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1.
Gac Sanit ; 35 Suppl 1: S30-S32, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33832620

RESUMEN

OBJECTIVE: The large-scale social distancing policy conducted twice was unable to reduce the rate of development of COVID-19 widespread in Makassar, yet it increased. One of the causes was that social awareness is still lacking especially for people in the poverty line. This study attempts to describe the social behavior of people in poverty line toward COVID-19 case in Makassar. METHOD: This research is a qualitative descriptive study based on the case. The data analysis was undertaken qualitatively. RESULTS: The results revealed that the limited understanding of people in poverty line about COVID-19 and health protocols makes their behavior indifferent and disobedient to health protocols. In addition, the government's top-down approach to deal with COVID-19 pandemic was ineffective. However, bottom-up collaborative interventions need to be carried out through a group approach to gain an understanding of the COVID-19 health protocol, especially for people in poverty line and other vulnerable groups.


Asunto(s)
/prevención & control , Conductas Relacionadas con la Salud , Conocimientos, Actitudes y Práctica en Salud , Colaboración Intersectorial , Pandemias , Pobreza , Participación de los Interesados , /epidemiología , /transmisión , Participación de la Comunidad , Agencias Gubernamentales , Política de Salud , Humanos , Indonesia/epidemiología , Administración en Salud Pública , Investigación Cualitativa , Responsabilidad Social , Participación de los Interesados/psicología , Población Urbana
2.
Artículo en Inglés | PAHO-IRIS | ID: phr-53563

RESUMEN

[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.


Asunto(s)
Preparaciones Farmacéuticas , Agencias Gubernamentales , Aprobación de Drogas , United States Food and Drug Administration , Organización Panamericana de la Salud , América Latina , Región del Caribe , Preparaciones Farmacéuticas , Agencias Gubernamentales , Aprobación de Drogas , Organización Panamericana de la Salud , América Latina , Región del Caribe , Preparaciones Farmacéuticas , Agencias Gubernamentales , Aprobación de Drogas , Organización Panamericana de la Salud , Región del Caribe
5.
J Prim Care Community Health ; 12: 2150132721995450, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33648364

RESUMEN

IMPORTANCE: Social media is widely used by various segments of society. Its role as a tool of communication by the Public Health Departments in the U.S. remains unknown. OBJECTIVE: To determine the impact of the COVID-19 pandemic on social media following of the Public Health Departments of the 50 States of the U.S. DESIGN, SETTING, AND PARTICIPANTS: Data were collected by visiting the Public Health Department web page for each social media platform. State-level demographics were collected from the U.S. Census Bureau. The Center for Disease Control and Prevention was utilized to collect information regarding the Governance of each State's Public Health Department. Health rankings were collected from "America's Health Rankings" 2019 Annual report from the United Health Foundation. The U.S. News and World Report Education Rankings were utilized to provide information regarding the public education of each State. EXPOSURE: Data were pulled on 3 separate dates: first on March 5th (baseline and pre-national emergency declaration (NED) for COVID-19), March 18th (week following NED), and March 25th (2 weeks after NED). In addition, a variable identifying the total change across platforms was also created. All data were collected at the State level. MAIN OUTCOME: Overall, the social media following of the state Public Health Departments was very low. There was a significant increase in the public interest in following the Public Health Departments during the early phase of the COVID-19 pandemic. RESULTS: With the declaration of National Emergency, there was a 150% increase in overall public following of the State Public Health Departments in the U.S. The increase was most noted in the Midwest and South regions of the U.S. The overall following in the pandemic "hotspots," such as New York, California, and Florida, was significantly lower. Interesting correlations were noted between various demographic variables, health, and education ranking of the States and the social media following of their Health Departments. CONCLUSION AND RELEVANCE: Social media following of Public Health Departments across all States of the U.S. was very low. Though, the social media following significantly increased during the early course of the COVID-19 pandemic, but it still remains low. Significant opportunity exists for Public Health Departments to improve social media use to engage the public better.


