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OBJECTIVE To provide suggestions and reference for enriching the selection of anti-infective medicines for children in China and promoting the establishment of the Essential Medicine List for Children in China. METHODS Descriptive analysis method was used to statistically compare the differences and similarities of anti-infective medicines included in the World Health Organization Model List of Essential Medicines for Children （EMLc）， World Health Organization Model List of Essential Medicines （EML） and National Essential Medicine List （NEML） in terms of drug category， variety， dosage form， specification， symbol mark， etc. RESULTS All anti-infective medicines of EMLc were covered by EML （85.3%）. NEML lacked the information of anti-infective medicines relatively， and contained few new categories； for example， the third-generation and above cephalosporins in EMLc were not included， and the drug dosage forms were also relatively limited （mainly tablets， capsules and injections）， but the specifications were relatively rich. CONCLUSIONS With reference to EMLc， the guidance on the use of essential medicines for children in China should be added from the aspects of age， body weight， combined medication， etc.， and the dosage forms suitable for children such as oral liquid preparations and scored tablets should be added to NEML； when updating the NEML the newer drugs suitable for children such as cefixime and dacatavir should be included. Finally， with reference to the continuity of EML and EMLc， the Essential Medicine List for Children in China should be established based on NEML to meet the drug needs of children and promote the safe use of drugs in children.
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OBJECTIVE To sort out the common presentation forms and components of the framework of domestic and foreign essential medicine lists （EMLs）， in order to provide reference for optimizing the framework of the Chinese EML. METHODS The latest edition of the EMLs of WHO， China， South Africa， India， Malaysia and other typical countries were compared， and the similarities and differences of the presentation form and constituent elements of the list framework were analyzed. RESULTS & CONCLUSIONS The common presentation forms of WHO and typical countries’ EMLs included version， classifications and symbols， of which management ideas， functions， and implementation difficulties varied； common framework elements included target population， hospital levels， drug use conditions， core and supplementary lists and procurement priority. Through comparison， it was found that the information covered by the Chinese EML was relatively thin， and the framework design had not yet fully played the ideal role in guiding clinical rational drug use and optimizing the allocation of health resources， and there was still some room for improvement. It is recommended that China clarify the characteristics and roles of different presentation forms of the EML， and reasonably set the EML framework based on national conditions and development needs； the multi-dimensional drug information should be supplemented， such as clinical use， economy， and policy attributes of drugs in the EML， to ensure the rational use of essential drugs； it is also necessary to add “the level of hospitals” in the framework of the EML， refine the management requirements for the allocation and use of essential medicine， and optimize the resource allocation of hospitals.
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Background: Fixed dose combinations (FDCs) are combinations of two or more active drugs in a single pharmaceutical formulation. The rationality of FDC is a controversial and challenging issue in today’s practice of medicine. Aims and Objectives: The aim of the study was to assess the prescription pattern and rationality of FDCs in a tertiary care hospital. Materials and Methods: This is a record-based cross-sectional study conducted in the Department of Pharmacology, Government Medical College, Thrissur. The data were collected from the case records of 183 patients admitted under various departments during the month of January 2019. The FDCs prescribed were listed and the prescription pattern was assessed. All the FDCs were evaluated for rationality with the help of a comprehensive seven-point criteria by Panda et al. The data were analyzed using Epi info 7. Descriptive statistics were used to analyze the data. Results: Out of 183 case records, 39.3% contained at least one FDC, 13.1% contained two FDCs, and 4.4% contained three FDCs. The different drug classes prescribed as FDCs include anti-infective drugs 45%, vitamins and minerals 33%, analgesics 9%, and miscellaneous drug combinations 13%. The most prescribed anti-infective drug FDC is amoxicillin with clavulanic acid combination (56%). In our study, 92.5% of the antibacterial FDCs prescribed were rational and 7.5% irrational. According to the World Health Organization rationality criteria, 62% of the FDCs prescribed were rational and 38% were irrational. Conclusion: The present study showed the increased use of FDCs in tertiary care teaching hospital and most of the FDCs prescribed were rational (62%).
