Pharmacovigilance in tuberculosis: pilot experience of a Reference Center of Rio de Janeiro, Brazil
Introduction: Pharmacovigilance is a set of activities that aims to identify, evaluate, understand and prevent possible adverse events (AE) in the use of drugs through the early detection of safety related problems. Objective: To describe the experience of the pilot project of Pharmacovigilance in T...
| Autores: | , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2019 |
| País: | Brasil |
| Institución: | Fundação Oswaldo Cruz (FIOCRUZ) |
| Repositorio: | Vigilância Sanitária em Debate |
| Idioma: | portugués inglés |
| OAI Identifier: | oai:ojs.visaemdebate.incqs.fiocruz.br:article/1263 |
| Acceso en línea: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1263 |
| Access Level: | acceso abierto |
| Palabra clave: | Pharmacovigilance Adverse Events Notivisa Farmacovigilância Eventos Adversos |
| Sumario: | Introduction: Pharmacovigilance is a set of activities that aims to identify, evaluate, understand and prevent possible adverse events (AE) in the use of drugs through the early detection of safety related problems. Objective: To describe the experience of the pilot project of Pharmacovigilance in Tuberculosis carried out at the Professor Hélio Fraga Reference Center – ENSP/ Fiocruz, Brazil from July 2013 to February 2014. Results: We evaluated 15 reports where the main AE found were: Polyarthralgia (2); Peripheral neuropathy (1); Joint pain (5), one of these with insomnia; arthralgia (2); change in visual acuity (1); diarrhea (3); vomiting, headache, joint pain and nausea (1). The analyzed variables were: Severity, Non-serious, Adopted procedures and Suspicious drugs: Severity = eleven were clinically important and, among them, one was reported as persistent or significant disability. Non-severe = four notifications described. Proceedings adopted = four reports with interruption of the suspected drug; in four the dose was reduced and in seven the dosage was maintained. Suspected medicines = Levofloxacin was the most prescribed drug suspected of causing AE. Conclusions: The results showed that some drugs used in the treatment of resistant tuberculosis are more likely to cause AE. There is a need to adopt measures where medicines are the object of permanent attention. |
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