Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica / 中国结合医学杂志

Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.

Fundamentos del Diseño Universal para el Aprendizaje Desde la Perspectiva Internacional / Fundamentals of Universal Design for Learning from an International Perspective

RESUMEN: El presente estudio se enmarca en el ámbito educativo, concretamente, en el área de la educación inclusiva, profundizando en el Diseño Universal para el Aprendizaje (DUA). El DUA se concibe como un enfoque teórico y práctico que actúa como una herramienta eficaz para alcanzar una educación de calidad y equidad dentro del movimiento de la inclusión educativa. El objetivo de este estudio es analizar la presencia de los fundamentos del DUA (derecho de la educación; diversidad; Diseño Universal; currículo flexible; igualdad de oportunidades; neurociencia y tecnologías de la información y la comunicación) en los documentos publicados por los organismos internacionales con competencia en materia educativa y de repercusión mundial. La metodología de la investigación es de corte cualitativo utilizando el análisis documental. Las categorías de análisis corresponden a los siete fundamentos del DUA. Las fuentes documentales para el estudio han sido fundamentalmente las páginas web de los organismos internacionales y la base de datos UNESDOC, obteniéndose una muestra definitiva de once documentos pertenecientes a la literatura gris. Tras la revisión documental, los resultados han evidenciado que no todos los documentos objeto de estudio contemplan en su contenido las categorías de análisis. En suma, se observan carencias en cuanto a la presencia de los siete fundamentos del DUA en los documentos publicados analizados, por lo que se requiere de un nuevo tratamiento a nivel internacional del DUA con el fin de promover una educación de calidad e inclusiva, que atiende y respeta a las diferencias individuales dentro del proceso de enseñanza-aprendizaje.

ABSTRACT: The present study was carried out in the frame of the educational field, specifically in the area of​​inclusive education, going deeper into the Universal Design for Learning (UDL). UDL is conceived as a theoretical and practical approach that acts as an effective tool to achieve quality education and equity within the educational inclusion movement. The objective of this study is to analyze the presence of the fundamentals of UDL (education law; diversity; Universal Design; flexible curriculum; equal opportunities; neuroscience and information and communication technologies) in documents published by international organizations with competence in education and global impact. The research methodology is of a qualitative nature and uses documentary analysis. The categories of analysis correspond to the seven fundamentals of UDL. The documentary sources of the study were mainly the web pages of international organizations and the UNESDOC database, obtaining a definitive sample of eleven documents belonging to the gray literature. After the document review, the results showed that not all documents under study include the categories of analysis in their content. In summary, there are gaps in the presence of the seven fundamentals of UDL in the published documents analyzed, which is why a new international treatment of the UDL is needed to promote an inclusive and quality education that meets and respects individual differences within the teaching-learning process.

Management of vaccine cold chain delivery by international organizations / 上海预防医学

Most of serious vaccine-related adverse events in China are believed to be due to the poor management of vaccine cold chain delivery.It is an urgent need to strengthen the vaccine management system.To obtain a more comprehensive understanding of the management of vaccine cold chain delivery, including practical experience in specific regions and its supervision, we reviewed the documents/guidelines/literature, published by the WHO, GAVI and UNICEF in recent ten years, on vaccine cold chain delivery.The current study serves a good reference for the regulation, policy formulation and optimization of vaccine management.

Preference of Japanese Global Health Personnel—Lessons Learned from a Qualitative Study / 国際保健医療

