Cai Hongning,Sun Lihua

(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China)

Abstract Objective To explore the current situation and problems of the pharmacy organization and pharmaceutical services in primary medical and health institutions so as to provide a reference for improving relevant policies.Methods Multi-stage stratified random sampling was used to collect questionnaires from primary medical and health institutions in 5 provinces,and 102 questionnaires were distributed.Then Excel 2016 and IBM SPSS 21.0 software were applied for descriptive statistical analysis,chi-square test and multiple response analysis.Results and Conclusion A total of 92 primary medical and health institutions participated in the survey,and 92 valid questionnaires were recovered.The survey shows that 54.1% of the institutions have established more than 8 pharmaceutical administration regulations.63.5% and 31.8% of the institutions have formulated pharmaceutical administration and pharmacotherapy team charters (or management systems).29.7% of institutions have pharmacy personnel in accordance with relevant regulations.The higher proportion of pharmacy services are prescription review and adjustment,medication guidance,collecting and reporting adverse reactions,medication errors and medication hazard information.Primary medical and health institutions still need to further improve their pharmaceutical administration system,organizational structure,pharmacy professional training and clinical pharmacy service.

Keywords:primary health care institutions; pharmaceutical administration; system construction; organizational structure; pharmaceutical service

With the promotion of strengthening primary health care reform,China’s primary medical and health institutions should provide more basic medical and public health services.As an important part of their work,the purpose of pharmaceutical administration of primary medical and health institutions is to provide effective supervision for rational drug use[1].Strengthening the construction of the pharmacy department in medical institutions and improving the management level of pharmacists are the important measures to implement medical quality assurance[2].Therefore,China’s government has formulated policies and regulations for the pharmaceutical administration in medical institutions.“Regulations on Pharmaceutical Administration of Medical Institutions” promulgated in 2011 (hereinafter referred to as the “Regulations”) clearly stipulate that medical and health institutions at all levels should establish pharmaceutical administration organizations and pharmacy departments in accordance with the regulations.In order to further strengthen the pharmacy administration of medical institutions,China issued the “Opinions on Strengthening Pharmaceutical Administration of Medical Institutions and Promoting Rational Use of Drugs” in 2020,emphasizing the improvement of pharmaceutical administration and pharmacotherapy committee system.Establishing pharmacy organizations and providing pharmacy services in the primary medical and health institutions are the important ways to improve the modern hospital management system and pharmacy service level of medical institutions.

Through the questionnaire survey,we can better understand the current status of primary medical and health institutions in terms of pharmaceutical administration regulations,organizations,pharmacy professionals and pharmaceutical services.Thus,we can discover problems and solve them in the primary health care institutions.This will provide empirical support and reference for relevant policies and measures.

1 Objects and methods

1.1 Respondents

A multi-stage stratified random sampling method was used in the survey.The provinces (cities and autonomous regions) across the country were stratified according to the differences in geographical location,administrative regions,and regional GDP(GDP in 2017,the same below)[3].At the same time,a typical sample was taken into consideration comprehensively on the completeness of the relevant policies of the pharmaceutical administration in the primary medical and health institutions in each province.Five provinces (Jiangsu,Henan,Hubei,Liaoning and Gansu) were selected.According to the regional GDP and the convenience of transportation,3 cities were selected in each province,and 3 primary medical and health institutions were selected in each city (equal stratified sampling,that is,community health service centers/stations:health centers in towns:village clinics=1:1:1).A total of 45 primary medical and health institutions were selected.In view of the convenience of geographical location,Shenyang and Chaoyang were added in Liaoning Province,and 47 more primary medical and health institutions were selected.The sampling situation in Liaoning Province are Dalian,Shenyang,Benxi,Chaoyang and Fuxin.Each city has 10 primary medical and health institutions (fixed proportion stratified sampling,that is,community health service centers/stations:health centers in towns:village clinics=1:2:2).A total of 50 primary medical and health institutions were selected in Liaoning Province.In summary,there were 92 primary medical and health institutions in the sample.One or two persons in charge of the institutions or pharmacy work answered the questionnaires.

