Pharmacy in China

The beginnings of pharmacy in China are ancient (see Chinese alchemy). According to legend, Shennong (about 2000 BCE) who sought out and investigated the medicinal value of several hundred herbs. He reputed to have tested many of them on himself, and to have written the first Pen T-Sao, or native herbal, recording 365 drugs. He is said to have tasted hundreds of herbs to test their medical value.

The most well-known work attributed to Shennong is The Divine Farmer's Herb-Root Classic. This work is considered to be the earliest Chinese pharmacopoeia. It includes 365 medicines derived from minerals, plants, and animals. Shennong is credited with identifying hundreds of medical (and poisonous) herbs by personally testing their properties, which was crucial to the development of traditional Chinese medicine.

Still worshiped by native Chinese drug guilds as their patron god, Shennong conceivably examined many herbs, barks, and roots brought in from the fields, swamps, and woods that are still recognized in Pharmacy today. The "Pa Kua" is a mathematical design symbolizing creation and life. Medicinal plants include podophyllum, rhubarb, ginseng, stramonium, cinnamon bark, and, ma huang, or Ephedra.

Unlike the prevailing practice in other, particularly Western countries, the duties of the pharmacist and physician are not entirely separated. Chinese doctors are allowed to dispense drugs themselves and the practice of pharmacy is sometimes integrated with that of the physician, particularly in traditional Chinese medicine. The idea of separating the two professions has been debated as the trend for specialization has increased in the health sciences. Other countries such as South Korea, Japan and Taiwan have successfully separated the jurisidications to legally separate the practice of prescribing from the practice of dispensing. That legislation has also specified that only pharmacists may supply scheduled pharmaceuticals to the public, and that pharmacists cannot form business partnerships with physicians or give them "kickback" payments. Possible reform for this area is being considered by the Chinese regulatory authorities.

Since the economic reform period of the 1980s, the development of the Chinese pharmaceutical industry has led to the introduction of new and effective drug substances. It also changed the role of the pharmacist. The scope for extemporaneous compounding of medicines was much diminished and with it the need for the manipulative skills that were previously applied by the pharmacist to the preparation of bougies, cachets, pills, plasters, and liquids. Pharmacists continue, however, to fulfill the prescriber's intentions by providing advice and information; by formulating, storing, and providing correct dosage forms; and by assuring the efficacy and quality of the dispensed or supplied medicinal product.

In the future, pharmacists are expected to become more integral within the health care system. Rather than only dispensing medication and other routine duties, pharmacists are to be involved more in patient care with their particular knowledge and skills.

Since 1949, health care in China has improved. The number of hospitals has increased. While medicines previously were scarce, China now produces approximately 75 percent of the drugs it needs. China has a long history of traditional medicine; although there are attempts to integrate the concepts of traditional and Western medicine, the practices are still segregated. All hospital pharmacies in China have the responsibilities to guarantee the safe and effective use of drugs within the hospital and to do research. Even though Chinese factories manufacture many pharmaceutical products, the hospital pharmacy must manufacture many more.

Hospitals have established Agreed Prescription programs, whereby drugs are manufactured in large batches, repackaged, and distributed to other hospital pharmacies in the area if needed. Quality is assessed chemically and by modern techniques when equipment is available. Most large hospitals now have automated facilities to manufacture sterile solutions. Each hospital has a medical supply committee that supervises the procurement of medical supplies and the reasonable use of drugs.

A government resolution mandates that every hospital pharmacy do research. A primary focus of their research is the integration of traditional and Western medicine. Concepts of traditional and Western medicine are taught in separate pharmacy schools. Most pharmacy undergraduate programs are four years, but some schools recently changed to five years. Challenges for hospital pharmacists in China have been to develop the theoretical and technological knowledge of pharmacy, and to expand the scientific and technical information system that is necessary to do research.

The course of instruction leading to a Bachelor of Science in pharmacy (BPharm) extends at least four years. The first and frequently the second year of training, embracing general education subjects, are often provided by a school of arts and sciences. Many institutions also offer graduate courses in pharmacy and cognate sciences leading to the degrees of Master of Science and Doctor of Philosophy in pharmacy, pharmacology, or related disciplines. These advanced courses are intended especially for those who are preparing for careers in research, manufacturing, or teaching in the field of pharmacy.

Since the treatment with drugs encompasses a wide field of knowledge in the biological and physical sciences, an understanding of these sciences is included for pharmaceutical training. The basic four-year curriculum in the colleges of pharmacy, for example, embraces physics, chemistry, biology, bacteriology, physiology, pharmacology, and many other specialized courses. As the pharmacist is engaged in a business as well as a profession, special training is provided in merchandising, accounting, computer techniques, and pharmaceutical jurisprudence.

Subjects:

• Clinical pharmacy
• Pharmacy practice
• Pharmaceutical care
• Pharmacy administrative sciences
• Pharmacotherapy
• Pharmacoeconomics
• Pharmacogenetics
• Pharmacogenomics
• Pharmacoepidemiology

Reforms made to provide an individualized, state-of-the-art learning environment that facilitates the development of students' knowledge, skills, attitudes and behaviors needed by the pharmacy profession and society at-large, so they provide high quality pharmaceutical care:

• critical-thinking,
• problem-solving,
• communication skills,
• technology skills
• patient-care skills.
• a pharmacy-focused basic science curriculum that is integrated with patient assessment, a problem-based learning case study sequence, an outcome-oriented assessment plan, and structured experiential clerkships in each year of the program.

Competency-based education with an emphasis on patient-oriented practice and accountability are the current and future trends in pharmacy education. Reforms have been made to promote state-of the-art pharmaceutical sciences in curricula when at the same time there is a shift from product-oriented to patient-oriented pharmacy education and practice. There has seen a radical change in curriculum and organisational structure focussing on problem-oriented and student centred educational methods, in order to optimally prepare future practitioners and scientists.

The pharmacy schools in China are experiencing the dramatic changes, together with the booming economy and continuous education reform. In the last ten years, one major structural change in the higher educational system was the merger of several medical and pharmacy schools with several major universities. The environment for these pharmacy schools have been changing dramatically from independent or medical university settings into being affiliated to comprehensive and multidisciplinary Universities. It presented the similar situation as those happened in the US during last century, when some state universities expanded into pharmacy education or merged with independent pharmacy schools.

There are 51 pharmaceutical institutions of higher learning (including universities and colleges) in China according to the statistics made by the end of 1995. Within these 51 institutions there are 95 programs which have enrolled 3,968 state-planned undergraduate students. In 1995 more students were enrolled in some specialties than in 1990 because of the rapid development of the health and medical economies in China which need more personnel in the fields of pharmacy. The number of the students studying various specialties increased greatly, e.g., pharmaceutical analysis by 64.5 percent, microbial pharmacy by 122 percent, pharmacology of traditional Chinese pharmacy by 200 percent, management of medical and pharmaceutical enterprises by 300 percent and pharmaceutics of traditional Chinese materia medica by 64.2 percent.

To practice pharmacy in China in which a license is required, an applicant must be qualified by graduation from a recognized college of pharmacy, meet specific requirements for experience, and pass an examination conducted by the Chinese Pharmaceutical Association as appointed by the government.

Pharmacy laws generally include the regulations for the practice of pharmacy, the sale of liquids, the dispensing of narcotics, and the labeling and sale of dangerous drugs. The pharmacist sells and dispenses drugs within the provisions of the food and drug laws of the country in which he practices. These laws recognize the national pharmacopoeia (which defines products used in medicine, their purity, dosages, and other pertinent data) as the standard for drugs.

