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OBJECTIVE To provide reference for improving the rational use of antimicrobial drugs in primary township medical institutions. METHODS Based on the county prescription pre-review center， a team led by anti-infective clinical pharmacists constructed the management mode for the use of antimicrobial drugs in county-level medical communities with clinical pharmacists as the main team by finding out the main problems in the use of antimicrobial drugs in primary township medical institutions， providing feedback on the problems， organizing relevant training for the problems， improving the customization rules of the prescription pre-review software， implementing the automatic interception and pharmacist online prescription review and other measures. Data on the use of antimicrobial drugs were collected and compared in the 15 primary township medical institutions between January-June in 2022 （before the implementation of the mode） and January-June in 2023 （after the implementation of the mode）. RESULTS Compared with before the implementation of the mode， the utilization rate of antimicrobial drugs in outpatients of primary township medical institutions decreased from 24.97% before the implementation of the mode to 19.39% after the implementation of the mode； the utilization rate of antimicrobial injection in outpatients decreased from 66.10% to 46.80%； the utilization rate of intravenous drip of antimicrobial drugs in outpatients decreased from 52.33% to 40.35%； the rates of combined use of antimicrobial drugs in outpatients decreased from 12.70% to 8.19%； the reasonable rate of antimicrobial prescribing in outpatients increased from 55.28% to 73.93%. After the implementation of the mode， the proportion of antimicrobial prescriptions for each diagnosis was basically the same as before； the defined daily dose system （DDDs） and proportion of a few antimicrobial drugs changed compared with before according to the anatomical therapeutic chemical classification of drugs， among which DDDs of lincomycin， gentamicin and other drugs declined significantly； DDDs of antimicrobial drugs for each classification was basically the same as before according to AWaRe classification. CONCLUSIONS The management mode of the use of antimicrobial drugs led by anti-infective clinical pharmacists is constructed in the prescription pre-reviewing center of county-level medical communities， which can effectively improve the rational use of antimicrobial drugs in the primary township medical institutions.
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To provide prevention and control strategies of occupational exposure risks to cytotoxic drug in medical institutions， improve the awareness of protection among medical staff，and reduce potential occupational exposure risks，the Guidelines for the Prevention and Control of Occupational Exposure Risk to Cytotoxic Drugs in Medical Institutions is developed. Based on the World Health Organization Guidelines Development Manual，the exposure risk issues of the cytotoxic drug collected from the time that it entered the hospital to the several stages after delivery to hospital，such as transportation，receipt，storage，unpacking，dispensing，use of finished products，and waste disposal. Delphi method is used to construct identification of clinical issues，and evidence-based research method is used to develop relevant evidence. Quality evaluation is conducted by using the recommended GRADE method. The consensus is reached on the recommendation opinions and evidence levels through expert consensus method. By combining engineering controls，administrative controls and personal protective equipment at different levels，a graded control approach is established. A total of 37 clinical issues are identified，resulting in 36 recommendations. This guideline provides reference and supplementation for the formulation of cytotoxic drug prevention and control measures in medical institutions.
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Under the national policy background of traditional Chinese medicine（TCM）registration review and approval reform， TCM preparations in medical institutions（hereinafter referred to as medical institution preparations） have human use experience， conform to the characteristics of TCM clinical practice， and have advantages in the research and development of innovative Chinese medicines. Therefore， the research and development mode based on clinical experience prescription-medical institution preparations-innovative Chinese medicines has attracted widespread attention from the industry. However， in the process of development and use of medical institution preparations， there are generally clinical problems that restrict their transformation into innovative Chinese medicines， resulting in a relatively weak collection basis of human use experience and insufficient clinical evidence for supporting the research and development of new TCM medicines. In this paper， on the basis of sorting out the supporting regulations and relevant technical requirements of human use experience， and analyzing the clinical problems restricting the transformation of medical institution preparations， it provides suggestions for medical institutions to carry out high-quality research on human use experience of preparations in the process of TCM clinical practice from the aspects of continuously exploring clinical value， improving the construction of information system， focusing on the TCM clinical practice and giving full play to the advantages of discipline cooperation. By realizing the whole life cycle management of medical institution preparations based on three-combination evaluation evidence system， we can promote the transformation of medical institution preparations into innovative Chinese medicines.
