Methodology for the Development of Clinical Practice Guideline for Chinese Patent Medicine（Part 1）： Development Status and Characteristics / 中医杂志

The irrational use of Chinese patent medicines （CPM） is becoming more and more prominent， which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines， and promote its development， this paper introduced the concept of CPM guidelines， summarized the characteristics of the two development modes， namely “taking CPM as the key” and “taking disease/syndrome as the key”， and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems， three suggestions have been put forward to optimize the quality of CPM guidelines， which were clarifying the target users and scope of CPM guidelines， establishing an open and transparent mechanism of the personnel involvement and process steps， and formulating implementable and operable recommendations for the use of CPM.

Consensus on whole-process pharmaceutical care for iodine contrast medium / 中国药房

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.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine（Part 5）： Retrieval and Synthesis of Key Information on Rational Drug Use / 中医杂志

Recommendations for Chinese patent medicine （CPM） based on key information on rational drug use are one of the important conditions for enhancing guideline enforceability as well as facilitating guideline implementation. In this study， we discussed in detail of the key information on the rational use of CPM in five aspects， which are dosage， drug discontinuation， drug-drug and drug-food interactions， safety and economy. Following the process of multi-source search， synthesis and prioritization， it is suggested to collect key information on the rational use of CPM from a multi-source search of drug instructions， policy documents， literature， and clinical experts' experiences. Then the searched information should be summarized and prioritized with the principle that taking drug instructions as the basis and other-sources information for check and supplementation. Finally， methodological recommendations for the retrieval and synthesis of key information on rational drug use in guideline recommendations has been formed.

Research progress in therapy drug monitoring of levetiracetam / 中国药房

Levetiracetam （LEV） is the second generation of broad-spectrum anti-epileptic drug. LEV has the advantages of rapid absorption， short half-life， precise efficacy， good tolerance and few drug interactions. In order to improve the clinical efficacy of LEV， and reduce the occurrence of adverse reactions， children， pregnant women， the elderly， and patients with renal insufficiency should receive therapeutic drug monitoring （TDM）. Clinically， the samples are usually plasma or serum， and the TDM methods are mostly immunoassay or chromatography. There is currently no consensus on the effective concentration range of LEV， and the correlation between plasma concentration and adverse reactions is also unclear. The main factors affecting LEV plasma concentration include age， pregnancy， and patient compliance. How to interpret TDM results and adjust dosage based on the results will be the focus of future work.

Establishment and application of drug use evaluation criteria of argatroban / 药物流行病学杂志

Objective To establish the argatroban drug use evaluation(DUE)criteria and provide reference for the rational use of argatroban in clinical practice.Methods Based on the domestic and foreign drug instructions of argatroban,referring to relevant guidelines and literature,the DUE standard rules were established by expert consultation.Using the established standard rules,the medical records of argatroban in the Fuzhou First Hospital Affiliated with Fujian Medical University from August 2020 to August 2022 were evaluated for the rationality of medication.Results A total of 368 medical records were included,the rational rate of drug use was 48.64％,and the irrational drug use was mainly without indications(46.19％)and inappropriate combination of drugs(4.35％).Conclusion The rational rate of argatroban clinical use in the hospital is not high,and the problems mainly include off-indication drug use and unreasonable combination drug use.Through the establishment and clinical application of DUE standard rules,the clinical use of argatroban can be further standardized and the ability of rational drug use can be improved.

Establishment and application of drug use evaluation criteria for roxadustat / 药物流行病学杂志

Objective To establish the drug use evaluation(DUE)standards of roxadustat,and to evaluate its clinical application to promote its rational use.Methods Based on the drug labels,referring to relevant guidelines and expert consensus,the DUE criteria for roxadustat were established through the Delphi method,including items such as drug indications,drug use process and the results of medication.A retrospective study was conducted to evaluate the rationality of cases which included inpatients who used roxadustat for the first time from January 1,2020 to December 31,2022,with a medication period of more than one month in Fujian Provincial Hospital.Results A total of 175 medical records were included,of which 14 records were fully met the clinical application evaluation criteria,and the medication reasonable rate was 8.0％.The unreasonable situation were mainly manifested in the inappropriate clinical outcomes(92.0％),the inappropriate use dosages(52.6％),inappropriate monitoring of adverse reactions(34.9％),inappropriate timing of administration(13.1％),drug interactions(8.7％),inappropriate drug conversion(5.7％),inappropriate efficacy monitoring(4.0％).Conclusion The established DUE standards for roxadustat are scientific,practical and feasible,and the evaluation results show a rate of irrationality in the use of roxadustat in the hospital,and it is necessary to standardize the use of roxadustat in terms of dosage,adverse reaction monitoring,and timing of administration.

