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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 evaluate the effects of the implementation of National Essential Medicine System on the utilization rate of hormone drugs in primary medical institutions in China systematically.METHODS:Retrieved from CJFD,Wanfang database and VIP,the literatures about the use of hormone drugs were collected before and after the implementation of National Essential Medicine System.Meta-analysis was performed by using Stata 13.0 software after utilization rate dam extraction and quality evaluation with Cochrane system evaluator manual 5.1.0.RESULTS:A total of 20 literatures were included.Results of Meta-analysis showed that utilization rate of hormone drugs after the implementation of National Essential Medicine System was significantly lower than before implementation,with statistical significance [RD =-0.03,95 ％ CI (-0.05,-0.02),P＜ 0.001].Results of subgroup Meta-analysis of utilization rate of hormone drugs in different areas before and after the implementation of National Essential Medicine System showed that the utilization rate of hormone drugs in eastern areas was significantly lower after the implementation of National Essential Medicine System than before [RD=-0.06,95％ CI(0.09,-0.03),P=0.001] with statistical significance.There was no statistical significance in the utilization rate of hormone drugs in middle area [RD=-0.02,95 ％ CI(0.06,0.02),P=0.235] or western area [RD=-0.01,95％ CI (-0.02,0),P=0.122] before and after the implementation of National Essential Medicine System.CONCLUSIONS:The implementation of National Essential Medicine System reduces the utilization of hormone drugs in primary medical institutions.The effect of the eastern area is more obvious than in middle and western area.
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OBJECTIVE:To provide reference for further implementation and perfection of National Essential Medicine Sys-tem. METHODS:Stratified random sampling method was used to select 252 doctors from Sichuan Luzhou. Questionnaire survey was performed among them about recognition and behavior of them to National Essential Medicine System. Related investigation da-ta was analyzed statistically. RESULTS:A total of 252 questionnaires were issued and 243 valid questionnaires were collected with effective recovery rate of 96.4%. Of 242 respondents who had heard of National Essential Medicine System,the respondents who had heard but not clear occupied the highest percentage (52.1%). Of 149 participants who had participated in national essential medicine knowledge training or study,the proportion ofonly one knowledge training or studywas the highest(57.0%). The sur-vey respondents had a maximum of 45.0% and a minimum of 16.5% of common sense about National Essential Medicine System. After the implementation of National Essential Medicine System,respondents often propagandized National Essential Medicine Sys-tem to diagnosis and treatment objects accounted for only 23.1%. The proportion ofno changechosen for items of work motiva-tion,work efficiency and workload was the highest (all occupied 58.3%);the proportion oflittle influencechosen for item of clinical medication habit was the highest(38.8%). 86.4% of respondents were willing to give priority to the use of national essen-tial medicines;the top 4 reasons wereto obtain training and guidance on the use of essential medicinesto set utilization rate of essential medicines in primary health care institutionsto strengthen the propaganda of National Essential Medicine Systemto evaluate physician's prescriptions regularly. 13.6% were not willing to give priority to the use of national essential medicines;the top 4 reasons werelack of the confidence of the use of national essential medicinespoor accessibility of essential medicinesfear of medical accidents due to prescription essential medicines,lead to medical disputesdon't know what is essential medi-cine. CONCLUSIONS:The primary physicians'perceptions of National Essential Medicine System and the implementation of the System in Luzhou need to be strengthened. The main reason is that few national essential medicine knowledge training or study and poor effects. That the government's supporting poli-cy is not perfect may be one of reasons.
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OBJECTIVE:To improve the level of sampling test management of national essential medicine in China.METHODS:The sampling test system of national essential medicine was analyzed in terms of background,difficulty,experience and effect,so as to make suggestions for the work in the future.RESULTS & CONCLUSIONS:In view of the difficulties,such as personnel,equipment,funds and mechanism,sampling test of national essential medicine can be finished successfully by "establishing management principle,information system and focusing on evaluation".The basic database of national essential medicine quality has establisaed successfully so as to establish the quality database of national essential medicine,strengthen the supervision of national essential medicine,form the resultant force to prevent the risk of quality safety.It is suggested to consider about both "full coverage" and "randomness",play the role of "information database" and "risk warning" and objectively treat its "versatility" and "scientificity" of sampling test management of national essential medicine in the future.
