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Journal of Clinical Hepatology ; (12): 1759-1762, 2022.
Article in Chinese | WPRIM | ID: wpr-941532


In November 2018, the U.S. food and drug administration (FDA) issued guidance for the development of drugs for chronic hepatitis B virus infection (draft for comments) (hereinafter referred to as draft for comments), and in April 2022, the FDA issued Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment, which has been updated with some details based on the Draft for Comments. This guidance further emphasizes the importance of HBsAg clearance in clinical trials, and classifies chronic suppressive therapy into two categories, namely noninferiority (NI) (or superiority) test with nucleos(t)ide analogues as control and add-on superiority trial with nucleos(t)ide analogues as control, and as for the latter, HBV DNA is no longer recommended as a primary endpoint of the trial, which poses a huge challenge to the development of innovative drugs targeting HBV DNA. The new finite duration therapy should aim to eliminate HBsAg and reduce virologic relapse and the risk of liver disease progression during treatment cessation. Reduction in HBsAg from baseline is not recommended as a primary endpoint for phase Ⅲ clinical trials, since the correlation between such reduction and clinical response remains unclear. In addition, this guidance also specifies the duration of treatment cessation and treatment consolidation period and the criteria for withdrawal of nucleos(t)ide analogues.

Article in Chinese | WPRIM | ID: wpr-927366


The application status of acupuncture and moxibustion therapy for assisted reproductive field in the United States was analyzed, and the existing problems and future development directions were discussed. According to the survey on the 456 websites of assisted reproductive clinic in the United States mentioned in the report of U.S. Centers for Disease Control and Prevention (CDC), 111 clinics among 456 assisted reproductive clinics recommend and used acupuncture and moxibustion therapy, accounting for 24.3%. Acupuncture and moxibustion therapy had obvious effect, good safety and low cost, and the assisted reproductive institutions in the United States had a high degree of application and recognition to acupuncture and moxibustion therapy. However, some problems, such as immature treatment scheme, unclear mechanism and imperfect insurance policies, still existed. In the future, the advantages of Chinese traditional acupuncture and moxibustion should combine with international modern assisted reproductive technology, and multi-center and large-sample clinical randomized controlled trials and basic experimental research on the mechanism of acupuncture and moxibustion for assisted reproduction should be carried out.

Acupuncture , Acupuncture Therapy , Medicine, Chinese Traditional , Moxibustion , Reproduction , United States
Article in Chinese | WPRIM | ID: wpr-923567


@#Objective To analyze the educational characteristics of physical therapy in universities of United States, and provide reference for the international development of rehabilitation therapy education in China.Methods Based on the data collected from the official websites of three universities in the United States and the databases at home and abroad, combined with the author's learning experience, the characteristics of physical therapy education in universities of United States in detail was analyzed.Results Characteristics of physical therapy education in universities of United States had strict accreditation system, course objectives oriented by practicing competence, comprehensive curriculum plan, educational concept of student-centered, high level of teaching informatization, diversified teaching and learning evaluation system, which conformed to the goal of rehabilitation competency of World Health Organization.Conclusion Physical therapy education in United States has remarkable characteristics and a well-developed system, which has certain reference value for China.

Rev. bras. parasitol. vet ; 31(1): e017121, 2022.
Article in English | LILACS-Express | LILACS, VETINDEX | ID: biblio-1357153


Abstract In June 2012, a tick was found parasitizing a man in the city of São Paulo, who had recently returned from a visit to Pennsylvania, in the northeast of the United States. The tick was removed and sent to the São Paulo State Department of Health, where it was identified as a male of the species Dermacentor variabilis (Say, 1821), according to the literature and taxonomic keys. The tick was subjected to a PCR test to search for rickettsiae, but the result was negative. The fact that a human entered Brazilian territory unaware that he was parasitized by a hard tick not belonging to the national tick fauna is significant because of the possibility that an exotic species could be introduced and take hold in this country. Another major risk to public health is that this arthropod could be infected with the bacterium Rickettsia rickettsii, as this ectoparasite is the main vector of Spotted Fever on the East Coast of North America.

Resumo Em junho de 2012, foi enviado ao serviço da Secretaria de Estado da Saúde de São Paulo um carrapato que foi encontrado em parasitismo sobre um homem adulto na cidade de São Paulo, que havia chegado recentemente de uma viagem de turismo aos Estados Unidos, onde visitou o estado da Pensilvânia, situado na região Nordeste Americana. O carrapato foi identificado como um macho da espécie Dermacentor variabilis, (Say, 1821), de acordo com a literatura e chaves taxonômicas, sendo submetido ao teste da PCR para pesquisa de riquétsias, porém o resultado foi negativo. O fato de um ser humano ter cruzado a fronteira do Brasil, parasitado, sem o seu prévio conhecimento, por um carrapato duro, não pertencente à ixodofauna nacional, é de grande importância pela chance de introdução e estabelecimento no território brasileiro de uma espécie exótica. Outro grande risco para a saúde pública é que esse artrópode poderia estar infectado com a bactéria Rickettsia rickettsii, pois esse ectoparasito é o principal vetor da Febre Maculosa na costa Leste Norte Americana.

