Darsana Suresh Kumar, P. Shobha, Messaline Sunitha

A RETROSPECTIVE ANALYSIS OF ADVERSE DRUG REACTIONS REPORTED TO AN ADVERSE DRUG MONITORING CENTRE OF PHARMACOVIGILANCE PROGRAMME OF INDIA IN A TERTIARY CARE HOSPITAL

  • General Medicine
  • General Earth and Planetary Sciences
  • General Environmental Science
  • General Medicine
  • Ocean Engineering
  • General Medicine
  • General Medicine
  • General Medicine
  • General Medicine
  • General Earth and Planetary Sciences
  • General Environmental Science
  • General Medicine
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Introduction: Pharmacovigilance plays an important role in the detection and analysis of new ADRs that occur once the drug enters the market. The objective of our study is to retrospectively analyze the adverse drug reaction (ADRs) reported to our tertiary Care Hospital over a period of six years. The ADRs were recorded in the Suspected Adverse Drug Reporting Form issued Methods: by the Indian Pharmacopoeia Commission, which was categorized as per the system affected and type of ADRs. Causality assessment, seriousness of reaction, and management were also analyzed. Results: Female patients (68%) were more affected than male patients (32%). Patients between the ages of 18- 65 most commonly experienced ADRs (65.6%). The most commonly affected organ system was skin and connective tissue (65.1%) followed by the immune system (9.9%). Amoxicillin-clavulanic acid (28) followed by tramadol (22), were the most commonly implicated drugs for causing the ADRs. The highest percentage of ADRs recorded were categorized as probable (95%). In conclusion, the skin and Conclusion: connective tissue was the most affected system followed by the immune system. The amoxicillin-clavulanic acid combination has caused maximum ADRs (28) followed by tramadol (22) and piroxicam (21). The causality analyses showed that the majority of ADRs were categorized as probable (95%). This pattern of ADRs is corresponding to results from other studies in India. These ndings can be used to improve patient's safety and health outcomes in our demographic area. However, a more stringent ADR surveillance and reporting system should be implemented to overcome the disparity between occurrence and reporting of ADRs.

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