Drug use evaluation of ozagrel sodium based on weighted TOPSIS method / 药物流行病学杂志

Objective To establish evaluation of ozagrel sodium by weighted TOPSIS method so as to provide a reference for improving the rational use of ozagrel sodium.Methods Based on the drug instructions,guidelines,relevant literatures and Delphi method,the evaluation criteria for the clinical rationality of ozagrel sodium were formulated.Attribute hierarchical model(AHM)was used to assign weights to the indicators,the weighted TOPSIS method was employed to analyze and evaluate the rationality of 108 patients that discharged from the Third People's Hospital of Henan Province from January 2021 to April 2022.Results The reponse rates of two rounds of expert advice questionnaires were 100％,the authoritative coefficients(Cr)were 0.85,0.83(＞0.70),and the experts fully affirmed the items of the standard.Among the 108 cases evaluated,37 cases(34.26％)were judged to be reasonable,52 cases(48.15％)were judged to be basically reasonable and 19 cases(17.59％)were judged to be unreasonable.The main unreasonable problems were manifested in indications,the timing of administration,drug course and monitoring of efficacy and laboratory parameters.Conclusion The method of DUE of ozagrel sodium based on weighted TOPSIS is more comprehensively and intuitively.The application of ozagrel sodium in the hospital is relatively standardized,but there are problems in the course of medication,indications,and timing of administration.So it is necessary to promote the rational use by strengthening the cooperation between pharmacists and physicians,and improving pharmaceutical intervention.

Establishment and application of drug use evaluation criteria of fibrinogenase for injection / 药物流行病学杂志

Objective To establish the drug use evaluation(DUE)standard of fibrinogenase for injection and provide a reference for the rational clinical application of fibrinogenase for injection.Methods Based on the specification of fibrinogenase for injection,the DUE standard was established from three aspects:drug indication,drug process and drug results,with reference to relevant guidelines and literature,and through discussion with clinical experts.A retrospective survey was conducted to evaluate the inpatients using fibrinogenase for injection from January 2021 to December 2021 in Ningde Hospital of Traditional Chinese Medicine,Fujian Province.Results A total of 256 patients were included,with a medication reasonable rate of 61.72％.The irrational use of drugs was mainly including the inappropriate usage and dosage(3.91％),off-label medication(1.95％),no skin test(8.98％),too long or inadequate course of medication(25.00％).Conclusion The DUE standard established of fibrinogenase for injection is scientific,practical and feasible.The use of fibrinogenase for injection in contraindications and high blood coagulation state,and off-label medication can be further optimized.

Multicenter retrospective investigation and analysis of the rationality of the application of human albumin in cardiac surgery during the perioperative period / 药物流行病学杂志

Objective To investigate the clinical application of perioperative human serum albumin(HSA)in cardiac surgery in multiple regions in China,and to evaluate the rationality of its clinical application in conjunction with the clinical guidelines,in order to provide a reference for promoting the rational application of HSA.Methods The medical records of patients who underwent cardiac surgery from April to June 2019 in eight hospitals across the country were retrospectively collected.The statistical information on patients'general information,the dosage,course of treatment,and cost of HSA,and the serum albumin level before and after medication was analyzed to evaluate the use of HSA.Relevant evaluation criteria were established,and the rationality of its medication was evaluated.Results Data from a total of 449 patients were included for analysis,the appropriate rate of medication was 81.1％.The course of medication was mostly＞2-5 days and the total amount of HSA was mostly 50-99 g.The main purpose of medicaiton were improving colloid osmotic pressure,reducing exudation to improve interstitial edema,postoperative volume expansion.Conclusion Clinical attention should be paid to ensure the rational application of HSA in cardiac surgery during the perioperative period and prevent the abuse of blood products.

Review of drug utilization research based on real-world data / 药学实践与服务

In recent years, the rapid development of medical information technology has made it critical to analyze large-scale diagnosis and therapeutic data and extract rules based on real medical environment. This has become an essential approach for marketing evaluation and regulatory decision-making of drugs and devices both domestically and internationally. Real world study （RWS）, as a novel methodology for clinical evaluation of drugs in the field of drug utilization research （DUR）, have presented opportunities and challenges for observational studies in assessing actual efficacy or effectiveness. However, despite being a popular methodological approach among scholars in the field, there are still limitations and deficiencies when analyzing population medication characteristics in RWS. Systematic evaluation research methods have not yet been established, leading to inadequate generation of real-world evidence （RWE）. The research design, methodological pathways, evaluation indicators, confounding factors, and bias management involved in DUR based on real-world data （RWD） were reviewed in this artical with the intention of providing guidance for further exploration into DUR.

