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OBJECTIVE To investigate the factors influencing the changes in purchasing quantity in the procurement varieties of the first batch of volume-based drug centralized procurement （hereinafter referred to as centralized procurement）. METHODS Using 25 procurement varieties of the “4+7” policy as research objects， the changes in purchasing quantity of procurement varieties were analyzed before and after the implementation of the “4+7” pilot， renewal and expansion policies. The influential factors were determined from the three levels of drugs， medical institutions and regions； and the multiple linear regression model was used to analyze the influential factors for the changes in the purchasing quantity of procurement varieties. RESULTS Before and after the implementation of the “4+7” pilot， renewal and expansion policies， the purchasing quantity increased by 52.1， －0.2， 85.8 ten thousand DDDs on average， compared with base period. During pilot， renewal and expansion period， DDDc decrease in procurement varieties was positively correlated with the increase in purchasing quantity （P＜0.01）. During the pilot and renewal period， the number of absolutely alternative varieties was positively correlated with the increase in purchasing quantity （P＜0.1）. During the pilot and expansion period， the number of alternative varieties to a certain extent was negatively correlated with the increase in purchasing quantity （P＜0.05）. During the renewal period， the increment of purchasing quantity in tertiary hospitals was smaller than that of primary medical institutions （P＜0.05）. CONCLUSIONS There is a relationship between the decline of DDDc and the changes in the purchasing quantity， that is， the more the drug price dropped， the more the purchasing quantity increased. The number of alternative varieties for centralized procurement will affect the changes in their purchasing quantity， but it is not always stable. With the implementation of the policy， the volume of primary medical institutions gradually exceeds that of tertiary institutions， indicating that the consumption of centralized purchased varieties is transferred to the primary medical institutions， and centralized procurement has promoted the implementation of the hierarchical diagnosis and treatment system.
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Since the Guangdong alliance launched the centralized procurement of Chinese patent medicine， manufacturers have engaged in fierce price competition to obtain the qualification for selection. In order to ensure that manufacturers have lowered the price without decreasing quality， the evaluation criteria for the quality of Chinese patent medicine is constructed on the basis of the characteristics of traditional Chinese medicine. The evaluation criteria consist of the production process and therapeutic effect evaluation. The evaluation indicators involve raw materials， processing and clinical use covering the whole life cycle of Chinese patent medicine. The evaluation of production process includes 3 secondary indicators （the quality of traditional Chinese medicine， the quality of traditional Chinese medicine decoction pieces and the quality of Chinese patent medicines） and 13 tertiary indicators （standardized production， quality inspection， processing specifications， technical processes， safety risk control， etc.）， which fully reflect the quality control of key links in the production of Chinese patent medicine. The therapeutic effect evaluation includes 5 secondary indicators （theoretical origin of formulation， proactive research by production enterprises， evidence-based medical evidence， clinical use， and technological embodiment） and 18 tertiary indicators （theoretical sources， post-market effectiveness re- evaluation， clinical guidelines， expert consensus， etc.） to assess the quality and efficacy of Chinese patent medicine from multiple perspectives and levels. This study is a useful supplement to the scheme of centralized procurement of Guangdong alliance， which can not only provide data support for selecting “low-cost and high-quality” Chinese patent medicine， but also provide information reference for hospitals to make procurement decisions.
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OBJECTIV E To in vestigate the situation ，achievements and proble ms of consistency evaluation policy of generic medicines in China. METHODS The descriptive analysis was performed after collecting and sorting out the information of generic medicine passing consistency evaluation （GMPCE） published on the official website of the National Medical Products Administration. The basic information ，the distribution and changes of GMPCE were analyzed statistically in National Essential Medicine List （hereinafter refer to as “essential medicine list ”），Medicine List for National Basic Medical Insurance ，Industrial Injury Insurance and Maternity Insurance （hereinafter refer to as “medical insurance list ”）and the result of the successful selection of centralized medicine procurement organized by the state （hereinafter refer to as “centralized procurement list ”）. RESULTS From 2017 to 2021，415 chemical generic drugs had passed consistency evaluation in China ，including 309 varieties，1 822 specifications， 6 dosage forms ，and 17 pharmacological mechanisms ，basically belonging to 30 provinces，and 492 drug manufacturers （except 12 products had not been found the manufacturers ）；the proportion of GMPCE in essential medicine list increased from 0.96％ in 2012 edition to 25.40％ in 2018 edition；that of GMPCE in medical insurance list increased f rom 2.13％ in 2017 edition to 11.68％ in 2021 edition；in the first 5 batches of centralized procurement list，GMPCE accounted for 81.65％，and the maximum price drop after entering the list was 97.52％. CONCLUSIONS The policy linkage has been achieved with the continual increase of the number of GMPCE and their total amount in three lists in China. The accessibility and affordability of related medicines have been improved with the apparent decrease of the price of those medicines. H owever，total number of GMPCE is a little small，with the higher repetition rate of variety and the low proportion in the three lists ；the guarantee measures of those medicine supply need to be strengthened.
