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亚洲社会药学

亚洲社会药学

《亚洲社会药学》是由沈阳药科大学主办的药学类英文季刊。主要以世界各地药学研究人员、药师、医药院校等相关教学人员为主要读者。本刊的办刊宗旨为促进国内外社会药学研究成果及有关信息的集中、快速、广泛的传播与交流，推动我国社会药学事业的全面发展。刊登内容包括：社会用药的特点、规律以及所产生的社会问题；全社会医药资源的优化配制与高效利用；药事法规及药品政策应发挥的主要作用等。
  • 发文量：65
  • 被引量：0
  • H指数：0
  • 开始收录时间：2019,14(1)
  • CNKI综合因子：0.0
  • 维普期刊影响因子： 0.03
  • 万方期刊影响因子：0.0
  • 创刊时间：1983
  • 国内刊号/CN：-
    国际刊号/ISSN：1818-0884
  • 发行周期：季刊
    邮发代号：-
  • 主管单位：-
    主办单位：沈阳药科大学
亚洲社会药学-联系信息
  • 主编：黄泰康
  • 电话：024-23986082 43520798
  • 邮箱：tx830127@163.com;qkgjb2006@126.com
  • 地址：辽宁省沈阳市沈河区文化路103号
  • 邮编：110016
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亚洲社会药学 >2023年第3期

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  • 摘要：Objective To analyze the application of EU real-world evidence in the decision-making of new drug research and development(R&D),and to provide policy recommendations for China’s government to make new drug R&D decisions.Methods The relevant policy documents of the EU on the development of new drugs and other domestic and foreign literature on the real-world evidence were analyzed to obtain the role and application of the current EU real-world evidence in the implementation of new drug development policies.Results and Conclusion At present,the EU is carrying out the national synchronous scientific advisory policy,urging the formation of a European innovation framework,and providing decision-making for new drug R&D selection and program design based on real-world evidence.It is recommended that China build a real-world medical database and design a new drug screening platform to help companies,scientific research institutions assess target drugs.In addition,a national scientific advisory platform should be set up to integrate scientific research strength and provide technical support for new drug R&D institutions.
  • 摘要：Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.
  • 摘要：Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in China.Methods Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United States.Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical data.In addition,the RWE has a wide range of applications in the field of medical devices in China.In recent years,the RWE has received extensive attention in the medical field in the United States.The FDA has issued related guidelines,and its applications have gradually formed a complete system.Research on RWE will become the development trend of clinical evaluation of medical devices in the future.While attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.
  • 摘要：Objective To summarize the concept,background,application value of real-world evidence(RWE)and its enlightenment to China based on the analysis of the information about the RWE supporting health decision in the European Union,and to provide a reference for Chinese health departments.Methods Through literature research and data collection,the requirements of EU countries,especially some typical countries,for clinical evidence in health decision were obtained,and the application of RWE in supporting health decision in EU was analyzed with specific cases.Results and Conclusion RWE plays an increasingly important role in supplementing the evidence base of clinical trials,verifying the safety and effectiveness of medical devices,and accelerating the market access of new drugs.With the improvement of RWE quality,RWE will not only be used in the evaluation of biological agents and chemical drugs,but also play an important role in the evaluation of traditional Chinese medicine and the post-marketing evaluation of medical devices.
  • 摘要：Objective To introduce the concept and plan design of pragmatic clinical trials based on real-world study(RWS)so as to provide both guidance for clinical trials and reference for relevant personnel studying RWS.Methods A retrospective study was made on the design of real-world clinical trials at home and abroad in recent years to summarize their design process and applications.Results and Conclusion The advantages of combining randomization and real-world data in clinical trials are important methods for evaluating medical interventions in the real clinical environment.Practical clinical trials can evaluate the therapeutic effects of interventions in real or close to real medical environments to obtain the best real-world evidence.
