Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety
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. Afte...
Збережено в:
| Автори: | , , , , , , |
|---|---|
| Формат: | Online |
| Мова: | Англійська |
| Опубліковано: |
InTechOpen
2021
|
| Предмети: | |
| Онлайн доступ: | ONIX_20210602_10.5772/intechopen.79986_434 |
| Теги: |
Немає тегів, Будьте першим, хто поставить тег для цього запису!
|
| _version_ | 1869526188907560960 |
|---|---|
| author | Cosimo Antonazzo, Ippazio Salvo, Francesco Raschi, Emanuel Pariente, Antoine Moretti, Ugo Poluzzi, Elisabetta De Ponti, Fabrizio |
| author_browse | Cosimo Antonazzo, Ippazio De Ponti, Fabrizio Moretti, Ugo Pariente, Antoine Poluzzi, Elisabetta Raschi, Emanuel Salvo, Francesco |
| author_facet | Cosimo Antonazzo, Ippazio Salvo, Francesco Raschi, Emanuel Pariente, Antoine Moretti, Ugo Poluzzi, Elisabetta De Ponti, Fabrizio |
| author_sort | Cosimo Antonazzo, Ippazio |
| collection | Directory of Open Access Books |
| description | 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. |
| format | Online |
| id | doab-20.500.12854ir-70277 |
| institution | Directory of Open Access Books |
| language | eng |
| publishDate | 2021 |
| publishDateRange | 2021 |
| publishDateSort | 2021 |
| publisher | InTechOpen |
| publisherStr | InTechOpen |
| record_format | ojs |
| spelling | doab-20.500.12854ir-702772025-01-15T21:22:55Z Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety Cosimo Antonazzo, Ippazio Salvo, Francesco Raschi, Emanuel Pariente, Antoine Moretti, Ugo Poluzzi, Elisabetta De Ponti, Fabrizio pharmacovigilance, signal, spontaneous reporting system, disproportionality analysis thema EDItEUR::M Medicine and Nursing::MB Medicine: general issues::MBN Public health and preventive medicine 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. 2021-02-10T12:58:18Z 2021-06-02T10:12:06Z 2019 chapter ONIX_20210602_10.5772/intechopen.79986_434 https://library.oapen.org/handle/20.500.12657/49320 https://directory.doabooks.org/handle/20.500.12854/70277 eng open access image/jpeg image/jpeg image/jpeg n/a n/a n/a https://library.oapen.org/bitstream/20.500.12657/49320/1/63595.pdf https://library.oapen.org/bitstream/20.500.12657/49320/1/63595.pdf https://library.oapen.org/bitstream/20.500.12657/49320/1/63595.pdf InTechOpen 10.5772/intechopen.79986 10.5772/intechopen.79986 035ecc65-6737-43cf-a13a-6bdf67ce01f4 open access |
| spellingShingle | pharmacovigilance, signal, spontaneous reporting system, disproportionality analysis thema EDItEUR::M Medicine and Nursing::MB Medicine: general issues::MBN Public health and preventive medicine Cosimo Antonazzo, Ippazio Salvo, Francesco Raschi, Emanuel Pariente, Antoine Moretti, Ugo Poluzzi, Elisabetta De Ponti, Fabrizio Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety |
| title | Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety |
| title_full | Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety |
| title_fullStr | Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety |
| title_full_unstemmed | Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety |
| title_short | Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety |
| title_sort | chapter evolving roles of spontaneous reporting systems to assess and monitor drug safety |
| topic | pharmacovigilance, signal, spontaneous reporting system, disproportionality analysis thema EDItEUR::M Medicine and Nursing::MB Medicine: general issues::MBN Public health and preventive medicine |
| topic_facet | pharmacovigilance, signal, spontaneous reporting system, disproportionality analysis thema EDItEUR::M Medicine and Nursing::MB Medicine: general issues::MBN Public health and preventive medicine |
| url | ONIX_20210602_10.5772/intechopen.79986_434 |
| work_keys_str_mv | AT cosimoantonazzoippazio chapterevolvingrolesofspontaneousreportingsystemstoassessandmonitordrugsafety AT salvofrancesco chapterevolvingrolesofspontaneousreportingsystemstoassessandmonitordrugsafety AT raschiemanuel chapterevolvingrolesofspontaneousreportingsystemstoassessandmonitordrugsafety AT parienteantoine chapterevolvingrolesofspontaneousreportingsystemstoassessandmonitordrugsafety AT morettiugo chapterevolvingrolesofspontaneousreportingsystemstoassessandmonitordrugsafety AT poluzzielisabetta chapterevolvingrolesofspontaneousreportingsystemstoassessandmonitordrugsafety AT depontifabrizio chapterevolvingrolesofspontaneousreportingsystemstoassessandmonitordrugsafety |