ObjectiveTo investigate the drug utilization in primary healthcare system of Xinjin county of Chengdu in 2010. MethodsThe drug utilization information in regional health information platform of Xinjin county were collected. Microsoft Excel 2003 software was used to describe the types, forms and expenditure of medicines, particularly the use of antibiotics among outpatients and inpatients. ResultsThe drug utilization of 17 hospitals in Xinjin county in 2010 was summarized below:a) there were 1 507, 1 356 and 695 kinds of drugs dispended for outpatients, and 1 271, 1 023 and 317 for inpatients in county-level hospitals (CLH), township hospitals (TH) and community healthcare centre (CHC), respectively. Among which, oral biomedicine and traditional Chinese medicine (TCM) accounted for about 45% of total types, and 46% to 73% of total drug expenditure among outpatients; while oral biomedicine and the injection accounted 37% to 61% of total types of medicines dispended to inpatients, particularly injection of biomedicine accounting for over 75% of total drug expenditure among inpatients. b) The expenditure of top 30 drugs in primary care hospitals accounted for 50% of total drug expenditure among outpatients and over 85% among inpatients. c) Among the top 20 drugs, there were 15 antibiotics, which accounted for 26.5% of total drug expenditure in Xinjin county. The top 10 antibiotics were mainly cephalosporin, accounting for 59.36% and 66.27% of total antibiotics expenditure among outpatients and inpatients respectively. Conclusiona) The main forms of medicines dispended to outpatients are oral biomedicine and TCM, while oral agents and injection of biomedicine are the majority of medicines used for inpatients. b) The top 30 drugs should be monitored for rational use of drugs considering the huge expenditure. And c) the types, proportion of use and expenses of antimicrobial drugs ranked the first in CLH, CHC and TH, which may imply irrational use of antibiotics.
ObjectivesTo investigate Chinese health practitioners’ usage and demand for clinical practice guidelines in general so as to improve the development and implementation of guidelines.MethodsWe conducted a cross-sectional questionnaire survey that covered health practitioners from different levels of medical institutions in 17 provinces in China. Attitudes, adherence, usage barriers and demands for clinical practice guidelines were investigated.ResultsA total of 953 health practitioners were involved in the survey in which 931 completed the questionnaires. Respondents generally held positive attitudes toward guidelines and agreed that they improved quality of care and standardized diagnosis and treatment. More than 80% of the respondents reported a fine adherence to guidelines. The most reported barriers to follow the guidelines were " several guidelines are competing” and " lack of facilities and medical resources”. Most respondents agreed that it was necessary to establish a national guideline database, appraise implementation effect of guidelines, develop evaluation tools for guidelines that are applicable for Chinese clinical practice, and provide guidelines training.ConclusionsThis study finds favorable attitudes and fine adherence towards clinical guidelines in general in China. However, internal barriers, such as authority of guidelines, and external barriers, such as supplying system and patients’ preference, can affect guideline dissemination and implementation. It is suggested that establishing a national guidelines database, developing evaluation tools for guidelines that fit for Chinese clinical practice, and provision of guideline training, would facilitate the use of guidelines.
Objective To explore the serious situation of injection abuse, and its influence to average prescription fee. Methods The subjects of this study were health service settings in rural area of 9 provinces/cities in Midwest of China. The treatment prescription indicators of county and village health service settings were calculated. Results Prescription injection rates of health care facility in rural area of Midwest provinces/cities of China (25.8% to 62.2%,mean: 45.1%) were higher than the standard of WHO (13.4% to 24.1%), and the injection abuse situation was serious. Injection bause caused the increase of prescription fee. Excess usage of injection in health service settings was related to the economic level of the on-site county or village, and also related to the size and load of health service facilities. Conclusion Suggestions are proposed to the government health agency according to the results of the study: enhancing the lawmaking, establishing the related policy and effective measure, training the medical personnel, promoting the mass health education, investigating the effective injection management model in rural area, and reducing the rate of injection.
ObjectiveTo investigate the development, production and use of children’s drugs in Sichuan Province, analyze the problems existing in these links, and provide suggestions for ensuring that children’s needs for drugs are met. MethodsThe self-filling electronic questionnaire was used to investigate the production, procurement and use of children’s drugs in 14 pharmaceutical companies producing children’s drugs and 20 general hospitals with pediatric departments or children’s hospitals in Sichuan province. ResultsThe 14 surveyed pharmaceutical companies reported that 116 children’s drugs were being developed or produced (75 first-class children’s drugs with exact medication information for children, 41 second-class children’s drugs only noted as children's discretionary reduction or use according to clinician’s instructions), out of which 109 (93.97%) drugs had been approved for marketing, 21 (18.10%) were national essential medicines and 76 (65.52%) were covered by national basic medical insurance. The dosage forms of first-class children's drugs were mainly tablets (28, 37.34%) and granules (19, 25.34%), while oral solution (3, 4.00%), syrup (5, 6.67%) and other dosage forms suitable for children were less. According to the surveyed results on the use of children's drugs in hospitals, there were 57 children’s drugs whose minimum use units needed to be manually divided into smaller ones on average in each hospital, and it was the most common operation pattern that pharmacists informed nurses, patients or patients’ family members of the dose splitting methods and then splitting drugs’ minimum use units by themselves. ConclusionThere is a great demand for splitting minimum use units of drugs whose strength is too big for children in medical institutions, and some children’s drugs need to be developed and further modified to meet the clinical children’s drug needs. We should further increase investments and policy supports for the children’s drugs, promote children’s clinical trials, and encourage the research and development of children’s drugs.
