Zhao Jianfeng,Zhang Wei,Yu Hai

(1.School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;2.China Pharmacopoeia Commission,Beijing 100061,China;3.Liaoning Health Industry Group,Shenyang 110000,China)

Abstract Objective To explore the factors influencing the implementation of drug standards improvement in China,and to offer some suggestions for improving drug standards.Methods Factor analysis was used to investigate the influencing factors by referring to the literatures,experts' interview and collecting data through questionnaire,and then data were analyzed by SPSS21.0 statistical software.Results and Conclusion The results showed that there were four factors that affecting the plan of the national drug standards improvement.They were mechanism factor,design factor,constraint factor and motivation factor.And corresponding management suggestions for improving the efficiency of the plan were put forward.

Keywords:national drug standard;improvement practice;influencing factor;factor analysis

In 2007,the Eleventh Five-Year Plan for Food and Drugs was promulgated by the State Council,which clearly put forward the“action plan for improving national drug standards”.The 12th Five-Year Plan for Drug Safety further stressed that the purpose of the plan is to ensure the safety of the people's drug use,and to improve drug standards and drug quality.The 13th Five-Year Plan for Drug Safety proposes to complete the formulation and revision of 3 050 national drug standards[1-3].Since 2008,the central government has allocated nearly 100 million yuan each year in transferring payments to local governments for the revision of drug standards and research related to drug standards.The National Pharmacopoeia Committee is responsible for the organization and implementation of the work.The implementation of the national action plan for improving drug standards has enhanced the controllability and effectiveness of drug quality in China as a whole and it also played an important role in promoting the transformation and upgrading of the pharmaceutical industry.While positive progress and certain achievements were made,some problems appeared as well in the process of standard improvement.

Different from Western countries,China's Pharmacopoeia Committee has no laboratory that can be used to carry out standard research.Therefore,it has to entrust national drug testing institutions,scientific research institutes and drug manufacturers to carry out standard research.Due to the dispersion of the standard research chains,there are some problems such as weak control of the project completion schedule and quality.In addition,with the increase of supervision and inspection tasks of local drug inspection institutions in recent years,the plan for improving drug standards is also faced with some challenges.Therefore,strengthening the coordination and integration of the Pharmacopoeia Committee,the professional committees,and the relevant associations and the drug manufacturers are of great importance to carry out the plan for improving the drug standards.

Factor analysis is a common method in statistics.Its principle is to use a few factors to describe the relationship between many indicators or factors,and then to classify the more closely related variables into a category.Each type of variable is a factor,which is used to investigate the relation and difference between the original variables.Due to the characteristics of dimension reduction without subjective assignment,it has been widely used in the analysis of influencing factors.In this paper,factor analysis method is used to analyze the influencing factors of the plan,and some suggestions are put forward to promote the national drug standards.

1 The process of factor analysis

1.1 Selection of samples and variables

The national plan for the improvement of drug standards requires the cooperation and participation of several units,including the Pharmacopoeia Committee,industry associations,drug standards research institutions and manufacturing enterprises.They are not affiliated to each other,but they can carry out cooperation according to their respective division of labor.Therefore,the improvement of drug standards is the result of the comprehensive action of multiple departments,involving not only internal management and coordination,but also communication and connection with external units.Through practice,data query and experts' interviews,15 factors affecting the implementation of the national drug standards were drawn up as the initial influencing factors of this study.The factors affecting the preliminary formulation are shown in Table 1.

Table 1 The influencing factors of national plan for drug standards improvement

1.2 Questionnaire survey and data processing

Based on the preliminary factors,a questionnaire on the factors affecting the national drug standard plan was designed.Then the questionnaires were distributed to drug regulators,members of the Pharmacopoeia Committee,drug industry associations,and staff of drug manufacturers.The questionnaire adopted the scoring method of Likert scale 5,with“very good implementation”as the maximum value(5 points)and“very bad implementation”as the minimum value(1 point).A total of 200 questionnaires were issued,and 189 were actually recovered,among which 181 were valid.The basic information of the investigated personnel was shown in Table 2.The number of valid questionnaires met the requirements of exploratory factor analysis.In this study,SPSS Statistics 21.0 was used to process the questionnaire data for exploratory factor analysis.

Table 2 The basic information table of investigated personnel

1.3 The suitability testing

The SPSS Statistics 17.0 was used to test the affecting factors of the national plan for improving drug standards by Bartlett inspection and KMO,the KMO value is 0.815,between 0.8 and 0.9,the Bartlett ball testing' statistics significant probability is 0.000,less than 1%.Therefore,the sample data is suitable for factor analysis[4].

1.4 The factor extraction

The eigenvalue criterion was used to determine the number of the factors influencing the national drug standard plan in this study.The principal component with eigenvalue greater than or equal to 1 was taken as the initial factor,and the component with an eigenvalueless than 1 was abandoned.The cumulative variance percentage of the factors affecting the investigation of the observation variable data was shown in Table 3.

