Adverse drug reactions in a south Indian hospital--their severity and cost involved

Pharmacoepidemiol Drug Saf. 2003 Dec;12(8):687-92. doi: 10.1002/pds.871.


Purpose: The study was aimed to assess the pattern of occurrence of adverse drug reactions (ADRs) in the local population, severity of reported ADRs and additional financial resource utilisation associated with ADRs.

Methods: This was a prospective, spontaneous reporting study conducted over a period of 7 months by clinical pharmacists. The WHO definition of an ADR was adopted. Each ADR was assessed for its causality by using the WHO Probability Scale. The severity of each reported ADR was assessed using the criterion developed by Hartwig et al. The average cost incurred in treating the ADRs was calculated.

Results: A total of 270 suspected ADRs were reported and evaluated from 164 patients. A total of 3.7% of the hospitalised patients experienced an ADR, 0.7% of the admissions were due to ADRs and 1.8% had a fatal ADR. The gastrointestinal system (36.3%) was most commonly involved with an ADR. The drug class most commonly implicated with ADRs was cardiovascular (18.3%). Majority (47%) of the reactions were 'moderate' in severity. The total cost incurred in managing all the reported ADRs was Rs 76,564 (US$ 1595) with an average cost of Rs 690 (US$ 15) per ADR.

Conclusion: Detection and prevention of ADRs at the earliest is very important as they can cause not only morbidity and mortality but also involve high health care cost in their management. Well-trained pharmacists in the area of ADR detection, reporting and monitoring could prove as an asset in providing better patient care.

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems*
  • Aged
  • Child
  • Drug-Related Side Effects and Adverse Reactions*
  • Female
  • Hospital Mortality
  • Hospitalization / economics*
  • Humans
  • India
  • Male
  • Severity of Illness Index*