Background: Spontaneous Reporting Systems [SRS] are critical tools in the post-licensure evaluation of medical product safety. Regulatory authorities use a variety of data mining techniques to detect potential safety signals in SRS databases. Assessing the performance of such signal detection procedures requires simulated SRS databases, but simulation strategies proposed to date each have limit...

Efficiently mining multiple drug interactions and reactions from Adverse Event Reporting System (AERS) is a challenging problem which has not been sufficiently addressed by existing methods. To tackle this challenge, we propose a FCI-fliter approach which leverages the efforts of UMLS mapping, frequent closed itemset mining, and uninformative association identification and removal. By applying ...

BACKGROUND Many illnesses demonstrate seasonal and geographic variations. Pharmacovigilance is unique among public health surveillance systems in terms of the clinical diversity of the events under surveillance. Since many pharmacovigilance signal detection methodologies are geared towards looking for increased frequency of spontaneous adverse drug event (ADE) reporting over variable time frame...

Most drugs are used in a larger and more heterogenous population after they are brought to market than initially was evaluated in preapproval trials. Postmarketing pharmacovigilance provides data that enhance the rational and safe use of medications. In particular, the safety profile of drugs is dynamic; new information is continually assessed regarding use and outcomes. Among postmarketing sur...

AIMS To evaluate the pitfalls of incident reporting in a complex medical environment. METHODS Retrospective review of 211 incident reports in a paediatric cardiac intensive care unit (CICU). Two adverse event reporting databases were compared: database A (DA), the hospital's official reporting system, is non-anonymous and reports are predominantly made by nurses; database B (DB) is anonymous ...

Regulatory and ethical guidelines require clinical trial sponsors to disseminate clinical trial adverse event reports to involved investigators and human research ethics committees. Compliance with these guidelines has resulted in a major administrative burden for ethics committees. This burden does not necessarily contribute to the protection of clinical trial participants. Rationalisation of ...

OBJECTIVE (1) Become familiar with reported adverse events related to balloon dilation of the paranasal sinus ostia. (2) Understand the sequelae occurring with these events. STUDY DESIGN Retrospective analysis of a prospective database. SETTING OpenFDA database. SUBJECTS AND METHODS The OpenFDA program website of the Food and Drug Administration was queried with the Application Program In...

The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, rep...