Rev. cuba. salud pública ; 47(3)sept. 2021.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1409233


RESUMEN Introducción: La seguridad del paciente es un asunto preocupante para la salud pública global y, a su vez, resulta relevante por sus efectos en el propio paciente. Objetivo: Determinar la cultura de seguridad del paciente en los hospitales de una subred de Bogotá, Colombia. Métodos: Estudio cuantitativo, descriptivo, transversal. Previo consentimiento informado se aplicó el cuestionario de la Agency for Healthcare Research and Quality en español a 385 miembros del equipo de salud de la subred que tuvieran contacto directo con el paciente. Se excluyeron aquellos con menos de 3 meses de trabajo en la institución. Se analizaron datos según guía de la Agency for Healthcare Research and Quality. Resultados: El "aprendizaje organizacional-mejora continua" fue la dimensión de la cultura con mayor porcentaje de respuestas positivas (69 %), seguida del "trabajo dentro de las unidades" (65 %). El menor número de respuestas positivas se obtuvo en las dimensiones de "disponibilidad de personal" y "respuesta no punitiva al error", ambas con 31 % de respuestas positivas. Los porcentajes de eventos reportados por los respondientes en el último año fueron: ninguno el 52 %, de 1 a 2 el 29 %, de 3 a 5 el 13 %, 6 o más el 7 %. Un 52 % consideró el grado de seguridad como excelente o muy bueno, el 40 % como aceptable y el 8 % como pobre o malo. Conclusiones: Hay una cultura de "mejora continua" que tiende a constituirse en una fortaleza de cultura de seguridad del paciente, así como el trabajo dentro de las unidades. Además, los asuntos de personal y cultura punitiva frente al error requieren de una atención especial.

ABSTRACT Introduction: Patient's safety is an important concern for global public health, and at the same time it is relevant due to its effects in the patient. Objective: Determine the patient's safety culture in hospitals of a sub-network in Bogotá, Colombia. Methods: Quantitative, descriptive, cross-sectional study. With previous informed consent, it was applied a questionnaire of the Agency for Healthcare Research and Quality, in Spanish, to 385 members of the health staff if the sub-network whom have direct contact with the patients. Those with less than 3 months of work in the institution were excluded. Data was analyzed according to the guide of the Agency for Healthcare Research and Quality. Results: ´´Organizational learning - continuous improvement´´ was the dimension with a higher percentage of positive answers (69%), followed by ´´ work within the units´´ (65%). The smallest number of positive answers was obtained in the dimensions called ´´ personal availability´´ and ´´no punitive answer to errors´´, both with 31% of positive answers. The percentage of events informed by the respondents in the last year were: none (52%), 1 to 2 (29%), 3 to 5 (13%), 6 or more (7%). 52% considered the degree of safety as excellent or very well, 40% as acceptable and 8% as poor or bad. Conclusions: There is a culture of ´´continuous improvement´´ that tends to represent strength of the patient's safety culture, as well as the work within the units. In addition, the subjects related to personnel and punitive culture facing errors require a special attention.

Rev. bras. ter. intensiva ; 33(3): 384-393, jul.-set. 2021. tab, graf
Article in English, Portuguese | LILACS | ID: biblio-1347302


