OBJECTIVE To construct a scientific and systematic quality control index system for intravenous medication admixture， so as to ensure the safety of drug use and improve the quality of medical service. METHODS Based on literature analysis and cross-sectional survey， an initial indicator framework was formulated. Opinions were then gathered through two rounds of Delphi expert consultations， and the expert authority coefficient and Kendall’s coefficient of concordance were calculated to evaluate the consistency. Ultimately， the analytic hierarchy process was employed to determine the weights of each indicator and test for consistency in order to establish a scientific and systematic quality control indicator system for intravenous medication admixture. RESULTS The study conducted two rounds of expert consultation with an average positive coefficient of 95.92% and an average authority coefficient of 0.983. In the second round of the Delphi consultation， the Kendall’s coefficients of concordance for the first-， second-， and third-level indicators were 0.306， 0.440， and 0.394， respectively， all significantly higher than those in the first round （0.211， 0.274， 0.379）. The final quality control system for intravenous medication admixture consisted of 6 first-level indicators （personnel， medicines and consumables， facilities and equipment， process management， environmental hygiene， and outcomes）， 17 second-level indicators （e.g.， education and training， staffing structure， workload， medication management， consumables management， and equipment maintenance）， and 44 third-level indicators （e.g.， average daily workload per person， proportion of pharmacy professionals， competency assessment pass rate， work system assessment pass rate， continuing education frequency and pass rate， and medication inventory accuracy）. CONCLUSIONS The quality control system for intravenous medication admixture developed in this study demonstrates strong authority and scientific rigor， providing a theoretical basis and practical tool for the standardized management of intravenous medication admixture quality in hospitals.

OBJECTIVE To assess the scientific rigor， clarity and feasibility of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis （hereinafter referred to as the Guideline） through external review， in order to further revise and improve the Guideline recommendations. METHODS This study employed a cross-sectional survey research design， a convenience sampling method was adopted to select frontline medical workers in the field of osteoporosis （including clinical doctors， clinical pharmacists， and nurses） as well as patients or their family members. External review was conducted through a combination of closed-ended and open-ended electronic questionnaires to get feedback from them on the appreciation，clarity and feasibility of the 32 preliminary recommendations in the Guideline. RESULTS A total of 90 external review subjects from 15 hospitals were collected， including 45 clinical doctors， 15 clinical pharmacists， 15 nurses and 15 patients or their family members. The overall appreciation degree of recommendations was 99.38%， the overall clarity degree of recommendations was 98.92%， and the overall feasibility degree of recommendations was 99.65%. At the same time， 111 subjective suggestions were collected， which provided an important reference for the further improvement of the Guideline recommendations. Based on the above feedback， the Guideline steering committee and core expert group revised the wording of 12 draft recommendations without deletion， and finally determined 32 recommendations. CONCLUSIONS The external review provides an important basis for the final formation of the Guideline， further improves the scientific rigor， clarity and feasibility of the recommendations， and ensures the standardization， practicality and implementability of the Guideline.

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.

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

OBJECTIVE To investigate the preferences of patients who underwent solid organ transplantation regarding therapeutic drug monitoring （TDM） of mycophenolic acid （MPA） and explore the factors influencing patients’ decision-making process， so as to provide support for the development of individualized medication guidelines for MPA and improvement of clinical decision-making. METHODS The cross-sectional study was used to design the questionnaire on the patients’ preferences to accept MPA TDM， and involved patients who underwent solid organ transplantation and received MPA treatment at two tertiary hospitals in Beijing from April 14， 2022， to June 27， 2022. The Likert 5-level scoring method was used to score the patients’ preferences to accept MPA TDM， the influencing factors and their correlation of the patients’ preferences to accept MPA TDM were analyzed by Pearson correlation analysis and binary Logistic regression analysis， and the nonparametric test and chi-square test were used to rank and analyze the consistency of the factors affecting patients’ preference decision. RESULTS A total of 140 questionnaires were collected， and the effective recovery rate was 77.35%. The average preference score of 140 patients to receive MPA TDM was （4.01±0.65）， and the overall preference value was high. There were 116 （82.86%） patients agreed or strongly agreed with MPA TDM. Significant differences were observed in preference scores between patients who had previously undergone MPA TDM and those who had never undergone it （[ 4.30±0.53） scores vs. （3.80±0.65） scores， P＜0.001]. Additionally， patients’ preference scores were significantly influenced by their understanding level and attention level （P＜0.001）. The ranking of factors contributing to decision-making exhibited consistency （P＜0.001）. The factors were ranked in descending order of clinical efficacy， safety， comfortability， economy and time cost. CONCLUSIONS The patients who underwent solid organ transplantation hold high preferences towards MPA TDM. The primary factors influencing their decisions are their prior experience， understanding level， and attention level.

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.

OBJECTIVE To provide standardized guidance for the clinical application and management of biosimilars， and promote their widespread and rational use in clinical treatment. METHODS The design， planning， and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） followed the WHO Handbook for Guideline Development （2nd edition）， which fully considered the best current evidence from evidence-based medicine， multidisciplinary expert experience， and patient preferences and values. Grading of Recommendations Assessment， Development， and Evaluation （GRADE） approach was adopted to evaluate the quality of evidence and determine the strength of recommendations. RESULTS & CONCLUSIONS Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments， patient education， pre-treatment regimen before administration， and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.

