The vacated space of volume/price of the drugs centralized procurement with quantity in secondary and above public hospitals of China.

BACKGROUND: In 2018, the National Centralized Drug Procurement (NCDP) policy has been implemented in 11 provinces, and promoted across the country in 2019. The main feature of the policy is "volume for price", therefore, it is necessary to measure the price relationship, not only to reduce the price of drugs, reduce the burden of patients' medical costs, but also facilitate pharmaceutical companies to access enough innovation incentives. The aim of this study was to assess the vacated space effect of the drug centralized procurement by national organizations in exchange of price for quantity. METHODS: A difference-in-differences (DID) model was employed to analyze the effect of the 4 + 7 pilot drugs centralized purchasing policy on drug sales volume and selected versus clinically substitutable unselected varieties, using observational data from 2018 to 2019. We compared drug procurement data between secondary and above public hospitals in pilot and non-pilot cities throughout China. RESULTS: The study showed that the average treatment effect (ATE) of sales in the in-hospital market for the selected supply varieties in centralized purchasing is -0.42, and with a sales volume of 0.49. This indicates a volume-price vacated space of 1.16 ~ 1.17 DDD (defined daily dose)/Yuan, implying that for every 1 defined daily dose (DDD) increase in reported volume, the standardized price decreased by 1.16-1.17 Yuan. The ATE of in-hospital market sales for drugs not selected in centralized procurement shows a decrease of 0.13. This finding highlights the presence of the price linkage effect. The ATE of sales volume is 0.57, indicating a volume-price space of 4.38 ~ 4.39 DDD/Yuan for unselected drugs, approximately 3.75 higher relative to that of the selected ones. CONCLUSIONS: The ratio of the volume-price space of clinically substitutable unselected and selected drugs may serve as direct evidence for evaluating the shift from centralized purchasing of drug varieties to clinically substitutable other ones. To strengthen the volume-based negotiation approach and maximize the effectiveness of centralized purchasing policies, we recommend the strategic implementation of a three-tiered centralized purchasing system, the expansion of drug coverage, and the introduction of relevant constraints and incentives.

Impact of National Centralized Drug Procurement policy on chemical pharmaceutical enterprises' R&D investment: a difference-in-differences analysis in China.

Objective: This study aimed to evaluate the impact of the National Centralized Drug Procurement (NCDP) policy on chemical pharmaceutical enterprises' R&D investment and provide references for improving NCDP policy design and encouraging innovation in the pharmaceutical industry. Methods: Using the panel data of 102 Shanghai and Shenzhen A-share listed enterprises from 2016 to 2022 under the chemical pharmaceutical classification of Shenwan in Wind database as the research sample, this study developed difference-in-differences (DID) models on bid-winning and bid-non-winning enterprises, respectively, to evaluate the impact of NCDP policy on their R&D investment. In addition, this study tested the heterogeneity of bid-winning enterprises based on the bid success rate, the decline of drug price, and enterprise size. Results: The NCDP policy could encourage chemical pharmaceutical companies to increase R&D investment, but the low bid success rate and excessive drug price reduction would reduce their R&D enthusiasm, especially for small- and medium-sized enterprises. Discussion: It is suggested that the NCDP policy should be further improved: first, revise the bidding rule of the NCDP policy and increase the bid success rate so that more enterprises can win bids, and second, to solve the problem of excessive drug price reduction, evaluate the rationality of bid-winning prices, and introduce a two-way selection mechanism between medical institutions and supply enterprises. Integrate pharmacoeconomic evaluation into the NCDP rules to form a benign competition among enterprises. Third, attention should be paid to supporting policies for small- and medium-sized enterprises. By increasing procurement volume, shortening payment time limits, and increasing the proportion of advance payments, enterprises' cash flow shortages can be alleviated, thus achieving fairness and inclusiveness in the implementation of the NCDP policy.

Impact and implications of national centralized drug procurement in China.

The national centralized drug procurement (NCDP) policy, known as the "4 + 7" policy in China, has transformed pharmaceutical procurement and access by leveraging healthcare institutions' collective buying power to reduce drug prices substantially. This policy has profoundly impacted drug pricing mechanisms, healthcare expenditures, market dynamics, and the quality of available drugs. This commentary evaluates the efficacy, challenges, and broader implications of the NCDP, summarizes the current state of post-marketing monitoring of selected generic drugs for centralized procurement, and presents relevant considerations.

