Scielo RSS <![CDATA[Revista Panamericana de Salud Pública]]> http://www.scielosp.org/rss.php?pid=1020-498920160003&lang=pt vol. 39 num. 3 lang. pt <![CDATA[SciELO Logo]]> http://www.scielosp.org/img/en/fbpelogp.gif http://www.scielosp.org <![CDATA[Current status and regulation of bioanalytical laboratories engaged in quantifying immunosuppressants for transplant patients in Argentina]]> http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000300142&lng=pt&nrm=iso&tlng=pt RESUMEN Objetivo Establecer el estado de situación de los laboratorios analíticos que cuantifican inmunosupresores en pacientes con trasplantes que se encuentran bajo monitoreo terapéutico de drogas (TDM) de estos fármacos en Argentina, para establecer potenciales áreas de actuación perfectibles. Métodos Se realizó una encuesta en centros clínicos y analíticos de TDM de Argentina, coordinada por la Unidad de Farmacocinética Clínica del Hospital Garrahan y el Instituto Nacional Central Único Coordinador de Ablación e Implante, desde setiembre de 2013 hasta noviembre de 2014. Resultados Se incluyeron 27 centros clínicos y analíticos (muestra representativa nacional). El 45% fueron hospitales públicos. La mayoría (95%) monitorizan ciclosporina y tacrolimús; en menor medida, sirolimús y everolimús, y muy pocos el ácido micofenólico. La cantidad (mediana, rango) de muestras analizadas por mes para estos cinco fármacos fue de 251 (10 - 2024). Casi 60% de las muestras se analizaron en instituciones privadas. Solo cuatro (17%) de los encuestados informan valores del margen terapéutico. El 92% usa inmunoensayos como metodología analítica. El 68% de los encuestados que contaban con instalaciones bioanalíticas propias informaron poseer algún programa de garantía de calidad. Conclusiones El TDM de inmunosupresores es una práctica recomendada para pacientes con trasplante en Argentina. Se requiere generar iniciativas nacionales que desarrollen guías armonizadas para laboratorios analíticos que incluyan procesos de garantía de calidad con alcance regulatorio relacionados con el TDM. Por otra parte, también es necesario capacitar al personal técnico y profesional, e invitar a participar a organizaciones públicas y privadas del ámbito regulatorio, sanitario y de la investigación.<hr/>ABSTRACT Objective Determine the status of analytical laboratories that quantify immunosuppressants in transplant patients who are under therapeutic drug monitoring (TDM) for these drugs in Argentina in order to identify potential perfectible areas for action. Methods A survey of the clinical and analytical TDM centers in Argentina was conducted between September 2013 and November 2014 under the direction of the Garrahan Hospital Clinical Pharmacokinetics Unit and the National Unified Central Institute for Ablation and Implant Coordination. Results A nationally representative sample of 27 clinical and analytical centers was identified, of which 45% were public hospitals. Most of these centers (95%) monitor ciclosporin and tacrolimus, and to a lesser extent, sirolimus and everolimus; a small number of them also monitor mycophenolic acid. The median number of samples of these five drugs analyzed per month was 251 (range: 10-2024). Nearly 60% of the samples were analyzed in private institutions. Only four of the respondents (17%) reported values within the therapeutic margin. Of all the centers, 92% use immunoassay as the analytical methodology. Of the bioanalytical installations that have their own facilities, 68% reported that they also have their own quality assurance program. Conclusions TDM of immunosuppressants is a recommended practice for transplant patients in Argentina. Initiatives need to be taken at the national level to develop uniform guidelines for analytical laboratories that include TDM-related quality assurance processes with regulatory force. There is also a need to train technical and professional personnel and to invite the participation of public and private organizations in the regulatory, public health, and research areas. <![CDATA[Os ensaios clínicos e o registro de anticorpos monoclonais e biomedicamentos oncológicos no Brasil]]> http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000300149&lng=pt&nrm=iso&tlng=pt RESUMO Objetivo Analisar o percurso dos ensaios clínicos com anticorpos monoclonais e biomedicamentos