Pharmacovigilance response to the drug that is noxious and

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 commonly used 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 disability 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 analysis with aim to improve paediatric patient care.5
Under Pharmacovigilance Programme of India(PvPI),ADR Monitoring Centers(AMC)
are set up in medical college approved by Medical Council of India (MCI).6AMCs
are responsible for collecting 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 detection, manual
review of medical records using triggers has been demonstrated.8,10

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ADR 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 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. 


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