Study of Pharmacovigilance in the Department of Medicine in tertiary care hospital

Abstract

Objectives: This studywas to assess the clinical pattern and spectrum of ADRs reported in department of medicine, the assessment of ADRs by various scales, and to compare between patient reporting and HCP reporting of ADRs in terms of causality, severity, preventability factors and its impact on emotional, social and occupational life. Methods:Clinical evaluation and scrutiny of data was done to assess pattern, extent, severity and duration of the reactions, to detect any predisposing or underlying disease/pathological factors, and to assess any other organ/ system involvement as a part of the drug reaction. The pattern of reported ADRs was analyzed for their clinical types, and causative drugs. The causality of the reactions was assessed by WHO-UMC and Naranjo’s causality assessment scale (Annexure-5), severity of ADR using Modified Hartwig scale and preventability assessed by using Modified Schumock and Thornton scale. Regular awareness and motivational programme for the patients to report any suspected ADR to our pharmacovigilance unit was conducted.Results:Data was analyzed by using SPSS version 13 software. The data was analyzed using descriptive statistics namely mean and standard deviation for quantitative variables and the association between two different discrete variables was assessed using chi-square test. P-value was taken less than or equal to 0.05 (p≤0.05) for significant differences.Conclusion:The clinical spectrum of ADRs reported from the more common mild reactions like skin rashes, itching, nausea and vomiting to moderately severe reactions prolonging the hospital stay of the patients resulting in decrease in physical quality of life. No fatalities due to ADR were reported. The predominant causative agents were antimicrobials drugs, antiretroviral drugs, NSAIDs and antihypertensive drugs. Majority of ADRs were probable in causality assessment, moderate in severity and probably preventable. Majority of ADRs were reported by HCP ,while direct reporting of ADR by patients were negligible. Comparison of ADR reporting between HCP and patient revealed similarity in qualitative analysis in terms of presenting complaints, drug causing pattern and preventability of ADR. In contrast to HCP, patient reporting of ADR had very elaborative narration and highlighted more about emotional and occupational impact of ADR on patient’s life.