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OBJECTIVE：To provide reference for the better implementation of National Drug Centralized Procurement Policy （hereinafter referred to as the“National Centralized Procurement Policy”）. METHODS：Based on the stakeholder theory， combining with literature research and interview research methods，the role orientation，interest demands and mutual relations of the main stakeholders involved in National Centralized Procurement Policy，such as government departments，pharmaceutical enterprises，medical institutions and patients were analyzed. RESULTS & CONCLUSIONS：Government departments include medical insurance department，health department，drug supervision department and other departments，which plan and lead the National Centralized Procurement Policy；their main interest demand is to ensure the orderly implementation of the policy，the rational use and supply guarantee of the selected varieties in clinic，etc. Pharmaceutical enterprises include pharmaceutical production enterprises and pharmaceutical circulation enterprises，which directly participate in the National Centralized Procurement Policy； the main interest demand of drug production enterprises is to ensure reasonable profits to support their product R&D and promote enterprise transformation；that of pharmaceutical circulation enterprises is to obtain the variety distribution right， so as to improve the market share of enterprises，expand the breadth and depth of marketing，and obtain operating profits，etc. As the main provider of medical services and drugs， medical institutions are responsible for implementing the selected category results of the National Centralized Procurement Policy；their main interest demand is to improve its own popularity and reputation. Patients are not only the demanders of medical services and drugs，but also the main beneficiaries of the reform of National Centralized Procurement Policy；their main interest demand is to reduce the drug burden and ensure that the drugs used are safe and effective. In order to better promote the National Centralized Procurement Policy，it is suggested to give play to the leading role of the government and promote the reform of“tripartite system reform”in coordination with other policies；optimize the drug procurement mechanism and guide the reasonable formation of market price；encourage enterprises to continuously improve the quality of varieties through generic drug consistency evaluation，and strengthen quality supervision.
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Objective To analyze the impact of “4+7” City Drug Centralized Procurement Program on the utilization of cardiovascular medicines, and to provide a reference for optimizing the policy of generic medicines as substitutes for original medicines. Methods Eleven drugs, both generic and original were selected for treatment of cardiovascular diseases in an outpatient clinic of a tertiary hospital in Shanghai. The proportion of use of generic drugs and original drug, ratio of used amount, daily cost ratio, and potential cost savings rate of replacement of original drug by generic drug were analyzed before the “4+7” (2018.04.01-2018.09.30) and after the “4+7” (2019.04.01-2019.09.30). Results After the “4+7”, the proportion of the original research drug used decreased from 84.32% to 58.12%, and the ratio of amount of used money decreased from 86.02% to 78.16%; the proportion of generic medicines used increased from 15.68% to 41.88%, and the ratio of amount used increased from 13.98% to 21.84%; the daily cost ratio of generic medicine to original medicine decreased from 0.87 to 0.39. Under the same condition, the potential cost savings of replacing the original drug with generic drugs before and after the “4+7” were RMB 3.703 million and RMB 3.399 million, respectively, and the cost saving rate was 35% and 61%, respectively. Conclusion The “4+7” City Drug Centralized Procurement Program significantly increase the use of cardiovascular generic drugs and significantly reduce the cost of drugs; however, it has a small impact on the quantity and amount of generic drugs used. There is still a significant potential for cost saving. It is recommended to further increase the publicity of the policy on the substitution of original drug by generic, expedite the consistency evaluation process of generic drugs and take measures to avoid the widening of the price gap between original drugs and generics.
