title: Adverse drug reactions in pediatrics with a study of in-hospital intensive surveillance.
abstract: A two-part prospective study of adverse drug reactions (ADRs) in Indian children was carried out at a teaching general hospital. Using an in-hospital intensive surveillance scheme (IISS) for the detection of ADRs, indoor patients of one of the two units in the pediatric ward were monitored daily for 6 months, with the other unit serving as a control group. A total of 347 patients were monitored, 2781 daily orders written and 24,474 doses of 96 different drugs given. Six patients suffered from ADRs (1.73%), and 1 reaction proved fatal (0.29%), while the control group reported only 1 ADR in the same time period. The frequency of ADRs (p < 0.001) and their resultant mortality in Indian children was less than that in a western prototype study. Though IISS showed a marked increase in ADR reporting, it was too cumbersome for routine use in our country. In the second part of the study, 40 cases of ADRs seen over 2 years were analyzed. Antimicrobials, especially sulphonamides, accounted for a high percentage of cases mostly as skin rashes and fairly severe reactions were common. Patients on anti-tuberculous and anti-convulsant drugs required prolonged supervision for late onset reactions.
authors.affiliation: Department of Pediatrics, T.N. Medical College, Bombay.
authors.forename: V R
authors.initials: VR
authors.lastname: Dharnidharka
authors.forename: P N
authors.initials: PN
authors.lastname: Kandoth
authors.forename: R K
authors.initials: RK
authors.lastname: Anand
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000465:Algorithms; D015984:Causality; D002648:Child; D002675:Child, Preschool; D004342:Drug Hypersensitivity / Q000453:epidemiology* / Q000209:etiology; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D007297:Inpatients; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies