Prevalence and influencing factors of work-related musculoskeletal disorders among workers in chemical pharmaceutical industry / 环境与职业医学

Background Work-related musculoskeletal disorders (WMSDs) are one of the major occupational health problems in the world. Pharmaceutical industry is an important part of China's national economy. At present, there are few related studies reported at home and abroad. Objective To investigate the status and influencing factors of WMSDs in chemical pharmaceutical industry. Methods A cross-sectional epidemiological survey was conducted among all workers from three chemical pharmaceutical enterprises in Guangzhou. The Musculoskeletal Disorders Questionnaire was used to collect information on demographic characteristics, symptoms of musculoskeletal disorders, types of work, work organization, and and work postures. Multiple logistic regression method was used to analyze the risk factors of WMSDs in chemical pharmaceutical workers. Results In this study, 563 workers were selected as subjects. The total prevalence rate of WMSDs symptoms in the chemical pharmaceutical workers was 43.9% (247/563), and the leading body part-specific prevalence rate from high to low was 34.3% in the lower back, 24.3% in the upper back, 24.0% in the shoulders, and 23.8% in the neck. The prevalence rate of WMSDs symptoms in multiple body parts (30.0%) was 2.16 times higher than that in single body part (13.9%), and the prevalence rate of WMSDs symptoms in four body parts was the highest (11.4%). The results of multiple logistic regression analysis showed that age ≥50 years (reference age <30 years) (OR=2.140, 95%CI: 1.054-4.345), often or very often (reference never/rarely) long-time head rotating (OR=2.695, 95%CI: 1.753-4.142) and long-time keeping arms above shoulders (OR=1.902, 95%CI: 1.108-3.265) increased the risk of reporting WMSDs symptoms (P<0.05). Regarding education level, workers with high school and technical secondary school (OR=0.333, 95%CI: 0.175-0.636) or college and above (OR=0.413, 95%CI: 0.216-0.790) education had a lower risk of reporting WMSDs symptoms than those with middle school or below (P<0.05). Conclusion The prevalence rate of reporting WMSDs symptoms in chemical pharmaceutical industry is high, the involving body parts are lower back, upper back, shoulders, and neck, and reporting simultaneous occurrence of WMSDs symptoms in multiple body parts is common. The chemical pharmaceutical manufacturers can reduce the risk of WMSDs by strengthening the training on workers' ergonomics knowledge, paying attention to the less educated personnel, protecting the elderly workers, and avoiding awkward work postures, like rotating head for a long time and raising arms over shoulders.

Lean strategy for data mining and continuous improvement of Chinese pharmaceutical process: a case study of sporoderm-removal Ganoderma lucidum spore powder / 中国中药杂志

In the digital transformation of Chinese pharmaceutical industry, how to efficiently govern and analyze industrial data and excavate the valuable information contained therein to guide the production of drug products has always been a research hotspot and application difficulty. Generally, the Chinese pharmaceutical technique is relatively extensive, and the consistency of drug quality needs to be improved. To address this problem, we proposed an optimization method combining advanced calculation tools(e.g., Bayesian network, convolutional neural network, and Pareto multi-objective optimization algorithm) with lean six sigma tools(e.g., Shewhart control chart and process performance index) to dig deeply into historical industrial data and guide the continuous improvement of pharmaceutical processes. Further, we employed this strategy to optimize the manufacturing process of sporoderm-removal Ganoderma lucidum spore powder. After optimization, we preliminarily obtained the possible interval combination of critical parameters to ensure the P_(pk) values of the critical quality properties including moisture, fineness, crude polysaccharide, and total triterpenes of the sporoderm-removal G. lucidum spore powder to be no less than 1.33. The results indicate that the proposed strategy has an industrial application value.

Analysis of Lean Six Sigma Use in Pharmaceutical Production

Abstract Over the last years, pharmaceutical industries have adopted continuous improvement and operational excellence programs to optimize processes, improve quality and reduce operational costs. Worldwide, Lean Manufacturing (LM) and Six Sigma (SS), as well as the integration of the two methods: Lean Six Sigma (LSS) are the most used approaches in the continuous improvement of industries and services. This work aims to investigate the employment of the Lean Six Sigma methodology in the productive areas of pharmaceutical companies located in Brazil. Interviews were conducted with managers of pharmaceutical industries that apply the approach. The results indicated the greater use of Lean Manufacturing tools compared to Six Sigma and the influence of specific peculiarities of the pharmaceutical industry on the benefits that are achieved with the use of Lean Six Sigma. The approach is considered of great value as it provides substantial benefits to the pharmaceutical industry. It is concluded that the work corroborates to the theoretical and empirical knowledge about the methodology use in the context of Brazilian pharmaceutical industries, as well as contributes to the implementation, reformulation, and improvement of Lean Six Sigma programs in this industrial segment.

Na saúde e na doença: o trabalho na produção de medicamentos / In sickness and in health: labor in the production of medicines / En la salud en la enfermedad: el trabajo en la producción de medicamentos

Resumo Este artigo analisa a percepção dos trabalhadores sobre o ambiente de trabalho nas indústrias farmacêuticas com base em um estudo qualitativo composto por entrevistas semiestruturadas com trabalhadores do setor. Em posição antagônica ao cenário nacional de desindustrialização e desemprego, a produção de medicamentos segue em ascensão, em termos tanto de faturamento como de abertura de postos de trabalho, mesmo diante das recentes crises econômica e sanitária. Para compreender o modelo de produção da indústria farmacêutica e seus impactos na vida das pessoas que laboram no setor, foram entrevistados dez trabalhadores/as de duas fabricantes nacionais de medicamentos genéricos localizadas no Distrito Agroindustrial de Anápolis, em Goiás. Como resultado, observamos que as indústrias estudadas estão configuradas de acordo com formas sofisticadas de controle e intensificação da produção, o que deflagra um ambiente de trabalho passível de degradação da saúde física e mental.

