PHARMACOVIGILANCE STUDY OF PATIENTS RECEIVING TREATMENT AT MEDICAL ICU OF C. U. SHAH MEDICAL COLLEGE & HOSPITAL, SURENDRANAGAR

Background: Medical Intensive Care Unit (ICU) can be a potential place for Pharmacovigilance due to high frequency of Adverse Drug Reactions (ADRs). Regular evaluation can help in understanding the pattern of ADR and reduce the incidence of it. Aims and Objectives: To evaluate incidence of ADRs in patients receiving various modes of treatment at medical ICU of our tertiary care hospital and classify them. Materials and Methods: Study was carried out by actively observing 500 patients admitted at medical ICU over a period of 18 months. Suspected ADRs were reported and classified. Association between various factors was carried out by chi square test. Results: Total 59 (11.8%) ADRs were reported. Most common was hypotension 8 (13.56%) followed by headache 7 (11.86%). Highest group responsible for ADRs was fibrinolytic drugs 14 (23.73%). Coagulation and cardiovascular systems were commonest to involve with incidence rate of 16 (27.12%) and 14 (23.73%) respectively. Commonest type was A with incidence rate of 42 (71.19%). Significant association was noted between no. of drugs and increased incidence of ADRs (X²=4.5) (p<0.05), while association was not statistically significant with age (X²=2.01) (p>0.05) and hospital stay (X²=2.98) (p>0.05). 34 (57.63%) were mild, 22 (37.29%) were moderate, while 03 (5.08%) were severe in nature. Conclusion: Hypotension and fibrinolytics were noted as most common ADR and group of drugs responsible respectively at our ICU. Incidence of ADRs was significantly increased with increased number of drugs prescribed. Active observation with Pharmacovigilance activity can evaluate incidence and pattern of ADRs in better way.