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OBJECTIVE To explore wheth er there is a relationship between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence. METHODS By searching for medical damage liability disputes related to off-label drug use up to 2021 on pkulaw.cn ，documents were extracted to record objective factors ，subjective factors and judgment results ；whether there was evidence-based evidence was judged according to Off-label Drug Use List and Evidence-based Evaluation Standards for Off-label Drug Use of Guangdong Pharmaceutical Association ；univariate analysis was adopted to test the relationship between the judgment results and evidence-based evidence. RESULTS A total of 57 cases were included. Cases mainly occurred in the eastern China （63.2％）and tertiary hospitals （64.9％），the main appraisal agency was the appraisal center or institute（61.4％），and the most common type of off-label drug use was overdose drug use （45.6％）. Among the judgment results ， 23 cases（40.4％）of off-label drug use had a causal relationship with medical damage ，most of the responsibility of doctors was secondary responsibility （28.1％），and the actual compensation amount of the most cases were less than 100，000 yuan（54.4％）. There were 25 cases（43.9％）with evidence-based evidence. Univariate analysis found that for off-label drug use the claim amount of the case with evidence-based evidence was significantly higher than that of the case without evidence-based evidence （P＝ 0.040），and there was no significant correlation between evidence-based evidence and the actual compensation amount of the case （P＝0.741），causality determination （P＝0.256），liability type （P＝0.598）or appraisal agency （P≥0.260）. CONCLUSIONS There is no significant correlation between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence ，indicating that there may be certain differences between judicial trials and medical science. The off-label drug use should be regulated by establishing a complete off-label drug use management system and standardizing informed consent procedure for off-label drug use. 1610307322@pku.edu.cn
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OBJECTIVE To provide emp irical evidence for relevant decision makers in China to formulate and improve policies related to children ’s medicine use . METHODS Based on the purchase data （Jul. 2016-Jun. 2019）of 18 tertiary children ’s hospitals，the availability of medicines included in the 7th edition of WHO Model List of Essential Medicines for Children （WHO EMLc）and their influential factors were investigated according to standard medicine investigation method recommended by the WHO and Health Action International . RESULTS A totally 189 active ingredients listed in the 7th edition of WHO EMLc were available at 18 tertiary children ’s hospitals in China ，which referred to 229 medicines. The availability of Budesonide inhalation suspension，oral rehydration salt ，Immunoglobulin for injection and Water for injection was 100%. In each quarter from Jul . 2016 to Jun . 2019，the availability of more than half of the medicines exceeded 50%，and the availability of the medicines remained basically stable in each quarter . The overall availability of cardiovascular system medicines and blood system medicines was the highest，while that of antiparasitic medicines and dermatology medicines was lower . There were 28 medicines（12.2%）that were not approved for use in children in China ，the use of which were off -label. The medicines which had been approved for children and which were included in national essential medicine list had a significantly higher availability （P＜0.05）. CONCLUSIONS The availability of essential medicines for children is generally better at tertiary children ’s hospitals in China . But the use of some essential medicines in children are off -label. In order to ensure the safety and the availability of essential medicines for children ，it is suggested to introduce China ’s essential medicines list for children ，to promote clinical trials in children for commonly used medicines，and to updete the drug manual in time .
