Efficacy，safety and cost-effectiveness evaluation of voriconazole original and generic drugs / 中国药房

OBJECTIVE To evaluate the efficacy， safety and cost-effectiveness of generic drugs and original drugs of voriconazole. METHODS The information of patients who used voriconazole generic drugs selected in National Centralized Drug Procurement （generic drug group） or non-selected original drugs （original drug group） in the treatment of fungal infection was collected from the our hospital. The propensity score matching was carried out to eliminate bias. The comprehensive efficacy was evaluated according to clinical efficacy， image findings and microbiological test， and stratified analysis of different populations was conducted based on fungal species， underlying diseases， etc.， the efficacy of different stratifications was evaluated. Evaluation of safety was performed by using the incidence of adverse reactions. The total cost， defined daily doses （DDDs） and defined daily dose cost （DDDc） were used to evaluate the cost-effectiveness. RESULTS A total of 436 patients were included， and there were 190 patients in each group after matching. In terms of efficacy， the effective rates of voriconazole generic drugs and original drugs were 62.63% and 59.47% （P＝0.528）； in terms of safety， the incidence of adverse reactions caused by generic drugs and original drugs of voriconazole was 13.68% and 7.89%， respectively（P＝0.069）. In terms of cost-effectiveness， the average total cost of generic drugs was 4 636.26 yuan， and that of original drugs was 8 613.20 yuan （P＜0.001）. After the implementation of National Centralized Drug Procurement， replacement rate of generic drugs increased to 87.30%， and DDDc decreased by 59.08%. CONCLUSIONS The efficacy and safety of voriconazole generic drugs are similar to those of original drugs in the treatment of fungal infection， and it is more cost-effective in terms of treatment cost.

Multicenter study on the efficacy and safety of 3 kinds of Cephalosporin for injection from centralized procurement or non-centralized procurement / 中国药房

OBJECTIVE To compare the efficacy and safety of Cefazolin sodium for injection， Cefuroxime sodium for injection， and Ceftazidime for injection from nationally organized centralized drug procurement （hereinafter referred to as “centralized procurement”） and non-centralized procurement in patients with bacterial infection. METHODS The case data of hospitalized patients who had used 3 kinds of Cephalosporins for injection from centralized procurement or non-centralized procurement in the treatment of bacterial infections were retrospectively collected from 19 medical institutions in Kunming from January 2020 to September 2022. After balancing the baseline differences between the groups with the propensity score matching method， the effectiveness and safety differences of 3 kinds of Cephalosporins for injection from centralized procurement or non- centralized procurement were compared respectively. RESULTS After balancing the baseline differences among the groups， 394 cases in each group of Cefazolin sodium for injection from centralized procurement or non-centralized procurement， 472 cases in each group of Cefuroxime sodium for injection from centralized procurement or non-centralized procurement， 504 cases in group of Ceftazidime for injection from centralized procurement and 590 cases in group of non-centralized procurement were included in the analysis. In terms of effectiveness， there were no significant differences in clinical response rate， 72 h response rate， bacterial clearance rate， and the recovery rate of body temperature， white blood cell count， neutrophil count， neutrophil percentage， C-reactive protein， procalcitonin recovery between the centralized procurement group and non-centralized procurement group of Cefazolin sodium for injection and Cefuroxime sodium for injection （P＞0.05）. The proportion of patients in centralized procurement group of Ceftazidime for injection with C-reactive protein restored to normal reference range was significantly higher than that in non-centralized procurement group （46.9% vs. 27.9%， P＜0.05）， but there were no statistically significant differences in other effectiveness indicators among groups （P＞0.05）. In terms of safety， there was no statistical difference in the incidence of adverse drug reactions between centralized procurement group and non-centralized procurement group of 3 kinds of Cephalosporins for injection （P＞0.05）； the incidence of platelet count reduction in centralized procurement group of Cefazolin sodium for injection was significantly higher than non-centralized procurement group （20.7% vs. 7.1%， P＜0.05）， the incidence of eosinophilia elevation in centralized procurement group of Ceftazidime for injection was significantly higher than non-centralized procurement group （5.3% vs. 1.9%， P＜0.05）. In addition， there was no statistically significant difference in the abnormal rates of other laboratory indicators among the three types of injection Cephalosporins （P＞ 0.05）. CONCLUSIONS The efficacy of 3 kinds of Cephalosporin for injection from centralized procurement is not inferior to non- centralized procurement varieties， and the safety is equivalent to that of non-centralized procurement varieties.

