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OBJECTIVE To analyze the effect of pharmaceutical practice of pediatric pharmacists providing internet medication consultation services. METHODS A total of 8 356 children’s medication cases through the “Our Pharmacists” online medication consultation platform （hereinafter referred to as “Our Pharmacists”） were collected from July 2020 to June 2022. The general information， disease type and irrational drug use were analyzed statistically. RESULTS Among 8 356 cases， 4 234 were male and 4 122 were female； the age of children was mainly from 12 months to 3 years old； the consulting diseases were mainly respiratory diseases （46.56%）， followed by digestive system diseases （18.41%） and skin system diseases （12.71%）. Among respiratory diseases， the proportion of irrational drug use was 92.30%， mainly including the use of antibiotics without indication （83.59%）， inappropriate selection of Chinese patent medicines （61.14%） and compound cold medicines （49.77%）， etc. Among digestive system diseases， the proportion of irrational drug use was 71.15%， mainly including not using oral rehydration salts （48.85%）， inappropriate use of probiotics （31.19%）， the use of antibiotics without indication （26.89%）， etc. A total of 4 273 evaluations of pharmacist services were received from child guardians， with a five-star rating of 99.88%. CONCLUSIONS Pharmacists provide pediatric medication consultation services through “Our Pharmacists”， providing individualized evidence-based medication suggestions， increasing the safety of drug use and satisfaction with pharmaceutical care， and ensuring the safety of children medication.
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OBJECTIVE To analyze the current situation of pediatric drug use under centralized drug procurement， and to provide reference for the subsequent design of pediatric drug centralized procurement rules. METHODS The comparative analysis method was used to analyze the problems in the centralized procurement， clinical use and supply of pediatric drugs from the aspects of centralized procurement selection results and actual use of pediatric drugs， price difference and online prices of pediatric drugs. The solutions were put forward to optimize the centralized procurement and pricing rules of pediatric drugs. RESULTS & CONCLUSIONS The demands for pediatric drugs in China were increasing， but the supply of marketed pediatric drugs was insufficient （including insufficient coverage of disease fields， insufficient varieties， insufficient suitable dosage forms for children， insufficient specifications for children， etc.）， and the development of pediatric drugs was relatively difficult. After merging the dosage forms of centralized procurement according to the medical insurance list， some suitable dosage forms and specifications for children couldn’t be selected， resulting in a shortage of clinical pediatric medication. Relevant enterprises’ enthusiasm for developing and producing pediatric drugs and participating in online competitions had decreased. There was also the problem of underpricing of pediatric drugs under the drug price difference ratio rule. It is recommended that when conducting centralized drug procurement， special drugs for children should be grouped separately for centralized procurement based on attributes and the population covered by the indications. The specifications of suitable pediatric drugs that were not selected are converted into the agreed purchase quantity of medical institutions in a certain proportion. It is necessary to further optimize the pricing rules for pediatric specialized drugs， ensure a certain profit margin for such drugs， increase the willingness of production enterprises to research， develop and supply drugs， and thus ensure the use and supply of pediatric drugs.
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Good palatability of pediatric drugs improves the accuracy of dosing and adherence to dosing regimens. Many active pharmaceutical ingredients have an undesirable taste, so effective taste masking methods need to be developed to improve the palatability of pediatric medicines. This article mainly introduces the commonly taste masking techniques and taste evaluation methods, and puts forward suggestions on the concerns and general principles of the pharmaceutical evaluation of taste masking effects based on cases, in order to provide reference for the development of drug taste masking technology in children.
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Objective:To investigate and analyze the allocation and use of the common pediatric medical equipment and drugs in community health service centers, so as to provide decision-making reference for further strengthening the capacity-building of community children′s health services.Methods:Using multi-stage stratified random sampling method, 30 community health service centers in 14 cities were selected to investigate the basic situation of the sample centers, and the allocation and use of 21 kinds of commonly used pediatric medical equipment and 23 kinds of commonly used children′s drugs from April to August 2020.Results:The overall allocation rate of 21 commonly used pediatric medical equipment in the sample centers was 61.9%, and the overall utilization rate was 62.6%. The overall allocation rate of 23 commonly used drugs for children in the sample centers was 46.67%, and the overall utilization rate was 31.1%. There was a statistically significant difference in the utilization rate of equipment among different levels of urban community health service centers ( P<0.05); There were statistically significant differences in the allocation rate of commonly used children′s drugs among community health service centers under different regions, cities at different levels, types of jurisdictions, and institutional types ( P<0.05). Conclusions:The overall allocation and utilization rate of commonly used pediatirc medical equipment and drugs in urban community health service centers in China were relatively low, especially the drug utilization rate. The author suggested that the government should further strengthen the construction of grassroots pediatric diagnosis and treatment service capabilities, and reasonably equip commonly used pediatric medical equipment and drugs at the grassroots level.
