A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfilment of the requirements for the degree of Master of Medicine in the branch of Anaesthesiology Johannesburg, 2013 / Background: Microbial contamination of multi-dose vials is one of the mechanisms by which transmission of pathogens to patients can occur in anaesthesia. Common practice at Chris Hani Baragwanath Academic Hospital (CHBAH) is to use boluses of a self-prepared, multi-dose phenylephrine solution (referred to as the solutions) to treat hypotension, due to the vasodilatory effects of a spinal anaesthetic, in stable patients undergoing a caesarean section. Aims: The aims of this study were to determine if there was microbial contamination of the solutions used at CHBAH and to evaluate if appropriate labelling and aspiration practices were adhered to with regard to the solutions A sample was collected and the labelling data was documented from the solutions found in the obsteric theatres at CHBAH over a period of three months. The samples were sent to a laboratory for microbial investigation. Microbial contamination was identified in seven of 110 (6.36%) samples collected from the solutions. The name of the solution was indicated on all 110 (100%) containers and the concentration of the solution was indicated on 106 (96.36%) containers. The date the solution was prepared was indicated on 82 (74.55%) containers and the time the solution was prepared was indicated on 63 (57.27%) containers. Only nine (8.18%) of the healthcare workers that prepared the solutions confirmed it by placing a signature on the container. Labelling data was written directly on all 110 (100%) containers and a spike device was used in 71 (64.54%) containers. This study demonstrated microbial contamination of the solutions and that safe injection practices were not adhered to when intravenous medications were prepared and administered. This is important at CHBAH since a large proportion of South African patients are immunocompromised and susceptible to opportunistic infections. Inappropriate labelling of medications is a cause of medication administration errors and this may have serious legal implications for the anaesthetist.

Thesis (M.S.)--University of Michigan, 1977.

Orientador: Rodrigo Ramos Catharino / Texto em português e inglês / Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Ciências Médicas / Made available in DSpace on 2018-08-25T05:33:49Z (GMT). No. of bitstreams: 1 Rodrigues_LiviaRiberti_M.pdf: 1203619 bytes, checksum: a17baf81fa013532bd6c9d451b2336f2 (MD5) Previous issue date: 2014 / Resumo: Atualmente, as doenças cardiovasculares constituem uma das primeiras causas de mortes no Brasil e no mundo. Neste cenário, as estatinas constituem uma notável classe de medicamentos redutores de colesterol e têm sido associadas com uma expressiva diminuição da morbidade e mortalidade cardiovascular para pacientes em prevenção primária ou secundária da doença coronariana. Elas agem inibindo competitivamente a enzima HMG-CoA redutase, através da afinidade destes fármacos pelo sítio ativo da enzima. Esta enzima é responsável por catalisar a conversão do substrato HMG-CoA em mevalonato, um dos precursores do colesterol. A crescente necessidade e busca por medicamentos cada vez mais efetivos traz a preocupação na segurança destes produtos para seus usuários. Neste sentido, o conhecimento das impurezas e produtos de degradação torna-se necessário para garantir sua qualidade. Uma técnica muito utilizada para análises de impurezas e degradantes é a espectrometria de massas, pois é uma técnica sensível e seletiva e permite elucidar as estruturas químicas presentes na formulação do medicamento. Sendo assim, amostras de Atorvastatina cálcica foram analisadas pela técnica de espectrometria de massas por imagem (MALDI-MSI), permitindo a quantificação de impurezas do medicamento através da imagem da distribuição dessa impureza no comprimido. Dessa forma, é possível minimizar o preparo de amostra e obter um melhor conhecimento da formulação / Abstract: Currently, cardiovascular diseases constitute one of the first causes of deaths in Brazil and in the world. In this scenario, the statins are a notable class of medicines and cholesterol reducers have been associated with a significant reduction in cardiovascular