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OBJECTIVE：To investigate and study the problems in the items labeling of Chinese patent medicine instructions in National Essential Medicines List ，and to provide reference for rational drug use and instruction revision. METHODS ：Totally 268 Chinese patent medicines contained in the 2018 edition of National Essential Medicines List ，including 465 instructions of different . An dard docetaxel as first-line therapy in patients with meta - economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK[J]. Pharmacoeco - dosage forms ，were collected ，and the labeling rate and content problems of drug instructions were counted. RESULTS ：Of the 465 instructions，86.88％ were labeled with cautions. The labeling rates of ADR ，pharmacokinetics，contraindications，drug interactions ， clinical trials ，pharmacological toxicology and pharmacological action were low ，being 20.64％，0.21％，30.1％，1.07％，2.36％， 8.81％，1.93％. All other items were labeled. Incomplete description of ingredients ，incomplete information of decoction pieces and excipients accounted for 2.15％ and 48.81％，respectively；the expression of functional indications was varied ，and there were 12 expression methods ，among which 16.5％ of indications lacked TCM indications ；specifications were not uniform ，and there were 5 expression methods ；usage and dosage were not clearly marked ，and 465 instructions did not mention the usage and dosage for the elderly or pregnant and lactating women. Drug interactions ，ADR，matters needing attention and contraindications were not fully described with no substantive content ；only 0.64％ marked interaction with chemical medicine and 12.68％ marked contraindication content. CONCLUSIONS ：There are some problems in the description of Chinese patent medicine instructions in 2018 edition of National Essential Medicine List ，such as non-standard and incomplete. It is suggested to strengthen efforts to establish and improve the information collection and feedback mechanism of Chinese patent medicine ，and introduce policies to support enterprises to carry out basic and clinical research after listing ；and through actively carrying out basic and clinical research in line with the characteristics of traditional Chinese medicine ，guided by the theory of traditional Chinese medicine ，combined with the latest research results ，so as to further improve the contents of Chinese patent medicine instructions.
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OBJECTIVE：To compare the similarities and differences of antiepileptic drugs between 2019 edition of WHO Model List of Essential Medicines for Children （called“WHO-EMLc”for short ）and 2018 edition of the National Essential Medicines List （called“NEML”for short ），and to provide reference for the improvement of national essential medicines list and formulation of essential medicines list for children. METHODS ：By means of descriptive analysis ，the differences in the varieties ， dosage forms ，specifications and marker symbols of antiepileptic drugs were compared between WHO-EMLc and NEML. The marketing status of antiepileptic drugs included in WHO-EMLc and NEML were analyzed statistically. RESULTS & CONCLUSIONS：There were 9 kinds of antiepileptic drugs included in WHO-EMLc ，all of which were under the category of anticonvulsant/antiepileptic drugs. There were 6 kinds of antiepileptic drugs in NEML of China ，and the other three kinds of drugs included in WHO-EMLc were included in the category of psychotherapy drugs in NEML. Eight kinds of antiepileptic 126 drugs were shared by NEML and WHO-EMLc ， namely 109614043@qq.com carbamazepine， valproic acid ， phenytoin sodium ， pheno- barbital，lamotrigine，diazepam，lorazepam and midazolam. The special antiepileptic drug in NEML was ocazepine ，and edu.cn the special antiepileptic drug in WHO-EMLC was ethylsu c- cinate. Oral dosage forms involved in WHO-EMLc included oral solution ，ordinary tablet，enteric-coated tablet ，dispersed tablet ， etc.，while oral dosage forms involved in NEML included ordinary tablet ，dispersed tablet and oral solution. In terms of dosage form of a single drug ，the drug specifications in WHO-EMLc were more comprehensive than those in NEML. In WHO-EMLc ， lorazepam was labeled with “□”，indicating that it was more effective and safe in similar drugs . Lamotrigine ，midazolam injection and phenytoin （25 mg∶5 mL and 30 mg∶5 mL）were labeled with “*”，indicating that there were special precautions for the drug or dosage form and specification. In NEML ，diazepam was marked with “*”，and diazepam injection was marked with “△”， indicating that diazepam appeared repeatedly under different classifications ；diazepam injection should be used under the guidance of doctors with corresponding prescription qualifications or under the guidance of specialists ，and the use monitoring and efficacy evaluation should be strengthened. In addition ，most of the antiepileptic drugs included in WHO-EMLc had been marketed in China，but the dosage forms on the market were relatively simple ，which could not meet the drug demand of children. Our country could learn from WHO-EMLc selection method to further improve the national essential medicine list ，formulate essential medicine list for children which was suitable for Chinese national conditionsas soon as possible on the basis of disease spectrum and drug clinical comprehensive evaluation. At the same time ，the government should also encourage the development and production of children’s medicines to ensure that children fairly access to drugs.
