Incorporação de embalagens fracionáveis na produção de medicamentos no Brasil: consequências sanitárias, desafios técnicos e impasses legais.

Abstract

Fractionated drugs in Brazil are in the governmental agenda since the 1990s . The practices in commercial pharmacies are ruled by two sanitary documents emitted from National Surveillance Secretary towards the construction the sanitary sense according to the law. On the generics drugs politics implementation at end of 1990 decade, the fractionated drugs act was abolished for conflicting with the new edited politics. So the idea of fractioning drugs as idealizes stay slept until 2005 when a presidential regulation brings as official the act of obtaining fractionated drugs in commercial pharmacies. The main object of this study is to evaluate the potential conflict between the expected benefits and the manufacturing and selling of medicines available in package suited for fraction and relevant sanitary aspects neglected. There are localized other possible consequences and impacts due to the fractionated drugs implementation that are not identified in official documents and other publications. Also is examined how the activity of fractioning reception occurs by the lens of local legislation of Brazilian states and cities. The other relevant aspect, allied to others, is related to the extension of fractioning the so called over the counter medicines. The sanitary analysis developed points to the need of enlarge the discussion of theme not only for the commercial and technical fields, but also for including the exam of routine acts and the basis adopted by ANVISA in the building of the theme.