Objective To quantitatively analyze the policy of centralized drug procurement centralized drug procurement in order to provide reference for the subsequent policy formulation and improvement.Methods Text mining metho...Objective To quantitatively analyze the policy of centralized drug procurement centralized drug procurement in order to provide reference for the subsequent policy formulation and improvement.Methods Text mining method was used to process 15 centralized drugs procurement policies issued at the national level during 2015-2022,and a PMC index evaluation model of centralized drug procurement policies was established.Then,15 centralized drug procurement policies were quantitatively analyzed from the overall and comparative perspective through an evaluation model.Results and Conclusion The average PMC index of 15 centralized drug procurement policies was 6.95,which was acceptable on the whole.Among them,eight were excellent and seven were acceptable.As to the first-order variables,the centralized drugs procurement policy still lacks incentives and constraints.The comparative results show that there are differences in the content and structure of policies,but they are strongly related to each other.Chinese centralized drug procurement policy has been basically formed,which is closely related to medical insurance and medical policies.However,it is still necessary to pay attention to the structure of the policy to ensure the elaboration of the policy content.展开更多
Objective To construct an index system for evaluating the policy effect of centralized drug procurement,and to provide reference for comprehensively and systematically evaluating the policy of centralized drug procure...Objective To construct an index system for evaluating the policy effect of centralized drug procurement,and to provide reference for comprehensively and systematically evaluating the policy of centralized drug procurement.Methods Through combing the policies and literature research,the focus and expected goal of China’s centralized drug procurement policy were clarified.On the basis of policy concerns,combined with some theories and the implementation of drug centralized procurement policy,a primary evaluation index system was constructed.The index system was determined by expert consultation,and the weight of each index was calculated by analytic hierarchy process.Results and Conclusion The questionnaire recovery rates of the two rounds of expert consultation were 88.23%and 100%,the coefficients of authority of experts were 0.86 and 0.80,and the expert coordination coefficients were 0.338 and 0.294,respectively.Finally,the evaluation index system for the policy of centralized drug procurement was established,which included 4 first-level indicators,10 second-level indicators and 23 third-level indicators.The evaluation index system constructed in this paper can not only make up for the deficiency of systematic evaluation of the policy effect of the current centralized drug procurement,but also provide reference for further improving this policy.展开更多
US Congress passed the CARE Act in 1990 in response to a dramatically growing need for resources to combat the AIDS epidemic. One of the programs contained in the Act was the AIDS Drug Assistance Program (ADAP), a fed...US Congress passed the CARE Act in 1990 in response to a dramatically growing need for resources to combat the AIDS epidemic. One of the programs contained in the Act was the AIDS Drug Assistance Program (ADAP), a federally-funded but state-maintained and managed program primarily concerned with providing medication for low-income HIV/AIDS patients. While ADAP programs across the country reached one-third of all patients in 2007, these programs are now in budgetary danger due to the economic recession, state budgetary constraints, the rising cost of healthcare generally, and longer life expectancies associated with current highly active antiretroviral therapy (HAART). This paper first evaluates the current state of ADAP, its strengths and weaknesses, and examines its sustainability in the short term if short-term measures are taken. Concluding that such measures would not lead to long-term sustainability, this paper then argues for a long-term solution to ADAP’s current problems, namely a national, centralized ADAP standard for budgetary and administrative matters. Such a program would increase the long-term sustainability and effectiveness of current ADAP programs by employing more efficient, standard policies and allowing larger, wholesale purchases of costly HAART medications. Moreover, a national policy would address the disparity that currently exists in ADAP programs today with regard to both minorities and those on the waiting lists for treatment. The institution of a national ADAP program would certainly face many political hurdles. Consequently, this paper also looks to a recent political dispute, the enactment of the Affordable Care Act (ACA), for guidance. Using the passage of the ACA as an example could light the path for passage of a national ADAP standard. Ultimately, this would lead to a more effective and sustainable program for HIV/AIDS patients in the United States.展开更多
The drug problem has gradually penetrated into Mexican politics,economy,culture,and other fields since the 20th century,and has become an important factor affecting Mexico’s development.Enrique Pe?a Nieto took office...The drug problem has gradually penetrated into Mexican politics,economy,culture,and other fields since the 20th century,and has become an important factor affecting Mexico’s development.Enrique Pe?a Nieto took office in 2012,and implemented a new anti-drug policy.His government has made reducing violence a major goal of the anti-drug operation,using the national gendarmerie to counter the drug violence,and reforming the judiciary to prevention crime.Enrique Pe?a Nieto’s anti-drug policy has achieved certain results at the beginning of his term.However,the weakness of the national gendarmerie,corruption,and the sluggish economic development have affected the anti-drug policy,and caused it to fail.The drug problem in Mexico is affected by multiple factors,and its solution is a long one.展开更多
Objective To provide reference for improving Chinese innovative drug research and development incentive policies.Methods Based on investigating the incentive policies for innovative drug research and development in cl...Objective To provide reference for improving Chinese innovative drug research and development incentive policies.Methods Based on investigating the incentive policies for innovative drug research and development in clinical research,evaluation and approval in China,anti-tumor drugs were taken as the research object to discuss relevant policies from the perspective of clinical trials and registration approval based on data statistics and current situation analysis.Results and Conclusion Driven by a series of incentive policies for innovative drug R&D,great achievements have been made on anti-tumor drugs.However,there are problems such as concentration of drug targets,homogenization of clinical trials,and gaps in some drugs with large clinical needs.To improve incentive policies for innovative drug R&D,China should adhere to the orientation of clinical value,focusing on basic research and translational research,improving evaluation and approval capabilities,and establishing a sound ecosystem for innovative drugs.展开更多
Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives fo...Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives for generic drug manufacturers,so as to put forward relevant suggestions.Methods Literature research method and statistical analysis method were used to provide data support for paper writing,making suggestions,and enhancing the predictability of policy.Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations,high input costs for exploring evaluation methods,and greater market competition.Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs.However,difficulties in obtaining reference preparations,high input costs and complex evaluation methods all affect the enthusiasm of companies.Therefore,national and local regulatory agencies have issued some supporting policies,which should be improved to assist enterprises in conducting consistency evaluations.展开更多
Objective To evaluate the effect of some policies to prevent drug shortage and stabilize drug prices,and to provide reference for improving relevant policies.Methods With a combination of random stratified sampling an...Objective To evaluate the effect of some policies to prevent drug shortage and stabilize drug prices,and to provide reference for improving relevant policies.Methods With a combination of random stratified sampling and quota sampling,532 medical institutions in 20 provinces were selected to carry out questionnaire surveys.Then,a comparative analysis was made to study the changes of drugs on the shortage list and drugs on non-shortage list before and after the release of the policy of ensuring supply and stabilizing prices.Results and Conclusion The policy played an important role in curbing the growth of drug shortage in the medical institutions,but it did not curb the growth of drugs on non-shortage list.Besides,the drugs on non-shortage list showed an overall fluctuation and upward trend.Meanwhile,from the perspective of drug prices,the price stability problem of drugs on the shortage list and on the non-shortage list became more serious,and the average price increase was 256% and 239%,respectively.The implementation of policies related to the supply and price stability of drugs prevents the growth trend of drug shortages in the list of medical institutions,which has been recognized by most medical institutions.However,there is an increasing trend in the number of drugs on non-shortage list.In addition,the price increase of drugs on both the shortage list and non-shortage list is severe.Some medical institutions report that they have difficulties in using the information reporting system of drug shortage and the classification,grading and the alternative use of drug shortages.It is recommended to strengthen the management of price stabilization of drugs on the shortage list.Further attention should be paid to the supply and price stabilization of drugs on non-shortage list.At the same time,trainings in the classification and substitution of drug shortage and information reporting system should be actively organized,thus comprehensively improving the capabilities of medical institutions at all levels to deal with the problem of drug shortage.展开更多