morbidity and mortality for patients in primary or secondary prevention of coronary heart disease. They act by inhibiting competitively the enzyme HMG-CoA reductase, through the affinity of these drugs by the active site of the enzyme. This enzyme is responsible for catalyzing the conversion of HMG-CoA to mevalonate substrate, one of the precursors of cholesterol. The growing need and search for increasingly effective drugs brings the concern on the safety of these drugs for their users. In this sense, the knowledge of the impurities and degradation products becomes necessary to ensure their quality. A widely used technique for analysis of impurities and degrading is mass spectrometry, because it is a sensitive and selective technique and allows elucidating the chemical structures of the present formulation of the medicinal product. Thus, samples of Atorvastatin calcium were analyzed by the technique of mass spectrometry imaging (MALDI-MSI), which allows the quantification of impurities from the medicine through the image of the distribution of impurity in the tablet. That way, it is possible minimize sample preparation and get a better understanding of the formulation / Mestrado / Ciencias Biomedicas / Mestra em Ciências Médicas

O cuidado a saúde incorpora continuamente, novas tecnologias relacionadas a produtos e processos que podem trazer riscos, especialmente, quando não possuem embasamento técnico-científico. Ampolas de plástico são amplamente utilizadas no preparo de injetáveis, no entanto, a contaminação biológica das soluções na sua abertura é ainda questionável. Sabe-se que o risco de infecção tem etiologia multifacetada envolvendo aspectos complexos da microbiota endógena e das condições ambientais. O objetivo do estudo é contribuir para com a segurança microbiológica da abertura de ampolas com base no procedimento de desinfecção e, assim, minimizar os riscos de contaminação biológica no preparo de injetáveis. Trata-se de um experimento de laboratório que permitiu avaliar a esterilidade do conteúdo das ampolas e, consequentemente produziu evidencias acerca da segurança microbiológica no preparo de injetáveis. Para determinação se a abertura de ampolas possibilita veiculação bacteriana para as soluções utilizaram-se dois métodos de desinfecção do gargalo um com suabe e outro com algodão ambos umedecidos em álcool a 70%. Das 120 ampolas de plástico com água esterilizada 60 tiveram seus gargalos contaminados intencionalmente com Serratia marcescens (ATTCC 14756) e outra metade com Staphylococcus aureus resistente à meticilina (MRSA) (ATTCC 43300) na ordem de 106 UFC/mL. Na abertura das respectivas ampolas utilizaram-se os princípios e o rigor de assepsia em termos de higiene das mãos e uso de luvas esterilizadas. Na avaliação da positividade das culturas uma alíquota da solução de cada ampola foi pipetada em caldo nutriente e incubada a 35ºC por 14 dias. A fricção dos gargalos das ampolas com suabe ou bolas de algodão embebidas em 3 ml de álcool a 70% não foi eficaz na redução da contaminação do conteúdo destas ampolas. Evidencia-se que houve maior contaminação nas ampolas, intencionalmente contamindas com Serratia marcescens, que receberam desinfecção com suabe 19 (63,3%) comparado as ampolas 15 (50%) que foram desinfetadas com bolas de algodão embebidas em álcool. As ampolas contaminadas com Staphylococcus aureus resistente à meticilina independentemente de utilizar suabe ou bolas de algodão embebidas em álcool, a contaminação do conteúdo das ampolas foi alta 24 (80%) e 18 (60%), respectivamente. Das 60 (100%) ampolas contaminadas com Serratia marcescens 34 (56,7%) apresentaram contaminação da água destilada e, das 60 (100%) ampolas contaminadas com Staphylococcus aureus resistente à meticilina, 42 (70%) apresentaram contaminação. A elucidação do processo de contaminação do conteúdo de ampolas de plástico durante sua abertura é urgente, especialmente considerando a possibilidade do contato da solução com o meio externo e vice- versa. Consta-se que a temática carece de mais investimentos de pesquisa dado a relevância do procedimento de desinfecção na redução da carga microbiana. / The health care incorporates continuously new technologies related to products and administration processes that may pose risks, especially when there is no