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【Objective:】 Evaluating the service quality and medical experience of elderly-friendly medical institutions from the perspective of elderly patients and their accompanying relatives and friends is a specific measure and work focus to promote the construction of elderly-friendly medical institutions, optimize the medical procedures for the elderly, solve the intelligent technology difficulties encountered in the medical process for the elderly, promote public hospitals to fully implement preferential policies for elderly medical services, and continuously improve the health and well-being of the elderly. 【Methods:】 Based on literature analysis and expert consultation, the satisfaction evaluation indicators for elderly-friendly medical institutions were formed. The Analytic Hierarchy Process was used to assign weights to the indicators. And then, the satisfaction evaluation index system for elderly-friendly medical institutions was formed. 【Results:】 After two rounds of Delphi method, and the scoring and demonstration of 15 experts, four primary indicators and 21 secondary indicators were finally formed, and then, assigned weight coefficients to them through analysis. 【Conclusion:】 After the expert demonstration, the satisfaction evaluation system for elderly-friendly medical institutions has good reliability and validity, providing the basis for the construction of elderly-friendly medical institutions and contributing to the formation of a sustainable, systematic, and diversified elderly-friendly service system.
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From the perspective of medical institutions, this paper sorted out the contents of Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human regarding "exemption from ethical review". At the same time, combined with domestic and foreign regulations, this paper deeply considered and analyzed the applicable premise and special circumstances of the provisions from the implementation level, and then put forward suggestions from the perspective of practical operation of medical institutions, with a view to providing some practical guidance and reference for ethical practitioners of medical institutions.
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OBJECTIVE To analyze the patterns and characteristics of drug-related administrative penalty cases with medical institutions as parties from 2020 to 2022 in order to further improve drug management in medical institutions. METHODS A retrospective statistical analysis was used to summarize the drug-related administrative penalty decisions with medical institutions as parties， and to match them with the provisions of the Drug Administration Law （2019 version） for statistical analysis. RESULTS There were 144 complete administrative penalty decisions with medical institutions as parties. Analyzed by cause， 126 cases of administrative punishment for inferior drugs accounted for 87.50%， of which expired drugs accounted for more than 50.00% of the inferior drug cases； 15 cases （10.42%） were for purchasing drugs from enterprises or individuals not qualified to operate drugs. Analyzed by the range of punishment amount of the cases， 34 cases （23.61%） resulted in lighter penalties， while 81 cases （56.25%） resulted in reduced penalties. CONCLUSIONS There are extremely few medical institutions that have received administrative penalties for drug management violations. Medical institutions should strengthen the awareness of law-abiding， and know the red line of drug management and the illegal behavior that is easy to occur， so as to better strengthen drug quality management.
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In order to standardize the review and comment of national key monitoring drug prescriptions （medical orders） by medical institutions at all levels， the Sichuan Academy of Medical Sciences·Sichuan Provincial People’s Hospital took the lead in compiling the Review and Comment Rules of National Key Monitoring Drugs prescriptions （Medical Orders） herein after referred to as the Rules in accordance with the Second Batch of National Key Monitoring Rational Drug Use List （hereinafter referred to as the List） issued by the National Health Commission confirmed in Jan. 13， 2023. According to the laws and drug instructions issued by the national drug regulatory department， clinical guidelines and expert consensus， combined with the actual situation of patients （including age， body weight， liver and kidney function）， the writing group classified the common and unreasonable drug use problems for 30 kinds of drugs included in the List and develop the review and comment details. After two rounds of Delphi method questionnaire research and experts’ online meetings， and reviewed by the steering committee， the final Rules was formed. The Rules aim to provide reference for the evaluation of the rational use of drugs included in the List by medical institutions， so as to realize the standardized management of key monitoring drugs， promote the rational drug use in medical institutions， and ensure the safety of drug use for patients.
