When to publish measures of disproportionality derived from spontaneous reporting databases?
نویسندگان
چکیده
منابع مشابه
Performance of Stratified and Subgrouped Disproportionality Analyses in Spontaneous Databases.
INTRODUCTION Disproportionality analyses are used in many organisations to identify adverse drug reactions (ADRs) from spontaneous report data. Reporting patterns vary over time, with patient demographics, and between different geographical regions, and therefore subgroup analyses or adjustment by stratification may be beneficial. OBJECTIVE The objective of this study was to evaluate the perf...
متن کاملEstimating time-to-onset of adverse drug reactions from spontaneous reporting databases
BACKGROUND Analyzing time-to-onset of adverse drug reactions from treatment exposure contributes to meeting pharmacovigilance objectives, i.e. identification and prevention. Post-marketing data are available from reporting systems. Times-to-onset from such databases are right-truncated because some patients who were exposed to the drug and who will eventually develop the adverse drug reaction m...
متن کاملRisk of Myopathy Associated With DPP-4 Inhibitors in Combination With Statins: A Disproportionality Analysis Using Data From the WHO and French Spontaneous Reporting Databases.
Recently, a pharmacovigilance safety warning was released by the European Medicines Agency concerning the risk of myopathy and rhabdomyolysis associated with the use of dipeptidyl peptidase 4 (DPP-4) inhibitors (1,2). The warning was based on several cases in which DPP-4 inhibitors were used in association with statins; a drug-drug interaction was suggested (3). As statin use is likely to be co...
متن کاملUsing reporting guidelines to publish paediatric research.
Many medicines and devices used for the healthcare of children are unlicensed and untested for use in paediatrics, and clinicians often have to rely on evidence in adults that may not be generalisable to children. 2 There are a number of reasons why evidence in adults cannot always be safely extrapolated to children, including different pharmacokinetic and pharmacodynamic processes, and drug sa...
متن کاملUse of Measures of Disproportionality in Pharmacovigilance
Spontaneous reporting systems for suspected adverse drug reactions (ADRs) remain a cornerstone of pharmacovigilance. In The Netherlands ‘the Netherlands Pharmacovigilance Foundation Lareb’ maintains such a system. A primary aim in pharmacovigilance is the timely detection of either new ADRs or a change of the frequency of ADRs that are already known to be associated with the drugs involved, i.e...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: British Journal of Clinical Pharmacology
سال: 2011
ISSN: 0306-5251
DOI: 10.1111/j.1365-2125.2011.04087.x