Development of a multivariate prediction model to identify individual case safety reports which require clinical review
Sign Up to like & getrecommendations! Published in 2022 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.5553
Abstract: The number of Individual Case Safety Reports (ICSRs) in pharmacovigilance databases are rapidly increasing worldâwide. The majority of ICSRs at the Netherlands Pharmacovigilance Centre Lareb is reviewed manually to identify potential signal triggering reports (PSTR)… read more here.
Keywords: development multivariate; safety; individual case; case safety ... See more keywords
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration
Sign Up to like & getrecommendations! Published in 2024 at "Drug Safety"
DOI: 10.1007/s40264-024-01423-7
Abstract: In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk… read more here.
Keywords: reporting disproportionality; disproportionality; safety reports; case safety ... See more keywords
Why Are We Still Creating Individual Case Safety Reports?
Sign Up to like & getrecommendations! Published in 2018 at "Clinical therapeutics"
DOI: 10.1016/j.clinthera.2018.10.012
Abstract: The history of drug safety monitoring, or pharmacovigilance, has been an interesting one. Despite many and ongoing changes, it has typically been characterized by a rather slow-moving and reactive progression. Pharmacovigilance has always lagged behind… read more here.
Keywords: creating individual; individual case; safety reports; safety ... See more keywords
Closing the Loop with Ambulatory Staff on Safety Reports.
Sign Up to like & getrecommendations! Published in 2019 at "Joint Commission journal on quality and patient safety"
DOI: 10.1016/j.jcjq.2019.09.009
Abstract: BACKGROUND A commonly cited reason among nurses and physicians for not reporting safety events is a perceived lack of feedback from management on filed safety reports. This suggests that the value of a safety reporting… read more here.
Keywords: system; safety reports; safety; feedback ... See more keywords
Semantic Encoding Algorithm for Classification and Retrieval of Aviation Safety Reports
Sign Up to like & getrecommendations! Published in 2025 at "IEEE Transactions on Automation Science and Engineering"
DOI: 10.1109/tase.2024.3359356
Abstract: Automated analysis of aviation safety reports is helpful in effectively preventing future accidents and improving emergency response capabilities. To date, there are no publicly available large-scale aviation text similarity datasets, which hinders the successful application… read more here.
Keywords: aviation; encoding algorithm; safety reports; language ... See more keywords
Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database
Sign Up to like & getrecommendations! Published in 2021 at "Cephalalgia"
DOI: 10.1177/0333102420983292
Abstract: Objective To assess the safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation. Methods Safety reports of suspected adverse drug reactions were retrieved from VigiBase as of 31 December 2019, for a case-by-case… read more here.
Keywords: pregnancy; safety reports; safety; galcanezumab fremanezumab ... See more keywords
Change in the Number of Patient Safety Reports Through a 16-Year Patient Safety Initiative: A Retrospective Study Focusing on the Incident Severity and Type in a Japanese Hospital
Sign Up to like & getrecommendations! Published in 2022 at "Risk Management and Healthcare Policy"
DOI: 10.2147/rmhp.s385453
Abstract: Purpose To describe the long-term quantitative change in the number of submissions of patient safety reports after the introduction of a patient safety reporting system, focusing on incident severity and type. Patients and Methods This… read more here.
Keywords: safety; patient safety; number; incident severity ... See more keywords
Predicting the Severity of Runway Excursions from Aviation Safety Reports
Sign Up to like & getrecommendations! Published in 2023 at "Journal of Aerospace Information Systems"
DOI: 10.2514/1.i011145
Abstract: Despite all technological advances, runway excursions (REs) remain among the most frequent aviation accidents. Several factors have been shown to contribute to RE incidents. Although different studies have addressed the prediction of REs using quantitative… read more here.
Keywords: severity runway; runway excursions; safety reports; predicting severity ... See more keywords