INTERNATIONAL PHARMACY EDUCATION SUPPLEMENT Clinical Pharmacy Education in China

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1 INTERNATIONAL PHARMACY EDUCATION SUPPLEMENT Clinical Pharmacy Eucation in China Meloy Ryan, PharmD, MPH, a Hong Shao, PhD, b Li Yang, MS, c Xiao-Yan Nie, MS, b Suo-Di Zhai, BS, c Lu-Wen Shi, MS, b an William C. Lubawy, PhD a a University of Kentucky College of Pharmacy b Peking University School of Pharmaceutical Sciences, Beijing, China c Peking University Thir Hospital, Beijing, China Submitte February 2, 2008; accepte June 25, 2008; publishe December 15, Pharmacy eucation in China focuses on pharmaceutical sciences, with the bachelor of science (BS) of pharmacy as the entry-level egree. Pharmacy practice curricula in these programs are centere on compouning, ispensing, pharmacy aministration, an laboratory experiences, which are the traitional responsibilities for pharmacists. Aitional grauate-level training is available at the master of science (MS) an the octor of philosophy (PhD) levels, most of which concentrate on rug iscovery an rug evelopment research. Presently, the emphasis in practice is beginning to shift to clinical pharmacy. With this change, aitional egree offerings are being evelope to meet the growing eman for clinical pharmacists. There is also interest in eveloping more clinical skills in practicing pharmacists through aitional non-egree training. The Ministry of Eucation is consiering a proposal for an entry-level professional egree of master an/or octor in clinical pharmacy similar to the octor of pharmacy (PharmD) egree in the Unite States. Keywors: China, international pharmacy eucation, clinical pharmacy EDUCATIONAL PROGRAM DESCRIPTION Moern higher eucation in pharmacy in China began in the Qing Dynasty in Before the establishment of the People s Republic of China in 1949, there were 8 schools an universities offering pharmacy programs an egrees. 1 In 1955, the first university to recruit postgrauate pharmacy stuents in the People s Republic of China was Beijing Meical College (currently known as Peking University Health Science Center). 2 Toay, there are more than 257 pharmacy schools an universities that offer the BS egree an higher egrees throughout China. In 2005, more than 6,000 grauates receive BS egrees, 800 receive MS egrees, an 290 receive PhD egrees in pharmacy. 3 Traitionally, stuents receive a BS egree as an entry-level pharmacy egree. Stuents holing a BS egree can earn an MS egree in 3 years or a PhD in 5 years. Stuents with an MS egree can work towar a PhD with an aitional 3 years of stuy. In China, there is a system by which isciplines are catalogue into first or secon levels. First levels are similar to majors in the US, while secon levels are the equivalent of minors or areas of Corresponing Author: Hong Shao, PhD, School of Pharmaceutical Sciences Peking University, No. 38 Xueyuan R., Haiian District, Beijing, P.R. China Tel: Fax: h_shao@163.com 1 concentration within a major. Another route to pharmacy eucation is through bachelor or master egrees in meical sciences (BM or MM, respectively). These stuents eclare their first level as meical sciences an their secon level as clinical pharmacy. They are eligible for licensure as a pharmacist; however, they cannot practice meicine. Clinical pharmacy eucation in China has evelope only recently. Perhaps, because there is no stanarization of curricula, there are a variety of egrees offere from various programs (Table 1). BS egrees in pharmacy or meicine, MS egrees in pharmacy or meicine, an PhD egrees in pharmacy can all have components of clinical pharmacy. From 1989 to 1999, the West China School of Pharmacy at Sichuan University offere the first 5-year clinical pharmacy BS egree. Since 2000, the Ministry of Eucation has allowe only pharmaceutical sciences as a first-level iscipline for BS egrees. Stuents wishing to stuy clinical pharmacy at the bachelor s level may select clinical pharmacy as a secon-level area of concentration uner pharmaceutical sciences. As an exception, in 2008 China Pharmaceutical University was allowe to offer a firstlevel, 5-year BS egree in clinical pharmacy. Peking University evelope a 6-year continuous or ual egree BS/MS program in clinical pharmacy in 2001 an is the only university in China to offer such a egree.

2 Table 1. Clinical Pharmacy Eucational Offerings in China University Length of Program Degree(s) Aware Anhui Meical University 5 BM a Beijing University Chinese Meicine Binzhou Meical University 4 BS c China Meical University 5 BM a China Pharmaceutical University 5 BS Chongqing Meical University 4 BS c Dalian Meical University 5 BM a Fuan University 4 BS c 3 b MS c Fujian Meical University 4 BS c Guangong Pharmaceutical 4 BS c University Harbin Meical University 5 BM a Hebei Meical University 3 b MS c Huazhong University of 4 BS c Science an Technology Jilin University 3 b MS c Jinzhou Meical University 3 b MS c Nanchang University 4 BM a Peking University 6 MS 3 b /5 MS/PhD Secon Military Meical 4 BS c University Sichuan University 4 BS c Shanong University 7 MM e Shanghai Jiaotong University 3 b MS a Shenyang Pharmaceutical University 4 BS c Sun Yat-Sen University 3 b MS c Taishan Meical University 5 BS c Wuhan University 5 BM a Yangzhou University 4 BM a Abbreviations: BS5bachelor of science; MS5master of science; PhD5octor of philosophy; BM5bachelor of meical sciences; MM5master of meical sciences a Clinical pharmacy is a subspecialty of meical sciences in these programs b Caniates must hol a BS egree for the 3-year MS or a MS egree for the 3-year PhD c Clinical pharmacy is a subspecialty of pharmaceutical sciences (BS), or pharmaceutics, pharmacology, an pharmacognosy etc. (MS), not an inepenent specialty in these programs Caniates must hol a BS egree for the 5-year PhD e Clinical pharmacy is a specialty of meical sciences in this program 2 In 2007, the first 15 MS stuents grauate from this program at Peking University, the largest number of clinical pharmacy grauates in 1 year in China. In 2003, Peking University was permitte by the Ministry of Eucation to offer a 3-year post-baccalaureate MS in clinical pharmacy. 4 Shortly thereafter, programs were approve at 3 other universities (Sichuan University, China Pharmaceutical University, an Shenyang Pharmaceutical University). 3 Shanong University has another interesting egree option, the master of meicine in clinical pharmacy egree. In this program stuents complete a 7-year program in meicine after grauation from high school with a concentration in clinical pharmacy. From 2005 to 2007, 4 universities (Peking University, Sichuan University, China Pharmaceutical University, an Shenyang Pharmaceutical University) began to recruit caniates for a PhD egree in clinical pharmacy. The first grauates from these programs are expecte in late There are 2 possible routes for attaining/obtaining the PhD in clinical pharmacy: after grauating from a BS program, the stuent completes a 5-year PhD program; or after grauation from an MS program in clinical pharmacy or a relate pharmacy area, the stuent completes a 3-year PhD program. Applicants an Amission Criteria In China, stuents are amitte irectly to pharmacy programs from high school. There is no centralize ata repository to inicate the number of pharmacy applicants in China. However, in 2007, 10 million qualifie applicants applie for some type of higher eucation; of these, 5.67 million stuents were accepte into schools or universities. In 2005, more than 42,000 stuents entere a BS program in a pharmacy school. About 4,700 stuents began MS coursework, an of these, about 30 entere MS in clinical pharmacy programs. 3 All stuents intereste in higher eucation take a stanarize college entrance examination uring their final year of high school. Each college of pharmacy establishes a minimum examination score for amission. Stuents are amitte solely on the basis of these stanarize entrance examination scores. Curriculum BS stuents complete 4-5 years of unergrauate training, but there are no stanarize curricula or accreitation requirements for these programs. Courses inclue a mix of basic science (such as mathematics, physics, inorganic an organic chemistry, an philosophy), avance chemistry (such as analytical chemistry an meicinal chemistry), an basic pharmacy (such as pharmacognosy, pharmacology, pharmaceutics, pharmacokinetics, an pharmacy aministration). Some institutions also offer what are consiere biomeical courses, which may inclue introuctory iscussions of pathology an special populations of patients (ie, peiatrics, geriatrics). Stuents are traine

3 in the use of both Western an traitional Chinese meicines. For those stuents stuying hospital pharmacy, pharmacy practice is usually confine to a 6-month experience in a hospital pharmacy epartment. Other stuents may unertake research projects uner faculty supervision uring the final portion of the curriculum. While the curricula for clinical pharmacy programs are wiely variable, 3 curricular examples are offere in Table 2. A etaile escription of the curriculum for the ual egree 6-year BS/MS in clinical pharmacy program at Peking University follows. The curriculum is broken into 2 parts. The first part consists of a core unergrauate eucation as escribe above, as well as basic meical sciences courses (such as biochemistry, pathology, physiology, biology, immunology, anatomy an pathophysiology). This portion of the program is complete in 3.5 years. In orer to enter the secon part of the ual BS/MS in clinical pharmacy, stuents must pass all courses an successfully complete a grauate level English examination. The secon part of the egree program inclues courses in avance clinical pharmacy, pharmacy informatics, pharmacoeconomics, pharmacogenetics, introuction to pharmacy practice, an applie pharmacy policy, etc. In aition to these iactic experiences, stuents also have 2 courses combining iactic an experiential training. One is the primary pharmacy practice course that provies stuents with a general familiarity with the hospital pharmacy epartment, pharmacy aministration, the rug elivery system, therapeutic rug monitoring, an laboratory research. The secon course is a clinical meical theory an practice course in the areas of iagnosis, internal meicine, surgery, obstetrics an gynecology, peiatrics, respiratory, cariovascular, an gastrointestinal meicine. During this secon course of training, physicians serve as preceptors for the stuents. Stuents usually have half-ay meical courses in iagnostics, internal meicine, surgery, gynecology an obstetrics, an peiatrics taught by senior physicians. The other half of the ay is spent in a selecte clinical area learning the general meical routine an in small group problem-base learning activities. In the final 2 experiential months, stuents spen 2-3 weeks in various specialty areas of practice. Uner the supervision of both a physician an a clinical pharmacist, stuents participate in patient care rouns, review meication orers, perform therapeutic rug monitoring, an supply rug information to patients an other health care practitioners uring this time. Aitionally, they have final written examinations an oral practice examinations to evaluate their knowlege base. In the concluing 1.5 years (uring the secon part of training), stuents continue clinical learning in a specialize area of pharmacy practice an complete a research 3 project uner the supervision of pharmacy faculty members who may co-supervise stuents with a physician. Stuents ientify a clinical problem for laboratory work, culminating in a thesis project. Each thesis has 2 parts: clinical pharmacy practice an research. The thesis is juge on stuents creativity an the ability to solve problems from clinical practice. Following completion of this work, a thesis efense, an publication of the project in a major Chinese journal, stuents receive the MS in clinical pharmacy. The curricula for the postgrauate MS in clinical pharmacy egree vary wiely across the schools that offer this egree. For example, at Peking University, the curriculum is the same as that for the secon part of training in the 6-year entry-level pharmacy program, with aitional general eucation courses such as political science, ialectic (logic), statistics, an English. Stuents who pursue a clinical pharmacy PhD must spen a large portion of their program in laboratory research. These stuents are well groune in basic sciences, but often lack practice research, which is a recognize eficiency. At the present time, PhD training is not conucive to practice in clinical pharmacy, but may be the path to a university faculty appointment or a research position in the pharmaceutical inustry. Clinical Program Strengths In most pharmacy schools an universities in China, physicians are responsible for part of the clinical training of stuents pursing a BS, MS, or PhD egree in clinical pharmacy, serving as their co-avisor. Stuents become familiar with the working methos an moels use by physicians. This helps the stuents apply analytical processes to the clinical care of patients an fosters skills important to eveloping a goo working relationship with physicians. The senior clinical pharmacist serving as an avisor is responsible for helping stuents unerstan how to solve meication problems an apply analytical skills to clinical problems, an evelop skills for communicating with other healthcare practitioners, patients, an patients families. A pharmacy faculty member serves as a supervisor for MS an PhD clinical pharmacy stuents an is responsible for approving the subject an content of stuents theses an arranging for clinical experiences. Chinese pharmacy stuents gain a thorough knowlege of laboratory proceures an the scientific metho. The requirement of publishing a paper, as well as presenting an oral efense of the thesis or issertation project, ensures evelopment of writing an public speaking skills. The publication requirement also ensures peer review of the stuent s research by a wier auience.

4 Table 2. Example Clinical Curricula for Three Chinese Universities Course Type Public basic sciences Basic meical sciences Basic pharmacy Clinical meical sciences Clinical pharmacy Practice Sichuan University (5 yrs*) Guangong Pharmaceutical University (4 yrs) Shanong University (5 yrs) English; politics; philosophy; athletics; mathematics; computer science; chemistry (inorganic, organic, analytic, laboratory) physics; law; physical chemistry meical statistics; biochemistry; microbiology; immunology; human anatomy; physiology histology an embryology; cytobiology cytobiology; molecular pathophysiology biology; laboratory animals; meical psychology; histology an embryology; pathophysiology; genetics; functional laboratory; meical ethnics pharmacology; rug chemistry; rug analysis; pharmacy informatics; pharmacy aministration; pharmaceutics latin; research metho an esign; biopharmaceutics basic iagnostics; general surgery; internal meicine; peiatrics; obstetrics an gynecology; ermatology; otolaryngology; epiemiology; ophthalmology; neurology; psychiatry clinical pharmacology clinical pharmacokinetics; hospital pharmacy aministration; pharmacothrapeutics half-year clinic practice; half-year hospital pharmacy practice meicinal botany an pharmacognosy; natural rug chemistry; pharmacokinetics an biopharmaceutics general clinical meicine half-year hospital pharmacy practice traitional Chinese meicine; new rug esign; biopharmaceutics an pharmacokinetics; toxicology meical imaging; iagnostics; internal meicine; surgery; gynecology; peiatrics; infectious iseases; ermatology an venereal iseases; psychiatry clinical rug evaluation; rug-relate iseases an prevention; rug economics; rug epiemiology; pharmacotherapeutics one-year clinic an pharmacy practice; halfyear specialty practice a This is a past length of program in Sichuan University (West China School of Pharmacy). It was a representative program in Chinese clinical pharmacy before 2000 Assessment Teaching is assesse by 3 methos at many institutions: stuent, peer, an Ministry of Eucation evaluation. Stuent evaluation is conucte by survey methos. The peer evaluation usually takes the form of other faculty observing an assessing lectures for the faculty member being evaluate. Stuent an peer evaluations are not 4 uniformly conucte at all universities. The Ministry of Eucation also conucts a perioic review of course ocuments, observation of teaching, an iscussions of teaching quality with stuents. Competency- an ability-base eucational outcome assessments are still in evelopment for most programs in China. The majority of the BS programs in clinical

5 pharmacy have not been assesse systematically. Curricula for BS caniates in the clinical pharmacy concentration are not competency or abilities base uring the majority of the program. In the final year, limite abilities-base practice courses in hospitals are offere at some schools an universities. Curricula for MS in clinical pharmacy programs are graually eveloping competency- an abilities-base outcomes. At Peking University, some problem-base learning is often use in iactic settings an many institutions use oral an/or practice skills examinations uring experiential training. Accreitation At this time, there is no inepenent accreitation boy for pharmacy eucation in China. Instea, all national higher eucation institutions in China are evaluate an approve by the Ministry of Eucation every 5 years. This evaluation was first implemente in In an attempt to stanarize curricula in various universities an schools, the Ministry of Health is now eveloping unifie teaching materials for health care higher eucation. LICENSURE China first implemente a system of licensure for pharmacists in The Department of Human Resources in conjunction with various branches of the State Foo an Drug Aministration (SFDA), Peoples Republic of China, have istribute License Pharmacist Qualification System Temporary Rules an subsequently License Chinese Meicine Pharmacist Qualification System Temporary Rules. The SFDA is the governing boy that is charge with oversight of the licensing examination, registration of license pharmacists, an continuing eucation require for license pharmacists. 5 Passing the licensure examination is not require for all areas of pharmacy practice an the passing rate of examination is often low (12.83% in 2004, 18.18% in 2005, an 16.69% in 2006). 6 Some fiels such as pharmaceutical manufacturing, inustry, an management, as well as hospital pharmacies, clinic pharmacies, an community pharmacies, require at least 1 license pharmacist. However, in these situations, the license pharmacist may be in a supervisory role over unlicense pharmacists. 5 PRACTICE To meet social, economic, an evelopment goals for China, the national population shoul not excee 1.4 billion before If China attempts to meet the current US ratio of 1 pharmacist for 1500 people, 939,000 pharmacists will be require. A more moest goal of 1 pharmacist per 5000 people requires 280,000 pharmacists. 5 However, the annual number of pharmacy grauates has been approximately 10,000, which cannot meet the country s nees. 4 In orer to aress this eficiency, in August 2001, a 5-year plan was promulgate to increase the number of license pharmacists. 4 In the past, the major responsibilities of pharmacists were stocking, istributing, an ispensing meications. At this time, pharmacists o not have prescriptive authority. The public s concept of a pharmacist is generally associate with professionals working in the pharmacy epartment of hospitals an community pharmacies. Each year, almost all new pharmacists entere this traitional type of pharmacy practice. Of approximately 300,000 pharmacy grauates from 1949 to 1998, 156,000 (52%) worke in hospital pharmacies, 62,000 (21%) worke in the pharmaceutical inustry, an 27,000 (9%) worke in wholesale or community pharmacies. 5 As China s economy has evelope, the employment of pharmacy grauates has funamentally change. Currently, pharmacy grauates work in hospitals, community pharmacies, the insurance inustry, long-term care, pharmaceutical manufacturing, an research institutes. Fuan University School of Pharmacy surveye BS stuents grauating between 1996 an Their finings emonstrate a shift in employment from the previous stuy. 5 The majority (45.2%) of more recent grauates worke in research an evelopment; 28.8% became pharmaceutical manufactures representatives; an 15.4% entere hospital pharmacy. Grauates with traitional MS an PhD egrees plan to work in research an evelopment (76.5%), meication regulation (10.0%), clinical trials (4.3%), or as pharmaceutical manufacturers representatives (4.3%). The most severe shortage of pharmacists in China is in pharmacists with a clinical backgroun. Traitional pharmacy eucation emphasizes pharmaceutical sciences over clinical pharmacy. Although the eucation of clinical pharmacists began in a limite fashion in the early 1990s, there are few qualifie professional clinical pharmacists in China. A large number of the early clinical pharmacy grauates took ispensing positions in hospital pharmacies, marketing or research positions in the pharmaceutical inustry, or teaching or research positions in acaemia. Even now, the number of clinical pharmacy grauates annually is limite. Therefore, there are not sufficient clinical pharmacists or new grauates to meet the increasing eman. 8 Hospital pharmacy practice is changing from rugcentere to patient-centere, an the primary focus for hospital pharmacy is changing from rug supply to

6 pharmaceutical care. Thus, the pharmacist s activities are changing from rug ispensing an compouning to rational rug use an patient care. This kin of transformation has attracte outstaning pharmacy grauates, incluing those with avance egrees, to seek employment in hospitals. For grauates with an MS egree in clinical pharmacy, there are many clinical opportunities available incluing clinical pharmacology, clinical practice, patient management, pharmacy aministration, an laboratory research in hospitals, community pharmacies, pharmacy research institutes, pharmaceutical inustries, an government offices. Bachelor of science grauates can also work in hospital pharmacies, but their functions are primarily stocking shelves an managing inventory, ispensing, an compouning. They also may participate in laboratory research. Recently, some of these pharmacists have been aske to perform clinical pharmacy functions because of the lack of clinical pharmacists. Pharmacists practicing in community pharmacies manage pharmacy operations an provie patient counseling. The fiel of clinical pharmacy has grown since At that time, the government require all hospitals to evelop clinical pharmacy programs to aress rug-relate problems an to promote rational rug use in hospitals. 9 Many large general hospitals starte to ifferentiate a few practitioners as clinical pharmacists or hire grauates with an MS or PhD egree in clinical pharmacy. Currently, about 90% of grauates from MS in clinical pharmacy programs are working in clinical pharmacy. Aitionally, some pharmacists working in hospitals an the pharmaceutical inustry are electing to return to school to pursue a 3-year master of science in clinical pharmacy program or a 1-2 year postgrauate clinical pharmacy course specifically esigne for practicing pharmacists. The main venue of clinical pharmacists in China is in comprehensive meical centers an is focuse on a few specialty areas. However, clinical pharmacy is eveloping in more clinical areas an as the supply of clinical pharmacists