Pharmacovigilance in medical college which are approved by

Pharmacovigilance defines as ‘the
Science and Activities relating to the detection,evaluation,understanding and
prevention of adverse drug reactions to medicine or any medicine related
problems’.1 The safety of drug assessed in patients of an adult age group
cannot be extrapolated to paediatric age group, since Pharmacokinetics and
Pharmacodynamics of various drugs vary between both age groups.2According to
World Health Organization(WHO),Adverse Drug Reaction(ADR) is a response to the
drug that is noxious and unintended which occurs at doses normally used in
humans for prophylaxis, diagnosis and treatment of disease.2


It has been observed that
ADRs in children not only result in prolonged hospital stay but also may lead
to permanent deformities or even death.3The safety profile of drug thus marketed
with its testing done only on adult can vary significantly when they are used
in children.4Hence Pharmacovigilance focus not only effectiveness of drug but
also on safety and risk evaluation with a aim to improve paediatric patient
health care.5 Under Pharmacovigilance Programme of India(PvPI),Adverse Drug
Reaction Monitoring Centers(AMC) are set up in medical college which are approved
by Medical Council of India (MCI).6AMCs are responsible for collection of adverse
drug reaction as per Standard Operating Procedure (SOP),performing follow-up if
require for the completeness of ADR reports and uploading these reports in net
based software used for ADR reporting called as ‘VIGIFLOW’.7 In Adverse Drug
Reaction evaluation, conventional review of medical records using trigger tool
kit has been demonstrated.8,10

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ADRs in paediatric population
can be estimated by Pediatric Trigger tools. A trigger is defined as ‘Data or a
clue in the patient record that alerts the reviewer to the possibility of  medication harm. Triggers related to
medication use, for example, include abrupt interruption of medication use,
prescription of an antagonist, or an abnormal laboratory test result. 9Although
most of the research resources that use triggers are focused on adults 10,
efforts have been made to develop specific research instruments to be used in
children. 11 Thus, there are triggers for use in neonatology 12, pediatric critical
care. 13 Assessment of ADR is never done with Paediatric Trigger Tool Kit in
Indian Setup so there is dire need to conduct Intensive Pharmacovigilance with
the help of Paediatric Trigger Tool kit.