Regulatory bodies with responsibilities related to pharmacy are:

• General Administration of Quality Supervision, Inspection and Quarantine
• Ministry of Health
• State Food and Drug Administration
• National Institute for the Control of Pharmaceutical and Biological Products
• Ministry of Agriculture

Pharmaceutical research, in Chinese schools of pharmacy, embraces the organic chemical synthesis of new chemical agents for use as drugs and is also concerned with the isolation and purification of plant constituents that might be useful as drugs. Research in pharmacy also includes formulation of dosage forms of medicaments and study of their stability, methods of assay, and standardization.

Another facet of pharmaceutical research that has attracted wide medical attention is the "availability" to the body (bioavailability) of various dosage forms of drugs. Exact methods of determining levels of drugs in blood and organs have revealed that slight changes in the mode of manufacture or the incorporation of a small amount of inert ingredient in a tablet may diminish or completely prevent its absorption from the gastrointestinal tract, thus nullifying the action of the drug. Ingenious methods have been devised to test the bioavailability of dosage forms. Although such in vitro, or test-tube, methods are useful and indicative, the ultimate test of bioavailability is the patient's response to the dosage form of the drug.

Licensing systems for new medicinal products in China demand increasingly extensive and costly investigation and testing in the laboratory and in clinical trials to establish the efficacy and safety of new products in relation to the claims to be made for their use. Proprietary rights for innovation by the grant of patents and by the registration of trademarks have become increasingly important in the growth of the domestic pharmaceutical industry and its development internationally.

There are numerous pharmacy-related organizations. The Chinese Pharmaceutical Association (CPA) is the national organization of pharmacists and pharmaceutical scientists with the mission to represent and serve pharmacy and pharmaceutical sciences development in China. CPA was founded in 1907, it now has nearly 3000 senior individual members and 35 group members. Through its group members, CPA connects, represents and serves more than 105,000 pharmacists and pharmaceutical scientists around the country. The CPA is a member of the International Pharmaceutial Federation.

There are also other societies in which history, teaching, and the military aspects of pharmacy are given special emphasis.

About 120,000 retail pharmacies operate in China. Most of them are quite small—less than 200 m²—but a few are as large as 1,000 m² or more. The majority are licensed to carry medicines (prescription and over-the-counter [OTC]), traditional Chinese medicines, health foods (designated by the jian shi characters at the beginning of the registration certificate), and family planning products. Some retail pharmacies are also licensed to carry cosmetic products. It is relatively simple to add products the Chinese government classifies as cosmetics to a pharmacy's operating license. Chinese retail pharmacies do not carry products frequently found in US pharmacies, such as shampoo, diapers, nail polish, and batteries. China's pharmacies, however, sell products such as imported skin creams, specialty hair-care products (such as dyes or masks), and feminine-hygiene products.

All retail pharmacies prior to January 2003 -– when WTO rules took effect – had by law must have been government-owned. Many of the state-owned pharmacy companies had consolidated to establish chains or franchises, and many more have contracted day-to-day management to an entrepreneur who pays a small percentage of the profits to its hands-off government owner. In Beijing and Shanghai, the local governments stopped approving applications for new pharmacies about three years ago, but is allowing chain stores to increase their number of outlets. Therefore, any "new" retail pharmacy in these markets must be affiliated with an existing outlet. In Shanghai, pharmacies must also contend with a rule that prohibits chains from opening outlets within a certain distance of existing pharmacies.

Local administrations for industry and commerce and local health bureaus oversee and regulate the pharmacies. Their monitoring of retail outlets includes spot checks of the types of products being sold, follow-ups on consumer complaints, and verification that retail prices match registered prices. Government monitors also verify that products comply with government regulations on labeling and other matters, and that merchandising and advertising materials are compliant and registered.

Chinese pharmacies have been undergoing dramatic changes as the retail medicine market opens up. Under planned reforms, China's retail pharmacies will begin selling a much higher volume of prescription drugs, and hospital pharmacies will eventually be restricted to dispensing prescriptions for inpatient use. Retail pharmacies' businesses will consist more and more of high-volume prescription drug sales and high-margin healthcare and personal-care products, including OTC drugs, health foods, family planning products, and beauty products, similar to a European or North American drugstore model.