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OBJE CTIVE To inv estigate the antibiotic use and rationality for children in community health service institutions from Beijing ，and to provide reference for promoting rational use of antibiotics in primary healthcare institutions. METHODS All the prescriptions for children from primary healthcare institutions in 2019 were extracted from prescription review system of community health service institutions in Beijing. The use of antibiotics was described according to the related indicators of the World Health Organization/International Network for Rational Use of Drug （WHO/INRUD）. The structure of antibiotics use was analyzed according to the anatomical therapeutic chemical （ATC）classification as well as the WHO AWaRe classification and diagnosis. RESULTS A total of 288 primary healthcare institutions and 10 422 prescriptions for children were included. The number of institutions in high-income areas ，middle-income areas and low-income areas were 119，80 and 89 respectively，and the number of prescriptions involved were 2 430，2 163 and 5 829 respectively，including 1 447 prescriptions involving antibiotics （13.9％）. Among 1 447 prescriptions，the rate of prescriptions involving combined use of antibiotics was 1.4％（20 pieces）；the rate of prescriptions involving antibiotics injection was 9.7％（141 pieces）；4.8％ antibiotics prescriptions were rated as unreasonable （69 pieces）. The three most commonly used antibiotics were the macrolides （40.2％），the second-generation cephalosporins （26.5％） and the third-generati on cephalosporins （23.4％）. The proportion of antibioti cs prescriptions from groups of access ，caution， reserve and not recommended were 9.1％，92.1％，0.3％，and 0， respectively. The rate of antibiotics prescriptions fortonsillitis was the highest （31.9％ ）. Among 69 irrationalantibiotics prescriptions ，main of them were irrational drug use （56 pieces，81.2％）. CONCLUSIONS The rate of antibiotics prescriptions for children in primary healthcare institutions from Beijing is lower than the standard of WHO antibiotics prescription rate （20.0％-26.8％），but the use rate of antibiotics at caution grade is too high.
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OBJECTIVE：To esta blish a sc ientific and objective post competency evaluation index system for the drug registration specialist. METHODS ：By searching the competency model literature of drug registration and registration related documents，combined with Spencer ’s Competency Dictionary and Hay ’s Competency Dictionary ，post competency evaluation index system for drug registration specialist was formulated preliminarily. Through two rounds of Delphi expert consultation ，experts in related fields of drug registration were consulted by letter ，the evaluation indexes were screnned and revised ，and the weight of the indexes was calculated by using the superior order diagram method. Based on questionnaire survey ，232 drug registration personnel were selected as research objects ，and then exploratory factor analysis ，confirmatory factor analysis and internal consistency reliability analysis were used to test the constructed evaluation index system. RESULTS ：The post competency evaluation system of drug registration specialist covered 4 core dimensions （registered professional ability ，relationship management ability ，professional development ability ，personal comprehensive quality ），11 sub-scales，and 41 measurement items ；the weight of the index was confirmed. The establishment process of the evaluation system showed that the expert consultation had high enthusiasm and good coordination；exploratory factor analysis and confirmatory factor analysis had proved the scientific rationality of the index system. CONCLUSIONS：The post competency evaluation index system for drug registration specialist is comprehensive ，integrated and scientific，can provide reference for evaluation and management of the drug registration specialist practice.
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OBJECTIVE：To study general chara cteristics and medication of medical damage liability disputes cases caused by medication error ， and to provide references for related departments and medical staff for preventing and reducing medication-induced medical disputes. METHODS ：A total of 240 cases of medical damage liability disputes cases caused by medication error were collected from Peking University ’s Fabao Law Database during Jan. 2001 to Feb. 2020，and analyzed in terms of general situation ，damage outcome ，level of the hospital involved ，liability judgment and compensation ，types of medication error and drug types. RESULTS ：medication-related medical damage liability disputes accounted for 25.3％ of overall medical damage disputes ；the most damage result of patients was death （68.3％）；medical negligence forensic appraisal was conducted as the main appraisal pattern with a proportion of 57.9％；the average case compensation was 203，000 yuan；the hospitals involved were mainly tertiary hospitals （48.8％）；the main type of medication error involved was prescription error ； chemical medicine was mainly involved ，of which the top three categories were systemic antibacterial ，systemic corticosteroids and antipsychotics. CONCLUSIONS ：ADR caused by medication errors are the common causes of medical disputes. Medical institutions should focus on improving the relevant systems and processes ，strengthen the construction of pharmaceutical information and automation system ，and reduce the probability of medication errors ；at the same time ，great importance should be paid to the cultivation of pharmaceutical talents in hospital ，give full play to the role of pharmacists ，and strengthen the monitoring and intervention of medication errors. Finally ，the relevant national judicial departments should constantly improve the settlement mechanism of medical damage liability disputes to provide reasonable protection for both doctors and patients.
