Dermatological Adverse Drug Reactions in a Tertiary Care Teaching Hospital of Punjab-A Pharmacovigilance Study

JOURNAL TITLE: AMEI's Current Trends in Diagnosis & Treatment

1. Meenakshi Gupta
2. Jaswinder Singh
3. Vikram Bhandari
4. Preet Sood
5. Deepika Tikko
6. Rahat Kumar
7. Narinder Singh
Publishing Year
Author Affiliations
    1. Department of Pharmacology, Shri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India
    1. Department of Pharmacology, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India
    1. Department of Pharmacology, Sri Guru Ram Das Institute of Medical Sciences & Research, Amritsar, Punjab, India
  • Article keywords
    Adverse drug reactions, Dermatology, Pharmacovigilance, Urticaria


    Introduction: Adverse drug reactions (ADRs) constitute a significant economic burden on society. ADRs to skin are common; however, information about their incidence, severity, and ultimate health effects is scanty. The aim of the present study was to detect, document, assess, and report the suspected ADRs in the Department of Dermatology at a tertiary care teaching hospital, Amritsar, so as to treat ADRs and also stop the indiscriminate use of drugs in clinical practice. Material and methods: A prospective study was undertaken in patients presenting with ADRs in the outpatient Department of Dermatology in the tertiary care teaching hospital, Amritsar, Punjab, from June 2015 to May 2018. The data obtained were collected, compared, and reviewed, calculating the percentage to assess their significance and evaluation. A total of 152 ADRs were detected during the study period. Results: The most common age group presenting with adverse cutaneous drug reactions (ACDRs) was 18 to 35 years (54%) and the most common ADR was urticaria (30.2%) followed by fixed drug eruptions (16.4%). The most common drugs responsible for ACDRs were non-steroidal antiinflammatory drugs (NSAIDs) and fluoroquinolones followed by systemic steroids, oral contraceptive pills, ampicillin, angiotensin converting enzyme (ACE) inhibitors, antimalarial, clofazimine, and so on. According to the WHO causality assessment, 13.0% cases were certain, 56.1% were probable, and 30.7% were possible in nature. On severity assessment by the modified Hartwig and Siegel scale, 72.3% ACDRs were mild, 25% were moderate, and 2.05% cases were of severe category. Preventability assessment by the modified Schumock and Thornton scale revealed that 69.1% ACDRs were definitely probable, 20.51% were probably preventable, and 13.8% were not preventable. Conclusion: The study findings indicate that ADR reporting helps in identifying the most common drugs associated with dermatological reactions. Thus it helps us to provide better patient treatment by the early identification and management of dermatological reactions.

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