Thesis (M.Sc.) - Cairo University - Faculty of Medicine - Department of Pharmacology

Background and aim: Pharmacovigilance is a key component of effective drug regulation systems, clinical practice and public health programs. The present work is a prospective observational study that was conducted in the intensive care unit, Kasr-Alainy, Cairo University Hospitals. Two hundred patients were included in the study and were divided into eight groups according to the main reason for admission, where group (1) cardiovascular, group (2) respiratory system diseases, group (3) neurology, group (4) gastrointeterology reasons, group (5) sepsis and septic shock, group (6) renal diseases, group (7) endocrinology and group (8) other reasons. Results: The study revealed, high incidence of MEs, unnecessary medication was the top prevalent type and majority of them was potentially significant. Acute kidney injury was most prevalent ADR followed by liver impairment, hypotension, bleeding and heparin induced thrombocytopenia. while liver impairment was most prevalent in (group 1), heparin induced thrombocytopenia in (group 3) and hypotension in (group 6), the rest of the groups followed the same distribution as total incidence. Majority of patients experienced clinically relevant adverse DDIs, few of them were classified as "Contraindicated". Top five classes of drugs with highest incidence of ADEs included; antimicrobials, cardiovascular, anti-ischemic, blood and gastrointestinal agents. Among different groups of the study the main therapeutic category showed higher incidence of ADEs.There was positive correlation between ADRs, DDIs and number of comorbidities

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