A Research Article on Crises Management in Pharmacovigilance

Abstract

A series of unanticipated adverse events or adverse drug reactions (ADRS) that occur over a short period of time and, if confirmed, call into question the risk/benefit ratio, resulting in a crisis situation. In general, a crisis is a period of trauma, discomfort, and changes that are unavoidable. It is frequently difficult to forecast what triggers a crisis, but crises almost always result in changes—typically for the worse. A crisis has the potential to have a major negative impact on the (organization's) operations or to expose the (organization) to severe environmental, economic, reputational, or legal risk. A low-probability, high-impact circumstance that essential stakeholders regard as endangering the organization's viability and that these individuals subjectively perceive as hazardous.