ADVERSE DRUG REACTION MONITORING AND ASSESSMENT OF CAUSALITY IN INTENSIVE CARE UNIT, IN THE DEPARTMENT OF MEDICINE AT A TERTIARY CARE HOSPITAL OF CENTRAL INDIA

Pandey Vivek, Singh Amita*, Singh Prabhakar, Raj Bhupendra and Dubey Vandana

ABSTRACT

Adverse drug reactions (ADRs) are considered as one among the leading causes of morbidity and mortality. Aims & Objectives: The aims of study are to assess the causality of suspected ADRs and their frequency & pattern in intensive care unit of medicine department. Material and Methods: This study was conducted between August 2015 to July 2016. All cases that have suspected ADRs conform to WHO definition, having of age 18 years or more were enrolled in the study. Total 164 cases with suspected ADRs were presented during study. The data were analyzed by Microsoft word - excel version 2007. All the multiple responses were presented in terms of number and percentage. Results: Total 4860 patients were admitted in medicine ICU during study period, out of which 2714 were males and 2146 were females. Maximum 49 (29.13%) patients with suspected ADRs were belong to ≥60 years of age and minimum 13 (6.08%) were belong to 30-39 years of age group. Gastrointestinal system is the most commonly (35.21%) involved organ system and nausea is most commonly (19.13%) reported ADR, followed by vomiting, diarrhea and skin rashes. Among the drug groups antimicrobials were associated with maximum (17.73%) ADRs followed by NSAIDs (9.56%), hypoglycemics (6.08%), steroids and others. The causality assessments of suspected ADRs were evaluated as 55.65% being probable, 43.04% as possible and 1.3% was evaluated as being definite. Conclusion: In our study the gastrointestinal system is the most common affected organ system; nausea is the most common ADR and antimicrobials are the drugs having highest incidence of suspected ADRs. Causality assessments ADRs were evaluated as most common (55.65%) cause was as being probable, 43.04% as possible and minimum (1.3%) was evaluated as being definite.

Keywords: Adverse drug reaction (ADR), Naranjo’s Probability Assessment Scale, Polypharmacy, WHO.