oncológicos realizados em instituições brasileiras de 2003 a 2012. Método Neste estudo retrospectivo e descritivo, realizou-se um levantamento junto aos repositórios ClinicalTrials.gov e ReBEC. Foram incluídos ensaios de fase II ou III com participação do Brasil e registro em pelo menos um dos repositórios. Após a seleção dos ensaios, foi investigada a trajetória dos anticorpos monoclonais e biomedicamentos desde a pesquisa até o registro sanitário junto a Agência Nacional de Vigilância Sanitária (Anvisa), Food and Drug Administration (FDA) e European Medicines Agency (EMA). Resultado Nove ensaios foram selecionados, todos randomizados controlados. Oito eram de fase III e um de fase II. Dois ensaios utilizaram cegamento duplo e sete eram abertos. Todos apresentaram recrutamento para ambos os sexos, com idade mínima de 18 anos. A média de recrutamento foi de 985,2 pacientes. Sete ensaios estavam finalizados e dois haviam sido encerrados prematuramente. Todos os ensaios foram financiados por indústrias farmacêuticas não brasileiras e enfocaram câncer renal, colorretal, gástrico, de pulmão (não pequenas células), linfoma não-Hodgkin e melanoma, envolvendo a utilização de cetuximabe, figitumumabe, ipilimumabe, rituximabe, bevacizumabe e interferon alfa-2a. A FDA foi a primeira agência a registrar os medicamentos, seguida pela EMA, a não ser no caso do interferon alfa-2a, recusado pela EMA. Não foi possível avaliar o ano de aprovação no Brasil pela Anvisa. Conclusão A participação do Brasil nos ensaios clínicos com anticorpos monoclonais e biomedicamentos oncológicos é insuficiente. A limitação do conteúdo disponível sobre os estudos, histórico de registro e outros elementos relevantes é uma fragilidade importante das fontes consultadas.<hr/>ABSTRACT Objective To analyze the pathway of clinical trials of monoclonal antibodies and biological medicines for cancer treatment involving Brazilian institutions from 2003 to 2012. Method This retrospective, descriptive study was based on review of two clinical trial registries, ClinicalTrials.gov and the Brazilian registry ReBEC. Phase II or III studies with participation from Brazilian institutions listed in at least one of the registries were included. Following selection of the trials, the pathway of monoclonal antibodies and biological medicines was investigated from the research stage until licensing by the Brazilian Agency for Sanitary Surveillance (Anvisa), Food and Drug Administration (FDA), and European Medicines Agency (EMA). Results Nine trials (eight phase III and one phase II) were selected. All had a randomized, controlled design. Two trials were double-blind and seven were open-label, and all recruited adults (≥ 18 years of age) of both sexes. The mean number of patients recruited per trial was 985.2. Seven trials had been completed and two had been terminated early. All trials were sponsored by non-Brazilian pharmaceutical companies and focused on renal, colorectal, gastric, and lung (non-small cell) cancer, non-Hodgkin lymphoma, and melanoma, and involved the use of cetuximab, figitumumab, ipilimumab, rituximab, bevacizumab and interferon alfa-2a. The FDA was the first agency to license the drugs, followed by EMA, except in the case of interferon alfa-2a, which was not approved by EMA. We were unable to determine the year of drug licensing by Anvisa in Brazil. Conclusions The participation of Brazil in clinical trials of monoclonal antibodies and biological medications for cancer treatment is insufficient. The quality of the available information on trials, history of licensing, and other relevant elements is a major weakness of the sources reviewed. <![CDATA[The new United Nations approach to sustainable development post-2015: Findings from four overviews of systematic reviews on interventions for sustainable development and health]]> http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000300157&lng=pt&nrm=iso&tlng=pt ABSTRACT Objective To identify reported interventions that facilitate sustainable development and have had a positive impact on health in four areas: sustainable food production; sustainable energy use; sustainable jobs (“decent work”); and prevention of toxic exposure to chemicals. Methods Systematic review methods were used to synthesize evidence from multiple systematic reviews and economic evaluations. A