RESUMO Objetivo: Descrever as práticas clínicas atuais relacionadas à utilização de cânula nasal de alto fluxo por intensivistas pediátricos brasileiros e compará-las com as de outros países. Métodos: Para o estudo principal, foi administrado um questionário a intensivistas pediátricos em países das Américas do Norte e do Sul, Ásia, Europa e Austrália/Nova Zelândia. Comparou-se a coorte brasileira com coortes dos Estados Unidos, Canadá, Reino Unido e Índia. Resultados: Responderam ao questionário 501 médicos, dos quais 127 eram do Brasil. Apenas 63,8% dos participantes brasileiros tinham disponibilidade de cânula nasal de alto fluxo, em contraste com 100% dos participantes no Reino Unido, no Canadá e nos Estados Unidos. Coube ao médico responsável a decisão de iniciar a utilização de uma cânula nasal de alto fluxo segundo responderam 61,2% dos brasileiros, 95,5% dos localizados no Reino Unido, 96,6% dos participantes dos Estados Unidos, 96,8% dos médicos canadenses e 84,7% dos participantes da Índia; 62% dos participantes do Brasil, 96,3% do Reino Unido, 96,6% dos Estados Unidos, 96,8% do Canadá e 84,7% da Índia relataram que o médico responsável era quem definia o desmame ou modificava as regulagens da cânula nasal de alto fluxo. Quando ocorreu falha da cânula nasal de alto fluxo por desconforto respiratório ou insuficiência respiratória, 82% dos participantes do Brasil considerariam uma tentativa com ventilação não invasiva antes da intubação endotraqueal, em comparação com 93% do Reino Unido, 88% dos Estados Unidos, 91,5% do Canadá e 76,8% da Índia. Mais intensivistas brasileiros (6,5%) do que do Reino Unido, Estados Unidos e Índia (1,6% para todos) afirmaram utilizar sedativos com frequência concomitantemente à cânula nasal de alto fluxo. Conclusão: A disponibilidade de cânulas nasais de alto fluxo no Brasil ainda não é difundida. Há algumas divergências nas práticas clínicas entre intensivistas brasileiros e seus colegas estrangeiros, principalmente nos processos e nas tomadas de decisão relacionados a iniciar e desmamar o tratamento com cânula nasal de alto fluxo.

ABSTRACT Objective: To describe current clinical practices related to the use of high-flow nasal cannula therapy by Brazilian pediatric intensivists and compare them with those in other countries. Methods: A questionnaire was administered to pediatric intensivists in North and South America, Asia, Europe, and Australia/New Zealand for the main study. We compared the Brazilian cohort with cohorts in the United States of America, Canada, the United Kingdom, and India Results: Overall, 501 physicians responded, 127 of which were in Brazil. Only 63.8% of respondents in Brazil had a high-flow nasal cannula available, in contrast to 100% of respondents in the United Kingdom, Canada, and the United States. The attending physician was responsible for the decision to start a high-flow nasal cannula according to 61.2% respondents in Brazil, 95.5% in the United Kingdom, 96.6% in the United States, 96.8% in Canada, and 84.7% in India. A total of 62% of respondents in Brazil, 96.3% in the United Kingdom, 96.6% in the United States, 96.8% in Canada, and 84.7% in India reported that the attending physician was responsible for the decision to wean or modify the high-flow nasal cannula settings. When high-flow nasal cannula therapy failed due to respiratory distress/failure, 82% of respondents in Brazil would consider a trial of noninvasive ventilation before endotracheal intubation, compared to 93% in the United Kingdom, 88% in the United States, 91.5% in Canada, and 76.8% in India. More Brazilian intensivists (6.5%) than intensivists in the United Kingdom, United States, and India (1.6% for all) affirmed using sedatives frequently with high-flow nasal cannulas. Conclusion: The availability of high-flow nasal cannulas in Brazil is still not widespread. There are some divergences in clinical practices between Brazilian intensivists and their colleagues abroad, mainly in processes and decision-making about starting and weaning high-flow nasal cannula therapy.

Humans , Child , Noninvasive Ventilation , Cannula , United States , Brazil , Surveys and Questionnaires , Critical Care
Investig. desar. ; 29(1): 133-154, ene.-jun. 2021. graf
Article in Spanish | LILACS, COLNAL | ID: biblio-1346391


RESUMEN Sin duda, la frontera entre Estados Unidos y México es un espacio territorial de la mayor relevancia en la geopolítica en América. En este artículo se hace una mirada a esta frontera desde la perspectiva de los imaginarios, los medios y el arte, que complemente aquella centrada en la geopolítica, que es la manera en que tradicionalmente se ha estudiado. Se indaga en la percepción de los ciudadanos de frontera, particularmente en los que habitan en El Paso, Texas, y en Ciudad Juárez, México, con el objetivo de ubicar los imaginarios que tienen sobre este territorio de separación y de encuentro de manera simultánea, y en espacial sobre tres objetos que definen esta frontera: el muro, el río Bravo y el desierto. Asimismo, se analizan diversas producciones artísticas y mediáticas para ampliar la perspectiva de configuración de los imaginarios fronterizos.

ABSTRACT Undoubtedly the border between the United States and Mexico is a territorial space of the greatest relevance in geopolitics in America. This article takes a look at this frontier from the perspective of imaginaries, the media and art, which complements the one focused on geopolitics, which is the way it has traditionally been studied. It investigates the perception of border citizens, particularly those who live in El Paso, Texas, and Ciudad Juárez, Mexico, with the aim of locating the imaginaries they have on this territory of separation and encounter simultaneously, and spatially on three objects that define this border: the wall, the Rio Grande and the desert. Likewise, various artistic and media productions are analyzed to broaden the perspective of configuration of border imaginary.