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OBJEC TIVE To provide reference for clinical comprehensive evaluation of pediatric drugs in China. METHODS Taking pediatric anti-allergic drugs as an example ，the clinical comprehensive evaluation methods of pediatric drugs in medical institutions were explored from the aspects of theme selection ，evaluation content and dimension ，evaluation index ，evaluation method and evaluation result report. RESULTS & CONCLUSIONS During the clinical comprehensive evaluation of pediatric drugs，under the guidance of relevant national guidelines for clinical comprehensive evaluation ，the evaluation topics could be selected according to the three principles of importance ，relevance and evaluability ，and then an appropriate evaluation index system could be developed around the six dimensions of safety ， effectiveness， economy， suitability，accessibility and innovativeness；qualitative and quantitative data integration analysis of the drugs to be evaluated were performed. In the evaluation ， it is necessary to focus on children ’s clinical basic drug use practice and decision-making needs ，normatively，scientifically and reasonably define the core index set and standard data set required by different dimensions of evidence ，standardize the collection and use of real-world data ，and effectively combine other types of evidence to truly play its advantageous role in the clinical comprehensive evaluation of pediatric drugs in China.
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OBJECTIVE To provide refere nce for the optimization and adjustment of the relevant policies in the field of pediatric drug in China. METHODS“Children”“pediatrics”and“drugs”were taken as the keywords to search the official websites of the State Council ，the National Health Commission ，the National Healthcare Security Administration ，the State Administration of Market Regulation and other relevant ministries and commissions ，and collect the relevant pediatric drug policies issued at the national level from January 1，2010 to December 31，2021. Content analysis method was used to summarize ，code and statistically analyze the policy tools used in the policy research documents. RESULTS A total of 39 policy documents and 327 policy tools were included in this study. According to statistics ，from 2011 to 2021，China issued national policy documents on pediatric drug use every year ，and in recent years ，the issuance of documents was relatively intensive. The main body of issuing pediatric drugs policy was the national health department and drug supervision and administration department （71.79％，28/39），and the number of documents issued by relevant ministries and commissions alone （76.92％，30/39）was significantly more than the number of documents jointly issued by multiple ministries and commissions （23.08％，9/39）. The environmental policy tools were the most widely used （64.83％，212/327），followed by s upply-oriented policy tools （30.28％，99/327），and demand-oriented policy tools were the least used （4.89％，16/327）. CONCLUSIONS The development of pediatric drug use in China is in its infancy. It is suggested that China should optimize supply-oriented policy tools，increase capital investment and the use of public health service tools ；adjust environmental policy tools ，accelerate the legislation of pediatric drugs ，and increase the proportion of incentive policy tool ；attach importance to demand-oriented policy tools ，strengthen international exchanges and the application of service outsourcing in the field of pediatric medication ；plan the use of various policy tools as a whole ，and coordinate the use proportion of three types of policy tool and their sub policy tools，so as to enhance the initiative of policy tools ，form policy synergy ，and jointly promote the development of pediatric drug use.
