Navegando por Palavras-chave "Pharmaceutical preparations"
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- ItemAcesso aberto (Open Access)Avaliação da qualidade farmacêutica de doses de medicamentos psicoativos: implicações na terapêutica medicamentosa(Universidade Federal de São Paulo (UNIFESP), 2018-04-26) Eserian, Jaqueline Kalleian [UNIFESP]; Galduroz, Jose Carlos Fernandes [UNIFESP]; http://lattes.cnpq.br/8366139801463833; http://lattes.cnpq.br/6545149413561453; Universidade Federal de São Paulo (UNIFESP)Introdução: A prática de divisão de comprimidos e a utilização de medicamentos líquidos de uso oral administrados com o auxílio de acessórios (gotejadores, copos medida e seringas dosadoras) possibilitam a obtenção de uma grande variedade de doses individualizadas, sendo de grande utilidade para esquemas de ajuste de doses, componente essencial no gerenciamento de medicamentos psicoativos. Entretanto, questões relacionadas à eficácia e segurança da divisão de comprimidos têm sido discutidas com relação a desvios substanciais na quantidade de substância ativa entre as metades, ao mesmo tempo que a utilização de alguns medicamentos líquidos de uso oral tem sido investigada pelas vigilâncias sanitárias em relação à obtenção de doses apropriadas. Objetivo: Avaliar as características físico-químicas e determinar os efeitos da prática de divisão de comprimidos e utilização de medicamentos líquidos de uso oral contendo substâncias psicoativas na obtenção de doses preconizadas pela clínica. Metodologia: Utilizou-se como modelo de obtenção de doses individualizadas medicamentos de referência, genéricos e similares na forma de comprimidos com vinco (haloperidol), medicamentos líquidos de uso oral com apresentação em gotejador em PVC (haloperidol), gotejador em vidro (clonazepam), copo medida (valproato de sódio) e seringa dosadora (carbamazepina). Foram avaliados o teor e uniformidade de conteúdo de doses para os comprimidos divididos tanto mecanicamente quanto não mecanicamente e para os medicamentos líquidos de uso oral. Para os comprimidos, avaliaram-se ainda as propriedades físicas, variação de peso e perda de massa. A quantificação dos medicamentos foi feita de acordo com métodos farmacopeicos. Resultados e discussão: Todos os acessórios avaliados apresentaram, em magnitude e extensão variadas, ao menos um fabricante com doses nas faixas de sub ou superdose. A maior variação na quantidade de substância ativa entre as doses foi observada para comprimidos divididos mecanicamente (60,7%). Houve variação na quantidade de substância ativa nas doses entre os fabricantes para a mesma quantidade de líquido dispensada em até 37,8% para o gotejador em PVC, 33,5% para o gotejador em vidro, 27,6% para o copo medida e 12,3% para a seringa dosadora. A qualidade do produto e a quantidade de substância ativa dispensada por dose são essenciais tanto para a segurança e eficácia do tratamento com medicamentos psicoativos quanto para esquemas de ajuste de doses. Diferenças entre os fabricantes de um mesmo medicamento podem potencialmente comprometer uma eventual substituição entre os mesmos durante o decorrer do tratamento. Conclusão: O risco inerente de administração de sub ou superdoses decorrente do fato de que parte dos acessórios e das metades de comprimidos avaliados não cumpriu a finalidade de fornecer doses exatas e precisas, além da falta de padronização entre os fabricantes de um mesmo medicamento, acarreta em implicações clínicas iminentes associadas.
- ItemAcesso aberto (Open Access)Oncoaudit: desenvolvimento e avaliação de aplicativo para enfermeiros auditores(Escola Paulista de Enfermagem, Universidade Federal de São Paulo (UNIFESP), 2014-04-01) Grossi, Luciane Mandia; Pisa, Ivan Torres [UNIFESP]; Marin, Heimar de Fatima [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Objective:To develop a web and mobile device application to search for chemotherapy drugs to support nursing audits of hospital bills and to evaluate user satisfaction and tool usability.Methods:Research of technological production for development of an application for web and mobile technology. The product was evaluated by nurse auditors using the System Usability Scale questionnaire. It was also evalutated by health informactics professionals using Nielsen's heuristics.Results: The application is available at http://telemedicina6.unifesp.br/projeto/oncoaudit. The mobile version can be is accessed at http://play.google.com/intl/pt-BR/about/index.html. Nurse evalaution indicated that the web and mobile versions addressed user needs. In the usability evaluation, 14 problems were identified in the mobile version and eight in the web system. Implementation of improvements according to the evaluation findings were made in both versions.Conclusion: The methods for development and evaluation were adequate to achieve the proposed objective.
- ItemAcesso aberto (Open Access)Psychoactive drug advertising: a comparison of technical information from three countries: Brazil, United States and United Kingdom(Associação Paulista de Medicina - APM, 2005-11-01) Mastroianni, Patricia De Carvalho [UNIFESP]; Galduróz, José Carlos Fernandes [UNIFESP]; Carlini, Elisaldo Araujo [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)CONTEXT AND OBJECTIVE: Studies carried out in the 1970s and 1980s showed that there were country-dependent disparities in the information given for the same drug in medical advertisements. National and international regulations have been published to do away with such disparities and to foster the rational use of drugs. The purpose of this study was to compare the information contained in psychoactive drug advertisements published in psychiatric journals in Brazil, the United States and the United Kingdom, before and subsequent to the publication of the United States Export Act, in 1986, the WHO criteria, in 1988, and the Brazilian Sanitary Surveillance Agency Resolution no. 102, in 2000. TYPE OF STUDY AND SETTING: Content analysis, at Centro Brasileiro de Informações sobre Drogas Psicotrópicas (Cebrid). METHODS: We gathered advertisements from Brazilian, American and British psychiatry periodicals published before and after each ruling. We analyzed a total of twenty-four Brazilian advertisements that were for the same psychoactive drugs as advertised in American and/or British publications from the same period. RESULTS: We observed that Brazilian advertisements omitted information on usage restrictions, such as contraindications, adverse reactions, interactions, warnings and precautions, and that such information was present in American and British advertisements. CONCLUSIONS: The data suggest that disparities in the information given for the same drug still persist. The information depends on the country in which each drug is marketed. The legislation is insufficient for eradicating such disparities.
- ItemSomente MetadadadosSpectrofluorimetric Determination of Coumarin in Commercial Tablets(Springer, 2011-03-01) Marcolan, Mirian; Martins, Priscila Alfonso; Pedrosa, Valber A.; Rodrigues, Maira R.; Oliveira, Hueder P. M. de; Codognoto, Lucia [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Univ Vale do Paraiba; Universidade de São Paulo (USP); Universidade Federal Fluminense (UFF); Univ Camilo Castelo BrancoA simple, rapid and effective analytical method based on fluorescence spectroscopy for the determination of coumarin in pharmaceutical formulations without pre-treatment or pre-concentration step was development. Coumarin had maximum excitation and emission at 310 nm and 390 nm, respectively. Optimum conditions for the detection of coumarin were investigated. Under optimized conditions, we observed a linear behavior for the sign of coumarin in the concentration range of 2.5 x 10(-6) to 1.0 x 10(-4) mol L(-1), with linearity of 0.998 and sensitivity of 2.9 x 10(10) u.a/mol L(-1). the proposed method was validated in terms of accuracy, precision and specificity of coumarin using the standard addition and external calibration. It was noted that the results support (P < 0.05), indicating that the matrices were not an interference in the determination of coumarin by fluorescence spectroscopy. the results were favorable compared with those obtained by reference chromatographic methods.
