PROFILE OF CUTANEOUS ADVERSE DRUG REACTIONS IN PATIENTS ATTENDING THE DERMATOLOGY OUTPATIENT DEPARTMENT OF A TERTIARY CARE HOSPITAL, GANGTOK

Karma Tenzing Bhutia; Chandrakala Sharma; Rukma lal Sharma

doi:10.22159/ajpcr.2023.v16i11.48288

Authors

Karma Tenzing Bhutia Department of Pharmacology, Sikkim Manipal Institute of Medical Sciences, Gangtok, Gangtok, Sikkim, India.
Chandrakala Sharma Department of Pharmacology, Sikkim Manipal Institute of Medical Sciences, Gangtok, Sikkim, India. https://orcid.org/0009-0007-4703-4864
Rukma lal Sharma Department of Dermatology, Central Referral Hospital, Gangtok, India.

DOI:

https://doi.org/10.22159/ajpcr.2023.v16i11.48288

Keywords:

Cutaneous adverse drug reactions (CADRs), erythematous rash, Naranjo scale, Hartwig’s severity assessment scale

Abstract

Objectives: The present study was undertaken to evaluate the frequency of occurrence of cutaneous adverse drug reactions (ADRs) in patients attending dermatology outpatient department (OPD) and to assess causality and severity of the reported cutaneous ADRs, using different scales.

Methods: The study involved descriptive through retrospective review of patient medical records for patients who attended dermatology OPD for a period of 9 months. Patients’ records specifying with cutaneous ADRs were taken for the study.

Results: The record of 30 patients reported with cutaneous ADRs with certain exclusions was studied. Higher incidence was found among females with 20–40 years of age. The most common presenting symptom was found to be erythematous rash (33%) and the drug groups involved in reactions were NSAIDS, beta-lactams, antitubercular drugs, and antifungals (16.7% each). The most common drug associated with cutaneous ADRs (CADRs) was itraconazole and aceclofenac (16.7% each). On the Naranjo scale, 86% reactions were labeled as “possible” while others as “doubtful”. All the reactions were labeled as mild on Hartwig’s Severity Assessment Scale.

Conclusions: Lack of post-treatment follow-up could be a reason for the difference in the causality result as compared to other studies. The data recorded in this study can be utilized as reference for future studies with large population.

Downloads

Download data is not yet available.

References

Mahapatra S, Keshri PU. Adverse cutaneous drug reactions in a tertiary care center patient: A prospective analysis. J Appl Pharm Sci 2012;2:96-8.

Gohel D, Bhatt SK, Malhotra S. Evaluation of dermatological adverse drug reaction in the outpatient department of dermatology at a tertiary care hospital. Ind J Pharm Pract 2014;7:42-9. doi: 10.5530/ijopp.7.3.9

World Health Organization. International Drug Monitoring: The Role of National Centre. Technical Report Series. Vol. 498. Geneva: World Health Organization; 1972.

Devi K, George S, Criton S, Suja V, Sridevi PK. Carbamazepine-the commonest cause of toxic epidermal necrolysis and Steven-Johnson syndrome: A study of 7 years. Indian J Dermatol Venereol Leprol 2005;71:325-8. doi: 10.4103/0378-6323.16782, PMID 16394456

Marzano AV, Borghi A, Cugno M. Adverse drug reactions and organ damage: The skin. Eur J Intern Med 2016;28:17-24. doi: 10.1016/j. ejim.2015.11.017, PMID 26674736

Riedl MA, Casillas AM. Adverse drug reactions: Types and treatment options. Am Fam Physician 2003;68:1781-90. PMID 14620598

Patel TK, Thakkar SH, Sharma D. Cutaneous adverse drug reactions in Indian population: A systematic review. Indian Dermatol Online J 2014;5(Suppl 2):S76-86. doi: 10.4103/2229-5178.146165, PMID 25593813

