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 investigate the pharmaceutical affairs management in healthcare institutions from Haidian district of Beijing， and propose countermeasures and suggestions for improving the related work. METHODS The current status of pharmaceutical affairs management in 66 healthcare institutions from Haidian district of Beijing was surveyed through on-site inspections， and the results were statistically analyzed. The inspection items included six special projects： pharmaceutical affairs management and organizational structure of pharmacy departments； drug quality management and control， prescription review， clinical application management of antimicrobial drugs， management of adverse drug events， and management of special drugs. These areas were further divided into a total of 27 specific inspection sub-items. RESULTS & CONCLUSIONS The total proportion of healthcare institutions that fully complied or basically complied with each special project was 90.9%， 97.0%， 86.3%， 90.9%， 90.9%， and 96.9%， respectively. The overall comparison among healthcare institutions that fully or substantially met the standards across medical institutions at different levels showed that the performance of tertiary healthcare institutions was better than that of secondary and primary healthcare institutions. The pharmaceutical affairs management in healthcare institutions within the jurisdiction was proceeding in an orderly manner. There is still room for improvement in further establishing and perfecting the functions of the pharmaceutical affairs management committee， implementing the 2021 Edition of Management Regulations for β -lactam Antimicrobial Skin Tests， enforcing the adverse drug reaction management system， and strengthening the refined management of narcotics and psychotropic drugs.

Formulating a well-defined research question and developing a scientifically sound study protocol is important for ensuring the quality of pharmacoepidemiological research.Based on the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition),this research provided an interpretation of the sections related to the formulation of research questions and the development of study protocols.First,it clarified the sources and scope of research questions,outlining a two-step approach—question generation and definition—and introduces relevant evaluation tools and defining frameworks.Furthermore,it systematically explained the key elements of a study protocol and provides an in-depth explanation of the research methodology and its critical aspects.Finally,the paper highlighted the importance of feasibility assessment,emphasizing that the process of defining research questions and study protocols is dynamic and iterative.Compared with the previous edition,the 2nd edition of the guidelines offers more detailed and updated guidance on question formulation and protocol development.It added three new elements—such as protocol archiving or registration—and three new content items,including study objectives.The 2nd edition also expanded the methodological framework and strengthens feasibility assessments,thereby enhancing the comprehensiveness and rigor of its practical guidance.By integrating guideline content with practical experience,this paper provided insights into its implications for pharmacoepidemiological research and serves as a reference for researchers in the field.

Formulating a well-defined research question and developing a scientifically sound study protocol is important for ensuring the quality of pharmacoepidemiological research.Based on the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition),this research provided an interpretation of the sections related to the formulation of research questions and the development of study protocols.First,it clarified the sources and scope of research questions,outlining a two-step approach—question generation and definition—and introduces relevant evaluation tools and defining frameworks.Furthermore,it systematically explained the key elements of a study protocol and provides an in-depth explanation of the research methodology and its critical aspects.Finally,the paper highlighted the importance of feasibility assessment,emphasizing that the process of defining research questions and study protocols is dynamic and iterative.Compared with the previous edition,the 2nd edition of the guidelines offers more detailed and updated guidance on question formulation and protocol development.It added three new elements—such as protocol archiving or registration—and three new content items,including study objectives.The 2nd edition also expanded the methodological framework and strengthens feasibility assessments,thereby enhancing the comprehensiveness and rigor of its practical guidance.By integrating guideline content with practical experience,this paper provided insights into its implications for pharmacoepidemiological research and serves as a reference for researchers in the field.

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.

