Targeted Spontaneous Reporting on Drug Safety Alerts Issued by Pharmacovigilance Programme of India: A New Origin of Pharmacovigilance in India

Abstract

However, our primary goal is to increase the safety alerts by utilizing already established AMC setup. There are some methods which are employed in the collection of ADRs, a few of which include enclosure of suspected ADR reporting form with inpatients case sheets, using social networking sites, websites, and handouts being placed. Apart from the active surveillance, passive surveillance also plays a pivotal role in present topic of interest. The objective of this study was to analyse the reporting rate of safety alerts by adopting targeted spontaneous reporting methodology, which is a complementary method to routine safety monitoring system. To implement a targeted spontaneous reporting method, initial data are required to support the study; however, in the present scenario, we considered PvPI alerts as basic data. We conducted this study to increase the reporting rate on safety alerts to establish the safety signals, and to further communicate to the national database for regulatory inventions. Hence, the information is communicated to all HCPs working at the PGIMER to pay attention during the medical care and treatment while prescribing respective medications.