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OBJECTIVE： To provide reference for improving pediatric medication of National Essential Medicine List （NEML） and establishing Chinese essential medicine list for children. METHODS： NEML （2018 edition） were compared with WHO Essential Medicines List for Children （WHO EMLc） in respects of target population， special symbols， categories and varieties， dosage form and specification. The related suggestions were put forward. RESULTS & CONCLUSIONS： WHO EMLc is specifically used for children under 12 years old， and defines specific age and body mass. NEML is applicable to all age groups （including children）. WHO EMLc includes 4 types of special symbols， i.e. “□” （the drug with the best efficacy and safety in the same kind of drugs， which matches the selection principle of NEML）， “a” （limited age or body weight， not found in NEML）， “*” （special dosage， specially emphasized indications and age not recommended for use， listing substitute drugs， not found in NEML）， “[c]” （placed next to a drug or a specification indicating that they are only used by children； and placed next to a supplementary list indicating that they need expert diagnosis， monitoring facilities， medical care for children， similar to the “Δ” in NEML）. NEML in China includes chemical drugs and biological products， Chinese patent medicines and TCM decoction pieces. Among them， there are 26 categories and 417 types of chemical drugs and biological products. Compared with WHO EMLc， NEML has no blood products and special drugs for newborns. As far as antimicrobial agents are concerned， WHO EMLc has strict limits and classifications. However， due to the lack of guidelines for special antimicrobial agents for children in China， the application of NEML antimicrobial agents in pediatrics is still difficult to define and classify. The number of coincident varieties in the 2 lists was 149， and the coincidence rate was 35.2％. In terms of drug dosage， WHO EMLc’s dosage form are more abundant and flexible， such as scored tablet， compressible fragments， intramuscular injections， and oral solutions suitable for children which are not included in NEML. In terms of drug specifications， 2 lists basically consider about the special needs of children taking small dosage and to some extent take into account the complementarity of dosage forms and specifications. The author suggests that the relevant departments in China should draw lessons from the mature experience of WHO EMLc， add new labeling symbols in NEML， expand drug dosage forms， implement classified management of antimicrobial drugs， and timely launch Chinese Essential Medicines List for Children so as to lay a solid foundation for further improving the accessibility and safety of essential medicines for children in China.
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OBJECTIVE: To investigate and study the 2012 edition of National Essential Medicine List chemical medicines and biological products off-label drug use in pediatrics, analyze the causes of off-label use of medications, provide the suggestion for off-label drug use in pediatrics. METHODS: To adopt questionnaire survey in different regions of the 10 third-grade class-A children's hospital off-label use of medications in 2012 edition of National Essential Medicine List chemical medicines and biological products of 309 types which excluded obstetrics and gynecology medication, family planning administration and national immunization programs with vaccine from 317 types. Excel 2007 software is used for data calculation and statistical analysis. RESULTS: CD20 categories, 22 dosage forms, which accounted for 80% of all drug categories are involved in off-label use of medications in 2012 edition of National Essential Medicine List. (2) Lack of children's dosage (62.95%) is mainly responsible for off-label of drugs. Off-label use of medications mainly manifest in off-labeling with pediatric indications (85.94%), of which labeling with pharmacological action without indication (45.63%) is the main type, and off-labeling with route of medication (66.96%). (3) 2013 edition of Chinese National Formulary (Chemical and Biological Products for Children) and 2010 edition of Chinese Pharmacopoeia of Clinical Medication Information are the main evidence for off-label drug use, account for 34.60% of the total number of cases. (4) 147 types of medicines which involved in off-label use are searched in a database named Micromedex. Indications have been approved by the the US Food and Drug Administration ( FDA) or not which labeling with children's dosage account for 27.10% of the total number of indications. CONCLUSION: Off-label drug use in the 2012 edition of National Essential Medicine List is an important public health issue for children. It reflects the lack of labeling with pediatric information. It is suggested that joint efforts should be paid by departments concerned and more support be provided to further improve the policy for children's medication.
