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Advisor(s)
Abstract(s)
A preparação de medicamentos citotóxicos por profissionais graduados em farmácia requer o máximo rigor para proteger os doentes e os próprios profissionais de saúde. O principal objetivo do presente estudo consistiu no desenvolvimento de uma proposta de padronização de formação para profissionais que manipulam citotóxicos. A metodologia do presente estudo resultou da combinação de uma revisão sistemática das diretrizes sobre manipulação de medicamentos citotóxicos e de um estudo observacional transversal sobre os resumos de características de medicamentos (RCM) dos medicamentos citotóxicos. A revisão sistemática decorreu da pesquisa nas bases de dados Pubmed, Cochrane, Web of Science e Lilacs de publicações entre 2004 e 2022. Foram incluídas as diretrizes que abordavam a formação em manipulação de citotóxicos e o principal critério de exclusão foi a aplicação limitada ao trabalho com citotóxicos em ambiente não hospitalar ou em unidades hospitalares específicas. Já no âmbito da seleção dos RCM, foram selecionados os documentos carregados na página do Infomed dos medicamentos citotóxicos sujeitos a manipulação comercializados em Portugal, em maio de 2022. Para evitar o risco de viés de publicação na seleção das diretrizes, foram consultados peritos na área da manipulação de citotóxicos. Os resultados obtidos foram tratados na ferramenta Microsoft Excel. Foram incluídas 18 diretrizes e 97 RCM. Verificou-se que, 66,7% das diretrizes recomendava a realização de formação prévia ao início de funções e 72,6% recomendava a realização de formação numa base periódica. As sugestões específicas mais frequentemente referidas foram as formações em utilização de equipamento de proteção individual (EPI) (50%) e em utilização de controlos de engenharia primários de contenção (50%). Foi sugerido um plano de formação estruturado em cinco níveis, contemplando dois níveis teóricos, dois níveis práticos simulados e um nível de formação prática em contexto real. A principal limitação do plano de formação apresentado consiste no tempo necessário para a sua concretização. Ainda assim, admite-se a adequação do plano de formação proposto com recurso aos conteúdos formativos mais habitualmente mencionados nas diretrizes e às necessidades de conhecimentos e capacidades implícitas nos RCM.
The preparation of cytotoxic drugs by pharmacy graduates requires the highest rigor to protect patients and health professionals themselves. The main objective of the present study was to develop a proposal for standardization of training for professionals handling cytotoxic drugs. The methodology of this study resulted from a combination of a systematic review of guidelines on cytotoxic drug handling and a cross-sectional observational study on summaries of medicinal product characteristics (SmPC) of cytotoxic drugs. The systematic review was performed by searching through Pubmed, Cochrane, Web of Science and Lilacs databases for publications between 2004 and 2022. Guidelines that addressed training in cytotoxic handling were included and the main exclusion criteria was the limited applicability to manipulation with cytotoxic drugs in non-hospital settings or in specific hospital units. As for the selection of SmPC, the documents uploaded to the Infomed page regarding cytotoxic drugs subject to manipulation marketed in Portugal, in May 2022, were considered. To avoid the risk of guideline publication bias, experts in cytotoxic manipulation were consulted. The obtained results were treated in Microsoft Excel. Eighteen guidelines and 97 SmPC were included. It was verified that 66.7% of the guidelines recommended the training before starting to perform cytotoxic drug manipulation and 72.6% of them recommended training on a regular basis. The most frequently mentioned specific suggestions were training in the use of personal protective equipment (50%) and in the use of primary engineering containment controls (50%). A 5-level structured training plan was suggested, comprising two theoretical levels, two simulated practical levels and one level of practical training in real context. The main limitation of the presented training plan is the time required for its implementation. Nevertheless, the adequacy of the proposed training plan is admitted, owing to the training contents most mentioned in the guidelines and to the needed knowledge and skills implicit in the SmPC.
The preparation of cytotoxic drugs by pharmacy graduates requires the highest rigor to protect patients and health professionals themselves. The main objective of the present study was to develop a proposal for standardization of training for professionals handling cytotoxic drugs. The methodology of this study resulted from a combination of a systematic review of guidelines on cytotoxic drug handling and a cross-sectional observational study on summaries of medicinal product characteristics (SmPC) of cytotoxic drugs. The systematic review was performed by searching through Pubmed, Cochrane, Web of Science and Lilacs databases for publications between 2004 and 2022. Guidelines that addressed training in cytotoxic handling were included and the main exclusion criteria was the limited applicability to manipulation with cytotoxic drugs in non-hospital settings or in specific hospital units. As for the selection of SmPC, the documents uploaded to the Infomed page regarding cytotoxic drugs subject to manipulation marketed in Portugal, in May 2022, were considered. To avoid the risk of guideline publication bias, experts in cytotoxic manipulation were consulted. The obtained results were treated in Microsoft Excel. Eighteen guidelines and 97 SmPC were included. It was verified that 66.7% of the guidelines recommended the training before starting to perform cytotoxic drug manipulation and 72.6% of them recommended training on a regular basis. The most frequently mentioned specific suggestions were training in the use of personal protective equipment (50%) and in the use of primary engineering containment controls (50%). A 5-level structured training plan was suggested, comprising two theoretical levels, two simulated practical levels and one level of practical training in real context. The main limitation of the presented training plan is the time required for its implementation. Nevertheless, the adequacy of the proposed training plan is admitted, owing to the training contents most mentioned in the guidelines and to the needed knowledge and skills implicit in the SmPC.
Description
O presente trabalho destina-se à obtenção do Título de Especialista, na Área Científica da Farmácia, nos termos do Decreto-Lei nº27/2021, de 16 de abril
Keywords
Citotóxicos Manipulação de fármacos Formação em contexto profissional Exposição ocupacional Antineoplásicos Cytotoxicity Drug handling Occupational training Occupational exposure Antineoplastic drugs