Asunto(s)
Agencias Gubernamentales , Conducta en la Búsqueda de Información , Pandemias , Salud Pública , Medios de Comunicación Sociales , California , Comunicación , Urgencias Médicas , Florida , Humanos , New York , Estados Unidos
9.
Expert Opin Drug Saf ; 20(3): 265-274, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33455482

RESUMEN

Introduction: Biosimilar medicines have transformed the healthcare landscape by providing improved access to life-saving medicines at a lower cost. Biosimilars are a distinct category of biologic therapeutics that enter the market after patent expiration of a reference molecule. Regulatory bodies worldwide have developed guidance to expedite the approval and entry of these drugs to the market. Biosimilar approval is based on a totality of the evidence approach, demonstrating similarity between the biosimilar and the originator in terms of physicochemical properties, quality characteristics, biological activity, safety, and efficacy.Areas covered: This article provides an overview of the biosimilar regulatory guidelines and discusses the importance and considerations of comparative clinical studies that are performed during biosimilar development. Two review assessment reports, one each from the EMA and the FDA, are presented.Expert opinion: The discussed case studies illustrate the importance of pharmacokinetic and pharmacodynamic studies in the regulatory approval of biosimilars. It is crucial for biosimilar developers to judiciously determine clinical parameters including biomarkers, endpoints, and acceptance criteria before executing clinical studies.


Asunto(s)
Productos Biológicos/administración & dosificación , Biosimilares Farmacéuticos/administración & dosificación , Aprobación de Drogas/legislación & jurisprudencia , Animales , Productos Biológicos/efectos adversos , Productos Biológicos/farmacología , Biomarcadores/metabolismo , Biosimilares Farmacéuticos/efectos adversos , Biosimilares Farmacéuticos/farmacología , Ensayos Clínicos como Asunto/métodos , Unión Europea , Agencias Gubernamentales , Humanos , Estados Unidos , United States Food and Drug Administration
10.
Bioanalysis ; 13(2): 69-76, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33326307

RESUMEN

Coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 antibody testing an important supplement to nucleic acid testing. In the process of emergency approval, the Center for Medical Device Evaluation of the China National Medical Products Administration released The Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents. The Clinical Study Requirement section of the Key Point has put forward requirements in terms of reference methods and subject enrolment among others, which can ensure that the test results can meet the clinical needs. This article draws on the experience of the China NMPA in evaluating diagnostic reagents used to supplement the gold standard test method in the early stage of an epidemic of an infectious disease, as well as to serve as reference for clinicians and regulators.


Asunto(s)
Anticuerpos Antivirales/análisis , Indicadores y Reactivos/normas , Reacciones Antígeno-Anticuerpo , China , Aprobación de Recursos , Agencias Gubernamentales , Humanos , Estudios Multicéntricos como Asunto , Pandemias , Selección de Paciente , Estándares de Referencia , Reproducibilidad de los Resultados , Proyectos de Investigación
11.
Rev Esp Salud Publica ; 942020 Dec 16.
Artículo en Español | MEDLINE | ID: mdl-33323924

RESUMEN

Neonatal Screening Programs (PCN) have widely demonstrated their benefits since Dr. Guthrie published his developments on Phenylketonuria (PKU) in 1961. This paper describes how a simple and effective organization, which incorporates all the fundamental actors under the responsibility of the Public Health Directorate (DSP), has managed to ensure that the PCN of the Basque Country meets all the objectives required for a population screening. The acceptance by Basque society of the PCN allowed it to exceed 95% coverage in its second year of operation. Likewise, the limited negative social impact of PCN is evidenced by its low number of false positives and incorrect samples. Excellent response times allow every newborn with a positive result to have an early diagnosis and optimal initiation of treatment. There are two relevant experiences that support the importance of the effective exercise of the responsibility of the DSP. Congenital adrenal hyperplasia (CAH) was incorporated into the PCN in 1991 meeting all technical and clinical criteria. At the request of the experts, the DSP ordered in 1993 to cease this activity showing that it did not provide the expected benefits. The problems of organically integrating the PCN into the healthcare system were also experienced. The need to compete for resources put public health activities, including the PCN, at risk and led to their return to direct dependence on the DSP. The availability of this structure, in addition to facilitating the incorporation of other screenings, allows facing the future challenges.


Asunto(s)
Agencias Gubernamentales/organización & administración , Tamizaje Neonatal/organización & administración , Administración en Salud Pública , Garantía de la Calidad de Atención de Salud/organización & administración , Diagnóstico Precoz , Humanos , Recién Nacido , Tamizaje Neonatal/métodos , España , Gobierno Estatal
12.
Aten. prim. (Barc., Ed. impr.) ; 52(10): 697-704, dic. 2020. tab, mapas, graf
Artículo en Español | IBECS | ID: ibc-199590

RESUMEN

OBJETIVO: Describir las características de los informes de posicionamiento terapéutico (IPT) publicados en España en el periodo 2013-2019. Diseño y fuente de datos: Revisión sistemática de todos los IPT publicados en la página web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Selección de estudios: Se incluyeron todos los IPT realizados desde mayo de 2013, hasta marzo de 2019. Extracción de datos: Las principales variables recogidas fueron los grupos terapéuticos evaluados, el número de IPT, el tiempo de elaboración, la existencia de restricciones a las indicaciones autorizadas y la información sobre la eficiencia. RESULTADOS: En el periodo evaluado se realizaron 214 IPT, con un tiempo medio de elaboración de 8,8 meses, casi tres veces el objetivo de 3 meses planteado inicialmente. El 57% de los IPT establecieron restricciones de uso respecto a las indicaciones de sus fichas técnicas. El 26% de los IPT hicieron referencia a la existencia de datos económicos, aunque ninguno incluyó detalles sobre la eficiencia. Se actualizaron el 10% de los IPT. CONCLUSIONES: Para que los IPT puedan cumplir su objetivo de mejorar la eficiencia del proceso de evaluación y la coherencia en las decisiones sobre precio, reembolso y financiación de medicamentos por parte del SNS es preciso que se cumplan los plazos establecidos para su publicación, se incorpore sistemáticamente información sobre la eficiencia de los fármacos y se actualicen los informes con la nueva información generada


OBJECTIVE: Describe the characteristics of the therapeutic positioning reports (TPRs) published in Spain in the period 2013-2019. Design and data source: Systematic review of all TPRs published in the website of the Spanish Agency of Medicines and Health Products (AEMPS). Selection of studies: All TPRs published since May 2013, until March 2019 Data extraction: The main variables collected were the therapeutic groups assessed, the number of TPRs, the time of elaboration, the existence of restrictions versus the authorized indications and the information on the efficiency of medicines. RESULTS: During the period under review, 214 TPRs were carried out, with an average production time of 8.8 months, almost three times the objective of 3-month initially set. 57% of the TPRs established restrictions of use with respect to the approved indications. 26% of TPRs referred to the existence of economic data, although none included details on the efficiency. 10% of TPRs were updated. CONCLUSIONS: For TPRs to meet their objective of improving the efficiency of the assessment process and the consistency in the decisions on price, reimbursement and financing of medicines by the SNS, the deadlines established for publication must be met, incorporating systematically information on the efficiency of the drugs and including periodic updates with the new information generated


Asunto(s)
Humanos , Monitoreo de Drogas/normas , Servicios de Información sobre Medicamentos/normas , Factores de Tiempo , Monitoreo de Drogas/estadística & datos numéricos , Servicios de Información sobre Medicamentos/estadística & datos numéricos , Agencias Gubernamentales , España
14.
Pan Afr Med J ; 35(Suppl 2): 147, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33193962

RESUMEN

Coronavirus disease (COVID-19) caused by SARS-CoV-2-a new single-stranded RNA virus with respiratory system proclivity and epithelial cell- is a novel infectious disease that originated in Wuhan, China in December, 2019 and has spread to many countries with the total number of confirmed cases put at 20,259,579 cases as of 12th August, 2020. It is transmitted from human-to-human via droplets. When an infected person coughs or sneezes, these droplets find their way into the mouth or nostrils of another person that is within a close range. Alternatively it can be contracted by touching infected hard surfaces and using the same hands to touch the mouth, nose and eye(s). COVID-19 has been declared a global pandemic by the World Health Organization (WHO) on 11th March, 2020. There is currently no therapeutic substance accepted as a panacea for the prophylaxis of this infectious disease. As a result of this back drop, many nations have instituted fourteen (14) days quarantine for suspected cases, social distancing and border closure in an attempt to curb the spread of COVID-19. There has been several conspirary theories that emanated since the disease was declared a pandemic. This paper provides useful information to serve as reference to those who seek proper understanding of COVID-19 and its deleterious effects in the body, by distiguishing between the factsand the conspiracy theoriesof coronavirus disease.