Analysis of influential factors for purchasing quantity changes in the procurement varieties of the first batch of drug centralized procurement / 中国药房

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.

Analysis of the effects of national centralized drug volume-based procurement policy in public medical institutions of the Guangxi Zhuang Autonomous Region / 中国药房

OBJECTIVE To investigate the implementation effects of the national centralized drug volume-based procurement policy （abbreviated as “national centralized procurement policy”） in Guangxi Zhuang Autonomous Region prefecture， and to provide a reference for the future centralized drug procurement work of the medical institution. METHODS Drug procurement data before and after policy implementation were included in the study. The six secondary indicators （such as availability， affordability， and drug safety） and eighteen third-level indicators （such as completion rate of agreed purchase volume， affordability level， drug revenue proportion） were introduced， guided by the policy objectives and issues of concern to policy beneficiaries. Descriptive statistics was adopted to analyze the data before and after policy implementation （in 2019 and 2020） in terms of differences and change trends. RESULTS In terms of accessibility， the participation rate of medical institutions in Guangxi Zhuang Autonomous Region was 92.55%， the proportion of diseases involved and median completed procurement rate were 40.16%， and 287.82% respectively， and the total centralized delivery rate was 97.20%. In terms of affordability， the total reduction amplitude in drug price was 74.80% from 2019 to 2022； the charge for medicine per capita in hospitalization， the proportion of medicine used for outpatient service and hospitalization， decreased by 17.61%， 10.22%， and 20.10% in order； the burden levels on medical fares for patients were all below 1 in addition to chronic diseases， and anti-tumor drugs. In terms of the impact on medicine， the ratio of adverse drug reaction event cases in 2022 was 66.00%， an increase of 1.29% compared to the previous； since the implementation of the policy， 12 drugs from local pharmaceutical enterprises from Guangxi Zhuang Autonomous Region had passed the consistency evaluation， and the market concentration rate of the top 8 pharmaceutical companies was less than 20.00%. In terms of the impact on healthcare and medical insurance， the public medical institutions achieved generic substitution for originator drugs mostly until 2022； about 9.12% of drugs that were non- centrally purchased in the same category were used； 63.39% of people under investigation did not show a need for a second dressing change； drug expenditure decreased by 2.459 billion yuan. CONCLUSIONS The national centralized procurement policy achieves a significant effect in Guangxi Zhuang Autonomous Region. On the other hand， attention should be paid to these suggestions as follows: expanding the category of drugs used in clinic， conducting clinically comprehensive evaluation of selected drugs， and improving reasonable allocation strategy， etc.

Comparison of efficacy，safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia / 中国药房

OBJECTIVE To compare the efficacy， safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia （CAP）. METHODS A retrospective cohort study was conducted to screen and include CAP outpatients during the period of January to December 2021 in Lianyungang First People’s Hospital. They were divided into generic drug group （1 058 cases） and bid-winning drug group （1 121 cases） according to the drug source. Two groups were respectively given original and bid-winning Moxifloxacin hydrochloride tablets， 0.4 g each time， once a day. The efficacy indexes （clinical effective rate， remission time， treatment course， revisiting rate） and safety indexes （allergy， nervous system symptoms， etc.） were compared between the two groups； and the influence factors of clinical treatment failure were analyzed with multi-factor modified Poisson regression model. The economic indicators of the two drugs [quantity， consumption sum， defined daily doses （DDDs）， defined daily dose cost （DDDc）， price ratio， replacement rate] were compared. RESULTS There were no significant differences in the clinical effective rate， treatment course， revisiting rate， the incidence of nervous system symptoms and Q-T interval prolongation between the two groups （P＞0.05）. The remission time of original drug group was significantly shorter than that of bid-winning drug group， and the incidence of total adverse drug reaction， allergy reaction， gastrointestinal symptom reaction and hyperglycemia were significantly lower than those in bid-winning drug group（P＜0.05）. Multivariate Poisson regression analysis showed that bid-winning drug did not increase the risk of clinical treatment failure in CAP outpatients [RR＝1.132， 95%CI （0.883， 1.542）， P＝0.327]. However， antibiotic exposure history， more than 2 items of abnormal clinical manifestations and auxiliary examination all increased the risk of clinical treatment failure （P＜0.05）. Compared with before the implementation of centralized volume-based procurement policy， the quantity and DDDs of Moxifloxacin hydrochloride tablets increased significantly， while the consumption sum decreased significantly， DDDc of bid-winning drug decreased significantly， the price ratio of it to original drug decreased to 0.117， and the replacement rate increased to 69.44% after the implementation of centralized volume- based procurement policy. CONCLUSIONS Compared with original drug， bid-winning Moxifloxacin hydrochloride tablet shows reliable efficacy and obvious price advantage in the treatment of outpatient CAP， but the incidence of adverse drug reactions is higher.

