De Xianhui,An Lianyu,Wang Shuling

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

Abstract Objective To study the current status of licensed pharmacists in China,and to make suggestions for the sound development of regulation authorities and licensed pharmacists.Methods Literature review and data research were conducted to analyze the status of examinations,registration,academic qualification and professional composition of licensed pharmacists.And SWOT method was used to analyze the strengths,weaknesses,opportunities and threats for the development of licensed pharmacists.Results and Conclusion Licensed pharmacists have such advantages and opportunities as professionalism,favorable policies,and continuous expansion of market demand.However,they also face disadvantages and threats,such as low service capacity,weak service awareness and low social status.According to the results of SWOT analysis,it is suggested that the government should make use of the advantages of artificial intelligence to build a regulatory information platform and a public platform for electronic prescriptions.Meanwhile,a national accreditation agency for continuing education should be established,and academic exchanges between regional licensed pharmacists and physicians must be organized regularly.Besides,licensed pharmacists can use mobile phones and other information devices to keep abreast of national policy and new medical information.Therefore,their services will be recognized by the public,thus to protect the drug safety for the public.

Keywords:licensed pharmacist;professional qualification certificate;SWOT method;practice behavior

The development of the licensed pharmacist system in China has been more than 25 years since the release of the National Drug Safety of the 13th Five-Year Plan.With the promotion of pharmacy classification,outflow of prescriptions,chronic disease management,the increasing number of aging populations,the expansion of disease spectrum and the emergence of new drugs,the role of licensed pharmacists becomes important.Under the background of advocating the healthy China strategy,new national policy and changes in public demand for drugs have put forward new requirements for the future development of the licensed pharmacist team.Based on the literature review and data analysis,this paper expounds the status of licensed pharmacists.SWOT analysis method is used to elaborate the strengths,weaknesses,opportunities,and threats of licensed pharmacists so as to provide suggestions for the orderly and healthy development of licensed pharmacists in China.

1 Summary of licensed pharmacist policy

1.1 Changes in the meaning of licensed pharmacists

In 2019,the Professional Qualification System Regulations for Licensed Pharmacists stipulated that licensed pharmacists referred to the pharmaceutical technicians who passed national unified examination and obtained the Professional Qualification Certificate for Licensed Pharmacists of the People's Republic of China (hereinafter referred to as the Licensed Pharmacist Professional Qualification Certificate)and were registered to practice in the production,management,use,and other units that require pharmaceutical services.Compared with the old regulations in 1999,the scope of registration of licensed pharmacists was increased to other units that need pharmaceutical services,and the licensed pharmacist qualification certificate was revised to licensed pharmacist professional qualification certificate.

1.2 Development of the management system of licensed pharmacists

The first stage was from 1994 to 1999 when the qualification system for licensed pharmacists in China was formed.In 1994,the Interim Provisions on the Qualification System for Licensed Pharmacists was promulgated by the former Ministry of Personnel and the National Medicine Administration.In July 1995,the Interim Provisions on the Qualification System for Licensed Chinese Pharmacists was promulgated which marked the implementation of China's qualification system for licensed pharmacists.After 4 years,in April 1999,the Provisional Regulations on the Qualification System for Licensed Pharmacists was revised and the Implementation Measures for the Licensed Pharmacist Qualification Examination was released.Subsequently,the Methods for Qualification of Licensed Pharmacists were promulgated in September.In 2000,the original CFDA introduced such polices as Interim Measures for the Registration of Licensed Pharmacists,the Interim Measures for the Administration of Continuing Education for Licensed Pharmacists,and the Interim Provisions on the Circulation Management of Prescription Drugs and Non-prescription Drugs,which were compatible with the qualification system of licensed pharmacists,thus forming the management system of licensed pharmacist in China.

The second phase was from 2000 to 2019 when the licensed pharmacist system was perfected.In April 2000,the State Drug Administration issued the Good Supply Practice (GSP).The Ministry of Health released the GSP after revision in 2012.On May 18,2015,the State Food and Drug Administration revised the GSP.It was implemented in July 2016 and it stipulated that the legal representative of a pharmaceutical retail enterprise or the person in charge of the enterprise should have the qualification of licensed pharmacist.Enterprises shall have licensed pharmacists in accordance with relevant state regulations,and they are responsible for prescription review and guiding rational use of drugs.In 2002,the State Council issued the Regulations on the Implementation of the Drug Administration Law to provide legal basis for the licensed pharmacist system.In 2003,the former CFDA revised and implemented the Interim Measures for the Administration of Continuing Education for Licensed Pharmacists.In March 2015,the National Licensed Pharmacist Certification Center issued the Management Code for Wearing Licensed Pharmacists,and the badge design was divided into five levels.On February 21,2017,the State Council issued the 13th Five-Year National Drug Safety Plan,which clearly stated that a retail pharmacy must have a licensed pharmacist who guides the rational use of the drug.On March 2 of the same year,the State Pharmacy Administration Pharmacist Qualification Certification Center issued the Professional Pharmacist Business Practices to clarify the business activities of licensed pharmacists including prescription adjustment,medication guidance,drug treatment management,adverse drug reaction monitoring and health education,etc.Therefore,a relatively complete management system for licensed pharmacists was formed.

The third stage started from 2019 to the present which standardized the licensed pharmacist system.The State Food and Drug Administration and the Ministry of Human Resources and Social Security formulated the Provisions for the Professional Qualification System for Licensed Pharmacists and the Implementation Measures for the Professional Qualification Examination for Licensed Pharmacists which further regulated the licensed pharmacist qualification examination,registration,continuing education and other activities.These would help licensed pharmacists guide rational drug use and strengthen drug quality supervision.Therefore,a more refined licensed pharmacist system has been formed.

1.3 The importance of licensed pharmacists

The main duties of licensed pharmacists are to supervise drug quality and guide public drug safety[1]so as to reduce the occurrence of adverse reactions.According to the statistics of the State Drug Administration,in 2017,the National Adverse Drug Reaction Monitoring Network received 23.7% of new and serious adverse drug reactions/incident reports from pharmacists.Although the proportion was small,it did create a threat for the public.With the emergence of public self-medication awareness and the sale of non-prescribing medicines,it is convenient for the public to purchase medicines with the help of pharmacists.This situation highlights the importance of licensed pharmacists.Licensed pharmacists must not only undertake drug quality supervision of procurement,acceptance,storage,sales,and aftersales,but also provide pharmaceutical services to the public and guide rational drug use.Doctors,licensed pharmacists and nurses are the allies that protect public health and safety medications.

2 Status of licensed pharmacists in China

2.1 Licensed pharmacist examination

2.1.1 Examination of licensed pharmacists from 2008to 2018

It has been 21 years since on April 1,1999,when China started the Implementation Measures for the Licensed Pharmacist Qualification Examination.According to the data compiled by the National Drug Administration's Licensed Pharmacist Qualification Center,the statistical analysis of the overall status of the national licensed pharmacists from 2008 to 2018 was made.As shown in Figure 1,the number of applicants increased from 179 900 in 2008 to 687 600 in 2018,six times in 10 years,with an average number of 482 900 applicants per year.The number of applicants increased slowly from 2008 to 2011.But the number of applicants rose sharply from 2012 to 2015,reaching a peak of 1.112 4 million.One of the reasons was that in 2013 the Quality Management Standards for Pharmaceuticals was revised.Staffs in the pharmaceutical industry and related fields realized the importance of licensed pharmacists and were encouraged to take the test actively.The increase in the number of licensed pharmacists at this stage shows that the level of recognition of licensed pharmacists has increased in the pharmaceutical industry.In the past decade,the qualified rate of licensed pharmacists has averaged about 17%,with the highest rate of 29.19% in 2017,and the lowest of 11.12% in 2010.The number of applicants in 2018 fluctuated little,but the qualified rate dropped to 14.1%.The reduction in the qualified rate,to a certain extent,means the expansion of the licensed pharmacist team and the improvement of the professionalism of licensed pharmacists.

Fig.1 Examination of licensed pharmacists from 2008 to 2018

2.1.2 Status of obtaining professional qualification certificates from 2013 to 2018

The implementation of the licensed pharmacist system in China has been more than 25 years,and the number of people obtained vocational qualification certificates has increased from 279 900 in 2013 to 1.03 million in 2018.It is 3.7 times in 6 years.It can be seen that the expansion of the licensed pharmacist team is fast.According to the data of the National Licensed Pharmacist Certification Center,the number of people who obtained professional qualification certificates and the number of retail pharmacies in China from 2013 to 2018 are studied.Under the guidance of national policies,the number of people obtained professional qualifications from 2013 to 2018 increased steadily year by year.It increased fast from 2013 to 2015,reaching a peak of 56.62% in 2015.Since then,it has been in a downward trend which is related to the decrease in the number of applicants in 2016.As can be seen from Figure 2,the growth in the number of pharmacies slowed down from 2015 to 2016,with a negative growth rate in 2016.Therefore,the situation that there were too many small and numerous pharmacies was changed.

Fig.2 Number of people obtained vocational qualification certificates and number of pharmacies from 2013 to 2018

2.2 Status of licensed pharmacist registration

2.2.1 Registration of licensed pharmacists from 2008 to 2018

According to the data of the National Licensed Pharmacist Certification Center,by the end of 2018,the number of licensed pharmacists registered was 468 000.According to the National Bureau of Statistics,the total population of China at the end of 2018 was 1 395.38 million.According to the number of registered licensed pharmacists and the total population of the country,the number of licensed pharmacists per 10 000 populations is 3.4 peoples.Therefore,there is some distance for the number of licensed pharmacists per 10 000 populations stipulated by the 13th Five-Year National Drug Safety Plan in 2017.However,as shown in Figure 3,the number of licensed pharmacists per 10 000 populations is increasing in the past five years.

As shown in Figure 4,the number of people who obtained vocational qualification certificates in 2018 was 1.03 million,while the number of registered persons was only 468 000,and the registration rate was less than 50%.It can be seen that some vocational qualification certificates have not been fully utilized.This may be caused by such factors as employment filed,employment areas,and salary etc.Therefore,it is necessary for the government to introduce relevant policies to encourage people with professional qualifications to provide pharmaceutical services.As shown in Figures 4 and 5,the number of licensed pharmacists is quite different from that of hospital pharmacists from 2008 to 2015.However,after 2016,the gap has been gradually narrowed.It can be seen that the number of licensed pharmacists has increased.

Fig.3 Number of licensed pharmacists per 10 000 populations from March 2013 to 2019

Fig.4 Registration of licensed pharmacists from 2008 to 2018

Fig.5 Number of national pharmacists (s)from 2008 to 2017

2.2.2 Distribution of licensed pharmacists in the medical field

Fig.6 Distribution of licensed pharmacists registered in medical field in March 2019

According to the data of the National Licensed Pharmacist Certification Center,as shown in Figure 6,as of March 2019,429 202 licensed pharmacists registered in pharmaceutical retail enterprises,accounting for 89.5% of the total number of registrations,an increase of 3 990 over the previous month.The number of licensed pharmacists registered in pharmaceutical wholesale enterprises,pharmaceutical production enterprises,medical institutions and other filed was 34 512,3 802,11 147 and 371 respectively.Most of the licensed pharmacists work in retail pharmacies,and one store has one pharmacist.By the end of November 2018,there were still gaps between the number of registered pharmacists and the number of retail pharmacies,one was 414 000 and the other was 489 000.However,the number of licensed pharmacists registered in retail pharmacies has shown a steady upward trend under the guidance of related polices such as the 13th Five-Year National Drug Safety Plan,pharmacy classification,and medical insurance designated pharmacies.

2.2.3 Geographical distribution of licensed pharmacists registration

Due to the disparity in the level of economic development in various regions of China,most licensed pharmacists prefer to register in economically prosperous areas.The number of registered pharmacists in Northeast,Southwest,and Northwest China was 46 757,50 586,and 29 985 respectively.Therefore,the number of registered persons was relatively small compared with other three regions.However,by the end of 2016,there were 34 900 licensed pharmacists in the northeast and 73 318 in the western region (northwest and southwest),an increase of 11 767 and 7 353 respectively.

Fig.7 Geographical distribution of licensed pharmacists registration in August 2018

2.3 The qualifications and professional composition of licensed pharmacists

By the end of June 2018,the licensed pharmacists registered in retail pharmacies mainly had college degree or above,accounting for 74.8%,and 25.2%respectively.According to statistics from the Health and Welfare Committee,as shown in Figure 8,in 2016,the proportion of pharmacists in hospitals with college degree and above was 34.1%.But pharmacists with lower degree account for 65.9%.The proportion of licensed pharmacists in retail pharmacies with bachelor degree or above was slightly lower than that of hospital pharmacists.Compared with the licensed pharmacists in the United States who owned PhD,the overall qualification of Chinese pharmacists is low.In 2019,the Professional Qualification System Regulations for Licensed Pharmacists stipulated that applicants for licensed pharmacists should have junior college degrees instead of technical school degree,starting to improve the qualification of licensed pharmacists.

Fig.8 Proportion of hospital pharmacist (s)in 2016 (%)

Table 1 Licensed pharmacist qualifications

The requirements for licensed pharmacists to enter the profession in China are broad,and there are 112 885 pharmacists with other professionals in retail pharmacies.This is not conducive to ensuring the professionalism of the licensed pharmacist in their work,which may lead to uneven performance and lower their overall quality.The Provisions for Professional Qualifications of Licensed Pharmacists required that the non-pharmaceutical and non-Chinese pharmacy professionals can apply after working four years.

Table 1 Licensed pharmacist qualifications

3 SWOT analysis of the strengths and weaknesses of licensed pharmacists

The team of licensed pharmacists is indispensable in the construction of a healthy society.To develop pharmacist team,we should have an objective analysis on national economy,policy,medicine filed,the team itself,and the public.Then we can find out the strengths,weaknesses,opportunities and threats of licensed pharmacists in the context of medical reform so that we will provide recommendations for the future development of licensed pharmacists and reference for the government to make policy.

3.1 Opportunities for the development of licensed pharmacists

The first opportunity comes from the rapid development of China's economy,which means the demand for licensed pharmacists in the pharmaceutical market is huge.As China's macro economy is developing fast,the public pays more attention to health issues which stimulates the purchasing power of drugs and expands China's pharmaceutical market Second opportunity is China's policy,which leads to the expansion of licensed pharmacists.The 13th Five-Year National Drug Safety Plan and the classification of pharmacies have made clear requirements for the provisioning and capacity improvement of licensed pharmacists,which will improve the social status of licensed pharmacists.China's aging trend is obvious,and the patient population has risen sharply.According to some statistics,there are 16.65 million people over 65 years old in 2018,and the number of patients with high blood pressure and diabetes is more than 370 million.Faced with a large group of patients,licensed pharmacists will play an important role in maintaining drug quality and health guidance.Physicians have to focus on diagnosis of diseases and treatment plans and they cannot take medication counseling and pharmaceutical monitoring work into account.Therefore,pharmacists can work with physicians for drug treatment because there are too many patients in hospitals.The last opportunity come from the public drug safety requirement.As China's population structure changes and the number of patients with chronic diseases increases public's awareness of selfmedication will become more intense.While enjoying the convenience of medication,the public will also worry about the safety of medication.OTC sales methods require licensed pharmacists to reduce the occurrence of adverse reactions and provide timely medication guidance.