Abstract This article analyzes the perception of workers about the working environment in pharmaceutical industries based on a qualitative study composed of semi-structured interviews with workers in the sector. In an antagonistic position to the national scenario of deindustrialization and unemployment, the production of medicines continues to rise, in terms of both billing and job opening, even in the face of recent economic and health crises. To understand the production model of the pharmaceutical industry and its impacts on the lives of people working in the sector, ten workers from two national manufacturers of generic medicines were interviewed located in the Agroindustrial District of Anápolis, in Goias (Brazil). As a result, we observed that the studied industries are configured according to sophisticated forms of control and intensification of production, which triggers a work environment that can degrade physical and mental health.

Resumen Este artículo analiza la percepción de los trabajadores sobre el entorno laboral en las industrias farmacéuticas, basado en un estudio cualitativo compuesto por entrevistas semiestructuradas con trabajadores del sector. En una posición antagónica al escenario nacional de desindustrialización y desempleo, la producción de medicamentos sigue en aumento, en términos de facturación y apertura de puestos de trabajo, incluso frente a las recientes crisis económicas y sanitarias. Para comprender el modelo de producción de la industria farmacéutica y sus impactos sobre la vida de las personas que trabajan en el sector, se entrevistó a dos trabajadores/as de dos fabricantes nacionales de medicamentos genéricos ubicados en el distrito agroindustrial de Anápolis, en Goiás (Brasil). A consecuencia, observamos que las industrias estudiadas están configuradas de acuerdo con sofisticadas formas de control e intensificación de la producción, lo que desentora un entorno de trabajo que puede degradar la salud física y mental.

Good Clinical Practice (GCP) – an alternative, unarticulated narrative

GCP has become the gold-standard for clinical research; initiated as a guideline pertaining to new drug development, it became a law in many countries, extending its scope to include all research. GCP is an excellent document that outlines the responsibilities of stakeholders involved in clinical research. Widely acclaimed, and deservedly so, it is considered as the “go-to” document whenever questions arise during the conduct of a clinical trial. This article presents another narrative, one that has not been articulated so far. Irrespective of whether we consider GCP as a law or a guideline, it is viewed as an “official” document, without the overt realisation that this was actually an initiative of the pharmaceutical industry, the “masters of mankind”. While the stress on documentation and monitoring in GCP was justified, its over-interpretation led to increased costs of clinical trials, with the result that smaller companies find it difficult to conduct the already expensive trials. GCP as an idea is now so entrenched within the scientific community that the real aims which led to its birth and that can be mined from the ICH website, like the need for market expansion, have remained largely unnoticed and undocumented, and are being expressed here.

Las empresas en la investigación sobre las innovaciones en medicamentos

Propósito/Contexto. El papel de la industria farmacéutica se puede examinar desde múltiples ángulos. La presencia de estas empresas durante la pandemia ha sido obligada por la necesidad de contar, en el menor tiempo posible, con vacunas capaces de prevenir los contagios y medicamentos efectivos de tratar a los afectados, es decir, el desarrollo de productos innovadores. Metodología/Enfoque. Desde una perspectiva bioética se reflexiona sobre cuatro temas conexos con el rol de estas empresas en circunstancias análogas: las responsabilidades de los patrocinadores en los procesos de investigación; la contratación con las organizaciones de investigación por contrato (CRO); la relación con los investigadores y la interacción con los comités de ética en investigación (CEI) y, finalmente, sobre una manera de contener el doble estándar en investigación. Resultados/Hallazgos. Los patrocinadores tienen responsabilidades precisas que están orientadas por documentos y pautas internacionales. También hay una necesidad de tener una mayor claridad en el trabajo de las CRO y los investigadores pueden mejorar la interacción con los CEI; además, debe evitarse el dumping ético. Discusión/Conclusiones/Contribuciones. Se concluye que la industria farmacéutica tiene un papel de corresponsabilidad en los procesos de producción de medicamentos innovadores con los demás actores, con quienes ha de mantener un diálogo transparente y fluido, y debe orientarse no solo por las guías de buenas prácticas clínicas, sino principalmente por la Declaración de Helsinki. Un medio puede ayudar en la eliminación del doble estándar en investigación: el Código Trust, así las empresas farmacéuticas pueden contribuir a mejorar la cultura ética de la investigación.

Purpose/Background. The role of the pharmaceutical industry can be examined from multiple angles. The presence of these companies during the pandemic has been forced by the need to have, in the shortest possible time, vaccines capable of preventing infections and effective drugs to treat those affected, that is, the development of innovative products. Methodology/Approach. From a bioethical perspective, it reflects on four issues related to the role of these companies in analogous circumstances: the responsibilities of the Sponsors in the research processes; contracting with Contract Research Organizations; the relationship with researchers and interaction with the Research Ethics Committees (IRB); and, finally, on a way to contain the double standard in research. Results/Findings. The Sponsors have precise responsibilities that are guided by international documents and guidelines; there is a need for greater clarity in the work of CROs; researchers can improve interaction with IRBs; ethical dumping must be avoided. Discussion/Conclusions/Contributions. It is concluded that the pharmaceutical industry has a role of co-responsibility in the production processes of innovative medicines with other actors, with whom it must maintain a transparent and fluid dialogue and must be guided not only by the Good Clinical Practice Guidelines, but mainly because of the Declaration of Helsinki. One medium can help eliminate the double standard in research: the TRUST Code; thus, pharmaceutical companies can contribute to improving the ethical culture of research.

Objetivo/Contexto. O papel da indústria farmacêutica pode ser examinado de vários ângulos. A presença dessas empresas durante a pandemia foi forçada pela necessidade de se ter, no menor tempo possível, vacinas capazes de prevenir infecções e medicamentos eficazes para tratar os afetados, ou seja, o desenvolvimento de produtos inovadores. Metodologia/Abordagem. Do ponto de vista bioético, reflete sobre quatro questões relacionadas ao papel dessas empresas em circunstâncias análogas: as responsabilidades dos Patrocinadores nos processos de pesquisa; contratação de Organizações de Pesquisa Contratadas (CRO); o relacionamento com os pesquisadores e a interação com os Comitês de Ética em Pesquisa (CEP); e, por fim, uma forma de conter o duplo padrão na pesquisa. Resultados/Descobertas. Os Patrocinadores têm responsabilidades precisas que são guiadas por documentos e diretrizes internacionais; há necessidade de maior clareza no trabalho dos CROs; os pesquisadores podem melhorar a interação com as CEP; o dumping ético deve ser evitado. Discussão/Conclusões/Contribuições. Conclui-se que a indústria farmacêutica tem um papel de corresponsabilidade nos processos de produção de medicamentos inovadores com os demais atores, com os quais deve manter um diálogo transparente e fluido e deve ser pautada não apenas pelas Diretrizes de Boas Práticas Clínicas, mas principalmente por causa da Declaração de Helsinque. Um meio pode ajudar a eliminar o duplo padrão na pesquisa: o Código TRUST; assim, as empresas farmacêuticas podem contribuir para o aprimoramento da cultura ética da pesquisa.

Application of HACCP for development of quality risk management in a water purification system

Abstract The present work reports the implementation of the Hazard Analysis Critical Control Point (HACCP) methodology to analyze the water purification system of a pharmaceutical site, in order to assure the system quality and prevent failures. As a matter of fact, the use of HACCP for development and implementation of Quality Risk Management (QRM) is not usual in pharmaceutical plants and it is applied here to improve the performance of the water purification system of a polymerization pilot plant used to manufacture pharmaceutical grade polymer microparticles. Critical Control Points (CCP) were determined with the aid of a decision tree and questions were made to characterize whether identified hazards constitute actual CCPs and should be monitored. When deviations were detected, corrective actions were performed and action plans were used for following-up and implementation of corrective actions. Finally, microbiological and physicochemical parameters were analyzed and the obtained results were regarded as appropriate. Therefore, it is shown that HACCP constitutes an effective tool for identification of hazards, establishment of corrective actions and monitoring of the critical control points that impact the process and the quality of the final pharmaceutical product most significantly.

A oferta pública de medicamentos para aids e o papel de Farmanguinhos / Public supply of AIDS drugs and the role of Farmanguinhos

Resumo Este artigo descreve e analisa a participação do Instituto de Tecnologia em Fármacos (Farmanguinhos) na produção local de medicamentos antirretrovirais no Brasil. São também apresentadas as mudanças no padrão de provimento, a situação das parcerias para o desenvolvimento produtivo e a posição dos produtores nacionais para esses medicamentos. As estratégias metodológicas foram revisão bibliográfica, análise de documentos oficiais e dados fornecidos por Farmanguinhos e pelo Departamento de Condições Crônicas e Infecções Sexualmente Transmissíveis do Ministério da Saúde, via Lei de Acesso à Informação. Este artigo mostra que o estabelecimento das parcerias abriu novas perspectivas para o desenvolvimento da política de oferta pública de antirretrovirais para as pessoas vivendo com HIV, por contribuir para a sustentabilidade das despesas financeiras do Ministério da Saúde com medicamentos. Farmanguinhos é o laboratório público que fornece mais quantidades e recebe os maiores valores provenientes do fornecimento desses produtos ao Ministério da Saúde. Embora os medicamentos importados preponderem largamente em quantidade e valores pagos pelo Ministério da Saúde, Farmanguinhos permanece sendo um provedor fundamental na produção local de antirretrovirais. Apesar dos problemas verificados nas Parcerias, os ganhos nas competências tecnológicas na produção de antirretrovirais podem ampliar o horizonte tecnológico e produtivo do laboratório.

Abstract This article describes and analyses the part played by the Instituto de Tecnologia em Fármacos (Farmanguinhos) in local production of antiretroviral medicines in Brazil, as well as changes in the pattern of supply, the status of related Production Development Partnerships and the position of Brazilian producers of these medicines. The methodological strategies used were literature review and analysis of official documents and data provided by Farmanguinhos and by the Ministry of Health's Department of Chronic Conditions and Sexually Transmitted Infections, via the Information Access Law. This article shows that, by contributing to the sustainability of Ministry of Health expenditure on medicines, these partnerships have opened new prospects for developing the policy of public supply of antiretrovirals for people living with HIV. Farmanguinhos is the public laboratory that supplies the largest quantities of these products to the Ministry of Health and receives the largest revenues from supplying them. Although the imported medicines supplied to the Ministry of Health account for much larger quantities and revenues, Farmanguinhos continues to be a fundamentally important supplier of locally produced antiretrovirals. Despite the problems found in establishing the partnerships, the gains in antiretroviral production technology competences can broaden the laboratory's technological and production horizons.