Analysis of the use of insulin products in our hospital after centralized volume-based procurement / 中国药房

OBJECTIVE To analyze the implementation of insulin centralized volume-based procurement policy （hereinafter referred to as “centralized procurement”） in our hospital and its effect on the use of insulin products in clinical. METHODS The manufacturer， specifications， usage， sales amount and agreed purchase volume of insulin products in our hospital before （July 4， 2021 to January 3， 2022） and after （July 4， 2022 to January 3， 2023） the centralized procurement were collected. The defined daily dose （DDD） method was used to calculate defined daily doses （DDDs）， defined daily cost （DDC）， the progress of procurement completion and actual cost saving. RESULTS After the centralized procurement， the number of insulin products had increased from 20 to 29 in our hospital； except for the Insulin degludec/aspart injection in our hospital’s original insulin catalog that had not been centrally purchased， all other existing varieties had been included in centralized procurement catalog. The use of Insulin aspart 30 injection produced by Novo Nordisk （China） Pharmaceutical Co.， Ltd. always ranked the first place in the list of usage and DDDs before and after the centralized procurement. The sales amount of Insulin glargine injection produced by Ganli Pharmaceutical Co.， Ltd. and Tonghua Dongbao Pharmaceutical Co.， Ltd. increased significantly due to the significant increase in usage. The centralized procurement of Degu insulin injection from Novo Nordisk （China） Pharmaceutical Co.， Ltd. had achieved a relatively high completion rate in our hospital’s original insulin catalog， while the completion rate for new varieties was low. After the centralized procurement， our hospital actually saved a total of 1 388 582.66 yuan in expenses. CONCLUSIONS After the centralized procurement， the selection and usage of insulin varieties in our hospital are reasonable， which saves patients’ insulin treatment costs， and reduces economic pressure on patients and society.

Study on essential medicine system from the perspective of coordinated with centralized volume-based procurement policy / 中国药房

OBJECTIVE To provide a reference for further improvement of the essential medicine system. METHODS Statistical analysis method and comparative analysis method were used to explain the necessity of coordination between the two systems from the direct correlation and indirect impact of centralized volume-based procurement on the essential medicine system at the present stage. The relevant suggestions were put forward for the development of the essential medicine system in the new era from the perspective of improving institutional synergy. RESULTS & CONCLUSIONS There was a direct correlation between the policy of centralized procurement and the essential medicine system in terms of policy objectives and medicines selection. However， it also indirectly affects the use of essential medicines in medical institutions through production and supply， coincidence degree between the essential medicine list and the selected variety， and the consistency evaluation of generic drugs. It is suggested that in the selection of essential medicine list in the future， priority should be given to the selection of varieties through centralized procurement， and improve the drug supply guarantee capacity under the dual policy linkage； at the same time， incentive assessments for the allocation and use of essential medicines by various entities should be further strengthened to promote the further improvement and development of the essential medicine system.

Study on evaluation criteria for the quality of Chinese patent medicine purchased centrally by the Guangdong alliance / 中国药房

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.

Hospital Centralized Monitoring of Post-market Clinical Safety of Naoxintong Capsules in 7 345 Patients / 中国实验方剂学杂志

