Title:Clinical Pattern and Causality Assessment of Drug-induced Cutaneous
Reactions in a Tertiary Care Hospital in India: A Prospective Study
Volume: 17
Issue: 3
Author(s): Jerin James*, Althab B. Mohamed, Fayaz S. Hussain, Jamuna Rani and Sathyanarayanan Varadarajan
Affiliation:
- Department of Pharmacology, SRM Medical College Hospital & Research Centre, SRM Institute of Science and Technology,
Chengalpattu, India
Keywords:
Adverse drug reactions, causality assessment, naranjo scale, WHO-UMC scale, pharmacovigilance, hartwig scale, polypharmacy.
Abstract:
Background: Cutaneous Adverse Drug Reactions (ADRs) are common and pose a serious
challenge to physicians, especially in cases when the patient has many comorbidities, is polypharmacy,
or self-administers over-the-counter medications.
Objective: The objective of this study is to analyze the clinical pattern and incidence of cutaneous
ADRs and perform causality assessment using the WHO-UMC scale and Naranjo’s scale. The
severity of the reactions was determined by the Hartwig scale.
Methods: This was conducted as a prospective observational study in patients admitted to SRM
Medical College, Kattankulathur, Tamil Nadu, India, between November 2016 to August 2018 after
obtaining Institutional Ethics Committee clearance of all adverse drug reactions reported at the
hospital.
Results: Of the 158 ADRs reported during the time period, 101 were cutaneous ADRs, of which
the most common presentation was maculopapular rash (n=42; 41.58%). The most common drugs
which produced cutaneous adverse reactions were antimicrobials (n=58; 57.42%) followed by
NSAIDs (n=35; 34.6%). The causality assessment as per the Naranjo scale yielded 3.96% (4) cases
as definite, 81.18% (82) as probable, and 14.85% (15) as possible, whereas the WHO scale yielded
9 (89.10%) certain, 64 (63.36%) probable and 28 (27.72%) possible cases. The severity of the cases
determined as per the Hartwig scale yielded 82.17% cases as mild and 17.82% as moderate.
Conclusion: It is important to recognise the ADRs at the right time and exert caution in future use.
This can minimise harm to the patient both physically and financially and improve the outcome of
the treatment.