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In order to strengthen the supervision of the use of drugs in hospitals，the Sichuan Academy of Medical Sciences· Sichuan Provincial People’s Hospital took the lead in compiling the Principles for the Rational Use of National Key Monitoring Drugs （the Second Batch） with a number of experts from multiple medical units in accordance with the Second Batch of National Key Monitoring Rational Drug Use List （hereinafter referred to as “the List”） issued by the National Health Commission. According to the method of the WHO Guidelines Development Manual， the writing team used the Delphi method to unify expert opinions by reading and summarizing the domestic and foreign literature evidence of related drugs， and applied the evaluation， formulation and evaluation method of recommendation grading （GRADE） to evaluate the quality of evidence formed， focusing on more than 30 drugs in the List about the evaluation of off-label indications of drugs， key points of rational drug use and key points of pharmaceutical monitoring. It aims to promote the scientific standardization and effective management of clinical medication， further improve the quality of medical services， reduce the risk of adverse drug reactions and drug abuse， promote rational drug use， and improve public health.
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Pharmacy services in grassroots medical institutions provide professional pharmacy services for patients. This service not only expanded the scope of primary care delivery, but also meets the residents′need for appropriate medication. At present, the majority of grassroots medical institutions in China provide outpatient pharmacy services by means of pharmacy service alliance, and foreign grassroots medical institutions mainly provide pharmaceutical outpatient services with drug treatment management as the core for patients by granting pharmacists partial prescription rights.In recent years, pharmaceutical outpatient services in grassroots medical institutions had achieved good results in improving patient clinical outcomes, enhancing medication rationality, and enhancing patient compliance. However, there were many unresolved issues, including low public awareness, shortage of pharmaceutical talents, and imperfect guarantee systems. The author suggestted that efforts should be made to increase the publicity of pharmaceutical outpatient services, improve the training mechanism for pharmacists, strengthen cooperation between pharmacists and clinical physicians, include pharmacists in the contracted service team of family doctors, and improve various guarantee systems, in order to provide reference for promoting the sustainable development of pharmaceutical outpatient services in grassroots medical institutions in China.
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In recent years, the issue of conflicts of interest in the transformation of scientific and technological achievements in medical institutions in China has become prominent, mainly manifested as personal and institutional conflicts of interest, with the characteristics of complexity and sustainability. At present, there were some problems in the conflict management of scientific and technological achievements transformation of medical institutions, such as insufficient support of relevant laws, regulations and policies, insufficient supervision of medical institutions, and the lack of industry management atmosphere. The author suggestted that government departments should strengthen the formulation of relevant policies and regulations, medical institutions should establish an interest conflict management system and an independent management department, and industry associations should give full play to their role in assisting, so as to provide reference for promoting medical institutions to effectively manage interest conflicts in the transformation of scientific and technological achievements.
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Objective:To understand the status of medical science and technology achievement transformation policies in application, this study conducted a descriptive statistical analysis of the collected relevant policy texts according to type, time, and publication sector. On this basis, the X-Y two-dimensional analysis framework of policy texts is constructed using the dual dimensions of Howlett and Ramesh′s policy tool classification and policy development to classify policies into 3 categories: mandatory tools, voluntary tools, and hybrid tools, and to quantify the policy texts on the transformation of medical science and technology achievements, analyze the policy support received in the transformation of medical science and technology achievements and the policy obstacles in the transformation of achievements in China. Finally, this study was aiming to propose targeted countermeasure suggestions.Methods:The texts of medical achievement transformation policies were collected through the official websites of the State Council and the Ministry of Science and Technology, and combined with relevant literature. Research methods such as literature research method and quantitative and qualitative analysis method were applied to conduct the study. The policy samples were coded and organized, and two-dimensional analysis was conducted through the constructed X-Y two-dimensional analysis framework. The texts were quantitatively analyzed through a combination of quantitative and qualitative methods.Results:The results of the analysis of the coded data revealed that the current mandatory tools of China′s medical science and technology achievement transformation policy account for a relatively high proportion, and the use of voluntary tools still needed to be further improved. The use of various policy tools was uneven. The internal structure of various policy tools was also uneven, and there was still room for improvement.Conclusions:Through qualitative and quantitative analysis of the results of the application of medical science and technology achievement transformation policy in China, this paper puts forward 3 countermeasure suggestions: firstly, in the stage of policy strengthening and implementation, the implementation path and scheme of policy tools need to be refined so that the policy can realize implementation. Secondly, the balanced development of various policy tools, the coordination of policy formulation and implementation, the balanced role of mandatory tools, hybrid tools and voluntary tools, and the establishment of a smooth policy system for the transformation of medical science and technology results on this basis to improve the effectiveness of the policy. Thirdly, improve the internal orientation and evaluation mechanism of medical institutions to motivate medical institutions and medical personnel to carry out scientific and technological innovation and transformation work.