The impacts of national centralized drug procurement policy on drug utilization of medical institutions: an empirical study in a county-level hospital in China.

PURPOSE: Under the background of the regular implementation of the National Centralized Drug Procurement (NCDP) policy, this study aimed to assess the impacts of the NCDP policy on drug utilization of county-level medical institutions, and probe into the influencing factors of the changes in drug utilization. METHOD: A pre-post study was applied using inpatient data from a county-level medical institution in Nanjing. Drug utilization behavior of medical institutions of 88 most commonly used policy-related drugs (by generic name, including bid-winning and bid-non-winning brands) was analyzed, and the substitution of bid-winning brands for brand-name drugs after policy intervention was evaluated. RESULTS: After policy intervention, 43.18% of policy-related drugs realized the substitution of bid-winning brands for bid-non-winning brands (6.82% of complete substitution, 36.36% of partial substitution). Meanwhile, 40.90% of policy-related drugs failed to realize brand substitution. Multiple factors affected brand substitution, including: (1) Policy effect: brand substitution was more obvious after the intervention of the first and third round of NCDP. (2) Drug market competition: the greater the price reduction of bid-non-winning brands, the more the drugs for the same indication, the more likely that medical institutions keep using the same brands as they did before policy intervention. (3) Previous drug utilization of medical institutions: brand substitution was more obvious in drugs with large number of prescriptions and weak preference for brand-name drugs. CONCLUSION: The NCDP policy promoted the substitution of bid-winning brands for bid-non-winning brands. However, the NCDP policy remained to be further implemented in county-level medical institutions. Policy implememtation efforts, drug market competition and drug utilization of medical institutions would affect the implementation of the NCDP policy.

Impacts of national volume-based drug procurement policy on the utilization and costs of antihypertensive drugs in a Chinese medicine hospital: an interrupted time series analysis of 5138 patients.

Objectives: The study aimed to estimate the effects of National Volume-based Drug Procurement (NVBP) policy on drug utilization and medical expenditures of hypertension patients in public medical institutions in mainland China. Methods: This study used patient-level data based on electronic health records retrieved from the hospital information system of Nanjing Hospital of Chinese Medicine. Data on patients with hypertension who received care at this institution between 2016 and 2021 was used for analysis. Segmented linear regression models incorporating Interrupted Time Series (ITS) analysis were adopted to examine the effects of NVBP policy on drug utilization and health expenditures of eligible patients. Drug utilization volume and health expenditures were the primary outcomes used to assess the policy effects, and were measured using the prescription proportion of each drug class and the overall per-encounter treatment costs. Results: After the implementation of NVBP policy, the volume of non-winning drugs decreased from 54.42% to 36.25% for outpatient care and from 35.62% to 15.65% for inpatient care. The ITS analysis showed that the volume of bid-winning drugs in outpatient and inpatient settings increased by 9.55% (p < 0.001) and 6.31% (p < 0.001), respectively. The volume changes in non-volume based purchased (non-VBP) drugs differed between outpatients and inpatients. The proportion of non-VBP drugs immediately increased by 5.34% (p = 0.002) overall, and showed an upward trend in the outpatient setting specially (p < 0.001) during the post-intervention period. However, no significant differences were observed in the proportion of non-VBP drugs in inpatient setting (p > 0.05) in term of level change (p > 0.05) or trend change (p > 0.05). The average per-visit expenditures of outpatients across all drug groups exhibited an upward trend (p < 0.05) post policy intervention. In addition, a similar increase in the overall costs for chemical drugs were observed in inpatient settings (coefficient = 2,599.54, p = 0.036), with no statistically significant differences in the regression slope and level (p = 0.814). Conclusion: The usage proportion of bid-winning drugs increased significantly post policy intervention, indicating greater use of bid-winning drugs and the corresponding substitution of non-winning hypertensive drugs. Drug expenditures for outpatients and health expenditures per visit for inpatients also exhibited an upward trend, suggesting the importance of enhanced drug use management in Traditional Chinese Medicine hospital settings.

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 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.

Impact of China's National Centralized Drug Procurement Policy on pharmaceutical enterprises' financial performance: a quasi-natural experimental study.

