| BackgroundAntibacterial agents are one of the most widely used drugs in clinical,with the largest variety and usage.Irrational use of antibacterial agents will increase the "selected pressure" of bacteria,thus to accelerate the generation and development of bacterial resistance.Bacterial resistance not only impairs the infectious diseases treatment,increases the mortality rate,but also prolongs hospitalization,increases medical costs and occupies more medical resources,results in quite a burden to health system and society.With the development of globalization,the spread of drug-resistant bacteria is accelerated by population migration.The irrational use of antibacterial agents has become a global public health issue.As the most populous country,China also has the serious situation on the irrational use of antibacterial agents,leading to the continuous development of bacterial resistance.Among the five multidrug-resistant bacteria under global surveillance in China,the incidence rates is in t Medium to high level in the world except for the vancomycin resistant enterococcus.Series issues originated from antibacterial drugs used calls for the antimicrobial regulation and implement policy form the health administration and government.Since the beginning of the 21st century,China's health administrative departments have successively released a series of policies to regulate the clinical application of antibacterial agents in medical institutions,and established the "Center for Antibacterial Surveillance"(CAS)and "China Antimicrobial Resistance Surveillance System"(CARSS)to monitor drug use and bacterial resistance in 2005.However,the antibacterial agents irrational use proportion and antibiotics use intensity(AUD)still remain at higher level,because of the deficiency of the drug circulation and support system.the lack of knowledge,attitude and behavior among antibiotics supplying and demanding side.In 2011,in cooperation with the new round of medical and health system reform in China,as well as the antibacterial drug management policy package proposed by the world health organization(WHO),the Ministry of Health(MOH)has launched a three-year special rectification campaign for the clinical application of antibacterial drugs in the secondary and tertiary hospitals of China,and then series of policies continuously implemented to enforce the management of antibacterial agents use.Evaluation and systematic assessment upon the policy implementation will adapt based on the series policy goals set up for the antimicrobial regulation policies to the deeper understanding of anti-bacterial drug application regulations in China of the new era.and explore the potential reasons and inherent mechanisms.Therefore,the question discussed in this study is that after regulations on the antibacterial agents' clinical use had been implemented in 2011,what are the actual effects of the policies application?What are the problems and the unexpected effects?How to make a comprehensive and systematic discussion on the existing problems and their causes under the policy framework,so as to realize the diagnosis of the problems and find solutions?ObjectivesBased on the analysis of clinical use data of antibacterial agents of CAS,this study confirmed antimicrobial use problems in tertiary hospitals after policy implementation.Policy evaluation index system was established to assess the current situation of antibacterial drug application regulation in selected hospitals,and the reasons and inherence mechanism for the policy implementation of antibacterial agents were analyzed.Policy implications were put forward for the perfection and implementation of the regulation policy of clinical application of antibacterial drugs.The research objectives are as follows:1.To analyze whether the application of antibiotics in tertiary hospitals has met the policy goals after the implementation of the national anti-bacterial drug regulation policy,and confirm the problems emerging from the antibacterial agents use;2.To construct the evaluation index framework for the antibacterial drugs clinical application regulation in hospital:3.To analyze the current situation of clinical application regulation of antibacterial drugs in selected hospitals,and explore the reasons and affecting mechanism for implementation of the regulation:4.To propose policy suggestions for the regulation of clinical application of antibacterial agents promotion.MethodsThis study is conducted accordance with the process of high-value policy making circulation,which includes the summarizing feedback,identifying problems,analyzing causes and proposing policy implications plans.This study is a combination of monitoring data analysis and cross-sectional survey.The monitoring data are provided from CAS quarterly antibacterial agents data of 151 tertiary general hospital,ranged from the first quarter of 2011 to the third quarter of 2015.A standardized and analyzable data structure form was formed according to the ATC/DDD