More and more patients have been willing to buy non-prescription medicines in convenient drugstores instead of registering and queuing in hospitals. Large numbers of drug wholesalers have also entered the retail market due to the expected returns. Domestic pharmaceutical giant Sanjiu Enterprise Group has planned to open 8,000 to 10,000 outlets at a cost of 1.3 billion yuan (US$157 million).

China Nepstar is the largest retail drugstore chain in China, based on the number of directly operated stores. As of September 2007, the company had 1,791 stores in 62 cities. Nepstar has also planned to establish 5,000 to 10,000 chain stores in the next five years. It provides pharmacy services as well as a wide variety of other merchandise, including over-the-counter drugs, herbal products, personal care products and nutritional supplements. The company also offers 1,108 private-label products under its own brand name. For the six months ended June 30, China Nepstar reported earnings of $4.6 million, after paying preferred dividends, on sales of $124.3 million.[7]

As of 2003, China had 196 pharmaceutical enterprises with chain stores, reporting an annual sales volume of nearly 8 billion yuan (US$967 million). Most chain drugstores though are small in scale. Peace Pharmacy, one of China's largest drug store in Chongqing had only 300 chain stores. Besides medicines, medical equipment are also sold in Chinese drugstores. This has been to meet the demand of consumers who have begun to favor products for self-diagnosis and self-health care.

Rapid mergers and acquisitions, expansion in the retail industry is expected to gradually consolidate the sector.

Pharmacies, found in all towns, can help with minor injuries and ailments. Larger ones sometimes have a separate counter offering diagnosis and advice. Staff can usually help if the customer describes his or her symptoms. The selection of reliable Asian and Western products available is improving and it is possible to self-treat with herbal medicines. Contraceptives are widely available, as are antibiotics.

As a result of the development of society and national economy, the people's health care level and the sense of self-medication are gradually improving. Therefore, the demand for good pharmacy service especially for carrying out pharmaceutical care not only in hospital but also in community pharmacies are increasing.

The China Nonprescription Medicines Association (CNMA) is a guild of pharmaceutical manufacturers and distributors, especially of those manufacturers of non-prescription medicines and community pharmacies.[8] Based on the pharmaceutical care and licensed pharmacists system, the CNMA under the auspices of government and membership units, consulted the "International Good Pharmacy Practice for Developing Countries" and the "Standards for Quality of Pharmacy Services" and GPP documents of other countries available to constitute the Good Pharmacy Practice and Evaluation Standards of GPP especially for community pharmacies.

Limited resources, amidst increasing demand for services, are leading to significant change in the implementation of health care in China, especially manifested lately in the pricing and reimbursement of pharmaceuticals.

Pharmaceutical expenditures can exceed 30% of total health expenditures in some poorer areas; so greater scrutiny and control over drugs are evident lately. Pharmacoeconomic research, either used when health providers examine different treatments to make cost-effective decisions, or when regulatory institutions estimate the greater value of a new product to set a reimbursement level, marks the horizon for the world's pharmaceutical markets.

Pharmacoeconomics as a science has begun to advance with methodological guidelines as it is increasingly applied in many countries.

China today must confront significant cost-containment in health care, as seen in every developing nation of the world. Pharmacoeconomic research thus will likely find favor to facilitate the evaluation of resource utilization for greater efficiency and better health outcomes in its population; however, pharmacoeconomics currently is stagnating in China due to the lack of adequate academic research centers, pharmaceutical industry investment, and government coordination.

It is predicted that China will, out of necessity, end this lag as its health care system overcomes its limitation on pharmacoeconomic knowledge and lessens influences from the old pharmaceutical pricing and reimbursement system. The upsurge import of more Western drugs now with the World Trade Organization (WTO) entry is another force leading to China's eventual progress in this area.