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Objective:The study aims to analyze the problems faced in the clinical research and management of stem cells, explore the construction of the entire process of stem cells clinical research, and promote the healthy and orderly development of the clinical research of stem cells.Methods:By consulting the literature and retrieval of relevant policies and regulations, this study analyzed the problems faced by the supervision and management department, medical institutions and researchers, this study and discussed the countermeasures for strengthening the management of the entire process of clinical research of stem cells in medical institutions.Results:There were imperfect internal system and poor management process, insufficient quality control of cell products, low quality of project management, and insufficient clinical research consciousness of stem cell clinical research management in medical institutions.Conclusions:Combined with the current management measures, guidance principles and medical institutions, we should improve the internal system of medical institutions, promote the centralized management and informatization construction of projects, strengthen cell quality control in the hospital, cultivate talent echelons and improve academic and ethical review capabilities, actively explore the management model that is suitable for the entire process of stem cell clinical research for medical institutions in China.
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Objective:To analyze the terminal survey data of hospice care services in a district of Beijing in 2020, and discuss its current situation and existing problems of hospice care services in this district for countermeasures, hence providing reference for the development of hospice care services.Methods:Data were collected from the " Terminal Survey Forms of the Second Batch of Hospice Care Pilot Areas in China in 2020" , which were reported by 4 tertiary hospitals and 5 community health service centers in a district of Beijing. The reporting timeframe ranged from January to December 2020. Text analysis method was used to analyze the hospice care mode, relevant security policies, hospice care team, case diagnosis categories, average hospitalization days and patient cost burden. All the data were subject to descriptive analysis.Results:In 2020, only 4 tertiary hospitals carried out outpatient, consultation and inpatient services of hospice care among the 9 medical institutions in a certain district of Beijing, and none of them carried out home hospice care services. The number of doctors and nurses engaged in hospice care in the four hospitals was 35 and 40 respectively; There were 267 inpatient cases of hospice care, including 121 cases of malignant tumors, accounting for 45.32%; The average hospitalization days of hospice patients (40.0 days) was more than that of the hospital (7.8 days); The average daily hospitalization cost of hospice patients (3 428.7 yuan) was lower than that of the hospital (3 605.6 yuan); Hospice care services had not been included in the scope of medical insurance payment, and the relevant security policies were not perfect.Conclusions:The work of hospice care service in a district of Beijing remains at an initial stage, and the professional team building and supporting policies for hospice care fail to catch up with the demand in this district. The authors suggest to speed up the development of hospice care in primary medical institutions, build a network of " hospital -community-family" levels, enhance training of professionals and technical personnel of hospice care, as well as establish and improve the medical security system, so as to promote the rapid development of hospice care services in this district.