BACKGROUND: Clinical trial evidence is limited to identify better topical non-steroidal anti-inflammatory drugs (NSAIDs) for treating knee osteoarthritis (OA). We aimed to compare the clinical efficacy and safety of flurbiprofen cataplasms (FPC) with loxoprofen sodium cataplasms (LSC) in treating patients with knee OA. METHODS: This is an open-label, non-inferiority randomized controlled trial conducted at Peking University Shougang Hospital. Overall, 250 patients with knee OA admitted from October 2021 to April 2022 were randomly assigned to FPC and LSC treatment groups in a 1:1 ratio. Both medications were administered to patients for 28 days. The primary outcome was the change of pain measured by visual analog scale (VAS) score from baseline to day 28 (range, 0-10 points; higher score indicates worse pain; non-inferiority margin: 1 point; superiority margin: 0 point). There were four secondary outcomes, including the extent of pain relief, the change trends of VAS scores, joint function scores measured by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and adverse events. RESULTS: Among 250 randomized patients (One patient without complete baseline record in the flurbiprofen cataplasms was excluded; age, 62.8 ± 10.5 years; 61.4% [153/249] women), 234 (93.6%) finally completed the trial. In the intention-to-treat analysis, the decline of the VAS score for the 24-h most intense pain in the FPC group was non-inferior, and also superior to that in the LSC group (differences and 95% confidence interval, 0.414 (0.147-0.681); P <0.001 for non-inferiority; P = 0.001 for superiority). Similar results were observed of the VAS scores for the current pain and pain during exercise. WOMAC scores were also lower in the FPC group at week 4 (12.50 [8.00-22.50] vs . 16.00 [11.00-27.00], P = 0.010), mainly driven by the dimension of daily activity difficulty. In addition, the FPC group experienced a significantly lower incidence of adverse events (5.6% [7/124] vs . 33.6% [42/125], P <0.001), including irritation, rash and pain of the skin, and sticky hair uncovering pain. CONCLUSIONS This study suggested that FPC is superior to LSC for treating patients with knee OA in pain relief, joint function improvement, and safety profile.
Humans ; Female ; Middle Aged ; Aged ; Osteoarthritis, Knee/drug therapy* ; Flurbiprofen/therapeutic use* ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use* ; Pain/drug therapy* ; Treatment Outcome ; Double-Blind Method

OBJECTIVE To provide a reference for establishing an automatic checking mode and improving the checking efficiency of the unit dose dispensing system of oral drugs in hospital. METHODS The automatic checking process reengineering team was established in our hospital. ECRSI method was adopted to sort out the verification process and mode of drug bags for the unit dose formula of our hospital through five principles of eliminating， combining， rearranging， simplifying and increasing， and the hardware series problem and the problem of excessive system false-positive proportion were optimized. The drug bags for the unit dose formula were randomly selected from 10 wards， the efficiency and external error rates of manual check and automatic checking mode before and after optimization were compared， and the false-positive reporting failure in automatic checking mode was also compared before and after optimization. RESULTS After the establishment of the automatic checking mode of the unit dose formula for oral drugs， the average checking time of drug bags was significantly shorter than that of manual checking mode in the other 8 wards except for cardiovascular and renal departments （P＜0.05）. After the optimization of the automatic checking mode， the average checking time of drug bags in all wards was significantly shorter than that in manual checking mode （P＜0.05）. Compared with before optimization of the automatic checking mode， the average checking time of drug bags was shortened by 0.43 s， and the average checking time of drug bags in half of the wards was shortened significantly （P＜0.05）. At the same time， the false-positive proportion decreased from 96.83% before optimization to 92.76% after optimization （P＜0.05）. The external error rate dropped from 0.039‰ in manual checking mode to 0.019‰ before optimization and 0.015‰ after optimization （P＜0.05）. CONCLUSIONS Based on ECRSI method， the automatic checking mode for the unit dose dispensing system of oral drugs can effectively reduce the average checking time of drug bags， reduce external error and improve the work efficiency of pharmacists.

