Drug surveillance: topics for discussion and prospects
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.
Rozenfeld
S
Escola Nacional de Saude Publica, Fundacao Oswaldo Cruz, Rua Leopoldo Bulhoes, 1480, 8o andar, 21041-210, Rio de Janeiro, RJ, Brasil. rozenfeld@ensp.fiocruz.br.