Humans , Art , Border Areas , Video-Audio Media , Politics
Hist. ciênc. saúde-Manguinhos ; 28(1): 313-318, mar. 2021.
Article in Spanish | LILACS | ID: biblio-1154313


Resumen Se examina la gestión de Donald Trump, presidente de los EEUU, en la pandemia de covid-19.

Abstract This article examines President Donald Trump's handling of the covid-19 pandemic in the United States.

Humans , Politics , COVID-19/epidemiology , Government , United States/epidemiology
Rev. panam. salud pública ; 45: e10, 2021. tab, graf
Article in English | LILACS | ID: biblio-1252027


ABSTRACT Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

RESUMEN Objetivo. Describir el estado actual de la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones en América Latina y el Caribe mediante la evaluación de los marcos regulatorios nacionales para la aprobación de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada país. Métodos. Se realizaron búsquedas en los sitios web de las autoridades regulatorias de América Latina y el Caribe para identificar las regulaciones oficiales para la aprobación de nuevos medicamentos. La recopilación de datos se llevó a cabo en diciembre del 2019 y se completó en junio del 2020 para los países del Caribe. Dos equipos independientes recopilaron información sobre el reconocimiento directo o los procedimientos abreviados para la aprobación de nuevos medicamentos y los autoridades regulatorias de referencia (confiables) así definidos en la legislación nacional correspondiente. Resultados. Se encontraron documentos regulatorios sobre la aprobación de nuevos productos en los sitios web de veinte organismos regulatorios de América Latina y el Caribe, que abarcaban 34 países. Siete países no aceptan la utilización de decisiones de autoridades regulatorias extranjeras. Trece autoridades regulatorias (Argentina, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, México, Panamá, Paraguay, Perú, República Dominicana, Uruguay y el sistema regulador único para quince Estados del Caribe) aceptan de manera explícita confiar las decisiones para aprobación de nuevos medicamentos emitidas por la Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá. Diez países aceptan también utilizar las autorizaciones para la comercialización de Australia, Japón y Suiza. Argentina, Brasil, Chile y México son autoridades de referencia para ocho autoridades regulatorias en la región. Conclusiones. La utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se han convertido en una práctica común en América Latina y el Caribe. Trece de veinte autoridades regulatorias reconocen directamente o abrevian el proceso de aprobación de nuevos medicamentos en caso de que hayan recibido previamente la aprobación por parte de un organismo regulatorio de otra jurisdicción. La Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá son las autoridades regulatorias de otras jurisdicciones en las cuales los reguladores de América Latina y el Caribe confían más.

RESUMO Objetivo. Descrever a prática atual de uso de decisões regulatórias de outras jurisdições na América Latina e no Caribe (ALC) mediante avaliação os marcos regulatórios dos países para aprovação de novos medicamentos e verificar, para cada país, quais entidades reguladoras estrangeiras são consideradas autoridades reguladoras de confiança por cada país. Métodos. Foi realizada uma pesquisa nos sites das autoridades reguladoras da ALC para identificar as regulamentações oficiais para aprovação de novos medicamentos. A coleta de dados foi feita em dezembro de 2019 e concluída em junho de 2020 para os países do Caribe. Dois grupos independentes coletaram informações sobre o reconhecimento direto ou o procedimento abreviado para aprovação de novos medicamentos e as autoridades reguladoras de referência (de confiança) definidas como tal pela respectiva legislação nacional. Resultados. Documentos regulatórios relacionados à aprovação de novos produtos foram obtidos de 20 sites de órgãos reguladores da ALC, abrangendo 34 países. Sete países não admitem o uso de decisões regulatórias de entidades reguladoras externas. Treze autoridades reguladoras (na Argentina, Colômbia, Costa Rica, El Salvador, Equador, Guatemala, México, Panamá, Paraguai, Peru, República Dominicana, Uruguai e o Sistema Regulador do Caribe unificado para 15 Estados caribenhos) admitem explicitamente a admissibilidade de decisões regulatórias para aprovação de novos medicamentos de outras jurisdições, quais sejam: Agência Europeia de Medicamentos (EMA), Agência Reguladora de Alimentos e Medicamentos (FDA) dos EUA e Health Canada. Dez países também aceitam decisões para autorização de comercialização da Austrália, Japão e Suíça. Argentina, Brasil, Chile e México são autoridades de referência para oito agências reguladoras. Conclusões. O uso de decisões regulatórias de outras jurisdições tornou-se prática comum na América Latina e Caribe. Treze das 20 agências reguladoras reconhecem diretamente ou abreviam o procedimento de aprovação de novos medicamentos no caso de tal aprovação já haver sido concedida por uma autoridade reguladora de outra jurisdição. A EMA, a FDA e a Health Canada são as autoridades estrangeiras nas quais as agências reguladoras da América Latina e Caribe mais confiam.