  • 摘要：Objective To provide references for improving the authenticity and reliability of the retrospective study results,thus improving the quality of evidence in the real world and strengthening drug supervision and decision-making.Methods Literature review was used to study the data sources,the characteristics of retrospective research,the sources and the corrections of selective bias in the real world.Results and Conclusion The biases in retrospective study mainly come from admission rate bias,patient rate bias,survivors bias,health user bias and symptom bias.
  • 摘要：Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine(TCM).Methods The disadvantages of using randomized controlled trials for empirical prescriptions of TCM and the advantages of using real-world study(RWS)were analyzed by summarizing the previous RWS and the empirical prescriptions.Meanwhile,the methods for marketing of new TCMs derived from empirical prescriptions of TCM,the data source and trial design of the RWS were discussed.Results and Conclusion RWS can provide new ideas for the listing of new TCMs.With the improvement of relevant laws and regulations,RWS will promote the development of TCM greatly.To promote the application of RWS in the inheritance and development of empirical prescriptions of TCM,the government should improve laws and regulations as soon as possible,and enterprises and research institutions should strengthen patient privacy protection and clarify the responsible parties.
  • 摘要：Objective To explore the situation and trend of drug use in the treatment of hypertension in outpatient department of a hospital,and to provide reference for clinical rational drug use.Methods The data of 833 outpatients with hypertension in a hospital from July to December in 2020 were retrospectively analyzed.Results and Conclusion Among the 833 cases,calcium channel blocker(CCB)was the most frequently used drug(38.54%),followed by angiotensin receptor blocker(ARB)(13.81%),β-receptor blockers(β-RB)(10.44%),angiotensin-converting enzyme inhibitor(ACEI)(5.52%),and diuretics(0.72%).The combination rate was 37.09%(including single-pill combination,SPC).The highest rate was the combination of two drugs(28.21%),followed by the combination of three drugs(8.64%)and four drugs(1.20%).The DDDs and DDC of SPC were the highest among the six kinds of drugs.The use of antihypertensive drugs in outpatient department of the hospital is in line with the medication guidelines,but a small number of drugs are used irrationally,which needs further supervision and management.
  • 摘要：Objective To study the research status,research hotspots and development trends in the field of real-world data(RWD)through social network analysis and knowledge graph analysis.Methods RWD of the past 10 years were retrieved,and literature metrological analysis was made by using UCINET and CiteSpace from CNKI.Results and Conclusion The frequency and centrality of related keywords such as real-world study,hospital information system(HIS),drug combination,data mining and TCM are high.The clusters labeled as clinical medication and RWD contain more keywords.In recent 4 years,there are more articles involving the keywords of data specification,data authenticity,data security and information security.Among them,compound Kushen injection,HIS database and RWD are the top three keywords.It is a long-term research hotspot for Chinese and western medicine to use HIS to study clinical medication,clinical characteristics,diseases and injections.Besides,the research of RWD database has changed from construction to standardized collection and governance,which can make RWD effective.Data authenticity,data security and information security will become the new hotspots in the research of RWD.
  • 摘要：Objective To study the use of real-world evidence by EU and its member states for establishing a strategy for rare diseases and provide references for the inclusion of orphan drugs in China’s medical insurance.Methods A case analysis method was used to introduce the EU’s decision to include rare disease drugs in medical insurance by using real-world evidence because clinical data of rare diseases were difficult to obtain.Results and Conclusion China can use real-world evidence to make medical insurance decisions based on the experience of the EU and continue to invest more in rare diseases,which can solve the problem of few drugs for patients with rare disease.
  • 摘要：Objective To analyze the value of EU real-world evidence(RWE)in supporting the expanded indications for drugs and to provide reference for the decision-making of expanding drug indications supported by RWE in China.Methods By searching relevant domestic and foreign literature and case analysis,the practice of the RWE of EU to support the expansion indications for drugs was investigated.Results and Conclusion The EU uses RWE to carry out adaptive path research,which provides a new idea for drug R&D and approval.Besides,it also provides evidence in supporting the research of expanded indications for drugs.With the increasing cognition of RWE,it will play a key role in medical and regulatory decisions in China.