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ObjectiveTo establish microbial limit test methods for 44 pediatric drugs. MethodsAccording to the general guidelines in Chinese Pharmacopoeia （2015 and 2020 edition， volume Ⅳ），a suitability test of the methods for 44 drugs was carried out by pour-plate method， neutralization method or dilution method. ResultsTotal aerobic microbial count： chemical oral liquid samples can be tested by 1∶10 plate method；traditional Chinese medicine need to be neutralized firstly. Then oral liquids could be tested by 1∶10 plate method and 1∶100 plate method was used for granules. Total count of molds and yeasts： all the samples can be tested by the 1∶10 plate method. The recoveries of five test strains were between 0.5 and 2.0. The specified microorganisms were all detected in the test group， while not found in the negative control group. ConclusionThe microbial limit test methods for the 44 pediatric drugs are established and the results are reliable and can be used in the quality control．
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OBJECTIVE：To establish c harge-by-dose model for pediatric drugs in our hospital ，so as to provide reference for reducing patients ’expenditure，saving medical insurance funds and reducing drug proportion. METHODS ：Since June 2019，a total of 12 kinds of drugs with heavy usage ，high price and large savings in our hospital were selected to establish pediatric charge-by-dose list. The drugs included in the list were split into 1/2 or 1/5 small-sized drug for charge-by-dose model. The process，quality control standards and surplus （loss）drug record of charge-by-dose model were formulated to coordinate the use of pediatric drugs between pharmacies and pediatric departments. The quantity and amount of drugs which were split ，and the drug proportion in pediatric departments were compared between charge-by-dose model and charge-by-unit model （theoretical value of dosage conversion in the same period ）during Jun.-Dec. 2019. RESULTS ：From Jun. to Dec. 2019，the quantities of split drugs each month with charge-by-dose model and charge-by-unit model were （3 346.43±734.73）and（6 821.71±1 468.81）；the amounts of split drugs each month with two models were （53 576.03±10 958.78）yuan and （112 642.75±21 308.77）yuan， respectively，with statistical significance （P＜0.05）. The drug proportion in four pediatric internal medicines departments and one neonatal medicine department had decreased to varying degrees. CONCLUSIONS ：Pediatric drug charge by dose can reduce the use and amount of drugs ，save medical insurance expenditures ，decrease the drug proportion of department.
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Physiologically based pharmacokinetic (PBPK) modeling is an important tool to predict pharmacokinetic or pharmacodynamic profiles in special populations, especially in children and infants where designing and conducting clinical studies is difficult. The application of PBPK modeling can effectively promote the development of pediatric drugs and their clinical use. At present, PBPK modeling of pediatric populations is mainly applied in clinical trial design, drug-drug interaction (DDI) risk assessment, and dose selection in children. This review discusses the advantages of PBPK modeling in pediatric drug research and summarizes how to extrapolate a PBPK model from adults to children. The theoretical basis for pediatric PBPK models, the modelling process and important physiological parameters during the modeling process are introduced. Some successful applications of PBPK modeling in pediatric drug research and development are also presented. This review also analyzes the current limitations and future directions of pediatric PBPK modeling.
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Multiple sclerosis is a chronic immune-mediated disease of the central nervous system.There is increasing incidence of MS globally, and the incidence of pediatric MS is relatively low.Environment and genetics both contribute to the causes of MS, while the specific etiology is unknown.MS is characterized by dissemination in time(DIT) and dissemination in space(DIS). Pathology is progressive since first attack, and the treatment is progressive even for a lifetime.The McDonald MS criteria was revised again in 2017 for diagnosing this disease earlier.Several drugs have been developed in recent years, and some drugs have guide of children dosage.However, treatment for children is still off-label.This article introduces the epidemiology, etiology, clinical presentation and pathology of MS.
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OBJECTIVE： Te analyze the problems of clinical use in pediatric drug in China， and to put forward related countermeasures and suggestions. METHODS： Using “children” and “pediatrics” as retrieval words， registered drug information were retrieved from the website of China Food and Drug Administration； the data of pediatric drug use prescription was retrieved from hospital prescription system of 9 hospitals； all drug information were retrieved from national drug data management system； off-label drug use investigation and the literatures of pediatric drug use in medical institutions （5 representative third grade general medical institutions） were retrieved from CNKI and Wanfang database. General information and problems of pediatric drug use in China were investigated. RESULTS： A total of 170 009 items of registered drug information were retrieved， including 2 784 drug information items labeled with ”children” or ”pediatrics”， accounting for 1.64％；320 000 drug prescriptions from hospital prescription system of 9 hospitals covered 22 treatment areas involving 1 186 drugs and 51 dosage forms. Only 10％ suitable for children. The retrieval results of database showed that the incidence of children off-label drug use in outpatients prescriptions of 5 hospitals was in high level， mainly manifesting as without the information of pediatric drug use， hyper-indication drug use， hyper-dosage drug use. There were many problems in clinical pediatric drug use in China， such as less variety for children， single dosage form and specification， widespread off-label drug use， lack of scientific reference for drug use， difficulty in developing pediatric drug clinical trials， etc. CONCLUSIONS： Although the policies to protect children’s clinical drug use have been introduced in China， the problems facing children’s clinical drug use in China are still very serious. While further implementing relevant policies， it is necessary to establish a linkage management system led by government departments， with the full participation and mutual cooperation of society， enterprises， medical institutions and patients so as to guaratee the safety of pediatric drug use in clinic.
