An observational study to assess the possibility of patient participation in implementing pharmacovigilance in a busy tertiary care hospital

Abstract

BackgroundAdverse drug reactions are an important cause of morbidity and mortality worldwide. Monitoring adverse drug reaction is the primary function of Pharmacovigilance Programme of India (PvPI). The national program at the inception allowed only physicians, nurses, and pharmacists to report adverse drug reactions but has recently permitted even the consumers or patients to report. The knowledge, attitude, and practice of patients toward such a program have not been studied, and hence, the present study was conducted to assess the same. MethodsA questionnaire was prepared based on the review of literature and was filled up by the interviewer based on inputs from patients attending various outpatient departments and dispensary of a tertiary care center after obtaining informed consent. Descriptive statistical analysis was carried out, and the results are expressed in terms of means and proportions for continuous and categorical data, respectively. ResultsMajority of the patients were male (58.3%) and were using smart phones (63.9%). Most of the participants (91.6%) felt reporting adverse drug reaction is important, but only 37.7% thought of reporting the same. A very low percentage of participants (10%) were aware about the PvPI and the helpline number. ConclusionThe Indian health consumer is highly unaware about the existence of the PvPI and various tools available to report adverse drug reactions. It is the need of the hour to create awareness of the same by using the positive attitude toward the program.