1.Expert consensus on perioperative rational use and comprehensive clinical evaluation of NSAIDs in Shandong Province
Association CLINICAL ; Association CLINICAL ; Association COMPREHENSIVE ; Association PAIN ; Province WORKING
China Pharmacy 2025;36(4):385-394
OBJECTIVE To provide a basis for the rational use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the perioperative period, and provide practical methods and technical references for the evaluation and selection of NSAIDs in medical institutions. METHODS Initiated by the Affiliated Hospital of Qingdao University, Clinical Pharmacy Professional Committee of the Shandong Pharmacists Association, Clinical Individualised Drug Testing and Guidance Branch of the Shandong Medical Association, Comprehensive Clinical Medication Evaluation Working Committee of the Shandong Pharmacists Association, Pain Branch of the Shandong Medical Association in conjunction with several medical institutions in Shandong Province organized 22 pharmaceutical experts and medical experts from 17 hospitals in Shandong Province to form a consensus on the rational use and comprehensive clinical evaluation of NSAIDs in the perioperative period through the literature research method, expert interview method and questionnaire survey method based on evidence-based medicine. A comprehensive clinical evaluation was also conducted on a total of 13 specifications of 9 commonly used clinical drug varieties in Shandong Province, including celecoxib, etoricoxib, imrecoxib, ibuprofen (containing reference/original drugs and national/Shandong Province’s centralized volume-based procurement varieties). RESULTS & CONCLUSIONS A consensus opinion was formed on preoperative prophylactic use and postoperative use of NSAIDs, as well as contraindications, digestive tract risk, cardiovascular system risk, bleeding risk and kidney injury risk in the perioperative period. The evaluation and selection criteria of perioperative use of NSAIDs were established, involving 6 dimensions of safety, efficacy, economy, innovation, appropriateness, and accessibility. The results of comprehensive clinical evaluation showed that the top 6 drugs (scores over 70) were Celecoxib capsules (Celebrex) and Celecoxib capsules (Naiqi), Diclofenac sodium sustained-release tablets,Etocoxib tablets (Arcoxia) and Etocoxib tablets (Qimingshu), and Parecoxib sodium for injection. With the progress of clinical research, this consensus will be further updated and adjusted, and medical institutions can combine with the practice to develop a comprehensive clinical evaluation system of NSAIDs suitable for their institutions.
2.Expert consensus on artificial intelligence-assisted pharmaceutical care
Commission PHARMACY ; Association GERIATRIC ; Society SUB-ASSOCIATION
China Pharmacy 2025;36(13):1553-1562
OBJECTIVE To provide guidance for the scientific and standardized application of artificial intelligence (AI) technology in supporting pharmaceutical care services, and to promote the high-quality development of pharmaceutical care. METHODS Using keywords such as “artificial intelligence” and “pharmaceutical care”, a comprehensive search was conducted across domestic and international databases and relevant policy documents. Drawing upon practical experience in AI-assisted pharmaceutical care services in China, a consensus framework and preliminary recommendations were drafted. Consensus was defined as agreement by 70% or more of expert panel members. RESULTS & CONCLUSIONS Through two rounds of the Delphi method and multiple rounds of discussions, 23 strong recommendations (approval rate >90%) were formulated. These address the definition, scope, objectives, multiple application scenarios (including pharmaceutical outpatient, medication reconciliation, medication education, adverse drug event prediction and monitoring, home-based pharmaceutical care services, and drug supply), ethical considerations and accountability, challenges encountered, and quality control recommendations for AI-assisted pharmaceutical care. Intended for use by professional technical staff engaged in pharmaceutical care, managers, and AI technology developers within healthcare institutions, these recommendations provide guidance for the practice of pharmaceutical care in the era of AI.