Introduction: In China, the interest relationship between pharmaceutical enterprises and medical institutions has harmed the healthy development of pharmaceutical enterprises. In November 2018, the National Centralized Drug Procurement (NCDP) policy was published. The NCDP policy severs the interest relationship and significantly impacts on pharmaceutical enterprises's financial performance. Methods: Using the implementation of China's National Centralized Drug Procurement (NCDP) policy as a quasi-natural experiment, this study evaluated the impact of participation in the NCDP policy on pharmaceutical enterprises' financial performance. We developed a difference-in-difference model to estimate the change in financial performance after NCDP implementation, based on financial data on Chinese listed pharmaceutical enterprises. Results: We found that the bid-winning enterprises' financial performance significantly improved after participating in NCDP. This may be related to lower costs, market share expansion, and increased research and development investment by the bid-winning enterprises. Discussion: To further promote the high-quality development of pharmaceutical enterprises in China, the government should expand the variety of drugs on the NCDP list (NCDP drugs), while improving the drug patent protection system and the policies to support the bid-winning enterprises.

Problems and challenges encountered by Chinese medical institutions in implementing the national centralized drug procurement.

Objective: The problems and challenges encountered by Chinese medical institutions in implementing the national centralized drug procurement was investigated and analyzed in order to provide reference for the regulatory agencies to formulate policies. Methods: A questionnaire survey was conducted to collect the problems encountered by 329 Chinese medical institutions in implementing the national centralized drug procurement and the corresponding suggestions provided by relevant experts. Statistical analysis was performed to identify differences in the themes and the number of collected problems, further revealing the relevance to the region in which the medical institutions is located. Result: 1360 problems and suggestions were collected from 329 Chinese medical institutions that located in North (19.15%), Northeast (5.78%), East (33.43%), Central (10.03%), South (9.73%), Southwest (14.89%), and Northwest China (6.99%). There was statistically significant difference in the number of collected problems and suggestions between regions (p < 0.001). Furthermore, the content of gathered problems and suggestions involves in 15 themes including system construction, organizational system and work responsibilities, reasonable measurement and reporting of procurement volume et al. These themes that these medical institutions are focusing on are mainly centered on the supply guarantee (15%), reasonable measurement and reporting of procurement volume (11.40%) and guarantee measures for clinical priority use (9.48%) of drugs with national centralized procurement. Meanwhile, we found that problems regarding the supply guarantee of drugs with national centralized procurement displayed significant difference between regions (p = 0.0096). Conclusion: Chinese medical institutions are facing great challenges in implementing the national centralized drug procurement. The scientific study and judgment of the current situation and the construction of corresponding solution require a precise classification of the problems encountered by medical institutions in the process of implementing the national centralized drug procurement policy, which is of great practical significance for deepening the reform of the medical and health system.

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.

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.

Healthcare professionals' knowledge, attitude and practice towards National Centralized Drug Procurement policy in central China: A cross-sectional study.

Background: National Centralized Drug Procurement (NCDP), an ongoing government-led policy starting in 2019 in China, aimed at reducing drug costs. During the implementation of NCDP, healthcare professionals (HCPs) still have a certain degree of concern about the policy, which affects the clinical use of related drugs. Objective: This study aims to assess the level of knowledge, attitude and practice (KAP) of HCPs towards NCDP policy, together with the associated factors that determine their KAP. Methods: A cross-sectional study was conducted between September and November of 2021 in 30 hospitals in Hubei province in Central China. A self-designed online questionnaire including KAP towards NCDP policy was administered to HCPs. Logistic regression analysis was adopted to identify the factors associated with KAP. Results: A Total of, 742 HCPs completed the questionnaires. 43.4% of HCPs had good knowledge, 24.7% had a positive attitude, and 23.7% held good practice. Through multivariate logistic regression analysis, HCPs who are males, pharmacists, with senior professional titles and 6-10 years of professional working experience contributed to a higher knowledge level. Pharmacists and HCPs with good knowledge were more likely to have positive attitudes, while HCPs with higher education were less likely to have positive attitudes. Pharmacists, HCPs who had 11-20 years of professional working experience, worked in medium-size urban areas or had good knowledge were more likely to have good practice. Good practice is also associated with the positive attitude towards the efficacy of centralized-purchased medicines and impacts of NCDP policy. Conclusion: Only a small percentage of HCPs had good KAP towards NCDP policy. Pharmacists showed better KAP than physicians. The positive attitude towards the efficacy of centralized-purchased medicines and impacts of NCDP policy contributed to better practice. High-quality clinical evidence on the therapeutic effects and safety of the centralized-purchased drugs is needed.