Objective To introduce the evidence-based evaluation on off-label uses at home and abroad, so as to investigate a systematic method of evidence-based evaluation on off-label uses. Methods In combination with the domestic and international research literature, a systematic method of evidence-based evaluation on off-label uses was discussed from the following three aspects: sources of evidence, levels of evidence, and recommendation strength. Results Sources of evidence included Clinical Pharmacology, DRUGDEX? System, NCCN Drugs amp; Biologics Compendium and handsearched literature. Levels of evidence and recommendation strength could refer to the 2009 grade system of Oxford Centre for Evidence-Based Medicine, and the strength of recommendations and scientific support of DRUGDEX? System. Conclusion A systematic method of evidence-based evaluation on off-label uses is initially established.
Objective To explore the pathogen distribution and the characteristics of antibiotics use of patients with positive bile culture in order to provide evidence for appropriate antibiotic use. Methods Using a patient-based approach, the clinical and laboratory data of patients with positive bile culture between December 1st 2016 and November 30th 2017 were retrospectively analyzed. The pathogen distribution and antibiotics use of patients with bililary duct infections and colonizations were analyzed. Multidrug-resistant organism infections of patients with bililary duct infections were studied. Results There were 299 submitted bililary samples and in which 158 were culture-positive (52.8%). One hundred and ten strains of pathogens were found in 79 patients with positive bile culture, including 66 strains of Gram-negative (G–) organisms (60.0%), 37 strains of Gram-positive (G+) organisms (33.6%), and 7 strains of fungi (6.4%). The top three G– organisms were Escherichia coli (25 strains, 22.7%), Klebsiella pneumoniae (9 strains, 8.2%), and Acinetobacter baumanii (7 strains, 6.4%). The top three G+ organisms were Enterococcus faecium (10 strains, 9.1%), Enterococcus faecalis (6 strains, 5.5%), and coagulase negativeStaphylococcus (6 strains, 5.5%). The number of patients with bililary duct infections and colonizations were 42 and 37, respectively, with pathogens occupied mainly by G– bacteria. Ten strains of multidrug-resistant organisms were isolated from patients with bililary duct infections. Compared to patients with non-multidrug-resistant organism infections, the length of antibiotics use was longer in patients with multidrug- resistant organism infections (t=2.129, P=0.039). The rate of target therapy for antibiotics in patients with bililary duct infections was 76.2%. The rate of proper antibiotics use was 16.2% before positive bile culture and 78.4% after positive bile culture in patients with bililary duct colonizations. Conclusions Pathogens isolated from bile culture of infection and colonization are predominantly G– organisms. The bile culture and blood culture should be done for patients with suspected bililary duct infection. Infection and colonization should be distinguished for positive bile culture and antibiotic should be chosen according to drug susceptibility test results.
ObjectivesTo systematically review the efficacy of prophylactic antimicrobial use on preventing infections after arthroscopy.MethodsPubMed, EMbase, The Cochrane Library, CNKI, CBM and WanFang Data databases were electronically searched to collect clinical studies on the efficacy of prophylactic antimicrobial use on preventing infections after arthroscopy from January 1990 to September 2020. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies; then, meta-analysis was performed by using RevMan 5.3 software and Stata 15.0 software.ResultsA total of 8 retrospective cohort studies and 1 randomized controlled trial involving 60 136 subjects were included. The results of the meta-analysis showed that: there was no difference in the post-operational infection rate among patients with and without antimicrobial prophylaxis for arthroscopies (OR=0.51, 95%CI 0.25 to 1.04, P=0.06). For knee arthroscopies, the post-operational infection rate had no difference between patients with and without antimicrobial prophylaxis (OR=0.89, 95% CI 0.65 to 1.23, P=0.48). However, for shoulder arthroscopies, the post-operational infection rate in the antimicrobial prophylaxis group was significantly lower than that in the group without the antimicrobial prophylaxis(OR=0.18, 95%CI 0.08 to 0.37, P<0.000 01).ConclusionsCurrent evidence shows that there is no association between preoperative antimicrobial prophylaxis and a decreased infection rate for knee arthroscopies. Antimicrobial prophylaxis appears to lead to fewer infections after shoulder arthroscopies. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
With the real-world study (RWS) becoming a hotspot for clinical research, health data collected from routine clinical practice have gained increasing attention worldwide, particularly the data related to the off-label use of drugs, which have been at the forefront of clinical research in recent years. The guidance from the National Medical Products Administration has proposed that real-world evidence (RWE) can be an important consideration in supporting label expansions where randomized controlled trials are unfeasible. Nevertheless, how to use the RWE to support the approval of new or expanded indications remains unclear. This study aims to explore the structured process for the use of RWE in supporting label expansions of approved drugs, and to discuss the key considerations in such process by reviewing the documents from relevant regulatory agencies and publications from public databases, which can inform future directions for studies in this area.