Analysis of the Adverse Drug Reactions Collected Through Active Surveillance in the Pharmacovigilance Unit of a Tertiary Care Hospital

Abstract

Objectives: The objectives of the study were to analyze the various adverse drug reactions (ADRs) collected in the Pharmacovigilance Unit of Vydehi Institute of Medical Sciences and Research Centre with respect to their causality, severity, and preventability and also to identify the various risk factors, concomitant medications, and comorbid conditions with the occurrence of these events.Methods: A prospective, non-interventional, observational, and cross-sectional study was carried out in the various clinical departments of Vydehi Institute of Medical Sciences and Research Centre from June 2014 to May 2015. The Classes of drugs, Organ system involved, Comorbid conditions associated and Concomitant drugs involved in causing ADRs were looked into. The assessment for causality and severity was determined by Naranjo and Modified Hartwig and Siegel scales, respectively. The data were compiled and subjected to descriptive statistical analysis.Results: A total of 433 patients developing ADR reports were analyzed during our study period. Of these, 53.59% were females. 75% of them were of adult age group. Antimicrobials and chemotherapy group showed the maximum ADRs. The skin and appendages (27.6%) were the most affected organ system followed by the gastrointestinal system (22.8%). Comorbid conditions were found in 76 (20.1%) reports; of which diabetes (28.9%) and hypertension (26.3%) were maximum. 74 were serious reports. Maximum reports were probable and of mild severity.Conclusion: Through active surveillance of the ADRs helps in early detection and prevention of all the possible adverse events associated with the usage of drugs and thereby provides a better health-care treatment to the patients.

Analysis of Adverse Drug Events Reported at Peripheral Adr Monitoring Centre in Gujarat

“…In this study, most of the ADRs were reported from medications given by the parenteral route followed by medications given by the oral route, which is similar to another study by sen et al [13]. Most of the ADRs were reported with an antimicrobial group of drugs in our study which is similar to studies by patil et al [8,[10][11]13]. Causality assessment using WHO UMC scale criteria [15] in this study showed that most of the reactions were of probable followed by possible.…”