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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Prescription patterns play a critical role in healthcare delivery, affecting the efficacy of medication therapy and resource utilization. Rational prescribing practices are essential for safe and effective healthcare, necessitating comprehensive prescriptions containing medication details, prescriber information, and patient instructions. This review explores prescription completeness and rationality, utilizing WHO prescribing indicators and other completeness metrics, across Indian healthcare facilities. A systematic search was conducted in PubMed and Google Scholar for original research articles published between 2013 and 2023, focusing on WHO-recommended prescribing indicators and completeness criteria. Inclusion criteria covered articles in English, spanning primary, secondary, or tertiary care settings. Data from selected articles were extracted and analysed. Data were synthesized from sixty-seven studies, depicting various prescribing practices. The assessment encompassed prescribing, patient care, and facility indicators. Findings highlighted challenges such as illegible prescriptions, incomplete details, polypharmacy, brand name dominance, and inappropriate antibiotic use. Despite WHO recommendations, generic prescribing was limited. This review reiterates the need for interventions to enhance prescription quality, patient safety, and cost-effectiveness. Recommendations include adopting electronic prescribing systems, standardizing prescription formats, conducting regular prescription audits, implementing educational programs, promoting generic drug use, and adhering to essential medicines lists. These multifaceted strategies can improve prescribing practices and ultimately contribute to enhanced healthcare outcomes in India.
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Background: WHO estimates that more than half of all medicines are prescribed, dispensed or sold inappropriately. Nonsteroidal anti-inflammatory drugs are a group of drugs that are commonly prescribed for the treatment of fever associated with pain and inflammation. The objective was to assess the prescribing pattern of NSAIDs in fever patients. Along with this, we looked at the clinical indications for prescribing and the pattern of prescribing with respect to use of generic or trade names. Methods: This observational study was conducted in a tertiary care teaching hospital in Malappuram district of Kerala, India by extracting data of inpatients retrospectively from medical records for a six-month period. The reported prevalence of NSAID use in previous study was 20%, with a relative precision of 18% the sample size required was 500. The data was analyzed and expressed as absolute numbers and/or percentages. Results: Out of these 500 patients, Dengue fever was the most common diagnosis (86.6%) followed by Typhoid (2.8%) and Leptospirosis (2.4%). Among these, 392 (78.4%) received any of the NSAIDs. The most commonly prescribed drug was Paracetamol (77.04%). Among to the prescriptions, 91.7% were prescribed with generic names. As concomitant medications, antibiotics were prescribed at 21.2% cases, gastro protective agents were prescribed to 24.23% and vitamins were prescribed in 72.6% cases. Conclusions: This study has shown that the prescribing, usage and preferences of NSAIDs practiced rationally. No over use, under use or misuse of drugs was noticed.
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Background: Antimicrobial medicine (AMM) utilization patterns and rational drug use are important topics in, today’s world wrought with AMM resistance, irrational prescription of antibiotics, and lack of proper training such as, stewardship programmes for medical graduates and general practitioners. Our objective was to perform an audit of the, antimicrobial drug utilization pattern, evaluate the rationality of drug use, and perform a cost analysis of these drugs. Methods: An observational cross-sectional study design was implemented. The study location was a tertiary care, teaching hospital in suburban central India. Patients were recruited from the general medicine and general surgery, departments., Results: Out of 189 patients, the average age was 45.714 years and 67.725% were females. A total of 595 AMMs, were prescribed to 189 patients with an average of 3.148±1.578 drugs per patient. 6.5% drugs prescribed were, generic, 95% prescribed were included in the national essential medicine list, and 90% of patients prescriptions were, rational. The total expenditure on AMMs was ?726043.610, with a median expenditure of ?987.320., Conclusions: Drug utilization patterns vary between medicine and surgery departments. They also vary between, different institutions within the same country. Creating a structured standardized training program to uniformly train, healthcare professionals in conservative antibiotic prescription practices is needed. This study hopefully paves the, way for future studies to target critical areas in AMM prescription and to prospectively assess the impact of a, structured antibiotic stewardship program on AMM utilization patterns
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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.
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Objective To explore how to further improve the quality of home pharmacy services under the background of aging. Methods The development history of home pharmacy service in our country in recent years was summarized, and the current status and limitations of home-based pharmacy service were analyzed. Results Our country's home-based pharmacy service has gradually matured and standardized from the early stage of independent exploration in various regions, but its quality improvement is still restricted by multiple bottlenecks. It is recommended to increase the popularity of pharmacy services, broaden the promotion channels for rational drug use, and optimize the allocation of pharmacists. etc. to be improved. Conclusion It is of great significance to improve the quality of home-based pharmacy services for home-based patients in the community, and it requires the joint efforts of multiple parties to improve it.