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OBJECTIVE:To improve the level of sampling test management of national essential medicine in China.METHODS:The sampling test system of national essential medicine was analyzed in terms of background,difficulty,experience and effect,so as to make suggestions for the work in the future.RESULTS & CONCLUSIONS:In view of the difficulties,such as personnel,equipment,funds and mechanism,sampling test of national essential medicine can be finished successfully by "establishing management principle,information system and focusing on evaluation".The basic database of national essential medicine quality has establisaed successfully so as to establish the quality database of national essential medicine,strengthen the supervision of national essential medicine,form the resultant force to prevent the risk of quality safety.It is suggested to consider about both "full coverage" and "randomness",play the role of "information database" and "risk warning" and objectively treat its "versatility" and "scientificity" of sampling test management of national essential medicine in the future.
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OBJECTIVE:To provide reference for the further promotion ofNew Medical Reformand the further implementa-tion and improvement of National Essential Medicine System. METHODS:By systematic sampling,1728 outpatient prescriptions were randomly selected from a community health service center in Foshan during 2012 to 2015,and then analyzed and compared statistically in respects of the amount of drugs,rational drug use indexes,prescription cost,main disease composition,treatment cost. The change rules and characteristics of all the above mentioned information were all studied. RESULTS:The average number of medicines per prescription and the number of essential medicines decreased year by year,Comparied with 2012,the proportion of antimicrobial agents,the proportion of two or more antimicrobial agents,the proportion of injection prescription and the propor-tion of transfusion prescription were significantly reduced,the cost of medical treatment of patients decreased significantly;medi-cine cost and medicare reimbursement amount had increased to different extents,there was statistical significance(P<0.05). Multi-ple linear regression analysis(stepwise)showed that the cost of medical treatment was closely related to rationality of prescriptions. Respiratory diseases,cardiovascular and cerebrovascular diseases,gastrointestinal diseases were the top 3 of the major diseases, the proportion of prescriptions for respiratory diseases,gastrointestinal diseases decreased year by year,while that for cardiovascu-lar and cerebrovascular diseases increased year by year. CONCLUSIONS:The promotion ofNew Medical Reformand the imple-mentation of National Essential Medicine System play a positive role in promoting rational drug use and the quality of medical ser-vice in community health service center. However,there are still many problems in the community health service centers,such as too many medicines each prescription,the lack of diagnosis and treatment ability,the defects of medicine selection and administra-tion.
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OBJECTIVE:To provide reference for further developing the use of national essential medicine system and formulat-ing the plan for essential medicine that is consistent with the local situation. METHODS:A questionnaire survey was conducted on site to collect the 1 800 medical staffs chosen from 35 community health service institutions in Xinjiang with multi-stage stratified random cluster sampling to investigate the cognition to the national essential medicine,and it was statistically analyzed by SPSS 13.0 software. RESULTS:Totally 1 800 questionnaires were sent out and 1 642 were effective received with effective recovery of 91.2%. 26.5% acquired such specialized knowledge through professional training,and 50.0% by books and Internet;62.4% did never participated in training. Only 20.2% shared it for patients. The average score of recognition for the system was(6.09±2.86) scores,which was related to age,education,profession,work experience and the title (P<0.01). 75.2% supported this system. CONCLUSIONS:The basic medical staff just have some know of the concept of national essential medicine,but the understanding is still low. It is suggested to improve the cognition level by seminars and continuing training to strengthen reliability of all ethnic groups on essential medicine,change their bad medication habits,popularize common sense of rational drug use and form a good atmosphere for the implementation of the national essential medicine system in the whole society.