ObjectiveTo evaluate the clinical safety of Naoxintong （NXT） capsules after marketing， find out the potential risk factors of the drug as soon as possible， and reveal the incidence， nature， and clinical manifestations of the adverse events （ADE） and adverse reactions （ADR） of NXT capsules， so as to provide a basis for safe use of the drug in clinical practice. MethodA prospective， large-sample， multi-center observational cohort study was conducted to monitor all the 7 345 inpatients and outpatients orally taking NXT in 14 hospitals in China from January to December in 2018， with at least one follow-up. The demographic characteristics， disease type， NXT medication， ADR occurrence， characteristics， and prognosis of the patients were collected. SPSS 23.0 was used for single-factor and multivariate logistic regression to predict the influencing factors of ADR. ResultThe male and female patients accounted for similar proportions. There were 5 081 patients （79.40%） aged ≥60 years and 3 153 patients （49.27%） with body mass index （BMI） exceeding the normal standard. There were 344 （5.38%） patients with a history of allergy to medicines and food， 9 （0.14%） patients with a family history of allergy， and 52 （0.81%） patients with a history of allergic diseases. The ADRs associated with NXT occurred in 22 patients， with the incidence of 0.34%. The clinical manifestations of ADR appeared in 31 cases， involving 10 organs/systems， of which gastrointestinal system damage was the most common （17， 54.84%）. All ADRs were mild or moderate. Most ADRs （19， 86.36%） occurred within 4 weeks after administration. The patients with alleviated NXT-associated ADRs accounted for 81.82%. No indicators related to significant increases in ADR risks were found. ConclusionNXT is well tolerated in the general population. The hospital centralized monitoring for the clinical safety of oral Chinese patent drugs based on HIS data and Web tracking and follow-up system is an essential means for the post-market research on the safety of drugs.

Qualitative Study on Psychological Experience of Close Contacts with COVID-19 during the Centralized Isolation Medical Observation Period / 中国医学伦理学

To analyze the psychological experience of close contacts with COVID-19 during the centralized isolation medical observation (centralized isolation for short) period, 17 close contacts of COVID-19 who received medical isolation observation at designated locations in a city of China were selected by purposive sampling using qualitative study methods, and the interviewees were interviewed by full-coverage structured telephone. By analyzing the obtained data and summarizing the themes, it was found that the psychological status of the COVID-19 close contacts during the centralized isolation period could be classified into three themes: obvious negative emotions, somatization of psychological problems, and demand for social support. During the epidemic, when close contacts were quarantined as high-risk groups, they often had complex and difficult psychological experiences. Relevant departments should actively carry out online guidance channels and offline knowledge dissemination, actively conduct psychological interventions for close contacts, assist them to develop life plans to enrich the life of the centralized isolation period. At the same time, relevant departments should do a good job in logistics and life support services, create a comfortable isolated living environment, and effectively relieve the negative emotions of close contacts of COVID-19 during centralized isolation through a variety of positive and effective measures to ensure physical and mental health.

Centralized blood nucleic acid test data in Tibet: a retrospective analysis / 中国输血杂志

【Objective】 To retrospectively analyze the serological and nucleic acid testing(NAT) data of voluntary blood donors from six blood banks in Tibet, in order to explore the positive impact of NAT on reducing the risk of infective transfusion in a regional scope. 【Methods】 From 2018 to 2022, 38 718 voluntary blood donors from blood centers of Tibet, Shannan, Shigatse, Naqu, Nyingchi and Ngari were tested for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antigen (HIV) and antibody (Ag/Ab1+2) serological determination by enzyme-linked immunosorbent assay (ELISA). At the same time, Haoyuan and Daan nucleic acid detection systems were used for the combined detection of HBV-DNA, HCV-RNA and HIV-RNA. The results of NAT of reactive ELISA samples were statistically analyzed. 【Results】 A total of 178 ELISA-/NAT+ samples were detected in Tibet over the past five years, including 170 HBV-DNA positive cases, 8 HCV-RNA positive cases, and 0 HIV-RNA positive cases, with the positive rate at 0.460%.The detection rate of 624 ELISA+/NAT+ samples was 1.61%.The age of blood donors with hepatitis B in Shigatse area was slightly higher than that in other areas, and the difference was statistically significant(P<0.05) . 【Conclusion】 The centralized detection of viral nucleic acid in Blood Center of Tibet Autonomous Region can effectively reduce the missed detection of transfusion transmitted diseases and guarantee the blood safety in the region.