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OBJECTIVE： To explore the situation and research hotspots of drug centralized procurement study， and to find existing problems in the development of this field so as to provide reference for further improving drug centralized procurement in China. METHODS： The literatures were retrieved from CNKI， Wanfang and VIP database during 2000-Jun. 2018. CiteSpace software， which was a visualization software， was used to analyze statistically the publication time， author， research institution and keywords. RESULTS： A total of 3 455 literatures were included in the study. The number of literatures in this field had increased significantly since 2009. The author and institution cooperation network were scattered relatively. The research teams were mainly universities and research institutes， few of which were public hospitals. Before 2009，the scholars focused on feasibility analysis of the implementation of drug centralized procurement policy in China， analysis of centralized drug procurement system and model introduction. After New Medical Reform in 2009， great importance was attached to effect evaluation of essential medicine centralized procurement and rational drug use in public hospital. In recent year， the latest outbreak of the keywords were “drug pricing reform”“price negotiation”“medical insurance payment”“drug shortage”“tripartite linkage of medical institutions”“drug purchasing with quantity”“supply guarantee” and so on， which were the newest research hotspots. CONCLUSIONS： The research focus of drug centralized procurement is changing with the adjustment of national policy. At present， the focus of research in this field has shifted to the research on the mode and situation of drug purchasing with quantity， the reform of medical insurance payment standard， the negotiation of drug price in public hospitals and the reform of drug price. Under the background of “Tripartite Linkage of Medical Institutions”， the strategy of drug supply guarantee system was improved， and the countermeasures are explored to alleviate drug shortage and irrational drug use. In the future， cooperation and academic exchanges should be strengthened in this field so as to make the multi-center and multi-disciplinary cooperation mode should become the mainstream. At the same time， public hospitals should enhance their main position and actively participate in research on related topics， so as to promote to establish and improve the drug supply guarantee system and reduce the medical burden of the public.
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Objective To research the difference of medicines prices in the new round of centralized purchasing from 10 provinces,and provide references for further perfecting centralized medicines procurement of provinces in China.Methods Based on the 2015 national sample hospital medicines procurement ranking list and the new round centralized procurement of every province,15 kinds of medicines are selected.By comparative studying,the difference of 15 medicines price among 10 provinces is analyzed.And the difference of prices between the domestic medicines and imported medicines in reference to WHO/HAl drug price standard survey method,the prices of medicines in each province and the international reference prices are analyzed.Results The medicine prices are different in different provinces.The medicines prices of Fujian Province are obviously lower than other provinces.The prices of a few imported medicines are obviously higher than those of domestic ones.Median prices ratios of some medicines exceed the reasonable range.Conclusion It is suggested that every province should refer to the useful experience of Fujian Province in medicines centralized procurement,to improve their centralized procurement plans.Every province should grant equal bids for imported patents,domestic generic drugs and original medicines,to make them have consistency bidding.The international reference price is incorporated into the price limit reference system,to make more reasonable price limit standard.
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By analyzing relevant documents of procurement of drugs with target quantity in Shanghai, com-bined with onsite investigations and interviews, this paper summarizes the practice of procurement of drugs with target quantity in Shanghai from six aspects, namely the basic situation of centralized procurement, pilot scope and variety of procurement of drugs with target quantity, business qualification and certification, determination of successful bid-der, drug distribution, and drug payment settlement. This paper argues that Shanghai has successfully implemented the policy of procurement of drugs with target quantity, by scientifically establishing a comprehensive evaluation index of quality, setting up private drug procurement accounts, prepaying drug procurement loans and strengthening plat-form services and regulatory capabilities, in order to effectively guarantee the operation of procurement of drugs with target quantity. From this case study of Shanghai, it can draw the following implications that in order to successfully achieve procurement of drugs with target quantity mechanism, setting up functional departments of unified authority is the most important guarantee, and using technical means and platform building is the basic conditions. Therefore, the setting up of economic and technical bidding should focus on the individual properties of generic drugs, and the pro-moting of tripartite system reform will help to further expand the scope of procurement of drugs with target quantity.