Objectives  The need to develop and produce human resources for global health is increasing. The objective of this study was to reveal through qualitative research as a first step of Discrete Choice Experiment, which job ‘attributes’ are considered important by Japanese medical and non-medical personnel in considering employment at health-related international organizations. We then sought to identify appropriate support measures that match the chosen attributes for those who wish to work for international organizations. Methods  We requested a total of 20 subjects from 3 groups of Japanese medical and non-medical personnel; 1. those who wish to work for health-related international organizations (applicant group), 2. those who are currently working (working group) and, 3. those who resigned (resigned group).   Subjects were asked to choose and rank in order of importance, 11 pre-defined attributes when considering employment at international organizations, followed by semi-structured interviews.Results  All three groups chose job content, opportunity for self-realization and opportunity for capacity development as top three attributes. This was followed by duty station as second place tie for working group and fourth place for applicant and resigned groups.   However, for applicant and working groups, emphasis on employee’s entitlements such as work-life-balance, salary, welfare, job security/long-term contract ranked mid- to lower-level between fifth to eighth places. Guaranteed job where one can return to when one leaves the current post, ranked ninth place and opportunity for children’s education and opportunity for spouse’s job ranked tenth equally.   For the resigned group, work-life-balance and job security/long-term contract ranked fifth place equally but other attributes were not chosen.Conclusion  The study findings suggested that Japanese medical and non-medical personnel who aim for employment at health-related international organizations have tendencies to opt for utilization of their experiences and expertise, and search for capacity development and self-realization, rather than better employee entitlements or working/living conditions.   According to the attributes ranking, we consider implementation of career development seminars on expected job satisfaction at international organizations as the primary support measure to encourage and dispatch more personnel. However, publicity highlighting employee entitlements such as work-life-balance, working environment for women and welfare alongside salary may also provide better incentive.   Insecure contract terms, a lack of national organizations and hospitals that value the experience gained in international organizations present a challenge. There is a need to work with these organizations in the mid- to long-term to inform them on the benefits of accepting those staff wishing to return after a period working within international organizations.

Condiciones de emergencia de un movimiento americano de protección de la infancia: tensiones de género en la construcción de legitimidades, categorías y prácticas / Conditions surrounding the emergence of the child-protection movement in the Americas: gender tensions in the construction of legitimacy, categories and practices

Resumen El artículo analiza las condiciones de emergencia del movimiento americano de protección de infancia a principios del siglo XX, observando tres dimensiones principales: la infancia como preocupación central entre las demandas de mayor presencia estatal en los países de la región, el lugar que ocupó la ciencia en la búsqueda de esas transformaciones y los procesos de construcción de un circuito transnacional de protección para la "infancia americana". Sostiene que el análisis conjunto de estas dimensiones permite visibilizar que la organización social de los sexos y la rigidez con que se fijaron las categorías binarias de género fueron piezas determinantes para la legitimización de este movimiento, así como las versiones de infancia y familia que defendió.

Abstract The article analyzes the conditions surrounding the emergence of the child-protection movement in the Americas in the early twentieth century, focusing on three main aspects: child welfare as a central concern in calls for greater state involvement in countries in the region, the role of science in pursuing those transformations and the processes whereby a transnational circuit for "children of the Americas" was constructed. Combined analysis of these dimensions helps reveal that the social organization of the sexes and rigidly-fixed binary gender categories were determining factors in the legitimization of this movement, as were the versions of childhood and the family it advocated.

New Process of International Standardization of Wheelchair / 中国康复理论与实践

This article introduced the history of International Organization for Standardization(ISO)and the procedure to formu-late international standard,especially the classification of wheelchair and ISO Wheelchair Technical Committee.There are 37 ISO standards on wheelchair published,and other seven ones are being modified.The implication for develop-ment of standards on wheelchair in our contry was also discussed.

Study on Narcotics and Psychotropic Substances Control( Part Ⅰ):Development and Status Quo of Inter-national Narcotics and Psychotropic Substances Control / 中国药房

OBJECTIVE:To study the development and status quo of international narcotics and psychotropic substances (NPS)control,and to provide evidence for NPS control in China. METHODS:The development and status quo of NPS control by international organization were summarized and studied through retrieving and collecting literatures,reports and policies about NPS from domestic and foreign databases,news reports and international website. RESULTS & CONCLUSIONS:International narcot-ics control dated back to opium trade with China in 19th century. International narcotics control system was established preliminarily by Shanghai conference and Haiya conference. The end of World War Ⅰ,the establishment of the League of Nations and the sign-ing of a number of international treaties promoted the development of internal control system. Through World War Ⅱ,the establish-ment of the United Nations and the change of international control organization,a number of international treaties were integrated into Single Convention on Narcotic Drugs in the early 1960s,which was used as the foundation of narcotics control system all round the world. In 1970s,the adoption of Convention on Psychotropic Substances meant psychotropic substances were included in the scope of internal control. In 1980s,the signing of United Nations Convention against Illicit Traffic in Narcotic Drugs and Psy-chotropic Substances marked the establishment of three conventions system of international NPS control. At present,internal NPS control is based on three conventions system and NPS list by Commission on Narcotic Drugs,International Narcotics Control Board and United Nations International Drug Control Program. The vast majority of countries are parties to that. International control orga-nizations and listed control have a great influence on NPS control all round the world.