1.5 The rotation of factors

The orthogonal rotation method was adopted to analyze the sample data of influencing factors of the national action plan for improving drug standards,so that the load of common factors was close to plus or minus 1 or 0.In this way,the factor matrix could determine the common factors and integrate variables according to the transformation matrix of factor rotation,thus generating common factors.The factor matrix after rotation is shown in Table 4.The extraction method is the principal component analysis,the rotation method is the maximum variance rotation,and the number of iteration convergence is 5.As can be seen from the data in Table 4,after the rotation,the factor loading coefficient of the sample data of influencing factors of the national plan for drug standard improvement has been polarized.A total of four factors were extracted,which were the mechanism,design,constraint and motivation factors of the pharmaceutical industry.In addition,according to the results of lithotripsy(Fig.1),the rationality of extracting factors was further illustrated.

Table 3 Explanation of factor analysis of total variance variation

Table 4 The factor matrix after rotation

2 The analysis of results

2.1 The daily management of drug standards

Fig.1 The results of lithotripsy

The variance contribution rate of the daily management of drug standards is 36.905%,which is the dimension affecting greatly on the national drug standards improving plan.The dimension includes the number of standards management personnel drug(X1),the rationality to improve the drug standards(X3),the rationality of the subjects allocation(X5),the standardization of drug standard evaluation(X9),the timely communication with the units(X10),the acquisition and integration of regulatory information(X11),the appropriation method of project funds(X14),and the constraining relations with the units that undertake the projects(X15).This dimension reflects the power allocation of drug standard management and the standardization from standard project approval,standard supervision to standard evaluation.Drug standards issues should be done in multiple units,which inevitably involve internal coordination and external communication,the scientific and reasonable project management mechanism,the good cooperation,information exchange and communicating in time will affect the quality and efficiency of the national plan for improving drug standards to a large extent.

2.2 The scientific planning of drug standard subjects

The variance contribution rate of scientific planning is 19.982%.This dimension includes two factors,namely,the rationality of the subjects' goal(X2)and the number of subjects to improve the drug standards(X4).Whether the drug standards improving plan is reasonable or not will directly influence the quality and efficiency.This dimension reflects the rationality of goal setting,including whether the target can highlight the current problems of drug standards,whether it can be combined with the reality of each drug production and design,and whether the number of tasks can go through scientific argumentation.

2.3 The unit undertaking the projects of improving drug standards

The variance contribution rate of the unit undertaking the project of improving drug standards is 11.797%.This dimension mainly includes the research capacity of the unit(X6),the time assigned to the research(X7)and the enthusiasm in the research(X8).The undertaking unit of the drug standard project is the most direct force to participate in the research work.The degree to which the undertaking units attach importance to the improvement of the standard will affect the enthusiasm and working time in the improvement of the standard.If the subject of standard improvement is not attractive to scientific research institutions,it will lead to the failure of timely promotion and implementation of the standard improvement.

2.4 Drug manufacturers

The variance contribution rate of the regulatory environment is 6.078%.And the dimension includes the degree of cooperation of drug manufacturing enterprises(X12)and the enthusiasm that drug enterprises participating in the research(X13).The most reasonable standard can be worked out when pharmaceutical enterprises actively cooperate with the units that are responsible for the subject,otherwise,it will affect the progress and effect of the work.

3 Management suggestions

3.1 Improving the national drug standard management mode

As the national drug standard management personnel,reviewers and researchers are separated from each other,they do not have a direct affiliation.The existing current model affects the progress and quality of the project to some extent.Therefore,it is necessary to have a top-level design,and an efficient operation mechanism should be established on this basis.Meanwhile,the configuration of the management personnel should be strengthened,and the standard database of the drug should be set up to improve the information of the existing standard.In addition,solve the overabundance problem that the management personnel are responsible for by the information means and realize the sharing of the information and resources.To strengthen the construction of the ability of standards management,members of the pharmacopoeia should also be trained.In terms of policies,detailed measures should be formulated to encourage drug manufacturers to participate in the formulation and revision of drug standard with great enthusiasm.

3.2 Scientific design of plans for raising drug standards

Scientific plans will directly affect the efficiency and quality of the implementation of the standards improving.Therefore,it is necessary to strengthen the research for making statistical analysis of drug use in the market with the help of information technology and big data.Finding out the circulation and drug use in the market can improve the standards of drugs,especially the drug with large sales volume,but big quality difference.In addition,according to the actual situation of China's pharmaceutical industry,we can effectively integrate resources,interacting with the national drug evaluation sampling and other departments closely.To ensure that the plan can be implemented,the industry opinions of the research projects should be solicited and demonstrated.

3.3 Fostering a high-level drug standards research platform

The research platform can affect the quality of the project,so we should assign the standards improving tasks to the high-level research units according to their respective laboratory in specific areas,in other words,the units with highly researching ability involved in pharmaceutical standards should be selected.To ensure that the research work can be carried out in accordance with the requirements of unified standards,the training of the units undertaking the standard improving subjects should be strengthened.In addition,colleges and universities and scientific research institutes should play an important role in the development of drug standards.Therefore,it is important to urge scientific research institutions to invest more resources to participate in the national drug standards research through the development of professional title evaluation,performance awards and other incentive measures.And a set of scientific objectives and indicators system,as well as strict and complete evaluation procedures and methods should be made to evaluate the completion of the project in each laboratory.