Pawar MP, Pore SM, Pradhan SN, Burute SR, Bhoi UY, Ramanand SJ. Nevirapine: Most common cause of cutaneous adverse drug reactions in an outpatient department of a tertiary care hospital. J Clin Diagn Res 2015;9:FC17-20. doi: 10.7860/JCDR/2015/13672.6768, PMID 26672558

Thakkar S, Patel TK, Vahora R, Bhabhor P, Patel R. Cutaneous adverse drug reactions in a tertiary care teaching hospital in India: An intensive monitoring study. Indian J Dermatol 2017;62:618-25. doi: 10.4103/ijd. IJD_703_16. PMID 29263536

Directorate of Census Operations Sikkim. District Census Handbook, Series 12. Part 12b. p. 10. Available from: https://censusindia.gov.in/2011census/dchb/1100_part_b_dchb_sikkim.pdf

Suspected Adverse Drug Reaction Reporting Form. Available from: https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/ consumer

Parvin M, Mateti UV, Noronha TM. Evaluation of adverse drug reactions in dermatology department of a charitable hospital in India. Libyan J Med Sci 2019;3:77-82. doi: 10.4103/LJMS.LJMS_62_18

Lihite RJ, Lahkar M. A study on cutaneous adverse drug reactions in ADR monitoring centre of tertiary care hospital, Guwahati. J Appl Pharm Sci 2013;3:78-81. doi:10.7324/JAPS.2013.30315

Chatterjee S, Ghosh AP, Barbhuiya J, Dey SK. Adverse cutaneous drug reaction: A one year survey at a dermatology outpatient clinic of a tertiary care hospital. Indian J Pharmacol 2006;38:429-31. doi: 10.4103/0253-7613.28212

Alomar MJ. Factors affecting the development of adverse drug reactions (Review article). Saudi Pharm J 2014;22:83-94. doi: 10.1016/j. jsps.2013.02.003, PMID 24648818

Sheth HJ, Patel RP, Chaudhary RG, Malhotra SD. Analysis of cutaneous adverse drug reactions presenting to the dermatology department of a tertiary care teaching hospital: A prospective, observational study. Int J Pharm Sci Res 2019;10:1253-8. doi: 10.13040/IJPSSR.0975-8232

Modi A, Desai M, Shah S. Shah B. Analysis of cutaneous adverse drug reactions reported at the regional ADR monitoring center. Indian J Dermatol 2019;64:250. doi: 10.4103/ijd.IJD68216

Khondker L, Khan MS. Clinical profile of cutaneous drug reactions. J Pak Assoc Dermatologist 2014;24:160-3.

Janardhan B, Shailendra D. Prevalence and pattern of adverse cutaneous drug reactions presenting to a tertiary care hospital. Int J Respir Dermatol 2017;3:74-8. doi: 10.18203/issn.2455-4529

Nandha R, Gupta A, Hashmi A. Cutaneous adverse drug reactions in a tertiary care teaching hospital: A north Indian perspective. Int J Appl Basic Med Res 2011;1:50-3. doi: 10.4103/2229-516X.81982, PMID 23776774

Al-Abadie M, Oumeish F, Al-Rubaye M, Al-Abadie D, Ball PA, Morrissey H. Drug induced dermatological reaction of the 100 most commonly prescribed medications in UK hospitals. Int J Curr Pharm Res 2019;11:54-7. doi: 10.22159/ijcpr.2019v11i5.35703

Panneerselvam N, Kadhirvelu P, Somasundaram R, Jayaprakash S. A study on cutaneous adverse drug reactions reported in a tertiary care hospital, Kanchipuram. Asian J Pharm Clin Res 2020;13:74-6. doi: 10.22159/ajpcr.2020.v13i1.36

James J, Rani J. A prospective study of adverse drug reactions in a tertiary care hospital in south India. Asian J Pharm Clin Res 2020;13:89- 92. doi: 10.22159/ajpcr.2020.v13i1.36028