comprehensive search was conducted of at least 14 databases and 8 websites for each of the four overviews, using pre-defined protocols, including clear inclusion criteria. To qualify as “sustainable,” interventions needed to aim (explicitly or implicitly) to positively impact at least two dimensions of the integrated framework for sustainable development and had to include measures of health impact. Results In total, 47 systematic reviews and 10 economic evaluations met the inclusion criteria. The most promising interventions, such as agricultural policies, were identified for each of the four topics. While the evidence for the interventions is not strong because of the limited number of studies, there is no evidence of a definite negative impact on health. The only possible exception is that of taxes and subsidies—though this intervention also has the potential to be pro-equity with higher relative impacts for lower income groups. Conclusions The evidence found for effective interventions is useful for guiding countries toward the best options for non-health sector interventions that can positively impact health. This overviews shows that intersectoral work benefits every sector involved.<hr/>RESUMEN Objetivo Identificar las intervenciones notificadas que facilitan el desarrollo sostenible y han tenido un impacto positivo en la salud en cuatro áreas: producción sostenible de alimentos, uso sostenible de la energía, trabajo sostenible (“trabajo digno”), y prevención de la exposición a productos químicos tóxicos. Métodos Se usaron métodos de revisión sistemática para sintetizar la evidencia de múltiples revisiones sistemáticas y evaluaciones económicas. Sobre la base de protocolos predefinidos, incluidos criterios de inclusión claros, se realizó una búsqueda en al menos 14 bases de datos y ocho sitios web para cada una de las cuatro sinopsis de revisiones sistemáticas. Para ser consideradas “sostenibles,” las intervenciones debían estar dirigidas (explícita o implícitamente) a lograr efectos positivos en al menos dos dimensiones del marco integrado para el desarrollo sostenible e incluir mediciones de la repercusión en la salud. Resultados En total, 47 revisiones sistemáticas y 10 evaluaciones económicas cumplieron con los criterios de inclusión. Se identificaron las intervenciones más prometedoras, como las políticas agrícolas, para cada uno de los cuatro temas. Si bien la evidencia sobre las intervenciones no es sólida debido al número limitado de estudios, no hay indicios de un impacto negativo concreto en la salud. La única posible excepción se relaciona con los impuestos y subsidios, aunque esta intervención también tiene el potencial de favorecer la equidad con una repercusión relativa mayor en los grupos de menores ingresos. Conclusiones La evidencia sobre intervenciones eficaces es útil para guiar a los países hacia las mejores opciones de intervención en sectores que no son de salud pero cuya repercusión también será positiva en el de la salud. Estas sinopsis indican que el trabajo intersectorial beneficia a todos los sectores implicados. <![CDATA[Evolution of the concept of positive mental health: a systematic review]]> http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000300166&lng=pt&nrm=iso&tlng=pt RESUMEN Objetivo Caracterizar los modelos teóricos que han fundamentado las investigaciones empíricas sobre salud mental positiva desde el momento en que aparece el concepto en el campo de la salud hasta la actualidad. Métodos Se realizó un proceso sistemático de búsqueda de literatura, publicada en las bases de datos PubMed, Ebsco (Academic Search Complete, ERIC, Fuente Académica, MasterFILE premier, MedicLatina, Medline y Psychology and Behavioral Sciences Collection), Science Direct, Psicodoc, Springer Link, Taylor and Francys, Wiley Online Library, DOAJ (Directory of Open Access Journals), Redalyc, Scielo, Ovid, Embase y Proquest (Psychology Journals, Nursing and Allied Health Source, Health and Medical Complete y Social Science Journals). Se utilizó como criterio de búsqueda el descriptor “salud mental positiva”. Resultados De los 51 estudios consultados, 84% presentan un enfoque cuantitativo y también 84% están publicados en inglés y fueron realizados entre los años 2000 y 2014. Se identificaron cinco categorías en la utilización del concepto salud mental positiva: la ausencia de enfermedad como indicador de salud mental positiva, el modelo de Jahoda, el desarrollo de la escala de Lluch, la utilización del concepto de bienestar como sinónimo de salud mental positiva y un reciente interés por diseñar escalas de medición. Conclusiones La salud mental positiva no debe ser entendida como la antinomia del trastorno mental, la ausencia de enfermedad o la simple suma de atributos personales. Es importante avanzar en el desarrollo de modelos conceptuales que servirán como fundamento para el abordaje de la salud mental desde un enfoque centrado en la promoción de la salud.