Information about Serious ADRs Explored by Pharmacovigilance Approaches

BACKGROUND: Serious adverse events in relation to drugs may be life-threatening or fatal, may require hospitalization, can also result in significant, persistent, or permanent disability and impairment. These drug related events may also cause damage or disruption in the patient's body function/structure, affect physical activities or may result in congenital anomalies, leaving a transient or permanent affect on quality of life. In India, Pharmacovigilance Programme of India (PvPI) has a classification system for the analysis of ADRs which has been suggested based on dose relation, timing, and patient susceptibility. Despite all efforts, ADR monitoring and reporting activity is still poor in India. Data about serious ADRs is deficient so this study was planned as a preliminary initiative to contribute to PvPI.AIM: To study incidence of serious ADRs at a Tertiary care hospital.MATERIAL AND METHODS: This prospective observational study was carried out for duration of six months i.e. from July, 2014 to January, 2015 on patients admitted in a Medical College of North India. Data regarding the patient demographics and ADRs were collected by serial patient interviews in the Tertiary care Hospital collaborated by information in respective patient file. No changes in treatment decision, schedule or duration were made as part of study. The incidence rate of each ADR was calculated.RESULTS: A total of 66 serious ADRs were reported during this duration in 60 patients (27 males, 33 females). Mean age of patients was 46.90 years. ADR incidence was found to be 1.11 per patient. The average number of drugs prescribed was 1.64 per patient. The most common drug leading to Serious Adverse Drug Reaction was Phenytoin (13%) followed by Paclitaxel (10%). The most common ADR noted was Rash leading to hospitalization (31.18%) and Steven Johnson Syndrome (31.18%), followed by Fever (16.60%), Anaphylactic Reactions (5%), DRESS (5%) and Toxic epidermal necrolysis (5%). Patients suffering from serious ADRs had presented with diagnosis of seizures (20.75%) followed by ALL (7.73%).CONCLUSION: Most common serious ADRs reported were Rash and Steven Johnson Syndrome (31.18%)

Effect of Glycaemic Control on Quality of Life(HRQoL) in Diabetes

INTRODUCTION: Intensified glycaemic control is recommended in diabetes type 2 patients as it prevents or postpones chronic diabetic complications, but its effect on quality of life in the short and long term is still not clear.AIMS: To study effect of various anti diabetic treatment regimens on level of glycaemic control and Quality of life in patients of type 2 diabetes mellitus.MATERIALS AND METHOD: Patients with type 2 diabetes mellitus aged 30-70 years of either gender on oral anti-diabetic therapy for at least 1 year were enrolled. After taking written informed consent, patients were interviewed according to a pre-validated questionnaire regarding quality of life and responses along with investigations and treatment given were noted in the performa. Data obtained was analysed using percentage, mean, standard deviation and unpaired t tests.RESULTS:A total of 48 patients were enrolled. Patients were assigned to one of the three groups depending on number of anti-diabetic drugs prescribed. Fasting blood sugar was better controlled in patients taking one anti diabetic drug. Overall Quality of life was better in patients on dual drug therapy while overall impression in comparison to first visit to OPD was significantly better in patients on triple drug therapy from monotherapy and dual drug regimen patients.CONCLUSION: Overall Quality of life was better in patients on dual drug therapy while overall impression in comparison to first visit to OPD was significantly better in patients on triple drug therapy from monotherapy and dual drug regimen patients