Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children.

ABSTRACT:

Background

The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System.

Methods

The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure).

Results

A total of 7184 unique cases were identified from 27,5

SUBMITTER: Green JL 

PROVIDER: S-EPMC6303866 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature