A vigilância em saúde sob a perspectiva de seus trabalhadores / Vigilancia de la salud desde la perspectiva de sus trabajadores / Health surveillance from the perspective of workers

Objetivo: compreender a vigilância em saúde (vs) sob a perspectiva de seus trabalhadores. Materiais e método: estudo qualitativo baseado no método compreensivo-interpretativo, em que foram entrevistados 28 profissionais vin-culados à vs de um estado e de sua capital no Brasil. O material coletado por meio de entrevista foi analisado a partir da técnica de análise de conteúdo. Resultados: emergiram quatro categorias temáticas com relação à vs: concepção, articulação intrínseca e extrínseca, potencialidades e desafios. Os trabalhadores apresentaram uma concepção ampliada sobre a vs, entretanto a visão tecnicista e biomédica ainda persistiu. Conclusões: os trabalhadores relataram, como potencialidades, a satisfação e o comprometimento no exercício de suas funções e revelaram, como dificuldades, aspectos desestimulantes no cenário em curso. Nessa direção, os participantes apontaram para a alocação de mais verbas e investimentos no setor, para a valorização de suas carreiras e a necessidade de maior suporte por parte da gestão dos serviços.

Objetivo: comprender la vigilancia de la salud (vs) desde la perspectiva de los trabajadores de este sector. Materiales y método: estudio cualitativo bajo el método de interpretación integral, en el que se entrevistó a 28 profesionales vinculados a la vs en un estado de Brasil. El material recogido se analizó utilizando la técnica de análisis de contenido. Resultados: surgieron cuatro categorías temáticas en relación con vs: concepción; articulación intrínseca y extrínseca; potencialidades y desafíos. Los trabajadores presentaron una concepción ampliada sobre vs, sin embargo, la visión técnica y biomédica aún persiste entre los participantes. Conclusiones: los trabajadores informaron como potencialidades su satisfacción y el compromiso con el ejercicio de sus funciones. Entre las dificultades, señalaron aspectos desalentadores ante el escenario actual. En este sentido, los participantes ponen de manifiesta la necesidad de asignar más fondos e inversiones en el sector, reconocer el valor de su profesión y brindar mayor apoyo para la gestión de servicios.

Objective: Understanding health surveillance (sv) from the perspective of workers in this sector. Materials and method: Qualitative study under the comprehensive-interpretative method, in which 28 professionals linked to the sv of a Brazilian State and its capital were interviewed. The collected material was analyzed through the content analysis technique. Results: Four thematic categories emerged in relation to SV: conception; intrinsic and extrinsic articulation; potentialities and challenges. Participants presented an expanded conception about sv, although the technical and biomedical vision still remain as the main approach. Conclusions: Among the potentialities, participants reported satisfaction and commitment in the exercise of their functions. As for the difficulties, they revealed discouraging aspects based on the current scenario. In this direction, participants pointed as key elements the allocation of more funds and investment in the sector, more recognition and value to their careers, and the need for greater support from service management.

Early access to health products in France: Major advances of the French "Conseil stratégique des industries de santé" (CSIS) to be implemented (modalities, regulations, funding).

In a context of perpetual evolution of treatments, access to therapeutic innovation is a major challenge for patients and the various players involved in the procedures of access to medicines. The revolutions in genomic and personalized medicine, artificial intelligence and biotechnology will transform the medicine of tomorrow and the organization of our health system. It is therefore fundamental that France prepares for these changes and supports the development of its companies in these new areas. The recent "Conseil stratégique des industries de santé" launched by Matignon makes it possible to propose a regulatory arsenal conducive to the implementation and diffusion of therapeutic innovations. In this workshop, we present a number of proposals, our approach having remained pragmatic with a permanent concern to be effective in the short term for the patients and to simplify the procedures as much as possible. This was achieved thanks to the participation in this workshop of most of the players involved (industrial companies, "Agence nationale de sécurité du médicament et des produits de santé", "Haute Autorité de santé", "Institut national du cancer", "Les entreprises du médicament", hospitals, "Observatoire du médicament, des dispositifs médicaux et de l'innovation thérapeutique"…). The main proposals tend to favor the implementation of clinical trials on our territory, especially the early phases, a wider access to innovations by favoring early access programs and setting up a process called "autorisation temporaire d'utilisation d'extension" (ATUext) that make it possible to prescribe a medicinal product even if the latter has a marketing authorisation in another indication. In addition, we propose a conditional reimbursement that will be available based on preliminary data but will require re-evaluation based on consolidated data from clinical trials and/or real-life data. Finally, in order to better carry out these assessments, with a view to access or care, we propose the establishment of partnership agreements with health agencies/hospitals in order to encourage the emergence of field experts, in order to prioritize an ascending expertise closer to patients' needs and to real life.

The continuum of breast cancer care and outcomes in the U.S. Military Health System: an analysis by benefit type and care source.

PURPOSE: This study investigates transition rates between breast cancer diagnosis, recurrence, and death by insurance benefit type and care source in U.S. Military Health System (MHS). METHODS: The MHS data repository and central cancer registry linked data were used to identify women aged 40-64 with histologically confirmed breast cancer between 2003 and 2007. Three-state continuous time Markov models were used to estimate transition rates and transition rate ratios (TRRs) by TRICARE benefit type (Prime or non-Prime) and care source (direct, purchased, or both), adjusted for demographic, tumor, and treatment variables. RESULTS: Analyses included 2668 women with transitions from diagnosis to recurrence (n = 832), recurrence to death (n = 79), and diagnosis to death without recurrence (n = 91). Compared to women with Prime within each care source, women with non-Prime using both care sources had higher transition rates (TRR 1.47, 95% CI 1.03, 2.10). Compared to those using direct care within each benefit type, women utilizing both care sources with non-Prime had higher transition rates (TRR 1.86, 95% CI 1.11, 3.13), while women with Prime utilizing purchased care had lower transition rates (TRR 0.82, 95% CI 0.68, 0.98). CONCLUSIONS: In the MHS, women with non-Prime benefit plans compared to Prime had higher transition rates along the breast cancer continuum among both care source users. Purchased care users had lower transition rates than direct care users among Prime beneficiaries. IMPLICATIONS FOR CANCER SURVIVORS: Benefit plan and care source may be associated with breast cancer progression. Further research is needed to demonstrate differences in survivorship.

Defining reference levels for intra-operative radiation exposure in orthopaedic trauma: A retrospective multicentre study.

There is currently limited data to define reference levels for the use of ionising radiation in orthopaedic trauma surgery. In this multicentre study, we utilise methodology employed by the Health Protection Agency in establishing reference levels for diagnostic investigations in order to define analogous levels for common and reproducible orthopaedic trauma procedures. Four hundred ninety-five procedures were identified across four Greater London hospitals over a 1-year period. Exposure was defined in terms of both time and dose area product (DAP). Third quartile mean values for either parameter were used to define reference levels. Variations both between centres and grades of lead surgeon were analysed as secondary outcomes. Reference levels; dynamic hip screw (DHS) 1.9225000 Gycm(2)/70.50 s, intramedullary (IM) femoral nail 1.5837500 Gycm(2)/126.00 s, open reduction internal fixation (ORIF) clavicle 0.2042500 Gycm(2)/21.50 s, ORIF lateral malleolus 0.32250500 Gycm(2)/35.00 s, ORIF distal radius 0.1300000 Gycm(2)/56.00 s. Grade of surgeon did not influence exposure in dynamic hip screw, and was inversely related to exposure in intramedullary femoral nails. Less variation was observed with exposure time than with DAP. This study provides the most comprehensive reference to guide fluoroscopy use in orthopaedic trauma to date, and is of value both at the point of delivery and for audit of local practice.

Estudo retrospectivo de apreensões de alimentos da 1º Delegacia da Saúde Pública - Departamento de Polícia e Proteção à Cidadania

Os alimentos podem veicular diversos Micro-organismos patogênicos, causando varias afecções e surtos trazendo riscos à saúde pública. Essa contaminação pode ter ocorrência desde o início da produção da matéria-prima até as etapas de transporte, recepção, armazenamento e manipulação dos alimentos. Vencida a etapa de industrialização, os alimentos continuam expostos à contaminação nos centros de distribuição, supermercados, restaurantes, mercearias e na residência do consumidor. Esses alimentos podem estar contaminados por bactérias e suas toxinas, vírus, parasitas, metais pesados e produtos químicos. A ingestão de alimentos contaminados pode causar as Doenças Transmitidas por Alimentos, as quais representam alto risco à saúde da população, e geralmente são causadas por falhas em produção; armazenamento; processamento; manipulação; conservação de alimentos. O presente trabalho trata-se de um estudo retrospectivo, onde foram avaliadas as ocorrências da 10 Delegacia da Saúde Pública, DPPC (Departamento de Polícia e Proteção à Cidadania). O Departamento de Polícia de Proteção à Cidadania (DPPC) é um órgão de execução da Delegacia Geral de Polícia que tem a importante missão de orientar a população sobre seus direitos fundamentais e corrigir eventuais abusos, entre eles o risco à saúde pública através de alimentos impróprios e nocivos.

Food can transmit many pathogenic microorganisms, causing various diseases and outbreaks bringing risks to public health. This contamination may have occurred since the beginning of raw material production until transporting, receiving, storing and handling of food. After the industrialization step, the food continuous exposed to contamination in distribution centers, supermarkets, restaurants, grocery stores and the residence of the consumer. These foods can be contaminated by bacteria and their toxins, viruses, parasites, heavy metals and chemicals. The ingestion of contaminated food can cause the Foodborne Diseases, which represent high risk to public health, and are often causes by failures in production, storage, processing, manipulation and preservation of food. This resource is a retrospective study, evaluating the occurrence of the 1st Precinct of Public Health, DPPC (Department of Police and Protection of Citizenship). The Police Department for the Protection of Citizenship (DPPC) is an executive organ of the General Police Precinct that has the important task of educating the public about their fundamental rights and to correct abuses, including the risk to public health through food unfit and harmful.

[Hip Fracture--Epidemiology, Management and Liaison Service. What do we need to close care gaps in treating hip fracture?--How to include the UK experience into the care in Japan].

Various care gaps are noted in and between acute and rehabilitation hospitals, and after discharge from hospitals in Japan. In the most of acute care hospitals physicians take care of elderly fractured patients only by a request of orthopaedic team. This made a mean time until surgery was 4.5 days (2011). A critical pathway in treating hip fracture has certainly shortened days in the acute hospitals, care gaps may exist between hospitals. Although osteoporosis medication has started on discharge, it may be discontinued at home, in health or social care facilities under the care of primary care physicians. Even though it was estimated approximately 160,000 hip fractures per year in Japan, management of patients' address is not well established after discharge. In order to include the UK experience in Japan, two proposals were made for hospitals in treating hip fracture as follows. 1. Clinical auditing may be added to improve quality of care. An audit protocol is to be developed multidisciplinarily by orthopaedic surgeons and geriatricians, with interprofessional collaboration. 2. A fracture liaison service is to be established to make interprofessional care-mix possible, such as an increase of adherence of osteoporosis drugs and prevention of falls after discharge. A fracture liaison coordinator is to be assigned to the service in making a team approach possible to a patient and his/her family.

Lo psicológico en el plan integral de lucha contra la trata de personas Colombia 2007- 2012 / Psychological effects addressed in the comprehensive plan to fight against human trafficking - Colombia 2007-2012

La trata de personas es un fenómeno creciente a pesar de las disposiciones nacionales e internacionales para su control. La Estrategia Nacional Integral de Lucha Contra la Trata de Personas de Colombia (2007-2012), aunque hace un abordaje que contempla el cumplimiento de los compromisos del Estado en el sistema internacional, no se observa que considere las características del fenómeno ni que incluya una perspectiva de los sujetos involucrados desde una mirada de lo psicológico. Se analiza la propuesta del estado colombiano a la luz de la presencia de lo psicológico y se proponen dos alternativas de abordaje centradas en el diagnóstico y la identificación de las vulnerabilidades psicológicas de la población más proclive a ser víctima de trata de personas, como aspecto relacionado con la prevención para participar en la lucha contra este flagelo...

Trafficking in persons is a growing phenomenon despite the adoption of national and international dispositions created to control this problem. Although the Colombian Domestic Comprehensive Strategy Criminalizing the Trafficking in Persons (2007-2012), addresses the compliance of the State´s commitments in the international system it does not seem to consider the diverse range of effects of the phenomenon and does not include a perspective of the affected subjects by analyzing the psychological issues. We assess the Colombian governmental proposal to the light of the presence of psychological issues and offer two approaches focused on the diagnosis and the identification of the psychological vulnerabilities of individuals more likely to be affected by human trafficking as a related prevention factor to cooperate with the effort against this scourge...

The Vidant Health quality transformation.

BACKGROUND: Vidant Health (VH), a private, not-for-profit health system in eastern North Carolina, began a systemwide quality transformation in 2006 after a serious blood event resulted in a patient's death. METHODS: Systemwide patient safety training served as the foundation of the transformation. Strategic planning of the quality work outlined a series of approaches that included board literacy in quality, an aggressive transparency policy, patient-family partnerships, and leader and physician engagement. RESULTS: The transformation of the system has resulted in an 85% reduction in serious safety events, a 62% reduction in health care-associated infections, 98% optimal care in the Centers for Medicare & Medicaid Services (CMS)/Joint Commission core measures, Hospital Consumer Assessment of Healthcare Providers and Systems performance in the top 20%, and more than 150 patient advisors partnering with leaders, physicians, and frontline staff. From the bedside to the boardroom the improvement in quality is evident across VH's nine hospitals, 70 physician practices, ambulatory surgery, and home health, hospice, and wellness services. CONCLUSION: Strategic planning for quality set an ambitious agenda for VH's quality work and continues to drive action today. Engaging patients in quality work at all levels--as partners on performance improvement teams, in safety rounds, in quality improvement committee meetings, and in the boardroom--has been a deliberate strategy and a significant part of the quality transformation at VH. Additional requirements for public reporting, CMS's new payment reform, and the challenges inherent in the evolving health care industry at large make it imperative to maintain a focus on zero events of harm and exceptional patient experiences.

In and across bureaucracy: structural and administrative issues for the tobacco endgame.

This article assesses the structural choices for the proposed tobacco endgame strategies. I focus on the issues associated with particular structural choices for the location of the implementation. Specifically, I discuss issues related to implementation of the endgame within a specific single agency, and issues related to a more widespread, broad implementation involving several agencies. Where appropriate, I provide examples of how the dynamics discussed would apply to particular endgame strategies. Issues related to design, administration, authority and finances are raised.

Utilização do sistema de realizações governamentais por município (RGM) como ferramenta gerencial na SESAB: limites e potencialidades / Using the system of government achievements by municipality (RGM) as a management tool in SESAB: limits and potential / Uso del sistema de realizaciones gubernamentales por municipio (RGM) como herramienta de gestión en la SESAB: límites y posibilidades

O Sistema de Realizações Governamentais por Município (RGM) é destinado ao registro mensal das realizações do governo por municípios e configura-se como uma ferramenta gerencial disponível nas Secretarias do Estado da Bahia. Considerando o enfoque conceitual dos Triângulos de Governo e de Ferro da gestão, definidos no referencial de Carlos Matus, propõe-se como objetivo identificar os limites e as potencialidades do RGM como ferramenta gerencial para a cobrança e prestação de contas no processo de monitoramento da Secretaria da Saúde (Sesab) nos anos de 2010 e 2011. Para tanto, realizou-se uma análise documental, descritiva, de caráter exploratório, com base nos documentos disponíveis na Sesab atinentes ao sistema RGM. As potencialidades identificadas destacam características capazes de garantir a eficácia e qualificação do sistema de cobrança e prestação de contas de uma organização. Entre os limites verificados, identificou-se a subutilização do sistema RGM e de suas informações no processo de monitoramento da Sesab. Concluiu-se que, atendendo as potências apresentadas pelo sistema RGM, torna-se essencial estimular a adesão deste sistema para o acompanhamento dos compromissos e metas assumidos, incorporando-o como parte do processo de planejamento em saúde desenvolvido nesta instituição.

The System of Government Achievements by Municipality (RGM) is in charge of the monthly record of achievements of the government by municipalities, and it is configured as a management tool available in the State Departments of Bahia. Considering the conceptual approach of the Government Triangle and Iron Triangle of strategic management, as defined in the theoretical framework of Carlos Matus, this study proposes to identify the limits and potential of RGM as a management tool for recovery and accountability in monitoring process of the Health Department of the State of Bahia (Sesab) between 2010 and 2011. Therefore, there was performed a descriptive study of exploratory nature and document analysis from the available documents pertaining to the system in Sesab RGM. The potential identified highlight its features which ensure the effectiveness and qualification system for the collection and accountability of an organization. Among the limits checked identified the underutilization of RGM system and your information in the monitoring process of Sesab. Thus, given the powers given by RGM system, it is essential to stimulate compliance of this system to monitor the commitments made and targets, incorporating it as part of the health planning process developed in this institution.

El Sistema de Realizaciones Gubernamentales por Municipio (RGM) se destina al registro mensual de las realizaciones del gobierno por municipios y se configura como una herramienta de gestión disponible en las Secretarías del Estado de la Bahía. Teniendo en cuenta el enfoque conceptual de los Triángulos de Gobierno y de Hierro de la gestión, definidos en el marco de referencia de Carlos Matus, este estudio tiene el objetivo de identificar los límites y potencialidades del RGM como una herramienta de gestión para la en el proceso de monitoreo de la Secretaría de Salud (Sesab) entre los años de 2010 y 2011. Con este objetivo, se realizó un análisis de documentos, descriptiva y de carácter exploratorio, basado en los documentos disponibles en la Sesab referentes al sistema RGM. Las potencialidades identificadas, destacan características capaces de garantizar la eficiencia y la cualificación del sistema de cobranza y la rendición de cuentas de una organización. Entre los límites verificados se identificó la subutilización del sistema RGM y de sus informaciones en el proceso de monitoreo de la Sesab. Se concluye que, atendiendo a las potencialidades presentadas por el sistema de RGM, es esencial estimular la adhesión a este sistema para monitorear los compromisos y metas contraídos, incorporándolo como parte del proceso de planificación sanitaria desarrollada en esta institución.

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use.

The European Commission issued on March 17, 2011, a marketing authorization valid throughout the European Union (EU) for eribulin (Halaven; Eisai Limited). The decision was based on the favorable opinion of the Committee for Medicinal Products for Human Use recommending a marketing authorization for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least 2 chemotherapeutic regimens for advanced disease. Eribulin mesylate is a structurally simplified synthetic analogue of halichondrin B, which is a natural product isolated from the marine sponge Halichondria okadai (ATC code L01XX41). Eribulin is a nontaxane, microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates leading to G(2)-M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage. The recommended dose of eribulin is 1.23 mg/m(2) (equivalent to 1.4 mg/m(2) eribulin mesylate) to be administered intravenously over 2 to 5 min on days 1 and 8 of a 3-week cycle. In the pivotal trial, eribulin was associated with increased overall survival in patients with locally advanced or metastatic breast cancer who received at least 2 prior chemotherapy lines for advanced disease (median overall survival was 13.2 months in the eribulin arm vs. 10.6 months in the control arm; HR = 0.805; 95% confidence interval, 0.677-0.958; P = 0.014). The most common side effects are asthenia or fatigue and neutropenia. The objective of this article is to summarize the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary report and product information, including product characteristics, are available on the European Medicines Agency website.

[Medication errors in anaesthesia: a review of reports from the French Health Products Agency]. / Erreurs médicamenteuses en anesthésie : bilan et analyse des signalements reçus à l'Afssaps.

BACKGROUND: The purpose of this study was to assess medication errors and risks of medication errors during anaesthetic practice reported at the French Health Products Agency (Afssaps) from 2005 to 2010. STUDY DESIGN: Descriptive study. METHODS: The data are issued of "Medication errors and risks of medication errors" file which group together all cases received by the Medication Errors Unit at Afssaps since 2005. RESULTS: A total of 263 cases were observed by the Medication Errors Unit at Afssaps. Among them, 159 cases were risks of medication errors, 76 cases were patent medication errors and 28 were near misses. Among the 76 cases of patent medication errors, out of which 47 cases were appreciated with adverse reaction and 35 cases were classified as serious. Adverse events were classified as haemodynamic, respiratory and neurologic events. Most of the errors occurred during administration (65%), followed by dispensing errors (14%), storage errors (15%) or preparation errors (4%). Sixty-nine percent of cases of wrong drug errors were found, followed by 26% of errors of strength, 3% of incorrect route of administration errors and 2% of patient errors. In most of cases, similarity in packaging was underlined (n=83). CONCLUSION: This study showed that the majority of medication errors and risks of medication errors during anaesthetic practice, underline similarity in packaging. Results highlighted the importance of vial labeling presentation (readability and mention understanding) in anaesthetic practice.

European Medicines Agency, CAT Secretariat & US Food and Drug Administration.

The European Medicines Agency (EMA) and the Committee for Advanced Therapies (CAT) are responsible for reviewing applications for marketing authorization for Advanced Therapy Medicinal Products (ATMP), which include (stem) cell-based medicines, for the ATMP classification and certification procedure, and to provide scientific advice to developers of ATMPs. The CAT, an expert committee dedicated to ATMPs, was established by the Regulation (EC) No 1394/2007 on Advanced Therapies. The CAT came into operation in January 2009. ATMPs are defined in this Regulation as gene therapy and cell therapy medicinal products, and tissue-engineered products. The US FDA's Center for Biologics Evaluation and Research is responsible for ensuring the safety, purity, potency and effectiveness of many biologically derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products for the prevention, diagnosis and treatment of human diseases, conditions or injury. Human cells or tissue intended for implantation, transplantation, infusion or transfer into a human recipient are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps).

[Present status and prospects of professional facilities for wound healing].

It is essential for the development of modern clinical medicine to establish a professional facility and team for wound healing. There is some successful experience of constructing and running the wound healing center to be mirrored at home and abroad. The construction of the facility and team for wound healing will be promoted by guideline issuing, profession certification, and others, which would push forward the clinical treatment and basic research of wound healing.