licensed pharmacist system in china

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41 17 Licensed Pharmacist System in China /Asian Journal of Social Pharmacy,2007,2(2) Licensed Pharmacist System in China HUANG Shi-xi (Alliant International University, San Diego 10455, USA) Abstract Objective To review the development and practice of licensed pharmacist system in China and provide ideas for its reform. Method Methods of literature analysis were adopted to describe the history and practice of licensed pharmacist system in China. Results and Conclusion The future of licensed pharmacist system in China is promising. Licensed pharmacists will play a much important role in delivering medication and pharmaceutical care. Keywords: licensed pharmacist; system; management 中國執業藥師資格制度簡介 黃熙熙 (Alliant國際大學, 聖地亞哥 10455, 美國) 摘要:目的 瞭解中國執業藥師制度的歷史和現狀,為其改革提供思路。 方法 通過採用文獻分析,描述了中國 執業藥師制度的歷史和現狀。 結果與結論 執業藥師制度前景光明。隨著制度的深入推行,執業藥師將會在提 供優良藥品和藥學服務的過程中發揮更大的作用。 關鍵詞:執業藥師;制度;管理 The licensed pharmacist system in China has been implemented for 13 years since its first establishment in 1994. During these 13 years, this system has developed tremendously through continuous reform and exploration. This paper gives a brief introduction of the licensed pharmacist system in China. 1 The history of licensed pharmacist system in China The first development stage of licensed pharmacist Author’s information:HUANG Xi-xi,Alliant International University. Major research areas:administration and finance.Tel:1-858-729-3526. E-mail:[email protected] system in China was from 1994 to 1998. As a response to the central government’s policy of implementing two certificate systems (i.e., academic certificate and occupational qualification) and the availability of standards for various occupational qualifications and corresponding recruitments in November 1993, the Provisional Regulation of Licensed Pharmacist was promulgated by the State Medicine Administration and Ministry of Personnel in March 1994. One thousand qualified pharmacists were licensed in the same year, indicating the initiation of the system in the area of Western medicine. In July 1995, the Provisional Regulation of Licensed Pharmacist for traditional Chinese medicine was promulga-

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Page 1: Licensed Pharmacist System in China

17 4117

Licensed Pharmacist System in China/Asian Journal of Social Pharmacy,2007,2(2)

Licensed Pharmacist System in ChinaHUANG Shi-xi

(Alliant International University, San Diego 10455, USA)

Abstract

Objective To review the development and practice of licensed pharmacist system in China and provide ideas for its reform. Method

Methods of literature analysis were adopted to describe the history and practice of licensed pharmacist system in China. Results and

Conclusion The future of licensed pharmacist system in China is promising. Licensed pharmacists will play a much important role in

delivering medication and pharmaceutical care.

Keywords: licensed pharmacist; system; management

中國執業藥師資格制度簡介

黃熙熙

(Alliant國際大學, 聖地亞哥 10455, 美國)

摘要:目的 瞭解中國執業藥師制度的歷史和現狀,為其改革提供思路。方法 通過採用文獻分析,描述了中國

執業藥師制度的歷史和現狀。結果與結論 執業藥師制度前景光明。隨著制度的深入推行,執業藥師將會在提

供優良藥品和藥學服務的過程中發揮更大的作用。

關鍵詞:執業藥師;制度;管理

The licensed pharmacist system in China has been implemented for 13 years since its first establishment in 1994. During these 13 years, this system has developed tremendously through continuous reform and exploration. This paper gives a brief introduction of the licensed pharmacist system in China.

1 The history of licensed pharmacist system in China

The first development stage of licensed pharmacist

Author’s information:HUANG Xi-xi,Alliant International University.Major research areas:administration and finance.Tel:1-858-729-3526.E-mail:[email protected]

system in China was from 1994 to 1998. As a response to the central government’s policy of implementing two certificate systems (i.e., academic certificate and occupational qualification) and the availability of standards for various occupational qualifications and corresponding recruitments in November 1993, the Provisional Regulation of Licensed Pharmacist was promulgated by the State Medicine Administration and Ministry of Personnel in March 1994. One thousand qualified pharmacists were licensed in the same year, indicating the initiation of the system in the area of Western medicine. In July 1995, the Provisional Regulation of Licensed Pharmacist for traditional Chinese medicine was promulga-

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Licensed Pharmacist System in China/Asian Journal of Social Pharmacy,2007,2(2)

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ted by the State Administration of Traditional Chinese Medicine and Ministry of Personnel. A total of 434 licensed pharmacists were designated in the same year, signifying the implementation of the system in both Western and traditional Chinese medicines. The first license qualification examination for Western medicine practitioners was conducted in October 1995; the first examination for traditional Chinese medicine practitioners was given in October 1996. In January 1997, Chinese government officially brought forward the licensed pharmacist system in China. In this stage, the policy was put in force only among practitioners working in the manufacturing and distribution sectors. Little effort was exerted to implement the function of licensed pharmacists and the number of licensed pharmacists increased slowly. However, this stage laid a solid foundation for the future development of the system. The State Council undertook a fundamental reform in 1998. As a result, the State Drug Administration (SDA), an integrated drug supervisory and administrative department, was finally established in order to enforce the supervision and regulation of drugs. SDA was empowered with the authority to implement the licensed pharmacist system. This was a milestone in the development of China’s pharmacist management system which became an important component of drug supervisory and administrative system of China. In April 1999, the revised edition of the Provisional Regulation of Licensed Pharmacist was promulgated by the newly founded SDA and the Ministry of Personnel. According to this new edition of the regulation, the licensed pharmacist system was also applied to practitioners in medical institutions and the two management systems for Western and traditional Chinese medicines were combined into one system using uniform policy, curriculum, examination, registration, and management and classified practice. Furthermore, additional regulation items on registration and continuing education were enacted. In the same year, the requirement of minimum working period for licensed pharmacists was relaxed and the examination cycle was changed from once a year to once every two years. The new examination arrangement was more appropriate and reasonable. In October 1999, prescription and non-prescription classif icat ion system was carried out in selected

demonstration chain drugstores in several big cities like Beijing, Guangzhou, and Nanjing. This practice sent out a strong and definite signal that this new model of drug management would soon be implemented in China. This policy created a great demand for licensed pharmacists to ensure the quality of drug and conduct pharmaceutical care. It was a main driving force for increased number of pharmacists in a short period after its implementation. In January 2000, the Provisional Regulation of Trading Administration of Prescription and Non-prescription Drugs was released which stipulated that employment of licensed pharmacists was one of the most important conditions for drugstores to sell prescription drugs and non-prescription drugs of the first category. In addition, pharmacists in the store needed to fulfill duties required by the regulation. Later on, there were similar personnel requirements in Good Supplying Practice (GSP) which also gave an impetus to the demand for licensed pharmacists in China. In August 2001, SDA issued a 2004-2005 work plan for carrying out national licensed pharmacist management, which further reinforced the implementation of pharmacist policy in the settings of drug manufacturing, distribution and utilization, and set down specific measures for accelerating the increase of pharmacists. In September 2001, the Qualification Accreditation Center of SDA developed a software program for improving the efficiency of pharmacist registration. In July 2002, in order to improve the Compendium of Licensed Pharmacist Examination SDA released a new version in which some contents were revised and enriched to address the changing requirements of pharmacists’ knowledge, skills and competence for their practice. In September 2002, the Implementing Ordinance of Drug Administration Law went into effect which stipulated that employment of licensed pharmacists was one of the prerequisites for drug retailing enterprises that sell prescription drugs and non-prescription drugs of the first category. This was the first time that licensed pharmacists’ status and function were recognized in the form of law, which made the importance of pharmacists become much greater than before. Since 2002, those pharmacists who met specific requirements could participate in the one-subject examination. This policy, laid in 2001, was welcomed and

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highly praised by pharmaceutical professionals. It greatly motivated their enthusiasm in taking part in the qualification examination. China Licensed Pharmacist Association (CLPA) was established in February 2003. As a national academic organization of pharmacists, CLPA’s mission is to safeguard rights and interests, implement self-discipline, offer services and conduct coordination. In December 2003, the Journal of China Licensed Pharmacists sponsored by CLPA started publication. CLPA also hosts the China Licensed Pharmacist Forum (CLPF). With China’s affiliation to the World Trade Organization, the innovation of administrative and inspection system of Chinese government, the formation of market economy and the legislation of the licensed pharmacist system, CLPA would play a much more important role. In 2003, CLPA launched a long-distance continuing education system which is pharmacist-oriented and authorized by the State Food and Drug Administration (SFDA). Furthermore, CLPA promulgated the Required and Elective Courses of Licensed Pharmacist Continuing Education (2003 Edition) in May 2003. SFDA revised and released a new version of the Temporary Provisions of Continuing Education for Licensed Pharmacists in November 2003. From August 2000 to November 2001, three research groups comprised of experts were organized by SDA to translate foreign laws and regulation of licensed pharmacists, compare different licensed pharmacist systems, and review the licensed pharmacist management in China. Based on this work, the Law of Chinese Licensed Pharmacists was drafted and then submitted to the State Council in October 2003. Although this law was not released yet, the effort had an influence on the increase of licensed pharmacists so much that there were 14,174 new licensed pharmacists in 2006 and the total number reached 143,681 by the end of 2006.

2 Licensed pharmacists’ practice in China

Although the total number of licensed pharmacists reached 143,681, on average, there was only 1 licensed pharmacist per 13,000 people in China while the ratio attained 1:800-1500 in many Western countries. There was big shortage of licensed pharmacists in pharmacy practice.

Some experts estimated that there should be 1,000,000 licensed pharmacists to meet the needs in the future. The distribution of pharmacists in different sectors and regions was unbalanced. Eighty percent of pharmacists worked in the manufacturing sector and hospitals, while less than 10 percent in community pharmacies; 70 percent of pharmacists were in East China and only 30 percent in West China[1]. Nowadays, community pharmacies are becoming the most accessible primary health care facilities. From 2001 to 2004, a transitional policy implemented by SDA allowed Practicing Pharmacists to take the responsibility of licensed pharmacists to safeguard the quality of drug and pharmaceutical care because of shortage of licensed pharmacists in community pharmacies. During those years, patients received drugs and services from both practicing pharmacists and licensed pharmacists. The key to this problem is to increase the number of licensed pharmacists quickly and to ensure the monopoly of their function. In those community pharmacies employing pharmacists, pharmaceutical care is not well provided by pharmacists. Their major practice is still dispensing drugs to patients without conducting other services. The lack of appreciation for pharmaceutical services by health professionals, patients and health authorities is a major barrier to changing the pharmacists’ role or practice in community pharmacies. Some problems do exist in our services. First, nearly 80 percent of patients get their medication from hospitals. Community pharmacies dispense fewer prescriptions because hospitals are unwilling to lose their economic interest from drug sales. Under current health care system, most licensed pharmacists prefer working in hospital pharmacies than in community pharmacies, and community pharmacies practice in China is usually restricted to dispensing drugs. Pharmaceutical service is rarely provided because it is not profitable. In addition, licensed pharmacists in hospitals are not given adequate recognition for the reason that this policy is established by SDA rather than Ministry of Health. It’s necessary to better implement licensed pharmacist system in hospitals to encourage licensed pharmacists to change their work from the traditional model to the pharmaceutical care model. Second, people’s self-care consciousness is not well-established. The majority of customers know little or do not

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know about licensed pharmacists’ duties and responsibility at all. Pharmaceutical service is just a concept among professionals which is not known by the public. There is still a long way to go to enhance people’s awareness of self-medication and the function of licensed pharmacists. 3 Conclusion

The future of licensed pharmacist system in China is

promising. Licensed pharmacists will play a much important role in delivering medication and pharmaceutical care.

Reference

[1]FANG Yu, HUANG Tai-kang, YANG Shi-min. Licensed pharmacists’

practice in community pharmacy in China. Asian Journal of Social

Pharmacy, 2006,1(1):1-3.