• Kiran Roy
  • Divya S
  • Pratibha Nadig
  • . Bhanuprakash



Objectives: To monitor and analyse the suspected adverse drug reactions (ADRs) reported at Vydehi Hospital, Bengaluru.
Methods: A prospective observational study was conducted between July 2011 and August 2012. Suspected ADR - Central Drugs Standard Control
Organization forms submitted to pharmacovigilance unit were analysed for: (1) Type of reaction, (2) severity, (3) seriousness, (4) causal relationship
with the drug using the Naranjo and World Health Organisation (WHO) - UMC causality scale, (5) predictability of ADR and (6) group of suspected
drugs associated with ADR.
Results: 45 forms out 54 were complete as per the Pharmacovigilance Programme of India, which were analysed. 44 (97.7%) of the reactions were
Type B and 1 (2.2%) Type A. 24 (53.3%) of the reactions were mild, 20 (44.4%) were moderate, and 1 (2.2%) severe. 4 (8.8%) reactions were
considered serious. As per the Naranjo causality scale, 81.8% were possibly related and 18.2% probably related. Analysis as per WHO-UMC causality
scale showed that 16.6% of the reactions were probably or likely related and 83.3% possibly related. The predictability of an ADR was assessed for
30 of the 45 reports where single drug or fixed drug combination were prescribed. 27 (90%) were considered predictable amongst them. The major
group of drugs that caused the reactions were antimicrobials. The most common ADRs in our study were cutaneous reactions. 37.7% of ADRs were
noted in patients on combination of drugs.
Conclusions: Study revealed that the reporting rate was low. Only cutaneous reactions were reported. More awareness needs to be created to address
these issues.
Keywords: Adverse drug reactions, Pharmacovigilance, WHO-UMC, Naranjo's casuality scale.



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How to Cite

Roy, K., D. S, P. Nadig, and . Bhanuprakash. “MONITORING AND ANALYSIS OF ADVERSE DRUG REACTIONS IN A PRIVATE TERTIARY CARE TEACHING HOSPITAL”. Asian Journal of Pharmaceutical and Clinical Research, vol. 8, no. 2, Mar. 2015, pp. 335-7,



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