farmacovigilância: elementos para a discussão e perspectivas drug surveillance: topics for discussion and prospects
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ID: 258565
1998
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Abstract
A vigilância de medicamentos subdivide-se em dois grupos. O primeiro consiste nas ações de registro e fiscalização, que são as mais conhecidas da sociedade. O segundo grupo consiste nas ações de farmacovigilância, que são as de pesquisa e monitoramento de reações adversas. Essas últimas estão previstas na legislação federal do setor saúde que vigora desde a década de 70. Do mesmo modo, uma portaria recente prevê a criação do sistema nacional de monitoramento. O texto aborda de maneira panorâmica elementos da história, dos conceitos, das definições, da classificação, dos mecanismos de ação e do diagnóstico de reações adversas. São descritos os objetivos e as fontes de informação para os estudos de farmacovigilância, bem como a experiência nacional no campo.
Drug surveillance can be grouped into two areas. The first includes registration and inspection, activities that are more familiar to society at large. The second involves research and monitoring of adverse effects. Brazilian legislation has regulated this subject since 1970. A recent directive also provides for a national pharmaceutical surveillance system. This current article provides an overview of the history, definitions, pharmacological concepts, classification, and diagnosis of the adverse effects of drugs. An analysis is presented of the goals and sources of information for drug monitoring as well as some Brazilian experience in this field.
Drug surveillance can be grouped into two areas. The first includes registration and inspection, activities that are more familiar to society at large. The second involves research and monitoring of adverse effects. Brazilian legislation has regulated this subject since 1970. A recent directive also provides for a national pharmaceutical surveillance system. This current article provides an overview of the history, definitions, pharmacological concepts, classification, and diagnosis of the adverse effects of drugs. An analysis is presented of the goals and sources of information for drug monitoring as well as some Brazilian experience in this field.
| Reference Key |
rozenfeld1998cadernosfarmacovigilncia:
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| Authors | ;Suely Rozenfeld |
| Journal | iberian conference on information systems and technologies, cisti |
| Year | 1998 |
| DOI |
10.1590/S0102-311X1998000200002
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| URL | |
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