Study on resource carrying capacity of pharmaceutical industry in various regions of China based on entropy weight TOPSIS method / 中国药房

OBJECTIVE To provide reference for improving resource carrying capacity of pharmaceutical industry and guaranteeing the healthy and sustainable development of pharmaceutical industry of China. METHODS The evaluation system of resource carrying capacity was constructed ，including 4 primary indicators and 17 secondary indicators. The data of above indicators were selected from 31 provinces（autonomous regions and municipalities ）（hereinafter referred to as provinces ）of China during 2013-2020. The index weight and regional relevance were calculated by entropy weight technique for order preference by similarity to ideal solution（TOPSIS）method. RESULTS & CONCLUSIONS The weights of 4 primary indicators were 0.182 0 （industrial scale ），0.349 5（industrial innovation resources ），0.211 5（economic resources ）and 0.257 1（industrial development foundation）. It indicated that industrial innovation resources were the main factor affecting the resource carrying capacity of pharmaceutical industry ，followed by industrial development foundation and economic resources ，and the impact of industrial scale was the least. From 2013 to 2016 and from 2018 to 2020，the average closeness of the pharmaceutical industry in China ’s provinces were 0.259 6，0.267 1，0.253 6，0.249 9，0.250 5，0.248 5 and 0.252 0，respectively. It indicated that the resource carrying capacity of China ’s pharmaceutical industry showed a stable development trend ，but the overall development was in low level. The top 5 regions in terms of closeness of carrying capacity were Jiangsu ，Guangdong，Shandong，Zhejiang and Beijing ；the regions in the bottom 5 were Gansu ，Hainan，Qinghai，Tibet and Ningxia. Overall ，the resource carrying capacity of China ’s pharmaceutical industry showed a gradual decreasing trend from the eastern coastal area to the western inland area. For the provinces with the highest resource carrying capacity of pharmaceutical industry ，further development can be carried out on the basis of maintaining the original carrying capacity ；for the provinces with the middle resource carrying cap acity of p harmaceutical industry ，enhancing the development potential and improving the industrialfoundation are the main methods to improve the resource carrying capacity of pharmaceutical industry ；for the provinces wangjl@126.com with low resource carrying capacity of pharmaceutical industry ， it can be considered to start from their own unique advantages ， make full use of characteri stic industrial resources ，form a characteristic industrial foundation ，actively promote interregional cooperation ，implement regional cluster development and improve the resource carrying capacity of pharmaceutical industry.

Research on the development of bio-pharmaceutical industry integration and collaborative innovation in the Yangtze River Delta under the mode of Industry-University-Research cooperation / 中国药科大学学报

@#After the integration of Yangtze River Delta was elevated and developed into a national strategy, few domestic studies have been conducted to explore the integrated and collaborative development of biopharmaceutical industry in the Yangtze River Delta region, which, as an important region of biopharmaceutical industry in China, has initially formed the development mode of industrial clusters. In this study, based on the industry-university-research model of patent and fund project cooperation, the social network analysis (SNA) method is used to analyze and study the cooperation of patent and Major Projects of National Natural Science Foundation of China in the biopharmaceutical industry in the Yangtze River Delta region. The study shows that the industry-university-research cooperation in the biomedical field in the Yangtze River Delta region is still in the development stage and the degree of integration needs to be improved. Universities and research institutes are more inclined to cooperate with enterprises for invention patents and with other universities for fund project research.It is suggested that the Yangtze River Delta region should adopt the deep integration mode of industry-university-research, relevant leading scientific research institutions should establish open innovation platforms, and pharmaceutical universities should cultivate innovative talents with the advantages of their disciplines, and adopt "Revealing the List and Taking Command" or other ways to tackle key core technologies.

Empirical analysis on the regional characteristics and trend of pharmaceutical industry transfer in China / 中国药房

OBJECT IVE To provide reference for relevant decision-makers to formulate policies to guide the transfer of pharmaceutical industry. METHODS Using the statistical data from 2000 to 2019，taking industrial transfer index as index ，on the basis of 4 regions，our country was divided into 8 comprehensive economic areas ：the eastern coastal area ，the southern coastal area，the northern coastal area ，the middle reaches of the Yellow River area ，the middle reaches of the Yangtze River area ，the northeast area ，the southwest area and the northwest area. The regional characteristics and regularity of China ’s pharmaceutical industrial transfer were discussed in terms of space and time. RESULTS & CONCLUSIONS From 2004 to 2019，among the 31 provinces，pharmaceutical industry was transferred in 19 provinces，including Jilin ，Shandong，Henan and Gansu ，accounting for 61.3％；pharmaceutical industry was transferred out in 12 provinces，including Hebei ，Beijing，Xinjiang and Hubei ，accounting for 38.7％. There were 12 provinces whose absolute average values of industrial transfer index were greater than 0.2，indicating that China’s pharmaceutical industry had undergone large-scale migration among provinces ，and the scale of pharmaceutical industrial transfer varied significantly among provinces. From the perspective of regional distribution ，4 pharmaceutical industrial transfer-in centers had been formed in China ，the eastern coastal area ，the northeast area ，the middle reaches of the Yangtze River area and the southern coastal area ；industrial transfer followed the location selection mode from within areas to between areas. From the perspective of time change trend ，there was a phenomenon of gradient deviation in the transfer of pharmaceutical industry in various areas of China ，and there are 5 evolution types ，mainly including “up and down fluctuation ”，“first decrease and then increase”，“first increase and then decrease ”；the transfer of pharmaceutical industry was active in most areas ，and the transfer path remained relatively stable. In some areas ，the roles of transfer-out place and transfer-in place had been exchanged. According to the scale and trend of industrial transfer ，each area should formulate guiding policies to realize the coordinated development of inter-regional pharmaceutical industry.

