PREVALENCE AND CAUSALITY ASSESSMENT OF CUTANEOUS ADVERSE DRUGREACTIONS

  • Pharm D (Doctor of pharmacy ),Department of Pharmacy Practice MESCO College Of Pharmacy affiliated to Osmania University ,Hyderabad – 500006, Telangana, India.
  • M Pharm,(PhD).Associate professor, Department of Pharmacology,MESCO College of Pharmacy, affiliated to Osmania University ,Hyderabad – 500006, Telangana, India.
  • MBBS, MD (DVL), Assistant Professor , Department of Dermatology, Osmania General Hospital, Hyderabad – 500012 Telangana, India.
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Background: Cutaneous Adverse drug reactions (CADRs) are among the most frequent Adverse Drug Events (ADEs). Considering their impact on patient’s lives and relatively high incidence, identifying the risks and monitoring of CADRs is of great clinical significance to prevent patient from unwanted exposure to drug toxicity. Objective: To determine the prevalence of different types of CADR’s and there causal relationship with the offending drug. Material &methods: A prospective, observational and non-invasive study was carried out in Department of Dermatology at a Tertiary care hospital for duration of 6 months. Patients with 18 years or higher with visible skin lesions suspected to be drug related were included. Assessment was carried out by WHO, Naranjo’s and Hartwig and Siegel’s classification graded on a 3-point scale. Descriptive statistics were used to examine the normality of data and describe the analysis. Results: A total of 95 cases of suspected Cutaneous ADRs were recorded from a total population of 10, 000 patients, among which 90 cases were analyzed showing 34cases (37.8%) males and 56 (62.2%) females. Maximum patients belonged to the age group of 21-30 years (34.4%). The total Prevalence was found to be 0.9%, in which the highest Prevalence was seen in females(0.56%).The most common CADR observed was Steroid induced acne (38.6%) and most common group of offending drugs were Topical corticosteroids (38.8%). According to WHO and Naranjo’s scale most of the observed cases were classify as Probable (97.8%) and as per the Hartwig and Siegel’s classification, 56 cases (62.2%) were Moderate in severity. One case (1.1%) was fatal. Conclusions: A wide range of clinical spectrum of CADRs was observed. Out of which Steroid induced acne was the most common Cutaneous ADRs seen. Topical corticosteroids were the most common offending agent with highest Prevalence in females. Most of the cases were of Probable and Moderate in severity. Fatal case was observed with Toxic epidermal necrolysis. Further identification and reporting of CADRs is essential in promoting drug safety and better patient care, among health care professionals and patients.

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[Syeda Mehmooda Batool Bushra, Safa Riyaz, Salma Tasneem, Rumana Hameed, Syeda Rana Nikhat and N.M. Prasad Naik. (2017); PREVALENCE AND CAUSALITY ASSESSMENT OF CUTANEOUS ADVERSE DRUGREACTIONS Int. J. of Adv. Res. 5 (Jan). 2336-2346] (ISSN 2320-5407). www.journalijar.com

Syeda Mehmooda Batool Bushra
Osmania University

DOI:

Article DOI: 10.21474/IJAR01/3016      
DOI URL: https://dx.doi.org/10.21474/IJAR01/3016

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