increases, this type of practice is increasing. The clinical pharmacist works as part of a meical treatment team an performs the following types of clinical activities: Participates in aily clinical rouns; Obtains meication histories; Prevents, etects, an resolves meicationrelate problems; Provies rug information; Assists with meication selection; Devises treatment plans for iniviual patients; 6 Assesses efficacy an safety of treatment plans; Conucts/performs therapeutic rug monitoring of meications with a narrow therapeutic inex; Counsels patients regaring meications; Provies special monitoring for newly markete meications incluing collection, analysis, an reporting of ata for these meications; Performs rug usage evaluations an rational rug use evaluations; Performs research, particularly in the areas of evience-base meicine, pharmacogenomics, proteomics, population pharmacokinetics, clinical pharmacology, an bioavailability. Clinical Pharmacy Professional Development Some pharmacists working as clinical pharmacists in China have a great eal of on-the-job professional experience, but have not receive formal training in clinical pharmacy. Therefore, in aition to egree-granting programs, a great eal of professional evelopment is currently focuse on obtaining clinical pharmacy skills for practicing pharmacists. The Ministry of Health establishe 1-year clinical pharmacy training programs for currently practicing pharmacists in January The training inclues both iactic an experiential components. A systematic, stanarize, but iniviualize, metho to provie this continuing eucation is avocate that requires pharmacists to: (1) Begin thinking of themselves as clinicians; (2) Improve their knowlege base in clinical meicine, clinical pharmacy, an biology; (3) Improve their knowlege of meical ethics, patient psychology, an meicine aministration; (4) Develop their skills in communication, computer use, an foreign language; (5) Learn to participate in patient care rouns an other clinical pharmacy activities; (6) Learn to employ the hospital information system to avance the profession through such activities as establishing an averse rug reaction atabase or pharmacokinetics an pharmacoynamics atabases; (7) Participate in clinical professional meetings an avance training classes. The goal of this plan is to evelop aitional clinical pharmacists within 3 years from 50 of these training programs. These hospitals have been specifically certifie uner the Pharmacy Aministration Specialty Committee of Chinese Hospital Association beginning in This group is working collaboratively with clinical pharmacy specials an eucators to stanarize assessment an accreitation guielines for pharmacists an hospitals.

7 CLINICAL EDUCATIONAL CHALLENGES AND THE FUTURE Generally, pharmacy higher eucation in China requires further evelopment to meet societal nees. For example, the entry-level MS program in clinical pharmacy at Peking University currently grauates only stuents each year. The MS an PhD in clinical pharmacy programs o not have the capacity to prouce large numbers of clinical pharmacists. BS pharmacy eucation in most of China is basic science-oriente programs. To meet the increasing eman for clinical pharmacists, the Ministry of Eucation is currently assessing a plan propose by Peking University to evelop professional egrees in China that woul be similar to the PharmD egree in the Unite States. The propose names for these egrees are the master of clinical pharmacy (CPM) an the octor of clinical pharmacy (CPD). REFERENCES 1. Chinese Pharmaceutical Yearbook. Shanghai, China: The Secon Military Chinese Meical University Press; 2005: Su HD. Survey on the higher pharmacy eucation an its problems of renovation an evelopment. Pharm Euc. 1994;10: Chinese Pharmaceutical Yearbook. Shanghai, China: The Secon Military Meical University Press; 2006:234; The present situation an evelopment of health care personnel an license pharmacist. Available at: meia_file/rm/ip2/2001_9_17/yxzy/htm/yxzy04.htm. 5. Zhu S. The present situation an the tenency of license pharmacist qualification system rules in our country. China Pharmacist. 1999;4: Zhang QZ. The eucation of ientification on Traitional Chinese Meicine an the national qualification examination for license pharmacists. J Yunnan University Traitional Chin Me. 2008;31: Ye H. Investigation on the employment of all previous years pharmacy unergrauate/grauate. J Pharm Euc. 2006;22: Yu L, Tang R, an Xu T. Primary analysis of the insufficient effective eman on clinical pharmacist eucation. Sichuan Me J. 2008;129: China Ministry of Health an State Aministration of Traitional Chinese Meicine. Temporary regulation for pharmacy aministration in meical organizations. WeiYiFa (Ministry of Health Meical Official Document). 2002, No