Rol regulador del estado peruano en ensayos clínicos: las autorizaciones. Estudio cualitativo

Objetivos : Explicar el rol del Estado Peruano relacionado a los procesos participativos de los diversos actores que influyen en la regulación concerniente a la autorización de ensayos clínicos (EC). Metodología : Se presenta parte del estudio de caso correspondiente a una tesis de doctor llevada a cabo entre los años 2015 y 2017. Se utilizó información documental y se realizaron 14 entrevistas semiestructuradas a informantes claves. También se sistematizaron experiencias relacionadas a la autorización e inspección de ensayos clínicos, así como la verificación de centros de investigación. Se contó también con la información pública disponible del Instituto Nacional de Salud del Perú. El análisis se realizó dentro de un marco epistemológico y hermenéutico con la aprobación del Comité de Ética de la Facultad de Medicina de San Fernando. Resultados : Los temas identificados fueron los siguientes: demora en los tiempos regulatorios que autorizan los ensayos, aumento de las no autorizaciones en un determinado lapso de 3 años, suspensión de las autorizaciones para ejecutar EC en niños, lo que llevó a una progresiva reducción de las solicitudes y por consiguiente de los ensayos clínicos desde el año 2009 en adelante. Conclusiones : En el estudio realizado, la regulación del Estado Peruano en cuanto a la autorización de EC se ha debilitado al reducir el ejercicio de ciudadanía en salud de los participantes y las fortalezas de algunos actores, particularmente la generación de competencias de los investigadores para desarrollar EC.

Objectives : To explain the role of the Peruvian Government related to participation of different stakeholders influencing regulations for authorizing clinical trials (CT). Methodology : We present part of a case study corresponding to a PhD thesis performed between 2015 and 2017. We used document information and 14 semi-structured interviews with key informants were performed. We also systematized experiences related to clinical trial authorization and inspection, as well as verification of investigation sites. We also had access to publicly available information from the Peruvian National Institute of Health. The analysis was performed within epistemological and hermeneutical frameworks, and it was approved by the Ethics Committee from San Fernando Public Medicine School. Results : Issues identified were as follows: Delay in regulatory times authorized for CTs; suspension of authorizations for performing CTs in children, which led to progressive reduction in requests and consequently to a reduction in CTs from 2009 on. Conclusions : According to this study, regulations by Peruvian authorities have weakened, since participants and some stakeholders are not able to exert their rights, particularly with respect to competence generation for researchers when trying to develop CTs.

Global market for veterinary herbal products during the 2018-2019 period / Mercado mundial de produtos fitoterápicos veterinários durante o período 2018-2019

The industrial manufacturing of natural products for veterinary use represents a major weakness in the veterinary sector despite increased interest and the traditional ancestral knowledge that supports them. A cross-sectional, descriptive observational study was conducted to characterize the veterinary herbal products marketed worldwide during 2018 and 2019. A comprehensive thematic search limited to the 2018-2019 period was performed in the ScienceDirect, Scopus, PubMed, Web of Science, ResearchGate, and Academic Search Complete databases. The investigation identified 487 products registered in the global market manufactured by 54 companies, led by India, The Netherlands, and the United Kingdom. The market segments of animal production and phytomedicines were dominant with 73.7% and 53.0% of products, respectively. Cattle (22.2%), sheep-goats (16.2%), and canines (16.2%) were the most favored species. The most represented therapeutic indications were those intended to treat gastrointestinal disorders (30.47%), antimicrobials (16.66%), and antiparasitic agents (10.47%). The families Fabaceae, Lamiaceae, Asteraceae, Apiaceae, Malvaceae, and Rutaceae stood out because of their frequent use, encompassing 35.0% of the 137 declared species. Andrographis paniculata (Burm.f.) Nees and Withania somnifera (Lin) Dunal were the most important species. Oral formulations for internal use (72%) and liquids (51%) in 100 mL, 500 mL, and 1 L presentations showed the highest prevalence on the market. The global market for veterinary herbal products during the 2018-2019 period was relevant in the productive and medical animal sector. No differences were found between medicinal plant species used to formulate herbal products for human and animal use.(AU)

A fabricação industrial de produtos naturais para uso animal é uma das grandes fragilidades do setor veterinário, apesar de um crescente interesse e do suporte dado pelos conhecimentos tradicionais ancestrais. Foi realizado um estudo observacional descritivo transversal para caracterizar os fitoterápicos veterinários comercializados mundialmente no período de 2018-2019 através de uma busca temática exaustiva nas bases de dados ScienceDirect, Scopus, PubMed, Web of Science, ResearchGate e Academic Search Complete. O estudo mostrou a existência de 487 produtos registrados no mercado mundial, fabricados por 54 empresas, lideradas pela Índia, Holanda e Reino Unido. Os segmentos Danimal produtivo e fitomedicamentos dominam o mercado com 73,7% e 53,0% dos produtos, respectivamente. Bovinos (22,2%), ovinos-cabras (16,2%) e caninos (16,2%) foram as espécies mais favorecidas. As indicações terapêuticas mais representadas foram aquelas destinadas à correção de distúrbios gastrointestinais (30,47%), antimicrobianos (16,66%) e antiparasitários (10,47%). Devido à alta frequência de uso, destacam-se as famílias Fabaceae, Lamiaceae, Asteraceae, Apiaceae, Malvaceae e Rutaceae, que compreendem 35,0% das 137 espécies declaradas a saber, Andrographis paniculata(Burm.f.) Nees e Withania somnífera (Lin) Dunal, são as mais importantes. Constatou-se que as formulações para uso interno via oral (72%) e líquida (51%) em embalagens de 100, 500 e 1000 mL são as que prevalecem no mercado. O mercado global de produtos fitoterápicos durante o período de 2018-2019 foi relevante para animais produtivos e o setor médico. Não foram encontradas diferenças entre as espécies de plantas medicinais utilizadas em formulações de produtos fitoterápicos para uso humano e animal.(AU)