technical- scientific basis. Plastic ampoules are widely used in the preparation of injectables, however, biological contamination in solutions at its opening is still questionable. It is known that the risk of infection presents a multifaceted etiology involving complex aspects of endogenous microbiota and environmental conditions. The present investigation was carried out in order to contribute to the microbiological safety of opening ampoules based on disinfection procedure and thereby minimize the risk of biological contamination in the preparation of injectables. This is a laboratory experiment that allowed to evaluate the sterility of ampoules´ contents and consequently produced evidences regarding the microbiological safety in the preparation of injectables. To determine whether the opening of ampoules allows the carrying of bacteria into the solutions it was used two methods of ampoule neck disinfection, one with cotton balls and another with cotton swab both soaked with 70% alcohol. Of the 120 plastic ampoules containing sterile water, 60 had the ampoules necks intentionally contaminated with Serratia marcescens (ATTCC 14756) and the other half with methicillin-resistant Staphylococcus aureus (MRSA) (ATTCC 43300) of the order of 106 CFU/mL. At the opening of respective ampoules it was used the principles of strict asepsis and rigor in terms of hand hygiene and use of sterile gloves. In the evaluation of positive cultures an aliquot of solution from each ampoule was pipetted in nutrient broth and incubated at 35 °C for 14 days. Rub the ampoules necks with swab or cotton balls soaked with 70% alcohol in 3 ml was not effective in decreasing contamination of contents of those ampoules. It is evident that there were more contamination in ampoules intentionally contaminated with Serratia marcescens which received disinfection with swabs 19 (63.3%) if compared ampoules disinfected with cotton balls soaked in alcohol 15 (50%). Ampoules contaminated with methicillin-resistant Staphylococcus aureus neither swab nor cotton balls soaked in alcohol was effective, contamination of the contents of the ampoules 24 was high (80%) and 18 (60%), respectively. Of the 60 (100%) ampoules contaminated with Serratia marcescens 34 (56.7%) had distilled water contaminated, and from 60 (100%) ampoules contaminated with methicillin-resistant Staphylococcus aureus, 42 (70%) were contaminated. The elucidation of contamination process of contents of plastic ampoules during its opening is an urgent need, especially considering the possibility of contact of the solution with the external environment and vice versa. The evidence suggests that the issue needs more research investments given the relevance of the disinfection procedure in decreasing microbial load.

O cuidado a saúde incorpora continuamente, novas tecnologias relacionadas a produtos e processos que podem trazer riscos, especialmente, quando não possuem embasamento técnico-científico. Ampolas de plástico são amplamente utilizadas no preparo de injetáveis, no entanto, a contaminação biológica das soluções na sua abertura é ainda questionável. Sabe-se que o risco de infecção tem etiologia multifacetada envolvendo aspectos complexos da microbiota endógena e das condições ambientais. O objetivo do estudo é contribuir para com a segurança microbiológica da abertura de ampolas com base no procedimento de desinfecção e, assim, minimizar os riscos de contaminação biológica no preparo de injetáveis. Trata-se de um experimento de laboratório que permitiu avaliar a esterilidade do conteúdo das ampolas e, consequentemente produziu evidencias acerca da segurança microbiológica no preparo de injetáveis. Para determinação se a abertura de ampolas possibilita veiculação bacteriana para as soluções utilizaram-se dois métodos de desinfecção do gargalo um com suabe e outro com algodão ambos umedecidos em álcool a 70%. Das 120 ampolas de plástico com água esterilizada 60 tiveram seus gargalos contaminados intencionalmente com Serratia marcescens (ATTCC 14756) e outra metade com Staphylococcus aureus resistente à meticilina (MRSA) (ATTCC 43300) na ordem de 106 UFC/mL. Na abertura das respectivas ampolas utilizaram-se os princípios e o rigor de assepsia em termos de higiene das mãos e uso de luvas esterilizadas. Na avaliação da