guideline,and the name of antibacterial drugs were encoded and assigned with DDD values.Four medical institutions were selected for field investigation by means of objective sampling.The survey includes two parts:institutional investigation and qualitative interviews.The institutional questionnaire includes the clinical application management of antibacterial agents in hospitals,the antibacterial agents use among hospitalized patients,and the antibacterial agents' consumption in hospitals.In tertiary hospitals,10 key informants are interviewed,which included ? hospital leader,three hospital clinical application of antibacterial drugs management team members,2 clinical doctors,1 clinical pharmacist(or add one clinical doctor to replace),1 from infection management department,1 from inspection management department and 1 from pharmacy department.The analysis methods included three parts.First,the monitoring analysis.descriptive analysis,parameter estimation and hypothesis testing analysis,simple regression analysis,general linear model analysis,intermittent time series analysis and DU90%analysis were used depend on the data characteristics.The second was the assessment framework built according with the "structure-process-outcome" model,and the index was originated from the literature review,Delphi method and AHP method,the comprehensive evaluation was based on the advanced TOPSIS and weighted RSR methods.Lastly,qualitative methods,the theme framework analysis and PEST methods were used for the interview data.Excel 2016,SPSS23.0 and Stata14.0 were used to data analysis.Results1.Policies review.From January 2001 to December 2016,58 policies and regulations were issued related to anti-bacterial drug application regulation in China.The policy evolution can be divided into four stages.The first stage is 2001-04.which is the original stage,featured by the regulating the drug users' behavior of clinicians and residents.The second stage,from January 2005 to November 2010,is characterized by the gradual formation of e standardization of anti-bacterial drug application management and monitoring,which includes the establishment of the clinical pharmacist system,the prescription review system and national anti-bacterial drug application monitoring network The third stage is December 2010 to December 2015,the characteristics of this stage is the optimization of the drug structure,the drug problem solution and to build a long-term mechanism for emphasis,in view of the whole process of antimicrobial application,build the comprehensive management personnel among different departments and different functions,with a clear assessment index framework and backed by eulogizations and regulations.The antimicrobial application management starts to the new stage of systematization management.The fourth phase begins at 2016.The characteristics are that the application management of antibacterial drugs transformed from medical and health departments and institutions to the to the all-around management of government and society,while the antibacterial drugs management transformed from the all-around control to the key monitoring.2.CAS monitoring data analysis(1)Configuration of drug varieties.From 2011 to 2014.the number of antibacterial agents applications for inpatients in all monitored hospitals nation,wide dropped from 1 57 to 132,with a total decline of 15.92%,and the average annual growth rate was-3.14%.The northeast saw the biggest drop,at 23.79 percent.The total reduction rate of monitored hospitals was 40.83%in Shandong province,while the average annual compound growth rate was-12.30%.The drugs with a high proportion of antimicrobials used nationwide include broad-spectrum penicillin,penicillin compound,the first to third generation cephalosporins,macrolides and fluoroquinolones.The number of cephalosporins,macrolides and fluoroquinolones were highest in eastern regions.The most widely used drugs in Shandong province were broad-spectrum penicillin,penicillin compound drugs,the first to third generation cephalosporin drugs.Basically.all the inpatients been monitored for the antibacterial agents used substances to achieve the goal of policy regulation.There were significant differences in the use intensity of each monitored hospital among different years(F=62.64,P<0.01).Some hospitals hadn't met the standards of the required number of drugs for cephamycin and carbapenems.