Analysis of the current situation and countermeasures of pediatric drug procurement in China under the background of centralized drug procurement / 中国药房

OBJECTIVE To analyze the current situation of pediatric drug use under centralized drug procurement， and to provide reference for the subsequent design of pediatric drug centralized procurement rules. METHODS The comparative analysis method was used to analyze the problems in the centralized procurement， clinical use and supply of pediatric drugs from the aspects of centralized procurement selection results and actual use of pediatric drugs， price difference and online prices of pediatric drugs. The solutions were put forward to optimize the centralized procurement and pricing rules of pediatric drugs. RESULTS & CONCLUSIONS The demands for pediatric drugs in China were increasing， but the supply of marketed pediatric drugs was insufficient （including insufficient coverage of disease fields， insufficient varieties， insufficient suitable dosage forms for children， insufficient specifications for children， etc.）， and the development of pediatric drugs was relatively difficult. After merging the dosage forms of centralized procurement according to the medical insurance list， some suitable dosage forms and specifications for children couldn’t be selected， resulting in a shortage of clinical pediatric medication. Relevant enterprises’ enthusiasm for developing and producing pediatric drugs and participating in online competitions had decreased. There was also the problem of underpricing of pediatric drugs under the drug price difference ratio rule. It is recommended that when conducting centralized drug procurement， special drugs for children should be grouped separately for centralized procurement based on attributes and the population covered by the indications. The specifications of suitable pediatric drugs that were not selected are converted into the agreed purchase quantity of medical institutions in a certain proportion. It is necessary to further optimize the pricing rules for pediatric specialized drugs， ensure a certain profit margin for such drugs， increase the willingness of production enterprises to research， develop and supply drugs， and thus ensure the use and supply of pediatric drugs.

Effects of the national centralized drug procurement policy on drug availability and the structure of hospital drug use / 中国药房

OBJECTIVE To analyze the effects of the national centralized drug procurement （NCDP） policy on drug availability and the structure of drug use in public hospitals. METHODS Using hypoglycemic， lipid-lowering， antiviral drugs， and psychiatric drugs for the treatment of mental illness and depression as objects， the interrupted time series model was used to quantitatively evaluate the changes in consumption sum of drugs， consumption amount and daily cost of the target drugs in national sample hospitals as well as the changes in per capita medication frequency， outpatient prescription amount， and medical insurance surplus of target drugs in a third grade class A hospital before and after the implementation of NCDP policy. RESULTS After the implementation of the NCDP policy， the volume for the four bid-winning drugs increased significantly （P＜0.01 for the remaining three categories except for hypoglycemic drugs）， but DDDc （P＜0.01） and the amount of related drugs （P＜0.001） decreased significantly. The volume for the non-winning drugs （except for lipid-lowering drugs） decreased significantly （P＜0.05）， and DDDc also decreased significantly （P＜0.05 for other 3 categories except for psychiatric drugs）； the volume （P＜0.01） and DDDc （P＜0.01 only for psychiatric drugs） for alternative drugs all increased except for antiviral drugs. The structure of drug use for different drugs was affected differently by the NCDP policy，and that of hypoglycemic drugs was affected obviously； the proportion of alternative drugs increased after centralized procurement. The outpatient prescription amount of each hospital significantly decreased after centralized procurement，and the decrease in the cost paid by the patients using lipid-lowering and antiviral drugs related to centralized procurement was greater than 0.60； the remaining medical insurance amount for bid-winning drugs was approximately 1.252 5 million yuan. CONCLUSIONS NCDP policy effectively alleviates the burden of medical expenditure and also drives the structure changes of drug use such as the substitution of generic drugs for original drugs， the growth of the volume of alternative drugs.

Exploration of centralized closed-loop management mode for gynecological day surgery / 中华医院管理杂志

Day surgery can effectively improve the utilization of medical resources. In October 2015, an obstetrics and gynecology hospital established a gynecological day surgery center to centrally manage gynecological day surgery and continuously optimize the management process. In July 2019, the hospital established an intelligent information platform for gynecological daytime surgery managemen. Based on this platform, the " evaluation-appointment-hospitalization-follow-up-chronic disease management" information management process was implemented, the " pre hospital-in hospital-post hospital" full process medical quality and safety monitoring was carried out to form a centralized closed-loop management mode for gynecological day surgery led by gynecologists. Under this management mode, the number of gynecological day surgeries in the hospital has increased from 2 866 cases in 2019 to 4 065 cases in 2021, providing convenient medical services and personalized chronic disease management services, and ensuring the quality and safety of gynecological day medical care, for reference for promoting the high-quality development of day surgeries in specialized hospitals.

