||No drug which is
pharmacologically effective is entirely without hazard. There is no such
thing as a safe drug. Safety is a relative concept, concerning the disease,
the therapeutic alternatives and the individual perception and acceptance of
risk. Pharmacovigilance challenge it's not just the early identification of
drug utilization problems, but the rapid determination of its positive and
negative effects for individuals and for communities.
Causality assessment of reported adverse events during drug exposure is
crucial in Pharmacovigilance due to its implications in the benefit-risk
evaluation of medicines.