OBJECTIVE To systematically summarize the working model of pharmacy consultation in medical institutions in China， and to provide reference for the normalization of process， standardization of content and homogenization of services of pharmacy consultation. METHODS A systematic search of Chinese and English literature databases was conducted to incorporate the literature on the working model of pharmacy consultation published by medical institutions in China. Two researchers screened and extracted the key information， and ultimately conducted qualitative summary and descriptive analysis. RESULTS Based on the included 11 articles， the pharmacy consultation working models were explored by clinical pharmacists in China. The contents of consultation mainly involved anti-infection， parenteral nutrition， cancer pain， etc. The general concept of pharmacy consultation should refer to the constructed flowchart， specific consultation problems could refer to the pathway， mind map， or decision tree and other framework guidance to carry out the work. Finally， consultation opinions could be written according to the consultation system or specialty consultation templates， and the adoption of a new working model （such as pharmacist active consultation） could also promote the number and acceptance rate of pharmacy consultation. CONCLUSIONS A series of working models of pharmacy consultation have been initially explored in medical institutions in China. However， it is not yet perfect and lacks a unified quality control and evaluation system for pharmacy consultation， which should be the focus of future research and practice.

AIM:To systematically evaluate the clinical interchangeability of adalimumab biosimi-lars in terms of efficacy,safety,and immunogenici-ty,and to provide evidence-based reference for clinical interchangeability.METHODS:Randomized Controlled Trials(RCTs)on the interchangeability of adalimumab biosimilars were systematically searched in PubMed,Embase,Cochrane Library,CNKI,WANFANG and SinoMed from inceptions to October 2023.Data were extracted from the litera-ture that met the inclusion criteria,risk of bias was assessed using the Cochrane Handbook for System-atic Reviews of Interventions 5.0 bias risk assess-ment tool.Meta-analysis was performed using Rev-man 5.4 software.The certainty of evidence was graded using the GRADE tool recommended by the Cochrane Collaboration.This study was conducted according to the PRISMA guideline.RESULTS:Eigh-teen studies were included,with 7 focusing on pso-riasis and 11 on rheumatoid arthritis.Regarding ef-ficacy,for psoriasis,there were no statistical differ-ences in PASI 75 response rates and sPGA scores of ≤1 after 1-4 switches between biosimilars and the reference drug(P＞0.05,moderate-quality evi-dence).For rheumatoid arthritis,there were no sta-tistical differences in ACR 20/50/70 response rates after 1-3 switches(P＞0.05,moderate-quality evi-dence).Regarding safety,there were no statistical differences in the risk of adverse events after single or multiple switches for both diseases(P＞0.05,moderate-quality evidence).Regarding immunoge-nicity,there were no statistical differences in the rate of anti-drug antibody production after single or multiple switches(P＞0.05,moderate-quality evi-dence).High-quality evidence is still lacking for the interchangeability of adalimumab biosimilars in other indications.CONCLUSION:The switches be-tween adalimumab biosimilars and the reference drug have no significant impact on clinical efficacy,safety and immunogenicity for psoriasis and rheu-matoid arthritis patients.

AIM:To comprehensively evaluate the efficacy and safety of rituximab(RTX),tocilizumab(TCZ),and teprotumumab(TMB)in the treatment of thyroid-associated ophthalmopathy(TAO).METHODS:A systematic search was conducted in PubMed,Embase and Cochrane Library databases for systematic reviews/meta-analyses on TAO treat-ment,with the search time limited to January 2024.The Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA)2020 state-ment,Assessment of Multiple Systematic Reviews(AMSTAR)2 tool,and Grading of Recommenda-tions,Assessment,Development,and Evaluation(GRADE)were used to assess the reporting quality,methodological quality,and evidence quality of the included studies.RESULTS:The current systematic reviews on the three monoclonal antibodies in TAO treatment exhibited deficiencies in reporting quali-ty,methodological quality,and evidence quality.Di-rect comparative evidence between the three monoclonal antibodies is still lacking.Based on indi-rect comparative evidence,TCZ appears to be the most promising treatment option,followed by TMB and RTX.In terms of efficacy,TCZ and TMB signifi-cantly reduced the Clinical Activity Score(CAS),pro-ptosis,and improved quality of life.TCZ also signifi-cantly reduced the incidence of diplopia.RTX signif-icantly reduced disease response,while RTX and TCZ both significantly improved disease inactiva-tion rates.RTX showed no significant difference in diplopia,lid fissure changes,NOSPECS score and quality of life.The conclusions regarding safety are inconsistent,with TCZ and TMB potentially increas-ing the incidence of adverse events,while RTX showed no significant difference in safety com-pared to glucocorticoids or placebo.CONCLUSION:This study provides evidence-based insights for the selection of three monoclonal antibodies in the treatment of TAO.While TCZ may have advantages in efficacy,considering the limitations of existing evidence,more high-quality studies are needed to further verify and compare the efficacy and safety of different monoclonal antibodies in TAO treat-ment.