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Multiple sclerosis is a chronic immune-mediated disease of the central nervous system.There is increasing incidence of MS globally,and the incidence of pediatric MS is relatively low.Environment and genetics both contribute to the causes of MS,while the specific etiology is unknown.MS is characterized by dissemination in time (DIT) and dissemination in space (DIS).Pathology is progressive since first attack,and the treatment is progressive even for a lifetime.The McDonald MS criteria was revised again in 2017 for diagnosing this disease earlier.Several drugs have been developed in recent years,and some drugs have guide of children dosage.However,treatment for children is still off-label.This article introduces the epidemiology,etiology,clinical presentation and pathology of MS.
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For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.
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Child , Humans , Information Storage and RetrievalABSTRACT
OBJECTIVE:To evaluate evidence situation and implementation of global national drug policies on rational pediatric drug use,and to provide decision-making reference for setting up national drug policies for rational pediatric drug use which adapt to the situation of China.METHODS:By retrieving domestic and foreign related database,scanning drug management websites of WHO,the European Union as well as many countries and regions.A pre-designed data extraction form was used to collect information of the policies of rational pediatric drug use.The information was summarized and analyzed.RESULTS:A total of 45 literatures were included,involving WHO and the European Union,the United States,Canada,Britain,Ireland,Holland,Germany,Spain,France,Australia,New Zealand,China,India,Korea,Japan,South Africa and many other countries and regions.The main points of concern for the national policies of rational pediatric drug use in all countries included promoting the development of clinical trials of children's drugs,formulating and promoting essential medicine list for children,formulating and promoting standard treatment guideline of national pediatric formulary,etc.,and promoting pediatric drug monitoring after the listing.The United States,the European Union and Japan had enacted national laws and regulations on pediatric drug clinical trials;WHO,South Africa and India had developed pediatric essential medicine list;WHO,Britain and China had established pediatric formulary.CONCLUSIONS:It is suggested that the relevant departments should refer to the experiences of the United States and the European Union and other countries and regions to establish national drug policies which adapt to pediatric disease burden and drug use in China
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Population pharmacokinetics is an emerging discipline developed from the combination of classical pharmacokinetic compartment model and statistics principles, which has been received more and more attention in recent years. Population pharmacokinetics plays important roles in all stages of new drug research. In the early preclinical phase, population pharmacokinetic analysis can help to achieve the preliminary prediction of parameters from animal to human, optimize clinical trial designs, and shorten the time required for new drugs from laboratory to clinical trials. In clinical trials and applications stage, population pharmacokinetic research can help researchers investigate the related covariates that affecting pharmacokinetic behavior of patients comprehensively, and find potential drug-drug interactions in clinical. In addition, population pharmacokinetics has a unique advantage in pediatric drug development due to its strong analysis ability of sparse data. This paper provides a summary on the history and methods of population pharmacokinetics, and the application in new drug discovery and development.
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OBJECTIVE:To provide reference for promoting the development of related legislation work on ensuring pediatric drug use in China. METHODS:The legislation process of pediatric drug use in US,the effects of current Best Pharmaceuticals for Children Act and Pediatric Research Equity Act on pediatric drug use in US were intrduced and analyzed,suggestions on guarantee-ing the accessibility and safety on pediatric drug use in China were put forward. RESULTS & CONCLUSIONS:The policy6-month period of pediatric exclusive protectionin Best Pharmaceuticals for Children Act has motivated the enthusiasm of phar-maceutical companies developing pediatric studies,while it affects the marketing of generic drugs. Pediatric Research Equity Act has achieved remarkable effect in terms of ensuring the safety of pediatric drug use by forcing pharmaceutical companies to carry out pediatrics assessments,while there is no enough force for the marketed drugs that has not been widely used for children. En-couragement and enforcement are useful methods for promoting development of pediatric drug use. It is suggested to take measures like modifingone drug two formsin Prescription Management Regulations,accelerating approvals of related pediatric drugs on the premise that safety is guaranteed,implementing tax preference for related pharmaceutical companies that produced pediatric drugs,promoting the entry of drug reimbursement list and empowering CFDA to force pharmaceutical companies to implement pedi-atric studies to promote the accessibility and safety of pediatric drugs.
