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

Abstract

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.

Pattern of adverse drug reactions reported at the adverse drug reaction monitoring centre at tertiary care teaching hospital in North India

“…More ADRs were reported from males (55.86%) in the study conducted by Badar et al which was similar to our study. 6 A higher percentage of ADRs occur in adult age group (31-45 years) in our study. Maximum numbers of ADRs were reported in the age group of 31-40 years by Badar et al 6 The department reporting maximum ADRs (63.01%) was from dermatology department in the study conducted by Lilute et al 7 In the present study also, maximum number of ADRs were reported from skin department.…”

“…6 A higher percentage of ADRs occur in adult age group (31-45 years) in our study. Maximum numbers of ADRs were reported in the age group of 31-40 years by Badar et al 6 The department reporting maximum ADRs (63.01%) was from dermatology department in the study conducted by Lilute et al 7 In the present study also, maximum number of ADRs were reported from skin department. The most common drug class causing the ADRs in our study is antimicrobials (38%).…”

“…This result is consistent with the study carried out by Badar et al in which maximum number of ADRs occurred with antimicrobials. 6 In outcomes of the reactions, most of the patients have shown recovery after the withdrawal of offending drug with the treatment of ADRs. Four fatal reactions were also noted in the study.…”

A clinical study of morphological patterns of cutaneous adverse drug reaction and its causality assessment in tertiary care hospital of central India

“…16 In oner other study it was seen that CADRs was more common with amoxicillin-clavulanic acid (18.95%), ciprofloxacin (14.91%), amoxicillin (14.11%) and others which is in accordance with our study. 17 The most common group of drugs associated with fixed drug eruption were AMAs ofloxacin, sulfamethoxazole. This is in conformity with studies done in India reports of sulfonamide being emerging as the most common cause of Fixed drug eruptions (FDE).…”