Table 4 Strengths and Limitations of Pediatric Cough and Cold Safety Surveillance System Data Sources

National Poison Data System (NPDS)

• Structured data collection forms with required fields and common product database

• National coverage

• Medical management cases including follow-up and disposition when possible, often with healthcare providers

• Timely availability of data

• Legacy data since 1983

• Not all exposures are reported

• Self-reported exposures; most from non-clinical reporters

FDA Adverse Event Reporting System (FAERS)

• Structured data collection forms

• Publicly accessible datasets

• Regulated reporting requirements

• Legacy data since 1998

• Spontaneous reports; not all cases are reported

• Changes in reporting requirements over time

• Inconsistencies in reporting practices by manufacturers

• Self-reported cases; many from non-clinical reporters

• Duplicate cases

• Incomplete reports

• Delays in public data access

English Language Medical Literature

• Peer-reviewed publication

• Detailed clinical course

• Unstructured data

• Not all cases are reported

• Reporter bias (author and journal editors determine what may be of interest to report)

Participating Manufacturer Postmarket Safety Databases

• Structured data collection forms

• Follow-up and disposition documented when possible, often with healthcare providers

• Spontaneous reports; not all cases are reported

• Self-reported cases; many from non-clinical reporters

• Inconsistencies in documentation practices by manufacturers

News/media Reports

• Often include contextual information about exposures

• Higher likelihood of detecting fatal events

• Timely reporting

• Unstructured data

• Not all cases are reported

• Reporter bias (journalist determines what is of interest to report)

• Non-clinical reporters