The other side of the coin: safety of complementary and alternative medicine

Most consumers consider complementary and alternative medicine (CAM) products inherently safe. The growing simultaneous use of CAM products and pharmaceutical drugs by Australian consumers increases the risk of CAM-drug interactions. The Therapeutic Goods Administration (TGA) has a two-tier, risk-based regulatory system for therapeutic goods - CAM products are regulated as low risk products and are assessed for quality and safety; and sponsors of products must hold the evidence for any claim of efficacy made about them. Adverse reactions to CAM products can be classified as intrinsic (innate to the product), or extrinsic (where the risk is not related to the product itself, but results from the failure of good manufacturing practice). Adverse reactions to CAM practices can be classified as risks of commission (which includes removal of medical therapy) and risks of omission (which includes failure to refer when appropriate). While few systematic studies of adverse events with CAM exist, and under-reporting is likely, most CAM products and practices do not appear to present a high risk; their safety needs to be put into the perspective of wider safety issues. A priority for research is to rigorously define the risks associated with both CAM products and practices so that their potential impact on public health can be assessed.

Conditions promoting good multiprofessional collaboration practices in Swiss all-day schools

Multiprofessional collaboration in all-day schools refers to teamwork and coordination that takes place between professionals with different vocational backgrounds. In Switzerland, all-day schoolscomprise regular school instruction and school-based extracurricular activities. Nevertheless, multiprofessional collaboration can also refer to collaboration between education professionals in all-day schools and professionals outside the school in a community-based setting of extracurricular activities. A synthesis of the literature shows that collaboration inside and outside the school setting is promoted by conditions in three areas: structural characteristics of the institution, characteristics of the team, and interpersonal processes (Schüpbach, Jutzi & Thomann 2012). In view of these findings, it was the aim of this study to analyze conditions of good collaboration practices in all-day schools in Switzerland. This qualitative study examined 10 all-day schools in five different cantons in the German-speaking part of Switzerland that showed good collaboration practice. In the course of this study, we conducted 18 problem-centered interviews and 10 focus group discussions. In the process of data evaluation, we applied the method of qualitative content analy sis. The findings show that all of the three areas of conditions promoting good collaboration proved to be relevant in the whole sample of all-day schools. Nevertheless, for the three different types of collaboration found? The school- oriented, the mixed/in termediate, and the social environment-oriented type? We identified different conditions of good collaboration practice.

Use of antimicrobials in food-producing animals in Switzerland and in the European Union (EU)

The intensive and inappropriate use of antibiotics in both medicine and agriculture has selected for antibiotic resistant bacteria that cause severe problems in antibiotic therapy. In animal husbandry, antibiotics are used for therapeutic and preventive treatments of infectious diseases and as growth promoters. In Europe, many antibiotics used as growth promoters were of the same classes as important antibiotics used in human medicine. The European Union withdrew the authorization for the use of the major antimicrobial growth promoters between 1996 and 1999. In 1999 Switzerland decided to ban the use of all antimicrobials as growthpromoting feed additives. The regulations concerning antibiotic use in animal husbandry and the chronological reasons for the ban of antimicrobial growth promoters are described. This ban led to a decrease of the antibiotic volume deployed in agriculture. This measure helps to reduce the amount of antibiotic resistant bacteria in food-producing animals. However, the use of medicated feed is still a common practice to prevent and to remedy bacterial infections and thus still leads to resistant pathogens. Surveillance programs, single animal treatment, good manufacturing practices and vaccinations are additional measures to be taken to keep the level of resistances in bacteria low.

Using a systems approach in logistics design and planning

The international economic and business environment continues to develop at a rapid rate. Increasing interactions between economies, particularly between Europe and Asia, has raised many important issues regarding transport infrastructure, logistics and broader supply chain management. The potential exists to further stimulate trade provided that these issues are addressed in a logical and systematic manner. However, if this potential is to be realised in practice there is a need to re-evaluate current supply chain configurations. A mismatch currently exists between the technological capability and the supply chain or logistical reality. This mismatch has sharpened the focus on the need for robust approaches to supply chain re-engineering. Traditional approaches to business re-engineering have been based on manufacturing systems engineering and business process management. A recognition that all companies exist as part of bigger supply chains has fundamentally changed the focus of re-engineering. Inefficiencies anywhere in a supply chain result in the chain as a whole being unable to reach its true competitive potential. This reality, combined with the potentially radical impact on business and supply chain architectures of the technologies associated with electronic business, requires organisations to adopt innovative approaches to supply chain analysis and re-design. This paper introduces a systems approach to supply chain re-engineering which is aimed at addressing the challenges which the evolving business environment brings with it. The approach, which is based on work with a variety of both conventional and electronic supply chains, comprises underpinning principles, a methodology and guidelines on good working practice, as well as a suite of tools and techniques. The adoption of approaches such as that outlined in this paper helps to ensure that robust supply chains are designed and implemented in practice. This facilitates an integrated approach, with involvement of all key stakeholders throughout the design process.

Implantação e implementação das normas das Boas Práticas Laboratoriais (BPL) no laboratório de análises de resíduos da Universidade Estadual de Campinas

In the context of quality and good laboratory practices, the article recovers some historical data. From a specific Institutional situation (CPQBA/UNICAMP), is presented an experience of establishing and implementing a standard (NIT-DICLA-035) for good laboratory practice according to definitions of the Brazilian authority (INMETRO) responsible for regulating, monitoring, supervising and recognition in this area. The issue aims to focus on studies of pesticide residues in GLP parameters.

Comércio varejista de alimentos no município de São Paulo: a evolução da legislação sanitária

O código Sanitário Municipal de Alimentos, Decreto Municipal nº 25.544, de 14 de março de 1988, regulamentou a fiscalização sanitária de g~eneros alimentícios no varejo até 26 de novembro de 2002, data em que entrou em vigor a Lei Estadual nC 10.083, de 23 de setembro de 1998, Código Sanitário do estado de São Paulo, utilizado pelos serviços municipais de vigilância, em caráter temporário, até a promulgação do atual Código Sanitário do Município de São Paulo nº 13.735, em 9 de janeiro de 2004. Este código regulamenta todos os serviços e produtos de interesse da saúde, inclusive a produção e distribuição de alimentos e água para consumo humano. Por meio do estudo dos diferentes códigos vigentes no município e de legislações esparsas, foi possível identificar as nmudanças ocorridas na legislação e nos procedimentos administrativos da vigilância sanitária do varejo de alimentos no Município de São Paulo. Concluiu-se que o Código Sanitário do Município de São Paulo é uma legislação completa e atualizada, com previsão legal de utilização de regulamentos técnicos modernos de forma combinada, especialmente os que tratam da produção e distribuição de alimentos, com ênfase nas Boas Práticas de Fabricação (BPFs)

Listeria monocytogenes in two different poultry facilities: Manual and automatic evisceration

Listeriosis is a serious foodborne disease caused by Listeria monocytogenes, a pathogen often found in food processing plants. Poultry meat and its derivatives may harbor L. monocytogenes even if good manufacturing practices are implanted in abattoirs. Little information exists in Brazil on the frequency of L. monocytogenes contamination, even though the country is considered the top poultry meat exporter in the world. This study attempted to compare 2 exporters poultry facilities following same the standards but differing only in manual (plant M) or automatic (plant A) evisceration. Eight hundred fifty-one samples from food, food contact and non-food contact surfaces, water, and workers` hands were collected from cage to finished products over a 1-yr period. In plant A, 20.1% of the samples were positive for L. monocytogenes, whereas in plant M, 16.4% was found. The greatest incidence of contamination with the pathogen in plant A was found in non- food contact surfaces (27.3%), while in plant M, it was found in products (19.4%). The most prevalent serovars were 1/2a or 3a (plant M) and 4b, 4d, or 4e (plant A). Despite having proper hygiene and good manufacturing practices, controlling the entry and persistence of L. monocytogenes in processing facilities remains a formidable task.

Prerequisite Programs at Schools: Diagnosis and Economic Evaluation

In this study, 20 Brazilian public schools have been assessed regarding good manufacturing practices and standard sanitation operating procedures implementation. We used a checklist comprised of 10 parts ( facilities and installations, water supply, equipments and tools, pest control, waste management, personal hygiene, sanitation, storage, documentation, and training), making a total of 69 questions. The implementing modification cost to the found nonconformities was also determined so that it could work with technical data as a based decision-making prioritization. The average nonconformity percentage at schools concerning to prerequisite program was 36%, from which 66% of them own inadequate installations, 65% waste management, 44% regarding documentation, and 35% water supply and sanitation. The initial estimated cost for changing has been U.S.$24,438 and monthly investments of 1.55% on the currently needed invested values. This would result in U.S.$0.015 increase on each served meal cost over the investment replacement within a year. Thus, we have concluded that such modifications are economically feasible and will be considered on technical requirements when prerequisite program implementation priorities are established.

Clinical trials profile: Professionals and sites

Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. Clinical trials that comply with international and national regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate clinical trial groups in Brazil: professional qualification, site structure regulatory knowledge and Good Clinical Practice (GCP) adherence. This is a transversal study with investigators (PI) and sub investigator (SI). PI and SI data were initially identified from Curriculum Lattes from National Advice of Scientific and Technological Development. The study participants were submitted to a questionnaire, which was composed of qualitative and quantitative questions. A hundred PI and SI were interviewed. The most representative Brazilian regions were Southeast (68%) and South (18%). The main institutions involved were HCFMUSP complex and UNIFESP among others institutions. Academic graduation is observed in 86% of them and the higher degree is Doctorate (62%). 91% had GCP knowledge although only 74% had formal training. About the team, all of them are multidisciplinary with majority of nurses and pharmaceuticals. 88% had GCP knowledge although only 77% had formal training. 36%, 60% and 44% of clinical trials were in phase II,III and IV. In conclusion, researchers have appropriate skills and knowledge to perform clinical studies however there is still a need for training. The centers where the researchers work, have trained staff and adequate infrastructure for conducting clinical trials phase II,III and IV. (C) 2010 Elsevier Inc. All rights reserved.

Transcorneal Electrical Stimulation for Patients with Retinitis Pigmentosa: A Prospective, Randomized, Sham-Controlled Exploratory Study

PURPOSE. To assess the safety of transcorneal electrical stimulation (TES) and explore its efficacy in various subjective and objective parameters of visual function in patients with retinitis pigmentosa (RP). METHODS. Twenty-four patients in this prospective, randomized, partially blinded, good-clinical-practice study underwent TES (5-ms biphasic pulses; 20 Hz; DTL electrodes) 30 minutes per week for 6 consecutive weeks. The patients were randomly assigned to one of three groups: sham, 66%, or 150% of individual electrical phosphene threshold (EPT). Visual acuity (VA), visual field (VF; kinetic, static), electroretinography (Ganzfeld, multifocal), dark-adaptation (DA), color discrimination, and EPTs were assessed at all visits or four times, according to the study plan. RESULTS. TES using DTL electrodes was tolerated well; all patients finished the study. Two adverse (foreign body sensation), but no serious adverse events were encountered. There was a tendency for most functional parameters to improve (8/18) or to remain constant (8/18) in the 150% group. VF area and scotopic b-wave amplitude reached statistical significance (P < 0.027 and P < 0.001, respectively). Only desaturated color discrimination and VF mean sensitivity decreased. There was no obvious trend in the 66% group. CONCLUSIONS. TES was found to be safe in RP patients. Positive trends were discovered, but due to the small sample size of this exploratory study, statistical significance was reached only for VF area and scotopic b-wave amplitude. Further studies with larger sample sizes and longer duration are needed to confirm the findings and to define optimal stimulation parameters. (ClinicalTrials.gov number, NCT00804102.) (Invest Ophthalmol Vis Sci. 2011;52:4485-4496) DOI:10.1167/iovs.10-6932

Validação da eficácia dos procedimentos de limpeza, no equipamento de fabrico e embalagem, na indústria farmacêutica

Na indústria farmacêutica, a limpeza dos equipamentos e superfícies é muito importante no processo de fabrico/embalagem dos produtos farmacêuticos. Possíveis resíduos contaminantes devem ser removidos dos equipamentos e das superfícies envolvidas no processo. De acordo com as Boas Práticas de Fabrico (GMP), os procedimentos de limpeza e os métodos analíticos usados para determinar as quantidades de resíduos devem ser validados. O método analítico combinado com o método de amostragem utilizado na colheita de amostras deve ser sujeito a um ensaio de “recovery”. Neste trabalho apresenta-se uma estratégia inovadora para a validação de limpeza de formas farmacêuticas semi-sólidas. Propõe-se o uso de um método de amostragem que consiste na colheita direta de amostra após o seu fabrico, sendo a análise de resíduos feita directamente nesta amostra. Os produtos escolhidos para a avaliação da estratégia foram dois medicamentos dermatológicos, apresentados na forma de pomada e produzidos numa unidade de fabrico de vários produtos, pela Schering Plough Farma/ Merck Sharp & Dohme (Cacém, Portugal). Como métodos analíticos para a quantificação dos resíduos, utilizaram-se métodos validados por via espectrofotométrica (HPLC), usados na análise do produto acabado. A validação de limpeza foi avaliada através da análise de uma quantidade conhecida de pomada (produto B (*)), usando o método de análise da pomada fabricada anteriormente (produto A (*)), de modo a verificar-se a existência ou não de agente de limpeza e substâncias ativas deixadas após a limpeza do produto A, e vice-versa. As concentrações residuais das substâncias ativas e do agente de limpeza encontradas após a limpeza foram nulas, ou seja, inferiores ao limite de deteção (LOD), sendo que o critério de aceitação da limpeza utilizado foi de 6,4 x 10-4 mg/g para a substância ativa 1 (*); 1,0 x 10-2 mg/g para a substância ativa 2 (*); 1,0 x 10-3 mg/g para a substância ativa 3 (*) e de 10 ppm para o agente de limpeza. No ensaio de “recovery”, obtiveram-se resultados acima de 70% para todas as substâncias ativas e para o agente de limpeza nas duas pomadas. Antes de se proceder a este ensaio de “recovery”, houve a necessidade de ajustar as condições cromatográficas dos métodos analíticos de ambos os produtos e do agente de limpeza, por forma a obter-se valores da conformidade do sistema (fator de tailling e de resolução) de acordo com as especificações. A precisão dos resultados, reportada como desvio padrão relativo (RSD), deu abaixo de 2,0%, excepto nos ensaios que envolvem a substância ativa 3, cuja especificação é inferior a 10,0%. Os resultados obtidos demonstraram que os procedimentos de limpeza usados na unidade de fabrico em causa são eficazes, eliminando assim a existência de contaminação cruzada.