- ItemAcesso aberto (Open Access)Tratamento farmacológico da doença de buerger: revisão sistemática com metanálise(Universidade Federal de São Paulo (UNIFESP), 2016-06-29) Cacione, Daniel Guimaraes [UNIFESP]; Silva, Jose Carlos Costa Baptista da [UNIFESP]; http://lattes.cnpq.br/7216436712130915; http://lattes.cnpq.br/7260876757287907; Universidade Federal de São Paulo (UNIFESP)Objective: To assess the effectiveness of any pharmacological agent (intravenous or oral) compared with placebo or any other pharmacological agent in patients with Buerger's disease. Methods: A Cochrane systematic review was done. The Cochrane Vascular Trials Search Co-ordinator searched their Specialised Register (last searched in April 2015) and the Cochrane Register of Studies (Issue 3, 2015). The review authors searched trial registers and the European grey literature; screened reference lists of relevant studies, and contacted study authors and major pharmaceutical companies. Selection criteria was randomised controlled trials (RCTs) involving pharmacological agents used in the treatment of Buerger's disease. Two review authors, independently assessed the studies, extracted data and performed data analysis. Results: Five randomised controlled trials (total 602 participants) compared prostacyclin analogue with placebo, aspirin, or a prostaglandin analogue, and folic acid with placebo. No studies assessed other pharmacological agents such as cilostazol, clopidogrel and pentoxifylline or compared oral versus intravenous prostanoid.Compared with aspirin, intravenous prostacyclin analogue iloprost improved ulcer healing (risk ratio (RR) 2.65; 95% confidence interval (CI) 1.15 to 6.11; 98 participants; one study; moderate quality evidence), and helped to eradicate rest pain after 28 days (RR 2.28; 95% CI 1.48 to 3.52; 133 participants; one study; moderate quality evidence), although amputation rates were similar six months after treatment (RR 0.32; 95% CI 0.09 to 1.15; 95 participants; one study; moderate quality evidence). When comparing prostacyclin (iloprost and clinprost) with prostaglandin (alprostadil) analogues, ulcer healing was similar (RR 1.13; 95% CI 0.76 to 1.69; 89 participants; two studies; I² = 0%; very low quality evidence), as was the eradication of rest pain after 28 days (RR 1.57; 95% CI 0.72 to 3.44; 38 participants; one study; low quality evidence), while amputation rates were not measured. Compared with placebo, the effects of oral prostacyclin analogue iloprost were similar for: healing ischaemic ulcers (iloprost 200 mcg: RR 1.11; 95% CI 0.54 to 2.29; 133 participants; one study; moderate quality evidence, and iloprost 400 mcg: RR 0.90; 95% CI 0.42 to 1.93; 135 participants; one study; moderate quality evidence), eradication of rest pain after eight weeks (iloprost 200 mcg: RR 1.14; 95% CI 0.79 to 1.63; 207 participants; one study; moderate quality evidence, and iloprost 400 mcg: RR 1.11; 95% CI 0.77 to 1.59; 201 participants; one study; moderate quality evidence), and amputation rates after six months (iloprost 200 mcg: RR 0.54; 95% CI 0.19 to 1.56; 209 participants; one study, and iloprost 400 mcg: RR 0.42; 95% CI 0.13 to 1.31; 213 participants; one study). When comparing folic acid with placebo in patients with Buerger's disease and hyperhomocysteinaemia, pain scores were similar, there were no new cases of amputation in either group, and ulcer healing was not assessed (very low quality evidence).Treatment side effects such as headaches, flushing or nausea were not associated with treatment interruptions or more serious consequences. Outcomes such as amputation-free survival, walking distance or pain-free walking distance, and ankle brachial index were not assessed by any study. Overall, the quality of the evidence was very low to moderate, with few studies, small numbers of participants, variation in severity of disease of participants between studies and missing information regarding for example baseline tobacco exposure. Conclusions moderate quality evidence suggests that intravenous iloprost (prostacyclin analogue) is more effective than aspirin for eradicating rest pain and healing ischaemic ulcers in Buerger's disease, but oral iloprost is not more effective than placebo. Verylow and low quality evidence suggests there is no difference between prostacyclin (iloprost and clinprost) and the prostaglandin analogue alprostadil for healing ulcers and relieving pain respectively in severe Buerger's disease. Very-low quality evidence suggests there is no difference in pain scores and amputation rates between folic acid and placebo, in people with Buerger's disease and hyperhomocysteinaemia. High quality trials assessing the effectiveness of pharmacological agents (intravenous or oral) in people with Buerger's disease are needed.