Review of National Spontaneous Reporting Schemes

2002 ◽  
Vol 21 (4) ◽  
pp. 231-241 ◽  
Author(s):  
M. Louise Hughes ◽  
Cate M. C. Whittlesea ◽  
David K. Luscombe
Keyword(s):  
Spontaneous Reporting

Knowledge, Attitudes, and Practices of Pharmacovigilance and ADRs Spontaneous Reporting Among Pediatricians and Pediatric Residents in Jordan

2018 ◽  
Vol 13 (1) ◽  
pp. 45-54 ◽  
Author(s):  
Tareq L. Mukattash ◽  
Maysaa W. Alwadi ◽  
Rana K. Abu-Farha ◽  
Anan S. Jarab ◽  
Sameh A. Al-Zubiedi ◽  
...  
Keyword(s):  
Spontaneous Reporting ◽  
Pediatric Residents ◽  
Attitudes And Practices ◽  
Knowledge Attitudes And Practices

Adverse drug reactions with oral anticoagulants: data from sicilian spontaneous reporting system database

2021 ◽  
Author(s):  
Maria Antonietta Barbieri ◽  
Paola Maria Cutroneo ◽  
Chiara Baratelli ◽  
Giuseppe Cicala ◽  
Alessandro Battaglia ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Reporting System ◽  
Spontaneous Reporting System ◽  
Oral Anticoagulants ◽  
Drug Reactions ◽  
System Database

scholarly journals Detection of dechallenge in spontaneous reporting systems: A comparison of Bayes methods

2014 ◽  
Vol 46 (3) ◽  
pp. 277 ◽  
Author(s):  
ABazila Banu ◽  
SAppavu Alias Balamurugan ◽  
Ponniah Thirumalaikolundusubramanian
Keyword(s):  
Spontaneous Reporting ◽  
Bayes Methods ◽  
Reporting Systems

A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions

2002 ◽  
Vol 11 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Eug�ne P. van Puijenbroek ◽  
Andrew Bate ◽  
Hubert G. M. Leufkens ◽  
Marie Lindquist ◽  
Roland Orre ◽  
...  
Keyword(s):  
Signal Detection ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Drug Reactions ◽  
Reporting Systems

Medication errors associated with oral administration of methotrexate. Data from spontaneous reporting and medical literature review

2017 ◽  
Vol 148 (7) ◽  
pp. 330-332
Author(s):  
M. Esther Salgueiro-Vázquez ◽  
María Sáinz Gil ◽  
Silvia Fernández Peña ◽  
Luis H. Martín Arias
Keyword(s):  
Literature Review ◽  
Oral Administration ◽  
Medication Errors ◽  
Spontaneous Reporting ◽  
Medical Literature

Adverse Drug Reactions to acetaminophen and ibuprofen in the paediatric population: analysis of the Italian spontaneous reporting database

2021 ◽  
Vol 17 ◽  
Author(s):  
Valentina Pelliccia ◽  
Serena Rossi ◽  
Ilaria Zollino ◽  
Francesco Quagliarella ◽  
Giuseppe Buonocore
Keyword(s):  
Side Effects ◽  
Spontaneous Reporting ◽  
Soft Tissues ◽  
Population Analysis ◽  
Kidney Injury ◽  
Paediatric Population ◽  
Drug Reactions ◽  
Spontaneous Reporting Database ◽  
Drug Agency ◽  
Active Substances

Background: Acetaminophen and ibuprofen are the only antipyretics drugs approved in children, and are considered safe and well tolerated. However, data regarding the adverse drug reaction (ADR) profile of these drugs in children are scattered. Aim: The aim of our study is to evaluate the ADRs of acetaminophen and ibuprofen through an observational study over a period of 15 years (January 2005-April 2020). Reports of suspected ADRs to the active substances ‘acetaminophen’ and ‘ibuprofen’ are listed and accessible through the Italian spontaneous reporting database (RAM system) by AIFA (Pharmacovigilance of the Italian Drug Agency). Methods: Acetaminophen ADRs in paediatric populations were 15% of cases, with more frequent involvement of skin and soft tissue (54.36%) and gastrointestinal apparatus (44.09%); liver dysfunction accounts for 5.67%. Results: Ibuprofen paediatric ADRs were 26%: skin and soft tissues in 63.16% of cases, gastrointestinal tract in 47.75%, hematemesis and melena in 6.38%; kidney injury in 2.25% of cases. Conclusion: Children aged 2 to 11 are more frequently affected by ADRs than infants and adolescents. The risk of gastrointestinal and renal side effects is significantly higher with ibuprofen. Hepatobiliary side effects are more frequently linked to acetaminophen. Potentially fatal ADRs have been reported sporadically for both drugs.

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