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OBJECTIVE：To provide reference for improving the level of pharmaceutical care in hospitals and promoting the continuous transformation and upgrading of O 2O pharmaceutical care mode in medical institutions in China. METHODS ：Using “Internet”“Network”“O2O”“Pharmaceutical care ”“Medication education ”“Chronic disease management ”“Medication consultation ” “Science popularization and education ”as keywords ，related literatures were collected from CNKI ，VIP，Wanfang and other Chinese databases during Jan. 2012-Mar. 2020. The development process ，characteristics，service content ，advantages and disadvantages of O 2O pharmaceutical care mode in China were analyzed and summarized ，and relevant suggestions were put forward. RESULTS & CONCLUSIONS ：O2O pharmaceutical care in Chinese hospitals covers prescription review and dispensing ， drug distribution ，medication consultation after visiting ，medication education ，chronic disease management ，science popularization and education ，pharmacy clinic ，etc.，realizing the whole process of closed-loop management. At present ，O2O pharmaceutical care in Chinese hospital had gradually moved from stage 1.0 to stage 2.0. Artificial intelligence technology has also been widely integrated into all aspects of pharmaceutical care ，assisting hospital pharmacists to better practice the “patient-centered”service concept，not only improving the quality and value of pharmacists ’pharmaceutical care more efficiently and accurately ，but also promoting the sinking of high-quality pharmaceutical resources and serving the grassroots. O2O pharmaceutical care shows the advantage of optimizing the allocation of pharmaceutical care resources ，expanding the scope of pharmaceutical care ，improving the relationship between doctors and patients ，diverting patients with different needs ，and promote hierarchical diagnosis and treatment. However，there are still some problems ，such as the failure to effectively cover rural patients ，the risk of patient privacy leakage ， and the lack of special quality management standards ，which hinder the further development and improvement of scale advantage of O2O pharmaceutical care. It is suggested to further improve the pharmaceutical care function of the platform ，expand the consumer population，promulgate relevant laws and regulations as soon as possible ，carry out continuing education and training for pharmacists according to the needs of patients in grassroots areas ，establish and improve relevant laws and regulations ，and improve O 2O pharmaceutical care quality management standards， so as to promote the development of O 2O pharmaceutical care mode in the hospital in China.
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OBJECTIVE：To provide scientific basis for evaluating the burden caused by antibiotic resistance （AbR）and reference for policy making on crubing AbR in China. METHODS ：Databases including CNKI ，Wanfang database ，VIP，PubMed， Scopus，Medline and EconoLite from Jan. 1st 2016 to Aug. 10th 2020 were searched to collect studies on burden caused by AbR in China . After independent literature screening anddata extraction ，Newcastle-Ottawa scale （NOS）was used to evaluate the literature quality ，and a descriptive analysis was conduced to evaluate the health and economic burden caused by AbR. RESULTS ：A total of 27 Chinese and English literatures were included. The NOS scores of i ncluded literatures were 4-6，and all of them were retrospective case-control study ； the patients were divided into case group （resistance infection ） and control group （susceptible infection or non-infection ）； mortality，length of stay and medical expenditure were commonly applied as the measurement indexes. In the included studies ，the mortality of patients infected with AbR bacteria was 0.7-12.0 times that of patients infected with susceptible bacteria ；the mean or medium value of total length of stay was 0.9-2.5 times that of patients infected with susceptible bacteria ；the mean or medium of total medical expenditure was 1.0-2.7 times that of patients with susceptible bacteria infection. The differences in these indicators were greater between patients infected with AbR infections and those without becterial infections. CONCLUSIONS ：Bacterial drug resistance could increase the health and economic burden. However ，the existing relevant studies were mainly single center researches，the sample representation was insufficient ；the research design did not adjust for time-dependent bias ；the repeatability was low ，and the perspective of evalution was limited. It is urgent to carry out multicenter studies with higher quality to comprehensively evaluate the health and economic burden caused by AbR in China.
