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

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

  Strengths Limitations
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