Nicolas Langlitz PHARMACOVIGILANCE AND POST - BLACK MARKET SURVEILLANCE Pharmacovigilance : Watching out for Unexpected Side Effects
نویسنده
چکیده
Pharmacovigilance can be defined as a set of practices aiming at the detection, understanding, and quantitative assessment of the risks related to the use of drugs in a population and the prevention of consequential adverse effects. In its 2002 report The Importance of Pharmacovigilance, the WHO traces the development of these practices back to the thalidomide disaster in 1961 and the subsequent international efforts to address drug safety issues. In this broader understanding of the term, pharmacovigilance refers to any kind of attention that is being paid to adverse drug reactions. However, the term is also used in a more limited way, which—for reasons that will become clear—is closely connected to the latest developments in the history of pharmaceutics, especially to the emergence of patient activism. In this sense, pharmacovigilance exclusively refers to practices of postmarket surveillance.
منابع مشابه
Pharmacovigilance and post-black market surveillance.
Pharmacovigilance can be defined as a set of practices aiming at the detection, understanding and assessment of risks related to the use of drugs in a population, and the prevention of consequential adverse effects. In a narrower sense, the term refers exclusively to postmarket surveillance. This paper briefly outlines how pharmacovigilance has come to play a central role in the regulation of n...
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