1.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
2.Effects of different storage and transportation devices on the temperatures of “internet plus drug delivery”in hospital under high-temperature conditions in summer
Zheng CAI ; Chen SHANG ; Na HE ; Fang LIU ; Weilong SHI ; Zhe ZHAO ; Rongsheng ZHAO
China Pharmacy 2024;35(6):758-761
OBJECTIVE To explore suitable storage and transportation conditions for “internet plus drug delivery” under high- temperature conditions. METHODS A survey on high-temperature conditions in summer in Beijing was conducted; a retrospective analysis was conducted on “internet plus drug delivery” orders in our hospital from July 2021 to June 2022, summarizing the proportion and delivery range of drugs under different storage and transportation conditions. Additionally, simulation and validation experiments were performed to investigate optimal drug storage and transportation devices for “internet plus drug delivery” in Beijing under high-temperature conditions in summer. RESULTS The monthly average temperature in Beijing from June to August consistently exceeded 25.0 ℃ between 1991 and 2022. From July 2021 to June 2022, a total of 104 drugs were required to be stored below 25.0 ℃, accounting for 31.23% of the 333 drugs listed in our hospital’s “internet plus drug delivery” catalog in Beijing. These drugs were delivered 1 058 times, accounting for 19.63% of the total deliveries. Simulation and validation experiments demonstrated that the average maximum temperature during the next-day delivery process of “carton + foam box + composite aluminum film pearl cotton + 500 g ice bag×2 + gas column bag” was 9.6 ℃, the average minimum temperature was 2.7 ℃, and all the temperatures remained below 15.0 ℃, which could effectively ensure the quality of drugs. CONCLUSIONS Under the high-temperature conditions in summer in Beijing, the storage and transportation device of “carton + foam box + composite aluminum film pearl cotton + 500 g ice bag×2 + gas column bag” can meet the temperature requirements specified in the drug storage instructions for Beijing intra-city drug delivery.
3.Advanced subunit vaccine delivery technologies: From vaccine cascade obstacles to design strategies.
Yingying HOU ; Min CHEN ; Yuan BIAN ; Xi ZHENG ; Rongsheng TONG ; Xun SUN
Acta Pharmaceutica Sinica B 2023;13(8):3321-3338
Designing and manufacturing safe and effective vaccines is a crucial challenge for human health worldwide. Research on adjuvant-based subunit vaccines is increasingly being explored to meet clinical needs. Nevertheless, the adaptive immune responses of subunit vaccines are still unfavorable, which may partially be attributed to the immune cascade obstacles and unsatisfactory vaccine design. An extended understanding of the crosstalk between vaccine delivery strategies and immunological mechanisms could provide scientific insight to optimize antigen delivery and improve vaccination efficacy. In this review, we summarized the advanced subunit vaccine delivery technologies from the perspective of vaccine cascade obstacles after administration. The engineered subunit vaccines with lymph node and specific cell targeting ability, antigen cross-presentation, T cell activation properties, and tailorable antigen release patterns may achieve effective immune protection with high precision, efficiency, and stability. We hope this review can provide rational design principles and inspire the exploitation of future subunit vaccines.
4.Principles for the rational use of national key monitoring drugs (the second batch)
Yuan BIAN ; Min CHEN ; Shan DU ; Wenyuan LI ; Lizhu HAN ; Qinan YIN ; Xiaojiao CUI ; Xuefei HUANG ; Zhujun CHEN ; Yang LEI ; Yingying HOU ; Xiaoqing YI ; Yueyuan WANG ; Xi ZHENG ; Xinxia LIU ; Ziyan LYU ; Yue WU ; Lian LI ; Xingyue ZHENG ; Liuyun WU ; Junfeng YAN ; Rongsheng TONG
China Pharmacy 2023;34(20):2433-2453
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.
5.Clinical comprehensive evaluation of recombinant Mycobacterium tuberculosis fusion protein
Xiaofeng NI ; Sha DIAO ; Siyi HE ; Xuefeng JIAO ; Xiao CHENG ; Zhe CHEN ; Zheng LIU ; Linan ZENG ; Deying KANG ; Bin WU ; Chaomin WAN ; Binwu YING ; Hui ZHANG ; Rongsheng ZHAO ; Liyan MIAO ; Zhuo WANG ; Xiaoyu LI ; Maobai LIU ; Benzhi CAI ; Feng QIU ; Feng SUN ; Naihui CHU ; Minggui LIN ; Wei SHA ; Lingli ZHANG
China Pharmacy 2023;34(4):391-396
OBJECTIVE To evaluate the effectiveness, safety, economy, innovation, suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein (EC), and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin (TB-PPD) were analyzed by the method of systematic review. Cost minimization analysis, cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD, and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation, suitability and accessibility were determined by systematic review and improved Delphi expert consultation, and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness, safety, economy, innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent, while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight, the scores of effectiveness, safety, economy, innovation, suitability, accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD, EC performs better in all dimensions of effectiveness, safety, economy, innovation, suitability and accessibility. However, it is worth noting that EC should further improve its availability in the dimension of accessibility.