Objective:To explore and establish a standardized clinical thinking mode and decision-making pathway for lactation medication consultation services and ensure the harmonization and safety of medication for lactating women.Methods:Lactation medication consultation services for medical staffs conducted by pharmacists from June 2020 to August 2022 in Peking University Third Hospital were analyzed using methods of retrospective statistical analysis and root cause analysis. Application of mixed methods were used to establish a clinical thinking model for medication use during lactation and a clinical pathway for safe medication use during lactation. Lactation medication consultation service training for pharmacists was provided, questionnaire surveys before and after the training were conducted, and the effectiveness of improvement was evaluated.Results:A total of 1 218 medication consultation services provided by clinical pharmacists to medical staffs were collected in the hospital, including 44 cases (3.61%) related to lactation medication. Retrospective analysis showed that clinical pharmacists did not have a clear understanding of patients′ needs, incomplete consideration of drug-maternal-infant factors, and a limited way to retrieve information in the lactation medication consultation service. Based on the root cause analysis of the problems, a clinical thinking mode of "Questions (Q), Assessment (A), Search (S), and Plan (P)" (QASP) were established. Additionally, a clinical pathway for safe medication decision-making analysis and a standard medication consultation record template was developed. Compared with before training, clinical pharmacists made significant progress in clarifying factors related to lactation medication, evidence-based procedure, standardized documentation, and confidence in providing medication consulations (all P<0.001). Conclusion:The establishment of the QASP clinical thinking model and decision analysis model, based on the 3 factors of medication, mother, and baby for the consultation service of safe medication during lactation, can help clinical pharmacists carry out standardized medication consultation services for breast-feeding populations during lactation, and improve the quality of homogeneous pharmaceutical services.

Objective:To explore and establish a standardized clinical thinking mode and decision-making pathway for lactation medication consultation services and ensure the harmonization and safety of medication for lactating women.Methods:Lactation medication consultation services for medical staffs conducted by pharmacists from June 2020 to August 2022 in Peking University Third Hospital were analyzed using methods of retrospective statistical analysis and root cause analysis. Application of mixed methods were used to establish a clinical thinking model for medication use during lactation and a clinical pathway for safe medication use during lactation. Lactation medication consultation service training for pharmacists was provided, questionnaire surveys before and after the training were conducted, and the effectiveness of improvement was evaluated.Results:A total of 1 218 medication consultation services provided by clinical pharmacists to medical staffs were collected in the hospital, including 44 cases (3.61%) related to lactation medication. Retrospective analysis showed that clinical pharmacists did not have a clear understanding of patients′ needs, incomplete consideration of drug-maternal-infant factors, and a limited way to retrieve information in the lactation medication consultation service. Based on the root cause analysis of the problems, a clinical thinking mode of "Questions (Q), Assessment (A), Search (S), and Plan (P)" (QASP) were established. Additionally, a clinical pathway for safe medication decision-making analysis and a standard medication consultation record template was developed. Compared with before training, clinical pharmacists made significant progress in clarifying factors related to lactation medication, evidence-based procedure, standardized documentation, and confidence in providing medication consulations (all P<0.001). Conclusion:The establishment of the QASP clinical thinking model and decision analysis model, based on the 3 factors of medication, mother, and baby for the consultation service of safe medication during lactation, can help clinical pharmacists carry out standardized medication consultation services for breast-feeding populations during lactation, and improve the quality of homogeneous pharmaceutical services.

OBJECTIVE To analyze the adverse drug reaction （ADR）signals of ado-trastuzumab emtansine and brentuximab vedotin，so as to provide reference for clinical medication safety. METHODS Using the FDA adverse drug event reporting system （FAERS）database and OpenVigil 2.1 data platform ，the ADR of the two drugs were collected from being approved by FDA to the Sep. 30th，2021. The ADR signals were detected by frequency method and sorted according to the occurrence frequency and signal strength respectively. RESULTS & CONCLUSIONS A total of 2 319 and 3 178 ADR reports related to ado-trastuzumab emtansine and brentuximab vedotin were collected ，215 and 329 ADR signals were detected respectively. According to the occurrence frequency，the most frequent ADR s of the two drugs were thrombocytopenia （109 cases）and febrile neutropenia （198 cases）， separately，which were consistent with the drug instructions. According to the signal strength ，the spider nevus of ado-trastuzumab emtansine（report odds ratio of 451.46）and the noninfectious endocarditis of brentuximab vedotin （report odds ratio of 304.35） ranked first ，both of which were not reported in the drug instructions. It is suggested that attention should be paid not only to the most common ADR s of blood and lymphatic system caused by both drugs ，but also to the ADRs not reported in the drug instructions such as spider nevus of ado-trastuzumab emtansine and noninfective endocarditis of brentuximab vedotin.