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OBJECTIVE：To provide re ference for scientific management and rational use of antibiotics. METHODS ：Provincial antibiotic classification management lists were retrieved from official websites of provincial health administrative departments ， CNKI and other search engines from Apr. 2012 to Mar. 2020. The difference and adjustment of those lists were analyzed descriptively. RESULTS & CONCLUSIONS ： Since April 2012， 30 provinces released provincial antibiotic classification management lists ，among which only 10 provinces updated the lists. In the provincial classification management lists ，the list of Jiangsu included the most antibiotics （208 kinds），that of Xinjiang involved the least （101 kinds）. Among the 253 antibiotics included in the provincial lists ，134 antibiotics had two management levels ，and 19 antibiotics had three management levels. The 10 antibiotics with the most times of adjustment in the provincial lists mainly include nitimidazoles ，β-lautam compound preparations and quinolones. There was the phenomenon that the same antibiotics were simultaneously included or withdrawn from the lists ，and the grading management level was increased or decreased in the provincial adjustment. Provincial classification management lists updated slowly in China ，and the quantity and classification of drugs selected in the list were quite different. It is suggested that provincial health administrative departments should continuously optimizeand improve classification management list of antibiotics ， and form a long-term mechanism of dynamic adjustment of list and inter-provincial evidence sharing ，so as to promote the rational clinical use of antibiotics ，and curb bacterial resistance.
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OBJECTIVE：To study the effects of the deregulation of drug price control on drug price ，and to provide reference for policy formulation. METHODS ：The quarterly price data of 46 875 chemical and biological products （measured by fixed Laspeyres index ）were collected from 788 sample hospitals from the database of National Medical Economic Information Network during Jan. 2012 to Jun. 2017. Based on the interrupted time series model ，changes in the prices of overall situation of chemicals and biological products ，as well as the sub-group ，ie. low-cost drugs ，original and imitated drugs were analyzed after the government’s policies of canceling the price limit control and strengthening the price monitoring （including Notice on Printing and Distributing the Opinions on the Supply and Guarantee of Commonly Used Low-cost Drugs in 2014，Notice on Printing and Distributing the Opinions on Promoting the Reform of Drug Prices in 2015，etc.），returning to market competition ；the effects of canceling the price limit control on drug price were put forward. RESULTS & CONCLUSIONS ：After government deregulation for maximum retail price limit of commonly used low-priced drugs ，the price of low-priced drugs increased substantially （β3＝1.11×10－2， P＝0.008）. After the total abolition of drug price control ，there was no significant change in the overall chemical and biological products（β3＝－1.85×10－3，P＝0.175）and sub-group （low-cost drugs ：β3＝1.10×10－3，P＝0.066；original drugs ：β3＝－7.20×10－4， P＝0.549；generic drugs ：β3＝6.78×10－4，P＝0.784）drug prices. Within two years after government deregulation policy in 2015， drug prices and the drug market had remained stable. It can be seen that it is feasible for canceling the government ’s pricing and opening the price control in the mature market so as to make the price formulation return to the market ，combined with the government strengthening the price monitoring.
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OBJECTIVE：To provide reference for improving the equity of medicine in China ，and to provide reference for promoting the full coverage policy for essential medicine. METHODS ：Taking hypertension essential medicines full coverage policy in 4 areas of Taizhou in Zhejiang province as an example ，the electronic health records of patients in baseline year and the first ， second and third years after the implementation of the full coverage policy of hypertension were collected. The catastrophic expenditure of family drugs was used to measure the medicine cost burden ，and the effects of policy on the equity and change of local medicine cost burden were analyz ed by means of concentration index and its decomposition method. RESULTS ：With the increase of the proportion of patients taking free medicine ，the incidence of catastrophic expenditure on household medicines in the high，middle and low income group decreased year by year generally （decreasing from 6.3％，12.0％，16.4％ of baseline year to 4.7％，8.9％，12.4％ at the third year after the implementation of the policy ）；the gap among the three groups was in narrowed trendency. The concentration indexes of the baseline year and the first ，second，third year after the implementation of policy were －0.198，－0.186，－0.181，－0.202，the policy contribution rates of which were 0，－1.335％，－4.507％ and 1.936％；and the policy contribution rates in the change of the yearly concentration index were 20.8％，95.0％ and 57.6％. CONCLUSIONS ：The implementation of the full coverage policy for essential medicines is conducive to improving the equity of the medicine expenditure burden. The effect is affected by the implementation of policies and supporting systems ，but the comprehensive promotion of the equity of medicine requires multi-policy synergy.