Impact of National Centralized Drug Procurement Policy on Antiviral Utilization and Expenditure for Hepatitis B in China.

Background and Aims: The National Centralized Drug Procurement (NCDP) policy was launched in mainland China in April 2019, with entecavir (ETV) and tenofovir disoproxil fumarate (TDF) being included in the procurement list. We conducted the current study to investigate the impact of the NCDP policy on the utilization and expenditures of antiviral therapy for chronic hepatitis B (CHB) in China. Methods: Procurement records, including monthly purchase volume, expenditure, and price of nucleos(t)ide analogs (NAs), were derived from the National Healthcare Security Administration from April 2018 to March 2021. The changes in volumes and expenditures of the first-line NAs and bid-winning products were calculated. The effects of price, volume, and structure related to drug expenditure were calculated by the Addis and Magrini (AM) Index System Analysis. Results: The purchase volume of NAs significantly increased from 134.3 to 318.3 million DDDs, whereas the expenditure sharply decreased from 1,623.41 to 490.43 million renminbi (RMB) or 241.94 to 73.09 million US dollars (USD). The proportions of first-line NAs rose from 72.51% (ETV: 69.00%, TDF: 3.51%) to 94.97% (ETV: 77.42%, TDF: 17.55%). AM analysis showed that the NCDP policy decreased the expenditure of all NAs (S=0.91) but increased that of the first-line NAs in the bid-winning list (S=1.13). Assuming the population size of CHB patients remains stable and a compliance rate of ≥75%, the proportion of CHB patients receiving first-line antiviral therapy would increase from 6.36-8.48% to 11.56-15.41%. Conclusions: The implementation of the NCDP policy significantly increased the utilization of first-line NAs for CHB patients at a lower expenditure. The findings provided evidence for optimizing antiviral therapy strategy and allocating medical resources in China.

Understanding Engagement and the Potential Impact of an Electronic Drug Repository: Multi-Methods Study.

BACKGROUND: Centralized drug repositories can reduce adverse events and inappropriate prescriptions by enabling access to dispensed medication data at the point of care; however, how they achieve this goal is largely unknown. OBJECTIVE: This study aims to understand the perceived clinical value; the barriers to and enablers of adoption; and the clinician groups for which a provincial, centralized drug repository may provide the most benefit. METHODS: A mixed methods approach, including a web-based survey and semistructured interviews, was used. Participants were clinicians (eg, nurses, physicians, and pharmacists) in Ontario who were eligible to use the digital health drug repository (DHDR), irrespective of actual use. Survey data were ranked on a 7-point adjectival scale and analyzed using descriptive statistics, and interviews were analyzed using qualitative descriptions. RESULTS: Of the 161 survey respondents, only 40 (24.8%) actively used the DHDR. Perceptions of the utility of the DHDR were neutral (mean scores ranged from 4.11 to 4.76). Of the 75.2% (121/161) who did not use the DHDR, 97.5% (118/121) rated access to medication information (eg, dose, strength, and frequency) as important. Reasons for not using the DHDR included the cumbersome access process and the perception that available data were incomplete or inaccurate. Of the 33 interviews completed, 26 (79%) were active DHDR users. The DHDR was a satisfactory source of secondary information; however, the absence of medication instructions and prescribed medications (which were not dispensed) limited its ability to provide a comprehensive profile to meaningfully support clinical decision-making. CONCLUSIONS: Digital drug repositories must be adjusted to align with the clinician's needs to provide value. Ensuring integration with point-of-care systems, comprehensive clinical data, and streamlined onboarding processes would optimize clinically meaningful use. The electronic provision of accessible drug information to providers across health care settings has the potential to improve efficiency and reduce medication errors.

Impact of the National Centralized Drug Procurement Policy (4 + 7 policy) on the drug expenditures of patients treated in outpatient and emergency departments in a large tertiary level-A hospital in China: A single centre, interrupted time series.

