To study and report the adverse drug reactions in a tertiary care hospital in patients.
Background: Adverse drug reaction is an unwanted, undesirable effect of a medication that occurs during usual clinical use. Adverse drug reaction can effect a patient’s quality of life, often causing considerable morbidity and mortality.
Methodology: A prospective spontaneous reporting study was carried out in all departments of MNR hospital Sangareddy for a period of 6 months. Data for the study was taken from case sheets, investigation reports of patients who had experienced an adverse drug reaction, past history of medication, personal interviews with patient. For the causality assessment and severity assessment Naranjo scale, Hartwig and Siegel scale and WHO-UMC scale were used. Collected adverse drug reactions were reported in Apollo adverse drug reaction monitoring centre using WHO-UMC Vigi flow form.
Results: Out of 65 patients included for the study, 28(43.07%) were males and 37(56.92%) were females. Out of 65, more number (38) of patients who experienced adverse drug reactions were within the age group of 30-60 years. During the period of study Antibiotics -11(16.92%) caused more adverse drug reactions. Out of different departments, in general medicine - 36 (55.3%), more adverse drug reactions were detected. During the study the most occurring adverse drug reaction was vomiting - 9(18.8%). Based on the causality assessment most of the cases were Probable according to Naranjo scale and Possible according to WHO- UMC scale. Severity assessment showed Moderate according to modified Hartwig and siegel scale.
Conclusion: This study suggests that there is a need of spontaneous ADR reporting from all the departments of this tertiary care hospital for monitoring and assessment of adverse drug reactions. This study is useful as a preliminary in initiating a culture of ADR reporting among the health care professionals in hospital. In addition, clinical pharmacists should interact with health care professionals to develop and implement an ADR reporting strategy to achieveoptimal care for patients.