ABSTRACT
In recent years， the increasing scale and scope of public health emergencies have brought serious challenges to China's health emergency system. It is in urgent need to develop the existing health emergency system toward the goal of multi-industry， multi-discipline， multi-professional and multi-regional， while the concept of standardization is essential to achieve this goal. This article describes the construction process of health emergency standardization system by the World Health Organization， the International Organization for Standardization， the United States， and China； analyzes the problems of China's health emergency standardization system by comparing the system between China and the United States， proposes the construction dimensions of China's health emergency standard system， and suggests development strategies targeting the shortcomings of China's health emergency standardization.
ABSTRACT
OBJECTIVE：To provide reference for establishing stan dardized construction standard system of “internet+TCM pharmacy”. METHODS ： Questionnaire through literature review ， investigation and expert consultation were compiled. A questionnaire survey was carried out among TCM staff to understand the current situation and problems of “internet + TCM pharmacy”in Chinese medical institutions. Based on the results of the questionnaire ，a frame of standardized construction standard system for “internet+TCM pharmacy ”was tried to constructed. RESULTS & CONCLUSIONS：A total of 74 questionnaires were distributed and 74 were returned ，including 1 invalid questionnaire ，with an effective rate of 98.65％. Among the 73 respondents， more than 60％ were from TCM hospitals ，or with the title of vice senior or above ，and 55（75.3％）were national TCM characteristic technology inheritance talents. The survey results showed that more than 80％ of TCM pharmacies in medical institutions were equipped with full-time reviewers ，provided decocting service ，set up decocting room ，and carried out distribution service，and could achieve the same-day or part of the same-day delivery. More than half of the respondents believed that the prescriptions of TCM decoction pieces in their medical institutions were issued in strict accordance with the relevant requirements ， the rational drug use monitoring software was used ，and the error analysis of relevant work links was carried out regularly ， prescription coping training was regularly carried out for dispensers ，and decoction knowledge and operation process training were carried out for decoction personnel. However ，the vast majority of respondents （67，accounting for 91.8％）thought that their medical institutions only used traditional methods to control and evaluate the quality of finished decoction products. The results of the evaluation of the importance of 6 links and 17 key points of operation showed that the highest concentration of opinions was the quality of decoction pieces ，and the key points of operation were special drug treatment. The results of principle component analysis and maximum variance analysis showed that current construction of “internet+TCM pharmacy ”was mainly reflected in the two dimensions as TCM decocting ，consultation and distribution servi ces. Statistical analysis indicated that there were significant differences in staff training ，awareness of laws and policies ， regular error analysis ，patient satisfaction survey ，optimization of payment and consulting services among different levels and categories institutions （P＜0.05）. It was necessary to carry out the standardization construction of “internet+TCM pharmacy”. It is suggested that the standard system for standardized construction of“Internet + TCM pharmacy ”should be established from 5 aspects：basic construction conditions ，the standardization of procurement and acceptance ，the standardization of dispensing ，the standardization of decocting and distribution service and the standardization of pharmaceutical consultation services.
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The development of health building in the medical field is still in its infancy. The authors analyzed the development of health building evaluation standard system in the medical field of China, combined with the design experience of the first health building design identification hospital project in China, summarized the design measures of hospital health building according to the evaluation standard system, analyzed the correlation between different design majors and evaluation standards and the design emphasis. It also introduced the application value and practice of the main technology innovation in the process of hospital construction, so as to provide reference for the promotion of health building in the medical field.
ABSTRACT
Medicinal animal resource is an important component of traditional Chinese medicine resource. With the decreasing of wild medicinal animal resources, it is necessary to carry out the artificial breeding of medicinal animal to ensure the sustainable development of traditional Chinese medicine industry. There are 106 kinds of medicinal animals in Chinese Pharmacopoeia (2015 Edition), only 22 species (except livestock and poultry) of them have selection or breeding standards, while most of the 211 legislations are local standards. It is far behind the degree of agricultural standardization which can not achieve standardized production of animal medicinal materials. It is urgent to establish a technical standard system for production and processing of medicinal materials of animal-derivative, including basic, product, process, safety, environmental protection, management and working standards for common animal medicinal materials, which can fill the gap of industry and control the quality of animal medicinal materials, animal Chinese herbal pieces and products containing animal ingredients from the source.
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To study the evolution of Chinese ancient and modern pharmacopoeia standards and compare the domestic and foreign pharmacopoeias, further understand the international requirements on chrysanthemum quality, and establish a more suitable and modern standard system for high quality Chrysanthemi Flos pieces. Newly Revised Materia Medica, Welfare Pharmacy, Collected Essentials of Species of Materia Medica (Bencao Pinhui Jingyao), Chinese Pharmacopoeia and other herbal remedies in various generations were reviewed to summarize the evolution of domestic standards on Chrysanthemi Flos pieces. Then they were compared with those in European Pharmacopoeia, United States Pharmacopoeia, Japanese Pharmacopoeia and other foreign Pharmacopoeias to establish a modern and international high-quality Chrysanthemi Flos pieces standard system with Chinese medicine characteristics and produce more internationally recognized high-quality Chinese medicine pieces.
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Starting with the concepts of basic dataset and basic dataset of nursing management information of hospital of Tradtional Chinese Medicine (TCM),the paper introduces the research purpose,construction principle,construction method,construction contents and system framework of the basic dataset standard system of nursing management information of hospital of TCM,in order to lay a foundation for achieving nursing management data resource sharing and exchange of hospital of TCM.
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After the connotation of the standard system for digitalization of ancient medical documents was analyzed, its construction principles were elaborated with measures proposed for how to construct it.