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Objective To establish a rational drug use model of PIVAS and promote the rational drug use in clinical practices by enhancing the quality of prescription review by pharmacists. Methods The PIVAS physician orders received from 2014 to 2021 were extracted through the hospital information management (HIS) system. The types of irrational physician orders were statistically analyzed, the improvements were made by the method of quality control circle (QCC). Results The model of PIVAS rational drug use formed a standardized process. The proficiency of physician order review was improved. From 2014 to 2021, the number and proportion of unreasonable physician orders in PIVAS decreased year by year. Every type of unreasonable physician orders was improved year by year. Conclusion The professional and technical levels of pharmacist for physician order review at our hospital were improved by the model of PIVAS rational drug use. The quality of pharmaceutical service was significantly improved which ensured the safety of patients' medication.
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Objective To establish drug use evaluation(DUE)criteria for aminocaproic acid injection,and to evaluate and analyse clinical use of aminocaproic acid injection.Methods Based on the aminocaproic acid injection drug label,DUE of aminocaproic acid injection from three aspects(indications,medications and medication results)were established with reference to relevant literature.A retrospective survey was conducted to evaluate the rationality of medication for inpatients who used aminocaproic acid injection from July 1,2021 to June 30,2022 in Fuding Hospital of Fujian University of Traditional Chinese Medicine.Results A total of 143 midical records were included.73 cases fully met the DUE criteria,70 cases did not fully meet the DUE criteria,and the unreasonable rate was 48.95%.The most common types of irrational using of aminocaproic acid injection were inappropriate timing of perioperative prevention of medication(26.57%),overcourse in perioperative prevention of medication(23.08%),and contraindications(7.69%).Conclusions The aminocaproic acid injection DUE standard established is scientific,practical,the irrational rate of aminocaproic acid injection use is relatively high in this hospital,and the management of rational use of aminocaproic acid injection needs to be strengthened.
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The performance appraisal for tertiary public hospitals provides means for the rational management of drug use in public hospitals. Starting from October 2021, Hospital Z had established a drug performance appraisal system based on the relevant requirements for rational drug use in the performance appraisal for tertiary public hospitals, in view of the actual situation. The system included four indexes: weighted outpatient per capita drug cost, weighted inpatient per capita drug cost, rational drug use rate, and intensity of antibacterial drug use. Different scores were assigned to each indexi and scoring methods were developed. By dividing all drugs in the hospital medication catalog into three categories A, B, and C and assigning them different weights, as well as setting reasonable target values for each indexi, the hospital guided clinical departments to use drugs rationally. The proportion of drugs in hospital Z decreased from 28.75% in 2020 to 25.44% in 2022, the proportion of medical service revenue increased from 22.97% to 28.40%, the per capita outpatient drug cost decreased from 170 yuan to 166 yuan, and the per capita inpatient drug cost decreased from 7 318 yuan to 5 983 yuan. The number of departments with a 100% reasonable drug use rate increased from 11 in September 2021 to 16 in September 2022, and the intensity of antibacterial drug use decreased by 35.84%. The opplication of this drug performance appraisal system partly optimized the hospital′s income structure, controlled the growth of drug costs, promoted the rational use of drugs, so as to provid references for the rational drug use management of tertiary public hospitals.
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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.
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OBJECTIVE To explore the effects of posaconazole combined with proton pump inhibitors （PPI） on the blood concentration and the risk of invasive fungal disease （IFD） in patients with malignant hematological disorder. METHODS In accordance with the random number table method， 40 patients with malignant hematological disorders who were admitted to the hematology department of our hospital between December 2020 and December 2021 were chosen and divided into control group （20 cases） and observation group （20 cases）. The control group received Posaconazole oral suspension alone， while the observation group received Posaconazole oral suspension combined with PPI. The incidence of IFD， attainment rate of blood concentration， the time from the start of prophylaxis to IFD onset， the fatality associated with IFD， treatment of infected patients， and blood concentrations of posaconazole on 7th， 14th， 21st， and 28th day after posaconazole application were compared between 2 groups； the occurrence of adverse events during drug administration in the two groups was recorded. RESULTS The study was stopped because 2 patients in the observation group and 9 patients in the control group received hospital departures after taking posaconazole for fewer than 7 days. The incidence of IFD in the observation group was significantly higher than control group， and the attainment rate of blood concentration in the observation group was significantly lower than control group （P＜0.05）. There was no significant difference in the time from the start of prophylaxis to IFD onset， the fatality associated with IFD， treatment of infected patients and the incidence of adverse events （P＞ 0.05）. The blood concentration of posaconazole in the observation group was significantly lower than control group on 7th day of medication （P＜0.05）； there was no significant in blood concentration of posaconazole between 2 groups on the 14th day of medication （P＞0.05）. CONCLUSIONS Posaconazole combined with PPI can reduce the blood concentration of patients with malignant hematological disorders， increase the risk of IFD. Clinical practice should try to avoid the combination of the two or use them under the guidance of therapeutic drug monitoring.