A review of pharmacovigilance
Abstract
Introduction: Pharmacovigilance involves more than spontaneous reporting, and is more than just evaluating marketed medications. It has grown from a minor component of drug control to a major activity and expanded its scope to encompass the assistance for patient safety during clinical trials by ensuring adequate informed consent and institutional review boards (ethical committees); development of a safety profile for proper use of a new molecular entity and appropriate communication of that information to a range of relevant stakeholders; selection of the first safe dose for use in humans based on pharmacologic data obtained in animal studies; development of a safety profile. This study implicates the growth of pharmacovigilance in assessing the safety of drugs.
Methods: The subsequent information was obtained by reviewing the data from earlier published material. The obtained information was evaluated, compiled, deconstructed, reassembled, interpreted, and conclusions were reached.
Results: The supply of data necessary for assessing the advantages and dangers of medicines is, first and foremost, a scientific task. Good pharmacovigilance practice must be created to guarantee that data is gathered and used correctly for the intended purpose.
Conclusion: Pharmacovigilance has grown into an essential part of drug control. Signal management protocols ensure that surveillance operations monitor the produced product through collaborative actions with manufacturing specialists, analyze benefit-risk management and inspection readiness maintenance as a corporate culture process.
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