Drug Approval/legislation & jurisprudence , Government Regulation , Cross-Sectional Studies , Caribbean Region , Latin America
Rev. panam. salud pública ; 45: e36, 2021. graf
Article in English | LILACS | ID: biblio-1252020


ABSTRACT Objectives. To analyze changes in racial/ethnic disparities for unintentional injury mortality from 1999-2016. Methods. Mortality data are from the National Center for Health Statistics (NCHS) for all unintentional injuries, analyzed separately by injury cause (motor vehicle accidents [MVA], poisonings, other unintentional) for white,black, and Hispanic populations within four age groups: 15-19, 20-34, 35-54, 55-74 for males and for females. Results. Rates across race/ethnic groups varied by gender, age and cause of injury. Unintentional injury mortality showed a recent increase for both males and females, which was more marked among males and for poisoning in all race/ethnic groups of both genders. Whites showed highest rates of poisoning mortality and the steepest increase for both genders, except for black males aged 55-74. MVA mortality also showed an increase for all race/ethnic groups, with a sharper rise among blacks, while Hispanics had lower rates than either whites or blacks. Rates for other unintentional injury mortality were similar across groups except for white women over 55, for whom rates were elevated. Conclusions. Data suggest while mortality from unintentional injury related to MVA and poisoning is on the rise for both genders and in most age groups, blacks compared to whites and Hispanics may be suffering a disproportionate burden of mortality related to MVAs and to poisonings among those over 55, which may be related to substance use.

RESUMEN Objetivos. Analizar cambios en las disparidades por raza y grupo étnico en materia de mortalidad por traumatismos no intencionales de 1999 al 2016. Métodos. Los datos de mortalidad de todos los traumatismos no intencionales provienen del Centro Nacional de Estadísticas Sanitarias y se han analizado por separado por causa de traumatismo (colisiones automovilísticas, intoxicaciones y otras causas no intencionales) y por población blanca, negra e hispana, tanto en hombres como en mujeres, en cuatro grupos etarios: de 15 a 19, de 20 a 34, de 35 a 54 y de 55 a 74. Resultados. Las tasas en todos los grupos raciales y étnicos variaron según el sexo, la edad y la causa del traumatismo. La mortalidad por traumatismo no intencional mostró un aumento reciente tanto en hombres como en mujeres, que fue más marcado en el caso de los hombres, y por intoxicación en todos los grupos raciales y étnicos de ambos sexos. La población blanca mostró las tasas más elevadas de mortalidad por intoxicación y el incremento más acentuado en ambos sexos, con excepción de los hombres negros entre 55 y 74 años de edad. La mortalidad por colisión automovilística también registró un aumento en todos los grupos raciales y étnicos, con un incremento mayor en la población negra, mientras que la población hispana mostró tasas inferiores que la blanca o la negra. Las tasas de mortalidad por otros traumatismos no intencionales fueron similares en todos grupos salvo en el caso de las mujeres blancas de más de 55 años, cuyas tasas mostraron un incremento. Conclusiones. Los datos indican que, si bien la mortalidad por traumatismo no intencional relacionada con colisiones automovilísticas e intoxicación está en alza en ambos sexos y en la mayoría de los grupos etarios, la población negra en comparación con la blanca y la hispana puede estar presentando una carga desproporcionada de mortalidad relacionada con colisiones automovilísticas e intoxicación en personas mayores de 55, que podrían estar relacionado con el consumo de sustancias psicoactivas.

RESUMO Objetivos. Analisar as mudanças nas disparidades étnico-raciais da mortalidade por lesões acidentais no período 1999-2016. Métodos. Os dados de mortalidade foram obtidos do Centro Nacional de Estatísticas de Saúde (NCHS) dos Estados Unidos para todos os tipos de lesões acidentais e analisados em separado por causa de lesão (acidentes de trânsito de veículos a motor, envenenamento/intoxicação e outros tipos de acidentes) em grupos populacionais de brancos, negros e hispânicos de ambos os sexos divididos em quatro faixas etárias: 15-19, 20-34, 35-54 e 55-74 anos. Resultados. As taxas de mortalidade nos grupos étnico-raciais variaram segundo sexo, idade e causa de lesão. Houve um aumento recente na mortalidade por lesões acidentais nos sexos masculino e feminino, sendo mais acentuado no sexo masculino e por envenenamento/intoxicação em todos os grupos étnicos-raciais de ambos os sexos. A população branca apresentou as maiores taxas de mortalidade por envenenamento/intoxicação e o aumento mais acentuado na mortalidade em ambos os sexos, exceto por homens negros de 55-74 anos. Ocorreu também um aumento da mortalidade por acidentes de trânsito de veículos a motor em todos os grupos étnico-raciais, sendo mais acentuado em negros, e a mortalidade na população hispânica foi menor que em brancos ou negros. As taxas de mortalidade por outros tipos de acidentes foram semelhantes em todos os grupos, exceto em mulheres brancas acima de 55 anos que apresentaram taxas elevadas. Conclusões. Os dados analisados indicam que, apesar de a mortalidade por lesões acidentais por acidentes de trânsito de veículos a motor e envenenamento/intoxicação estar aumentando em ambos os sexos e na maioria das faixas etárias, em comparação a brancos e hispânicos, os negros possivelmente sofrem um ônus desproporcional de mortalidade por acidentes de trânsito e envenenamento/intoxicação no grupo acima de 55 anos que pode estar associada ao uso de substâncias químicas.

Humans , Male , Female , Adolescent , Adult , Middle Aged , Aged , Accidents/mortality , Mortality/ethnology , Racial Groups/statistics & numerical data , Ethnic Inequality , United States/epidemiology , Accidents/classification , Ethnicity/statistics & numerical data , Sex Factors , Age Factors , Health Status Disparities
China Pharmacy ; (12): 788-793, 2021.
Article in Chinese | WPRIM | ID: wpr-875809


OBJECTIVE:To c ompare the situation of adverse drug reaction (ADR) collection by social media between European and American countries and China ,so as to provide reference for the improvement of corresponding work in China. METHODS:By retrieving relevant literatures from CNKI ,Web of Science ,Elsevier ScienceDirect ,SpringerLink and so on , referring to the official website of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),the current situation of ADR collection by social media in European and American countries(organizations)such as the United States ,the European Union ,the United Kingdom ,France was introduced ,and compared with the corresponding work in China. The advantages and possible problems of using social media to collect ADR were analyzed so as to put forward some suggestions on how to use social media to collect ADR in China. RESULTS & CONCLUSIONS:Since 2013,many countries in Europe and the United States have started to collect ADRs using social media (such as Twitter ,Facebook),such as the draft on drug safety issues on social media issued by the Pharmaceutical Research and Manufacturers of America (PhRMA),and the EU organization ’s Innovative Medicines Initiative (IMI)network to identify adverse drug reaction in web media (WEB-RADR)projects. Through this way ,it is more convenient for patients to report ADR ,and helpful for the pharmacovigilance department to collect ADR information in time ,and can be used as an important supplement to the traditional drug safety information report. However ,there are some advantages ,such as mismatch between the health vocabulary spontaneously reported by patients and medical professional vocabulary ,the challenges of balancing the relationship between public health maintenance and patient privacy protection ,and various deviations affecting the reporting rate and quality of ADR collected by social media. When using social media (such as Wechat ,microblog,QQ and other social media or tools ,as well as applications and small programs )to collect ADR information in China ,it is suggested to ensure the ease of use and security of reporting ADR applications ,and improve the design of applications to comply with E 2B (R3) data elements and information specifications of ICH guidelines for the electronic transmission of individu al security reports. At the same time ,we should give full play to the supervisory role of regulatory department ,consider non-regulatory factors ,and take privacy protection measures to make it conform to ethics.

China Pharmacy ; (12): 776-781, 2021.
Article in Chinese | WPRIM | ID: wpr-875807


OBJECTIVE:To learn from the experie nce of post-marketing risk management of biopharmaceuticals in the United States,and to provide reference for post-marketing risk management of biopharmaceuticals in China. METHODS :By studying guidance documents and website information issued by FDA ,the risk management of biopharmaceuticals after marketing in the United States was analyzed. Taking infliximab as an example ,the specific implementation situation was introduced ,the management characteristics were summarized ,and the enlightenment and relevant suggestions were put forward for the risk management of biopharmaceuticals after marketing in China. RESULTS & CONCLUSIONS :The post-marketing risk management of biopharmaceuticals in the United States mainly includes two aspects as “risk evaluation and mitigation strategy (REMS)”and “post-marketing study and clinical trials system ”. The latter included post-marketing requirement (PMR) and post-marketing commitment(PMC). Taking infliximab as an example ,since it was approved by FDA in August 1998,its manufacturer submitted REMS to FDA in 2009 and obtained approval ,and proposed post-marketing studies and clinical trials for five times. It can be seen that FDA has issued specific guidelines for post-marketing risk management of biopharmaceuticals to encourage multi-role participation in risk management , realize effective communication with patients , and continuously supervise the risk of biopharmaceuticals,so as to reduce the risk of the use of biopharmaceuticals. For biopharmaceuticals ,China has not yet formulated systematic and specific implementation rules and guidelines ,and there is still lack in post-marketing risk management. It is suggested that China can learn from the measures and system of post-marketing risk management of biopharmaceuticals in the United States ,involve stakeholders in post-marketing management ,enhance patients ’awareness of drug use risks through effective communication,and further improve the post-marketing research management system to guarantee patients ’safety of drug use.