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OBJECTIVE:To promote the healthy development of TCM decoction piece. METHODS:Based on analyzing the literature,national policy and data,the advantages and urgent problems of bringing TCM decoction piece into the National Essen-tial Medicine List were summarized,and the suggestions for its health development were provided. RESULTS:Bringing TCM de-coction piece into the National Essential Medicine List relieved the economic burden of patients and provided opportunity for the de-velopment of TCM decoction piece industry. However,it existed problems,such as production,circulation,storage and monitor-ing;mutual conflict in the relevant supporting policies;inconsistent medicare reimbursement;and urgent improvement of quality standard. CONCLUSIONS:The relevant departments should establish and improve the quality standard system of TCM decoction piece,and clear the varieties of TCM decoction piece in the National Essential Medicine List,perfecting supporting policies such as medicare reimbursement and attaching importance to the training of professional talents can ensure scientific and rational services for the public health.
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OBJECTIVE:To provide reference for promoting the further implementation of national essential medicine system and related policies. METHODS:Hospital information system(HIS),Excel 2007 and SPSS 13.0 software were adopted to statisti-cally compare the changes in equipping the specific varieties of national essential medicines and the differences in the overall use of national essential medicines before and after implementing the National Essential Medicine System (2012 edition)(referred to NEMS,2012 edition) and cancelling drug addition policy in a public hospital in Chengdu. RESULTS:After implementing the NEMS(2012 edition),60 kinds of equipping national essential medicines increased in the hospital,including 38 kinds of chemical medicines and biological products,22 kinds of Chinese patent medicines;compared with before,the percentage of essential medi-cines to prescription drugs,prescription rate of essential medicines,average essential medicine in a single prescription and prescrip-tion rate of all essential medicines were significantly improved(P0.05). CONCLUSIONS:After implementing the NEMS(2012 edition)and cancelling drug addition policy,the equipping na-tional essential medicines are still insufficient,some indexes do not meet the requirements of Sichuan Province. It is suggested that the public medical and health institution at county-level should to choose suitable national essential medicines based on its specific situation;strengthen publicity and education,improve the popularity of physicians to national essential medicine system;strengthen the assessment and management of the use of essential medicines for physicians. Meanwhile,the government and the relevant de-partments are suggested to explore more effective and reasonable compensation mechanism to improve the enthusiasm of physicians to use the national essential medicines.
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OBJECTIVE:To provide reference for the further improvement of national essential medicines system. METHODS:Taking theBull's-eyecity Chengdu as an example,based on the trading areas,the existing problems in implementing essential medicine system were analyzed by qualitative and quantitative research methods,and countermeasures were put forward. RESULTS:From the point of view of quantitative data,the first level trading areas of both proportions of medical personnel per thousand ur-ban population and numbers of primary medical and health institutions per 100 thousands population in Chengdu were the lowest. From 2010 to 2012,the outpatient and inpatients increased 1.09 million people and 0.16 million beds per day in Chengdu primary health care institutions,the largest increase in the first level trading areas,and increase and decrease in the second and third level trading areas;outpatient and inpatient drug costs fell respectively 4 yuan and 109 yuan,medicine proportion declined 6.7%,in-crease in the first level trading areas,and decreased to varying degrees in the second and third level trading areas. From the point of view of qualitative interviews,the service ability got enhancement,but still could not meet the services demand,especially the pressure in the first level trading areas near center district remains heavy;drug cost was under controlled,but the subsidies needs to be increased,the per capita drug costs in the first level trading areas remains high;the drug income and medicine proportion were inhibited,especially the significant fell in the second and third level area,but the decrease of income may restrict develop-ment. CONCLUSIONS:It is suggested that more targeted drugs are needed for meeting the services demand,more sophisticated policy are needed for improving the subsidies,and more comprehensive medical conditions are needed for ensuring institutions'de-velopment.