  • 摘要：Objective To analyze the research and application status of real-world evidence(RWE)in the European Union(EU)and provide a reference for China’s government.Methods By consulting the policy guidelines issued by EU EMA and the documents of European countries at home and abroad,the basic principles and case notes of EU RWE implementation were comprehensively analyzed.Results and Conclusion Research on RWE in EU is mainly carried out from four aspects:R&D decision,application of expanded trial certificate,medical insurance decision,and supervision decision,which plays an important role in the progress of European clinical medicine.Therefore,researchers in China should draw lessons from these four perspectives and design reasonable research directions and programs.
  • 摘要：Objective To provide a reference for China to use real-world evidence(RWE)in drug approval and regulatory decision-making system.Methods The main content of“Real-World Evidence Program Framework”issued by the FDA was summarized by literature research method,and the related system construction in China was analyzed.Results and Conclusion To promote the use of real-world study(RWS)for drug regulatory decisions,China should issue guidelines on RWS.Besides,the construction of data standards and the shared database should be strengthened.Then,the demonstration projects should be introduced extensively and the guidance for RWS of enterprises must be enhanced.Meanwhile,close attention should be paid to dealing with the relationship between stakeholders.
  • 摘要：Objective To study the news reports on COVID-19 through comparing the forwarding volume and posting time of microblogs from the government media and non-government media and exploring the advantages and disadvantages of the two in mastering discourse power in public health emergencies,so to provide a reference for the government department to cope with online public opinion.Methods The GooSeeker data mining tool was used to collect the data of the six microblog accounts that reported the COVID-19 from January 1 to June 15,2020.Then the data were analyzed from two aspects of microblog forwarding volume and posting time.Results and Conclusion According to the analysis of the forwarding volume data,the government media had a greater influence on the public during the process of COVID-19.The analysis of the news release time showed that the government media and non-government media had similar ability in discourse power on public health emergencies.This paper proposes the following recommendations for government departments to enhance their abilities to cope with online public opinion on public health emergencies,such as releasing information promptly,cultivating opinion leaders,and reporting the fact to avoid public misunderstandings.
  • 摘要：Objective To put forward some suggestions for improving the procurement policy of Shenzhen Pharmaceutical Group.Methods The literature research and comparative research were used to compare the policies between Guangdong’s centralized drug procurement and Shenzhen Pharmaceutical Group’s procurement so as to analyze their advantages and disadvantages.Results and Conclusion The purchasing model of Shenzhen group purchasing organization(GPO)can ensure the timely supply of medicines.Besides,the cross-regional alliance system helps to achieve a true price-for-quantity exchange,and a market-based price linkage mechanism can effectively reduce drug prices.However,the online drug catalogue of Shenzhen GPO cannot fully cover the actual needs of hospitals for procurement.The market-based price linkage may lead to problems of drug quality or shortage of drugs.Therefore,the number of batches of drugs should be increased online appropriately.Meanwhile,a mechanism must be established to guarantee the supply and quality of low-priced drugs.
  • 摘要：Objective To explore the relationship between salary incentives for R&D personnel and R&D investment in China’s pharmaceutical industry through an empirical analysis so as to propose suggestions for increasing more R&D investment from the perspective of stimulating R&D personnel.Methods Based on the relevant data of the China’s pharmaceutical industry in the“China High-tech Industry Statistical Yearbook”and other data from the National Bureau of Statistics from 1995 to 2018,co-integration tests was used to construct error correction models and Granger causality tests to explore the relationship between R&D personnel salary incentives and R&D investment.Results and Conclusion There is a long-term balanced relationship between the salary level of R&D personnel in China’s pharmaceutical industry and the investment of R&D.For the per capita salary of R&D personnel increases by 1 unit,the internal expenditure of R&D investment will increase by 2.2451 units.In the short term,the per capita salary of R&D personnel has a slight negative impact on the internal expenditure of R&D investment.In addition,the salary incentives for R&D personnel have the most significant role in promoting R&D investment after five years of implementation.