China Pharmacy ; (12): 406-412, 2021.
Article in Chinese | WPRIM | ID: wpr-873479


OBJECTIVE:To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union (EU),the United States (U. S. )and Japan. METHODS:Literature analysis method was used to systematically compare the similarities and differences on definitions ,sources, detection methods and management process of pharmacovigilance signals among EU ,U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS :Regulatory authorities of the EU ,U. S. and Japan did not have a uniform definition on signals ;EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ,FDA adopted its own definition ,while the Japanese regulatory agency had no clear definition. Currently ,post-marketing surveillance still relied mainly on spontaneous reporting systems ;EU,U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ;EU mainly adopted the proportional reporting ratio method ,U. S. mainly adopts the multiple gamma Poisson Shrinker ,and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ,while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ,draw up guidelines on pharmacovigilance practices , strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ,for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.

China Pharmacy ; (12): 268-272, 2021.
Article in Chinese | WPRIM | ID: wpr-872675


OBJECTIVE:To study the cost control measures for Medicaid prescription drugs in the United States ,and to provide reference for medical insurance cost control in China. METHODS :The policy documents ,academic papers and news reports were studied to comb the practice of drug cost control policy of Medicaid project in the United States and its impact on medical insurance costs. The suggestions were put forward for medical insurance cost control in China. RESULTS & CONCLUSIONS:The cost control measures of Medicaid prescription drugs adopted in the United States include drug utilization management and drug cost control measure. The former included the list of preferred drugs ,pre-authorization and step therapy , prescription cost limit ,while the latter included the upper limit control of drug expenditure growth ,closed drug list management , etc. The list of preferred drugs is the basis of a series of drug cost control measures ,which provides a policy framework for prior authorization and step therapy ;pre-authorization and step therapy are the specific ways to controlling the cost ,and the use of low-cost drugs is encouraged through the guidance of specific cases ;the prescription cost limit starts from controlling the drug cost of a single patient and saves the medical insurance expenditure from another angle ;the drug growth caps control is controlling the total cost of medical insurance expenditure from aspect of overall cost ,which is a supplement to the traditional method ;closed drug list management is a new policy attempt to break through the limitation of preferred drug list. The prescription drug cost control measures adopted by Medicaid project can effectively reduce the drug expenditure to a certain extent ,but it also has the possibility of harming the interests of patients because it can interfere with doctors ’prescription right. China should further strengthen the role of medical insurance in the medical service system ,and carefully learn from the management measures of Medicaid drug utilization in the United States ;improve the dynamic control mechanism of medical insurance expenditure ,take special measures for key drugs ; improve the drug list management mechanism ,pay attention to the three links of access, exit and dynamic adjustment , guide medical cn institutions to use drugs rationally.

Article in Chinese | WPRIM | ID: wpr-912604


Objective:The development level of health science technology innovation plays crucial role in the sustainable development of economy and society in China. This article summarizes the experience of U. S., compares with the status quo of health science technology innovation in China, to provide possible reference for the future development in this field.Methods:This study mainly uses literature review, comparative reference and other methods to analyze the health science technology innovation and its development experience in U. S.Results:The U. S. has formed a health science and technology system with state-level research institutions as the main component, and has a strategic layout in the frontiers of basic medicine, key diseases, key population health, and medical device technology.Conclusions:Based on the experience of the u. s., China should establish a continuous medical research investment mechanism, strengthen the sharing of basic resources, attach importance to deployment in key areas, and continue to support cutting-edge research.

China Pharmacy ; (12): 1800-1804, 2021.
Article in Chinese | WPRIM | ID: wpr-886270


OBJECTIVE:To provide reference f or optimizing the curriculum management system of continuing education for licensed pharmacists in China. METHODS : The content and implementation system of continuing education curriculum management for licensed pharmacists in the United States was introduced ,and policy suggestions were put forward for the curriculum construction and management system optimization of continuing education for licensed pharmacists in China. RESULTS & CONCLUSIONS :The curriculum management of continuing education for licensed pharmacists in the United States has clear curriculum objectives ,missions and plans ,and evaluates the basic situation of the trainees before continuing education starts ,so as to carry out modular management of the curriculum (including continuing education courses based on knowledge ,application and practice). In terms of the implementation system of continuing education in the United States ,ACPE has put forward a lifelong learning model (pharmacist continuing career development model )that emphasizes autonomy and personalization ,and has detailed regulations on teaching methods ,learning cycle and fees. At the same time ,ACPE requires that the feedback of participants on the curriculum must be collected. Combined with the practice in China ,it is suggested that the relevant departments should formulate the Curriculum Standard of Continuing Education for Licensed Pharmacists , implement standardized management of the curriculum,improve the assessment mechanism of continuing education curriculum ,flexibly grant credits based on the actual education effect ,constantly update the concept and mode of continuing education ,and localize the international theory ,so as to continuously improve the continuing education management system of licensed pharmacists in China.

Article in Chinese | WPRIM | ID: wpr-934536


Standardized specialist training is key to postgraduate medical education. China is introducing the specialist training programs, yet without covering specialist training in obstetrics and gynecology(O&G). Shanghai took the lead in 2003 to pilot O&G specialists training programs within the region. This study introduced the specialist training programs in O&G in the US, and compared them with those in Shanghai, and recommending on launching O&G specialist training nationwide based on China′s specifics.

West Indian med. j ; 69(2): 129-133, 2021. tab, graf
Article in English | LILACS | ID: biblio-1341878


ABSTRACT Objective: In humans, males' births exceed females' births. This ratio is conventionally referred to as M/F and is used to denote male births divided by total births. This ratio is influenced by a large number of factors and has been shown to exhibit seasonality. This study was carried out in order to ascertain whether seasonal variation in M/F exists in the United States of America and whether such variations are influenced by race. Materials and Methods: Data on births by gender and race from 2003 to 2013 were obtained from Centres for Disease Control and Prevention Wonder section as four races: White, Black/African American, Asian/Pacific Islander and American Indian/Alaska Native. ANOVA and ARIMA tests were carried out. Results: This study analysed 45 103 146 live births (M/F 0.51182) over 2003 to 2013. M/F was highest in Asian/Pacific Islander (p < < 0.0001), followed by White (p = 0.002), American Indian/Alaska Native (p = 0.04) and Black/African American. Significant seasonality was present overall, with a peak in June, for Whites more than Black/African American. Conclusion: Parental stress lowers M/F, and lower M/F found in Black/African and American Indian/Alaskan births may be stress related. The dampened seasonality noted in Black/African American births may also be due to this phenomenon. More males were born in spring, as in other species, with interesting inter-racial differences.

Humans , Male , Female , Infant, Newborn , Seasons , Sex , Birth Rate , Racial Groups
Salud colect ; 17: e3054, 2021.
Article in Spanish | LILACS | ID: biblio-1252141


RESUMEN A partir del trabajo etnográfico con mujeres inmigrantes indocumentadas que desarrollaron episodios depresivos a causa de diversas formas de violencia, se recupera su experiencia sobre la atención que recibieron en el espacio clínico del país de acogida. A través de itinerarios terapéuticos de atención, el trabajo se centra en los estudios de caso de dos mujeres de origen mexicano en la ciudad de New York, para describir, con base en su experiencia, la comunicación y el encuentro entre médico y paciente; las expectativas de las migrantes en relación con los servicios de atención en salud mental; y los modelos explicativos sobre la depresión por parte de los pacientes y los médicos tratantes. Con lo anterior, buscamos contribuir al conocimiento sobre las formas de atención de los problemas de salud mental de mujeres indocumentadas en contextos de violencia.

ABSTRACT Based on ethnographic work with undocumented immigrant women who developed depressive episodes due to various forms of violence, this article recovers the women's experience of care in the clinic space of their host country. Through therapeutic itineraries of care, the article focuses on the case studies of two women of Mexican origin in New York City to describe, based on their experience, the communication and the encounter between the doctor and patient; the expectations of migrant women regarding mental health care services; and the explanatory models of depression of both the patients and the treating physicians. This analysis seeks to contribute to the knowledge regarding ways of treating the mental health problems of undocumented women in contexts of violence.

Humans , Female , Transients and Migrants , Undocumented Immigrants , Mental Health Services , Violence , Anthropology, Cultural
Rev. méd. Chile ; 148(12)dic. 2020.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1389277


This work addresses the controverted reproductive health policies in the last fifty years in the United States and in the last thirty years in Chile, since the return of democracy. They range from the inclusion of sex education programs in school curricula to the voluntary interruption of pregnancy and the recent emergence of institutional conscientious objection. The author provides a comparative analysis of the latter in both countries, considering the current political context in the United States and the constituent process development in Chile.