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.
Keywords:
Cutaneous adverse drug reactions, Cost of ADRs,
Preventability, Patient education.
