RESUMEN
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.
RESUMEN
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.