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OBJECTIVE:To provide reference for promoting the further implementation of national essential medicine system and rational use of drugs in community health service center. METHODS:Outpatients’information in Changqiao Street Communi-ty Health Service Center from Sept. 2,2009 to Nov. 25,2014 was collected to statistically analyze the drug variety,the number of prescriptions,the consumption sum and the DDDs before and after the implementation of essential medicine system and after the supplement of non essential medicines. RESULTS:Essential medicines occupied the main position of drug utilization in each stage, with substantial growth in respects of consumption sum and number of prescriptions;the sum of Chinese patent drugs and essential cardiovascular drugs occupied more than 50% of the total consumption sum and number of prescriptions,with higher growth rate;essential medicines occupied the top 10 in respects of consumption sum and DDDs,among which most were the drug varieties in“Shanghai supplement essential drugs in community health service center”(2010 Edition),with some overlap the varieties in“Na-tional Essential Medicine System”(2012 Edition);cardio-cerebrovascular drugs occupied the dominant position;the growth rates of cefotiam and atorvastatin took up the top 2 ranking in the list of consumption sum,while the growth rates of calcium carbonate D3 and irbesartan and hydrochlorothiazide took up the top 2 ranking in the list of DDDs. CONCLUSIONS:Essential medicine cata-log covers the common drugs in the community health service center,in which the rational use of Chinese patent drugs and antibac-terial deserves needs to be noticed. The clinical rational use of the essential medicines should be strengthened,the essential medi-cine catalog should be adjusted and non essential medicines should be supplied when necessary in order to truly meet the needs of patients and optimize the allocation of medical resources.
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OBJECTIVE:To provide reference for further optimizing the implementation of national essential medicine system in Liaoning province. METHODS:54 primary medical institutions in Liaoning province were selected,and document research,data collect and comparative analysis were performed for the statistical analysis of equipment,usage and distribution of essential medi-cines,etc. RESULTS:The average equipment of essential medicines in surveyed institutions in the 3rd quarter of 2012 and 2014 were 223.8 and 325.0 product regulations,respectively,with equipment rates of 42.9% and 46.8%;average outpatient prescription drug expenses per person in community health service centers in the 3rd quarter of 2012 and 2014 were 61.7,62.1 yuan and town-ship hospitals were 38.1,39.8 yuan,respectively,which were higher than national average level;shipping amount of manufactur-ers with the top 24 shipping amount was 43.00% to total amount,and 58 manufactures had no shipping amount;usage amount of varieties with the top 7 usage amount was 25.77% to total usage amount of essential medicines;distribution amount of commercial companies with the top 4 distribution amount was 41.27% to total amount. CONCLUSIONS:54 primary medical institutions in Lia-oning province equipment exist some problems,including low distribution rate,high price,shortage of medicines,high usage and distribution concentration,and so on. It is suggested that distribution enterprises should strengthen the construction of supply chain platform,optimizing distribution network and improving distribution capacity,and the government should strengthen supervision and financial support based on guarantee of reasonable profits of production companies and distribution companies.
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OBJECTIVE:To provide basis for the further implementation of the national essential medicine system in township hospitals. METHODS:By issuing questionnaires,an investigation was made on the basic information of township hospitals imple-menting“Health Ⅺ project”in Heilongjiang Province before and after the implementation of the national essential medicine system. Prescriptions of 4 days in 2008 and 2012 were extracted,statistically compared and analyzed by using random system cluster sam-pling medication rationality was evaluated. RESULTS:40 questionnaires and 3 173 prescriptions were recycled during the investiga-tion in 2009,and 40 questionnaires and 4 197 prescriptions were recycled in 2013. Compared with the township hospitals in project areas in 2008,the proportion of practice(assistant)physicians per township hospitals and the average number of beds were respec-tively increased by 1.5%and 4.6 in 2012. The average kind of prescription drugs was decreased from 2.9 kinds to 1.7 kinds,the us-age rate of infusion was decreased from 46.5%to 30.6%,antibiotics was decreased from 61.5%to 40.0%,two or more kinds anti-biotics was decreased from 18.9% to 4.8%,hormone was decreased from 11.9% to 4.2% and the rate of combined use of antibiot-ic and hormone was decreased from 9.2% to 2.8%;the drug expenditure of each outpatient service and hospitalization was respec-tively decreased 19.1% and 16.4%. There were significant differences(P<0.05). CONCLUSIONS:After the implementation of na-tional essential medicine system,the medication rationality of township hospitals in project areas has made great improvement,es-pecially on the aspects of prescription drug number,the combined usage rate of antibiotic and hormone,the usage of hormone and the drug expense burden,which reaches the policy targets;although the infusion rate and the usage of antibiotic show great im-provements,there are still some gaps between the current situation and the policy targets;the obvious decrease of the average drug expenditure of each service doesn’t make a relative decrease of the average expenditure of each medical service,which has a little increase.
