Pharmacovigilance of compounded drugs - Part 1: profile of Brazilian notifications
Introduction: Compounded drugs are extemporaneous pharmaceutical preparations, mostly used to enable the pharmacotherapy of special populations through personalized formulations. In this way, they are not subjected to clinical tests prior to their use, and pharmacovigilance actions are fundamental t...
| Autores: | , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2022 |
| País: | Brasil |
| Institución: | Fundação Oswaldo Cruz (FIOCRUZ) |
| Repositorio: | Vigilância Sanitária em Debate |
| Idioma: | portugués inglés |
| OAI Identifier: | oai:ojs.visaemdebate.incqs.fiocruz.br:article/1999 |
| Acceso en línea: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1999 |
| Access Level: | acceso abierto |
| Palabra clave: | Farmacovigilância Vigilância Sanitária Medicamento Manipulado Farmácia com Manipulação Notivisa Legislação Farmacêutica Pharmacovigilance Health Surveillance Compounded Drugs Pharmacy Compounding |
| Sumario: | Introduction: Compounded drugs are extemporaneous pharmaceutical preparations, mostly used to enable the pharmacotherapy of special populations through personalized formulations. In this way, they are not subjected to clinical tests prior to their use, and pharmacovigilance actions are fundamental to guarantee their safety. Objective: to describe the profile of compounded drugs registered in the notifications of technical complaints reported to the National Health Surveillance Notification System (NOTIVISA). Method: Descriptive exploratory study, retrospective to the period 2006-2016, of the notifications of compounded drugs reported to Notivisa. Results: 303 notifications of technical complaints regarding 26 officinal, 268 magistral and 09 unclassified medicines were analyzed. 107 different assets were identified. Those with action on the Digestive System and Metabolism were the most frequent (42.00%), followed by those with action on the Blood and Hematopoietic Organs (10.00%), Dermatological (10.00%) and Cardiovascular System (9.70%). The main quality deviations reported were related to liquid dosage forms, with the presence of foreign bodies, particles or precipitates being the most frequent (22.40%), followed by changes in packaging and labeling (18.60%). Conclusions: It waspossible to describe the main compounded drugs notified to Notivisa, their characteristics and active substances conveyed in the formulations, which can contribute to the actions of Health Surveillance in the masterful scope, which is still incipient in Brazil. |
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