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OBJECTIVE：To learn from pedia tric drug pricing and price incentive policy in Japan ，and to provide reference for the improvement of pediatric drug price system in China. METHODS ：The drug pricing strategy of Japan was analyzed ，and price incentive policy of pediatric drugs in Japan and its implementation status and effect were summarized. The suggestions of perfecting the price system of pediatric drugs in China were put forward . RESULTS & CONCLUSIONS ：The pricing strategy of medical insurance drugs in Japan included two types ，such as access pricing of medical insurance list and price adjustment of drugs in medical insurance list. Among them ，price incentive policy for pediatric drugs mainly included the premium for initial pricing of new pediatric drugs ，the premium for drugs with newly added pediatric indication included in medical insurance list and other measures（such as eligible drugs could obtain indirect price compensation ，and children ’s factors could be considered in health technology assessment ）. Overall ，these measures accelerated the R&D and marketing of Japanese pediatric drugs ，and effectively promoted the development of pediatric drugs in Japan. The author suggests that our country should carry out health technology assessment which reflects the particularity of pediatric drugs ，give appropriate direct price incentives to the payment price of pediatric drugs ，and reasonably set the price of drug specification suitable for children and give price incentives so as to promote the development of pediatric drugs in China.
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OBJECTIVE：To provide sugge stions for improving the variety of pediatric drugs and ensuring the safety of pediatric drug use in China. METHODS ：The historical evolution of laws and regulations on the marketing approval of pediatric drugs in the United States and the implementation results of relevant policies were summarized. Combined with the current situation of the development of pediatric drugs in China ，some suggestions were put forward to ensure the accessibility and safety of pediatric drug use in China. RESULTS & CONCLUSIONS ：Since 1994，the United States had issued a series of laws and regulations to encourage the development of pediatric drugs. At present ，the marketing approval of pediatric drugs were mainly based on the two laws of Best Pediatric Drug Act（BPCA）and Pediatric Research Equality Act （PREA）. From 1998 to 2019，the amount of supplements of pediatric drug information in drug instructions of the United States showed a fluctuating growth. As of April 2020，854 kinds of drugs had been modified in pediatric instructions ，792 of which had been carried out post marketing pediatric clinical research ，and the problem of incomplete pediatric instructions had also been greatly improved. At present ，China’s policies on pediatric drugs mainly included encouraging R&D innovation ，giving priority to review and approval ，and strengthening R&D technical guidance. Although certain achievements had been made ，there were still some problems ，such as imperfect policies and regulations ，and great difficulties carrying out pediatric drug clinical trials. It is suggested that our country should draw lessons from the American regulations on pediatric drugs ，pediatric research and the catalogue of pediatric drugs ，and establish a system and catalogue of ped iatric drug use suitable for China ’s national conditions ，so as to improve the effectiveness ，safety and accessibilityof pediatric drugs.
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Objective:To explore the effective dose range of Kaihoujian throat spray (for children) in treating acute pharyngitis and acute tonsillitis, in order to provide the reference for the usage and dosage in clinic. Method:A total of 160 juvenile SD rats were divided into 16 groups according to the body mass grade, namely normal group, model group, amoxicillin or ribavirin group, compound Yizhi Huanghua group and different doses of Kaihoujian (for children) groups. The different doses of Kaihoujian (for children) groups were divided into 12 treatment groups based on 2 sprays/time, 4 times/day, 4 sprays/time, 4 times/day, 6 sprays/time, 4 times/day, 8 sprays/time, 4 times/day, 2 sprays/time, 6 times/day, 4 sprays/time, 6 times/day, 6 sprays/time, 6 times/day, 8 sprays/time, 6 times/day, 2 sprays/time, 8 times/day, 4 sprays/time, 8 times/day, 6 sprays/time, 8 times/day, and 8 sprays/time, 8 times/day. Except for normal group, all of the remaining groups were included in three animal models, namely 5%ammonia-induced acute pharyngitis in rat, B type streptococcus haemolyticus-induced acute pharyngitis and tonsillitis in rabbit, and adenovirus-induced acute pharyngitis in mice. Then the optimal usage and dosage of Kaihoujian throat spray (for children) were evaluated based on pharyngeal lesion score and htoxylin eosin(HE) staining. Result:There were significant differences in pharyngeal and tonsil lesions between the model group and the normal group (PPPConclusion:The clinical usage and dosage of Kaihoujian throat spray (for children) in treating acute pharyngitis and tonsillitis were suggested to be 2 sprays/times, 6~8 times/day for 1~3 year-old children; 3~6 sprays/times, 6~8 times/day for 4~6 year-old children and 5~8 sprays/times, 6~8 times/day for 7~12 year-old children.