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OBJECTIV E To in vestigate the situation ，achievements and proble ms of consistency evaluation policy of generic medicines in China. METHODS The descriptive analysis was performed after collecting and sorting out the information of generic medicine passing consistency evaluation （GMPCE） published on the official website of the National Medical Products Administration. The basic information ，the distribution and changes of GMPCE were analyzed statistically in National Essential Medicine List （hereinafter refer to as “essential medicine list ”），Medicine List for National Basic Medical Insurance ，Industrial Injury Insurance and Maternity Insurance （hereinafter refer to as “medical insurance list ”）and the result of the successful selection of centralized medicine procurement organized by the state （hereinafter refer to as “centralized procurement list ”）. RESULTS From 2017 to 2021，415 chemical generic drugs had passed consistency evaluation in China ，including 309 varieties，1 822 specifications， 6 dosage forms ，and 17 pharmacological mechanisms ，basically belonging to 30 provinces，and 492 drug manufacturers （except 12 products had not been found the manufacturers ）；the proportion of GMPCE in essential medicine list increased from 0.96％ in 2012 edition to 25.40％ in 2018 edition；that of GMPCE in medical insurance list increased f rom 2.13％ in 2017 edition to 11.68％ in 2021 edition；in the first 5 batches of centralized procurement list，GMPCE accounted for 81.65％，and the maximum price drop after entering the list was 97.52％. CONCLUSIONS The policy linkage has been achieved with the continual increase of the number of GMPCE and their total amount in three lists in China. The accessibility and affordability of related medicines have been improved with the apparent decrease of the price of those medicines. H owever，total number of GMPCE is a little small，with the higher repetition rate of variety and the low proportion in the three lists ；the guarantee measures of those medicine supply need to be strengthened.
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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 o ptimize the t ype of nervous system medicines in National Essential Medicine List of China. METHODS：Various editions of WHO Essential Medicine Model List （WHO EML ）were consulted ，the collection of nervous system medicines was analyzed statistically ，and 2017 edition of WHO EML was compared with 2018 edition of National Essential Medicine List of China （NEML）. RESULTS ：During 1977-2017，the total number of nervous system medicines and disease coverage included in each edition of WHO EML had little change. Compared with 2017 edition of WHO EML ，2018 edition of NEML contained more medicines for nervous system disease （54 medicines vs. 30 medicines），and covered more disease types ， such as dementia （huperzine A ）and neuralgia （pregabalin），etc. However ，for the treatment of multiple sclerosis ，neuralgia， dementia and other diseases ，there were not many medicines to choose ，and some similar medicines （with the same or similar mechanism of action ）were collected repeatedly and some medicines had serious adverse reaction. CONCLUSIONS ：It is suggested that National Essential Medicine List should be continuously optimized and perfected ，the varieties of essential medicines for the treatment of nervous system diseases should be increased appropriately ，for improving the treatment effect of such diseases and reducing the cost burden of patients.
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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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Background: One of the important factors in health policy is recognised to be rational use of medicines (RUM). Physicians can influence the health and well-being of patients by prescribing appropriate drug in right doses and they should be taught to prescribe rationally at the earliest of their professional carrier.Methods: This cross-sectional, questionnaire-based study was carried out in SMHS hospital which is a tertiary-care teaching hospital associated with Government Medical College, Srinagar, Jammu and Kashmir, India.Results: Out of 106 resident doctors enrolled in the study, 96.2% respondents were aware about the term essential medicines of India, and 47.6% had National List of Essential Medicines of India available at their work place. When the participants were questioned about the term RUM only 17% of them responded positively, but majority of the resident doctors (88.67%) were aware about the ingredients of the drugs they use to prescribe. Though only 3.7% of our participating doctors always use essential medicines during their prescription writing but majority of them (96.22%) would always use to inform the patient regarding disease, drug therapy and monitoring of drug therapy.Conclusions: Considering the fact that respondents are future prescribers they should be aware of all aspects about RUM and improper knowledge in certain areas of RUM is a matter of concern that needs to be addressed.
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Background: In modern world, poor compliance has been the main reason of therapeutic failure. Many factors may be responsible for this. The reasons highlighted may be adverse drug reactions (ADRs), pill burden or economic reasons. Fixed drug combinations (FDC) have helped to solve this problem. The present study was conducted to see the ADR due to fixed dose combinations.Methods: After approval from institutional ethics committee, an observational study was conducted over a period of six months in December 2018 to May 2019 in adverse drug monitoring centre, GMC Jammu.Results: A total number of 112 ADRs were reported during the study period. FDCs were responsible for ADRs in 64 patients and single drug was responsible in 48 patients. As per latest WHO essential drug list, irrational FDC were responsible for ADRs in 44 patients and rational FDCs were responsible for ADRs in 20 patients.Conclusions: The results of present study underscores that drug combinations, FDC rational as well as irrational substantially contribute towards the pool of total ADRs.
