Browsing by Author "Silva, Fabricio Alves Barbosa da"
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- Proposal of a gold standard database model of adverse drug reactions reportsPublication . Rodrigues, Lídia Maria Lourençön; Silva, Fabricio Alves Barbosa da; Correia, Ricardo João Cruz; Rijo, Rui Pedro Charters Lopes; Alves, DomingosDuring the post-marketing period, when the drugs are used by large populations and for longer periods of time, unexpected adverse reactions (AR) may occur, which changes the risk-benefit ratio of the drugs, requiring a Regulatory action. Most post-marketing AR requires a significant increase in health care and result in damage, often fatal, to the patient. Therefore, the early detection of AR in the post-marketing period is the primary goal of a health system, in particular, pharmacovigilance systems. The main objective of this article is to show the stages of the development of an AR notification database to serve as the "gold standard" of a pioneering project in Brazil to process data automatically from the inclusion of electronic reporting systems into the Hospital Information Systems (HIS).