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- ItemAcesso aberto (Open Access)Construção e validação de conteúdo de instrumento para avaliação do sistema de medicação(Universidade Federal de São Paulo (UNIFESP), 2015-06-30) Pinto, Monica Jordão de Souza [UNIFESP]; Bohomol, Elena [UNIFESP]; Cunha, Isabel Cristina Kowal Olm [UNIFESP]; http://lattes.cnpq.br/8695765272291430; http://lattes.cnpq.br/0048156985550471; http://lattes.cnpq.br/2877373025374516; Universidade Federal de São Paulo (UNIFESP)Importante área dentro da segurança do paciente é a segurança no sistema de medicação, haja vista dados da literatura sobre erros de medicação. Alguns autores vêm discutindo a adoção de estratégias que melhorem os processos desse sistema, com o intuito de aumentar o custo-benefício do trabalho, garantir qualidade assistencial e, principalmente, prevenir erros e eventos adversos. Objetivo: Construir e validar o conteúdo de um instrumento para avaliação do sistema de medicação baseado no ?Protocolo de segurança da prescrição, uso e administração de medicamentos?. Método: Utilizou-se um desenho não experimental do tipo ?pesquisa metodológica?, com início em março de 2014 e término em dezembro do mesmo ano. As etapas seguidas foram: definição do construto; formulação dos itens; desenvolvimento de instruções para usuários e respondentes; e avaliação da confiabilidade, pelo coeficiente Alpha de Cronbach e da validade de conteúdo pela Técnica Delphi. Resultados: A primeira rodada Delphi durou 73 dias e contou com a participação de 40 painelistas. Foram enviados para avaliação 194 itens distribuídos em três áreas (prescrição, distribuição e administração) dos quais somente 16, da área prescrição, não atingiram o consenso estabelecido de 90% e foram reformulados em 14. A segunda rodada durou 35 dias, contou com a participação de 36 painelistas e apenas dois itens não alcançaram o nível de consenso de 90% e foram excluídos. Os demais foram aceitos pelo grupo o que significou que o instrumento final ficou com 190 itens. Os resultados do Alpha de Cronbach do instrumento geral e das três áreas do sistema de medicação foram satisfatórios e ultrapassaram o limite estabelecido de Alfa ? 0,75. Conclusão: Esse estudo permitiu a construção e validação de um instrumento para a avaliação da segurança do sistema de medicação com 102 itens do processo Prescrição, 34 do processo de Distribuição e 54 do processo de Administração.
- ItemAcesso aberto (Open Access)Diferenças de preços entre medicamentos genéricos e de referência no Brasil(Faculdade de Saúde Pública da Universidade de São Paulo, 2006-06-01) Vieira, Fabiola Sulpino [UNIFESP]; Zucchi, Paola [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)OBJECTIVE: To assess the magnitude of price difference between generic and innovator medicines and to evaluate the effect of the price competition between them. METHODS: From January 2000 to June 2004, 135 generic medicines and their respective innovator medicines were followed up for a period of up to four years. Prices were extracted from pharmaceutical market specific publications and recorded from the launching of generics and during their marketing period. RESULTS: The generic medicines were introduced on average at prices 40% lower than the innovator ones and this difference tended to increase over the years. The price difference between generic and innovator medicines increased in the subsequent four-year period after generic launching in 68%. CONCLUSIONS: The introduction of generic medicines in the Brazilian pharmaceutical market contributed for offering cheaper medicines. However, the competition between generic and innovator medicines did not promote markdown of the majority innovator medicines.
- ItemAcesso aberto (Open Access)Judicialização da Saúde: Características das ações judiciais recebidas na Secretaria de Ciência, Tecnologia e Insumos Estratégicos do Ministério da Saúde no ano de 2007(Universidade Federal de São Paulo (UNIFESP), 2011-01-26) Veloso, Sandra Ceciliano de Souza [UNIFESP]; Silva, Edina Mariko Koga da [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Introduction: Currently, the two largest financial resources demands for pharmaceutical assistance are exceptional medicines programme and legal demands service for the supply of medicines. The legal demands, and disrupt the service, commitment to fairness and collective contradict definitions. Therefore, it’s a priority a study that describes the characteristics of these actions to subsidize public health policies. Objective: To describe the characteristics of lawsuits received at the Secretary of Science, Technology and Strategic Inputs (SCTIE) of the Ministry of Health in the year 2007. Material and methods: A descriptive analysis that covers the total shares received in the year 2007. Were evaluated the distribution by State, the characteristics of requests, classification of medicines as the availability and regulatory and scientific evidence considerations. Results: In 2007 were received on the SCTIE 832 litigation processes. These actions were from 20 States of the Federation, being the largest number of actions, 207 (24,88%), from the State of Santa Catarina, followed by the State of Rio Grande do Sul with 127 (15,14%). Including the actions from the State of Paraná, the South region of the country totaled stock received 50,72% in 2007. Of the total of 832 actions 444 (53,37%) were requests for specific products or medicines. These are only two medical devices, the others are medicines. Most requested medicines were adalimumab and etanercept which together correspond to 16,89% of total requests and were generated by southern states in its majority. The 11 most requested medicines represent 47.07% of the total. In general the medicines indications were as regulation and are indicated for chronic diseases, two were not registered at ANVISA yet. The eleven medicines most requested were not found in the national essential medicines (RENAME) and 3 (three), adalimumab, etanercept and infliximab were already part of the exceptional dispensing medicines (CDME). Regarding the scientific evidence was found that for most medicines would need further studies for evidence of effectiveness, safety and cost-effectiveness. Conclusion: The analysis of lawsuits is needed for the evaluation of policies and management of health services and also to assist in identifying medicinal products for health technology assessment. Knowledge of the factors that lead to lawsuits medicines added approximation of judiciary with managers and health professionals can achieve the common goal of a quality public health, universal and comprehensive based on fairness.
- 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.
- 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.