  • 摘要：Objective To analyze the relationship between the profitability of pharmaceutical enterprises of different scales and their R&D investment.Methods The data of China’s pharmaceutical manufacturing industry from 1995 to 2016 were selected to establish a vector auto-regression mode,and then an impulse response function and variance decomposition were used to analyze the data.Results and Conclusion For large-scale pharmaceutical enterprises,1%increase in R&D input will lead to 0.792%increase of their main business profit.For medium-sized enterprises,if their main business profit increases by 1%,their R&D input will increase by 0.965%.Therefore,if their R&D input increases by 1%,their main business profit will increase by 1.036%.The improvement of the profitability of large-scale pharmaceutical enterprises cannot promote the increase of R&D capital investment.But the increase of profitability from medium-sized enterprises can promote the increase of R&D capital investment.As a result,the increase of R&D capital investment of large and medium-sized enterprises can improve corporate profitability.
  • 摘要：Objective To propose a method to identify the shortest catch-up path by using patent data based on the perspective of technology leapfrogging so as to provide a reference for the catch-up strategy formulation by the governments of the developing countries.Methods Firstly,the international patent classification(IPC)co-occurrence network was used to screen key technologies,and the TOP 5 countries and China were located from the aspects of technology life cycle and technological innovation capabilities.Next,the technology development path based on the ordered clustering algorithm and the main IPC number was set up.Finally,the Dijkstra algorithm was applied to identify the shortest catch-up path.Results and Conclusion Applying this method to the current biopharmaceutical industry with the most potential for development,the shortest catch-up paths are found in the selected C12N15,C07K14 and C12Q1 technology fields,proving the feasibility of the method.
  • 摘要：Objective To investigate the willingness of Shanghai residents to buy prescription drugs online.Methods By using e-questionnaire,Shanghai residents’perceptions of online prescription drugs were investigated,and 206 valid questionnaires were collected.Results and Conclusion 96.1%of the respondents knew the correct definition of prescription drugs.46.6%knew they could buy prescription drugs online.67.7%,through social media,knew they could buy prescription drugs online.72.3%knew a medical prescription should be required when buying prescription drugs online.And 83.5%refused to buy prescription drugs online because they were concerned about the quality and safety of drugs.The publicity of online-pharmacies and prescription drugs should be increased in China.Besides,the government supervision should be strengthened in the whole process of service to protect consumers’rights and benefits.Then,the channels of online purchase must be optimized for customers.Lastly,a medical insurance payment system should be set up for buying prescription drugs online.
  • 摘要：Objective To study the policies of integrating medical resources and centralized drug procurement in China from 2018 to 2020,and to provide a reference for large pharmaceutical commercial companies to select partners.Methods Analytic hierarchy process(AHP)and fuzzy synthesis evaluation method were used to establish the index evaluation system and assign values to each index.Results and Conclusion According to the questionnaire survey data,the weight of each evaluation index was determined,and the evaluation results were obtained by using the fuzzy synthesis evaluation method.The selection of production enterprises by large pharmaceutical commercial companies includes five first-level indicators and 11 second-level indicators.They can provide a favorable reference for the selection of production enterprises by large pharmaceutical commercial companies against the background of complex pharmaceutical industry.
  • 摘要：Objective To sort out the dimension and indicators of comprehensive value assessment of anti-tumor drugs abroad,and provide a reference for constructing a similar system in China.Methods The keywords such as anti-tumor drugs,value,assessment,method,and framework were used to search CNKI,WanFang database,VIP database,Embase,PubMed and Web of Science.Results and Conclusion According to the research on the value framework of anti-tumor drugs,6 first-level dimensions and 8 second-level indicators with common characteristics were summarized.In view of China’s national conditions,this study summarizes the available value judgment dimensions of anti-tumor drugs at home and abroad,so as to learn from international experience and their mature methodologies,and provide ideas for constructing a multi-dimensional value system of anti-tumor drugs in China.