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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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Background: Fixed Dose Combinations (FDCs) are defined by the World Health Organization (WHO) as combination of two or more active ingredients in a fixed ratio of doses. According to the FDA, “two or more drugs may be combined in a single dose when each component makes a contribution to the claimed effects, and the dosage of each component (i.e., amount, frequency, and duration) is such that the combination is safe and effective for significant patient population requiring such concurrent therapy. However, certain disadvantages like incompatible pharmacokinetics, inflexible dose ratio, increased toxicity and cost, contraindication of one component of the FDC decreased their utility. Adverse effect of any one component also limits their use. The aim of the study is to compare and evaluate the knowledge, attitude and practices about prescribing fixed dose combinations among junior resident doctors (JRs) and interns (INTs) at SDM College of Medical Sciences and Hospital Dharwad.Methods: A cross-sectional study was carried out in 134 doctors using pre-validated 10 item questionnaire with details of participant’s information followed by questions regarding knowledge, attitude and prescribing practice of fixed dose combinations was used as a tool, administrated to all the resident doctors and the collected data was analysed.Results: Our study revealed that knowledge about FDCs was lacking in JRs and INTs. They were not able to point out the actual advantages and disadvantages of FDCs. Knowledge about rational/irrational, banned FDCs and availability of WHO EML was also lacking.Conclusions: There is need to improve knowledge about rationality, essential medicine list, usage and banned FDCs in undergraduate medical students to promote the rational use of drugs.
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Objective To find a selection method system appropriate for China's essential drug list.Methods Collection and analysis of technical paper literature on essential drug list developement,adjustment technical papers,and literature on evidence-based medicine,pharmacoeconomics evaluation,and medical insurance budget analysis from WHO and other countries.On such basis,a method system for selecting China's essential medicine list can be proposed,with its feasibility analyzed and demonstrated.Results The GRADE assessment proposed by WHO was used to evaluate the efficacy and safety of the drug;the pharmacy economics evaluation is added to assess the economic efficiency;these were aided by the pharmacoeconomics evaluation for a comprehensive evaluation of the pharmacoeconomics of the drug in question,supplementing analysis of the medical insurance,and ensuring its affordability of essential medicine so selected.The theory of this system is well developed,and supporting software ready for application.Examples in Zhejiang Province regarding essential medicine for diabetes have proved this method feasible.Data acquisition constitutes a major roadblock for scientific selection due to barriers against medical insurance data sharing.Conclusions Theoretic basis and method tools are fully available for essential medicine selection,and the selection method system as proposed in this study prove feasible to some extent.Decision makers are recommended to scientifically select the essential drugs,and to encourage data sharing,in order to make the list more scientific and pragmatic.
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Objective:To establish an evaluation index system and quantitative method of evidence-based selec-tion of essential medicines in China and use Analytical Hierarchy Process (AHP) to construct the weight of the in-dex. Methods:Through the expert consultation method,the initial index system was established,after the experts ar-gument on the matrix of every two points, adjust the indicators, build the final index system, and then through the AHP,by the experts to determine the weight of the indicators. Results:Based on the literature study and expert con-sultation,the evaluation index system and its weight of the selection criteria of the basic drug were established. There are 8 indexes in the first-level indicators and the weight distribution was from high to low,the efficacy,safety,clini-cal guideline recommendation,quality reliability,economy,ease of use,list included,and availability. The second-ary indicators include 18 indexes. To improve the operability,the first level indicators are adjusted while the second level indicators are refined simultaneously. Conclusion:The index evaluation system determined by expert argumenta-tion and analytic hierarchy process in this study can be used to evaluate the medicines listed in the essential drug list and provide evidence for selection of essential medicines in China. It has certain theoretical feasibility. The empirical research shows that the index also has practical operability and can be improved.
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Background: The objective of present study was to assess the drug utilization pattern among the geriatric patients. Methods: Totally, 150 prescriptions of patients’ ≥65 years admitted in the medicine inpatient department of MVJ Medical College and Research Hospital, Hoskote were noted from September 2013 to March 2014 and demographic profile, drug utilization pattern, commonly used drugs as per anatomical therapeutic chemical classification (ATC) and WHO core indicators were assessed after taking informed consent from the patients. Results: Out of 150 patients, average age of geriatric patients was 66.83 years with female preponderance (59%). Maximum number of patients were having respiratory disorders (66.67%) followed by diabetes mellitus (35.3%), and cardiovascular diseases (32.67%). 76% patients had co-morbid diseases like diabetes mellitus (n=53), hypertension (n=49), and chronic obstructive pulmonary disease (n=41). A total of 849 drug formulations, containing 1050 active ingredients, were prescribed with average number of 7 (1050/150) drugs per prescription. Only 70 formulations were prescribed by their generic names, which is less than that prescribed by their brand names 779 and total of 146 (17.19%) drugs were prescribed as fixed dose combinations. Only 45.47% drugs were according to WHO Essential Medicines List. Drugs acting on respiratory system (n=189) were the most commonly used drugs in our study followed by drugs acting on the gastrointestinal system (n=130), antimicrobials (n=113), cardiovascular system (n=112), endocrine (n=83), and nutritional supplements (n=72). Polypharmacy was prevalent in 62% and about 22.67% of patients received <5 drugs. Pantoprazole was most frequently prescribed drug followed by aspirin 75 mg, adrenergic, and anticholinergic bronchodilators. Conclusion: Thus, irrational prescribing and polypharmacy were prevalent among elderly. Drug utilization data can help in assessing the quality of care given to the geriatric patients and promote rational use of medicines.
