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.