1.2 Survey content and methods

On the basis of literature research and expert consultation,the questionnaire was designed and revised through pre-investigation.Eventually,it was formed for institutions.Under the coordination of the relevant departments of the National Health Commission,the research team of this project went to five provinces to conduct a face-to-face questionnaire survey from August to October in 2018.The main contents of the questionnaire are(1) general situation:administrative position,type of organization,location of organization,range of services; (2) establishment of rules and regulations for pharmaceutical administration; (3) the management of pharmaceutical administration organization:personnel responsible for pharmaceutical affairs; (4) allocation and management of pharmaceutical professionals and technical personnel:number and training of personnel;(5) development of pharmacy services:contents of work.

1.3 Data processing methods

Statistical analysis was performed using Excel 2016 software and IBM SPSS 21.0 software.Descriptive statistical analysis was conducted on the general situation of the interviewees.Chi-square test,rank sum test and multiple response analysis were adopted for categorical variables.The test level wasα=0.05.

2 Results

A total of 92 primary medical and health institutions participated in the survey and 102 questionnaires were distributed.After excluding questionnaires with a blank rate higher than 20%and other questionnaires with logical contradictions among different topics,92 valid questionnaires were recovered,with an effective rate of 90.2%.Of the valid questionnaires,49 were filled out by the person in charge of the institution,while the remaining 43 were filled out by doctors or pharmacists.In terms of institution location,47.8% (44/92) of institutions are located in cities and towns,and 52.2% (48/92) of them are located in villages.The average number of residents covered by the services of the interviewed institutions is about 28 000,and the three groups of people receiving the most services are the elderly(15.5%),patients with chronic diseases (12.3%) and ordinary residents (11.5%).

2.1 Establishment of pharmaceutical administration rules and regulations in the institutions

A total of 85 institutions responded to the establishment of rules and regulations.The results show that among the specific requirements for pharmaceutical administration by the relevant national policies[4,5],54.1% of the institutions set up more than 8 items.The rules and regulations with a relatively high proportion are pharmacy drug management and use system,drug storage system,antibacterial drug management system,drug adverse reaction reporting and monitoring management system,and drug damage reporting system.However,the pharmaceutical group charter (or management system),regulations on the management of unsalable drugs,unqualified drug management system,and special drug management system are rarely established in the primary health care institutions.As shown in Table 1.

Table 1 Establishment of pharmaceutical administration rules and regulations in primary medical and health institutions (n=85)

The antibacterial drug management system has been established in the primary medical and health institutions in Jiangsu Province (100%),Hubei Province (85.7%),Henan Province (72.7%),Gansu Province (61.5%),and Liaoning Province (41.5%).Generally speaking,the internal drug administration rules and regulations of the surveyed institutions in Jiangsu Province are relatively complete,while the surveyed institutions in Liaoning Province are less complete.

2.2 Establishment of pharmaceutical administration organizations in the institutions

According to the “Regulations”,there are two types of pharmaceutical organizations in medical and health institutions in China,namely,pharmaceutical administration organizations and pharmacy departments.A pharmaceutical administration organization should be established in the primary health care institutions,namely the pharmaceutical administration and pharmacotherapy group.Besides,a corresponding pharmacy department should be set up,which is responsible for drug management,pharmacy professional technical services and other management.Among them,clinics and health centers in the towns or villages should not set up pharmaceutical administration organizations or pharmacy departments.The person in charge of the clinic or health center shall designate medical personnel to be responsible for pharmaceutical work.It can be seen from Table 1 that 63.5% and 31.8% of primary medical and health institutions have formulated the pharmaceutical administration group charter (or management system) and pharmacotherapeutics group charter(or management system) respectively.Meanwhile,Table 2 shows that 84.8% of primary medical and health institutions have personnel in charge of drugrelated management,and 14.1% of primary medical and health institutions(mostly village clinics) have no personnel in charge of pharmaceutical administration work.

