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%). CONCLUSIONS: Most common serious ADRs reported were Rash and Steven Johnson Syndrome (31.18%).