Melhoria da qualidade na produção biológica de vegetais

Dissertação de Mestrado, Tecnologia e Segurança Alimentar, 1 de Outubro de 2015, Universidade dos Açores.

Satisfação profissional dos enfermeiros em unidades de cuidados continuados integrados

A Satisfação no trabalho, definida como reações individuais, cognitivas, afetivas e avaliativas perante o trabalho (Locke, 1983), tem sido amplamente estudada no âmbito das organizações. A sua medição na área da saúde contribui para incrementar um bom ambiente na prática e bem-estar dos profissionais e para aumentar a qualidade dos cuidados. Em 2006 surge um novo contexto de trabalho através da criação da RNCCI, que pretende fazer face ao crescente aumento de população em situação de dependência ou incapacidade, mas também aliviar a sobrecarga e custos associados aos cuidados hospitalares. A reorganização do trabalho nas unidades de cuidados continuados acenta nos princípios da interdisciplinariedade e cooperação entre a equipa, requerendo mudança e adaptação à prática. Sendo os enfermeiros a classe profissional com maior tempo de contacto nos cuidados, importa verificar se estão satisfeitos com a mudança induzida. Assim, este estudo de natureza quantitativa pretende medir e analisar a satisfação profissional ddos enfermeiros que trabalham no serviço de longa duração e manutenção nas unidades de cuidados continuados do distrito de Braga, e verificar se esta variável é influenciada por fatores sociodemográficos e laborais. Para a recolha de dados utiliza-se a Escala de Avaliação da Satisfação no Trabalho para Enfermeiros - EASPE© (α=0,814) e um questionário sociodemográfico e profissional. A análise dos dados é efetuada com recurso à estatística descritiva e inferencial com utilização dos testes de Mann-Whitney e de Kruskal-Wallis. Os resultados obtidos evidenciam que os enfermeiros apresentam um nível de satisfação global no trabalho positivo, mas negativo nas dimensões satisfação com benefícios e recompensas e satisfação com promoção. Conclui-se, ainda, que a satisfação com promoção é influenciada pelas habilitações literárias, que a satisfação com a comunicação é influenciada pela remuneração, que a satisfação com benefícios e recompensas é influenciada pelo horário semanal e que a unidade de cuidados é determinante na satisfação global no trabalho.

Extraction of Trypanosoma cruzi DNA from food: a contribution to the elucidation of acute Chagas disease outbreaks

Abstract: INTRODUCTION: Before 2004, the occurrence of acute Chagas disease (ACD) by oral transmission associated with food was scarcely known or investigated. Originally sporadic and circumstantial, ACD occurrences have now become frequent in the Amazon region, with recently related outbreaks spreading to several Brazilian states. These cases are associated with the consumption of açai juice by waste reservoir animals or insect vectors infected with Trypanosoma cruzi in endemic areas. Although guidelines for processing the fruit to minimize contamination through microorganisms and parasites exist, açai-based products must be assessed for quality, for which the demand for appropriate methodologies must be met. METHODS: Dilutions ranging from 5 to 1,000 T. cruzi CL Brener cells were mixed with 2mL of acai juice. Four Extraction of T. cruzi DNA methods were used on the fruit, and the cetyltrimethyl ammonium bromide (CTAB) method was selected according to JRC, 2005. RESULTS: DNA extraction by the CTAB method yielded satisfactory results with regard to purity and concentration for use in PCR. Overall, the methods employed proved that not only extraction efficiency but also high sensitivity in amplification was important. CONCLUSIONS: The method for T. cruzi detection in food is a powerful tool in the epidemiological investigation of outbreaks as it turns epidemiological evidence into supporting data that serve to confirm T. cruzi infection in the foods. It also facilitates food quality control and assessment of good manufacturing practices involving acai-based products.

Segurança no acesso ao registo clínico eletrónico

Dissertação de mestrado integrado em Engenharia Biomédica (área de especialização em Informática Médica)