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OBJECTIVE：To e xplore the health economic burden of hypertension patients at county-level areas and its influential factors in China. METHODS ：A questionnaire survey was conducted on hypertension patients in 7 county-level public hospitals from 6 provinces as Hebei ，Shandong，Shanxi provinces by using a convenient sampling method. Catastrophic health expenditure was defined by the standard of “medical and health expenditure exceeding 10％ of household income ”. The incidence ， average gap and relative gap of catastrophic health expenditure were analyzed. A multi-factor Logistic regression model analysis was used to analyze the influential factors that lead to catastrophi c health expenditure. RESULTS ：A total of 1 378 questionnaires were sent out ，and 925 valid questionnaires were collected with effective rate of 67.13％ . The incidence of catastrophic health expenditure，average gap and relative gap among hypertension patients were 23.03％，19.37％ and 84.12％，respectively. At different income levels ，the incidence of catastrophic health expenditure，average gap and relative gap were 72.67％ ， 96.79％ and 133.18％ in the poorest household group ，and were 1.94％ ，0.47％ and 24.23％ in the richest household group. Among different types of medical insurance ，the incidence of catastrophic health expenditure in patients covered by “New Rural Cooperative Medical Scheme （NRCMS）”the highest （31.30％）. The household income ，complications and the type of health insurance had significant impacts on the incidence of catastrophic health expenditure in hypertension patients （P＜0.05）. CONCLUSIONS：The incidence of catastrophic health expenditure in hypertension patients with different income levels is different. As the income level raised ，the incidence of catastrophic health expenditures continued to decrease. But the protection of household health expenditure by NRCMS is weak. It is suggested that a certain policy preference should be given to families with low income and patients with chronic diseases ，so as to ensure the rights and interests of patients with hypertension .
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Objective@#To investigate direct and indirect economic burden, psychological impact, and quality of life in patients with psoriasis.@*Methods@#Patients with psoriasis were recruited nationwide from "the psoriasis patient mutual assistance network" , a WeChat official account of "psoriasis patient mutual assistance platform" , and WeChat groups of psoriasis patients in different regions between July and September in 2018. An internet-based online questionnaire survey was carried out on these patients by using a self-designed questionnaire and Dermatology Life Quality Index (DLQI) scale. Comparison of enumeration data was carried out by using chi-square test, and comparison of measurement data by using Mann-Whitney U test.@*Results@#A total of 497 valid questionnaires were collected, and 497 patients with psoriasis were enrolled into this survey, including 190 patients with mild to moderate psoriasis and 307 patients with severe psoriasis. These patients were from 8 geographic regions of China, and mainly in east China and north China. The total annual expenditure for psoriasis per patient accounted for 20% (8%, 50%) (M[P25, P75]) of the total annual income, the annual hospitalization rate was 21.3%, the annual sick leave or absence duration was 15.0 (1.0, 40.0) days, and the unemployment rate due to psoriasis was 37.0%. Of the 497 patients, 443 (89.1%) suffered from mental stress due to psoriasis, 169 (34.0%) had suicide intention, and 23 (4.6%) had ever attempted suicide. The DLQI score for all the patients was 14 (8, 19) , 307 (61.8%) patients reported a severe or extremely severe impact on the quality of life (DLQI > 10, severe psoriasis group) , and 190 (38.2%) patients reported a mild or moderate impact on the quality of life (0 ≤ DLQI ≤ 10, mild to moderate psoriasis group) . Compared with the mild to moderate psoriasis group, the severe psoriasis group showed a significantly higher ratio of total annual expenditure to total annual income (30% vs. 10.0%, P < 0.01) , hospitalization rate (26.4% vs. 13.2%, P < 0.01) , annual sick leave or absence duration (20.0 days vs. 5.5 days, P < 0.01) , unemployment rate (47.9% vs. 19.5%, P < 0.01) , proportion of patients with mental stress (99.0% vs. 73.2%, P < 0.01) , proportion of patients with suicide intention (46.3% vs. 14.2%, P < 0.01) and proportion of patients who had suicide behavior (6.8% vs. 1.1%, P < 0.01) .@*Conclusions@#Psoriasis imposes heavy economic and psychological burden on patients, and decreases their quality of life. Meanwhile, patients with severely or extremely severely affected quality of life have higher disease burden compared with those with mildly to moderately affected quality of life.