WHAT IS KNOWN AND OBJECTIVE: Like many countries in the world, China is also facing growing drug expenditures year by year. In particular, the rising cost of prescription drugs has been one of the critical factors leading to the serious burden on health insurance programs. The high cost of prescription drugs not only threatens the health budget but also limits the nation's investment in other public sectors. China implemented the National Centralized Drug Procurement (NCDP) policy, also known as the "4 + 7" policy, in tertiary hospitals in various provinces and cities across the country on 18 December 2019, aiming to lessen personal and national health insurance burdens by reducing drug procurement prices. The aim of this study is to explore the impact of the implementation of the NCDP policy on the drug expenditures of patients treated in outpatient and emergency departments and on national health insurance expenditures. METHODS: This study adopts interrupted time series (ITS) to evaluate the impact of China's implementation of the NCDP policy on the drug expenditures of patients treated in outpatient and emergency departments in a tertiary hospital. The NCDP policy was officially implemented on 18 December 2019. A segmented regression model is utilized to analyse the average monthly drug expenditures of patients treated in outpatient and emergency departments from January 2018 to June 2021, including the average monthly per-visit drug expenditures of all patients and the average monthly per-visit drug expenditures of patients who paid for drugs with health insurance and those who did not use health insurance. RESULTS: After the implementation of the NCDP policy, the overall average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments were immediately reduced by 233.954 CNY (p < 0.01). Compared with the continued downward trend for drug expenditures before the implementation of the NCDP policy, the long-term trend after policy implementation was not obvious (p = 0.051973>0.05). Similarly, the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments who use health insurance to procure drugs also immediately decreased by 505.287 CNY (p < 0.01), but the long-term trends before (p = 0.469>0.05) and after policy implementation (p = 0.51>0.05) did not exhibit obvious change. For the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments who did not use health insurance, the implementation of the NCDP policy did not produce an immediate reduction in drug expenditures (p = 0.3603>0.05). Although the average monthly per-visit drug expenditures decreased by 9.078 CNY (p < 0.01) before policy implementation, this trend ended after the policy was implemented (p = 0.0735>0.05), and no other changes were triggered. WHAT IS NEW AND CONCLUSION: This study reviews the data for a period of time before and after the implementation of the NCDP policy. The policy is shown to significantly decrease the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments.

CHINA PH ARMACY Volume 33，Number 15，August 15，2022 Semimonthly Table of Contents Expert consensus on the comprehensive clinical evaluation of lipid-lowering drugs under the centralized drug volume-based procurement policy in Shandong Province / 中国药房

Comprehensive clinical evaluation of drugs is an important technical tool to promote the return of drugs to clinical value. Under the background of normalization and institutionalization of centralized drug volume-based procurement ，it is very crucial to actively organize and carry out comprehensive clinical evaluation of drugs. As of March 2022，there are 5 lipid-lowing drugs that have been included in the centralized drug volume-based procurement of the state and Shandong Province. In order to actively promote the medical institutions to develop the comprehensive clinical evaluation of lipid-lowing drugs standardly ，led by the Shandong Provincial Hospital Affiliated to Shandong First Medical University ，supported by Shandong Hospital Association ，and 19 third grade class A hospitals in Shandong Province jointly participated ，Using Delphi method ，through three rounds of expert opinion investigation and extensive discussion ，Expert Consensus on the Comprehensive Clinical Evaluation of Lipid-lowering Drugs under the Centralized Drug Volume-based Procurement Policy in Shandong Province was developed. The expert consensus adopted the percentage system for quantitative evaluation. The comprehensive clinical evaluation on 15 lipid-lowing drugs involved in centralized drug volume-based procurement in Shandong Province was implemented from eight dimensions including pharmaceutical characteristics ，effectiveness，safety，economy，suitability，accessibility，innovation and other attributes ，and different recommendation levels were formed according to the scores. The development of this consensus will help medical institutions to reasonably allocate and use lipid-lowering drugs in the context of centralized drug volume-based procurement ，so as to better satisfy the national policy needs and continuously improve the quality of pharmaceutical services.

The impact of "4 + 7" volume-based drug procurement on the volume, expenditures, and daily costs of antihypertensive drugs in Shenzhen, China: an interrupted time series analysis.