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OBJECTIVE:To provide reference for promoting the prior usage of essential medicines and scientifically selecting of antitumor medicines in the national and local drug reimbursement list. METHODS:Entering the Human Resources and Social Se-curity Bureau websites in 10 cities(Beijing,Shanghai,Guangzhou,Nanjing,Wuhan,Xi’an,Chengdu,Shenyang,Jinan and Gui-yang),drug reimbursement list was downloaded to statistically analyze the containing of antitumor medicines(including 24 essential medicines). RESULTS:In antitumor medicines,there were 5 cities with more than 100 varieties,of which Shanghai had 255 vari-eties,which was far more than other cities;the numbers of medicines in class A were near 30 in all the cities except Beijing(67 va-rieties),and the number of class B was highest in Shanghai and lowest in Beijing. All the drug reimbursement lists in 10 cities con-tained 24 antitumor essential medicines,however,the classification was different according to the dosage forms,among which, parts of formulations of cytarabine(injections),doxorubicin(injections),busulfan (often release oral dosage forms),fluorouracil (often release oral dosage forms,injections),cyclophosphamide(often release oral dosage forms,injections),methotrexate(often release oral dosage forms,injections)and cisplatin were classified as class A medicines in all cities;oxaliplatin(injections)and pa-clitaxel (injections) were classified as class B medicines;busulfan,fluorouracil,cyclophosphamide and methotrexate were classi-fied as class B in Shanghai only. CONCLUSIONS:There are some differences in the distribution of antitumor essential medicines in drug reimbursement list in each city,the varieties in developed cities are relatively more,and developing cities are less. It is sug-gested to consider the tumor epidemiology characteristics and economic situations,reasonably select antitumor essential medicines into drug reimbursement list and reasonably adjust the proportion of class A and B to ensure the basic medication and drugs’reim-bursement.
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OBJECTIVE:To provide reference for dynamic adjustment of low-cost medicine lists and better guarantee of low-cost supply in those provinces,autonomous regions and municipalities[referred to provinces(autonomous regions or municipali-ties)]. METHODS:The varieties and frequency of medicines in the national and 31 province(autonomous regions or municipali-ties) lists were counted,and the influential factors were analyzed. RESULTS:The National Low-cost Medicine List included 533 varieties of medicines,including 283 western medicines,250 Chinese patent medicines and 60 exclusive varieties. There were total-ly 973 varieties of medicines in the 31 province(autonomous regions or municipalities),including 332 western medicines,630 Chi-nese patent medicines,11 ethnic medicines and 71 protected Chinese medicines. There was no big difference in the varieties be-tween the eastern and western areas,and less in the central areas. Guangxi province had the largest number of selected medicines (345 varieties) and Jiangxi province had the smallest (10 varieties). In all the varieties,Chinese medicines had a larger number than western medicines,and also better concentration. Ketotifen was the most frequent western medicine and Tongbianling capsule was the most frequent Chinese patent medicine,which appeared 30 and 29 times separately. The Provincial Low-cost Medicine Lists and the Essential Medicine Supplement Lists had a poor coincidence rate,and there was a moderate correlation between the varieties and the number of pharmaceutical manufacturers in the province(autonomous regions or municipalities). CONCLUSIONS:The adjustment of low-cost medicine lists should be combined with these in province(autonomous regions or municipalities) near-by,and notice the linkage with national essential medicine system to fundamentally ensure the clinical medication requirements of patients.
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OBJECTIVE:To provide references for the improvement of National Essential Medicine List.METHODS:The pertinent literature both at home and abroad was reviewed;the status quo and the problems of the National Essential Medicine List of China were expounded.RESULTS & CONCLUSION:It is suggested that its coverage be extended to cover the list of orphan drugs,meanwhile,an urban-rural essential medicine list and an essential medicine list for children should be established to enhance the hierarchy and practicability of National Essential Medicine List.