Volume : 2
Issue : 3
Online ISSN : 2393-9087
Print ISSN : 2393-9079
Article First Page : 169
Article End Page : 175
Drugs are approved for clinical use after passing stringent protocol of preclinical and clinical trials so that they are safe for human consumption. But they provide limited information as they are conducted under strictly controlled conditions and largely focus on efficacy evaluation and adverse drug reactions being secondary parameters assessed. Some ADR can be detected only after Long term use in a large population and in specific patient groups due to genetic variability or difference in life style and food habits, concomitant disease prevalence and medication use . We are reporting the scenario of spontaneous suspected ADRs reported at ADR Monitoring Center (AMC) of Pt JNM medical college Raipur, Chhattisgarh, India.
A retrospective, cross sectional observational study of ADRs reported spontaneously between June 2014 and May 2015 done at our AMC. The study protocol was approved from Institutional ethical committee. Odds ratio and Percentages were calculated. Of the total of 26 suspected ADRs received, 61.5% (n=16) were females. Only 11.53% (n=3) were serious. The most common ADR presented were with dermatological symptoms 65.38% (n=17) and the most common offending class of drug was of musculoskeletal class -NSAIDs -38.46% (10). 53.84 % (n=14) ADRs were possible, 26.92% (n=7) were probable, 15.38% (n=4) were certain and 3.84% (n=1) was unclassified. 57.69% (15) patients had received generic formulation and 73.07 % (n=19) ADRs were due to single drug formulation.
Measures to improve adverse drug reaction detection and reporting by all healthcare professionals should be undertaken, to ensure patient's safety.
Keywords: Adverse Drug Reaction (ADR), ADR Monitoring Center (AMC), health care professionals. National Coordinating Center – NCC, Pharmacovigilance program of India (PvPI), Central Drugs Standard control Organization (CDSCO).