Analysis of children's drug use in China: Serious shortage of prescription drugs in hospitals Enterprises concentrated in the retail market

In China, children are minors between 0 and 14 years of ageAccording to the National Bureau of Statistics, the number of children in China in 2018 was 249 million, representing 17.88 percent of the populationAccording to the China Health Statistics Yearbook data, the number of paediatric consultations in China General Hospital in 2017 was 24.2201 million, an increase of 9.42% year-on-year, and the number of pediatric patients in China General Hospital sits on the rise year by yearcompared with adults, children's immunity is weak and more likely to be infected with diseases, because the child's body has not yet matured, and adults have significantly different physiologically, liver and kidney function of the drug metabolic capacity and adverse reaction tolerance and adults there are significant differencesTherefore, clinical drug use should be fully, comprehensive, careful consideration of children's physiological characteristics, not suitable for direct use of adult medicationaccording to the State Drug Administration (NMPA) data show that up to now there are about 3000 special pediatric drugs, children only more than 60 kinds of drugs, accounting for about 1.7% of the entire drug preparation varieties; And children's drug use is mainly concentrated in the OTC retail market (antibiotics, cold fever, gastrointestinal and nutrition), foreign enterprises are mainly Johnson and Johnson, Wyeth, Pfizer and other enterprises, local enterprises are mainly Jichuan Pharmaceuticals, Sunflower Pharmaceuticals, a magenta pharmaceutical industry, SandaHuau Kangzhi Pharmaceuticals, Korea-U.SPharmaceuticals, China Resources 39 and other (Chart 1), of which Jichuan Pharmaceuticals and Sunflower Pharmaceuticals were the most prominent, with operating income reaching 6.94 billion yuan and 4.371 billion yuan in 2019 respectively (Chart 2)Chart 1: List of Drugs in China's OTC Retail Market
Chart 2: 2015-2019 Children's Retail Drug Enterprise Operating Income (unit: RMB 100 m)Source: Public Information, SGRCR finishingClinical Trials of Children's Drugs First ethicalrequirements are high, the design of the pilot program needs to take into account the characteristics and affordability of children's populationThe recruitment of research objects is difficult, the rate of loss of research process is relatively high, secondly, the requirements of clinical researchers are high, need to have high knowledge and experience in children's medicine, pharmacy, nursing, ethics, psychology and so on, and enterprises due to the long research and development cycle of pediatric drugs, resulting in low return on investment, and reduce the investment in children's drug research and developmentdue to the lack of suitable varieties, specifications and dosage forms, resulting in children's medications are mostly used in adult drug doses or over-instructions, especially in hospital prescription drugs for children, pediatricians can only rely on doctors long-term experience of medication, such as height-weight ratio or even simple dependence on adult dose percentage, lack of drug metabolism for children and In-depth study of side effects, NMPA conducted a joint survey on safe drug use for children, data show that the rate of unreasonable drug use in Chinese children as high as 12%-32%, the incidence of adverse drug use in children is about 12.9%, nearly 2 times that of adults, of which the newborn situ rate is 24.4%, nearly 4 times that of adultsAccording to the Current Situation study of clinical trials of children's drugs, Beijing Children's Hospital has 96.07 percent of the drugs used in children and 95.07 percent of prescription drugs are not children-specific drugsUntil May 2014, the former Health and Planning Commission, the National Development and Reform Commission and other six parts jointly issued "several opinions on the protection of children's drug use", is China's first comprehensive guidance document on children's drug use, involving children's drug research and development, use, reimbursement of the six relevant ministries to participate in promoting the development of children's drug use; The Basic Principles and the Announcement of the First Priority Review Varieties identified the varieties approved for priority review and approval of drug use for children; in March 2016, the Technical Guidelines for Clinical Trials of Paediatric Drugs in the Paediatric Population provideguidelines for the implementation of clinical trials of pediatric drug use; and in 2016-2019, the Health and Care Commission, the Ministry of Industry and Information Technology and the Food and Drug Administration launched a total of 108 lists of drugs to encourage research and development and declaration of children's drugs, however, as of now, There is no specific legislation on children's drugs in ChinaThe U.S has enacted the Paediatric Research Equality Act (PREA) and the Best Child Drug Act (BPCA) in order to obtain more data to support child drug use, and the Pediatric Drug Administration Regulations (The Food Regulation, PR) of January 27, 2007 in the European Union, which has prompted the Children's Drug Development Program to be part of the entire drug development program from the outset, and the European Medicines Agency (EMA) has accelerated the approval of children for drug use.