Spontaneous Adverse drug event reports to the Adverse Drug Event Manager (ADEM)
نویسندگان
چکیده
منابع مشابه
An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.
INTRODUCTION Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health ...
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BACKGROUND Antipsychotics are potent dopamine antagonists used to treat schizophrenia and bipolar disorder. The aim of this study was to evaluate the relationship between antipsychotic drugs and adverse hyperglycemic events using the FDA Adverse Event Reporting System (FAERS) database. In particular, we focused on adverse hyperglycemic events associated with atypical antipsychotic use, which ar...
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Medication constitutes a major clinical intervention that may yield significant benefits for the patients. Yet, it can also cause considerable harm, if inappropriately used/ applied. In the US, adverse drug effects are considered as one of the 10 principal causes of death, which has been estimated to harm at least 1.5 million patients/year, with about 25% of the cases being preventable [1]. Hos...
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OBJECTIVES 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. METHODS 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. The completeness was...
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BACKGROUND The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly a...
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ژورنال
عنوان ژورنال: Clinical Therapeutics
سال: 2015
ISSN: 0149-2918
DOI: 10.1016/j.clinthera.2015.05.364