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Functional abdominal pain is one of the most common problems in functional gastrointestinal disorders,and it's also one of the diseases benefit most from traditional Chinese medicine (TCM) treatment.This paper illustrates some key considerations on the study design of traditional Chinese medicine intended for the treatment of FAP based on the latest treatment and evaluation guidelines,technical guidance,professional authority works as well as the latest clinical studies,and combined with experience of clinical trial design.It hopes to offer helps for research designers in this genera.
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There is an increasing demand for neonatal and juvenile animal toxicity studies during the research and development of new drugs. In this paper,we discussed general evaluation parameters of pediatric non-clinical safety with pediatric drugs,such as growth and development and food intake,and paramenters of other organs and systems, such as the central nervous system,reproductive system, behavior evaluation in combination with our own experience. In addition,the characteristics of non-clin?ical safety evaluation of new traditional Chinese medicine materia medica used for juvenile animals were analyzed. This paper is intended reference for non-clinical safety evaluation of pediatric drugs and to gain some experience related to formulation of new guidelines.
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The safety and risk assessment of pediatric pharmaceuticals has become a hot spot on drug development and man?agement in recent years. The shortage and unreasonable use of pediatric medicines and lack of preclinical juvenile safety evaluation of marketed pharmaceuticals have caused safety problems,a serious threat to the health and safety of pediatric population. Therefore,gov?ernments have formulated relevant regulative and administrative regulations and policies. In preclinical research ,due to the similarity of the young animals and children in the development process,a series of juvenile animal studies were carried out and the respective guidelines were gradually improved in Europe and the US. Therefore,the toxic effects of pharmaceuticals on children can be effective?ly predicted. In this paper,a detailed analysis and explanation is provided on the difficulties confronted with on R& D of pediatric pharmaceuticals,physiological differences between children and adults,and particularly,the importance and focus of preclinical safe?ty evaluation of pediatric pharmaceuticals,in order to offer a reference for the safety evaluation of pediatric drugs in China.
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The orally disintegrating tablets(ODT)are the kinds of novel oral dosage forms which begin to gain popularity and acceptance since they can disintegrate/dissolve quickly in the oral cavity upon contact with saliva ,resulting in solutions or suspensions form of the administered medicine. The ODTs are perfect alternative for pediatric and geriatric patients with difficulty in swallowing , and uncooperative patients because of their convenience of self-administration and compactness. This communication reviews the appli?cations and technologies involved in formulation feature,lyophillization process,excipients selection,fast dissolving mechanism,and determination of disintegration time.
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Pediatric drug accessibility has become a global problem,pediatric drug shortages and off-label uses are very seri?ous. In China,lack of suitable varieties,appropriate dosage forms and specifications,weak foundations on clinical trials,irregular prescribing behavior and irrational drug use and other issues on pediatric drugs are still outstanding. To improve pediatric drug accessi?bility,it may need all aspects work together,that is,cooperation of the national macro-policy support,participation of enterprises and medical institutions,to establish realistic goals and programs to address pediatric drug problem. This paper studies the foreign pediat?ric regulation measures and policies and by comparing foreign policies to China′s current situation,we can find out the problems and defects,give appropriate advice,in order to provide advice and reference to promote the development of pediatric drug.
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The problem of pediatric drugs has been the challenges facing the world. The two most important issues are the lack of appropriate drug dosage forms for children and the safety and effectiveness data of drug use in children. How to encourage produc?tion enterprises to produce drug varieties,specifications and dosage forms suitable for children use,guide drug manufacturers to ob?tain drug use data are the most important work for pediatric drugs.Based on the literature home and abroad,we analyze the regulatory policies for the research and development(RD)and application of pediatric drugs in the USA,EU and Japan,which have made great efforts to encourage enterprises to conduct pediatric research. Their successful experiences are summarized and can be used as refer?ence for the establishment of the policies adaptive to the situation of China for the RD of pediatric drugs.
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Taking the differences between the pediatric drugs and adult drugs as the starting-point,this article analyzes the main problems of the pediatric drugs in China,such as the shortage of the pediatric drugs. The causes of the problems mainly include high research and development cost of the pediatric drugs,their limited market capacity,difficulty in recruiting trial participants,the less clinical trial institutions in pediatrics,and governments′incentive polices on research and development of pediatric drugs did not really play their roles. The countermeasures to solve these problems mainly include introducing relevant policy to guarantee the re?search and development companies′profit,selecting appropriate varieties of the pediatric drugs to research and develop,promoting the establishment of pediatric clinical trial institutions as soon as possible,and establishing particular passage for pediatric drugs ap?proval,in order to provide references for the government when making policies on pediatric drugs.