Analysis of the shortage of drugs in national centralized volume-based procurement and countermeasures and suggestions / 中国药房

OBJECTIVE To analyze the situation and causes of the shortage of drugs in centralized volume-based procurement， and to put forward countermeasures and suggestions for optimizing centralized procurement rules and improving the drug shortage supply guarantee system. METHODS The shortage data of the first five batches of centralized purchasing drugs during January 2019 and December 2021 were collected from the Shortage Database of Chinese medicine economic information； descriptive statistical analysis was performed for shortage frequency， varieties and reasons. RESULTS & CONCLUSIONS After the first five batches of centralized volumetric procurement policy landed， the frequency of drug shortage reported for selected specifications and selected enterprises increased significantly， mainly drug shortage of selected enterprises. The shortage of some varieties from selected enterprises in the short term was obvious， and most of them were commonly used clinical drugs. The occurrence of drug shortages was affected by various links such as the production， circulation and use， and the main reasons were shortage or monopoly of raw materials. In order to ensure the drugs supply， the government should scientifically assess the risk of production interruption of enterprises， further optimize centralized procurement rules， improve the reporting system for drug shortages， and attach importance to the supply of key drugs； in addition， hospitals should take a variety of measures within the scopes of policies to flexibly respond to drug shortages so as to avoid delaying the treatment of patients.

Class-imbalance Prediction and High-dimensional Risk Factor Identification of Adverse Reactions of Traditional Chinese Medicine with Centralized Monitoring in Real-world Hospitals / 中国实验方剂学杂志

ObjectiveTo achieve high-dimensional prediction of class imbalanced of adverse drug reaction（ADR） of traditional Chinese medicine（TCM） and to classify and identify risk factors affecting the occurrence of ADR based on the post-marketing safety data of TCM monitored centrally in real world hospitals. MethodThe ensemble clustering resampling combined with regularized Group Lasso regression was used to perform high-dimensional balancing of ADR class-imbalanced data， and then to integrate the balanced datasets to achieve ADR prediction and the risk factor identification by category. ResultA practical example study of the proposed method on a monitoring data of TCM injection performed that the accuracy of the ADR prediction， the prediction sensitivity， the prediction specificity and the area under receiver operating characteristic curve（AUC） were all above 0.8 on the test set. Meanwhile， 40 risk factors affecting the occurrence of ADR were screened out from total 600 high-dimensional variables. And the effect of risk factors on the occurrence of ADR was identified by classification weighting. The important risk factors were classified as follows：past history， medication information， name of combined drugs， disease status， number of combined drugs and personal data. ConclusionIn the real world data of rare ADR with a large amount of clinical variables， this paper realized accurate ADR prediction on high-dimensional and class imbalanced condition， and classified and identified the key risk factors and their clinical significance of categories， so as to provide risk early warning for clinical rational drug use and combined drug use， as well as scientific basis for reevaluation of safety of post-marketing TCM.

Analysis and thinking on the practice of local regional drug online procurement in China / 中国药房

OBJECTIVE To systemically sort out the main practices of local drug online procurement， so as to provide reference for national and local governments to improve drug online procurement policies and drug price formation mechanism. METHODS By searching the official websites of 31 provincial medical security bureaus and drug-centralized procurement platforms in China， the classification methods and main goals of local drug online procurement were summarized， then the main practices of local drug online procurement were analyzed based on the main goals， and corresponding suggestion was put forward. RESULTS & CONCLUSIONS There were two classification methods of online drug procurement in each province， one is based on online or purchase methods， and the other is based on drug dimensions. Five main objectives of online drug procurement in each province are to ensure reasonable drug prices， meet clinical drug demand， ensure stable drug supply， cooperate with the implementation of drug policies， and standardize the behavior of transaction subjects. In order to achieve the five goals， each province has taken some targeted measures， but the severity of the policy varies greatly. In order to further improve the online drug procurement policy and improve the market-oriented online drug price formation mechanism， it is suggested to build the top-level design of online drug procurement， strengthen the management of the price comparison relationship of similar drugs， give full play to the monitoring function of the drug-centralized procurement platform and establish a national unified drug-centralized procurement platform.

Effects of centralized volume-based procurement policy on the use of drugs for non-small cell lung cancer in a third-grade class-A cancer hospital / 中国药房

OBJECTIVE To analyze the effects of centralized volume-based procurement policy （hereinafter referred to as “centralized procurement”） on the use of anti-tumor drugs in medical institutions. METHODS The interrupted time series model was used to analyze the changes in the monthly purchase volume and purchase amount of docetaxel， gemcitabine and pemetrexed disodium in a third-grade class-A cancer hospital in Shanxi province from January 2018 to December 2021. RESULTS & CONCLUSIONS After the implementation of the centralized procurement policy， both the selected drugs and the non-selected drugs had different degrees of price reduction， and the price reduction of the selected drugs was far greater than that of the non- selected drugs； average monthly purchase volume and amount of docetaxel decreased significantly in that month after the implementation of the policy， while those of gemcitabine and pemetrexed disodium increased significantly （P＜0.05 or P＜0.01）. After the implementation of the policy， the average monthly purchase volume and amount of gemcitabine showed a downward trend， while those of docetaxel and pemetrexed disodium showed an upward trend （P＜0.05 or P＜0.01）. It is suggested that hospitals should strengthen pharmaceutical administration， and avoid adopting a “one size fits all” approach to non-selected drugs； relevant departments should further expand the collection range of anti-tumor drugs or carry out special collection of anti-tumor drugs， so as to save medical insurance funds and reduce medical expenses.

Clinical centralized safety monitoring and evaluation of traditional Chinese medicine formula granules / 中国中药杂志

Traditional Chinese medicine(TCM) formula granules are highly praised for the advanced, convenient, and modern use of Chinese medicinal materials. The safety of TCM formula granules has long been a concern of regulatory authorities and the medical industry. A multi-center, prospective, open, non-interventional, and centralized monitoring was carried out for the patients treated with TCM formula granules in 252 medical institutions from February 5, 2020 to April 19, 2022. All the case data and the incidence of adverse drug reactions/events were recorded. This study evaluated the safety of TCM formula granules, aiming to provide a reference for the clinically use. A total of 20 547 patients were included in this study. Four adverse events were recorded, including 3 adverse drug reactions with an adverse drug reaction rate of 0.015%, all of which occurred in the digestive system. There was no serious adverse event, and no factors related to adverse drug reactions/events were identified. The incidence of adverse drug reactions/events associated with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. TCM formula granules was rare, which proved their safety in clinical use. A comprehensive data mining and objective analysis was carried out for the medicines with high frequency in TCM formula granules, the commonly used medicine pairs and combinations, and departmental medication. The drug use characteristics, prescription rules, and departmental use of TCM formula granules were summarized, which can shed light on the prescription compatibility and clinical application.

Implementation status and suggestions of centralized volume-based procurement policy for drugs and medical consumables in China / 中国药房

OBJECTIVE To provid e reference and sugge stions for improving the volume-based procurement of drugs and medical consumables （hereinafter referred to as “consumables”）in China. METHODS The relevant policy documents of centralized volume-based procurement of drugs and consumables published from November 2018 to November 2021 were retrieved ； the implementation status and problems of centralized volume-based procurement of drugs and consumables in China were analyzed by using the policy analysis method and referring to relevant research literatures. RESULTS & CONCLUSIONS National health department and healthcare security administration guaranted the rational use of selected products in medical institutions through incentive and supervision measures ；healthcare security administration should optimize the way of medical insurance payment ， promote the medical institutions to control the fees by themselves ，and conduct the credit evaluation of bidding and procurement ； medical products administration should evaluate the consistency of drugs and supervise the quality of selected products. With the normalization of centralized volume-based procurement of drugs and consumables organized by the state and trans-regional alliance ， the drug varieties and dosage forms included in centralized procurement were increasingly in line with the demand of Chinese pharmaceutical market. The price of most selected drugs decreased by more than 50％，and the decrease of consumables was significantly higher than that of drugs. The selected enterprises were mainly domestic generic drug enterprises ，and domestic consumables had gradually become the competitors and substitute of imported consumables. However ，there were still some problems such as repeated bidding and procurement in various alliances and provinces （autonomous regions and municipalities ）， unclear construction of compensation mechanism in medical institutions ，inconsistent bidding and procurement rules and quality evaluation standards for consumables ，low localization rate of some consumables ，low innovation level and profitability of pharmaceutical enterprises and consumables manufacturers. Local centralized volume-based procurement should be encouraged ，and the bidding and procurement rules and quality evaluation standards of “one product ，one policy ”should be gradually established. Great importance should be paid to the construction of compensation mechanism of medical institutions ，standardize zhangqiuyu739632@126.com the dynamic adjustment of medical serv ice prices ；pharma- ceutical enterprises and consumables manufacturers should increase research and development investment to transform into innovative and diversified enterprises ，so as to improve the competitiveness of domestic drugs and consumables.