Abstract

Pharmacovigilance, international classification of diseases and adverse reaction reporting tools used in United States of America and Europe

Author(s): Nikhil Gupta, Kavita Bahmani and Ajit Jangra

Adverse Drug Reaction (ADR) identification is the most important goal during the post marketing phase. ADR identification is needed for the surveillance of drug safety. The spontaneous reporting of ADR and using collected data related every product is used for hypothesis generation and also for validation of new approaches. In United States of America U.S Food and Drug Administration (FDA) helps to study and find the adverse drug reaction data in the system and this data is publically available. FDA Adverse Event Reporting System (FAERS) and the data available always require substantial duration before using and various strategy are applied for cleaning the data. European Union drug regulating authorities Pharmaco vigilance (Eudra Vigilance) is the European data processing network management system for reporting and studying the suspected adverse reaction during new drug development.