Current applications within a few industrialized countries can serve as a prelude to describing lessons for and reforms taking place in China. There are encouraging, although not yet significant, steps being taken to embed more pharmacoeconomics into the Chinese health care system.[9]

Figures in China report almost 200,000 persons are said to have died in 2001 as a consequence of having taken counterfeit drugs.[10]

There are major difficulties for patients accessing expensive pharmaceuticals which encourage smuggling and even home manufacture. The state healthcare system does not cover many drugs, and for those that are covered there is a 30% copayment. The approval process is slow and bureaucratic. Only 100 new drugs were approved between 2001 and 2016 by the China Food and Drug Administration. Once approved, drugs have to be included in the National Reimbursement Drug List to qualify for coverage. Prices are much higher than in other Asian countries.[11]

Online pharmacies were first established in China in 2005. By the end of 2008, only 10 online pharmacies had obtained permission to sell over-the-counter drugs,[12] a figure that had increased to 639 by January, 2017.[13] Online sales increased in line with the number of pharmacies. The China Food and Drug Administration conducted a pilot reform to admit three businesses using their third-party platform to retail drugs online to consumers from 2013 until August 2016, accounting for to some extent difficulty in its regulation.[14]

The U.S. Pharmacopeia has an international facility in Shanghai's Zhangjiang Hi-Tech to work with Chinese companies and regulators on meeting international standards and ensuring the safety of pharmaceuticals, dietary supplements and ingredients. It opened in 2006 and was inaugurated in 2007.[15] (See: USP-China Quarterly Update)

• The Museum of Huqingyutang Chinese Pharmacy

• Chinese Pharmaceutical Association
• Campaign for Access to Essential Medicines
• Collaborating Centre on International Drug Monitoring in Uppsala
• Department of Essential Drugs and Medicines
• Evidence-based pharmacy in developing countries
• Essential medicines
• Good pharmacy practice
• India's National Institute of Pharmaceutical Education & Research
• List of pharmacy associations
• List of World Health Organization Essential Medicines
• Pharmaceutical industry in China
• State Food and Drug Administration
• Public health in China
• Pharmaceutical policy, national pharmaceuticals policy
• Pharmacies of Norway, for a country comparison
• Pharmacy Council of India
• National Formulary
• Universities Allied for Essential Medicines

• A History of Pharmacy in Pictures College of Pharmacy, Washington State University
• China World List of Pharmacy Schools, International Pharmaceutical Federation (FIP)
• Reaching China's Middle Class Through Retail Pharmacies - China Business Review 2001
• Zhu, Yi-Zhun., Zhou, FangMing., Lu, Wei-Yue., Ye, DeYong. and ZHENG, HaiAn. "A Comparison Study between Independent and University-affiliated Pharmacy Schools in China -- Does University Setting Benefit Pharmacy Education?" Paper presented at the annual meeting of the American Association of Colleges of Pharmacy, Sheraton San Diego Hotel & Marina, San Diego, California, USA, Jul 05, 2006.
• HC Wang, LY Chen, and AH Lau. Pharmacy practice and education in the People's Republic of China. 1993 The Annals of Pharmacotherapy: Vol. 27, No. 10, pp. 1278–1282.
• GJ Liu. Hospital pharmacy practice in the People's Republic of China. (1982) American Journal of Hospital Pharmacy, Vol 39, Issue 9, 1487–1490
• Chen Zongmin. "The development of higher pharmaceutical education in China's reform", Institute of Pharmaceutical Education, China Pharmaceutical University, Nanjing, Jiansu. American Association of Colleges of Pharmacy. Spring 1998.
• Qian Cai, J. Warren Salmon. "What Role May Pharmacoeconomics Play in Pharmaceutical Pricing and Reimbursement in China?" Journal of Pharmaceutical Finance, Economics & Policy (Volume 4 Number 1, 2005)

