Assessment of Causality, Severity and Preventability of Class of Drugs Causing Cutaneous Adverse Drug Reaction in Tertiary Care Hospital, Bangalore; An Observational Study

Author(s)

Varghese J1, Subedi A2, Thomas SM3, Ramaiah B2, mohammed Saeed M4
1KARNATAKA COLLEGE OF PHARMACY, bangalore, India, 2KARNATAKA COLLEGE OF PHARMACY, bangalore, KA, India, 3Karnataka College of Pharmacy, Bangalore, India, 4KARNATAKA COLLEGE OF PHARMACY, Bengaluru, India

OBJECTIVES : In the period of development of new drugs every day intended with a fast and effective therapeutic action, the risk of chance of adverse drug reaction is also increasing more. The number of subjects which are involved in the clinical trial phases cannot be generalized or extrapolated to the entire population.

METHODS : 154 patients with the diagnosis of Cutaneous ADRs were included in the study in the duration of six months (September 2019- February 2020). The information such as patient’s demographic details, drug history and pattern of the drug reaction was noted. The Naranjo’s ADR probability scale was use for the assessment of the causality of the CADRs, modified Hartwieg and Siegel scale for the assessment of severity of the reaction and Schumock and Thornton scale for the assessment of preventability of the reaction.

RESULTS : Out of the 154 cases, maximum number of cases i.e. 38.03 % of the cases were seen within 24 hour of administration of drug, followed by 33.3 % of the case seen in between 1-3 days of administration of drug, 23.07 % taking more than 3 days for the cutaneous lesions to appear whereas only 5.5 % of the reaction was seen immediately after the drug administration. Maximum number of maculopapular rash was seen within 24 hour of administration followed by fixed drug eruption, itching and redness and Urticaria.

CONCLUSIONS : Cutaneous ADRs can range from mild to severe increasing the financial burden, pain and mental stress to the patient. Their knowledge is very essential for the clinicians for the early recognition or diagnosis of the CADRs so that it can be treated more efficiently and promptly and early withdrawal of the culprit drug can save the patient from the fatal consequences.

Conference/Value in Health Info

2021-11, ISPOR Europe 2021, Copenhagen, Denmark

Value in Health, Volume 24, Issue 12, S2 (December 2021)

Code

POSC13

Topic

Clinical Outcomes, Health Service Delivery & Process of Care, Organizational Practices

Topic Subcategory

Academic & Educational, Clinical Outcomes Assessment, Hospital and Clinical Practices, Pharmacist Interventions and Practices

Disease

Drugs, Generics

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