Wednesday, January 29, 2014
The origin of pharmacovigilance or product vigilance (PV) itself was a reaction to public health disasters caused by medications such as the well-known thalidomide disaster in 1962. PV was all about collecting anecdotal reports of suspected adverse drug reactions (ADRs) and using these to detect significant, previously unrecognized hazards of medications after their introduction into clinical use. But there’s now a movement towards a proactive approach based on prevention rather than a reactive approach driven by public health outcomes. Regulators are moving from reactive safety oversight driven by procedural compliance to a practical, health-based approach which is clinically more relevant and meaningful (Kahn, 2013).
To view the complete white paper, please click here.