A banalidade do mal psicofarmacológico em tempos de performance / La banalidad del mal psicofarmacológico en tiempos de performance / La banalité du mal psychopharmacologique en temps de performance / The banality of psychopharmacological evil in times of performance

Resumo Este artigo tem por objetivo percorrer um caminho que parte da identificação do fenômeno da medicalização da vida. O estudo será organizado dentro de uma perspectiva genealógica, na medida em que é importante localizar que este objeto de estudo não se restringe apenas a uma questão médica, mas exige um esforço de articulação com outras áreas do saber. Assim, esta genealogia articula questões médicas com a crítica social acerca desse fenômeno, aliando medicina, sociologia, psicologia, economia e teoria política. O desenvolvimento será organizado tendo como pano de fundo as exigências de autonomia e performance na atualidade, no contexto do aumento da demanda psicofarmacológica. Se os benefícios da administração medicamentosa podem propiciar bem-estar subjetivo, por outro lado, os excessos ou a banalidade do mal psicofarmacológico tornam opacas as fronteiras entre o normal e o patológico.

Resumen Este artículo pretende seguir un camino que parte de la identificación del fenómeno de la medicalización de la vida. El estudio se organizará dentro de una perspectiva genealógica, debido a la importancia de conocer que este objeto de estudio no se limita a un tema médico, sino que requiere un esfuerzo para articularse con otras áreas del conocimiento. Así, esta genealogía articula la problemática médica con la crítica social sobre este fenómeno, combinando la medicina, la sociología, la psicología, la economía y la teoría política. Esta trama se organizará en el contexto de las demandas de autonomía y desempeño de la actualidad, en el contexto de una mayor demanda psicofarmacológica. Si, por un lado, los beneficios de la administración de medicamentos pueden proporcionar un bienestar subjetivo, por otro, los excesos o la banalidad del mal psicofarmacológico hacen que los límites entre lo normal y lo patológico sean opacos.

Résumé Cet article retrace un chemin qui commence par l'identification du phénomène connu sous le nom de médicalisation de la vie. Puisque cet objet d'étude n'est pas seulement une question médicale, nécessitant une articulation avec d'autres domaines de connaissance, l'étude propose une généalogie qui articule la critique médicale et sociale sur ce phénomène, en combinant la médecine, la sociologie, la psychologie, l'économie et la théorie politique. Cette tapisserie est tissé sur fond d'exigences actuelles d'autonomie et de performance, dans un contexte de demandes psychopharmacologique croissantes. Si les bénéfices de l'administration de médicaments peuvent procurer un bien-être subjectif, les excès ou la banalité du mal psychopharmacologique, en revanche, brouille les frontières entre normal et pathologique.

Abstract This paper traces a path that begins by identifying the phenomenon known as medicalization of life. Since this object of study is not only a medical issue, requiring an articulation with other areas of knowledge, the study proposes a genealogy that articulates medical and social criticism on this phenomenon, combining medicine, sociology, psychology, economics, and political theory. Such tapestry is weaved against the backdrop of current demands for autonomy and performance, in the context of increasing psychopharmacological urges. If the benefits of drug administration can provide subjective well-being, the excesses or the banality of psychopharmacological evil, on the other hand, blur the boundaries between normal and pathological.

Practice and analysis of international applications for scientific and technological innovation achievements in research hospitals: Take Zhongshan Hospital, Fudan University as an example / 中华医学科研管理杂志

Objective:With the fast increasing of patent applications and authorizations in the field of pharmaceutical industry in China, it is of great significance to deploy the international market in advance. This study takes the overseas patent application work of Zhongshan Hospital, Fudan University as an example, to explore feasible methods that suitable for research-oriented hospitals to help high-value patents enter the international market.Methods:Based on the working procedures and common ways of overseas patents declared by Zhongshan Hospital, Fudan University from 2018 to 2020, this study analyzes the process of international applications of scientific of technological innovation achievements of research-oriented hospitals and summarizes the elements of patent application through working practices.Results:A standardized international patent application approach in public hospitals should include the following six parts: value evaluation before international patent filing, selection of the country when entering the national phase, professional assistance of patent agency company, hospital internal audit process, multi-channel access to intellectual property management and operating capital support, professional talent team construction.Conclusions:A set of standardized procedures for the application of overseas patents in Zhongshan Hospital, Fudan University can help high-value patents enter the advanced market, which is operable and worthy for further generalization in other research hospitals.

Study on Technological Innovation System of Pharmaceutical Industry in Fujian Province ：Based on System Causal Loop Diagram and Problem Basic Model Analysis / 中国药房

OBJECTIVE：To p rovide reference for improving the level of technological innovation and promoting the high-quality development of pharmaceutical industry in Fujian province. METHODS ：A total of 452 people were interviewed by relevant departments of pharmaceutical industry ，industry associations ，pharmaceutical enterprises and some consumers in Fujian province. After sorting out the interview data ，based on the theory of causal loop diagram and problem basic model methods ，the key variables and problem basic models affecting the technological innovation system of pharmaceutical industry in Fujian province were investigated . The leverage solutions and suggestions were put forward. RESULTS & CONCLUSIONS：The scientific and technological innovation environment ，managers’innovative ideas ，scientific and technological innovation motivation ，enterprise profits，product’s market competitiveness ，social organizations of pharmaceutical industry ，and industrialization of scientific and technological innovation achievements in the technological innovation system of pharmaceutical industry in Fujian province were closely related to the technological improvement of pharmaceutical industry in Fujian province. There were basic modes of “the rich getting richer ”for the technological innovation system of pharmaceutical industry in Fujian province ，i.e. the investment of external resources on scientific and technological innovation of pharmaceutical enterprises was mostly concentrated in the pharmaceutical enterprises above designated size. At the same time ，due to the lack of industry-research-university interaction and the unsmooth achievement transformation channel ，some small and medium-sized pharmaceutical enterprises with the potential of scientific and technological innovation or with traditional advantages may form the problem basic model “to attend to trifles and neglect the essentials”. It is suggested that the subjects related to pharmaceutical industry should give full play to the role of various scientific and technological platforms ，strengthen the attention and support to innovative small and medium-sized pharmaceutical enterprises ， create and optimize the financial service environment for scientific and technological innovation of pharmaceutical enterprises ，and support pharmaceutical enterprises with innovation power and potential to carry out technological innovation projects.