3.Expert consensus on quality control of home-based pharmaceutical services in the close-knit regional medical community of Sichuan and Chongqing
Association Medical CHONGQING ; Center CHONGQING ; Chongqing THE
China Pharmacy 2025;36(14):1689-1696
OBJECTIVE To provide reference for further unifying and standardizing the quality of home-based pharmaceutical services in close-knit regional medical community of Sichuan and Chongqing, and ensuring medication safety of patients. METHODS Under the guidance of the Chongqing Medical Association and the Chongqing Pharmaceutical Administration Quality Control Center, and led by the Bishan Hospital Affiliated to Chongqing Medical University and the Yongchuan Hospital Affiliated to Chongqing Medical University, 14 medical institutions in the Sichuan-Chongqing region jointly participated. Based on existing regulations, guidelines, and expert consensus, questionnaire survey was conducted to investigate the implementation status of home- based pharmaceutical services within the close-knit regional medical community of Sichuan and Chongqing. Subsequently, the Delphi method was employed for expert consultation and the analytic hierarchy process was used to determine indicator weights, ultimately establishing a quality control system for home-based pharmaceutical services in the close-knit regional medical community of Sichuan and Chongqing. RESULTS & CONCLUSIONS This consensus has established a quality control system for home-based pharmaceutical services within the close-knit regional medical community of Sichuan and Chongqing, encompassing three dimensions: service qualification evaluation, necessity evaluation, and service quality evaluation. Among them, service quality evaluation serves as the core component of the quality control system, incorporating 16 secondary indicators, which are further classified into 9 core indicators and 7 general indicators based on their significance. Meanwhile, this consensus proposes a phased quality control strategy. Under the framework of the close-knit regional medical community in Sichuan and Chongqing, this strategy takes execution priority and execution effectiveness as 69 its core. It allows for flexible handling of the rigid requirements concerning service qualifications and necessity, thereby providing a unified and operable quality control toolkit for the close-knit regional medical community in Sichuan and Chongqing.
4.Chinese expert consensus for therapeutic drug monitoring of meropenem
Meropenem WRITING ; Association SOCIETY
China Pharmacy 2025;36(16):1958-1967
OBJECTIVE To standardize the implementation methods for therapeutic drug monitoring (TDM) of meropenem and ensure the accuracy of TDM results, thereby facilitating the scientific development of individualized treatment regimens for meropenem. METHODS The expert consensus was launched by the Society of Therapeutic Drug Monitoring Pharmacists of Chinese Pharmacists Association. The compilation team comprised experts in clinical pharmacy, TDM technology, and pharmaceutical administration, and it was developed in accordance with the relevant recommendations from the methodology handbook of WHO and the guidelines for TDM guidelines development. Twelve clinical questions were selected through a three- round Delphi voting process conducted by the committee, followed by a comprehensive review of relevant original articles, systematic reviews, and guidelines through general databases. The GRADE approach was employed to evaluate the quality of evidence so as to formulate the consensus recommendations. The experts’ opinions were organized, revised and finally formed into a consensus. RESULTS Ultimately, the consensus presented 14 recommendations, mainly regarding all aspects of TDM processes including necessity, method, monitor timing, target PK/PD, medication adjustments based on PK/PD, and the quality control of TDM. CONCLUSIONS This consensus provides standardized methods and process suggestions for meropenem TDM in medical institutions in China, and is of great significance for meropenem individualized drug use, improving clinical efficacy, and ensuring drug safety.
5.Consensus on whole-process pharmaceutical care for iodine contrast medium
Association CLINICAL ; Association EXPERT
China Pharmacy 2024;35(1):1-9
OBJECTIVE To explore the whole-process pharmaceutical care model of iodine contrast medium and promote the rational clinical use of iodine contrast medium. METHODS Clinical Professional Committee on Rational Drug Use of China Medical Education Association and Expert Committee on Drug Evaluation and Clinical Research of Guangdong Pharmaceutical Association organized domestic experts to establish a working group on the Consensus on the whole-process pharmaceutical care for iodine contrast medium. The working group conducted literature searches, evidence-based analysis, and discussions on the development process, indications, contraindications, adverse drug reactions, drug interactions, drug use for special population, pharmaceutical care, and other key topics to summarize the content and process of the whole-process pharmaceutical care for iodine contrast medium. This consensus was ultimately formed. RESULTS The consensus on whole-process pharmaceutical care for iodine contrast medium included an evaluation of the patient, renal function, combined drug use, and hydration regimen before examination, the presence of contrast agent extravasation or suspected acute adverse reactions during examination, observation time points and follow-up after examination, and the presentation of specific work in each stage through pharmaceutical care flowchart. The medication monitoring record form was also formed to record the work situation. CONCLUSIONS The consensus has established a whole-process pharmaceutical care system for iodine contrast medium, providing scientific evidence for clinical physicians and nursing staff in the rational use of such special drugs, and also serving as a reference for pharmacists in providing related pharmaceutical care.
6.Evidence-based guideline for the management of clinical application of biosimilars in China (2024 edition)
Zaiwei SONG ; Yang HU ; Lingling YU ; Jun ZHU ; Lingli ZHANG ; Yu ZHANG ; Liyan MIAO ; Suodi ZHAI ; Rongsheng ZHAO
China Pharmacy 2024;35(16):1933-1945
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.
7.Expert consensuses on the application of nanopore sequencing technology in the detection of pathogenic micro-organisms
Shuyao ZHANG ; Tieying HOU ; Xiaoyan LI ; Shilong ZHONG ; Junyan WU ; Bin HUANG ; Society DIVISION ; Association EXPERT ; Microorganisms THE
China Pharmacy 2024;35(14):1673-1731
OBJECTIVE To improve the diagnosis and treatment level of critically ill infectious diseases, standardize the clinical application of nanopore sequencing and promote the sound development of the technology. METHODS Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society and Expert Committee of Precision Medicine for Clinical Treatment of Guangdong Pharmaceutical Association initiated and organized multidisciplinary experts to discuss and determine the consensus writing outline by using the nominal group method, forming a preliminary consensus draft; expert consultation was performed by using Delphi method, and then experts’ opinions were analyzed and revised to form consensus. RESULTS & CONCLUSIONS Consensuses of Experts on the Application of Nanopore Sequencing Technology in the Detection of Pathogenic Microorganisms covers targeted sequencing, metagenomic sequencing and whole genome sequencing, and is standardized in terms of sample collection and storage, detection process, bioinformatics analysis and report interpretation; the recommendations are provided for the key issues.
8.Expert consensus on pharmaceutical active consultation service in medical institutions
Association Pharmaceutical CHONGQING ; Institutions THE
China Pharmacy 2024;35(23):2837-2843
OBJECTIVE To further standardize the implementation and management standards of pharmaceutical active consultation in medical institutions and provide a reference for providing high-quality pharmaceutical services. METHODS Guided by the Chongqing Pharmaceutical Association and led by the Third Affiliated Hospital of Chongqing Medical University, a panel of experts consisting of pharmaceutical and medical management professionals from multiple medical institutions was established to discuss the basic requirements, service processes, quality control, and evaluation improvement of pharmaceutical active consultation. The drafting team then organized, summarized, analyzed and revised the opinions, and provided feedback to ultimately form a consensus. RESULTS & CONCLUSIONS This consensus provides a detailed exposition of the basic requirements, service processes, quality control, and evaluation improvement of pharmaceutical active consultation, offering standards for the implementation of pharmaceutical active consultation in medical institutions in China, which is of major implications for strengthening the pharmaceutical service capabilities of medical institutions.
9.Real World Data Use in Pharmaceutical Companies in Japan: Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association
Ryo KOTO ; Shinichi ASABE ; Akira ITO ; Kasumi DAIDOJI ; Manabu ISHII ; Kanae TOGO ; Hiroshi MATSUZAWA
Japanese Journal of Pharmacoepidemiology 2024;29(1):15-28
Objective:To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design:Web based-questionnaire surveyMethods:This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results:[Background] Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5%) have “experienced in utilization of RWD”, and 12 (11.8%) have “experienced in considering utilization of RWD”. [Utilization by RWD Type] By data source, hospital-based claim data was the most frequently used (65 cases, 63.7%), followed by insurance-based claim data (61 cases, 59.8%), surveys (38 cases, 37.3%), and EMR (36 cases, 35.3%) in experienced RWD utilization. Conclusion:This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.
10.Real World Data Use in Pharmaceutical Companies in Japan: Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association
Ryo KOTO ; Shinichi ASABE ; Akira ITO ; Kasumi DAIDOJI ; Manabu ISHII ; Kanae TOGO ; Hiroshi MATSUZAWA
Japanese Journal of Pharmacoepidemiology 2024;():29.e2-
Objective:To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design:Web based-questionnaire surveyMethods:This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results:[Background] Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5%) have “experienced in utilization of RWD”, and 12 (11.8%) have “experienced in considering utilization of RWD”. [Utilization by RWD Type] By data source, hospital-based claim data was the most frequently used (65 cases, 63.7%), followed by insurance-based claim data (61 cases, 59.8%), surveys (38 cases, 37.3%), and EMR (36 cases, 35.3%) in experienced RWD utilization. Conclusion:This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.


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