Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

• Main Author: Cosimo Antonazzo, Ippazio (auth)
• Other Authors: Salvo, Francesco (auth), Raschi, Emanuel (auth), Pariente, Antoine (auth), Moretti, Ugo (auth), Poluzzi, Elisabetta (auth), De Ponti, Fabrizio (auth)
• Format: Electronic Book Chapter
• Language: English
• Published: InTechOpen 2019
• Subjects: Public health & preventive medicine; pharmacovigilance, signal, spontaneous reporting system, disproportionality analysis
• Online Access: OAPEN Library: download the publication; OAPEN Library: description of the publication

This chapter aims to describe current and emerging roles of spontaneous reporting systems (SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the near future, which entails the so-called era of Big Data, keeping in mind both regulator and researcher viewpoints. After a panorama on key data sources and analyses of post-marketing data of adverse drug reactions, a critical appraisal of methodological issues and debated future applications of SRSs will be presented, including the exploitation and challenges in evidence integration (i.e., merging and combining heterogeneous sources of data into a unique indicator of risk) and patient's reporting via social media. Finally, a call for a responsible use of these studies is offered, with a proposal on a set of minimum requirements to assess the quality of disproportionality analysis in terms of study conception, performing and reporting.