The Influence of Technology Innovation Investment on Financial Performance of Pharmaceutical Enterprises Based on Threshold Effect / 中国药房

OBJECTIVE： To provi de reference for relevant departments to formulate innovation subsidy policies for pharmaceutical enterprises and enterprises to make their own business strategy decisions. METHODS ：The listed enterprises in China ’s pharmaceutical industry listed before 2012 were selected as the sample enterprises. The annual reports of listed enterprises in pharmaceutical industry and related panel data in CSMAR database during 2012-2019 were colected. Referring to related literatures ， multivariate regression model and threshold model were established to investigate the effects of technology innovation investment ability of sample enterprises ，so as to put forward relevant suggestions. RESULTS & CONCLUSIONS ：A total of 57 sample enterprises were included. The panel data of sample enterprises showed that the technology innovation investment of Chinese pharmaceutical enterprises was basically increasing year by year ，but compared with international standards ，the technology innovation investment of Chinese pharmaceutical enterprises still needed to be improved. The results of multiple regression model showed that the technology innovation investment of pharmaceutical enterprises had no significant impact on their current financial performance and the financial performance of the first and second lags （P＞0.05）. The results of threshold model showed that there was a significant single threshold effect between technology innovation investment and financial performance when enterprise size was taken as the threshold variable （P＜0.05）. When the enterprise size was less than the threshold value of 20.986，the enterprise ’s technology innovation investment had a negative impact on its financial performance （P＜0.05）；when the enterprise size was greater than the threshold value of 20.986，the correlation between the enterprise ’s technology innovation investment and financial performance was not significant （P＜0.05）. It is suggested that China ’s pharmaceutical enterprises should carry out technology innovation activities according to their own strength ，and enterprise managers should formulate different innovation development strategies according to the ac tual situation ，enable enterprises to maintain a reasonable capital structure by broadening financing channels ，identify innovation points according to their own ability ，reduce costs and risks ，and innovate R&D modes，so as to promote the transformation and effective utilization of R&D achievements. Government departments should give full play to the guiding role ，encourage pharmaceutical enterprises to maintain the vitality of R&D and innovation and guide the sustainable innovation and healthy development of the pharmaceutical industry.

Study on Performance Indicator System of Green Supply Chain in Pharmaceutical Industry / 中国药房

OBJECTIVE： To provide refe rence for improving the performance of drug supply chain and sustainable development of the pharmaceutical industry in China . METHODS ：By collecting literatures and combining with the characteristics of drug supply chain ，the questionnaire was designed with Likert 5 scale. After the questionnaire was tested and modified by 10 experts，a preliminary index system framework was formed. The formal questionnaire was prepared by the questionnaire test method；37 experts were consulted by Delphi method ，the index weight was determined by AHP method ，and the index reliability was tested by statistical analysis method ；finally，a pharmaceutical enterprise was taken as an example to measure the index system. RESULTS ：The positive coefficient of the first round of expert consultation was 100％，and that of the second round was 94.59％；average degree of authority of experts was 0.832 6；expert coordination coefficient of the first round was 0.218 2，and that of the second round was 0.396 5. The green supply chain performance indicator system of the pharmaceutical industry included 6 first-level indicators and 26 second-level indicators ，such as drug greenness ，green marketing ，operation process ，drug quality ， drug safety and drug economy. The consistency ratio of the first-level indexes and all second-level indexes were all less than 0.1， the overall Cronbach ’s α coefficient of the index system was 0.892 1. The measured results of a pharmaceutical enterprise showed that the highest score of the pharmaceutical enterprise was the “drug quality ”index，with an absolute score of 3.962 7；the lowest score was the “drug greenness ”index，with an absolute score of 2.297 9. The green supply chain performance evaluation score was 3.167 8，which was at a medium level. CONCLUSIONS ：The established index system has good reliability and validity ，and is expected to provide reference for the performance evaluation of green supply chain in China ’s pharmaceutical industry.

Los médicos y la industria farmacéutica: impacto sobre actitudes y hábitos de prescripción / Physicians and the pharmaceutical industry: impact on prescription attitudes and habits

Resumen Introducción: La relación médico-industria farmacéutica (IF) se ha identificado como un problema ético por favorecer conflictos de interés derivados de los beneficios que reciben los médicos y que pueden afectar su juicio clínico. Objetivo: Identificar la frecuencia de participación de médicos en actividades financiadas por la IF, las actitudes de estos profesionales hacia los representantes de la IF, su conducta prescriptiva y la asociación de sus características y del trabajo con la participación en actividades financiadas por la IF. Método: Encuesta transversal a médicos internistas y cardiólogos. El cuestionario incluyó características de los médicos y centro de trabajo, participación en actividades financiadas por la IF, actitudes hacia los representantes y conducta de prescripción. Resultados: Se analizaron 455 cuestionarios, 78.5 % de los encuestados tuvo conocimiento de la relación médico-IF, la mayoría respondió reunirse con representantes de la IF, 30 % indicó haber recibido subsidios financieros y 10 % consideró que los obsequios afectan su prescripción. Tener conocimiento previo de la relación médico-IF se asoció con menor participación en actividades educativas financiadas por por la IF. Conclusión: Las prácticas y preferencias hacia la IF muestran la necesidad de diseñar estrategias para evitar la prescripción inapropiada.