Table 2 Personnel in charge of pharmaceutical administration in different types of primary medical and health institutions (n=92)

The “Regulations” requires that pharmaceutical administration and pharmacotherapy teams should be composed of the heads of departments such as pharmacy,medical services,nursing,hospital infection and clinical departments,as well as personnel with professional qualifications of pharmacists and doctors.The results show that the personnel responsible for pharmaceutical administration in the primary medical and health institutions are mainly the heads of the pharmacy departments (46.2%),persons with professional qualifications of pharmacists and doctors (36.3%),and the heads of medical department(34.1%).As shown in Table 3.

Table 3 Identity of personnel in charge of pharmaceutical administration in primary health care institutions(n=91)

2.3 Allocation and training of pharmacy professionals in the institutions

2.3.1 Allocation of pharmacy professionals

The results show that among the surveyed primary health care institutions,the proportion of pharmacy professionals accounted for an average of 5.9% of the health workers.And 29.7% of the institutions could meet the requirement of relevant regulations (the proportion of pharmacy professionals accounted for ≥ 8%).40.2% of the institutions had no pharmacy professionals.Table 4 shows the distribution of various types of professional and technical personnel in different types of primary medical and health institutions.In terms of clinical pharmacists,21.7% of the institutions didn’t have clinical pharmacists,19.5% of the institutions only had one clinical pharmacist,and 10.8% of the institutions had two clinical pharmacists.

Table 4 Allocation of health professionals in different types of primary medical and health institutions(n=2 295)

Regarding the needs of pharmacy professionals,59.1% of the interviewees believed that the number of pharmacy staff should be increased due to job demand.While 37.1% of the interviewees believed that the number of pharmacy staff should remain basically unchanged.

2.3.2 Training in pharmacy services

The results show that 29.5% of the interviewees have not participated in training related to pharmacy services.66.7% of the interviewees have participated in the training,of which 25.7% of the interviewees participate frequently and 41.0% of them occasionally participate,as shown in Table 5.As to different provinces,the participation rate of training in Jiangsu Province is the highest (100.0%),and the participation rate of training in Gansu Province is the lowest(53.9%).

Table 5 Participation of training in pharmacy services in primary medical and health institutions (n=105)

The training content related to pharmacy services mainly included three aspects,such as knowledge of rational drug use,adverse drug reactions,and relevant knowledge of essential drugs.The interviewees also participated in drug compatibility,monitoring and early warning of shortage of drugs and supply guarantee,standardized management of special drugs,training on common diseases,infectious disease prevention,prescription management and others.The interviewees believed that it was necessary to carry out training on medication guidance (81.0%),first aid drugs (77.1%),chronic medication management(75.2%),etc.As shown in Fig.1.

Fig.1 Demand for pharmacy training from interviewees in primary health care institutions

2.4 Development of pharmaceutical services in the institutions

The survey results show that the higher proportion of pharmacy services carried out by the primary medical and health institutions interviewed are prescription review and adjustment,medication guidance,collecting and reporting information on adverse reactions,medication errors,and adverse events.However,the proportion of establishing medication files for patients,regularly returning visits,and intervening in the problem of irrational drug use are the lowest.As shown in Table 6.

Table 6 Development of pharmaceutical service in primary medical care institutions (n=92)

3 Discussion

3.1 Improving the rules and regulations of pharmaceutical administration in primary medical and health institutions for supervision

According to the survey,only 54.1% of primary medical and health institutions have established more than eight pharmaceutical administration rules and regulations,indicating that primary medical and health institutions did not pay enough attention to the construction of the pharmaceutical administration system.Many domestic scholars pointed out that the pharmaceutical administration systems were not sound in primary medical and health institutions.Besides,some institutions without a complete quality management system prescribed counterfeit or inferior drugs for patients[6].Due to the lack of drug validity management system,there are such problems as expired drugs,nearly expired drugs mixed with normal drugs[7].Because of the lack of drug procurement and supply system,an unreasonable procurement plan leads to excessive drug inventory,which is easy to make drugs unsalable[8].In addition,primary medical and health institutions with some systems also have problems that it is difficult to implement them.Many primary medical and health institutions have an incorrect concept on the regulations and rules.Therefore,the system cannot function as a supervision[9,10].In view of the differences between primary medical and health institutions and large hospitals,it is recommended that primary medical and health institutions should make good use of antimicrobial drugs while ensuring drug procurement,acceptance,storage,maintenance,and management in accordance with relevant regulations.Besides,they should strengthen the construction of necessary rules and regulations such as the unsalable drug management regulations,unqualified drugs management system,and special drugs management system for the supervision.