positividade das culturas uma alíquota da solução de cada ampola foi pipetada em caldo nutriente e incubada a 35ºC por 14 dias. A fricção dos gargalos das ampolas com suabe ou bolas de algodão embebidas em 3 ml de álcool a 70% não foi eficaz na redução da contaminação do conteúdo destas ampolas. Evidencia-se que houve maior contaminação nas ampolas, intencionalmente contamindas com Serratia marcescens, que receberam desinfecção com suabe 19 (63,3%) comparado as ampolas 15 (50%) que foram desinfetadas com bolas de algodão embebidas em álcool. As ampolas contaminadas com Staphylococcus aureus resistente à meticilina independentemente de utilizar suabe ou bolas de algodão embebidas em álcool, a contaminação do conteúdo das ampolas foi alta 24 (80%) e 18 (60%), respectivamente. Das 60 (100%) ampolas contaminadas com Serratia marcescens 34 (56,7%) apresentaram contaminação da água destilada e, das 60 (100%) ampolas contaminadas com Staphylococcus aureus resistente à meticilina, 42 (70%) apresentaram contaminação. A elucidação do processo de contaminação do conteúdo de ampolas de plástico durante sua abertura é urgente, especialmente considerando a possibilidade do contato da solução com o meio externo e vice- versa. Consta-se que a temática carece de mais investimentos de pesquisa dado a relevância do procedimento de desinfecção na redução da carga microbiana. / The health care incorporates continuously new technologies related to products and administration processes that may pose risks, especially when there is no technical- scientific basis. Plastic ampoules are widely used in the preparation of injectables, however, biological contamination in solutions at its opening is still questionable. It is known that the risk of infection presents a multifaceted etiology involving complex aspects of endogenous microbiota and environmental conditions. The present investigation was carried out in order to contribute to the microbiological safety of opening ampoules based on disinfection procedure and thereby minimize the risk of biological contamination in the preparation of injectables. This is a laboratory experiment that allowed to evaluate the sterility of ampoules´ contents and consequently produced evidences regarding the microbiological safety in the preparation of injectables. To determine whether the opening of ampoules allows the carrying of bacteria into the solutions it was used two methods of ampoule neck disinfection, one with cotton balls and another with cotton swab both soaked with 70% alcohol. Of the 120 plastic ampoules containing sterile water, 60 had the ampoules necks intentionally contaminated with Serratia marcescens (ATTCC 14756) and the other half with methicillin-resistant Staphylococcus aureus (MRSA) (ATTCC 43300) of the order of 106 CFU/mL. At the opening of respective ampoules it was used the principles of strict asepsis and rigor in terms of hand hygiene and use of sterile gloves. In the evaluation of positive cultures an aliquot of solution from each ampoule was pipetted in nutrient broth and incubated at 35 °C for 14 days. Rub the ampoules necks with swab or cotton balls soaked with 70% alcohol in 3 ml was not effective in decreasing contamination of contents of those ampoules. It is evident that there were more contamination in ampoules intentionally contaminated with Serratia marcescens which received disinfection with swabs 19 (63.3%) if compared ampoules disinfected with cotton balls soaked in alcohol 15 (50%). Ampoules contaminated with methicillin-resistant Staphylococcus aureus neither swab nor cotton balls soaked in alcohol was effective, contamination of the contents of the ampoules 24 was high (80%) and 18 (60%), respectively. Of the 60 (100%) ampoules contaminated with Serratia marcescens 34 (56.7%) had distilled water contaminated, and from 60 (100%) ampoules contaminated with methicillin-resistant Staphylococcus aureus, 42 (70%) were contaminated. The elucidation of contamination process of contents of plastic ampoules during its opening is an urgent need, especially considering the possibility of contact of the solution with the external environment and vice versa. The evidence suggests that the issue needs more research investments given the relevance of the disinfection procedure in decreasing microbial load.