Pharmacovigilance
Introduction Pharmacovigilance is defined as "science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem". When marketing approval for a medication occurs, safety data from the clinical trial and nonclinical studies are abridged in the labelling; however, adverse drug events may not have been fully detected by this time. The clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period of time. Consequently, data from post marketing studies and the spontaneous reports are reviewed periodically, and a formal evaluation occurs when new information suggests important safety issues. Spontaneous Reporting Spontaneous reporting systems collect dat...