Investigation of rational drug use behaviors and knowledge levels of older individuals: a cross-sectional study

SUMMARY OBJECTIVE: The aim of this study was to examine older individuals' rational drug use behavior, their knowledge of rational drug use, and the factors affecting it. METHODS: This study was conducted cross-sectionally with 440 patients aged 65 years who received inpatient treatment in internal medicine and surgery clinics between October 2021 and November 2022 using a Rational Drug Use Scale and rational drug use behavior questions. RESULTS: The findings showed that the mean age of older adults was 72.56±5.84 years, and 51.8% were men. It was determined that 79.1% of the older adults did not check their expiration date before using the medicines, and 85.9% of them retained the remaining medicines after treatment. Results indicated that 77.3% of older adults knew less about rational drug use. Additionally, a significant difference was observed between older adults' marital status, educational status, possession of outdated drugs at home, self-use of antibiotics without examination, and mean score on the Rational Drug Use Scale (p<0.05). CONCLUSION: The results showed that the rational drug use knowledge level of older adults was low and that there were differences in the knowledge levels of rational drug use according to certain behaviors and factors.

Cost-minimization analysis of drugs used for empirical treatment of urinary tract infection in a tertiary care hospital

Background: Urinary tract infections (UTIs) are one of the commonly encountered infections and a large number of drugs are indicated in UTI ranging from oral conventional drugs to most advanced injectable drugs. Cost-minimization analysis (CMA) is employed to project the least costly drug when two treatments are shown to be therapeutic equivalents. Aims and Objectives: This study aims to perform a CMA at a tertiary care center to determine the least expensive drug for UTI and to project a cheapest alternative from available options based on the results of CMA. Materials and Methods: This was a cross-sectional study conducted over duration of 3 months in the clinical departments on patients diagnosed to have UTI and prescribed empirical antimicrobial treatment. The approval of Institutional Ethics Committee was sought before beginning the study. Pattern of drug prescription and average cost incurred in the treatment of patients with empirical antimicrobial therapy was calculated. CMA included the projection of the least expensive drug based on average cost incurred per patient in outpatients and inpatients respectively. Results: A total of 59 patients of UTI given empirical treatment were included in the study. Fluoroquinolones and cephalosporins were commonly used drugs for empirical treatment of UTI. Nitrofurantoin (average cost of 11–14 Rs. per patient) can be projected as the cheapest drug for empirical treatment of UTI on outpatient basis as well as a drug to supplement injectables in indoor patients. Injectable ciprofloxacin can be projected as the most inexpensive alternative for empirical treatment of UTI in patients of the inpatient department. Conclusion: Nitrofurantoin for oral treatment and ciprofloxacin in injectable form are cheapest among available alternatives for empirical treatment of UTI. To prevent treatment failures and increase in cost of treatment, correlation of results of CMA with local antimicrobial sensitivity pattern is important.

Analysis of the current performance of pharmacy outpatient services at grassroots medical institutions at home and abroad / 中华医院管理杂志

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.

Exploration and practice of physician-pharmacist joint clinic service / 中华医院管理杂志

In order to expand the breadth and depth of pharmaceutical services, in March 2022, a tertiary hospital opened a physician-pharmacist joint clinic based on clinical specialty clinics. The hospital formulated a fixed outpatient scheduling system, clarified service targets, established outpatient treatment processes and quality management systems, and standardized pharmacist communication models, to provide patients with " one-stop" standardized pharmaceutical services. As of December 2022, the pharmaceutical joint outpatient service had opened more than 100 consultations and served 1 709 patients. This practice provided reference for promoting the high-quality development of pharmaceutical services in medical institutions in China.

Principles for the rational use of national key monitoring drugs （the second batch） / 中国药房

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.

Review and comment rules of national key monitoring drug prescriptions （medical orders） / 中国药房

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.

Expert consensus on off-label drug use in the three Northeastern provinces of China（solid tumors and hematology） / 中国药房

OBJECTIVE To provide theoretical basis for the rational use of drugs in medical institutions， assist in improving the quality of pharmaceutical services， and thus meet clinical drug demands. METHODS Adopting consensus meetings， Liaoning Pharmaceutical Association，Jilin Pharmaceutical Association and Heilongjiang Pharmaceutical Association collaborated with clinical and pharmaceutical experts in the region to compile the expert consensus on off-label drug use in the three Northeastern provinces of China after many votes and discussions by collecting and collating the information related to off-label drug use in medical institutions from the three northeastern provinces of China，and referring to and citing off-label drug use stated in some expert consensus and medication catalog. RESULTS Finally， a total of 198 pieces of off-label drug use information for 70 drugs were included in the two sections of solid tumors and hematological diseases in Consensus of Experts on Drug Use beyond the Instructions in the Three Provinces of Northeast China. CONCLUSIONS Consensus of Experts on Off-label Drug Use in the Three Northeastern Provinces of Northeast China （solid tumors and hematology）offers a theoretical foundation for rational drug use in the treatment of solid tumors and hematological diseases within medical institutions，and has a positive significance in improving the effectiveness and safety of drug treatment.