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This study focuses on comparing the 2015 edition of WHO model list of essential medicines for children with the 2012 edition of list of national essential medicines for children in respects of drug categories,dosage forms,specifications and medica?tion information. The number of essential medicines available for children in China roughly equals to that of WHO model list of essen?tial medicines for children. Though China′s list provides more specific and children-agreeable specifications,it lags behind the WHO list with respect to the number of dosage forms and information concerning pediatric weight limitation ,drug combination and alterna?tives. It is recommended that research and development on dosage forms for children should be strengthened to solve the problem of pe?diatric drugs shortage. Also,more clinical trials should be developed as supporting evidence. Based on adapting to the needs of basic health services of children,essential medicines list for children in China should be established.
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The orally disintegrating tablets (ODT) are the kinds of novel oral dosage forms which begin to gain popularity and acceptance since they can disintegrate/dissolve quickly in the oral cavity upon contact with saliva, resulting in solutions or suspensions form of the administered medicine. The ODTs are perfect alternative for pediatric and geriatric patients with difficulty in swallowing, and uncooperative patients because of their convenience of self-administration and compactness. This communication reviews the applications and technologies involved in formulation feature, lyophillization process, excipients selection, fast dissolving mechanism, and determination of disintegration time.
ABSTRACT
The safety and risk assessment of pediatric pharmaceuticals has become a hot spot on drug development and management in recent years. The shortage and unreasonable use of pediatric medicines and lack of preclinical juvenile safety evaluation of marketed pharmaceuticals have caused safety problems, a serious threat to the health and safety of pediatric population. Therefore,governments have formulated relevant regulative and administrative regulations and policies. In preclinical research, due to the similarity of the young animals and children in the development process, a series of juvenile animal studies were carried out and the respective guidelines were gradually improved in Europe and the US. Therefore, the toxic effects of pharmaceuticals on children can be effectively predicted. In this paper, a detailed analysis and explanation is provided on the difficulties confronted with on R&D of pediatric pharmaceuticals, physiological differences between children and adults, and particularly, the importance and focus of preclinical safety evaluation of pediatric pharmaceuticals, in order to offer a reference for the safety evaluation of pediatric drugs in China.
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This study focuses on comparing the 2015 edition of WHO model list of essential medicines for children with the 2012 edition of list of national essential medicines for children in respects of drug categories, dosage forms, specifications and medication information. The number of essential medicines available for children in China roughly equals to that of WHO model list of essential medicines for children. Though China’s list provides more specific and children-agreeable specifications, it lags behind the WHO list with respect to the number of dosage forms and information concerning pediatric weight limitation, drug combination and alternatives. It is recommended that research and development on dosage forms for children should be strengthened to solve the problem of pediatric drugs shortage. Also, more clinical trials should be developed as supporting evidence. Based on adapting to the needs of basic health services of children, essential medicines list for children in China should be established.
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Taking the differences between the pediatric drugs and adult drugs as the starting-point, this article analyzes the main problems of the pediatric drugs in China, such as the shortage of the pediatric drugs. The causes of the problems mainly include high research and development cost of the pediatric drugs, their limited market capacity, difficulty in recruiting trial participants, the less clinical trial institutions in pediatrics, and governments’ incentive polices on research and development of pediatric drugs did not really play their roles. The countermeasures to solve these problems mainly include introducing relevant policy to guarantee the research and development companies’ profit, selecting appropriate varieties of the pediatric drugs to research and develop, promoting the establishment of pediatric clinical trial institutions as soon as possible, and establishing particular passage for pediatric drugs approval, in order to provide references for the government when making policies on pediatric drugs.
ABSTRACT
The problem of pediatric drugs has been the challenges facing the world. The two most important issues are the lack of appropriate drug dosage forms for children and the safety and effectiveness data of drug use in children. How to encourage production enterprises to produce drug varieties, specifications and dosage forms suitable for children use, guide drug manufacturers to obtain drug use data are the most important work for pediatric drugs.Based on the literature home and abroad, we analyze the regulatory policies for the research and development(RD) and application of pediatric drugs in the USA, EU and Japan, which have made great efforts to encourage enterprises to conduct pediatric research. Their successful experiences are summarized and can be used as reference for the establishment of the policies adaptive to the situation of China for the RD of pediatric drugs.