3.2 Threats for the development of licensed pharmacists

The first threat is that China does not have a law to protect licensed pharmacists' legitimate rights and interests[2].In recent years,the relevant policies issued by the government for licensed pharmacists are regulations,but not laws.Therefore,they are not clear about the rights and obligations of licensed pharmacists[3].The second threat is that the policy for licensed pharmacist in China is advancing slowly,and there is commercialization in pharmaceutical market.Because most hospitals in China have to rely on medicine to make profit,it is slow to promote the policy of prescription outflows.The commercialization of pharmaceutical market makes it hard for licensed pharmacists to practice in hospitals.The third threat is the strict supervision of licensed pharmacists in China.In 2019,the government started rectification of licensed pharmacists for six months by introducing regulatory measures in various provinces and cities.It means that licensed pharmacists with irregular practices will be severely punished.The fourth threat is that the public does not trust licensed pharmacists.The traditional idea of valuing doctors over pharmacists is deeply rooted in China and the public does not recognize and trust the work of licensed pharmacists.The fifth threat is the trend of implementing grading management for licensed pharmacists.On the basis of grading and classification of pharmacies,it is possible to implement the grading management of licensed pharmacists in the future and the standards will be more rigorous.Therefore,there will be a tendency for the survival of the fittest in the team of pharmacists.

3.3 Strengths for the development of licensed pharmacists

The first strength is that the government continues to make good policies.The state has started to improve the capability of licensed pharmacists,such as extending their examination period from three years to four years,and providing opportunities of internships.These are conducive to the longterm development of licensed pharmacists.The second strength is the convenience of communication between licensed pharmacists and the public.Licensed pharmacists offer the public pharmacy service directly,which is helpful to solve the public's medication problems timely.The vast majority of pharmacists work in the pharmaceutical terminals and their interaction with the public is conducive to the promotion of the professional value of licensed pharmacists.The third strength is that licensed pharmacists have a reserve of pharmaceutical expertise.Although the professional service level of licensed pharmacists needs to be improved,compared with other practitioners,they have professional advantages and can provide pharmacy services to the public.Pharmacy technicians are an indispensable team in the process of achieving China's healthy strategy.

3.4 Weaknesses for the development of licensed pharmacists

The first weakness is that there are differences in the level of licensed pharmacists in various regions.Due to the different access conditions and academic composition,pharmacists' professional level and service capacity are uneven and they are closely related to the specific regional development imbalance[4].The second weakness is that some licensed pharmacists do not have a strong sense of professional responsibility[5].Some pharmacists have shifted their duties,and there is still a gap in the number of licensed pharmacists.The third weakness is that some retail pharmacies pay more attention to profits when they hire licensed pharmacists,which means that they want licensed pharmacists to focus on sales instead of pharmacy services.The fourth weakness is that some licensed pharmacists are not active to update knowledge.Therefore,it is not conducive for them to guide the public to use drugs rationally.The fifth weakness is that the public has low recognition of licensed pharmacists[6].Compared with doctors and nurses,licensed pharmacists are not popular in the public because there is a misunderstanding of the role of licensed pharmacists.Many people think that licensed pharmacists are selling drugs.See Table 3 for details.

4 Suggestions on the development of licensed pharmacists

Based on the results of the SWOT analysis of the licensed pharmacist team,we can provide some recommendations for the development of licensed pharmacists.

Table 3 SWOT analysis of licensed pharmacists

4.1 WT suggestions—the government should build information platform for pharmacist management

First,with regard to the allocation of licensed pharmacists,the government should not blindly copy the American model.American prescription drugs are sold in pharmacies,so professional pharmacists are needed in the pharmacies.In China,90% of prescription drugs are sold in hospitals,which means licensed pharmacists in pharmacies have no prescription opportunities.Therefore,the government must vigorously promote the policy of prescription outflows.First,it should solve the problem of the stakeholders involved in the outflow of prescription.Then a public electronic prescription platform can be established so that pharmacies with conditions and qualifications will download prescriptions from the platform,and licensed pharmacists can provide medication guidance to patients.For prescription drugs,remote consultation can help if there is no hospital prescription.To have remote prescription and remote review,relevant regulations should be formulated to supervise it.For special prescription drugs,such as blood products,narcotics,etc.,pharmacist should give the patient a face-to-face consultation.Second,as to improving the ability of licensed pharmacists,the government should establish a unified national qualification system so that licensed pharmacists can continue their education.In addition practical and applied courses should be provided in the continuing education as soon as possible to strengthen the ability of licensed pharmacists.Meanwhile,the government can also provide some free foreign continuing education platforms.Licensed pharmacists can choose learning content according to their needs,or conduct academic experience exchange meetings to learn from each other.Third,as to strengthening the professional ethics of licensed pharmacists,provincial administrative departments should regularly conduct policy and professional ethics education activities for licensed pharmacists so that they can recognize their social responsibilities.Fourth,in the era of Internet and mobile communication,the government can transform the traditional supervision mode to realize efficient and real-time information supervision.For instance,they can use remote monitoring equipment to supervise licensed pharmacists' work in real time.As the supervision is becoming stricter,we should accelerate the promotion of favorable policies and provide financial support.For example,we can further motivate licensed pharmacist by refining their professional titles.This will realize the coordination between stricter supervision and favorable policy.Fifth,the state can clarify the responsibility of licensed pharmacists through legislation,which will protect the rights of licensed pharmacists and improve their social status as well.

