Pharmacovigilance or a clue in the patient record

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

 

It has been observed that
ADRs in children only result in hospital admissions or 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 and benefits 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 event 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 Event
detection, manual review of medical records using triggers has been demonstrated.8,10

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ADR in pediatric 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 research instruments 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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