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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 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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Background: Irrational prescribing is a common phenomenon, seen among medical practitioners. Knowledge, awareness, and attitude denote the practicing trends among the practitioners. The objective of this study was to describe the prescribing practices in Ophthalmology outpatient department (OPD) to promote rational prescribing. Methods: This study was conducted between January 2011 to June 2011, in Department of Pharmacology and Ophthalmology, SGRRIM and HS, Dehradun, Uttarakhand. A total number of 255 prescriptions were randomly collected from the Ophthalmology OPD and were analyzed for various parameters using national essential medicine list 2011 and World Health Organization drug use indicators. Results: A total number of 255 prescriptions were evaluated for prescribing pattern, 153 (60%) patients were between 16 and 45 years of age, the male: female ratio was 1.13:1. 237 (93%) patients from middle socioeconomic status. Diseases pattern observed were conjunctivitis 102 (40%), refractive error 45 (17.64%), stye 12 (4.7%), cataract 9 (3.52%), and miscellaneous 87 (34.12%). One hundred and thirty-eight (54.11%) patients received antimicrobial agents, fluoroquinolone (ofloxacin, moxifloxacin, gatifloxacin, etc.) were the most frequently prescribed antimicrobial drugs, analgesics (diclofenac and ketorolac) were prescribed to 45 (17.64%) patients, 54 (21.17%) received steroids (dexamethasone and prednisolone), 96 (37.64%) patients received other drugs (carboxymethylcellulose [CMC], multi-vitamins, zinc preparations, acyclovir, and anti-allergics). Fixed dose combinations (FDCs) were used in 90 (35.29%) patients, the most common combination was antimicrobials with steroids. All the drugs were prescribed by brand names and 1.9 drug/prescription was used. Conclusion: Topical antimicrobial agents are the most commonly used drugs in ophthalmic OPD in our setup; the most common FDCs prescribed were antimicrobials with steroids, the other commonly used drugs were analgesics, CMC and anti-allergic drugs.
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To analyze the problems in the essential medicine of Chinese materia medica (CMM) in China and make the corresponding suggestions to provide a reference for the improvement of our characterized essential medicine list of CMM. By reviewing literatures, we learnt from foreign experience and analyzed the current situation of the essential medicine of CMM, stated the five primary problems existing in the part of the national essential medicine list of CMM, and proposed the suggestions. The problems are as follows: selection of the list in CMM is more based on the expertise with subjective factors; The proportion of the list in Chinese patent drug (CPD) is not clear; The access to the essential medicines of CMM is poor; There are many security risks with the quality of CMM injections and the prominent phenomenon of irrational use in CMM. The suggestions are as follows: to strengthen the evidence-based decision-making, improve the scientificity of the evidence in selecting the essential medicine of CMM, definite the proportion of the CPD in the list as soon as possible, strengthen the equipment and use of essential medicines of CMM, strengthen the ADR's monitoring and reevaluation of CMM injections, strengthen the guidance and advocacy of CMM, and reduce irrational drug use as well.
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Objective The national essential medicine select system is the core of Chinese medicine policy.How to select drugs fundamental for eyes scientifically is an important ring in establishing the Chinese essential drug system.The present study attempted to compare the National Essential Medicines List and National Essential Insurance List of China with that of the WHO in order to provide reasonable evidence for the adjustment of a new National Essential Medicines List of China. MethodsThe WHO Essential Medicine List (15th edition,Version in 2007),National Essential Medicine List (Version in 2009,China),2009 National Essential Medicine List Chemical Medicine Name (Version in 2009) and National Essential Insurance List of China (Version in 2004) were reviewed.The similarity and difference in the category and number of drugs in the National Essential Medicines List and National Essential Insurance List between China and WHO were compared and analyzed.A descriptive method was adopted to analyze the sorts and numbers of eye drugs in the lists mentioned above.The analysis of drug price was based on the summary sheet from Zhejiang Province. ResultsLittle difference was found in the numbers of eye drugs between the National Essential Medicines List of China and WHO Essential Medicines List.Differences in the sorts of eye drugs were observed in the lists,especially between the National Essential Medicines List of China and WHO Essential Medicines List.Except for levofloxacin,all of the drugs in the National Essential Medicine List of China were included in the National Essential Insurance List of China.ConclusionThe selecting principle and renewing procedure of the National Essential Medicines List and National Essential Insurance List of China should be further improved in China based on the list from WHO.More attention should be paid to the standard,dosage form,affordability,maneuverability etc.during the selecting procedure of eye essential drugs.