Pharmacovigilance or a clue in the patient record

Pharmacovigilance defines as ‘TheScience and Activities relating to the detection,evaluation,understanding andprevention of adverse reactions to medicine or any other medicine relatedproblems’.1 The safety of drug used in patients of an adult age group cannotbe extrapolated to paediatric age group, since Pharmacokinetics andPharmacodynamics of many commonly used drugs vary between two agegroups.2According to World Health Organization(WHO),Adverse DrugReaction(ADR) is a response to a drug that is noxious and unintended and occursat doses normally used in humans for prophylaxis, diagnosis and treatment of disease.2 It has been observed thatADRs in children only result in hospital admissions or prolonged hospital staybut also may lead to permanent disability or even death.3The safety profileof drug thus marketed with its testing done only on adult can varysignificantly when they are used in children.4Hence Pharmacovigilance focusnot only effectiveness and benefits but also on safety and risk analysis with aimto improve paediatric patient care.

5 Under Pharmacovigilance Programme ofIndia(PvPI),ADR Monitoring Centers(AMC) are set up in medical college approvedby Medical Council of India (MCI).6AMCs are responsible for collectingadverse event as per Standard Operating Procedure (SOP),performing follow-up ifrequire for the completeness of ADR reports and uploading these reports in netbased software used for ADR reporting called as ‘VIGIFLOW’.7 In Adverse Eventdetection, manual review of medical records using triggers has been demonstrated.8,10 ADR in pediatric populationcan be estimated by Pediatric Trigger tools. A trigger is defined as ‘Data or aclue in the patient record that alerts the reviewer to the possibility of harm.

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Triggers related to medication use, for example, include abrupt interruption ofmedication use, prescription of an antagonist, or an abnormal laboratory testresult. 9Although most research instruments that use triggers are focused on adults10, efforts have been made to develop specific research instruments to beused in children. 11 Thus, there are triggers for use in neonatology 12,pediatric critical care. 13 Assessment of ADR is never done with Paediatric TriggerTool Kit in Indian Setup so there is dire need to conduct Intensive Pharmacovigilancewith the help of Paediatric Trigger Tool kit.  

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