Comparison of Patient Adverse Drug Reaction Reporting Systems in Nine Selected Countries. [PDF]
Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems, reporting forms, awareness raising-activities, and the statistics related to patient reporting in the selected countries.
Worakunphanich W+4 more
europepmc +3 more sources
Determinants of signal selection in a spontaneous reporting system for adverse drug reactions [PDF]
Aims Detection of new adverse drug reactions (ADR) after marketing is often based on a manual review of reports sent to a Spontaneous Reporting System (SRS). Among the many potential signals that are identified, only a limited number are important enough to require further attention.
Eugène van Puijenbroek+4 more
openalex +8 more sources
Completeness of adverse drug reactions reports of the Saudi adverse event reporting system
To assess completeness of reports in the Saudi Adverse Event Reporting System (SAERS), which is a part of the Saudi Food and Drug Authority pharmacovigilance system for monitoring the safety of medications.A cross-sectional study was conducted in Riyadh, Saudi Arabia using the reports that were received between December 2009 and June 2012 in the SAERS.
Thamir M. Alshammari+3 more
openalex +5 more sources
Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System [PDF]
Evidence highlights the allergenic potential of PEGylated drugs because of the production of anti-polyethylene glycol immunoglobulins. We investigated the risk of hypersensitivity reactions of PEGylated drugs using the Italian spontaneous adverse drug reaction reporting system database.We selected adverse drug reaction reports attributed to medicinal ...
Salvatore Crisafulli+11 more
openalex +4 more sources
AbstractA well‐known problem in spontaneous reporting systems (SRSs) for adverse drug reactions (ADRs) is under‐reporting, that is, the problem that not all occurrences of ADRs are reported to the SRS. We look at the question of how to draw statistical conclusions from analyses of SRS data using reporting odds ratios.
P.G.M. van der Heijden+3 more
openalex +10 more sources
Developing and Integrating an Adverse Drug Reaction Reporting System with the Hospital Information System [PDF]
We have developed an adverse drug reaction (ADR) reporting system integrating it with Hospital Information System (HIS) of the University of Tokyo Hospital. Since this system is designed with JAVA, it is portable without re-compiling to any operating systems on which JAVA virtual machines work.
Satoshi Kataoka+3 more
openalex +4 more sources
An adverse-drug-reaction-reporting system at a teaching hospital in India [PDF]
Nidhin Mohan+2 more
openalex +4 more sources
Adverse drug reactions in neonates: a brief analysis of the FDA adverse event reporting system [PDF]
IntroductionDrug trials in neonates are scarce, and the neonates may consequently be at risk of adverse drug reactions (ADRs). Spontaneous ADR reporting is an important tool for expanding the knowledge on drug safety in neonates. This study explores the quality of current neonatal ADR reports and the ADR reports of the most common drugs used in ...
Pernille Kähler Byskov+6 more
openalex +6 more sources
Awareness of Adverse Drug Reaction Reporting System in General Population [PDF]
Background: Safety of drugs has become a major issue in public healthcare. Spontaneous reporting of adverse drug reaction (ADR) is the cornerstone in management of drug safety. We aimed to investigate the awareness and knowledge of spontaneous ADR re-porting in general public of Korea.Methods: A total of 1,500 study subjects aged 19-69 years were ...
So Hyeon Ahn+4 more
openalex +4 more sources
Low awareness of adverse drug reaction reporting systems: a consumer survey [PDF]
To determine levels of public awareness of consumer adverse drug reaction (ADR) reporting systems in Australia.Cross-sectional study conducted in 2012 of residents of the Hunter Valley region of New South Wales, who participated in a computer-assisted telephone interview (CATI), and a national sample, who completed an online Pureprofile survey ...
Robertson, Jane, Newby, David A.
openaire +3 more sources