Objective To analyze the current situation of drug regulation after introducing the new policy for China’s online pharmacy,and to provide reference for the regulation of online pharmacy based on the international exp...Objective To analyze the current situation of drug regulation after introducing the new policy for China’s online pharmacy,and to provide reference for the regulation of online pharmacy based on the international experience.Methods Through literature research and comparative analysis,the history of policies for online pharmacy in China was investigated,and the current situation and problems of regulation for online pharmacy were explored.Results and Conclusion It is found that the body,basis and behavior of online prescription drug supervision in China should be improved.Combining experience in regulating online prescription drug at home and abroad,we provide some suggestions for the implementation of China’s online prescription drug policy by establishing a government-led multiple regulatory mechanism,standardizing the access qualifications for enterprises with business in online prescription drugs,improving the prescription inquiry and review system,and paying attention to consumer needs.展开更多
Objective To study the current situation of China’s pharmacovigilance system,and to provide some suggestions for the improvement of related policies.Methods A policy modeling consistency(PMC)index model of pharmacovi...Objective To study the current situation of China’s pharmacovigilance system,and to provide some suggestions for the improvement of related policies.Methods A policy modeling consistency(PMC)index model of pharmacovigilance policy was constructed to quantitatively assess the samples of policies combining text mining.Then,the PMC surface was established to obtain the visualization results of China’s pharmacovigilance policy samples,and their shortcomings were clearly analyzed by comparison.Results and Conclusion Forty-one percent of China’s pharmacovigilance policies were rated as excellent,54%as acceptable,and the overall evaluation was acceptable.But there is still some room for improvement.On the whole,there are problems of insufficient policy synergy,lack of policy incentives and constraints,and incomplete coverage of policy functions.It is recommended that China’s pharmacovigilance policy system should be optimized by strengthening policy coordination,increasing policy incentives and constraints,and guiding multi-subjects to participate in coordination.These findings and recommendations can provide operational ideas for the system of China’s pharmacovigilance policy.展开更多
Background:Atherosclerotic cardiovascular disease remains the leading cause of death worldwide.This study aims to explore the impact of national volume-based procurement(NVBP)on Chinese patent medicines and provide ev...Background:Atherosclerotic cardiovascular disease remains the leading cause of death worldwide.This study aims to explore the impact of national volume-based procurement(NVBP)on Chinese patent medicines and provide evidence for improving policies and promoting rational drug use.Methods:The study was based on data from the China National Health Insurance Agency that spanned January 2019 to December 2020.Descriptive analysis was conducted using volume and expenditure as variables.Interrupted time series analysis was applied to further analyze Chinese patent medicines.Results:The unit prices of atorvastatin and rosuvastatin decreased by 25%-96%,whereas the prices of Zhibitai and Xuezhikang fluctuated slightly.The affordability is measured as the monthly expenditure on treatment divided by the daily wage.After policy implementation,the affordability of atorvastatin and rosuvastatin improved from 0.242 to 0.014 and from 0.247 to 0.019,respectively.The defined daily doses(DDDs)for atorvastatin and rosuvastatin also increased,whereas total expenditures decreased in hospitals of all levels.Both at the national level and at all levels of hospital,the policy had no significant impact on expenditures for Zhibitai and Xuezhikang and their defined daily doses.Conclusions:The NVBP saved costs in the short term by incorporating high-quality,widely used lipid-lowering drugs.Notably,the policy impacted lipid-lowering chemical drugs,whereas Chinese patent medicines remained largely unaffected.Doctors'use of Chinese patent medicines did not decline,highlighting the clinical specificity of these medicines.展开更多