  • 摘要：Objective To analyze relevant policies and measures on the management of orphan drug reimbursement in foreign countries to provide a reference for future reimbursement management in China.Methods According to the percentage of health care expenditure in GDP,the completeness of rare disease policies,and the total population,Russia,Australia,and India were selected as the reference.Based on the existing literature,the main content and characteristics of the reimbursement of rare disease drugs were analyzed.Results and Conclusion Russia manages rare diseases in the form of lists.Special rare diseases are reimbursed by federal or regional finances,and ordinary rare diseases are reimbursed by statutory medical insurance funds.Orphan drugs in Australia are included in the pharmaceutical benefits scheme(PBS)and the lifesaving drugs program(LSDP),LSDP provides fully reimbursed drugs for eligible rare disease patients.India’s proposal takes health system sustainability into consideration.China should carry out epidemiological research to legally determine the rare diseases,establish reasonable reimbursement standards,and improve the multi-level reimbursement system.
  • 摘要：Objective To provide a reference for future budget of health insurance fund for the COVID-19 pandemic in other parts of China or other major public health events.Meanwhile,it also offers a reference for the government to introduce and adjust the policy of health insurance funds after the pandemic.Methods Models of the income,expenditure and cumulative balance of health insurance fund in Hubei Province in 2020 were established and compared.The former was mainly established and tested using SPSS 26.0 and Excel,while the latter was obtained by inferential analysis.Results and Conclusion The COVID-19 pandemic reduced the income and increased expenditure of the health insurance fund in Hubei Province in 2020,resulting in a deficit.The COVID-19 outbreak has caused a deficit in health insurance fund of Hubei Province in the short term,but in the long term,the outbreak will not have a major impact on the health insurance fund.
  • 摘要：Objective To analyze the impact of the first batch of centralized drug procurement on foreign pharmaceutical enterprises since the national centralized drug procurement policy has brought great impact on pharmaceutical market,and put forward some suggestions on their marketing transformation in China.Methods Firstly,the documents of the drug centralized procurement were studied,and then the sales figures before and after the implementation of the policy were retrieved from MiNET.At the same time,the relevant business adjustment information of foreign pharmaceutical enterprises was collected for analysis.Results and Conclusion The sales of related products of foreign pharmaceutical enterprises have dropped sharply,so they have stripped off these products and reduced their staff.It is suggested that foreign pharmaceutical enterprises should adjust the structure of sales team,strengthen the layout of the market in the county,and accelerate the introduction of innovative drugs to cope with centralized drug procurement.
  • 摘要：Objective To analyze the current status of pediatric drug development in China from the perspective of pediatric drug registration and clinical trials so as to provide a reference for its improvement.Methods The registration and clinical trials explicitly labeled as pediatric drugs were analyzed by using the Insight Database,National Medical Products Administration(NMPA),and other publicly available information.Results and Conclusion The number of applications for pediatric drug registration was 196,and 104 were for domestic drugs,accounting for 53.06%.The number of pediatric drugs included in the priority review was 116,and 70.18%have completed the review.However,the number of new pediatric drug marketing applications is still not optimistic.Only 5 applications for pediatric drug registration are accepted by Center for Drug Evaluation(CDE),accounting for 4.63%.There are difficulties in recruiting pediatric subjects in clinical trials,with 42.08%of completed recruitment projects.Besides,there are few institutions for drug clinical trials,the distribution of institutions and professional certification are uneven.Therefore,enterprises should be encouraged to carry out research and development of pediatric drugs from two aspects:improving the policy for pediatric drugs and strengthening the clinical management of pediatric drugs to guarantee their safe use.
  • 摘要：Objective To evaluate the effect of health care reform policy in China comprehensively and provide suggestions for its further implementation.Methods Data on the effect of health care reform were obtained from“China Health Statistics Yearbook”and National Bureau of Statistics of China and the indicators were selected by corrected item total correlation(CITC)and Cronbach’sαreliability coefficient.Then,the selected indicators were calculated through the prospect theory model.Meanwhile,the gray relation analysis method was introduced to enlarge the differences between the advantages and disadvantages to make the comprehensive evaluation result more obvious.Results and Conclusion The implementation of China’s health care reform has a significant impact on China’s medical and health system.However,the effect of the policy will become less with the increase of the total amount.An effective management can ensure that the policy continues to play its role.
