STUDY OF SUSPECTED ADVERSE DRUG REACTION AND ITS REPORTING SYSTEM
Nimmy N. John*, Annie James, Jithya Raphel, K. Sai Mounica, V Vijayasarathi
A Prospective observational study on reporting of adverse drug reaction was conducted in Navodaya medical college hospital & Research center, Raichur. The aim of the study was to detect, document, assess and report the suspected adverse drug reaction. Suspected ADRs were analyzed for causality, severity and outcome using validated scales. A total of 15 ADRs were identified during the study period of September 2017 to February 2018 of which 7(46.6%) were male and 8(53.3%) were female. Severity of ADRs were assessed using Naranjo’s causality assessment scale revealed that 9(60%) of ADRs were probable and 6(40%) ADRs were possible. The systems affected were dermatological 9(60%), gastro intestinal 2(13.3%), central nervous and cardiovascular 1(6.66%) each and others 2(13.3%). Drugs that are suspected to cause ADRs were beta lactam antibiotics 6(40%), analgesics 3(20%), antihypertensive 2(13.33%), anti-tuberculoid 2(13.33%), aminoglycoside antibiotics 1(7%) and antidepressants 1(7%). Severity of ADRs were assessed and found that 6(40%) mild, 3(20%) moderate, 6(40%) severe. Outcome of ADRs were assessed of which 7(46.6%) recovered and 8(53.3%) were recovering. Our study concludes that ADRs are significant problem in hospital in-patients contributing to morbidity and resulting in considerable financial burden.
Keywords: Adverse drug reactions, drugs, Naranjo’s causality assessment scale, severity, systems affected.
[Full Text Article]