(2)DDDs and cost of antibacterial agents.In the period of the policy implementation,the DDDs and cost of antibacterial agents showed a trend of decline and then rise.The second quarter of each year were the peak of antibacterial agents use.From the first quarter of 2011 to the first quarer of 2013,the DDDs and cost of antibacterial drugs in Shandong province decreased by 43.13%and 41.06%respectively,which gradually increased after that.The dosage and costs increased by 88.06%and 56.67%respectively.Compared with 2011,2014 across the country.region,and the narrow spectrum of penicillin drugs dosage of Shandong province and expense proportion fell,the penicillin class compound,third-generation cephalosporin,penicilliunm carbon alkene,fluoroquinolone ketone and sugar peptide drug dosage proportion increase.the dosage of third-generation cephalosporins and fees accounted for the most,26.36%and 27.52%.respectively.penicillium carbon alkene and sugar peptide drug dosage and cost,the biggest percentage increase dosage proportion increased 1.80 times and 1.62 times respectively.charge ratio increased by 44.97%and 35.21%respectively.Carbapenems were the prevailing used in surveillance hospitals in the eastern region,accounting for 6.17%and 18.85%.Compared with 2011,the proportion of cephalosporins,fluoroquinolones.carbapenems and glycopeptide in the monitoring hospital of Shandong province increased in 2014.From 2011 to 2014.the proportion of injectable antibacterial drug dosage nationwide increased from 80.39%to 85.79%,and the proportion of amount increased from 97.62%to 98.37%.Eastern regions tended to use more expensive injectable antibacterial agents.The dosage and expense ratio of injectable antibacterial drugs were reduced in Shandong monitoring hospital,accounting for 74.56%and 96.60%,respectively.Nationwide,there was no significant difference in out-of-list drug dosage and expense ratio before and after policy intervention(P?0.264),while the special grade drug dosage and expense ratio increased significantly by 0.696 percent and 0.258 percent per month after policy implementation(P=0.000).The amount and cost of special grade drugs in central and western regions increased significantly(P<0.01).The cost of special grade drugs is highest in the eastern region.After the implementation of the hierarchical management policy.After the implementation of the policy.the use and expense ratio of special grade antibiotics in monitoring hospital in Shandong province dropped significantly by 0.528%and 0.840%per quarter(P<0.01).In 2014,the ratios of the DDDs and costs of broad-spectrum antibacterial drugs and narrow-spectrum antibacterial drugs in hospitals across the country and monitoring hospitals in Shandong province were both higher than that in 2011,with 6.84 and 8.83 in hospitals across the country and 4.94 and 9 in Shandong province respectively.(3)Antibiotics use intensity.In 2014,70.86%of the monitoring hospital's AUD was not controlled below 40DDDs/100 inpatient-days,and there were significant differences in AUD changes of the monitoring hospitals between different years(F=62.64,P<0.01).The anti-biotics control in western regions were the best,followed by eastern and the central region.Half of the monitoring hospitals in Shandong province did not meet the control criteria of the AUD.There were significant differences in AUD in the internal monitoring hospitals in various regions at different times(P<0.01).The correlation between the AUD and the number of strains used in national monitoring hospitals was in 2011,2013 and 2014(P<0.05).(4)Application criteria.nationally,the top 10 drugs in terms of usage rate were mainly penicillin compound drugs,cephalosporin(containing compound preparations)and fluoroquinolone antibacterial drugs,the proportion of compliance with national guidelines is 74.63%on average,and the compliance rate has been gradually reduced since 2012.Compared with 2011,the compliance of the guidelines for the application of antibiotics in monitoring hospitals in all regions increased in 2014,among which the compliance in northeast was the lowest.Cephalosporins and levofloxacin are the most used drugs in Shandong monitoring hospital each year.The average annual rate of drug use recommended by national guidelines for du90%was 86.57%.3.Construction the evaluation index framework.The evaluation framework index system of clinical application regulation of hospital antibacterial drugs constructed in this study includes three primary indicators,which were the system construction,system execution and implementation results.It was followed by the 12 secondary indicators,including organization composition,technical support system composition,microbial test rate,antibacterial agents application and monitoring and management,clinical(urgent)prescription index,and antibacterial agents index for surgical prevention,etc.And also 55 tertiary indicators.A total of 19 experts from different research fields were consulted for two rounds of expert consultation.The authority degree of two rounds of expert consultation was 0.77 and 0.775,and the coordination coefficient was 0.471 and 0.575,respectively.The chi-square test was statistically significant,indicating that the results were satisfactory.After the evaluation with AHP,the relative importance of the implementation result is the largest.with the weight of 0.3957,followed by the system execution index,with the weight of 0.3238.4.Evaluation of clinical application regulation of hospital antibacterial drugs.The four tertiary general hospitals involved in the survey have met the requirements