4.2 SO suggestions—licensed pharmacists and licensed physicians should be organized to have academic exchange activities

First,the government can make full use of the national examination policy dividends to motivate more people to join the team of pharmaceutical technicians.Second,licensed pharmacists can use the convenience of working at the drug circulation terminal to participate in continuing education and field training,which will help them win public recognition and matching treatment.Third,local drug regulatory bureaus and other institutions can organize academic exchange activities between licensed pharmacists and physicians to establish a good cooperative relationship.Therefore,pharmacists can learn the clinical experience of physicians and communicate with them timely in prescription reviews,which can not only standardize prescriptions,but also ensure public medication safety.

4.3 ST suggestions—licensed pharmacists can make full use of information devices such as mobile phones to keep abreast of policy trends

First,licensed pharmacists can take advantage of information equipment,such as mobile phones,to surf some pharmaceutical WeChat public numbers or medical websites so that they can keep abreast of national policies.As the national supervision is becoming strict,pharmacists should take the initiative to conduct self-inspection as soon as possible.Second,licensed pharmacists should have a sense of crisis because there are cases of survival of the fittest in every industry.Updating their knowledge constantly,and timely understanding the pharmacological effects and adverse reactions,pharmacists can meet the public's demand for safe medication.Third,the government and licensed pharmacists should take the initiative to change the current situation.According to the changing needs of the industry and the public,they can continue to develop and break through the current status of one standard management for licensed pharmacists.They should formulate professional qualification evaluation standards,team management norms,and urban and rural differentiated allocation as well as the way to improving their ability and career development path.

4.4 WO suggestions—licensed pharmacists must provide drug treatment services to gain public trust

First,licensed pharmacists should be aware of their own deficiencies,and constantly improve the service level and quality to prevent them from falling behind.Second,licensed pharmacists should enhance their service awareness and pay attention to drug treatment management.They must collect information on drugs,diseases,and patient records.Then they can analyze and evaluate the cases from such aspects as indications,effectiveness,safety and compliance.Finally they can formulate plans for patients' disease index detection,drug treatment intervention changes.Patients' medication record and drug programs for chronic disease management will be made to carry out the follow-up work.Third,the enthusiasm and good communication of licensed pharmacists to patients is the basis for winning the trust of patients.The practicing ability of pharmacists is the prerequisite for winning social trust.Fourth,as to the problem of insufficient number of licensed pharmacists,the government may formulate incentive policies to encourage qualified personnel to take the exams.Fifth,as to the low public awareness,relevant institutions can produce promotional videos,brochures to increase public awareness of licensed pharmacists.In the future,licensed pharmacists will be as popular as doctors.See Table 4 for details.

Table 4 Suggestions for the development of licensed pharmacists

Through SWOT analysis of the strengths,weaknesses,opportunities and threats of licensed pharmacists,we can see that licensed pharmacists should face their own capabilities and career orientation.With the help of the favorable national policies,they can improve their level of service and have a correct outlook on occupation to ensure the public safety medication.The healthy development of the licensed pharmacist team is also inseparable from the cooperation of the government,pharmaceutical market,the public and licensed pharmacists themselves.We are looking forward to building a team of licensed pharmacists for the public soon.