CUTANEOUS ADVERSE DRUG REACTIONS AMONG PATIENTS IN DEPARTMENT OF DERMATOLOGY IN A TERTIARY CARE HOSPITAL
Main Article Content
Keywords
CADRs (Cutaneous ADRs), Causality, Preventability, Severity-Assessment, Fixed Drug Eruption (FDE)
Abstract
Skin is one of the major organ for adverse reactions. Cutaneous adverse drug reactions (CADRs) are the most common type of adverse drug reaction and the clinical presentation varies (incidence is 2-5%). They are mistaken for signs of underlying disease, resulting in unnecessary investigations and delay in treatment. The treatment of ADRs increases the costs of patient care. [1-5] So awareness about them was found to be essential for early detection and prevention. This study aimed to find the proportion of CADRs, causality, severity, preventability and drugs producing it in a tertiary care hospital.
Methods
A cross-sectional study was conducted among 160 patients attended in the outpatient department, who had a history of drug intake within a period of 1 week, in the department of Dermatology in a tertiary care hospital Kerala India. Only 40 (25%) patients had cutaneous ADRs. All the relevant information was recorded in the CDSCO[3] suspected adverse drug reaction reporting form by the Dermatologist was collected and analysed. Causality was assessed using Naranjo Algorithm.[6] Severity was assessed by Modified Hartwig and Siegel Scale.[7] The preventability was assessed using Modified Schumock and Thornton scale.[8] Data were analysed using descriptive statistics.
Results
In the present study, out of 40 patients with cutaneous ADR, the highest incidence of cutaneous ADRs was in the age group of 41 -50 years (23%), and more frequently in male patients (52.5 %). Antimicrobials were the most commonly implicated drugs (55%) followed by Non-Steroidal Anti-inflammatory drugs (NSAIDs) (28%) and anti-epileptics (5%). The most commonly observed morphological pattern was maculopapular rash (22.5%) followed by fixed drug eruptions (12.5%) and 5% had Steven Johnson Syndrome. 32.5% cases had concomitant medicines. Causality assessment was certain, probable and possible for 0%, 25% and 75% of the reactions respectively. One case was of level 5 severity, 37 cases of mild (level 2) severities and two cases of moderate (level 4) severity. 97.5 % cases were not preventable and 2.5% cases was probably preventable.
Conclusion
Antimicrobials were the culprit drugs for most of the cutaneous adverse reactions followed by NSAIDs. Identification and timely reporting of cutaneous adverse drug reactions reduces their future occurrences and encourages rational prescribing and reduces the cost of healthcare.
References
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Dr. Vinimol C.
Assistant Professor, Department of Pharmacology, Government Medical College, Thrissur, Kerala, India.
Dr. Asish R.
Associate Professor, Department of Oral Medicine and Radiology, Government Dental College, Thiruvananthapuram, Kerala, India.
Dr. Sneha Prabha M.P.
Assistant Professor, Department of Pharmacology, Government Medical College, Kollam, Kerala, India.
Dr. Lailakumari S.
Professor, Department of Dermatology, Government T.D Medical College, Alappuzha, Kerala, India.