ABSTRACT
Pediatric drug accessibility has become a global problem, pediatric drug shortages and off-label uses are very serious. In China, lack of suitable varieties, appropriate dosage forms and specifications, weak foundations on clinical trials, irregular prescribing behavior and irrational drug use and other issues on pediatric drugs are still outstanding. To improve pediatric drug accessibility, it may need all aspects work together, that is, cooperation of the national macro-policy support, participation of enterprises and medical institutions, to establish realistic goals and programs to address pediatric drug problem. This paper studies the foreign pediatric regulation measures and policies and by comparing foreign policies to China’s current situation, we can find out the problems and defects, give appropriate advice, in order to provide advice and reference to promote the development of pediatric drug.
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OBJECTIVE:Analyze drug use of pediatrics in China,and to provide reference for promoting research,develop-ment and supply of pediatric drugs. METHODS:Analyze the data of drug use in 2 632 514 pediatric patients aged from 0 to 14 of 78 sample hospitals from Beijing,Shanghai,Tianjin,Hangzhou,Zhengzhou,Guangzhou and Chengdu in“The Hospital Prescriptions Cooperation Project”of Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association,statistical analysis was performed by using Excel and Access software. RESULTS:Pediatric patients in 78 sample hospitals of 7 regions had used 1 572 kinds of drugs from 2013 to 2014,but only 31.04%of drugs were pediatric drugs;both the ratio of pediatric drug types and the ra-tio of pediatric drugs use frequency had a great gap in different drug classifications. The ratio of drug use frequency in injection ad-ministration was 57.97%,and it was greatly higher than that of oral administration(31.04%). Among oral solid preparations,the ratio of drug use frequency for drugs with unreasonable specification was 29.57%,and ratio of drug types was 40.99%. CONCLU-SIONS:The pediatric patients had a great drug shortage in kinds,dosage forms and specifications in 78 sample hospitals of 7 re-gions during 2013-2014. Off-label drug use,high frequence of injection use,tablets used after breaking and other irrational phenom-ena were found in pediatric patients during clinical drug therapy,which reduced high risk of drug use. It is recommended that gov-ernment should strengthen and improve incentives mechanism of research,development and supply of pediatric drugs,so as to solve pediatric drug shortage in China,promote rational clinical drug therapy for children and guarantee the safety of drug use in pe-diatrics.
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Research on laboratory animals is an important issue in biomedicine.Children are a special drug-using population.The selection of suitable experimental animals is a key issue to ensure the scientific quality of research for pediatric drugs.Based on the review of a large number of literature, the authors summarized the application of suckling mice in the pharmacological research and toxicological evaluation of pediatric drugs for the treatment of common diseases in children.We also summarized the existing problems in pediatric toxicology and proposed solutions for providing a reference of test animal application in pediatric drug research.
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OBJECTIVE:To provide reference for regulating pediatric clinical drugs. METHODS:Package inserts of pediatric drugs used by the outpatient,inpatient and emergency pharmacies of our hospital during January and March in 2015 were collected. The information about pediatric drugs in the package inserts,including drug name,indications or functions,specification,adminis-tration and dosage,was calculated and analyzed. 815 kinds of drugs applicable to adults and children in our hospital were studied to summarize and analyze the dosage form,specification and dose of pediatric applicable drugs. RESULTS:438 package inserts were collected,including 327 related to chemicals and biologicals among which those imported or produced by sino-foreign joint venture were labeled with more complete information about drug use for children compared to those made in China,and 111 rele-vant to Chinese patent medicines and natural medicines for which there were significantly insufficient information about drug use for children. The applicable drugs with the dosage form for children and those with the specification therefor respectively accounted for 51.17% and 31.65% of the above-mentioned 815 kinds of drugs,and were mainly available as injections,tablets or capsules, granules and oral liquid. The drugs labeled with the dose based on the age group of children such as infant,preschooler,school child and adolescent(1-18 years old)accounted for 61.24% of those with the specification for children,the drugs labeled with the dose for babies (28 d-1 year old) accounted for 26.74% thereof,and the drugs labeled with the dose for neonatus (younger than 28 d)accounted for 12.02% thereof. CONCLUSIONS:The label information and variety of pediatric applicable drugs are marked-ly insufficient. It is suggested that our country should formulate relevant policies,strengthen the development of pediatric drugs and improve the data for clinical use thereof to ensure the safety of clinical use for children.