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Adverse drug reactions in pediatrics with a study of in-hospital intensive surveillance

V R Dharnidharka1, P N Kandoth, R K Anand

  • 1Department of Pediatrics, T.N. Medical College, Bombay.

Indian Pediatrics
|June 1, 1993
PubMed

Insights

Adverse drug reactions (ADRs) in Indian children occurred at a lower frequency than in Western studies. While intensive surveillance increased ADR detection, it proved too resource-intensive for routine use.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety Surveillance
  • Clinical Toxicology

Background:

  • Adverse drug reactions (ADRs) pose a significant risk in pediatric populations.
  • Understanding ADR patterns in Indian children is crucial for public health.
  • Existing surveillance methods may not be optimal for resource-limited settings.

Purpose of the Study:

  • To prospectively investigate the incidence and characteristics of ADRs in Indian children.
  • To compare ADR rates in Indian children with Western data.
  • To evaluate the feasibility of an intensive surveillance scheme for ADR detection.

Main Methods:

  • A two-part prospective study was conducted at a teaching hospital.
  • Part 1: Intensive in-hospital surveillance (IISS) in one pediatric unit vs. a control unit over 6 months.
  • Part 2: Retrospective analysis of 40 ADR cases over 2 years.

Main Results:

  • ADR incidence was 1.73% with a 0.29% mortality rate in the monitored group.
  • ADR frequency and mortality were significantly lower than in a comparable Western study (p < 0.001).
  • Antimicrobials (especially sulfonamides) were common culprits, often causing skin rashes; anti-tuberculous and anti-convulsant drugs led to late-onset reactions.

Conclusions:

  • ADRs and associated mortality in Indian children appear lower than in Western populations.
  • Intensive surveillance (IISS) effectively increased ADR reporting but was too cumbersome for routine implementation.
  • Antimicrobials are a major cause of ADRs in this population, necessitating careful monitoring.

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