Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety
| Autor: | Francesco Salvo, Ugo Moretti, Antoine Pariente, Elisabetta Poluzzi, Ippazio Cosimo Antonazzo, Emanuel Raschi, Fabrizio De Ponti |
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| Přispěvatelé: | Raschi, Emanuel, Moretti, Ugo, Salvo, Francesco, Pariente, Antoine, Cosimo Antonazzo, Ippazio, De Ponti, Fabrizio, Poluzzi, Elisabetta |
| Rok vydání: | 2019 |
| Předmět: |
Drug
medicine.medical_specialty business.industry media_common.quotation_subject InformationSystems_INFORMATIONSTORAGEANDRETRIEVAL pharmacovigilance signal spontaneous reporting system disproportionality analysis 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Spontaneous reporting Pharmacovigilance Data_FILES medicine 030212 general & internal medicine Intensive care medicine business GeneralLiterature_REFERENCE(e.g. dictionaries encyclopedias glossaries) media_common |
| Zdroj: | Pharmacovigilance |
| DOI: | 10.5772/intechopen.79986 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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