A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study

Abstract

Background: An adverse drug reaction (ADRs) is determined as response to a drug that is noxious unintended excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The main aim of the study is to detect, understand and report ADR’S.Methods: This study is prospective observational study conducted for 6 months in in-patient setting in a tertiary care hospital. Naranjo’s, WHO causality scale, Siegel scale, Schumock and Thornton scale are used to assess ADR. Graph Pad Prism and SAS software’s are used.Results: Data was collected from a total of 1000 patients of which 121 (12.1%) patients were effected with 150 ADRs. Among 121 patients AdrAd was 60.66% and AdrIn was 39.33%. Of 121 patients 97 patients with single ADR, 28 patients with 2 ADRs, 10 patients were with three ADRs. ADR onset divides acute (10%), Latent (39%) and sub-acute (51%). ADR occurred are recovered (54%), Recovering (13%). Naranjos scale interprets definite (0.9%), probable (50.9%), possible (42.97%). According to WHO scale certain (2.7%), unlikely (2.7%), possible (38.84%). Hartwig and Siegel scale results are mild (12.4%), moderate (66.12%) and severe (12.4%). Schumock and Thornton preventability results are definitely (25.45%), probably (68.18%) and not preventable (6.36%).Conclusions: Every health care professional should be aware of the Pharmacovigilance principles and also should be aware of suspected ADR reporting form of PVPI. By applying the above scales it is easy for health care professionals to assess an ADR.

A Cross-Sectional Pharmacovigilance Study on Adverse Drug Reaction in a Tertiary Care Teaching Hospital

“…According to the organ affected analysis, our studies concluded that the dermatology system was more affected by the ADRs compared to other systems, Skin rash was commonly seen in the dermatology system. Our findings were similar to the study conducted by Kalyani et al [5].…”

“…Here probable cases were more found as compared to the possible. These findings were the same as the study conducted by S. SreAkshayaKalyani et.al [5,[8][9][10][11][12].…”

“…Our study shows that the incidence rate of ADRs was found to be more for females when compared to males [5]. Our studies also show that older adults between the ages of 46-60 years were found to have a higher frequency of occurring ADRs followed by children, adults, and young adults, respectively.…”

“…Both studies concluded that the numbers of recovered cases were found more [7]. According to S. SreAkshayaKalyani et.al., ADR that occurred after hospitalization was more compared to the ADRs that lead to hospitalization [5]. But according to our study the ADR that occurred after hospitalization and ADR that lead to hospitalization are the same.…”

“…According to our study, the incidence rate was found to be 0.13. It may differ across the hospitals, state, and country [4,5].…”