Abstract
Pharmacovigilance reflection was first published in the British Medical Journal in 1877 by chloroform issues. New era of the Pharmacovigilance was initiated by the children’s big issues related to teratogenic effects. To ensure the benefits of use of drugs out weights the risks & thus safe guard the health of the paediatric population. Pharmacology in paediatric population has specific needs in Pharmacovigilance. Altered pharmacokinetics and Pharmacodynamic of drugs make paediatric patients susceptible to drugs adverse drug reactions. A systemic review from past few years starting from 1877 considering the deaths noted due to its adverse effects. The WHO global individual case safety report data base reported the ADRs in children upto7.7% by using the spontaneous reporting system. It is necessary to develop a proactive Pharmacovigilance and patient safety programs with a focus in risk analysis and management, in which ADR reporting should be mandatory.
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