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Objective: To investigate the current situation of safety protection of medical staffs in medical institutions in Jiangsu Province, and to provide scientific basis for strengthening the safety protection of infectious diseases and protecting the occupational health of medical staffs. Methods: From September to October 2020, 1274 medical staffs in 43 medical and health institutions were randomly selected as the subjects. The self-made questionnaire for infectious disease prevention and protection was used to analyze the pre-job training and exposure to occupational harmful factors of the respondents. The influencing factors of using protective equipment and occupational injury were analyzed by binary logistic regression. Results: A total of 1216 valid questionnaires were collected with effective recovery of 95.4%. There were 312 males (25.7%) and 904 females (74.3%) , with an average age of (35.8±9.2) years and average working years of (13.6±9.9) years. Among them, 1143 (94.0%) had participated in pre-job training, 535 (44.0%) thought they were exposed to occupational harmful factors of infectious disease prevention, 1082 (89.0%) used protective equipment in daily operation, and 462 (38.0%) had occupational injury. According to binary logistic regression analysis, the utilization rates of protective equipment for medical staffs in Centers for Disease Control and Prevention (OR=2.473, 95%CI: 1.327-4.607, P=0.004) , 30-39 years old (OR=1.586, 95%CI: 1.038-2.426, P=0.033) , 40-49 years old (OR=2.257, 95%CI: 1.243-4.098, P=0.007) , 50 years old and above (OR=5.879, 95% CI: 1.755-19.692, P=0.004) and pre-job training (OR=2.580, 95%CI: 1.301-5.116, P=0.007) were higher than their respective control groups. And medical staffs with graduate degree or above (OR=0.342, 95%CI: 0.167~0.699, P=0.003) had lower utilization rate of protective equipment. Female (OR=1.902, 95%CI: 1.364-2.654, P<0.001) , 30-39 years old (OR=1.589, 95%CI: 1.157-2.181, P=0.004) , bachelor degree (OR=2.070, 95%CI: 1.419-3.021, P<0.001) , exposure to occupational harmful factors (OR=2.753, 95%CI: 2.086-3.634, P<0.001) were the risk factors for occupational injury of medical staffs. Centers for Disease Control and Prevention (OR=0.129, 95%CI: 0.086-0.194, P<0.001) and wearing protective equipment according to regulations (OR=0.597, 95%CI: 0.431-0.827, P=0.002) were the protective factors for occupational injury of medical staffs. Conclusion: At present, the occupational injury rate of medical staffs in Jiangsu Province is high due to various factors in the prevention and control of infectious diseases. It is necessary to pay attention to occupational safety protection, strengthen pre-job training and actively advocate "standard prevention", so as to reduce the exposure risk of harmful factors and promote occupational health of medical staffs.
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Adult , Female , Humans , Male , Middle Aged , Communicable Diseases , Medical Staff , Occupational Health , Risk Factors , Surveys and QuestionnairesABSTRACT
Narcotic drugs and class Ⅰ psychotropic substances have always been special management drugs in medical institutions. Although relevant policies and regulations have been introduced at the national level ，there are problems of poor policy understanding and inconsistent implementation in medical institutions in the process of policy implementation. In order to standardize the management of narcotic drugs and class Ⅰ psychotropic substances in medical institutions of Yunnan province ， based on the preliminary research and Delphi expert consultation ，this editing group finally formed the Expert Consensus on Key Links Quality Control Management of Narcotic Drugs and Class I Psychotropic Substances in Medical Institutions of Yunnan Province by focusing on the key aspects of quality control of key links for narcotic drugs and class Ⅰ psychotropic substances in medical institutions ，aiming to provide reference for the clinical use and management of narcotic drugs and class Ⅰ psychotropic substances in medical institutions of Yunnan province.
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OBJECTIVE To understand the future development trend of dispensing and use for preparations of medical institutions，and to provide countermeasures and suggestions for promoting the high-quality development of application and dispensing use for preparations of medical institutions . METHODS The development history of dispensing and use for preparations of medical institutions of China was reviewed as a whole ，and then the differences of domestic dispensing and use institutions for preparations of medical institutions over the years were compared from different perspectives ；and the differences between domestic institutions and Japan ’s hospital preparation dispensing and use institutions were compared. The development trend of dispensing and use for preparations of medical institutions of China was summarized to put forward countermeasures and suggestions. RESULTS & CONCLUSIONS The development process of dispensing and use for preparations of medical institutions of China could be roughly divided into the initial stage （2001-2004），the forming stage （2005-2018） and the development stage （2019-present）. Year by year ，the dispensing and use institutions of preparations of medical institutions had shown that the scope of dispensing and use had been expanded ；the approval process had been accelerated ，and the responsibilities of all parties had been clearly defined. Compared with Japan ，regulatory model for preparations of medical institutions was relatively simple in China. In the future ，the large-scale promotion and application of preparations of medical institutions will be normalized ，the time limit for dispensing approval will be shortened ，the approval process will be simplified ，the access threshold for dispensing and use will be gradually lowered ，and the supervision of dispensing and use will be strengthened during and after the event. It is recommended to strictly control the quality and safety of preparations of medical institutions ，implement classified management of use for preparations of medical institutions ，and further improve the supervision mechanism during and after the event.