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Objective:To conduct a systematic review on the implementation effects of National Essential Medi-cine System ( NEMS) since the new health care reform and provide some suggestions to further improve the NEMS. Methods:Databases and relevant international organization reports were searched to collect studies related to the im-plementation of NEMS in China. The database search occurred from January 2009 to December 2014. Results:A to-tal of 1 292 studies were finally included, encompassing 1,277 Chinese papers, 12 English papers, and 3 WHO/HAI reports. A lot of researches have been done on NEMS, but the techniques of NEMS evaluation are not perfect. The sample representativeness is poor, and the longitudinal follow-up studies of the microscopic view is insufficient. . Evi-dence-based evaluation research using big data has just started. Conclusions: The research on NEMS should be strengthened. The NEMS evaluation should not only be based on national conditions, but it should also be in combi-nation with an international, multidimensional evaluation framework in terms of availability, affordability and rational drug use, so as to provide evidences to perfect the NEMS.
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Objective:To evaluate the knowledge, attitudes and practices ( KAP) on National Essential Medi-cine System among pharmacists from secondary public hospitals in Shaanxi province. Methods: The quantitative re-search of KAP questionnaire is used, and the content of questionnaire includes personal information, knowledge, atti-tudes and practices. Results: A total of 520 copies of questionnaires were distributed and 82. 3% were effective. Respondents’ overall knowledge and attitudes are at the middle level;the main way to obtain knowledge is via training and meeting;respondents’ education level and frequency of participating in training have a significant impact on their level of knowledge;the degree of attention paid by hospitals has yet to be strengthened; and respondents are mostly concerned about the supply and distribution of essential drugs. Conclusion: In order to improve the awareness and recognition levels of pharmacists on the implementation of National Essential Medicine System in secondary public hospitals, the government should take the relevant measures, including introducing the high educated persons into secondary public hospitals, organizing related training programs and standardizing the daily monitoring of essential drugs in secondary public hospitals, etc.
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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 understand the status of the use of national essential medicines,and provides reference for further implementing the national essential medicine system and promoting the priority use of national essential medicines. METHODS:Ac-cording to the statistics analysis of the use of national essential medicines(for example the antihypertensives and oral hypoglycemic agents)in Beijing,Shanghai and Guangzhou areas,the related influential factors about priority use of national essential medicines were explored. RESULTS:The proportions of use amount of national essential medicines in our hospital in 2012-2013 to the total amount of medicines were 21.20% and 18.75%,respectively,with a downtrend;the proportion of antihypertension drugs to total amount was only 14.05%and 13.70%,respectively;compared with the same generic drugs with individual pricing,the GMP prod-ucts of Valsartan capsule,Bisoprilol tablet and Amlodipine tablet had no advantages in DDDs,or even lower. DDDs of individual pricing drugs of Acarbose tablet in medical institutions in Beijing area and tertiary hospitals in Shanghai and Guangzhou area in 2011-2012 were much higher than the generic GMP products with the same generic drugs. CONCLUSIONS:The clinical use of na-tional essential medicines in our hospital and parts of the country still remains to be further improved,the influential factors includ-ed reimbursement mechanism,awareness rate of related knowledge,physicians’habit to drug use and pursuing economic benefits. The propaganda and training should be strengthened,awareness rate of medical staff and publics to national essential medicines, the availability of national essential medicines and national essential medicine system and medicare reimbursement payment policy should be improved,and the priority use of national essential medicines should be promoted by more measures combination use.