• Professional Code or Legal Sanctions: Pharmacy in China by Du Liping, University of Melbourne (Health & History, 2004. 6/1: 87–96)
• Pharmacy in Hong Kong The Pharmaceutical Journal Vol 267 No 7179 p911-936; 22–29 December 2001
• Good Pharmacy Practice (GPP) in Developing Countries
• Public health development of China Shandong Statistical Bureau
• An important task of the 21st century: Strengthening international exchange and cooperation in pharmaceutical education Zongmin, Chen, Na, Li, Taikang, Huang. American Journal of Pharmaceutical Education. Vol. 64, No. 2 (2000)
• Integrating R&D with Manufacturing and Pharmaceutical Education in China Wang Qiang, Shi Zhixiang, and Chen Zongmin. American Journal of Pharmaceutical Education. Vol. 64, No. 4 (2000)
• The Teaching Contents and Methods of International Pharmaceutical Business Ma Aixia. American Journal of Pharmaceutical Education. Vol. 65, No. 3 (2001)
• Deepening the Reform of Higher Pharmaceutical Education for the 21st Century Xiaoming Wu. American Journal of Pharmaceutical Education. Vol. 64, No. 3 (2000)

Pharmacovigilance

• Wang Yue et al. Regional pharmacovigilance practice in China The International Journal of Risk and Safety in Medicine Volume 20, Number 1-2 / 2008 pp. 51–56
• Zhou Yibing et al. An Overview of Adverse Drug Reaction Monitoring in China International Journal of Pharmaceutical Medicine, Volume 20, Number 2, 2006 , pp. 79–85(7)

Pharmacoeconomics

• Pharmacoeconomics and Outcome Research in China Shanlian Hu. MD. MSc. ProfessorSchool of Public Health, Fudan University, ISPOR 2nd Asia-Pacific Conference, March 6, 2006.
• Liu G.G.; Liu C. Potential Expanded Use of Pharmacoeconomics and Outcomes Research in China Pharmaceutical Development and Regulation, Volume 1, Number 3, 2003 , pp. 169–177(9)
• Liu Bao Peng; Chong Qing Tan; Xiao Min Wan; Cui, Wei. "Cost-Utility Analysis in China: Differences and Difficulties Compared with Developed Countries". PharmacoEconomics, Volume 25, Number 7, 2007, pp. 619–619(1)

• China Association of Chain Drug Stores
• Chinese Pharmaceutical Association Committee on Professional Hospital Pharmacy
• Clinical Pharmacy Network in China
• WinPharm
• yxbj.com
• China Pharmacy Network
• Chinese Pharmacy Network
• China: Where East Meets West China's pharmacy chain drug stores, RCVA Group
• Modernized Chinese Medicine International Association (MCMIA)
• BeiJing WEIBIAO Center For Drug Standard Research Development
• China to Improve Standards of Pharmacy Degrees for Overseas Students (Xinhua; July 26, 2007)
• The quality and safety of traditional traditional Chinese medicines (Aust Prescr 2003;26:128-30)
• Fake Anti-malarials found in Yunnan Province, China USP, Drug Quality and Information Program

Chinese pharmaceutical policy

• Chinese Pharmaceutical Policy Studies - WHO Health Systems and Services, Medicines and Health Technologies

International conferences

• The 7th Asian Conference on Clinical Pharmacy July 2007, Shanghai
• 67th International Congress of FIP World Congress of Pharmacy and Pharmaceutical Sciences
• Industrial Pharmacy section
• Pharmaceutical Curriculum Development: An evolutionary or a revolutionary process? Pre-PSWC2007 Workshop (April 21, 2007)

People

• CELEBRATED BRIDGE–BUILDER PASSES ON, BUT LIFE WORK CONTINUES Guo-jie John Liu, MSPharm'50: January 9, 1915 – March 21, 2006 (University of Michigan College of Pharmacy)
• White paper: 150,000 people in China obtain pharmacist's qualifications Xinhua 2008-07-18

Comparative study

• China / European Union: Overview of Community Pharmacy