3.2 Regulating the establishment of pharmaceutical administration organizations and pharmacy departments in primary medical and health institutions to strengthen the assessment mechanism

The survey results show that 37.1% of the institutions have not established pharmaceutical administration group charter,while 68.6% of the institutions have not established pharmacotherapeutics group charter.14.1% of the institutions (mostly village clinics) have no personnel responsible for pharmaceutical administration,60.4% of the institutions have one person responsible for pharmaceutical administration.Most village clinics have fewer staff,especially in some remote areas with low economic development level.There is only one doctor in a village clinic and it is impossible for him to set up a pharmaceutical administration agency.Therefore,at the system level,village clinics with relatively weak foundations should focus on the compliance and actual effect of pharmacy services rather than the form of pharmaceutical administration organization.We should make good use of county medical communities in remote areas with insufficient medical resources by establishing medical collaboration network to ensure the management of township health centers.

3.3 Reasonable allocation of pharmacy professionals and optimization of pharmacy training

The “Regulations” requires that all types of medical institutions pharmacy professionals should not be less than 8% of the institution’s health workers,and they should have an appropriate number of clinical pharmacists according to the scale of institutions.Besides,these pharmaceutical professionals should undergo standardized training.The survey shows that the number of personnel in primary medical and health institutions,especially pharmacy professionals,is not enough.What is worse,even some non-professionals (such as nursing staff) can take the place of the professionals.In addition,most pharmacy staff in primary health institutions still have the problem of low overall quality[11].Therefore,we should first increase the number of pharmacy talents by introducing more high quality professionals.Secondly,the training content of pharmacy should be increased,and we can focus on medication guidance,first aid drug training,chronic illness,pharmaceutical administration and other aspects to improve the quality of pharmacy talents and pharmacy services.

3.4 Carrying out pharmacy services with rational drug use as core

The survey reveals that pharmacy services conducted by primary medical and health institutions are limited to traditional medication guidance and other projects.As to establishing medication files for patients,regularly returning visits to intervene in the problems of irrational drug use,participating in the formulation and implementation of clinical medication programs,clinical medication monitoring,evaluation and extraordinary warning and other work for reasonable medication,it is obvious these institutions haven’t had sufficient practice.As a result,they have a high incidence of irrational drug use.For the requirements of high-quality development of pharmacy services,it is urgent to clarify the function of pharmacists in these institutions.Once the powers and responsibilities of pharmacists are clarified,pharmacy services with rational drug use can be carried out smoothly.

3.5 Limitations

The limitation of this study is that the selection of samples is based on the regional economic development level and other factors to meet the multi-stage stratified sampling principle.Therefore,it does not meet the strict national sampling survey requirements.The survey results cannot be simply extrapolated,but they can roughly reflect the current state of the construction of pharmaceutical organizations and pharmacy services in China’s primary medical and health institutions in a certain period of time.

4 Conclusions

With the continuous deepening of the reform of the medical and health system,pharmaceutical administration of primary medical and health institutions has shifted from guaranteeing drug supply to pharmaceutical technical service management[12].Patient-centered pharmacy services with rational drug use have also been carried out in an orderly manner throughout the country.However,at present,there are still some problems in primary medical and health institutions,such as the lack of pharmaceutical administration system,inadequate pharmaceutical organization,limited number and low-level of pharmacy professionals,and more traditional pharmacy services.It is recommended that the supervision function should be exerted by improving the pharmaceutical administration rules and regulations in primary medical and health institutions.The establishment of pharmaceutical administration organizations and pharmacy departments of primary medical and health institutions should be standardized to strengthen the evaluation mechanism.Besides,pharmacy professionals should be rationally allocated to these institutions with optimized pharmacy training.Lastly,pharmacy services with rational drug use should be carried out to transform and enhance the functions of primary pharmaceutical organizations and pharmacy services.