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J Pharmacol Pharmacother. 2012 Oct;3(4):308-13. doi: 10.4103/0976-500X.103687.

Intensive monitoring of adverse drug reactions in hospitalized patients of two medical units at a tertiary care teaching hospital.

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Department of Clinical Pharmacology, Seth G S Medical College and KEM Hospital, Mumbai, India.



To detect incidence of adverse drug reactions (ADRs) in hospitalized patients and to assess their causality, seriousness, preventability, and the possible economic impact.


This was a prospective study carried out in two medical units at a tertiary care, teaching hospital, for about 18 months. All the admitted patients who developed an ADR after admission (group A) or who were admitted primarily for the treatment of an ADR (group B) were included. Descriptive statistics with 95% CI, χ(2), χ(2) for the trend and kappa test were used.


Out of 6601 patients, 140 patients developed 154 ADRs with an incidence of 2.12%. Causality of the majority of the ADRs in group A was 'possible' while those in group B was 'probable'. Among 109 ADRs (34 serious) in group A, 38 were preventable. On the other hand, out of 45 serious ADRs in group B, 19 were preventable. The total cost of 154 ADRs in 140 patients was Rs. 1,49,803 with an average of Rs. 1070 per patient. The preventable cost for 57/154 ADR was Rs. 96,310.


Around 2% of the hospital patients develop ADRs. A large number of these ADRs were preventable. A substantial saving can be made if adequate caution is exerted.


Adverse drug reaction; economic impact; intensive monitoring; preventability

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