Asunto(s)
Actitud Frente a la Salud , Betacoronavirus/patogenicidad , Infecciones por Coronavirus/epidemiología , Deluciones , Pandemias , Neumonía Viral/epidemiología , Aerosoles , Microbiología del Aire , Betacoronavirus/fisiología , Bioterrorismo , Control de Enfermedades Transmisibles/organización & administración , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/prevención & control , Infecciones por Coronavirus/terapia , Infecciones por Coronavirus/transmisión , Decepción , Fómites , Genocidio , Agencias Gubernamentales , Personal de Salud , Humanos , Pandemias/prevención & control , Neumonía Viral/prevención & control , Neumonía Viral/terapia , Neumonía Viral/transmisión , Política , Cuarentena , Investigadores , Medios de Comunicación Sociales
15.
Respir Res ; 21(1): 257, 2020 Oct 08.
Artículo en Inglés | MEDLINE | ID: mdl-33032592

RESUMEN

BACKGROUND: Coronavirus Disease 2019 (COVID-19) spread rapidly around the world. We aimed to describe the epidemiological characteristics and the entire evolution of COVID-19 in Wuhan, and to evaluate the effect of non-pharmaceutical intervention by the government. METHODS: The information of COVID-19 cases until Mar 18, 2020 in Wuhan were collected from the national infectious disease surveillance system in Hubei province. RESULTS: A total of 49,973 confirmed cases were reported until Mar 18, 2020 in Wuhan. Among whom, 2496 cases died and the overall mortality was 5.0%. Most confirmed cases (25,619, 51.3%) occurred during Jan 23 to Feb 4, with a spike on Feb 1 (new cases, 3374). The number of daily new cases started to decrease steadily on Feb 19 (new cases, 301) and decreased greatly on Mar 1 (new cases, 57). However, the mortality and the proportion of severe and critical cases has been decreasing over time, with the lowest of 2.0 and 10.1% during Feb 16 to Mar 18, 2020, respectively. The percentage of severe and critical cases among all cases was 19.6%, and the percentage of critical and dead cases aged over 60 was 70.1 and 82.0%, respectively. CONCLUSION: The number of new cases has dropped significantly after the government taking the isolation of four types of personnel and the community containment for 14 days. Our results indicate that the mortality and proportion of severe and critical cases gradually decreased over time, and critical and dead cases are more incline to be older individuals.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/epidemiología , Agencias Gubernamentales , Pandemias/prevención & control , Neumonía Viral/epidemiología , Aislamiento Social , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , China/epidemiología , Infecciones por Coronavirus/diagnóstico , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , Neumonía Viral/diagnóstico , Adulto Joven
17.
Br J Nurs ; 29(19): 1132-1133, 2020 Oct 22.
Artículo en Inglés | MEDLINE | ID: mdl-33104427

RESUMEN

Emeritus Professor Alan Glasper, from the University of Southampton, discusses the role of the newly created Institute for Health Protection, which has subsumed the work of Public Health England and other organisations.


Asunto(s)
Infecciones por Coronavirus/prevención & control , Agencias Gubernamentales/organización & administración , Pandemias/prevención & control , Neumonía Viral/prevención & control , Rol Profesional , Infecciones por Coronavirus/epidemiología , Inglaterra/epidemiología , Humanos , Neumonía Viral/epidemiología
20.
Cuad Bioet ; 31(102): 183-202, 2020.
Artículo en Español | MEDLINE | ID: mdl-32910671

RESUMEN

The article deals with the analysis of the criteria for the allocation of scarce health resources during the pandemic produced by the COVID 19 virus in Spain. It critically analyses the absence of a legal-constitutional perspective in the elaboration of such criteria and suggests the incorporation of the criterion of equity as a guarantee of the effective exercise of the constitutional right to health protection by vulnerable persons.


Asunto(s)
Betacoronavirus , Recursos en Salud/ética , Pandemias/ética , Asignación de Recursos/ética , Constitución y Estatutos , Infecciones por Coronavirus/prevención & control , Teoría Ética , Agencias Gubernamentales , Prioridades en Salud , Recursos en Salud/legislación & jurisprudencia , Recursos en Salud/provisión & distribución , Accesibilidad a los Servicios de Salud/ética , Accesibilidad a los Servicios de Salud/legislación & jurisprudencia , Derechos Humanos/legislación & jurisprudencia , Humanos , Grupos Minoritarios , Pandemias/legislación & jurisprudencia , Pandemias/prevención & control , Neumonía Viral/prevención & control , Publicaciones , Asignación de Recursos/legislación & jurisprudencia , Rol , Justicia Social , Sociedades Médicas , España/epidemiología , Triaje/ética , Poblaciones Vulnerables
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