  • 摘要：Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China.Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature,field investigation and research re-lated policies.Results and Conclusion When introducing co-line products,we should focus on combining prod-uct reality,establish a cross-professional team in comprehensive quality,R&D,equipment,and production.Then we can coordinate quality risk management to integrate with each other to avoid“shortcomings”in different links,which will affect the effectiveness of risk management.When a company conducts co-line production,it should rely on quality risk management theories to establish a scientific quality management system,reasonably use qual-ity risk assessment tools to evaluate the types of co-line production,and control key risk factors effectively.These methods can ensure the risk of co-production within an acceptable range.
  • 摘要：Objective To study the influence of national drug centralized procurement policy on pharmaceutical enterprises manufacturing generic drugs and original drugs,so as to provide a reference for them to make different strategic choices.Methods Through the literature research on the related policies and the bidding data,the national drug centralized policies were studied systematically.Combined with the bid-winning price and price reduction range of the winning enterprises in the three rounds of centralized procurement,their difficulties,strategic choices and the winning factors were investigated.Besides,a model was established to clarify the optimal price of enterprises in the process of drug procurement.Results and Conclusion The strategic choices of enterprises in participating national drug centralized procurement are influenced by many factors such as the market share of the original varieties,active pharmaceutical ingredients(APIs)and cost.Therefore,corresponding strategies should be formulated according to the characteristics and interests of enterprises.
  • 摘要：Objective To discuss issues related to telemedicine in the context of the“Internet plus”and the prevention of novel coronavirus in early 2020,so as to provide some reference for the rapid development of Internet plus telemedicine.Methods Literature analysis method was used to summarize the current status of telemedicine at home and abroad.Descriptive statistical analysis and comparative analysis were also conducted to analyze the data of population and health in the“China Health Statistical Yearbook”and“China Statistical Yearbook”from 2009 to 2018.Results and Conclusion The distribution of medical demand and medical resources is uneven in 31 provinces,municipalities and autonomous regions,such problems are more serious between urban and rural areas in different regions.The population’s demand for medical care and the allocation of medical resources have the characteristics of positive correlation,large urban-rural differences and regional imbalance.Confronted with the situation that the uneven distribution of medical resources provides potential development opportunities for telemedicine and the difficulties in the further development of telemedicine,the government should formulate policies to improve the publicity of telemedicine,setting up a full coverage of telemedicine service system.Besides,hospitals should ensure the information security monitoring.
  • 摘要：Objective To study the relationship between essential drug list and the provisions on the drug coverage in tertiary hospitals,and put forward the corresponding countermeasures and suggestions for the adjustment of essential drug list and the improvement of relevant policies.Methods Expert consultation and statistical methods were used to classify the drugs in the list of essential drugs according to different diseases.Besides,the matching degree of basic drug allocation and prescription policy was analyzed.Results and Conclusion Among the 685 drugs in the national essential drug list of 2018 edition,453 drugs were used to treat minor illness,accounting for 66.1%of the total number of essential drug list.232 drugs were for serious illness or fatal illness,accounting for 33.9%of the total number of essential drug list.The current essential drug list does not match the national requirements for drug plan coverage in tertiary hospitals,which needs further adjustment and improvement.

    亚洲社会药学的期刊信息

    • 创刊时间：1983
    • 地区：CN
    • 语言：中文
    • 热门主题：DRUG PHARMACEUTICAL PHARMACY PATENT ANALYSIS JOURNAL INFORMATION ENTERPRISE RESEARCH VACCINE
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    • 通讯地址：辽宁省沈阳市沈河区文化路103号
    • 邮编：110016
    • 联系电话：024-23986082 43520798
    • 邮箱：tx830127@163.com;qkgjb2006@126.com
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