目的探讨我国药品临床综合评价政策的优化思路。方法采用ROST CM 6软件对国务院及各部委2014年1月至2024年10月出台的21项药品临床综合评价相关政策文件进行文本挖掘,构建政策一致性(PMC)指数模型,并对其进行量化分析,计算PMC指数和PMC...目的探讨我国药品临床综合评价政策的优化思路。方法采用ROST CM 6软件对国务院及各部委2014年1月至2024年10月出台的21项药品临床综合评价相关政策文件进行文本挖掘,构建政策一致性(PMC)指数模型,并对其进行量化分析,计算PMC指数和PMC凹陷指数,进行PMC曲面分析。结果21项政策文件评价结果中,仅有1项为优秀,2项为合格,其余均为良好;PMC指数均值为5.94,PMC凹陷指数均值为4.06,整体处于良好状态,但仍有提升空间。结论我国药品临床综合评价政策基本完善,建议加强各部委联合发文,畅通政策衔接;拓展政策内容中的评价对象,重视评价质量控制;强调评价结果服务于国家药物政策决策及对企业的反哺作用。展开更多
文摘Objective To quantitatively analyze the policy of centralized drug procurement centralized drug procurement in order to provide reference for the subsequent policy formulation and improvement.Methods Text mining method was used to process 15 centralized drugs procurement policies issued at the national level during 2015-2022,and a PMC index evaluation model of centralized drug procurement policies was established.Then,15 centralized drug procurement policies were quantitatively analyzed from the overall and comparative perspective through an evaluation model.Results and Conclusion The average PMC index of 15 centralized drug procurement policies was 6.95,which was acceptable on the whole.Among them,eight were excellent and seven were acceptable.As to the first-order variables,the centralized drugs procurement policy still lacks incentives and constraints.The comparative results show that there are differences in the content and structure of policies,but they are strongly related to each other.Chinese centralized drug procurement policy has been basically formed,which is closely related to medical insurance and medical policies.However,it is still necessary to pay attention to the structure of the policy to ensure the elaboration of the policy content.
文摘Objective To construct an index system for evaluating the policy effect of centralized drug procurement,and to provide reference for comprehensively and systematically evaluating the policy of centralized drug procurement.Methods Through combing the policies and literature research,the focus and expected goal of China’s centralized drug procurement policy were clarified.On the basis of policy concerns,combined with some theories and the implementation of drug centralized procurement policy,a primary evaluation index system was constructed.The index system was determined by expert consultation,and the weight of each index was calculated by analytic hierarchy process.Results and Conclusion The questionnaire recovery rates of the two rounds of expert consultation were 88.23%and 100%,the coefficients of authority of experts were 0.86 and 0.80,and the expert coordination coefficients were 0.338 and 0.294,respectively.Finally,the evaluation index system for the policy of centralized drug procurement was established,which included 4 first-level indicators,10 second-level indicators and 23 third-level indicators.The evaluation index system constructed in this paper can not only make up for the deficiency of systematic evaluation of the policy effect of the current centralized drug procurement,but also provide reference for further improving this policy.
文摘US Congress passed the CARE Act in 1990 in response to a dramatically growing need for resources to combat the AIDS epidemic. One of the programs contained in the Act was the AIDS Drug Assistance Program (ADAP), a federally-funded but state-maintained and managed program primarily concerned with providing medication for low-income HIV/AIDS patients. While ADAP programs across the country reached one-third of all patients in 2007, these programs are now in budgetary danger due to the economic recession, state budgetary constraints, the rising cost of healthcare generally, and longer life expectancies associated with current highly active antiretroviral therapy (HAART). This paper first evaluates the current state of ADAP, its strengths and weaknesses, and examines its sustainability in the short term if short-term measures are taken. Concluding that such measures would not lead to long-term sustainability, this paper then argues for a long-term solution to ADAP’s current problems, namely a national, centralized ADAP standard for budgetary and administrative matters. Such a program would increase the long-term sustainability and effectiveness of current ADAP programs by employing more efficient, standard policies and allowing larger, wholesale purchases of costly HAART medications. Moreover, a national policy would address the disparity that currently exists in ADAP programs today with regard to both minorities and those on the waiting lists for treatment. The institution of a national ADAP program would certainly face many political hurdles. Consequently, this paper also looks to a recent political dispute, the enactment of the Affordable Care Act (ACA), for guidance. Using the passage of the ACA as an example could light the path for passage of a national ADAP standard. Ultimately, this would lead to a more effective and sustainable program for HIV/AIDS patients in the United States.