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OBJECTIVE:To provide reference for improving the level of pediatric drug supply and guarantee. METHODS:Questionnaire survey about the situation and causes of pediatric drug shortage was conducted in 13 third-level hospitals of Jiangsu province [directors of pharmacy department(or drug purchasers)and clinical pharmacists of each surveyed hospital]. The survey da-ta were analyzed statistically so as to provide suggestions. RESULTS:A total of 26 questionnaires were distributed,and 26 effec-tive questionnaires were collected with effective recovery rate of 100%. In 13 hospitals,special drugs for children were mostly less than 5% of hospital drug list. There were 82 kinds of special drugs for children(containing hospital preparation),mainly including Chinese patent medicine(35.37%),drugs for respiratory system(12.20%),vitamin,mineral substance and enteral and parenteral nutrient solution(10.98%). The most types of anti-infective drugs,antineoplastics,nervous system drugs and psychotropic drugs, digestive system drugs were in shortage among 126 pediatric drugs in shortage(8.73%). The reasons for pediatric drug shortage mainly included price(38.10%),production break(32.54%),failure to bid or no supply(13.49%). The shortage of cheap drugs with price of 0.01-10.00 was the most serious,accounting for 57.94% of the varieties in shortage supply. Respondents thought that special drug shortage most affected clinical treatment(38.46%),followed by poisoning rescue drugs(30.77%)and orphan drugs(15.38%). CONCLUSIONS:Special drugs for children account for a very small proportion in the hospital drugs list. Pediatric drug shortage is affected by many factors. Cheap drug shortage is the most serious. The shortage of special drugs for children and poison-ing rescue drugs is considered to have a great impact on clinical treatment. It is suggested to establish special drugs for children pro-tective policy,improve drug circulation,promote pediatric drug clinical trial and intensify the research and development of special drugs for children so as to guarantee pediatric drug supply.
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In current research and development of new drugs,the demand for toxicological study using neonatal and juvenile animals is becoming increasingly urgent. In this paper,we discussed the characteristics,importance and necessity of nonclinical safety evaluation for pediatric drugs,considerations for research design,selection of animal species and age,route and duration of drug administration and evaluation indexes. In addition,the characteristics of nonclinical safety evaluation of new traditional Chinese materia medica used for children were analyzed. It is hoped that these studies will not only provide support and reference for nonclinical safety evaluation of pediatric drugs but help accumulate material in formulating relevant guidelines.
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OBJECTIVE:To provide reference for rational use and standard management of antibiotics. METHODS:The relevant information for antibiotics used in the inpatients of our hospital involved in antibiotics special rectification during 2011 to 2014 were extracted from hospital information system,and the relevant data of antibiotics use were analyzed statistically. The changes of several indicators in the inpatients of our hospital were investigated,including the utilization rate and amount of antibiotics,DDDs and the uti-lization rate of typeⅠincision antibiotics for prophylactic use. RESULTS:The ratio of consumption sum of antibiotics in total con-sumption sum were decreasing from 2011 to 2014. The utilization rate of antibiotics and of typeⅠincision antibiotics for prophylactic use were decreased significantly,decreasing from 77.30% and 47.57% in 2011 to 57.24% and 5.89% in 2014. The consumption sum of cefepime occupied the first 3 places in 3 years. DDDs of cefotaxime and cefoperazone/sulbactam occupied the first 2 places in 4 years. CONCLUSIONS:The development of“antibiotics special rectification activities”have achieved remarkable results in our hospi-tal,the various index of antibiotics in the inpatients have been obviously improved,and clinical application of antibiotics become more reasonable,which lay a good foundation for continuous improvement of clinical application and management of antibiotics.
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OBJECTIVE: To analyze the safety monitoring effects of pediatric drug data protection regime in the US and provide the suggestions to improve the safety of pediatric drugs in China. METHODS: Theoretical analysis and case study of Duragesic (Fentanyl transdermal patch). RESULTS: The pediatric drug data protection regime promoted safety monitoring effectively. CONCLUSION: II is necessary to establish pediatric drug data protection system in China by referring to the experience of US, to enhance the lilecycle risk management and the responsibilities of enterprises, so as to improve the safety of pediatric drug.