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An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines (TCMs). However, the current quality standard research lacks top-level design and systematic design, mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "iVarious" system. This system highlighted a holistic strategy for effectiveness, security, integrity and systematization of quality and safety control standards of TCMs. The establishment of "iVarious" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.
ABSTRACT
An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines (TCMs). However, the current quality standard research lacks top-level design and systematic design, mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "iVarious" system. This system highlighted a holistic strategy for effectiveness, security, integrity and systematization of quality and safety control standards of TCMs. The establishment of "iVarious" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.
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To understand the history development and changes of Citri Grandis Exocarpium and initially establish its standard system after exploring the historical origins and modern development of Citri Grandis Exocarpium. In CNKI, Wanfang database and other academic search platforms were searched for literature on Citri Grandis Exocarpium and Chinese medicine standard system； the books related to its modern cultivation techniques and processing technology were also accessed, and after combining with the actual situation analysis, the prospective design of the standard system of Citri Grandis Exocarpium was finally established with research conclusion. The earliest records of the Citri Grandis Exocarpium were documented in the Northern and Southern Dynasties, but its medicinal value was discovered in the Song Dynasty. Its drug use was developed on the basis of Jupi（orange peel） and Citri Exocarpium Rubrum. In 21st century, a number of large-scale, intensive Citri Grandis Exocarpium bases have been formed due to high price, good planting efficiency, and rapid growth of cultivation areas. The standard system includes the technical specifications of seed selection and seedling cultivation of Citri Grandis Exocarpium, technical norms of cultivation, technical specifications of fertilizing and weeding, technical specifications of irrigation and drainage, technical standard of pest and disease control, standard of medicinal materials grade, standard of processing technology of sliced pieces and the quality standard of slices, etc.
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On August 9, 2015, the State Council promulgated the "Opinions of the State Council on the reform of drug and medical device review and approval system" (Guofa 2015 No. 44), and established the "clinical value-oriented drug innovation" model to encourage the research and development of new drugs. Following that, China Food and Drug Administration (CFDA) promulgated the "Notice on several policies for drug registration review and approval" (2015 No. 230 ) on November 11, 2015, clearly specifying that CFDA would "implement one-time approval for clinical trials application of the new drugs, and no longer take a phased declaration, review and approval system; for the new drugs that apply for clinical trials, mainly review the scientific natureof the clinical protocols and the risk control of the new drugs to guarantee the safety of subjects". Accordingly, the evaluation ideas and forms of new drug registration have also been adjusted greatly. For example, issues like the rationality of the drug manufacturing process, whether the scale can reflect the stability of the process, whether the preparation process is sufficient, and whether the choice of dosage form is reasonable are no longer the focus of evaluation before clinical trials. Issues regarding whether the preparation process design is reasonable, whether the effective components can be transferred to the preparation to a maximum extent, whether the process parameters determined in small and middle pilot trials can adapt to the requirements of mass production, no longer act as the reasons for refusing the clinical trials. The corresponding risks shall be borne by the applicant as the subject of liability. The focus in registration evaluation is mainly transferred to how to ensure the consistence of quality between clinical trial samples and the samples already available on market by guaranteeing stable sources of drug raw materials and stable quality of medicines as well as control of the whole preparation process. These issues run through the whole process of new drug development, but also have different focuses in different stages. According to the "Measures on communicating about drug research and development and technical review" (2016 No. 94) (On Trial) issued by CFDA on June 2, 2016, the applicants may communicate with the drug evaluation center in different phases in the process of new drugs registration in respects of medicine material problems, technological problems, and quality control of the preparations. In this paper, the transformation of Chinese medicine research model was described mainly in the following aspects: how to control the quality of medicines from origins, technology design of the preparation and technology process research, and how to establish whole-process quality system. The paper also reflects the concept that the quality of new Chinese drugs research and development comes from design.
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Through analysis of the existing problems of standardization in the field of forensic medicine, combined with standardized methods in the course of evolution, applying the theory and method of standard system and complex standardization, and points out that the forensic medicine ifeld standardization methods should be according to the demand, through building standard system to guide the standardization work and to ifll standard missing items, improve the existing standards, and actively adapt to the need of development of multi discipline cooperation in forensic medicine, and promote the establishment of standard-complex.
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OBJECTIVE:To promote the healthy development of TCM decoction piece. METHODS:Based on analyzing the literature,national policy and data,the advantages and urgent problems of bringing TCM decoction piece into the National Essen-tial Medicine List were summarized,and the suggestions for its health development were provided. RESULTS:Bringing TCM de-coction piece into the National Essential Medicine List relieved the economic burden of patients and provided opportunity for the de-velopment of TCM decoction piece industry. However,it existed problems,such as production,circulation,storage and monitor-ing;mutual conflict in the relevant supporting policies;inconsistent medicare reimbursement;and urgent improvement of quality standard. CONCLUSIONS:The relevant departments should establish and improve the quality standard system of TCM decoction piece,and clear the varieties of TCM decoction piece in the National Essential Medicine List,perfecting supporting policies such as medicare reimbursement and attaching importance to the training of professional talents can ensure scientific and rational services for the public health.
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Literature,achievements and other materials on acupuncture-moxibustion standardization research in recent years were collected and summarized domestically and overseas. The process of acupuncture-moxibustion standardization in China was reviewed through two phases. Also,we compared domestic acupuncture-moxibustion standardization study with the foreign one. It is considered that its domestic development is sound but challenged by world competition in its internationalization. Going forward,acupuncture-moxibustion standardization system is needed to be completed and become international. Contemporary techniques should be used including big data,artificial intelligence,internet of things,and cloud computing,etc., and its application engineering research will be improved so as to drive Chinese medicine modernization.