Other sources of information for monitoring drug safety: Now and in the future

Abstract

The main goal of pharmacovigilance has always been considered the earliest possible identification and characterization of adverse drug reactions (ADRs), with the aim of issuing strategies to minimize as much as possible the exposure of patients to a risk that is not balanced by a major benefit. This process forces each new drug to pass through three different safety filters: preclinical studies, pre-authorization clinical trials and post-authorization studies, the latter including spontaneous reporting of ADRs and observational studies. Each of these filters has breaches that may delay the identification of risks related to the pharmacological treatment, with a consequent injury that accumulates overtime to such an extent to involve millions of people.