文摘The drug problem has gradually penetrated into Mexican politics,economy,culture,and other fields since the 20th century,and has become an important factor affecting Mexico’s development.Enrique Pe?a Nieto took office in 2012,and implemented a new anti-drug policy.His government has made reducing violence a major goal of the anti-drug operation,using the national gendarmerie to counter the drug violence,and reforming the judiciary to prevention crime.Enrique Pe?a Nieto’s anti-drug policy has achieved certain results at the beginning of his term.However,the weakness of the national gendarmerie,corruption,and the sluggish economic development have affected the anti-drug policy,and caused it to fail.The drug problem in Mexico is affected by multiple factors,and its solution is a long one.
文摘Objective To provide reference for improving Chinese innovative drug research and development incentive policies.Methods Based on investigating the incentive policies for innovative drug research and development in clinical research,evaluation and approval in China,anti-tumor drugs were taken as the research object to discuss relevant policies from the perspective of clinical trials and registration approval based on data statistics and current situation analysis.Results and Conclusion Driven by a series of incentive policies for innovative drug R&D,great achievements have been made on anti-tumor drugs.However,there are problems such as concentration of drug targets,homogenization of clinical trials,and gaps in some drugs with large clinical needs.To improve incentive policies for innovative drug R&D,China should adhere to the orientation of clinical value,focusing on basic research and translational research,improving evaluation and approval capabilities,and establishing a sound ecosystem for innovative drugs.
文摘Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives for generic drug manufacturers,so as to put forward relevant suggestions.Methods Literature research method and statistical analysis method were used to provide data support for paper writing,making suggestions,and enhancing the predictability of policy.Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations,high input costs for exploring evaluation methods,and greater market competition.Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs.However,difficulties in obtaining reference preparations,high input costs and complex evaluation methods all affect the enthusiasm of companies.Therefore,national and local regulatory agencies have issued some supporting policies,which should be improved to assist enterprises in conducting consistency evaluations.
文摘Objective To evaluate the effect of some policies to prevent drug shortage and stabilize drug prices,and to provide reference for improving relevant policies.Methods With a combination of random stratified sampling and quota sampling,532 medical institutions in 20 provinces were selected to carry out questionnaire surveys.Then,a comparative analysis was made to study the changes of drugs on the shortage list and drugs on non-shortage list before and after the release of the policy of ensuring supply and stabilizing prices.Results and Conclusion The policy played an important role in curbing the growth of drug shortage in the medical institutions,but it did not curb the growth of drugs on non-shortage list.Besides,the drugs on non-shortage list showed an overall fluctuation and upward trend.Meanwhile,from the perspective of drug prices,the price stability problem of drugs on the shortage list and on the non-shortage list became more serious,and the average price increase was 256% and 239%,respectively.The implementation of policies related to the supply and price stability of drugs prevents the growth trend of drug shortages in the list of medical institutions,which has been recognized by most medical institutions.However,there is an increasing trend in the number of drugs on non-shortage list.In addition,the price increase of drugs on both the shortage list and non-shortage list is severe.Some medical institutions report that they have difficulties in using the information reporting system of drug shortage and the classification,grading and the alternative use of drug shortages.It is recommended to strengthen the management of price stabilization of drugs on the shortage list.Further attention should be paid to the supply and price stabilization of drugs on non-shortage list.At the same time,trainings in the classification and substitution of drug shortage and information reporting system should be actively organized,thus comprehensively improving the capabilities of medical institutions at all levels to deal with the problem of drug shortage.