of policies and regulations in the construction of the antibacteirial agents management system,the construction of technical support system and the allocation of antibacterial agents varieties.In terms of human resource construction,the number of clinical pharmacists in 3 hospitals is 3,and the number of clinical pharmacists in 1 hospital is 4.Most of participants worked for prescription comment,ward rounds and consultation,but not the clinical medication process substantially.The prescription comment work hadn't met the national policy requirements in the selected hospitals.All hospital outpatients and emergency patients had better control of antibacterial agents application indicators.However,in terms of antimicrobial application indicators,the rate of antibacterial agents use among hospitalized patients in 3 hospitals was over 50%.Intravenous infusion was the main route of antimicrobial administration for hospitalized patients.In terms of special use of grade antibacterial agents,the usage rate of carbapenems was 9.86%on average.The average length of stay was longer than the total stay length.By using the combination method based on advanced TOPSIS and weighted rank sum ratio,the hospital D performed the best and almost the optimal level of the process indicators.5.Effectiveness evaluation of clinical application regulation implementation of hospital antibacterial drugs.At present,the structural problems in the regulation of clinical application of antibacterial drugs are mainly reflected in the shortage of clinical pharmacists.the insufficiency of existing human resources to meet the requirements of antibacterial drug management,the emphasis on microbiological detection and the insufficiency of ability.In terms of process,there are problems in the implementation of policies such as the submission of pathogenic microorganism for examination,out-patient drug restriction and prescription comment,as well as the cognition of medical staff regulation policy.In terms of results,the main problems were the intensity of outpatient and emergency drug use,and the bad control of the timing of antibacterial drug use in class I incision surgery.Regulation on the implementation of hospital antimicrobial application mechanism including the complexity of policy issues,the diversity of the function object,target groups,conduct the characteristics of policy problem such as the right amount of adequacy of policy resources,its clarity and correctness of specific policy factors,quality of the target group's obey,regulation and working attitude,communication and coordination between the organization and policy factors such as the external environment.PEST analysis found that the factors included in political environment were policy document issued,ASPs project development,and the support of the laws and regulations.The economic environment factors were the overall economic environment,health and drug expenses,pharmaceutical industry,etc.And social environment,including the factors of patients' attitude,retail management,health education and intervention and others.In terms of technological environment,the influencing factors included development of antimicrobial agents,grassroots drug use and supervision,anti-bacterial drug monitoring technology,and human resources supervision.Lonclusion1.The goals of antibacteirial drug application regulation policy has not been fully realized.After the policy implementation,the hospital antibacterial agents dosage declined,while the drug utilization structure did not change,the drugs recommended careful clinical use saw a rising trend,such as penicillin class compound.third-generation cephalosporin,fluoroquinolone drugs and a special management of penicillium carbon alkene and peptide drug dosage of sugar.2.The scientific and practicability of the evaluation index system for clinical application of antibacterial agents in hospitals established by structure-process-result has been verified,which can be used as the referenced guidance of anti-bacterial application management in medical institutions to help identify problems in practice.3.External and internal factors of medical institutions affected the clinical application of antibacterial drugs of medical institutions and the realization of the goal implementation of rules and regulations.The external factors include political,economic,social and technological environment,while the internal factors include improper work coordination among departments,medical staff cognition on clinical application of antibacterial drug regulation policy,poor and lack of supervision personnel,etc.,resulting in poor regulation policy implementation effect.Policy suggestion1.To improve the systematicness of regulations and policies governing the use of antimicrobial agents2.Improve Improve policy accessibility.3.Strengthen the supervision and administration of antimicrobial agents by various means.4.Strengthen education and training. |
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