Farmacovigilância veterinária : subnotificação de eventos adversos no sistema português
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2024
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Desde a sua criação, em 1963, a farmacovigilância para medicamentos veterinários tem sido alvo de constantes melhorias. A implementação das mesmas, resultou num aumento da legislação na área do medicamento veterinário e numa maior sensibilização do médico veterinário, para a necessidade de reportar eventos adversos. Um sistema de farmacovigilância baseado na comunicação espontânea de eventos adversos, pelos médicos veterinários, é uma ferramenta poderosa na deteção de potenciais riscos no uso de medicamentos veterinários. No entanto a subnotificação de eventos adversos continua a ser um desafio que muitos sistemas de farmacovigilância na europa enfrentam. O sistema de farmacovigilância português, quando comparado com outros sistemas europeus, demonstra-se pouco desenvolvido tecnologicamente e apresenta ferramentas e métodos desatualizados que podem contribuir para a subnotificação de eventos adversos em Portugal. O presente estudo visa entender os desafios e obstáculos que o médico veterinário português encontra na comunicação de eventos adversos, perante o atual sistema de farmacovigilância, e a sua correlação com a subnotificação de eventos adversos. Desta forma, foi elaborado um questionário contendo 29 questões, preenchidos via online e por telefone, ao qual se obteve 127 respostas de médicos veterinários. Dos resultados obtidos, aferiu-se a necessidade de atualização do sistema de farmacovigilância veterinária português. Verificou se que, especialmente em situações de falha de eficácia prevista ou utilização em cascata, os médicos veterinários não comunicaram o evento adverso apesar de terem verificado a sua existência. A quantidade de tempo dispensada na comunicação é um dos principais fatores da não comunicação de eventos adversos. Palavras-chave: Farmacovigilância veterinária, questionário, eventos adversos, médico veterinário, medicamento veterinário
Since its creation in 1963, pharmacovigilance for veterinary medicines has been the subject of constant improvements. Their implementation has resulted in an increase in legislation in veterinary medicines and greater awareness among veterinarians of the need to report adverse events. A pharmacovigilance system based on spontaneous reporting of adverse events by veterinarians is a powerful tool for detecting potential risks in the use of veterinary medicines. However, under-reporting of adverse events remains a challenge faced by many pharmacovigilance systems in Europe. The Portuguese pharmacovigilance system, when compared to other European systems, is technologically underdeveloped and has outdated tools and methods that may contribute to the underreporting of adverse events in Portugal. This study aims to understand the challenges and obstacles faced by Portuguese veterinarians in reporting adverse events, given the current pharmacovigilance system, and its correlation with the underreporting of adverse events. A questionnaire containing 29 questions was drawn up and completed online and by telephone, resulting in 127 responses from veterinary surgeons. The results showed that the Portuguese veterinary pharmacovigilance system needs to be updated. It was found that, especially in situations of lack of expected efficacy or use under the cascade, veterinarians did not report the adverse event despite having verified its existence. The amount of time spent on reporting is one of the main factors in not reporting adverse events. Key words: Veterinary pharmacovigilance, questionnaire, adverse events, veterinarian surgeon, veterinary medicines.
Since its creation in 1963, pharmacovigilance for veterinary medicines has been the subject of constant improvements. Their implementation has resulted in an increase in legislation in veterinary medicines and greater awareness among veterinarians of the need to report adverse events. A pharmacovigilance system based on spontaneous reporting of adverse events by veterinarians is a powerful tool for detecting potential risks in the use of veterinary medicines. However, under-reporting of adverse events remains a challenge faced by many pharmacovigilance systems in Europe. The Portuguese pharmacovigilance system, when compared to other European systems, is technologically underdeveloped and has outdated tools and methods that may contribute to the underreporting of adverse events in Portugal. This study aims to understand the challenges and obstacles faced by Portuguese veterinarians in reporting adverse events, given the current pharmacovigilance system, and its correlation with the underreporting of adverse events. A questionnaire containing 29 questions was drawn up and completed online and by telephone, resulting in 127 responses from veterinary surgeons. The results showed that the Portuguese veterinary pharmacovigilance system needs to be updated. It was found that, especially in situations of lack of expected efficacy or use under the cascade, veterinarians did not report the adverse event despite having verified its existence. The amount of time spent on reporting is one of the main factors in not reporting adverse events. Key words: Veterinary pharmacovigilance, questionnaire, adverse events, veterinarian surgeon, veterinary medicines.
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VETERINARY MEDICINE, PHARMACOVIGILANCE, DRUGS (PHARMACOLOGY), ADVERSE DRUG REACTIONS, VETERINARIANS, MESTRADO INTEGRADO EM MEDICINA VETERINÁRIA, VETERINÁRIA, MEDICINA VETERINÁRIA, FARMACOVIGILÂNCIA, MEDICAMENTOS, REAÇÕES AOS MEDICAMENTOS, VETERINÁRIOS, Mestrado Integrado em Medicina Veterinária