Introduction Pharmacovigilance programs protect patient health and safety by identifying
adverse event signals through postmarketing surveillance of claims data and spontaneous …

Background Electronic reporting and processing of suspected adverse drug reactions
(ADRs) is increasing and has facilitated automated screening procedures. It is crucial for …

Background The growing interest in using electronic healthcare record (EHR) databases for
drug safety surveillance has spurred development of new methodologies for signal …

Background Pharmacovigilance signal detection largely relies on individual case reports,
but longitudinal health data are being explored as complementary information sources …

The safety profile of a drug evolves over its lifetime on the market; there are bound to be
changes in the circumstances of a drug's clinical use which may give rise to previously …

Purpose Data mining on electronic health records (EHRs) has emerged as a promising
complementary method for post‐marketing drug safety surveillance. The EU‐ADR project …

ABSTRACT Purpose The Food and Drug Administration (FDA) conducted a quality
assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) …

Objective Medication safety requires that each drug be monitored throughout its market life
as early detection of adverse drug reactions (ADRs) can lead to alerts that prevent patient …

Objective: It is vital to detect the full safety profile of a drug throughout its market life. Current
pharmacovigilance systems still have substantial limitations, however. The objective of our …

Large-scale drug safety surveillance and pharmacovigilance are key components of
effective drug regulation systems, clinical practice, and public health programs [1]. Although …