Rethinking post-market drug safety surveillance: Pharmacovigilance as integral part of hospital Quality Management Systems

Boyd cycle, or OODA loop, explains fundamental principles of decision-making loop based on observation, orientation, decision, and action. Pharmacovigilance functions are primarily driven by regulatory requirements and the desire to avoid adverse consequence stemming from non-compliance. Observation part of the loop follows requirements defined in laws and regulations and consists of a systematic screening of defined sources for specific information about marketed drugs.