6.Construction and effect evaluation of simulation teaching system based on the competency of resident pharmacists
Shujie DONG ; Siqian ZHENG ; Xiaohan XU ; Weilong SHI ; Huibo LI ; Rongsheng ZHAO ; Li YANG
China Pharmacy 2023;34(1):107-110
OBJECTIVE To build a standardized simulation teaching system for resident pharmacists and evaluate its effects, and to provide reference for improving the competency of resident pharmacists. METHODS The established simulation teaching system for pharmacy residents’ standardized training in the study included revising the simulation teaching syllabus, setting up simulation teaching courses, implementing the teaching method through “six types of simulations”, applying objective structured clinical examination (OSCE) for assessment, building a simulation teaching team and strengthening the simulation teaching management. The effect evaluation was perfermed with mixed research method, and qualitative and quantitative research methods were used to collect and analyze data and information. RESULTS &&CONCLUSIONS Compared with the traditional teaching system, the passing rate of graduation examination (71.4% vs. 100%) and the score of after-department examination ([ 76.2±7.8) vs. (90.4±4.9)] under the simulation teaching mode were higher; through questionnaire surveys and qualitative interviews, we found that resident pharmacists who went through simulation teaching gave positive feedback on the role and impact of this system. The simulation teaching system can be used with good generalizability for the standardized training of resident pharmacists, and can provide strong basis and support for the high-quality development of hospital pharmacy.
7.Interpretation of Acute,Perioperative,and Long-term Antithrombotic Therapy Strategies in the Elderly
Qinan YIN ; Lizhu HAN ; Yuan BIAN ; Xuefei HUANG ; Xingyue ZHENG ; Yujie SONG ; Weinan LUO ; Rongsheng TONG
Herald of Medicine 2023;42(12):1752-1757
In January 2023,the European Society of Cardiology(ESC)Working Group on thrombosis published its 2022 updated consensus document on acute,perioperative,and long-term antithrombotic therapy for the elderly.Since the elderly are often accompanied with multiple organ changes and multiple diseases,the risk of hemorrhagic and ischemic events is increased,and they often take multiple drugs and have poor compliance with treatment,which pose significant challenges to clinical antithrombotic management.This article elaborates on how to assess the risk of thrombosis and bleeding,the treatment strategy of oral antithrombotic drugs,the treatment strategy of parenteral antithrombotic drugs,and the perioperative antithrombotic therapy protocols,with the aim of providing clinicians with references for the treatment of antithrombosis in the elderly.
8.Application and Effect Evaluation of 4M1E Refined Management Method in Optimizing Outpatient Pharmacy Service in Our Hospital
Xiaohan XU ; Bowen JIE ; Zheng CAI ; Rongsheng ZHAO
China Pharmacy 2021;32(4):490-495
OBJECTIVE:To explore refined management mode of outpatient pharmacy ,and to improve the efficiency and quality of outpatient pharmacy service. METHODS :From the hospital information and big data center of our hospital ,the outpatient pharmacy prescription data under the traditional management mode were collected ;fish bone analysis was used to find out the factors that may affect the waiting time of patients ,the work efficiency and quality of pharmacy ;4M1E method was adopted to improve the related problems and implement refined management. The prescription data of 10 working days before improvement,stage 1 and stage 2 of refined management were selected. The work efficiency of pharmacists ,average waiting time of patients ,dispensing errors and inventory errors before and after the improvement were compared and analyzed to evaluate the effects of refined management. RESULTS :By fishbone diagram ,the factors influencing the waiting time of patients ,the work efficiency and quality of outpatient pharmacy service in our hospital included personnel factors ,machine factors ,material factors , method factors ,environmental factors ,such as the number of personel and time alloction was unreasonable ,the machine was aging,etc. After the implementation of refined management ,the outpatient pharmacy of our hospital had taken a variety of measures,such as adjusting the staff working time and refining the performance rew ard scheme ,maintaining the automatic dispensing machine and updating the prescription scanning equipment,setting up temporary drug containers and opti- mizing the location number ,strengthening drug management and relevant personnel training , openning the window ofcharacteristic single variety dispensing. The statistical results com showed that in the first stage of fine management ,the number of dispensing prescriptions and the number of p rescription items in the outpatient pharmacy of our hospital increased slightly in 10 working days. Due to the decrease of the number of on-the-job staff and the change of the number and time of open windows ,the cumulative working hours of on-the-job staff decreased from 1 680 hours to 1 440 hours;the number of dispensing prescriptions and prescription items per hour per capita increased from 52.0 pieces,58.7 to 65.1 pieces,69.6(P<0.05);the number of dispensing errors decreased from 30 to 5;there was no significant change in waiting time of patients and inventory errors. In the second stage of fine management ,when the amount of dispensing prescriptions in outpatient pharmacy of our hospital was similar ,the number of dispensing prescriptions and the number of prescription items per hour per capita increased from 52.0 pieces,58.7 to 59.9 pieces,67.3,respectively(P<0.05);the average waiting time of patients decreased from 9.30 min to 7.32 min(P<0.05). After further refining the error data collection method and adjusting the performance incentive scheme ,the number of dispensing errors in outpatient pharmacy increased to 75,and the number of inventory errors decreased from 5 to 0. CONCLUSIONS :By 4M1E method,outpatient pharmacy of our hospital carry out refined management ,to achieve the improvement of work efficiency and quality,shorten the waiting time of patients
9.Interpretation of Novel Coronavirus Infection :Expert Consensus on Guidance and Prevention Strategies for Hospi tal Pharmacists and the Pharmacy Workforce
Rongsheng ZHAO ; Yiheng YANG ; Li YANG ; Zijian LI ; Fang LIU ; Zhenyu REN ; Wei LIU ; Zhanmiao YI ; Yingqiu YING ; Xiaoxiao LI ; Yingying YAN ; Huibo LI ; Shujie DONG ; Weilong SHI ; Xiaohan XU ; Pengxiang ZHOU ; Zaiwei SONG ; Siqian ZHENG ; Ying LIU ; Shen ZHOU ; Suodi ZHAI
China Pharmacy 2020;31(4):385-389
OBJECTIVE:To provid e reference for pharmaceutical workers to better understand Novel Coronavirus Infection : Expert Consensus on Guidance and Prevention Strategies for Hospital Pharmacists and the Pharmacy Workforce (hereinafter referred to as “expert consensus ”),and to apply and practice in specific work ,so as to give full play to the role of pharmacists to help fight the epidemic.METHODS :The background of the formulation and revision of the expert consensus were introduced ,and its main contents and viewpoints were interpreted. RESULTS & CONCLUSIONS :The text of expert consensus is divided into 8 parts,mainly including disease diagnosis and treatment [SARS-CoV- 2 infection related background ,clinical manifestations and diagnosis, treatment],hospital pharmacy (prevention and control strategy ,work guidance ),drug and facility support management(key drug/facility/equipment support ,management and use of the drug in special circumstances ),information sources and related resources ,etc.,which comprehensively and detailedly provide information ,guidance and strategies for coronavirus SARS-CoV-2 infection prevention and control to play the role of pharmacists in hospital pharmacy well ,do well in the protection of staff in different pharmaceutical posts ,drug security work in response to epidemic situation ,and develop pharmaceutical care. So far,the understanding of SARS-CoV- 2 in the pharmaceutical industry is relatively limited. Based on the accumulated experience and progress in epidemic prevention and control ,the expert consensus will be updated and improved continuously ,so as to provide guidance and help for hospital pharmaceutical personnel.
10.Construction of Integrated Emergency Management Model for Novel Coronavirus Pneumonia Epidemic Prevention and Control in Hospital Pharmacy Department
Shujie DONG ; Li YANG ; Chen CHEN ; Xianwei KONG ; Zheng CAI ; Yawei DU ; Fang LIU ; Jinping ZHU ; Hua JIANG ; Jing HUANG ; Xianhua ZHANG ; Jian WEN ; Xue LI ; Tao HAN ; Hongying GUO ; Jing CUI ; Yuan SHUAI ; Jing LI ; Yingying YAN ; Wei LIU ; Huibo LI ; Yiheng YANG ; Zijian LI ; Rongsheng ZHAO
China Pharmacy 2020;31(5):513-517
OBJECTIVE: To provide reference for improving emergency capacity of the hospital pharmacy department in response to the novel coronavirus pneumonia (COVID-19) epidemic. METHODS :According to the related regulations and requirements of Law of the People ’s Republic of China on the Prevention and Control of Infectious Diseases ,combined with the situation of COVID- 19 epidemic prevention and control ,and management experience of relevant hospitals ,on the basis of in-depth analysis of drug supply and quality assurance ,drug dispensing management ,provision of clinical pharmaceutical services and other related material support of hospital pharmacy department,integrated emergency management model was constructed for COVID- 19 epidemic prevention and control ,and the precautions and response measures of each link were sorted out. RESULTS :Integruted emergency management mode for COVID-19 epidemic prevention and control in hospital pharmacy department included but was not limited to human resource management,drug and disinfection products supply management (mainly including key treatment drugs and disinfection product list formulation,control,inventory increase ,etc.);drug dispensing management (mainly including prescription ,pharmacy window , planning quantitative reserve , drug return , etc.);clinical pharmaceutical care management (mainly including providing pharmaceutical information support ,online pharmaceutical service ,monitoring drug safety ,etc.);personnel protection and disinfection (mainly including personnel protection ,environment and window ,equipment and container ,paper prescription disinfection,etc.);special management of donated drugs ;prevention and control knowledge training ;pharmaceutical education and scientific research management ,etc. CONCLUSIONS :The integrated emergency management model for epidemic prevention and control is helpful for hospital pharmacy to manage public health emergencies. During the outbreak of COVID- 19,hospital pharmacy department should start integrated emergency management mode for epidemic prevention and control ,strengthen the risk control of each link ,and play a good role in the key functional departments in the special period.

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