Seasonal and Geographic Variation in Adverse Event Reporting

Seasonal and Geographic Variation in Adverse Event Reporting

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...

Adverse event reporting systems and safer healthcare.

At the heart of improvement and safety in healthcare is the now-familiar tenet that was espoused decades ago by Demming and paraphrased by Berwick. Need we repeat it again? Every defect should lead to improvement processes that make care safer. It is time to deliver on the promise of reporting systems in patient safety. While it is clear that event-reporting systems are now central elements in ...

Standardizing adverse drug event reporting data

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...

The Vaccine Adverse Event Reporting System (VAERS).

Immunizations against most vaccine-preventable diseases will be needed indefinitely unless the disease is eradicated. Public acceptance of immunizations may be threatened as vaccine coverage increases and disease decreases, however, due to the increase in both causally and coincidentally related vaccine adverse events. The post-marketing surveillance for such events in the USA in response to th...

Towards an Adverse Event Reporting Ontology