Current situation of International Organization for Standardization/Technical Committee 249 international standards of traditional Chinese medicine / 中国结合医学杂志

<p><b>OBJECTIVE</b>To review the current situation and progress of traditional Chinese medicine (TCM) international standards, standard projects and proposals in International Organization for Standardization (ISO)/ technical committee (TC) 249.</p><p><b>METHODS</b>ISO/TC 249 standards and standard projects on the ISO website were searched and new standard proposals information were collected from ISO/TC 249 National Mirror Committee in China. Then all the available data were summarized in 5 closely related items, including proposed time, proposed country, assigned working group (WG), current stage and classifification.</p><p><b>RESULTS</b>In ISO/TC 249, there were 2 international standards, 18 standard projects and 24 new standard proposals proposed in 2014. These 44 standard subjects increased year by year since 2011. Twenty-nine of them were proposed by China, 15 were assigned to WG 4, 36 were in preliminary and preparatory stage and 8 were categorized into 4 fifields, 7 groups and sub-groups based on International Classifification Standards.</p><p><b>CONCLUSION</b>A rapid and steady development of international standardization in TCM can be observed in ISO/TC 249.</p>

Discussion on Standardization ISO 15189 quality management system as the teaching content for laboratory medicine / 中华医学教育探索杂志

ISO 15189 standard quality management system developed by the International Organi-zation for Standardization (ISO) embodies the international medical laboratory's latest quality management concept, and puts forward the quality improvement method of the standard. In this research, ISO 15189, as an important content in practice teaching for laboratory medicine, was designed according to the elements of this system. Students were requested to participate in every linkage of laboratory quality management by writing system document, taking part in quality activity, and practicing the key and difficult points of tech-nique in quality system in order not only to cultivate their basic idea of ISO 15189 standard, but also to make them familiar with the basic patterns of laboratory accreditation system and process, which could make them become the backbone of the laboratory quality management quickly in their vocational positions in the future.

Comparison and Investigation of the National Standards for Tinted Contact Lenses between Various Countries

PURPOSE: In this study we investigated the safety level of the national standard for tinted soft contact lenses by comparing the standards in various countries. METHODS: To evaluate the current guidelines for tinted soft contact lenses such as form and appearance, diameter, curvature radius, vertex power, cylindrical refractivity and cylindrical axis, luminous/ultraviolet ray (UV) transmittance, moisture content, oxygen permeability coefficient, extractables, elution test, cytotoxicity, sensitization, eye irritation test, acute systemic/subchronic/subacute toxicity, genotoxicity and biocompatibility safety test using rabbit eyes and sterility test. We compared the standards of International Organization for Standardization (ISO), Food and Drug Administration (FDA) of the United States, Ministry of Health, Labor and Welfare (MHLW) of Japan and Ministry of Food and Drug Safety (MFDS) of Korea. RESULTS: The guidelines for tinted soft contact lenses of ISO, FDA and MFDS are similar to soft contact lenses but MHLW of Japan classifies these lenses and sets specific guidelines. First, the oxygen permeability coefficient measured at 6mm from the center should be maintained over 80%. Also, coloring should not affect the oxygen permeability coefficient significantly. Regarding the physical (form and appearance, diameter, curvature radius, moisture content) and optical (vertex power, cylindrical refractivity and cylindrical axis, luminous/UV transmittance, oxygen permeability coefficient) characteristics, no differences were found between ISO and MFDS. However, several differences were found in chemical characteristics (extractables, elution test) and biological stability (cytotoxicity, sensitization, eye irritation test, acute systemic/subchronic/subacute toxicity test, genotoxicity, biocompatibility safety test using rabbit eyes, sterility test). For example, the elution test is required only by MFDS. CONCLUSIONS: The reinvestigation into the effectiveness of the elution test is needed and new evaluation measures including scanning electron microscopy and atomic force microscopy designed for tinted soft contact lenses to evaluate the size of the optical area, the location and roughness of the pigmented layer are required.

Diversity, Utility, Analytical Methods and Use Implications of Aroma-active Compounds from Select Angiosperm Familie.