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OBJECTIVE： To evaluate the economics of the full coverage policy for hypoglycemic essential medicines in Taizhou city， and to provide reference for improving medicine accessibility and essential medicine system in China. METHODS： The electronic health records and financial input data of diabetic patients were extracted from different districts and counties of Taizhou city during 2009-2016. In cohort study design， taking the implementation time of each district and county’s policies as the breakpoint， the data recorded annually were processed as annual data， forming the cohort data for 1 year before （baseline year） and 3 years after the implementation of the policies. According to the choice of free medicines after the implementation of the policy， they were divided into policy group and control group. Propensity score matching was used to balance the differences between two groups to get the final sample， and then the economics of the policy was evaluated with the methods of difference-in-differences. The cost and benefit of implementation policy were calculated. RESULTS： Totally 14 744 people of each group were got by propensity score matching. The mean annual financial expenses on free medicine per capita were 263.8 yuan. Compared with baseline year， mean annual medicine expenses per capita reduced by the policy were 649.2 yuan， and mean annual hospitalization expenses per capita were 624.7 yuan. Thus the input-output ratio of the policy was 1 ∶ 4.8. CONCLUSIONS： The implementation of the policy is beneficial to reduce the cost burden of patients and economical. It can be popularized and sustained through scientific design combined with relevant policies.
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OBJECTIVE： To provide the empirical basis for improving full coverage policy of essential medicines in China and promoting the fairness and accessibility of medicine. METHODS： Taking Taizhou diabetes essential medicines full coverage policy as an example， the electronic health records of diabetic patients in Taizhou city from 2011 to 2017 were collected， and the cost burden of patients was evaluated by whether catastrophic expenditure of family drugs had occurred. The concentration index was used to analyze the fairness of catastrophic expenditure on household medicines， and the effects of various influencing factors on the fairness of local medicine expenditure affordability were evaluated by year-by-year comparing the relevant indexes from baseline year to the third year of policy implementation. RESULTS & CONCLUSIONS： The concentration index of catastrophic expenditure on household medicines is negative from baseline year to the third year of policy implementation， which indicates that catastrophic expenditure on household medicines for diabetic patients in Taizhou mainly occurs in low-income groups. From the result of decomposition of concentration index， among the factors that affect the fairness of catastrophic expenditure on drugs in diabetic families， the contribution rate of “taking free essential medicines” keeps at top five places year by year， and the contribution value is positive， which shows that the implementation of policies is conductive to reducing the unfairness of catastrophic expenditure on household medicines in low-income families. Full coverage policy of essential medicines effectively improves the fairness of medicine expenditure affordability. In addition， scientific and reasonable essential medicines selection mechanism， the guarantee level of the policy， collaboration with multiple factors should be promoted so as to improve the fairness and accessibility of essential medicines.