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In order to promote the standardization of drug selection in medical institutions ，enhance the level of pharmaceutical affairs management of medical institutions and promote the safe ，effective，economical and appropriate use of drugs in the treatment of diseases ，the Drug Selection Guideline for Medical Institutions （hereinafter refer to as the Guideline ）is formulated. The development of the Guideline for medical institutions is following the latest definition of Institution of Medicine （IOM）， National Academy of Sciences and based on the methodology of WHO handbook for guideline development. During the construction of the Guideline ，the research points of the Guideline are constructed on the basis of Delphi method ；a drug selection and evaluation system with 10 primary indicators and 30 secondary indicators as the core is also designed. The evaluation indexes can be divided into research indexes and policy indexes according to their attributes and main sources of evidence. The GRADE method is used to evaluate the quality of the evidence system for research indexes ，while the policy indexes are graded according to the Legislation Law of the People ’s Republic of China . On this basis ，the evaluation methods of those indexes are constructed by using evidence-based medicine method ，the recommendation is formed through expert consensus method ，and finally a standard guideline for drug selection in medical institutions is formed.
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The standardization of pediatric Tuina is beneficial to pediatric Tuina practitioners in a norm practices. The paper collects the content from teaching textbooks, TCM ancient books and database literature, and tries to develop the technical specifications of pediatric Tuina by four rounds Delphi surveys and expert consensus. This specification covers the manipulation of pediatric Tuina, the position of acupoints, the effects of acupoints and the diagnosis and treatment of pediatric Tuina, including indications, contraindications, cautious use, operation steps and methods.
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Objective:This paper aims to explore the management of human genetic resources in medical institutions, according to reflections of the management mode of a particular hospital, providing possible reference for other medical institutions.Methods:The management system of human genetic resources was constructed refer to the McKinsey 7S model. Approved projects information includes the types of projects, characteristics of human genetic resources involved and the characteristics of principal investigator are analyzed.Results:A total number of 82 projects were approved Since the implementation of newly updated Regulation of the People′s Republic of China on the Administration of Human Genetic Resources (hereinafter referred to as the regulations), and majority of which are drug clinical trials. The human genetic resources materials and data involved are mainly blood, urine, serum, plasma, clinical data, imaging data, etc. Most of the principal investigators with senior professional title are from key disciplines.Conclusions:McKinsey 7S model provides a new reference path for medical institutions to carry out human genetic resources management.
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【Objective】 To investigate the incidence and composition of adverse reactions to blood transfusion(ARBT) in Qingdao hospitals in recent years. 【Methods】 The "Statistical Table of Adverse Reactions to Blood Transfusion in Medical Institutions" issued by Qingdao Quality Control Center of Blood Transfusion throughout 2020 to 2021, involving 96 hospitals in the region, were collected and analyzed, including the number, proportion and types of ARBT, as well as the types of blood components transfused. 【Results】 From 2020 to 2021, 296 676 cases of blood transfusion in 96 hospitals occurred, and the incidence of ARBT was 0.27% (814/296 676), of which the incidence of ARBT involving plasma transfusion was 0.17% [accounting for 39.07% (318/814) of all transfusion reactions], involving platelet transfusion was 0.68% [31.08% (259/814)], involving erythrocyte transfusion was 0.11% [27.64% (225/814)] and cryoprecipitation transfusion 0.03% [1.47% (12/814)]. The types of ARBT were anaphylaxis 77.64% (632/814), fever 19.78% (161/814), transfusion-related dyspnea 1.47% (12/814), transfusion-related circulatory overload 0.37% (3/814), purpura 0.25% (2/814) and transfusion-related hypotension 0.25% (2/814), delayed hemolysis 0.12%(1/814) and acute hemolysis 0.12%(1/814), respectively. 【Conclusion】 In recent years, the incidence of ARBT in local medical institutions is lower than that of domestic general level, and the main reactions are anaphylaxis and fever following the transfusion of plasma or (and) platelets.The monitoring and control of ARBT should be strengthened in each hospital with accurate and timely report, and active preventive measures should be taken to control or reduce the incidence of ARBT effectively.