Abstract Introduction: The physician-pharmaceutical industry relationship has been identified as an ethical problem, due to conflicts of interest motivated by the benefits that doctors receive and that can affect their clinical judgment. Objective: To identify the frequency of physicians participation in activities financed by the pharmaceutical industry (PI), their attitudes towards PI representatives (PIRs), their prescriptive behavior and the association between their characteristics and their workplace with their participation in activities financed by the PI. Method: Cross-sectional survey to internists and cardiologists. The questionnaire included characteristics of the doctors and their workplace, participation in activities financed by the PI, attitudes towards PIRs, and prescription behavior. Results: 455 questionnaires were analyzed; 78.5 % of surveyed subjects were aware of the physician-PI relationship, the majority acknowledged meeting with PIRs, 30 % indicated having received financial subsidies and 10 % considered that gifts affect their prescription. Having prior knowledge of the physician-PI relationship was associated with less participation in PI-financed educational activities. Conclusion: Practices and preferences towards the PI show the need to design strategies to avoid inappropriate prescription.

Compartilhamento de risco na saúde suplementar brasileira / Risk sharing in Brazilian supplementary health

Objetivos: Este trabalho discute os recentes impactos do avanço tecnológico no mercado da saúde e a crescente importância do aumento de custos em toda a sua cadeia e investiga uma alternativa para aumentar o acesso a essas novas tecnologias por um maior número de pessoas na saúde suplementar. Nesse contexto, o objetivo geral proposto para este trabalho foi evidenciar as visões de gestores de saúde com papel de destaque no Brasil a respeito do uso de modelos de compartilhamento de risco (risk sharing) em diferentes geografias e em diferentes financiadores no sistema. Pretendeu-se aprofundar o tema com o cumprimento dos seguintes objetivos específicos, também sob a perspectiva dos participantes da pesquisa: verificar a utilização desses modelos de pagamento e, consequentemente, determinar as características e adaptações necessárias a eles; identificar os desafios para a consolidação do risk sharing na saúde suplementar; verificar o impacto do risk sharing nos custos com saúde das operadoras a partir da percepção dos entrevistados. Métodos: Trata-se de estudo qualitativo, com entrevistas em profundidade com os principais gestores e formadores de opinião em saúde de diferentes instituições no Brasil, totalizando 25 entrevistas. A análise de conteúdo foi escolhida como método de interpretação e construção das categorias para a análise. Resultados: Os resultados foram agrupados nas seguintes categorias: as sugestões e adaptações sugeridas para o melhor funcionamento na realidade brasileira; as críticas e desafios aos modelos propostos. Os resultados sugerem que o compartilhamento de risco pode ser uma alternativa capaz de promover uma nova forma de relacionamento entre os pagadores e a indústria fabricante, substituindo o tradicional modelo de remuneração, que limita a relação linear com todos os setores, buscando sempre o objetivo de atender o paciente com novas alternativas de acesso. Conclusões: Em meio à complexidade do sistema de saúde brasileiro, é importante que os players avaliem novas alternativas de remuneração e incorporação tecnológica. Os desafios são inúmeros, desde a efetivação do perfil dos pacientes elegíveis até a aplicabilidade do risk sharing que ocorre a partir do interesse de ambas as partes em trazer novas tecnologias ao sistema, sem impactos orçamentários significativos, desde que seja viável clínica e economicamente, gerando valor em saúde, na efetividade e nos resultados de desfecho em taxa de sobrevida real

Objectives: This paper discusses the recent impacts of technological advancement on the health market, the growing importance of increasing costs throughout its chain, and investigates an alternative to increasing the access of these new technologies to a greater number of people within supplementary health. In this context, the general objective proposed for this work was to highlight the views of health managers with a prominent role in Brazil regarding the use of risk-sharing models in different regions and in different payers in the system. It was intended to deepen the theme with the fulfillment of the following specific objectives, also from the perspective of the research participants: verify the use of these payment models and consequently determine the characteristics and necessary adaptations for them; identify the challenges for the consolidation of risk-sharing in Supplementary Health; to verify the impact of risk-sharing on health costs of operators based on interviewees' perceptions. Methods: This is a qualitative study with in-depth interviews with main health managers and opinion makers from different institutions in Brazil, totaling 25 interviews. Content analysis was chosen as a method of interpretation and construction of categories for analysis. Results: The results were grouped into the following categories: the suggestions and adaptations suggested for the best operation in the Brazilian reality; criticisms and challenges to the proposed models. The results suggest that risk-sharing may be an alternative capable of promoting a new form of relationship between payers and the manufacturing industry, replacing the traditional remuneration model, which limits the linear relationship with all sectors, always seeking the objective of assisting the patient with new access alternatives. Conclusions: Amid the complexity of the Brazilian health system, it is important for players to evaluate new alternatives for remuneration and technological incorporation. The challenges are innumerable from the realization of the profile of eligible patients and the applicability of risk-sharing that occurs from the interest of both parties in bringing new technologies to the system, without significant budgetary impacts, as long as it is clinically and economically viable, generating health value, effectiveness, and outcomes in survival rates in real world evidences