guarantee for children Combined with the reality of our country, the fund compensation system is more feasible As for the source of the fund, it can be divided into three parts, that is, part of the profits of drug manufacturers, government investment and social donations In addition, in order to be fair and just, we should separate the examination and determination department of adverse drug reactions from the claim department in order to eliminate their interests Finally, a comprehensive evaluation system and a clinical database should be established It is necessary for the state to sort out and analyze the data of children's drug use and carry out comprehensive evaluation regularly Specifically, the national health and family planning administration should actively organize child drug experts and relevant associations, summarize clinical drug use experience in time, collect and sort out safe drug use data, issue scientific and standardized child drug use guidelines and update them regularly to provide guidance for medical institutions and medical personnel to use children's drugs; the food and drug administration should provide guidance for some clinical use For drugs that have been lacking data on children's drug use for many years, it is necessary to strengthen post marketing re evaluation and monitoring, organize argumentation, guide drug manufacturers to supplement and improve data on children's drug use, and revise drug specifications; all kinds of medical institutions at all levels should speed up the informatization of children's drug use management, standardize doctors' and children's drug prescription behavior, and improve scientific diagnosis and treatment and rational drug use Level In addition, attention should also be paid to strengthening the connection with the current laws and regulations, and some guiding norms should be made for more detailed regulations in the future