文摘Objective To analyze the current situation of drug regulation after introducing the new policy for China’s online pharmacy,and to provide reference for the regulation of online pharmacy based on the international experience.Methods Through literature research and comparative analysis,the history of policies for online pharmacy in China was investigated,and the current situation and problems of regulation for online pharmacy were explored.Results and Conclusion It is found that the body,basis and behavior of online prescription drug supervision in China should be improved.Combining experience in regulating online prescription drug at home and abroad,we provide some suggestions for the implementation of China’s online prescription drug policy by establishing a government-led multiple regulatory mechanism,standardizing the access qualifications for enterprises with business in online prescription drugs,improving the prescription inquiry and review system,and paying attention to consumer needs.
文摘Objective To study the current situation of China’s pharmacovigilance system,and to provide some suggestions for the improvement of related policies.Methods A policy modeling consistency(PMC)index model of pharmacovigilance policy was constructed to quantitatively assess the samples of policies combining text mining.Then,the PMC surface was established to obtain the visualization results of China’s pharmacovigilance policy samples,and their shortcomings were clearly analyzed by comparison.Results and Conclusion Forty-one percent of China’s pharmacovigilance policies were rated as excellent,54%as acceptable,and the overall evaluation was acceptable.But there is still some room for improvement.On the whole,there are problems of insufficient policy synergy,lack of policy incentives and constraints,and incomplete coverage of policy functions.It is recommended that China’s pharmacovigilance policy system should be optimized by strengthening policy coordination,increasing policy incentives and constraints,and guiding multi-subjects to participate in coordination.These findings and recommendations can provide operational ideas for the system of China’s pharmacovigilance policy.
基金funded by the Beijing Natural Science Foundation(grant number 9232010)Capital's Funds for Health Improvement and Research(grant number 2022-2-4079).
文摘Background:Atherosclerotic cardiovascular disease remains the leading cause of death worldwide.This study aims to explore the impact of national volume-based procurement(NVBP)on Chinese patent medicines and provide evidence for improving policies and promoting rational drug use.Methods:The study was based on data from the China National Health Insurance Agency that spanned January 2019 to December 2020.Descriptive analysis was conducted using volume and expenditure as variables.Interrupted time series analysis was applied to further analyze Chinese patent medicines.Results:The unit prices of atorvastatin and rosuvastatin decreased by 25%-96%,whereas the prices of Zhibitai and Xuezhikang fluctuated slightly.The affordability is measured as the monthly expenditure on treatment divided by the daily wage.After policy implementation,the affordability of atorvastatin and rosuvastatin improved from 0.242 to 0.014 and from 0.247 to 0.019,respectively.The defined daily doses(DDDs)for atorvastatin and rosuvastatin also increased,whereas total expenditures decreased in hospitals of all levels.Both at the national level and at all levels of hospital,the policy had no significant impact on expenditures for Zhibitai and Xuezhikang and their defined daily doses.Conclusions:The NVBP saved costs in the short term by incorporating high-quality,widely used lipid-lowering drugs.Notably,the policy impacted lipid-lowering chemical drugs,whereas Chinese patent medicines remained largely unaffected.Doctors'use of Chinese patent medicines did not decline,highlighting the clinical specificity of these medicines.
文摘目的探讨我国药品临床综合评价政策的优化思路。方法采用ROST CM 6软件对国务院及各部委2014年1月至2024年10月出台的21项药品临床综合评价相关政策文件进行文本挖掘,构建政策一致性(PMC)指数模型,并对其进行量化分析,计算PMC指数和PMC凹陷指数,进行PMC曲面分析。结果21项政策文件评价结果中,仅有1项为优秀,2项为合格,其余均为良好;PMC指数均值为5.94,PMC凹陷指数均值为4.06,整体处于良好状态,但仍有提升空间。结论我国药品临床综合评价政策基本完善,建议加强各部委联合发文,畅通政策衔接;拓展政策内容中的评价对象,重视评价质量控制;强调评价结果服务于国家药物政策决策及对企业的反哺作用。
