A PHARMACOVIGILANCE STUDY IN ICU PATIENTS AT DEPARTMENT OF MEDICINE IN TERTIARY CARE HOSPITAL, SGMH REWA, MP, INDIA
Pandey vivek, Raj Bhupendra*, Singh Prabhakar, Singh Amita and DubeyVandana
Pharmacovigilance is “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of pharmaceutical products. Aims & Objectives: The aims of study is to assess the frequency & pattern of ADRs and the group of drugs commonly involved to producing the suspected ADRs 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. Conclusion: In our study the majority of patients with suspected ADRs were females. 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.
Keywords: Pharmacovigilance, World Health Organization (WHO), Adverse drug reaction (ADR), Adverse drug event (ADE).
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