BACKGROUND: In 2019, Chinese government launched a nationwide volume-based drug procurement aiming at reducing drug prices and saving drug costs through economies of scale, which aroused widespread attention. The first round of the policy pilot was implemented in 4 municipalities and 7 sub-provincial cities, referred to as "4 + 7" policy. In the "4 + 7" policy, 7 antihypertensive drugs were included. This study was conducted to evaluate the impact of "4 + 7" policy on the use of policy-related antihypertensive drugs. METHOD: This study applied single-group Interrupted Time Series (ITS) design. We used drug purchasing data from the Centralized Drug Procurement Survey in Shenzhen 2019, covering 24 months from January 2018 to December 2019. Antihypertensive drugs related to "4 + 7" policy were selected as study samples, including 7 drugs in the "4 + 7" List and 17 alternative drugs. Alternative drugs refer to antihypertensive drugs that have an alternative relationship with "4 + 7" List drugs in clinical use and have not yet been covered by the policy. "4 + 7" List drugs were then divided into bid-winning and bid-non-winning products according to the bidding results. Purchase volume, expenditures, and daily costs were selected as outcome variables, and were measured using Defined Daily Doses (DDDs), Chinese Yuan (CNY), and Defined Daily Drug cost (DDDc). RESULTS: After "4 + 7" policy intervention, the procurement volume of bid-winning antihypertensive drugs significantly increased (3.12 million DDD, 95 % CI = 2.14 to 4.10, p < 0.001), while the volume of non-winning drugs decreased (-2.33 million DDD, 95 % CI= -2.83 to -1.82, p < 0.01). The use proportion of bid-winning antihypertensive drugs increased from 12.31 to 87.74 % after policy intervention. The overall costs of the seven "4 + 7" List antihypertensive drugs significantly declined (-5.96 million CNY, 95 % CI= -7.87 to -4.04, p < 0.001) after policy intervention, with an absolute reduction of 36.37 million CNY compared with the pre-"4 + 7" period. The DDDc of bid-winning antihypertensive drugs significantly decreased (-1.30 CNY, 95 % CI= -1.43 to -1.18, p < 0.001), while the DDDc of non-winning (0.28 CNY, 95 % CI = 0.11 to 0.46, p < 0.01) and alternative (0.14 CNY, 95 % CI = 0.03 to 0.25, p < 0.05) antihypertensive drugs increased markedly. CONCLUSIONS: The implementation of "4 + 7" policy promoted the drug use hypertensive patients gradually concentrated on the quality-guaranteed bid-winning drugs, which might be conducive to improve the overall quality level of drug use of Chinese hypertensive patients. Besides, a preliminary positive policy effect of price cut and cost-saving was observed in the antihypertensive drug category. In the future, price monitoring and drug use management regarding policy-related drugs should also be strengthened.

Influence of Chinese National Centralized Drug Procurement on the price of policy-related drugs: an interrupted time series analysis.

BACKGROUND: The Chinese government implemented the first round of National Centralized Drug Procurement (NCDP) pilot (so-called "4 + 7" policy) in mainland China in 2019. This study aims to examine the impact of "4 + 7" policy on the price of policy-related drugs. METHODS: This study used drug purchasing order data from the Centralized Drug Procurement Survey in Shenzhen 2019, covering 24 months from January 2018 to December 2019. "4 + 7" policy-related drugs were selected as study samples, including 25 drugs in the "4 + 7" procurement list and 57 alternative drugs that have an alternative relationship with "4 + 7" List drugs in clinical use. "4 + 7" List drugs were then divided into bid-winning and bid-non-winning products according to the bidding results. Single-group Interruption Time Series (ITS) analysis was adopted to examine the change of Drug Price Index (DPI) for policy-related drugs. RESULTS: The ITS analysis showed that the DPI of winning (- 0.183 per month, p < 0.0001) and non-winning (- 0.034 per month, p = 0.046) products significantly decreased after the implementation of "4 + 7" policy. No significant difference was found for the immediate change of DPI for alternative drugs (p = 0.537), while a significant decrease in change trend was detected in the post-"4 + 7" policy period (- 0.003 per month, p = 0.014). The DPI of the overall policy-related drugs significantly decreased (- 0.261 per month, p < 0.0001) after "4 + 7" policy. CONCLUSIONS: These findings indicate that the price behavior of pharmaceutical enterprises changed under NCDP policy, while the price linkage effect is still limited. It is necessary to further expand the scope of centralized purchased drugs and strengthen the monitoring of related drugs regarding price change and consumption structure.