<hr/>ABSTRACT Objective Characterize the theoretical models that have underpinned empirical research on the concept of positive mental health from the time it first emerged in the field of health up to the present. Methods A systematic search of the literature was conducted in PubMed, EBSCO (including Academic Search Complete, ERIC, Academic Source, MasterFILE Premier, MedicLatina, MEDLINE, and the Psychology and Behavioral Sciences Collection), Science Direct, Psicodoc, Springer Link, Taylor &amp; Francis, Wiley Online Library, Directory of Open Access Journals (DOAJ), Redalyc, SciELO, Ovid, Embase, and ProQuest (including Health and Medical Complete, the Nursing and Allied Health Source, Psychology Journals, and Social Science Journals). The search criterion was the descriptor “positive mental health.” Results Of 51 studies consulted, 84% used a quantitative approach; 84% were published in English; and the same percentage were conducted between 2000 and 2014. The concept of positive mental health has been applied in essentially five different ways: as the absence of disease; as the subject of the Jahoda model; as a combination of factors on the Lluch scale; as a synonym of well-being; and as part of more complex scales of measurement. Conclusions Positive mental health should not be viewed as the opposite of a mental disorder, the absence of disease, or the sum of a given set of personal conditions. It is important to move forward in the development of conceptual models that will serve as a basis for approaching mental health from the perspective of health promotion. <![CDATA[International Health Regulations, Ebola, and emerging infectious diseases in Latin America and the Caribbean]]> http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000300174&lng=pt&nrm=iso&tlng=pt RESUMEN La determinación por parte de la Organización Mundial de la Salud de que el brote de enfermedad por el virus del Ébola constituía un evento de salud pública de importancia internacional llevó a los países que no estaban afectados a aplicar medidas para prevenir y detectar la introducción del virus en sus territorios y para reaccionar frente a ella. El brote brindó la oportunidad de evaluar la aplicación operativa de las capacidades básicas del Reglamento Sanitario Internacional y la preparación de los sistemas de salud para hacer frente a un caso posible o confirmado de enfermedad por el virus del Ébola. Un marco rector de salud pública aplicado en los países de América Latina y el Caribe, que abarca autoevaluaciones preparatorias, visitas a los propios países y seguimiento, sugiere que esa región debe aumentar sus esfuerzos por consolidar y mantener los progresos en las capacidades básicas y en la preparación del sistema de salud para hacer frente a eventos de salud pública que tengan repercusiones a escala nacional o internacional.<hr/>ABSTRACT The World Health Organization’s determination of the Ebola virus disease outbreak as a public health event of international concern prompted non affected countries to implement measures to prevent, detect, and manage the introduction of the virus in their territories. The outbreak provided an opportunity to assess the operational implementation of the International Health Regulations’ core capacities and health systems’ preparedness to handle a potential or confirmed case of Ebola virus disease. A public health framework implemented in Latin America and Caribbean countries encompassing preparatory self-assessments, in-country visits, and follow-up suggests that the region should increase efforts to consolidate and sustain progress on core capacities and health system preparedness to face public health events with national or international repercussions.