Introduction: An “aroma-active compound” (AAC) has a “flavor”- ie: a “distinct taste and odor”. An example is menthol. All aromatic plants (APs), including some medicinal plants, such as Mentha×piperita (Family Lamiaceae), produce a group of fat-soluble secondary metabolites called “essential oils” (EOs) for various ecophysiological reasons. An EO has a “flavor” because it contains one or more AACs. A typical EO is a complex mixture of several AACs, with wide ranging, dose-dependent pharmacological/ toxic effects. Owing to their complexity and variability, many EOs need to be standardized to ISO’s criteria. Professional use of EOs/ AAPs in food and drugs is controlled by good manufacturing practice (GMP). Aim: Given the immense diversities in sources, chemical structures, and bioactivities of EOs/ AACs, which are greatly patronized in foods and drugs, this review focused on their: i) sources in plants, beneficial attributes and liabilities; and ii) chemistry and analytical methods, in order to gain a better insight into their regulation in foods and drugs. Methodology: Using the 2009 Angiosperm Phylogenic Grouping (APG) of plants as a guide, pertinent literature was perused to ascertain: i) the taxa of APs; ii) their EOs/ AAPs; and iii) the methods for analyzing EOs/ AACs in raw materials (RMs) and finished products (FPs). Results: The literature revealed scores of AACs with varying health implications. But their levels in samples are usually unknown, or extremely hard to ascertain, owing to costs and complexities of the methods used. Conclusions: Given the wide ranging effects of EOs/ AAPs vis-à-vis the dearth of data on their levels in samples, it is recommended that their regulation in FPs should focus on: i) controlling the wholesomeness of RMs; and ii) on enforcing strict GMP in using such RMs. Meanwhile relevant agencies should sponsor research into more cost-effective methods.

Standardization development in ISO/TC 249 related to acupuncture and moxibustion / 全日本鍼灸学会雑誌

It has been five years since TC 249 was established as a new Technical Committee (TC) at the International Organization for Standardization (ISO), specializing in the field of Chinese traditional medicine. In the second Plenary Meeting held in Den Haag (2011), five working groups (WGs) were established within the TC, two of which specialize in standard development of acupuncture needles (WG3) and other medical devices used in traditional medicine (WG4). Japanese delegates have participated in the discussion within these WGs, paying close attention so as to keep the proposals under discussion consistent with existing Japanese standards and certification standards regulated by the Ministry of Health, Labour and Welfare. However, since most of the participants in TC 249 are clinicians or researchers engaged in medical practices, and not experts on domestic/international standards, discussions on harmonization of the submitted projects often become complicated. In this manuscript, four experts (two from academia and two from companies that manufacture acupuncture needles and moxibustion devices) who attended the fourth plenary meeting held in Durban, South Africa, in May 2013, report on the stage of progress of standardization development in WG3and WG4.

Towards equal partnership and evaluation of the international organizations: Lessons learnt from JICA projects on polio eradication in Laos / 国際保健医療

As globalization has been accelerated, the partnership is getting important in the international society. JICA projects in Laos on "Public health" and "Pediatric infectious disease prevention" had achieved its goal of regional polio eradication under the strong partnership with Laos government, JICA, WHO and UNICEF. The global commitment at the WHO assembly contributed to the achievement by sharing common goal and partnership, which enabled to draw sufficient financial supports. However, in general, fewer efforts have been done among Japanese researchers/experts to examine the appropriateness of top-down global health policies. JICA should break away form the power of ministries which possess huge vested interests in ODA business so that the agency can find and address problems actively in the project sites. In this way, as one of influential nations in Asia, we can build equal partnerships in the international society, respecting diversity of environment and cultures of developing countries. It is also important to evaluate the funding flows and activities of the international organizations, which have been widely criticized for being lack of transparency.

Discussion of GMP Certification in Pharmaceutical Enterprise after 2004 in China / 中国药房

OBJECTIVE:To predict the trend of Good Manufacturing Practice(G MP)certification in China after2004.METHODS:The development and the current situation of GMP certification were summarized,the problems as well as the suggestions were put forward.RESULTS&CONCLUSIONS:GMP certification after2004should be integrated with Inter?national Organization for Standardization(ISO),the domain correlated drug and"Good Agricultural Practices"(GAP),it should be design rational project of GMP certification on the basis of specificity of enterprises in China.