Purpose: To analyze the clinical, pharmacological and economical aspects of the cutaneous adverse drug reactions (ADRs) reported at Civil Hospital, Ahmedabad, India.
Methods: A prospective observational study over a period of one and half years (November 2006 to April 2008) was undertaken. Semi-spontaneous reporting along with a review of case record forms were used. The reports were analyzed for clinical pattern, causal drug groups, causality (WHO-UMC criteria), severity (Hartwig and Siegel scale) and preventability (modified Schumock and Thornton criteria). The cost of ADRs was calculated on the basis of hospital expenditure per patient and the amount spent by patients themselves.
Results: Out of 143 reports, chemotherapeutic agents (39 %) were the most commonly suspected drugs followed by unknown medicines (29 %). Most of the ADRs were designated as possible or probable (69 %) and moderately severe (96.5 %) in nature. However, 14 – 16 % were definitely preventable. Cost incurred by the hospital was Indian national rupees (INR) 374,255, i.e.,USD 8241. While average cost incurred by outpatients was INR 99 (USD 2.18) and that of hospitalized patients was INR 264 (USD 5.81).
Conclusion: A large number of cutaneous ADRs are due to unknown medicines. This calls for strict drug control mechanisms, patient education regarding self-medication and maintenance of prescription records. The cost associated with ADRs is high. ADR monitoring is essential to reduce patient suffering as well as to achieve the substantial savings in health care cost.