Adverse Cutaneous Drug Reactions at a Rural-Based Tertiary Health-Care Center in Gujarat: An Eleven Year Study

Area of Science:

• Dermatology
• Pharmacovigilance
• Clinical Medicine

Background:

• Adverse cutaneous drug reactions (ACDR) represent significant undesirable changes in skin, appendages, or mucous membranes induced by medications.
• Understanding ACDR is crucial for patient safety and effective pharmacovigilance.

Purpose of the Study:

• To investigate the demographic profiles of patients experiencing ACDR.
• To characterize the clinical presentations, mucocutaneous involvement, and causative agents of ACDR.
• To assess the causality of drug reactions using established scoring systems.

Main Methods:

• An observational study of 728 ACDR cases diagnosed between April 2010 and March 2021 at a rural tertiary healthcare hospital.
• Utilized causality assessment tools including WHO-UMC criteria, Naranjo probability scale, and Hartwig score.
• Data collected on patient demographics, clinical patterns, and offending drugs.

Main Results:

• The most affected age group was 21-30 years, with erythematous rash being the commonest complaint.
• Antimicrobials were identified as the most frequent causative drug group (47.39%).
• Oral mucosa was the most commonly involved site, and maculopapular rash was the predominant reaction pattern.

Conclusions:

• A broad spectrum of adverse cutaneous drug reactions was observed in the study population.
• Antimicrobial agents are the leading cause of ACDR, necessitating careful prescribing and monitoring.