A surveillance study of cutaneous adverse drug reactions in a tertiary care teaching hospital in India

Vandana Badar, Vidisha Vivek Parulekar, Priti Garate


Background: Skin is one of the most common targets of adverse drug reactions (ADRs) The practice of pharmacovigilance all over the world is 5% whereas in India, it is below 1%. Hence, the purpose of our study is to monitor and analyze the suspected cutaneous adverse drug reactions (ACDRs) reported at our tertiary care teaching hospital, to characterize the nature and predictability, severity and preventability of ACDRs and identify most common drugs causing cutaneous ACDRs so that they can be given cautiously and with keen surveillance.

Methods: An observational study was conducted in patients attending outpatient and inpatient department for a period of 3 years. All ACDRs of patients were referred by health care professionals and the diagnosis were made by concern doctors. The recorded data was filled in the ADR form obtained from pharmacovigilance program of India (2011) and Central Drug Standard Control Organization (CDSCO) website.

Results: Out of 1399 ADR reports analyzed, 564 reports (40.31%) were of ACDRs, female to male ratio was 0.85. Redness (44.32%) was most common symptom, followed by itching (44.14%) and rash (19.14%). Antimicrobials (43.97%), NSAIDS (21.63%), Anti-retroviral therapy drugs (13.65%) were common groups. As per WHO-UMC causality classification, modified Hartwig and Siegel severity scale, Thornton and Schumock preventability scale, ACDRs were probable, mild and possibly preventable respectively.

Conclusions: Effective ADR monitoring plays a role in safety of medicines. So, awareness regarding early diagnosis and prompt treatment should be created among the health care professionals and reporting of ACDRs should be regularly practiced by all the departments.


Cutaneous adverse drug reactions, Modified Hartwig severity scale, Thornton-Schumock preventability scale, WHO-UMC causality classification

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