Establishment and application of evaluation criteria for clinical rational drug use of atosiban based on AHP-TOPSIS method / 中国药房

OBJECTIVE To establish evaluation criteria for rational drug use of atosiban in clinic， and to provide reference for rational drug use of atosiban in clinic. METHODS Based on the drug instructions of atosiban acetate injection and related guidelines， the experts of the Evaluation Group of Rational Drug Use formulated the evaluation criteria of rational drug use， including 5 primary indexes and 8 secondary indexes. The weight coefficients of secondary indexes were calculated by analytic hierarchy process （AHP）， and the use of atosiban acetate injection in 190 pregnant women from the Third Affiliated Hospital of Guangzhou Medical University （referred to as “our hospital”） was evaluated retrospectively by technique for order preference by similarity to an ideal solution （TOPSIS）. The evaluation results were divided into three levels including reasonable， basic reasonable and unreasonable application based on the relative approach degree. RESULTS Among 190 pregnant women， 49 （25.8%） were treated with atosiban reasonably， 39 （20.5%） were treated with atosiban basic reasonably， and 102 （53.7%） were treated with atosiban unreasonably. The evaluation results obtained by AHP-TOPSIS method were consistent with the actual situation in clinic. The main problems of the unreasonably use were super indications， unreasonable usage and dosage， over the course of treatment and the lack of proper economic consideration. CONCLUSIONS The rationality evaluation criteria of atosiban’s clinical application are established by AHP-TOPSIS method； the evaluation results obtained by this method are quantifiable， scientific and reliable. The unreasonable use of atosiban is common in our hospital， and the management should be strengthened in clinical application.

Research hotspots and trends on potentially inappropriate medication from 2012 to 2021 / 中国药房

OBJECTIVE To quantitatively and qualitatively analyze the progress of potentially inappropriate medication （PIM） research by means of bibliometrics， and to predict the hotspots and trends of PIM， so as to provide reference for PIM research in China. METHODS The research literature related to PIM were searched from Web of Science core database， and the publication trend of the literature was analyzed on the bibliometric online analysis platform and CiteSpace 5.8.R3 software. The research results were visualized and analyzed， and the research hotspots of PIM were summarized through gCLUTO. RESULTS About PIM research， the annual number of the literature issued from 2012 to 2021 showed a continuous growth trend totally； the United States had the largest number of literature （241 pieces）； the University of Sydney in Australia was the research institution with the largest number of literature （59 pieces）； O’Mahony D from University College Cork， Ireland， published the most literature （23 pieces）； the research of PIM involved 57 disciplines， among which there was the largest number of literature about gerontology （384 pieces）； International Journal of Clinical Pharmacy was the journal with the largest number of literature （61 pieces）； Journal of the American Geriatrics Society was cited most frequently （1 197 times）. The hotspots of PIM research mainly focused on seven aspects： the standard of PIM， the safety and economy research of PIM， the risk factors research of PIM， the PIM research of chronic patients， the PIM research of antipsychotics， the research of pharmacists’ participation in PIM management， and the PIM research about palliative care of tumor patients. CONCLUSIONS The heat of research on PIM has been on the rise， and there is little cooperation between countries and institutions， and more cooperation is needed. In the future， the focus of Chinese pharmacists’ research on PIM may be on the deep localization of PIM standards， PIM intervention and precise medication guidance， and PIM management of specific diseases and drugs.

Application practice of drug clinical comprehensive evaluation thinking in management of temporary drug purchase in hospital / 中国药房

OBJECTIVE To explore the construction of a new scientific management model for temporary drug purchase，and to provide a reference for hospitals to improve the level of rational drug use. METHODS Guided by clinical diagnosis and treatment needs and patient medication safety， our hospital carried out the whole process management practice of temporarily purchased drugs by optimizing the review process， creating a review team， formulating pre-audit and post follow-up evaluation standards based on comprehensive drug evaluation， and evaluated the practice effect through the number of temporary purchase applications， implementation rate， drug structure optimization and other indicators. RESULTS Since January 2021， our hospital had implemented a new mode of temporary drug purchase management. By December 2022， clinical pharmacists had reviewed 111 temporary drug procurement applications， effectively intercepted 13 irrational drug use applications （11.71%）， reduced the overall implementation rate of temporary drug procurement by 8.36%，and proposed five batches of drug structure optimization suggestions； 24 drugs were successively introduced such as camrelizumab，sorafenib，busulfan. After optimizing the management mode，the number of temporary drug procurement applications decreased by more than half from 133 in 2019 and 138 in 2020 to 66 in 2021 and 45 in 2022. CONCLUSIONS The model is helpful to optimize the hospital drug catalog， strengthen rational drug use，ensure the safety of patients’ drug use， and fully reflects the professional value of clinical pharmacists in hospital pharmacy management and rational drug use.