Abstract

IMPORTANCE OF REPORTING ADVERSE DRUG REACTIONS AT A TERTIARY CARE HOSPITAL

Sheik-Davooth Mohammedmeeran*, Thirumalai Nambi Thothathri,
Parameswari Ramasamy and Sarojini Ramasami

ABSTRACT

AIM: To study the importance of reporting adverse drug reactions (ADRs) caused by different group of drugs in various departments of Government Rajaji Hospital, Madurai, Tamilnadu and assessing the relationship between the reactions and the drugs by using WHO Causality assessment scale (WCAS). Materials and Methods: The study involved total of 434 Individual Case Safety Reports(ICSRs) from January 2015 to November 2015, at the Department of Dermatology, Medical Oncology, General Medicine, Pediatrics, Obstetrics &Gynecology and ART centre of the hospital and were assessed by WCAS. All the ADRs were supported with relevant clinical biochemical data. Results: A total of 434 ADRs were reported in our study. Age wise analysis showed that 91% were above 16 years, 8% were between 3 to 16 years and 1% was below 3 years. Analysis of causative agents revealed that 52% of cases were reported for anti-cancer drugs; 19% for antibiotics; 5% cases for antiepileptics; 5% cases for anti-retro viral drugs; 3% for ATT drugs and the remaining 14% for miscellaneous drugs. According to the WCAS, 51% of ICSRs were possible cases and 49% were probable ICSRs. On analysis of outcome of the reactions, 274 cases were recovering; 43 cases were recovered; 104 cases were not recovering; 3 cases were fatal and 10 cases were reported as unknown cases. Conclusion: The study emphasizes the creating the culture of reporting the ADRs from all the department of hospital so as to confirm the existing ADRs and also to find out the unlisted reactions for regulatory actions.

Keywords: Adverse drug Reactions, Individual case safety reports, WHO causality assessment scale, unlisted reactions.