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OBJECTIVE： To investigate the effects of full coverage policy for essential hypertension medicines on economic burden of hypertensive patients in Taizhou of Zhejiang Province， and to further provide reference for the practice and promotion of the policy for essential medicines. METHODS： By querying electronic health records database of hypertension patients and statistics of health bureaus in different districts and counties of Taizhou city， the data of electronic health records of hypertension patients were extracted 1 year before and during 3 years after the implementation of full coverage policy for essential medicines in all districts and counties. The patients who had consistently taken free medicines were included in the policy group； the patients who had never taken free medicines were included in the control group. The policy group and control group were matched 1 ∶ 1 by propensity score matching method. Per capita drug cost and per capita hospitalization cost of patients before and after the implementation of full coverage policy for essential medicines were calculated. The input-output ratios of the policy were calculated. RESULTS： During the 3 years after the implementation of the policy， each patient saved 91.3， 272.0 and 464.1 yuan respectively. The hospitalization cost for each patient increased by 65.6 and 46.2 yuan in the first and second year， and decreased by 352.8 yuan in the third year， respectively. A three-year per capita input of policy was 50.0， 147.2 and 278.5 yuan， with input-output ratio of 0.51， 1.28 and 2.25. CONCLUSIONS： The full coverage policy for essential hypertension medicines in Taizhou city demonstrates economic efficiency to some extent， but researches about the impact of policy on disease treatment needed to be conducted. It is necessary for the government departments to invest continuously for a long time and improve the supporting measures so as to make the policy more profitable.
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OBJECTIVE： To analyze the current status and trend of opioids consumption in China， and to provide reference for rational use of opioids. METHODS： Purchasing data on five opioids as fentanyl， morphine， pethidine， oxycodone and hydromorphone， were extracted from the database of the Medicine Economic Information Network from 2014 to 2016. Drug consumption was measured by the daily dose per million population （unit： S-DDD）， and the consumption amount of all opioids and different dosage forms （including oral dosage form， injection and other form） in China and different districts were analyzed and compared. RESULTS： The consumption amount of five opioids increased from 69.62 S-DDD in 2014 to 78.64 S-DDD in 2016. The consumption amount of hydromorphone and oxycodone showed an upward trend， while the consumption amount of morphine was basically unchanged， and the consumption amount of fentanyl and pethidine showed a downward trend. The consumption amount of oral dosage form increased from 39.77 S-DDD in 2014 to 45.61 S-DDD in 2016， the consumption amount of the injection increased from 20.74 S-DDD in 2014 to 24.23 S-DDD in 2016， and the consumption amount of other form decreased from 9.11 S-DDD in 2014 to 8.81 S-DDD in 2016. The consumption amount of oral dosage form was around twice that of injection， with the gap expanding yearly. Regionally， the consumption amount of five opioids in the eastern region was the highest， followed by the western region， and the lowest but the highest growth rate in the central region from 2014 to 2016 （in 2016， consumption amount of eastern， western and central regions were 94.04， 67.90， 63.78 S-DDD， with increase rate of 8.50％， 11.77％， 16.17％， compared with 2014）. Morphine was the most widely used drug in all regions， followed by fentanyl； in the eastern and central regions， the use of oral and injection dosage form increased year by year； in western region， the use of oral dosage forms increased while that of injection decreased year by year. CONCLUSIONS： The opioids consumption in China is increasing overall， with regional differences. Nonetheless， the overall consumption is still low. On the premise of strict supervision， it is necessary to take measures to promote the rational use of opioids in different areas.
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OBJECTIVE:To investigate and analyze the situation of measurement method for antimicrobial resistance(AMR) burden research,in order to provide methodology literature support for conducting AMR burden research in China. METHODS:Retrieved from PubMed,ProQuest Health & Medical Complete,Springer datebase,related researches were summarized,and foreign calculation method of resistance burden of commonly used antimicrobial and matters of attention were analyzed. RESULTS& CONCLUSIONS:AMR burden is usually evaluated using indicators like the number of resistant incidents,deaths due to AMR, excess length of stay and economic burden of AMR. The issues needed to be considered during calculating the burden included the perspective,definition of the outcome indicator,controlling the length of stay before infection,selection of control group, adjustment for severity of illness,time point calculation,calculation of onset time of infection,definition of the cost and scale of the economic burden. Future studies needs to be focused on a social perspective to estimate the burden of AMR,so as to provide baseline data evidence for decision makers to further control the resistance.
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OBJECTIVE:To investigate the reliability and validity of the Chinese version Morisky Medication Adherence Scales-8 in assessing medication compliance of the patients with rheumatoid arthritis.METHODS:The Chinese version of MMAS-8 was used to evaluate the compliance of 200 rheumatoid arthritis patients who responded to the WeChat public issue from the public forum of China rheumatism.Item analysis,homogeneity test,reliability analysis,and validity analysis were all conducted.RESULTS:The eight items showed significant difference between the two extreme groups as head and tail 27％ of the total score in Levene method F test (P＜0.001).t test of variance inequality was adopted,with significant difference (P＜0.001).Correlation coefficient between the 7 items and the total score was higher than 0.400,and the 8 items were significantly correlated with the total score (P＜0.001).Internal consistency reliability coefficient Cronbach's α was 0.657,and standardized Cronbach's α was 0.662.For construct validity,KMO was 0.638,Bartlett's sphericity test was 246.278,factor analysis method was adopted to extract 3 common factors,and explainable total variance was 58.846％.Pearson correlation coefficient was 0.435 between MMAS-8 total score and MA-VAS score (P＜0.001).CONCLUSIONS:Reliability and validity of the Chinese version MMAS-8 for the determination of medication compliance in patients with rheumatoid arthritis are good.
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OBJECTIVE:To make proposals to improve narcotics and psychotropic substances(NPS)control in China. METH-ODS:NPS control system of international organizations,the United States,Britain and China were compared in terms of concept, classification,regulatory basis and agency,etc. The suggestions and reference were put forward. RESULTS & CONCLUSIONS:NPS of international organizations,the United States,Britain and China are drug types included in relevant categories,besides ana-leptics,precursor chemicals and other drugs are included in control catalogue by the United States and Britain. NPS are divided in-toⅠ-Ⅳcategories by international organizations,Ⅰ-Ⅴcategories by the United States,A,B,C categories and temporary catego-ry by Britain,and narcotics,first and second class psychotropic substances by China. NPS control basis of the United States,Brit-ain and China are Controlled Substances Act,Misuse of Drugs Act and Regulations on Narcotics and Psychotropic Drugs Control, respectively;major regulation organizations are Controlled Substances Enforcement Administration,Advisory Committee on Drug Abuse subordinated to Ministry of Interior,Special Drug Section under China Food and Drug Administration,respectively;there al-so are differences in the functions of control organization and cooperative units. Considering about the problems of NPS control in China,it is suggested to improve laws and regulations system,establish independent system,extend abuse surveillance network and encourage chronic non-cancer pain therapy.
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OBJECTIVE:To study the development and status quo of international narcotics and psychotropic substances (NPS)control,and to provide evidence for NPS control in China. METHODS:The development and status quo of NPS control by international organization were summarized and studied through retrieving and collecting literatures,reports and policies about NPS from domestic and foreign databases,news reports and international website. RESULTS & CONCLUSIONS:International narcot-ics control dated back to opium trade with China in 19th century. International narcotics control system was established preliminarily by Shanghai conference and Haiya conference. The end of World War Ⅰ,the establishment of the League of Nations and the sign-ing of a number of international treaties promoted the development of internal control system. Through World War Ⅱ,the establish-ment of the United Nations and the change of international control organization,a number of international treaties were integrated into Single Convention on Narcotic Drugs in the early 1960s,which was used as the foundation of narcotics control system all round the world. In 1970s,the adoption of Convention on Psychotropic Substances meant psychotropic substances were included in the scope of internal control. In 1980s,the signing of United Nations Convention against Illicit Traffic in Narcotic Drugs and Psy-chotropic Substances marked the establishment of three conventions system of international NPS control. At present,internal NPS control is based on three conventions system and NPS list by Commission on Narcotic Drugs,International Narcotics Control Board and United Nations International Drug Control Program. The vast majority of countries are parties to that. International control orga-nizations and listed control have a great influence on NPS control all round the world.